RESUMO

Hemorrhoids are a common and painful condition, with conventional treatments such as endoscopic rubber band ligation (ERBL) and injection sclerotherapy often falling short due to high recurrence rates and significant post-operative pain. A clinical trial by Qu et al introduces a novel approach called endoscopic poli-docanol foam sclerobanding (EFSB). This multicenter randomized trial involved 195 patients with grade II and III internal hemorrhoids and demonstrated that EFSB significantly reduced recurrence rates and post-procedural pain while improving symptom relief and patient satisfaction compared to ERBL. The study's strengths include its robust design, comprehensive outcome evaluation, and patient-centered approach. Despite limitations such as the single-blind design and relatively short follow-up period, the findings suggest that EFSB could enhance clinical practice by offering a more effective and patient-friendly treatment option. Further research is needed to validate these results and explore the long-term benefits and cost-effectiveness of EFSB.

Assuntos

Hemorroidas , Satisfação do Paciente , Polidocanol , Soluções Esclerosantes , Escleroterapia , Humanos , Polidocanol/administração & dosagem , Polidocanol/uso terapêutico , Hemorroidas/terapia , Hemorroidas/cirurgia , Hemorroidas/diagnóstico , Escleroterapia/métodos , Escleroterapia/efeitos adversos , Soluções Esclerosantes/administração & dosagem , Soluções Esclerosantes/uso terapêutico , Resultado do Tratamento , Recidiva , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Ligadura/métodos , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/administração & dosagem , Endoscopia/métodos , Análise Custo-Benefício

RESUMO

OBJECTIVE: The prognosis of extra-nodal NK/T cell lymphoma (ENKTL) is poor, and the optimal therapy remains controversial. This study aims to evaluate the safety and efficacy of a new combined modality therapy. METHODS: Phase-2 study of pegaspargase, etoposide and gemcitabine (PEG) combined with involved field radiation therapy (IFRT) in newly-diagnosed patients with early-stage ENKTL. Patients received 4 course of PEG followed by IFRT. The primary endpoints were complete response (CR), partial response (PR), and objective response rate (ORR) after IFRT. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and adverse events. RESULTS: 34 consecutive patients with Ann Arbor stage I/II were enrolled. 3 patients progressed on PEG, while the remaining 31 received IFRT. The ORR was 88.2% (30/34), included 28 (82.4%) complete and 2 (5.8%) partial responses. With a median follow-up of 56.0 months (Interquartile Range [IQR], 36.0-66.9 months), the estimated 5-year PFS and OS were 87.4% (95% Confidence Interval [CI],69.5%-94.8%) and 97.1% (95%CI, 80.1%-99.6%), respectively. Most adverse events were hematological and easily managed. CONCLUSIONS: PEG followed by IFRT is a safe and effective initial therapy for early-stage ENKTL, demonstrating impressive PFS and OS rates. This promising approach warrants further validation in a randomized controlled trial (Registered at Clinicaltrials.gov NCT02705508).Trial registration: ClinicalTrials.gov identifier: NCT02705508.

Assuntos

Protocolos de Quimioterapia Combinada Antineoplásica , Asparaginase , Desoxicitidina , Etoposídeo , Gencitabina , Linfoma Extranodal de Células T-NK , Polietilenoglicóis , Humanos , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapêutico , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Linfoma Extranodal de Células T-NK/radioterapia , Linfoma Extranodal de Células T-NK/mortalidade , Linfoma Extranodal de Células T-NK/tratamento farmacológico , Linfoma Extranodal de Células T-NK/terapia , Masculino , Feminino , Pessoa de Meia-Idade , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/uso terapêutico , Asparaginase/administração & dosagem , Asparaginase/uso terapêutico , Asparaginase/efeitos adversos , Etoposídeo/administração & dosagem , Etoposídeo/efeitos adversos , Etoposídeo/uso terapêutico , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Idoso , Estadiamento de Neoplasias , Resultado do Tratamento

RESUMO

PURPOSE: Peginterferon alfa-2b (Peg-IFN α-2b) has demonstrated superior efficacy over nucleos(t)ide analogs (NAs) in the treatment of chronic hepatitis B (CHB), particularly among patients with low levels of hepatitis B surface antigen (HBsAg). This study aims to determine whether patients with ultra-low HBsAg levels (< 200 IU/mL) can achieve significantly higher clinical cure rates with abbreviated courses of Peg-IFN α-2b therapy. METHODS: In this retrospective analysis, CHB patients with HBsAg levels below 200 IU/mL were categorized into a Peg-IFN α-2b group and a control group. The Peg-IFN α-2b group received Peg-IFN α-2b for a minimum of 24 weeks, with the possibility of early discontinuation upon achieving HBsAg clearance, and were followed through week 48. The control group remained untreated for hepatitis B virus (HBV), and was observed for 24 weeks. HBsAg clearance rates were compared between groups. Univariate and multivariate logistic regression analyses were employed to identify factors associated with HBsAg clearance . RESULTS: By week 24, the HBsAg clearance rate in the Peg-IFN α-2b group was notably 52.1% (38/73), contrasting sharply with the mere 1.3% (1/77) observed in the control group. Within the Peg-IFN α-2b group, a substantial 97.3% (71/73) of patients noted a reduction in HBsAg levels. Besides, the decision to continue or discontinue treatment after the 24-week mark had no significant impact on the HBsAg clearance rate at week 48. Multivariable analysis pinpointed baseline HBsAg levels (OR = 0.984, p = 0.001) and the presence of fatty liver (OR = 5.960, p = 0.033) as independent predictors of HBsAg clearance. CONCLUSION: Our findings confirm that a 24-week course of Peg-IFN α-2b yields robust efficacy in CHB patients with ultra-low HBsAg levels. Prolonging treatment beyond the 24-week threshold is deemed unnecessary. Both baseline HBsAg level and the presence of fatty liver emerged as significant predictors for HBsAg clearance.

