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INTRODUCTION: Aidi injection (Aidi), a traditional Chinese medicine injection, is often practiced to control malignant pleural effusion (MPE). OBJECTIVES: We performed a registered systematic review and meta-analysis (PROSPERO: CRD42022337611) to clarify the clinical role of Aidi in MPE, reveal optimal combinations of Aidi and chemical agents, their indications, therapeutic route and usage, and demonstrate their clinical effectiveness and safety. METHODOLOGY: All randomized controlled trials (RCTs) about Aidi in controlling MPE were collected from Chinese and English databases (up to October 2022). We clustered them into multiple homogenous regimens, evaluated the risk-of-bias at outcome level using a RoB 2, extracted and pooled the data using meta-analysis or descriptive analysis, and finally summarized their evidence quality. RESULTS: All 56 studies were clustered into intrapleural administration with Aidi alone or plus chemical agents, and intravenous administration with Aidi for MPE. Intrapleural administration with Aidi alone displayed similar clinical responses on Cisplatin (DDP) alone. Only administration with Aidi plus DDP significantly improved complete response and quality of life, and displayed a low pleurodesis failure, disease progression, hematotoxicity, gastrointestinal and hepatorenal toxicity. For patients with moderate to massive effusion, Karnofsky Performance Status score ≥ 50 or anticipated survival time ≥3 months, Aidi (50 ml to 80 ml each time, one time each week and three to eight times) plus DDP (20 to 30 mg, 40 to 50 mg, or 60 to 80 mg each time) significantly improved clinical responses. Most results had moderate to low quality. CONCLUSIONS: Current evidences indicate that Aidi, a pleurodesis agent, plays an interesting clinical role in controlling MPE. Aidi plus DDP perfusion is a most commonly used regimen, which shows a significant improvement in clinical responses. These findings also provide an indication and possible optimal usage for rational drug use.

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Introduction: The staphylococcal enterotoxin C (SEC), a commercially available bio-product from Staphylococcus aureus (S. aureus), has been widely used to control MPE. Objectives: We designed and performed a new systematic review (SR) and meta-analysis to clarify the perfusion protocols with SEC, determine their clinical effectiveness and safety, and reveal the indication and optimum usage for achieving the desired responses. Methodology: All randomized controlled trials (RCTs) about SEC for MPE were collected from electronic databases (from inception until July 2021), and clustered into multiple logical topics. After evaluating their methodological quality, we pooled the data from each topic using the meta-analysis or descriptive analysis, and summarized the evidence quality using the grading of recommendation assessment, development, and evaluation (GRADE) approach. Results: All 114 studies were clustered into SEC perfusion alone or plus chemical agents. The SEC alone showed a better complete response (CR), a lower pleurodesis failure, and adverse drug reactions (ADRs), and a higher fever than cisplatin (DDP) alone. The SEC and chemical agents developed 10 perfusion protocols. Among them, only SEC and DDP perfusion showed a better CR, a lower failure, disease progression and ADRs, and a higher fever than DDP alone. The SEC (100-200 ng per time, one time a week for one to four times) with DDP (30-40 mg, or 50-60 mg each time) significantly improved clinical responses for patients with moderate to large volume, Karnofsky performance status (KPS) scores ≥40, ≥50, or ≥60, and anticipated survival time (AST) ≥2 or 3 months. Most results were moderate to low quality. Conclusion: Current pieces of evidence indicate that super-antigen SEC is a pleurodesis agent, which provides an attractive alternative to existing palliative modalities for patients with MPE. Among 10 protocols, the SEC and DDP perfusion is a most commonly used, which shows a significant improvement in clinical responses with low ADRs. These findings also provide a possible indication and optimal usage for SEC and DDP perfusion.

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BACKGROUND: Thymic peptides (TPs) are often used to control malignant pleural effusion (MPE). So, we performed a clustered systematic review and meta-analysis to clarify the treatment regimens of TPs for MPE, demonstrate their clinical effectiveness and safety, and reveal the indications and optimal usage for a desired effectiveness. MATERIALS AND METHODS: We collected all trials of TPs for MPE from Chinese and English databases (from inception until May 2021). After evaluating their bias risk, we pooled the data from each regimen using the meta-analysis or descriptive analysis, and summarized the evidence quality using the Grading of Recommendation Assessment, Development and Evaluation approach (GRADE). RESULTS: Thirty-four trials were clustered into TPs for MPE from lung cancer or miscellaneous tumors. The TPs combined with chemical agents were mainly used in MPE from lung cancer. All five regimens, only thymosin with oxaliplatin (L-OHP) significantly improved the complete response (CR) [2.40 (1.84 to 3.13)], quality of life [2.04 (1.20 to 3.48)], 0.5- and 1-year overall survival (OS) rate [5.75 (3.02 to 10.92) and 5.29, (1.71 to 16.36)]. It also up-regulated the T lymphocyte levels, and reduced the pleurodesis failure, disease progression and adverse events. In patients with moderate to large volume, Karnofsky Performance Status score ≥ 50 or anticipated survival time ≥ 3 months, the thymosin (300 mg/time, one time/week and lasting two to eight times) with oxaliplatin (100 mg/m2) achieved a desired response. Most results were moderate quality. CONCLUSIONS: The current evidences indicate that the TPs are important pleurodesis agents, which combination with chemical agents are mainly used in MPE from lung cancer. The thymosin with L-OHP is a main regimen, which shows a significant improvement in clinical responses, antitumor immunity, and with a reasonable security. The evidence also provides indications and optimal usage for achieving a desired effectiveness.

