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Efficacy and Safety of Quxie Capsule () in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial.
Zhang, Tong; Yang, Yu-Fei; He, Bin; Yi, Dan-Hui; Hao, Jie; Zhang, Da.
Afiliación
  • Zhang T; Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
  • Yang YF; Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. yyf93@vip.sina.com.
  • He B; Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
  • Yi DH; School of Statistics, Renmin University of China, Beijing, 100872, China.
  • Hao J; Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
  • Zhang D; Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Chin J Integr Med ; 24(3): 171-177, 2018 Mar.
Article en En | MEDLINE | ID: mdl-28840585
OBJECTIVE: To verify the efficacy and safety of Quxie Capsule () in patients with metastatic colorectal cancer (mCRC). METHODS: The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope. The treatment group received conventional therapy combined with Quxie Capsule for 3 months. The control group was treated with conventional therapy combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to age, right or left-sided disease, and second-line therapy to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until Dec 31st 2016. RESULTS: The median OS was 23 months in the treatment group [95% confidence interval (CI): 15-not calculated] vs. 14 months in the control group (95% CI: 11-22, P=0.060). The OS of the treatment group tended to be longer than that of the control group (P>0.05). In the subgroups of patients <65 years old, left-sided colon, and 2nd-line therapy, the treatment group showed a significant survival benefit compared with the control group (P=0.006, 0.038, 0.013, respectively). There were no significant differences between the two groups in PFS (P>0.05). Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group. CONCLUSIONS: Quxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicamentos Herbarios Chinos / Neoplasias Colorrectales Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Chin J Integr Med Asunto de la revista: TERAPIAS COMPLEMENTARES Año: 2018 Tipo del documento: Article País de afiliación: China Pais de publicación: China
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicamentos Herbarios Chinos / Neoplasias Colorrectales Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Chin J Integr Med Asunto de la revista: TERAPIAS COMPLEMENTARES Año: 2018 Tipo del documento: Article País de afiliación: China Pais de publicación: China