Assuntos

Antivirais , Antígenos de Superfície da Hepatite B , Hepatite B Crônica , Interferon alfa-2 , Interferon-alfa , Polietilenoglicóis , Proteínas Recombinantes , Humanos , Hepatite B Crônica/tratamento farmacológico , Estudos Retrospectivos , Proteínas Recombinantes/uso terapêutico , Proteínas Recombinantes/administração & dosagem , Masculino , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/administração & dosagem , Antígenos de Superfície da Hepatite B/sangue , Feminino , Interferon-alfa/uso terapêutico , Antivirais/uso terapêutico , Adulto , Interferon alfa-2/uso terapêutico , Interferon alfa-2/administração & dosagem , Pessoa de Meia-Idade , Resultado do Tratamento , Vírus da Hepatite B/efeitos dos fármacos , Adulto Jovem

Assuntos

Asparaginase , Dessensibilização Imunológica , Hipersensibilidade a Drogas , Polietilenoglicóis , Asparaginase/uso terapêutico , Asparaginase/efeitos adversos , Humanos , Dessensibilização Imunológica/métodos , Polietilenoglicóis/uso terapêutico , Antineoplásicos/uso terapêutico , Antineoplásicos/efeitos adversos

RESUMO

BACKGROUND: Titanium has been the conventional implant material of choice for fixation in both primary and metastatic spine tumour surgeries (MSTS). However, these implants result in artefact generation during post-operative computed tomography (CT) or magnetic resonance imaging (MRI), resulting in poor planning of radiotherapy (RT) and suboptimal tumour surveillance. Carbon fibre-reinforced polyetheretherketone (CFR-PEEK) implants have gained momentum for instrumentation in MSTS due to their radiolucent properties. This in turn does not sacrifice the biomechanical strength of the implants. In this study, we compared the peri-operative outcomes, post operative imaging artefacts and dosimetricdata of CFR-PEEK implants to titanium implants to asses for potential benefits in post-operative RT planning in patients who underwent MSTS. METHODS: This is a retrospective study involving 42 patients operated for MSTS. Patient-related data including demographics, tumour pathology, intra-operative data, functional outcome, and RT-related data were collected for both groups. All patients were followed-up post-operatively for a minimum of 2 years or until demise, whichever was earlier. RESULTS: In our study, 20 (47.6%) patients had CFR-PEEK implants, while 22 (52.4%) of patients had titanium implants used for MSTS. Both groups of patients had similar clinical outcomes for pain and overall survival predictability pre-operatively (P>0.05). Mean number of levels instrumented by titanium screws were 6.8±2.93, while for the CFR-PEEK screws were 4.07±1.05. Mean volume of artefact generated during post operative CT was 75.1±43.4 mm3 in titanium group and 13.3±14.2 mm3 in CFR-PEEK group (P=0.005). The mean time taken to contour the artefacts was 17.3±5.84 minutes in the titanium group, while the CFR-PEEK group took 9.60±7.17 minutes (P=0.049). CONCLUSIONS: Our study suggests that carbon fibre reinforced PEEK screws significantly reduce artefact generation and the time taken to contour them during post-operative RT planning, while delivering equivalent clinical and functional outcomes as compared to standard titanium implants.

Assuntos

Benzofenonas , Fibra de Carbono , Cetonas , Polietilenoglicóis , Polímeros , Próteses e Implantes , Neoplasias da Coluna Vertebral , Humanos , Estudos Retrospectivos , Masculino , Feminino , Pessoa de Meia-Idade , Polietilenoglicóis/uso terapêutico , Neoplasias da Coluna Vertebral/cirurgia , Neoplasias da Coluna Vertebral/secundário , Adulto , Idoso , Metástase Neoplásica