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INTRODUCTION: A modified and recombinant human endostatin (Rh-endostatin) is often used in the control of malignant pleural effusion (MPE) through intrapleural infusion. OBJECTIVES: To demonstrate the clinical response, survival, and safety of Rh-endostatin plus chemical irritants, their optimal combinations, treatment threshold, and optimal usage, we performed a new systematic review and meta-analysis. METHODOLOGY: All randomized controlled trials (RCTs) were collected from Chinese and English electronic databases (from inception until August 2020). We pooled the data using a series of meta-analyses and summarized the evidence quality following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: We included 75 RCTs recruiting 4,678 patients, which reported six combinations for Rh-endostatin plus chemical irritants. Among the six combinations, only Rh-endostatin plus cisplatin (DDP) with enough trials might improve the complete response [2.29 (1.93, 2.71)] and quality of life [3.01 (2.49, 3.63)] and reduce treatment failure [0.29 (0.25, 0.33)] and progressive disease [0.27 (0.22, 0.34)]. It might not increase the risk of adverse drug reactions. For patients with lung cancer, moderate to massive effusion, initial treatment, Karnofsky Performance Status (KPS) score ≥60, or anticipated survival time ≥3 months, Rh-endostatin (30-45 mg each time, once or twice a week 3-4 times) plus DDP (30-60 mg/m2) obtained a significant improvement in clinical response and a reduction of failure and progressive disease. Most results had good robustness and moderate quality. CONCLUSIONS: Current evidence suggests that Rh-endostatin with DDP may be an optimal combination, which may improve clinical response and reduce failure and progressive disease with good safety. Rh-endostatin (30-40 mg each time, once or twice a week 3-4 times) with DDP (30-40 mg/m2) may be an optimal usage for achieving an ideal response.

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Introduction: Aidi injection (Aidi) is composed of cantharidin, astragaloside, ginsenoside, and elentheroside E. As an important adjuvant therapy, Aidi in combination with gemcitabine and cisplatin (GP) is often used in the treatment of non-small cell lung cancer (NSCLC). Objectives: We performed a new evaluation to demonstrate the clinical efficacy and safety of the Aidi and GP combination and further explored an optimal strategy for achieving an ideal response and safety level in advanced NSCLC. Methodology: We collected all the related trials from Chinese and English-language databases, analyzed their methodological bias risk using the Cochrane evaluation Handbook for Systematic Reviews of Interventions Version 5.1.0, extracted all the data using a predefined data extraction form, pooled the data using a series of meta-analyses, and finally summarized the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: We included 70 trials with 5,509 patients. Compared with GP alone, the Aidi and GP combination showed a significant improvement in the objective response rate (ORR) [1.82 (1.62-2.04)], disease control rate (DCR) [2.29 (1.97-2.67)], and quality of life (QOL) [3.03 (2.55-3.60)] and a low incidence of hematotoxicity and gastrointestinal and hepatorenal toxicity. Aidi might be more suitable for patients who are first-treated, elderly, or patients with a Karnofsky Performance Status (KPS) score ≥ 60 or anticipated survival time (AST) ≥3 months. An Aidi (50 ml/day, 7-14 days/cycle for one to two cycles), gemcitabine (1000 mg/m2), and cisplatin (20-30 mg/m2, 40-50 mg/m2, or 60-80 mg/m2) might be an optimal regimen for realizing an ideal response and safety level. Most results were robust and of moderate quality. Conclusion: Current evidence indicates that Aidi's value in adjuvant chemotherapy may be broad-spectrum, not just for some regimens. The Aidi and GP combination may show a good short-term response, antitumor immunity, and safety level in patients with NSCLC. Aidi (50 ml/day, 7-14 days/cycle for one and two cycles) with GEM (1000 mg/m2) and DDP (20-30 mg/m2 or 40-50 mg/m2) may be an optimal regimen for realizing an ideal goal in patients who are first-treatment, elderly, or have a KPS score ≥ 60 or AST≥3 months.

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Multidrug-resistant tuberculosis (MDR-TB) threatens global public health. Poor access to health care due to financial hardship contributes to further transmission of the disease. The study aimed to:A cross-sectional study was conducted in 2 hospitals designated for MDR-TB from January to August 2018. Data were collected by interviewing eligible MDR-TB outpatients and reviewing the medical records. The magnitude of financial burden was documented by total cost and distribution of cost components. Catastrophic payments were measured by 2 indicators: catastrophic health expenditure (CHE) and catastrophic total costs (CTC), both of which were estimated by incidence and intensity. Their associated factors were determined using logistic regression models.Of 161 households affected by MDR-TB, the average total costs due to MDR-TB treatment in the first year was US$ 8266 and consisted of 72% direct medical costs, 5% direct non-medical costs and 23% indirect costs (income loss). Thirty seven percent of direct medical costs were covered by insurance. Overall, the incidence of CHE and CTC was 68.3% and 87.0%, respectively. Both incidence and intensity for the 2 defined catastrophic costs increased when a households income decreased. Five significant factors of catastrophic costs were low household income, absence of students in a family, hospital length of stay, male gender, and job/productivity loss.Households with MDR-TB patients shouldered a high financial burden which was mainly driven by direct medical costs and income loss in Guizhou. Greater catastrophic payments were associated with hospital length of stay and socioeconomic status, especially had a dose-response relationship with households income. Our findings suggest that financial and social protection of local policies for MDR-TB should be improved by preparing a uniform and comprehensive insurance package to cover sufficiently direct medical costs, and introducing social pro-poor assistance policies for risk families to protect them from financial hardship.

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BACKGROUND: Aderivative of Shiitake mushrooms, Lentinan is used to control malignant pleural effusion (MPE) through intrathoracic infusion. PURPOSE: To determine the clinical response, survival and safety of Lentinan plus chemical irritants, and the optimal combinations with chemical irritants, indication, threshold and optimal regimen for achieving the desired responses. STUDY DESIGN: We performed a new systematic review and meta-analysis following the PRISMA guidelines. METHODS: We collected all randomized controlled trials (RCTs) regarding Lentinan plus chemical irritants from Chinese and English electronic databases (from inception until March 2019). We evaluated their bias risk, synthesized data using meta-analysis, and summarized evidence quality following the Grades of Recommendation Assessment, Development and Evaluation approach. RESULTS: We included 65 RCTs involving 4,080 patients and nine chemical irritants. Most trials had unclear bias risk. Lentinan with cisplatin significantly improved complete response [Risk ratio (RR) = 1.68, 95% confidence intervals (CI) (1.51 to 1.87), p < 0.00001, Fig.3a] and quality of life [RR = 1.51 95% CI (1.41 to 1.62), p < 0.00001, Fig.4], and decreased the risk of treatment failure, myelosuppression, gastrointestinal reaction, and chest pain. For patients with moderate to large volume of the pleural effusion, primary treatment, KPS score ≥ 50-60, or anticipated survival time ≥ 3months, Lentinan (3-4 mg/time, once a week for three to four times) withcisplatin (30-40 mg/m2 or 50-60 mg/m2) significantly improved complete response and decreased failure. Most results were robust and moderate quality. CONCLUSION: The results suggest that Lentinan with chemical irritants, especially cisplatin is beneficial to the patient with MPE, and provide evidence for the indication, threshold, and optimal regimen that may achieve success and decrease failure.

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PURPOSE: Chemotherapy-induced hepatorenal toxicity often decreases tolerance for further therapies and results in poor quality of life and prognosis for patients with lung cancer. In this meta-analysis, all related studies were systematically re-evaluated to determine whether Aidi injection relieves hepatorenal toxicity and improves tumor response, and to determine its threshold and the optimal treatment regimen for obtaining the desired responses. METHODS: All studies regarding Aidi injection with chemotherapy were gathered from Chinese and English databases (from inception until January 2019). Their bias risk was evaluated and the data were synthesized using meta-analysis; the quality of evidence of all outcomes was rated by using the Grades of Recommendation Assessment, Development, and Evaluation approach. FINDINGS: Eighty randomized controlled trials containing 6279 patients were included in the study. Most of the trials showed unclear risk of bias. Aidi injection with chemotherapy increased the objective response rate (risk ratio [RR], 1.32; 95% CI, 1.25-1.40) and the disease control rate (RR, 1.15; 95% CI, 1.12-1.17) and resulted in a lower incidence of hepatotoxicity (RR, 0.61; 95% CI, 0.55-0.69) and nephrotoxicity (RR, 0.62; 95% CI, 0.53-0.72) than that of chemotherapy alone. Subgroup analyses showed that treatment with 50 mL per time, 10 to 14 days per cycle, and 2 to 3 cycles of Aidi injection with chemotherapy resulted in a low incidence of hepatorenal toxicity. All of the results were robust, and their quality was moderate. IMPLICATIONS: The moderate evidence indicates that Aidi injection with chemotherapy may improve tumor response and result in a low incidence of hepatorenal toxicity in patients with lung cancer. Aidi injection may relieve hepatorenal toxicity and exhibit an important protective effect against chemotherapy-induced hepatorenal toxicity. Based on the subgroup analysis results, Aidi injection seems to lower the threshold for chemotherapy. Treatment with 50 mL per time, 10 to 14 days per cycle, and 2 to 3 cycles may be the optimal usage for attaining a decrease in hepatorenal toxicity.