RESUMO

Predicting hepatitis B surface antigen (HBsAg) clearance is important for chronic hepatitis B (CHB) patients receiving pegylated interferon-alfa (Peg-IFN) therapy. We aimed to determine the predictive value of serum hepatitis B core antibody (anti-HBc) for HBsAg clearance. A total of 189 HBeAg-negative CHB patients who received Peg-IFN based therapy were retrospectively included and classified into two groups: nucleos(t)ide analogues (NAs) add-on Peg-IFN group (add-on group, n = 94) and Peg-IFN combined with NAs or Peg-IFN monotherapy group (combination or monotherapy group, n = 95). After 48 weeks of treatment, 27.5% (52/189) and 15.9% (30/189) of patients achieved HBsAg clearance and seroconversion, respectively. Patients in the combination or monotherapy group tended to achieve relatively higher HBsAg clearance (31.6% vs. 23.4%, p = 0.208) and seroconversion (21.1% vs. 10.6%, p = 0.050) rates than those in the add-on group. In combination or monotherapy group, anti-HBc levels at week 12 were lower in patients with HBsAg clearance (9.0 S/CO vs. 9.9 S/CO, p < 0.001) and seroconversion (8.8 S/CO vs. 9.8 S/CO, p < 0.001) than those without. Anti-HBc level at week 12 was an independent predictor of HBsAg clearance and seroconversion. Patients with lower anti-HBc levels at week 12 showed a more significant decline in HBsAg levels during treatment. Combination of anti-HBc at week 12 and baseline HBsAg could identify over 70% of patients who achieved HBsAg clearance after 48 weeks of treatment. In addition to HBsAg, anti-HBc level could be used as a promising marker for selecting HBeAg-negative CHB patients who are more likely to respond to Peg-IFN-based therapy.

Assuntos

Antivirais , Anticorpos Anti-Hepatite B , Antígenos de Superfície da Hepatite B , Antígenos E da Hepatite B , Hepatite B Crônica , Interferon-alfa , Humanos , Hepatite B Crônica/tratamento farmacológico , Hepatite B Crônica/imunologia , Hepatite B Crônica/virologia , Hepatite B Crônica/sangue , Antígenos de Superfície da Hepatite B/sangue , Antígenos de Superfície da Hepatite B/imunologia , Masculino , Feminino , Adulto , Estudos Retrospectivos , Anticorpos Anti-Hepatite B/sangue , Antivirais/uso terapêutico , Pessoa de Meia-Idade , Antígenos E da Hepatite B/sangue , Interferon-alfa/uso terapêutico , Vírus da Hepatite B/imunologia , Antígenos do Núcleo do Vírus da Hepatite B/imunologia , Antígenos do Núcleo do Vírus da Hepatite B/sangue , Resultado do Tratamento , Quimioterapia Combinada , Soroconversão , Adulto Jovem , Polietilenoglicóis/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Proteínas Recombinantes/imunologia

RESUMO

PURPOSE: To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second-line monotherapy for treating small-cell lung cancer (SCLC) patients. METHODS: According to the "3 + 3" dose-escalation principle, patients received intravenous JK1201I at 180 or 220 mg/m2 once every 3 weeks for four cycles. Progression-free survival (PFS), overall survival (OS), median progression-free survival (mPFS), and median overall survival (mOS) were evaluated. The Kaplan-Meier method was used to analyze PFS and overall OS. Brookmeyer and Crowley's method was used for mPFS and mOS. RESULTS: This study included 29 patients with stage III-IV SCLC (stage IIIa, n = 1; stage IIIb, n = 1; and stage IV, n = 27). Of these, 26 patients were enrolled in the 180 mg/m2 dose group, and 3 patients were enrolled in the 220 mg/m2 dose group. No dose-limiting toxicity (DLT) was noted during the first 28 days of treatment. Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). In the 220 mg/m2 group, one patient (33.3%, 1/3) experienced neutropenia or leukopenia. In the 180 mg/m2 group, 38.5% (10/26) of patients achieved an objective response rate (ORR), with a disease control rate (DCR) of 73.1% (19/26). The mPFS and mOS were 3.4 and 12.1 months, respectively. In the 220 mg/m2 group, one patient had stable disease, and one had progressive disease (PD). The ORR, DCR, mPFS, and mOS were 0% (0/3) and 33.3% (1/3), 2.7 months and 2.7 months, respectively. CONCLUSION: JK1201I exhibits promising efficacy and relatively low toxicities as a second-line monotherapy for SCLC, warranting further large-scale clinical studies to evaluate its efficacy in greater detail.

Assuntos

Irinotecano , Neoplasias Pulmonares , Polietilenoglicóis , Carcinoma de Pequenas Células do Pulmão , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Carcinoma de Pequenas Células do Pulmão/mortalidade , Carcinoma de Pequenas Células do Pulmão/patologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/mortalidade , Idoso , Irinotecano/uso terapêutico , Irinotecano/administração & dosagem , Irinotecano/efeitos adversos , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/efeitos adversos , Adulto , Resultado do Tratamento , Estadiamento de Neoplasias , Intervalo Livre de Progressão