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The Aidi injection contains multiple active ingredients, including astragaloside (Re, Rb1, and Rg1), ginsenoside, cantharidin, elentheroside E, and syringin, and it is administered with vinorelbine and cisplatin (NP) to treat non-small-cell lung carcinoma (NSCLC). In this study, we performed a systematic review and meta-analysis to determine the clinical efficacy and safety of the Aidi injection with NP, and the optimal threshold and treatment regimen to produce the desired responses. We collected all studies regarding the Aidi injection with NP for NSCLC from Chinese and English databases (up to April 2019). Risk of methodological bias was evaluated for each study. Data for analysis were extracted using a standard data extraction form. Evidence quality was assessed following the Grading of Recommendations Assessment, Development and Evaluation approach. We included 54 trials containing 4,053 patients for analysis. Combining the Aidi injection with NP significantly increased the objective response rate (odds ratio [OR], 1.32; confidence interval [CI], 1.23, 1.42), disease control rate (OR, 1.14; CI, 1.11, 1.18), and quality of life (OR, 1.80; CI, 1.61, 1.98), with decreased risks of myelosuppression, neutropenia, thrombocytopenia, anemia, gastrointestinal reaction, and liver dysfunction. For patients with a Karnofsky Performance Status score of ≥60, the Aidi injection (50 mL/day, two weeks/cycle, with two to three cycles) treatment with vinorelbine (25 mg/m2) and cisplatin (30-35 mg/m2 or 40-50 mg/m2) might be the optimal regimen for producing the desired tumor response and achieving a good safety level. Most results were robust, and their quality was moderate. The results suggest that administration of the Aidi injection and concomitant NP is beneficial to NSCLC, and provide evidence for the optimal threshold and treatment regimen that may improve tumor response with a good safety level.

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BACKGROUND: Synthetic thymic peptides (sTPs) are used with chemotherapy to treat non-small cell lung cancer (NSCLC). In this study, we have performed a systematic review and meta-analysis of published trials to confirm the clinical efficacy and safety of sTPs, and determine the optimal types, usages, and sTP/chemotherapy combinations to produce the desired responses. MATERIALS AND METHODS: We collected all studies regarding combined sTP therapy and chemotherapy for NSCLC from the Chinese and English databases (up to October 2018). Bias risk was evaluated for each. Data for meta-analysis was extracted using a pre-designed form. Evidence quality was rated using the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS: We included 27 randomized controlled trials containing 1925 patients, most with unclear bias risk. Combining sTPs with chemotherapy significantly increased the objective response rate [1.28, (1.13 to 1.45)], disease control rate [1.10, (1.01 to 1.18)], quality of life (QOL) [2.05, (1.62, 2.60)], and 1-year overall survival rate [1.43, (1.15 to 1.78)], with decreased risks of neutropenia, thrombocytopenia, and gastrointestinal reactions. Optimal conditions included treatment in combination with gemcitabine or navelbine and cisplatin, twice a week, with one 3-week cycle. In these conditions, thymosin α1 improved both antitumor immunity and tumor response. Most results had good robustness, and their quality ranged from moderate to very low. CONCLUSIONS: The results suggest that treatment with sTPs, especially thymosin α1, and concomitant chemotherapy is beneficial to the patient, and provide evidence for optimal treatment regimens that may increase patient QOL and survival.

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BACKGROUND AIMS: Cytokine-induced killer (CIK) cells are the most commonly used cellular immunotherapy for multiple tumors. To further confirm whether chemotherapy with CIK cells improves clinical effectiveness and to reveal its optimal use in non-small cell lung cancer (NSCLC), we systematically reevaluated all relevant studies. METHODS: We collected all studies about chemotherapy with CIK cells for NSCLC from the Medline, Embase, Web of Science, China National Knowledge Infrastructure Database (CNKI), Chinese Scientific Journals Full-Text Database (VIP), Wanfang Data, China Biological Medicine Database (CBM), Cochrane Central Register of Controlled Trials (CENTRAL), Chinese clinical trial registry (Chi-CTR), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and U.S. clinical trials. We evaluated their quality according to the Cochrane evaluation handbook of randomized controlled trials (RCTs) (version 5.1.0), extracted the data using a standard data extraction form, synthesized the data using meta-analysis and finally rated the evidence quality using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: Thirty-two RCTs with 2250 patients were included, and most trials had unclear risk of bias. The merged risk ratios values and their 95% confidence intervals of meta-analysis for objective response rate, disease control rate, 1- and 2-year overall survival rates, 1- and 2-year progression-free survival rates were as following: 1.45 (1.31-1.61), 1.26 (1.16-.37), 1.42 (1.23-1.63), 2.06 (1.36-3.12), 1.93 (1.38-2.69) and 3.30 (1.13-9.67). Compared with chemotherapy alone, all differences were statistically significant. CIK cells could increase the CD3+ T cells, CD3+ CD4+ T cells, NK cells and the ratio of CD4+/CD8+ T cells. The chemotherapy with CIK cells had a lower risk of hematotoxicity, gastrointestinal toxicity, liver injury and a higher fever than that of chemotherapy alone. The evidence quality was "moderate" to "very low." CONCLUSIONS: The available moderate evidences indicate that chemotherapy with CIK cells, especially autologous CIK cells, can significantly improve the tumor responses, 1- and 2-year overall and progression-free survival rates in patients with advanced NSCLC. This treatment does have a high risk of fever. The optimal use may be treatment with one or two cycles and in combination with vinorelbine and cisplatin, paclitaxel and cisplatin, or docetaxel and cisplatin.

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WHAT IS KNOWN AND OBJECTIVE: Sodium cantharidinate has been widely used in lung cancer treatment in China. To investigate whether sodium cantharidinate improves clinical effectiveness in non-small-cell lung cancer, we systematically re-evaluated all related studies. METHODS: All studies of cantharidinate for non-small-cell lung cancers (NSCLC) were selected from the MEDLINE, EMBASE, Web of Science (ISI), China National Knowledge Infrastructure Database (CNKI), Chinese Scientific Journals Full-Text Database (VIP), Wanfang, China Biological Medicine Database (CBM), Cochrane Central Register of Controlled Trials (CENTRAL), Chinese clinical trial registry (Chi-CTR), WHO International Clinical Trials Registry Platform (WHO-ICTRP) and US-clinical trials databases (established to September 2017). Their quality was evaluated using the Cochrane evaluation handbook of randomized controlled trials (RCTs) (5.1.0). The data were extracted following PICO principles and synthesized through meta-analysis. RESULTS AND DISCUSSION: We included 38 trials involving 2845 patients, but most trials had an unclear risk of bias. Sodium cantharidinate could increase the objective response rate (ORR) (1.52, (1.40-1.66]), disease control rate (DCR) (1.20, [1.16-1.25]) and quality of life (QOL) (1.76, [1.56-1.98]), but not the 1-year overall survival (OS) rate (1.16, [0.91-1.47]) and the 2-year OS rate (1.21, [0.51-2.91]). Subgroup analysis revealed that sodium cantharidinate and vitamin B6 at 0.5, 0.4 or 0.3 mg, and cantharidinate at 0.5 mg could all increase the ORR and DCR. Cantharidinate therapy had a lower risk of neutropenia (0.58, [0.50-0.67]), thrombocytopenia (0.57, [0.45-0.72]), gastrointestinal reaction (0.65, [0.52-0.82]) and nausea/vomiting (0.56, [0.41-0.76]) than that of chemotherapy alone. Sensitivity analysis showed that the results had good robustness. WHAT IS NEW AND CONCLUSION: Current evidence reveals that sodium cantharidinate can improve tumour responses and QOL with a lower risk of haematotoxicity and gastrointestinal toxicity than chemotherapy alone in NSCLC. However, the evidence does not indicate that it can improve long-term survival rates.

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ETHNOPHARMACOLOGICAL RELEVANCE: As an important Chinese herb injection, Aidi injection is composed of the extracts from Astragalus, Eleutherococcus senticosus, Ginseng, and Cantharis. Aidi injection plus paclitaxel-based chemotherapy is often used to in the treatment of non-small cell lung cancer (NSCLC) in China. AIM OF THE STUDY: The objective of this study is to further confirm whether Aidi injection can improve the tumor responses and survivals, and reveal its safety, optimal usage and combination with paclitaxel. MATERIALS AND METHODS: A meta-analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All randomized controlled trials (RCTs) concerning the Aidi injection plus paclitaxel-based chemotherapy for NSCLC were selected. Main outcomes were objective response rate (ORR), disease control rate (DCR), survivals, quality of life (QOL) and adverse drug reactions (ADRs). All data were extracted by using a standard data extraction form and synthesized through meta-analysis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for rating the quality of evidence. RESULTS: Thirty-one RCTs involving 2058 patients were included, and most trials had an unclear methodological bias risk. The risk ratio (RR) and 95% confidence intervals (CI) of ORR, DCR, QOL, neutropenia, thrombocytopenia, gastrointestinal toxicity and liver injury were as following: 1.32 (1.20-1.46), 1.14 (1.09-1.20), 1.89 (1.66-2.16), 0.61 (0.51-0.74), 0.62 (0.45-0.87), 0.59 (0.49-0.72) and 0.52 (0.36-0.75). Compared to chemotherapy alone, all differences were statistically significant. Subgroup analysis showed that only with the TP, Aidi injection could increase the ORR and DCR. Treatment with 100 ml, 80 ml or 50 ml/time, and 14 days/2 cycles or 21 days/2-4 cycles, Aidi injection could increase the ORR and DCR, respectively. Sensitivity analysis showed that the results had good robustness. None of the trials reported the overall survivals (OS), progression free survival (PFS). The quality of evidences was moderate. CONCLUSIONS: Current moderate evidence revealed that Aidi injection plus paclitaxel-based chemotherapy, especially TP can significantly improve the clinical efficacy and QOL for patients with stage III/IV NSCLC. Aidi injection can relieve the risk of hematotoxicity, gastrointestinal toxicity and liver injury in patient with NSCLC receiving paclitaxel-based chemotherapy. The optimal usage may be 50 ml/time and 14 days/2 cycles.