RESUMO

Primary myelofibrosis (PMF) is the most aggressive of the myeloproliferative neoplasms and patients require greater attention and likely require earlier therapeutic intervention. Currently approved treatment options are limited in their selective suppression of clonal proliferation resulting from driver- and coexisting gene mutations. Janus kinase inhibitors are approved for symptomatic patients with higher-risk PMF. Additionally, most ongoing clinical studies focus on patients with higher-risk disease and/or high rates of transfusion dependency. Optimal treatment of early/lower-risk PMF remains to be identified and needs randomized clinical trial evaluations. Pegylated interferon alfa is recommended for symptomatic lower-risk PMF patients based on phase 2 non-randomized studies and expert opinion. Ropeginterferon alfa-2b (ropeg) is a new-generation pegylated interferon-based therapy with favorable pharmacokinetics and safety profiles, requiring less frequent injections than prior formulations. This randomized, double-blind, placebo-controlled phase 3 trial will assess its efficacy and safety in patients with "early/lower-risk PMF", defined as pre-fibrotic PMF or PMF at low or intermediate-1 risk according to Dynamic International Prognostic Scoring System-plus. Co-primary endpoints include clinically relevant complete hematologic response and symptom endpoint. Secondary endpoints include progression- or event-free survival, molecular response in driver or relevant coexisting gene mutations, bone marrow response, and safety. Disease progression and events are defined based on the International Working Group criteria and well-published reports. 150 eligible patients will be randomized in a 2:1 ratio to receive either ropeg or placebo. Blinded sample size re-estimation is designed. Ropeg will be administered subcutaneously with a tolerable, higher starting-dose regimen. The study will provide important data for the treatment of early/lower-risk PMF for which an anti-clonal, disease-modifying agent is highly needed.

Assuntos

Interferon alfa-2 , Interferon-alfa , Polietilenoglicóis , Mielofibrose Primária , Proteínas Recombinantes , Humanos , Mielofibrose Primária/tratamento farmacológico , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/administração & dosagem , Método Duplo-Cego , Interferon-alfa/uso terapêutico , Interferon-alfa/efeitos adversos , Interferon-alfa/administração & dosagem , Interferon alfa-2/uso terapêutico , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Resultado do Tratamento , Idoso

RESUMO

Background and aims: Limited data have been reported on achieving functional cure using pegylated interferon (Peg-IFN) alpha-2b treatment for postpartum hepatitis B e antigen (HBeAg)-negative women with chronic hepatitis B virus (HBV) infection. This study was to assess the effectiveness and safety of Peg-IFN alpha-2b in HBV postpartum women without HBeAg and identify factors linked to the functional cure. Methods: A total of 150 HBeAg-negative postpartum women were retrospectively recruited.47 patients received Peg-IFN alpha-2b [Peg-IFN(+) group] and 103 patients did not [Peg-IFN(-) group]. Propensity score matching (PSM) was used to adjust the baseline imbalance between the two groups. The patients were followed for at least 48 weeks. The primary endpoints were hepatitis B surface antigen(HBsAg) loss and HBsAg seroconversion at 48 weeks. Logistic regression analysis was used to assess factors associated with HBsAg loss at 48 weeks. Results: At week 48,the HBsAg loss and seroconversion rate in Peg-IFN(+) group were 51.06%(24/47) and 40.43%(19/47), respectively. Even after PSM, Peg-IFN(+) group still showed higher HBsAg loss rate (50.00% vs 7.14%,p<0.001) and higher HBsAg seroconversion rate (38.10% vs 2.38%,p<0.001). Baseline HBsAg levels (Odds Ratio [OR]: 0.051, 95% Confidence Interval [CI]: 0.003-0.273, P=0.010), HBsAg at week 24 (OR:0.214, 95%CI:0.033-0.616, P=0.022), HBsAg decline at week 24 (OR:4.682, 95%CI: 1.624-30.198, P=0.022) and postpartum flare (OR:21.181, 95%CI:1.872-633.801, P=0.030) were significantly associated with HBsAg loss at week 48 after Peg-IFN alpha-2b therapy. Furthermore, the receiver operating characteristic curve (ROC) showed that the use of baseline HBsAg<182 IU/mL, HBsAg at week24 < 4 IU/mL and HBsAg decline at week24>12IU/mL were good predictors of HBsAg loss. No serious adverse events were reported. Conclusion: Peg-IFN alpha-2b treatment could achieve a high rate of HBsAg loss and seroconversion in HBeAg-negative postpartum women with reliable safety, particularly for patients experience postpartum flare and have low baseline HBsAg levels.

Assuntos

Antivirais , Antígenos de Superfície da Hepatite B , Antígenos E da Hepatite B , Hepatite B Crônica , Interferon alfa-2 , Interferon-alfa , Polietilenoglicóis , Período Pós-Parto , Proteínas Recombinantes , Humanos , Feminino , Hepatite B Crônica/tratamento farmacológico , Polietilenoglicóis/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Adulto , Antígenos E da Hepatite B/sangue , Antivirais/uso terapêutico , Interferon-alfa/uso terapêutico , Estudos Retrospectivos , Interferon alfa-2/uso terapêutico , Antígenos de Superfície da Hepatite B/sangue , Resultado do Tratamento , Vírus da Hepatite B/imunologia , Vírus da Hepatite B/efeitos dos fármacos , Adulto Jovem , Soroconversão