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BACKGROUND: Tanreqing injection (TRQ) is often used in the treatment of pulmonary infection in patients with tuberculosis (TB). But its efficacy and safety are still unclear; to further reveal its efficacy and safety, the authors systematically evaluated all relevant trials. METHODS: The authors searched published trials using the search strategy as (Tanreqing OR "Tanreqing injection") AND ("Tuberculosis" [MeSH] OR Tuberculosis OR TB) in Embase, PubMed, CNKI, VIP, Wanfang Database, CBM and CENTRAL, and ongoing trials in Chinese and U.S. clinical trials and World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) (established to January 2017). The authors evaluated the methodological bias risk of all included trials using the Cochrane evaluation handbook of randomized controlled trials (RCTs) (5.1.0), extracted data following the PICO principles, and synthesized the data using meta-analysis. RESULTS: Twenty-six RCTs involving 2404 patients were included. In TRQ alone versus antibiotics, the merged risk ratio (RR) values and their confidence interval (95% CI) of meta-analysis for overall efficacy, lesion absorption, and bacterial clearance were as follows: 1.05 (0.99-1.10), 0.98 (0.89-1.08), and 1.36 (1.09-1.70). All differences were not statistically significant. In TRQ plus antibiotics versus antibiotics, the RR values and their 95% CI of overall efficacy, lesion absorption, and bacterial clearance were as follows: 1.17 (1.10-1.25), 1.24 (1.11-1.38), and 1.61 (1.36-1.90). All differences were statistically significant. Except for the bacterial clearance, sensitivity analyses showed that the overall efficacy had good stability. CONCLUSIONS: TRQ may have the same overall efficacy as antibiotics in pulmonary infection in patients with TB. TRQ plus antibiotics may improve the clinical efficacy. TRQ may have synergistic effect to antibiotics through bacteriostatic activity and eliminating inflammatory mediators. Its antibacterial activity may be better than some antibiotics and does not increase adverse drug reaction. But all these need new evidences for further investigation.

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Background. Aidi injection is an important adjuvant anticancer drug commonly used in China. Can Aidi injection plus docetaxel-based chemotherapy improve clinical efficacy with good safety in NSCLC? To further reveal its clinical effectiveness, we systematically evaluated all the related studies. Method. We collected all the studies about Aidi injection plus docetaxel-based chemotherapy for NSCLC on Medline, Embase, Web of Science, CNKI, VIP, Wanfang, CBM, CENTRAL, Chi-CTR, and US-clinical trials. We evaluated their methodological bias risk according to the Cochrane evaluation handbook (5.1.0), extracted data following the predesigned data extraction form according to the PICO principle, and synthesized the data using meta-analysis. Results. We included 36 RCTs with 2837 patients, and most studies had unclear bias risk. The merged RR values and their 95% CI of meta-analysis for ORR, DCR, and QOL were as follows: 1.30 (1.19, 1.42), 1.17, (1.12, 1.22), and 1.73 (1.54, 1.95). The merged RR values for neutropenia, thrombocytopenia, anemia, gastrointestinal toxicity, hepatorenal dysfunctions, and alopecia were as follows: 0.70 (0.61, 0.79), 0.63 (0.53, 0.75), 0.60 (0.48, 0.75), 0.76 (0.65, 0.89), 0.56 (0.36, 0.88), and 0.58 (0.36, 0.93). Compared with chemotherapy alone, all differences were statistically significant. Subgroup analysis showed that, with 100 ml, 80-100 ml, and 50 ml, Aidi injection could increase the tumor response and Aidi injection plus DP, DC, and DO could increase the tumor response. Meta-analysis results had good stability. Conclusions. Aidi injection plus docetaxel-based chemotherapy, especially plus DP, DC, and DO, may significantly improve the clinical efficacy and QOL in NSCLC. It may also have low risk of hematotoxicity, gastrointestinal toxicity, and low risk of inducing hepatorenal dysfunctions. Aidi injection may have attenuation and synergistic efficacy to docetaxel chemotherapy. All these need to have new evidence to be proved.