RESUMO

Several evidence gaps exist regarding the use of long-acting polyethylene glycol recombinant human growth hormone (PEG-rhGH) in children with idiopathic short stature (ISS), particularly studies conducted in real-world settings, with long-term follow-up, involving varied dosing regimens, and in comparison with daily rhGH. The study aimed to evaluate the effectiveness, safety, and adherence of once-weekly PEG-rhGH for catch-up growth in children with prepubertal ISS compared to daily rhGH. A real-world retrospective cohort study was conducted in prepubertal children with ISS in China. Children who voluntarily received once-weekly PEG-rhGH or daily rhGH were included and were followed up for 2 years. Ninety-five children were included, 47 received PEG-rhGH 0.2-0.3 mg/kg weekly and 48 received daily rhGH. Outcome measures included effectiveness in catch-up growth, adverse events, and treatment adherence. Height velocity increased significantly in both groups during rhGH therapy. In children who received PEG-rhGH treatment, height velocity was 10.59 ± 1.37 cm/year and 8.75 ± 0.86 cm/year in the first and second year, respectively, which were significantly more than those who received daily rhGH (9.80 ± 1.05 cm/year, P = 0.002, and 8.03 ± 0.89 cm/year, P < 0.001). The height standard deviation score improved at the end of the second year for all children (P < 0.001). However, children who received PEG-rhGH showed more excellent improvement than those with daily rhGH (1.65 ± 0.38 vs. 1.50 ± 0.36, P = 0.001). In children who received PEG-rhGH, lower missed doses were observed than those with daily rhGH (0.75 ± 1.06 vs. 4.4 ± 2.0, P < 0.001). No serious adverse events were observed. CONCLUSION: PEG-rhGH demonstrated superior effectiveness and adherence compared to daily rhGH in the treatment of children with ISS. The safety profiles were similar between the two treatments. WHAT IS KNOWN: • Recombinant human growth hormone (rhGH) has been used to increase adult height in children with idiopathic short stature (ISS), and its safety profile is comparable to other indications for growth hormone treatment. • The use of long-acting rhGH in children with ISS is still an area of uncertainty. WHAT IS NEW: • This 2-year real-world study provides new evidence that PEGylated rhGH (PEG-rhGH) is more effective than daily rhGH in promoting catch-up growth in children with ISS. • PEG-rhGH also demonstrated superior treatment adherence compared to daily rhGH in children with ISS. • The safety profiles of PEG-rhGH and daily rhGH were found to be similar.

Assuntos

Estatura , Transtornos do Crescimento , Hormônio do Crescimento Humano , Polietilenoglicóis , Proteínas Recombinantes , Humanos , Estudos Retrospectivos , Masculino , Hormônio do Crescimento Humano/administração & dosagem , Hormônio do Crescimento Humano/uso terapêutico , Feminino , Criança , Transtornos do Crescimento/tratamento farmacológico , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/uso terapêutico , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/uso terapêutico , Estatura/efeitos dos fármacos , China , Resultado do Tratamento , Pré-Escolar , Seguimentos , Esquema de Medicação

RESUMO

Objective: This study aimed to evaluate the efficacy and safety of polyethylene glycol loxenatide (PEG-Loxe) compared to those of dapagliflozin in patients with mild-to-moderate diabetic kidney disease (DKD), a prevalent microvascular complication of type 2 diabetes mellitus (T2DM). The study is set against the backdrop of increasing global diabetes incidence and the need for effective DKD management. Methods: This study constituted a single-center, randomized, open-label, clinical trial. The trial included patients with mild-to-moderate DKD and suboptimal glycemic control. Eligible participants were randomly allocated to one of the two groups for treatment with either PEG-Loxe or dapagliflozin. The primary endpoint was the change in UACR from baseline at 24 weeks. Results: Overall, 106 patients were randomized and 80 patients completed the study. Following 24 weeks of treatment, the PEG-Loxe group exhibited a mean percent change in baseline UACR of -29.3% (95% confidence interval [CI]: -34.8, -23.7), compared to that of -31.8% in the dapagliflozin group (95% CI: -34.8, -23.7). Both PEG-Loxe and dapagliflozin showed similar efficacy in reducing UACR, with no significant difference between the groups (p = 0.336). The HbA1c levels decreased by -1.30% (95% CI: -1.43, -1.18) in the PEG-Loxe group and by -1.29% (95% CI: -1.42, -1.17) in the dapagliflozin group (p = 0.905). The TG levels decreased by -0.56 mmol/L (95% CI: -0.71, -0.42) in the PEG-Loxe group and -0.33 mmol/L (95% CI: -0.48, -0.19) in the dapagliflozin group (p = 0.023). Differences in TC, HDL-C, LDL-C, SBP, and DBP levels between the groups were not statistically significant (all p > 0.05). Safety profiles were consistent with previous findings, with gastrointestinal adverse events being more common in the PEG-Loxe group. Conclusions: PEG-Loxe is as effective as dapagliflozin in improving urine protein levels in patients with mild-to-moderate DKD and offers superior benefits in improving lipid profiles. These findings support the use of PEG-Loxe in DKD management, contributing to evidence-based treatment options. Clinical Trial Registration: www.chictr.org.cn, identifier ChiCTR2300070919.

Assuntos

Compostos Benzidrílicos , Diabetes Mellitus Tipo 2 , Nefropatias Diabéticas , Glucosídeos , Polietilenoglicóis , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Masculino , Feminino , Pessoa de Meia-Idade , Nefropatias Diabéticas/tratamento farmacológico , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/administração & dosagem , Glucosídeos/uso terapêutico , Glucosídeos/efeitos adversos , Glucosídeos/administração & dosagem , Compostos Benzidrílicos/uso terapêutico , Compostos Benzidrílicos/efeitos adversos , Idoso , Hipoglicemiantes/uso terapêutico , Hipoglicemiantes/efeitos adversos , Resultado do Tratamento , Hemoglobinas Glicadas/análise , Glicemia/efeitos dos fármacos , Glicemia/análise , Adulto

RESUMO

BACKGROUND: Endoscopic rubber band ligation (ERBL) is a nonsurgical technique for the treatment of symptomatic internal hemorrhoids but is limited by recurrence and post-procedural pain. AIM: To evaluate satisfaction, long-term recurrence, and post-procedural pain in managing internal hemorrhoids using a combination of polidocanol foam sclerotherapy and ERBL. METHODS: This was a prospective, multicenter, randomized study. A total of 195 consecutive patients diagnosed with grade II-III internal hemorrhoids were enrolled from four tertiary hospitals and randomly divided into a cap-assisted endoscopic polidocanol foam sclerobanding (EFSB) or an ERBL group. All patients were followed-up for 12 months. Symptom-based severity and post-procedural pain were assessed using a hemorrhoid severity score (HSS) and a visual analog scale (VAS). Continuous variables were reported as medians and interquartile range. RESULTS: One hundred and ninety-five patients were enrolled, with 98 in the EFSB group. HSS was lower in the EFSB group than in the ERBL group at 8 weeks [4.0 (3.0-5.0) vs 5.0 (4.0-6.0), P = 0.003] and 12-month [2.0 (1.0-3.0) vs 3.0 (2.0-3.0), P < 0.001] of follow-up. The prolapse recurrence rate was lower in the EFSB group at 12 months (11.2% vs 21.6%, P = 0.038). Multiple linear regression analysis demonstrated that EFSB treatment [B = -0.915, 95% confidence interval (CI): -1.301 to -0.530, P = 0.001] and rubber band number (B = 0.843, 95%CI: 0.595-1.092, P < 0.001) were negatively and independently associated with the VAS score 24 hours post-procedure. The median VAS was lower in the EFSB group than in the ERBL [2.0 (1.0-3.0) vs 3.0 (2.0-4.0), P < 0.001]. CONCLUSION: Cap-assisted EFSB provided long-term satisfaction and effective relief from the recurrence of prolapse and pain 24 hours post-procedure.

Assuntos

Hemorroidas , Polidocanol , Recidiva , Soluções Esclerosantes , Escleroterapia , Humanos , Polidocanol/administração & dosagem , Polidocanol/uso terapêutico , Hemorroidas/terapia , Hemorroidas/diagnóstico , Hemorroidas/cirurgia , Pessoa de Meia-Idade , Feminino , Masculino , Estudos Prospectivos , Escleroterapia/métodos , Resultado do Tratamento , Ligadura/métodos , Soluções Esclerosantes/administração & dosagem , Adulto , Idoso , Índice de Gravidade de Doença , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/diagnóstico , Satisfação do Paciente , Medição da Dor , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/uso terapêutico

RESUMO

BACKGROUND: Poly-ether-ether-ketone (PEEK) was introduced in dentistry as an alternative to metal alloys. OBJECTIVE: To assess the effectiveness of PEEK-fixed retainers in preserving the stability of mandibular anterior and participant satisfaction as compared to the Dead-soft coaxial fixed retainer (DSC). TRIAL DESIGN: A single-centre, two-arm parallel groups randomized clinical trial. METHODS: The patients treated with pre-adjusted orthodontic appliances who have a Little's Irregularity Index (LII) ≤ 0.5 mm have been enrolled in the trial. PEEK retainers were prepared to round 0.8 mm wire by computer-aided design and manufacturing, and the DSC wire was carefully adapted to the lingual surface of the lower anterior teeth. The primary outcome was the stability of lower anterior teeth as assessed by LII, while the secondary outcomes were changes in occlusal parameters, retainer failure, and patient satisfaction. The data were collected at the debonding stage (T0), 1 month (T1), 3 months (T3), and 6 months (T6) after starting the trial, except for patient's satisfaction, which was recorded using an electronic form at T1 and T6. BLINDING: Single blinding of participants. RESULTS: A total of 46 participants with an age range of 12-28 years old were randomly allocated to the two groups (n = 23 in each). Only one participant dropped out; therefore, 45 participants were analysed. The DSC group showed a significant increase in LII at T3. Both retainer groups had comparable occlusal measurements, failure frequency, and survival time, with no significant difference. The patients in the DSC group reported a statistically significant perception of change in the position of their teeth compared to those in the PEEK group. HARMS: No harmful effects have been reported. LIMITATIONS: Limited follow-up duration and the inability to blind the operator due to the nature of the intervention. CONCLUSIONS: After 6-month retention, the PEEK retainer was equally effective to DSC retainers in maintaining the teeth alignment, with no significant differences regarding the failure frequency, survival rate, and general patient satisfaction. TRIAL REGISTRATION: https://register.clinicaltrials.gov. (NCT05557136).