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OBJECTIVE: Cytokine-induced killer cells (CIK) therapy is the most commonly used cellular immunotherapy. The CIK plus radiotherapy was clinically used in a wide range of treatment, but the efficacy of their combination against lung cancer is not clear yet. Therefore, we systematically evaluated all the related studies to reveal the combination's clinical efficacy and safety in lung cancer. MATERIALS AND METHODS: We collected all the studies about CIK plus radiotherapy for lung cancer in Medline, Embase, Web of Science (ISI), China National Knowledge Infrastructure Database (CNKI), Chinese Scientific Journals Full-Text Database (VIP), Wanfang Database, China Biological Medicine Database (CBM) and Cochrane Central Register of Controlled Trials (CENTRAL), Chinese clinical trial registry (Chi-CTR), WHO International Clinical Trials Registry Platform (WHO-ICTRP) and US-clinical trials (March 2017). We evaluated their bias risk according to the Cochrane evaluation handbook of randomized controlled trials (RCTs), extracted all the data, and synthesized the data using meta analysis. RESULTS: We included 16 RCTs involving 1197 patients with lung cancer, and most trials had unclear risk of bias. Meta-analysis showed that CIK therapy could increase the objective response rate (ORR) (1.32, 1.21 to 1.44), the disease control rate (DCR) (1.13, 1.04 to 1.23), the 1-year overall survival (OS) rate (1.38, 1.16 to 1.63) and the 2-year OS rate (1.23, 1.11 to 1.35). DCs-CIK cells increased the 3-year OS rate (1.66, 1.20 to 2.29). DCs-CIK therapy could increase the CD3+T cells (2.27, 1.47 to 3.06), CD4+T cells (1.28, 0.74 to 1.81), NK cells (2.04, 0.74 to 3.33) and CD4+/CD8+ T cells ratio (1.20, 0.64 to 1.76) and decrease the CD8+T cells (-0.84, -1.60 to -0.08). CIK plus radiotherapy had lower risk of leukopenia (0.85, 0.76 to 0.95) and higher risk of fever (5.50, 2.71 to 11.17) than that of radiotherapy alone. Subgroup analysis showed that CIK plus radiotherapy, mainly three dimensional conformal radiotherapy (3D-CRT) could increase the ORR, DCR, 1- and 2- year OS rate in non-small cell lung cancer (NSCLC), and only DCR in small cell lung cancer (SCLC). Compared with CIK plus pure radiotherapy, except for the ORR, DCR, 1-year OS rate, CIK plus chemoradiotherapy could still increase the 2-year OS rate. DCs-CIK could increase the ORR, DCR, 1- and 2-year OS rate, CIK cells could only increase the ORR and the 1-year OS rate. CONCLUSIONS: CIK plus radiotherapy can improve the clinical response, OS and PFS in lung cancer. It may have low risk of leukopenia and high risk of fever. CIK plus chemoradiotherapy, mainly 3D-CRT can improve the clinical response, OS and PFS in NSCLC. DCs-CIK cells can improve the 1-, 2- and 3-year OS rate, and the 1- and 2-year PFS rate, and CIK cells only improve the 1-year OS rate. DCs-CIK cells can repair the antitumor immunity.

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OBJECTIVES: Aidi injection can significantly improve clinical response and reduce radiochemotherapy related toxicity. Can Aidi injection improve the survival in non-small-cell lung cancer (NSCLC)? Therefore, to further reveal it, we systematically evaluated all related studies. METHODS: We collected all studies about Aidi injection for NSCLC in Medline, Embase, Web of Science(ISI), China National Knowledge Infrastructure Database(CNKI), Chinese Scientific Journals Full-Text Database(VIP), Wanfang, China Biological Medicine Database (CBM), Cochrane Central Register of Controlled Trials (CENTRAL), Chinese clinical trial registry (Chi-CTR) and WHO International Clinical Trials Registry Platform (WHO-ICTRP), and US-clinical trials (established to June 2016). We evaluated their quality according to the Cochrane evaluation handbook of randomized controlled trials (RCTs) (5.1.0), extracted data following the PICO principles, and synthesized the data by meta-analysis. RESULTS: We included 25 RCTs involving 2662 patients with NSCLC which most studies had unclear risk of bias. The merged risk ratios (RR) values and their 95% CI of meta-analysis for objective response rate (ORR) and disease control rate (DCR) were as following: 1.19(1.09-1.29) and 1.07(1.03-1.11). The merged RR values and their 95% CI of meta-analysis for the 1-, 2- and 3-year overall survival (OS) rate were as following: 1.23(1.14-1.33), 1.46(1.22-1.74) and 1.67(1.04-2.69). All differences were statistically significant. Subgroup analysis showed that Aidi injection plus different therapies had different effects on 1-, 2- and 3-year OS rate. Sensitivity analysis showed that the RR of ORR, DCR, 1- and 2- year OS rate had good stability, and 3-year OS rate had poor stability. CONCLUSIONS: Available evidences indicate that Aidi injection can significantly improve the clinical response and OS rates in patients with NSCLC and especially, the 1- and 2-year OS rate. But, Aidi injection plus different therapies had different effects on overall survival. It is still unclear whether Aidi injection can improve the PFS and HR.