Assuntos

Benzofenonas , Cetonas , Contenções Ortodônticas , Satisfação do Paciente , Polietilenoglicóis , Polímeros , Humanos , Cetonas/química , Cetonas/uso terapêutico , Polietilenoglicóis/química , Polietilenoglicóis/uso terapêutico , Masculino , Feminino , Polímeros/química , Adolescente , Adulto Jovem , Desenho de Aparelho Ortodôntico , Adulto , Criança , Colagem Dentária/métodos

RESUMO

BACKGROUND AND AIMS: Data on the safety and effectiveness of tenofovir alafenamide (TAF) plus peginterferon-alpha (Peg-IFN-α) in children with chronic hepatitis B (CHB) are lacking. The current study aimed to present the characteristics of four pediatric CHB patients who obtained a functional cure by using TAF and Peg-IFN-α. METHODS: In this case series study initiated in May 2019, ten children who had no clinical symptoms or signs received response-guided (HBV DNA undetectable, hepatitis B e antigen [HBeAg] loss or seroconversion, and hepatitis B surface antigen [HBsAg] loss or seroconversion) and functional cure-targeted (HBsAg loss or seroconversion) TAF (25 mg/d, orally) plus Peg-IFN-α-2b (180 µg/1.73m2, subcutaneously, once weekly) in combination (9/10) or sequential (1/10) therapy. The safety and effectiveness of these treatments were monitored. RESULTS: As of April 2024, four out of ten children obtained a functional cure after a mean of 31.5 months of treatment, and the other six children are still undergoing treatment. These four cured children, aged 2, 4, 8, and 6 years, were all HBeAg-positive and had alanine aminotransferase levels of 80, 47, 114, and 40 U/L; HBV DNA levels of 71200000, 93000000, 8220, and 96700000 IU/mL; and HBsAg levels of 39442.8, 15431.2, 22, and 33013.1 IU/mL, respectively. During treatment, all the children (10/10) experienced mild or moderate adverse events, including flu-like symptoms, anorexia, fatigue, and cytopenia. Notably, growth retardation (8/10) was the most significant adverse event; and it occurred in three cured children (3/4) treated with combination therapy and was present to a low degree in the other cured child (1/4) treated with sequential therapy. Fortunately, all three cured children recovered to or exceeded the normal growth levels at 9 months posttreatment. CONCLUSIONS: TAF plus Peg-IFN-α-2b therapy is potentially safe and effective for pediatric CHB patients, which may provide important insights for future clinical practice and study designs targeting functional cures for children with CHB.

Assuntos

Antivirais , Quimioterapia Combinada , Hepatite B Crônica , Interferon-alfa , Polietilenoglicóis , Proteínas Recombinantes , Tenofovir , Humanos , Tenofovir/uso terapêutico , Tenofovir/administração & dosagem , Tenofovir/análogos & derivados , Hepatite B Crônica/tratamento farmacológico , Hepatite B Crônica/virologia , Masculino , Feminino , Antivirais/uso terapêutico , Antivirais/efeitos adversos , Antivirais/administração & dosagem , Criança , Proteínas Recombinantes/uso terapêutico , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/administração & dosagem , Interferon-alfa/uso terapêutico , Interferon-alfa/administração & dosagem , Interferon-alfa/efeitos adversos , Pré-Escolar , Resultado do Tratamento , Interferon alfa-2/uso terapêutico , Interferon alfa-2/administração & dosagem , Antígenos de Superfície da Hepatite B/sangue , Antígenos E da Hepatite B/sangue , Vírus da Hepatite B/genética , Vírus da Hepatite B/efeitos dos fármacos , DNA Viral/sangue , Alanina/uso terapêutico , Alanina/análogos & derivados

Assuntos

Antivirais , Humanos , Antivirais/uso terapêutico , Antígeno B7-H1/antagonistas & inibidores , Polietilenoglicóis/uso terapêutico , Receptor de Morte Celular Programada 1/antagonistas & inibidores , Interferon-alfa/uso terapêutico , Hepatite B Crônica/tratamento farmacológico , Vírus da Hepatite B/efeitos dos fármacos , Hepatite B/tratamento farmacológico

Assuntos

Antivirais , Humanos , Antivirais/uso terapêutico , Antígeno B7-H1/antagonistas & inibidores , Polietilenoglicóis/uso terapêutico , Receptor de Morte Celular Programada 1/antagonistas & inibidores , Interferon-alfa/uso terapêutico , Hepatite B Crônica/tratamento farmacológico , Vírus da Hepatite B/efeitos dos fármacos , Hepatite B/tratamento farmacológico