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OBJECTIVE: DC-CIK therapy included DC-CIK cells and Ag-DC-CIK cells. To further confirm whether DC-CIK reconstructs the antitumor immunity and improves the tumor responses and reveals its optimal usage and combination with chemotherapy, we systematically reevaluated all the related studies. MATERIALS AND METHODS: All studies about DC-CIK plus chemotherapy for NSCLC were collected from the published and ongoing database as CBM, CNKI, VIP, Wanfang, ISI, Embase, MEDLINE, CENTRAL, WHO-ICTRP, Chi-CTR, and US clinical trials (established on June 2017). We evaluated their methodological bias risk according to the Cochrane evaluation handbook of RCTs (5.1.0), extracted data following the predesigned data extraction form, and synthesized the data using meta-analysis. RESULTS: We included 28 RCTs (phase IV) with 2242 patients, but most trials had unclear bias risk. The SMD and 95% CI of meta-analysis for CD3+ T cells, CD3+ CD4+ T cells, CD3+ CD8+ T cells, CD4+/CD8+ T cell ratio, CIK cells, NK cells, and Treg cells were as follows: 1.85 (1.39 to 2.31), 0.87 (0.65 to 1.10), 1.04 (0.58 to 1.50), 0.75 (0.27 to 1.22), 3.87 (2.48 to 5.25), 1.51 (0.99 to 2.03), and -2.31(-3.84 to -0.79). The RR and 95% CI of meta-analysis for ORR and DCR were as follows: 1.38 (1.24 to 1.54) and 1.27 (1.20 to 1.34). All differences were statistically significant between DC-CIK plus chemotherapy and chemotherapy alone. Subgroup analysis showed that only DC-CIK cells could increase the CD3+T cells, CD3+ CD4+T cells, CD3+ CD8+T cells, and CD4+/CD8+ T cell ratio. In treatment with one cycle or two cycles and combination with NP or GP, DC-CIK could increase the CD4+/CD8+ T cell ratio. All results had good stability. CONCLUSIONS: DC-CIK therapy can simultaneously improve the antitumor immunity and tumor responses. DC-CIK therapy, especially DC-CIK cells, can improve antitumor immunity through increasing the T lymphocyte subsets, CIK cell, and NK cells in peripheral blood. The one cycle to two cycles may be optimal cycle, and the NP or GP may be optimal combination.

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Gemcitabine and cisplatin is the first line chemotherapy for non-small cell lung cancer with high toxicity. Aidi injection is a cantharidin and astragalu-based Chinese herbs injection in China. Has Aidi injection attenuation and synergistic efficacy to GP in NSCLC? There is lack of strong evidence to prove it. To further reveal it, we systematically evaluated all related studies. We collected all studies about Aidi injection plus GP for NSCLC in Medline, Embase, Web of Science, CNKI, VIP, Wanfang Database, CBM, CCRCT, Chi-CTR, and US-clinical trials (established to June 2015). We evaluated their quality according to the Cochrane evaluation handbook of randomized controlled trials (5.1.0), extracted data following the PICO principles and synthesized the data by Meta analysis. Thirty six RCTs with 2582 NSCLC patients were included, with general methodological quality in most trials. The RR values and their 95% CI of Meta-analysis for ORR, DCR and QOL were as following: 1.28 (1.17, 1.39), 1.11(1.07, 1.15) and 1.81 (1.61, 2.03). The merged RD values and their 95% CI of Meta-analysis for myelosuppression, neutropenia, thrombocytopenia, neurotoxicity and nausea and vomiting were as following: -0.23(-0.29, -0.17), -0.17(-0.22, -0.11), -0.13(-0.18, -0.08), -0.06(-0.17, 0.05) and -0.15(-0.21, -0.10). To compare with GP alone, all differences were statistically significant. The available evidence indicates that Aidi injection plus GP can significantly increase the clinical efficacy and improve the QOL of patients with NSCLC. Aidi injection can reduce myelosuppression, neutropenia, thrombocytopenia neurotoxicity and nausea/vomiting. These indirectly reveal that Aidi injection has the attenuation and synergistic efficacy to GP chemotherapy in NSCLC.

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BACKGROUND: Aidi injection is an adjuvant chemotherapy drug commonly used in China. Can Aidi injection restore the cellular immunity and improve the clinical efficacy in non-small-cell lung cancer (NSCLC) patients treated with platinum-based chemotherapy? There is a lack of strong evidence to prove it. To further reveal it, we systematically evaluated all related studies. We collected all studies about the clinical efficacy and cellular immunity of Aidi injection plus platinum-based chemotherapy for NSCLC in Medline, Embase, Web of Science, China national knowledge infrastructure database (CNKI), Chinese Scientific Journals Full-Text Database (VIP), Wanfang, China biological medicine database (CBM) (established to June 2015), Cochrane Central Register of Controlled Trials (CCRCT) (June 2015), Chinese clinical trial registry, and US-clinical trials (June 2015). We evaluated their quality according to the Cochrane evaluation handbook of randomized controlled trials (RCTs) (5.1.0), extracted data following the patient intervention control group outcomes principles and synthesized the data by meta-analysis. Seventeen (RCTs) with 1390 NSCLC patients were included, with general methodological quality in most trials. The merged relative risk (RR) values and their 95% CI of meta-analysis for objective response rate (ORR) and disease control rate (DCR) were as follows: 1.26 (1.12, 1.42) and 1.11(1.04, 1.17). The merged standardized mean difference (SMD) values and their 95% CI of meta-analysis for the percentage of CD3T cells, CD4T cells, CD8T cells, natural killer (NK) cells, and CD4/CD8 T cell ratio were as follows: 1.41, (0.89, 1.92), 1.59, (1.07, 2.11), 0.85, (0.38, 1.33), 1.64 (0.89, 2.39) and 0.91, (0.58, 1.24). Compared with platinum-based chemotherapy alone, all differences were statistically significant. These results might be overestimated or underestimated. CONCLUSIONS: Aidi injection plus platinum-based chemotherapy can improve the clinical efficacy of patients with NSCLC. Aidi injection could significantly restore the cellular immunity damaged by platinum-based chemotherapy. It may be an important tumor immune modulator and protector for patients with NSCLC treated with chemotherapy.

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