RESUMO

OBJECTIVE: Selected populations of patients with chronic hepatitis B (CHB) may benefit from a combined use of pegylated interferon-alpha (pegIFN-α) and nucleos(t)ides (NUCs). The aim of our study was to assess the immunomodulatory effect of pegIFN-α on T and natural killer (NK) cell responses in NUC-suppressed patients to identify cellular and/or serological parameters to predict better T cell-restoring effect and better control of infection in response to pegIFN-α for a tailored application of IFN-α add-on. DESIGN: 53 HBeAg-negative NUC-treated patients with CHB were randomised at a 1:1 ratio to receive pegIFN-α-2a for 48 weeks, or to continue NUC therapy and then followed up for at least 6 months maintaining NUCs. Serum hepatitis B surface antigen (HBsAg) and hepatitis B core-related antigen (HBcrAg) levels as well as peripheral blood NK cell phenotype and function and HBV-specific T cell responses upon in vitro stimulation with overlapping HBV peptides were measured longitudinally before, during and after pegIFN-α therapy. RESULTS: Two cohorts of pegIFN-α treated patients were identified according to HBsAg decline greater or less than 0.5 log at week 24 post-treatment. PegIFN-α add-on did not significantly improve HBV-specific T cell responses during therapy but elicited a significant multispecific and polyfunctional T cell improvement at week 24 post-pegIFN-α treatment compared with baseline. This improvement was maximal in patients who had a higher drop in serum HBsAg levels and a lower basal HBcrAg values. CONCLUSIONS: PegIFN-α treatment can induce greater functional T cell improvement and HBsAg decline in patients with lower baseline HBcrAg levels. Thus, HBcrAg may represent an easily and reliably applicable parameter to select patients who are more likely to achieve better response to pegIFN-α add-on to virally suppressed patients.

Assuntos

Antivirais , Antígenos E da Hepatite B , Hepatite B Crônica , Interferon-alfa , Células Matadoras Naturais , Polietilenoglicóis , Proteínas Recombinantes , Humanos , Hepatite B Crônica/tratamento farmacológico , Hepatite B Crônica/imunologia , Hepatite B Crônica/sangue , Interferon-alfa/uso terapêutico , Antivirais/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Feminino , Adulto , Masculino , Polietilenoglicóis/uso terapêutico , Células Matadoras Naturais/imunologia , Células Matadoras Naturais/efeitos dos fármacos , Pessoa de Meia-Idade , Antígenos E da Hepatite B/sangue , Antígenos do Núcleo do Vírus da Hepatite B/imunologia , Antígenos do Núcleo do Vírus da Hepatite B/sangue , Quimioterapia Combinada , Antígenos de Superfície da Hepatite B/sangue , Vírus da Hepatite B/imunologia , Linfócitos T/imunologia , Linfócitos T/efeitos dos fármacos , Resultado do Tratamento , Nucleosídeos/uso terapêutico

RESUMO

Axons successfully repaired with polyethylene glycol (PEG) fusion tecnology restored axonal continuity thereby preventing their Wallerian degeneration and minimizing muscle atrophy. PEG fusion studies in animal models and preliminary clinical trials involving patients with digital nerve repair have shown promise for this therapeutic approach. PEG fusion is safe to perform, and given the enormous potential benefits, there is no reason not to explore its therapeutic potential.

Assuntos

Traumatismos dos Nervos Periféricos , Polietilenoglicóis , Humanos , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/administração & dosagem , Traumatismos dos Nervos Periféricos/cirurgia , Animais , Regeneração Nervosa

Assuntos

Interferon alfa-2 , Interferon-alfa , Policitemia Vera , Polietilenoglicóis , Proteínas Recombinantes , Adulto , Humanos , Aberrações Cromossômicas , Interferon alfa-2/uso terapêutico , Interferon-alfa/uso terapêutico , Policitemia Vera/tratamento farmacológico , Policitemia Vera/genética , Polietilenoglicóis/uso terapêutico , Proteínas Recombinantes/uso terapêutico

RESUMO

BACKGROUND: Patients with cirrhosis commonly undergo endoscopic cyanoacrylate injection for gastric and esophageal variceal bleeding. However, postoperative infections can increase the risk of rebleeding and mortality. AIM: This study aimed to determine the risk of postoperative infections and its associated factors following cyanoacrylate injection treatment in these patients. METHODS: A retrospective analysis was conducted on 57 patients treated with ligation (ligation group), 66 patients treated with cyanoacrylate injection (injection group), and 91 patients treated with conservative treatment (control group) at the Nanchong Central Hospital. RESULTS: The rate of postoperative infection was similar among the cyanoacrylate, ligation, and conservative treatment groups, with no significant statistical difference observed ( P  = 0.97). Multivariate analysis identified postoperative Child-Pugh score and renal insufficiency as two independent risk factors for postoperative infection. The rebleeding rate in the injection group was significantly lower than in the other groups ( P  = 0.01). Mortality was significantly higher in the control group compared with the ligation and injection groups ( P  = 0.01). CONCLUSION: Cyanoacrylate combined with lauromacrogol injection did not significantly increase the risk of infection compared with ligation and conservative treatments, and it was more effective in reducing the risk of rebleeding. This method is safe, effective, and holds clinical value for broader application.

Assuntos

Cianoacrilatos , Varizes Esofágicas e Gástricas , Hemorragia Gastrointestinal , Recidiva , Humanos , Varizes Esofágicas e Gástricas/etiologia , Varizes Esofágicas e Gástricas/terapia , Masculino , Feminino , Estudos Retrospectivos , Cianoacrilatos/efeitos adversos , Cianoacrilatos/administração & dosagem , Cianoacrilatos/uso terapêutico , Pessoa de Meia-Idade , Fatores de Risco , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Ligadura , Idoso , Resultado do Tratamento , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/uso terapêutico , Polietilenoglicóis/efeitos adversos , Adulto , Infecção da Ferida Cirúrgica/etiologia , Cirrose Hepática/complicações