Zhang Tong, Yang Yu-Fei, He Bin, Yi Dan-Hui, Hao Jie, Zhang Da
Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
School of Statistics, Renmin University of China, Beijing, 100872, China.
Chin J Integr Med. 2018 Mar;24(3):171-177. doi: 10.1007/s11655-017-2962-2. Epub 2017 Aug 24.
To verify the efficacy and safety of Quxie Capsule () in patients with metastatic colorectal cancer (mCRC).
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.
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.
Quxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).
验证祛邪胶囊治疗转移性结直肠癌（mCRC）患者的疗效和安全性。
本研究为随机、双盲、安慰剂对照试验。60例mCRC患者通过密封信封以1:1的比例随机分为两组。治疗组接受常规治疗联合祛邪胶囊治疗3个月。对照组接受常规治疗联合安慰剂治疗3个月。主要观察指标为总生存期（OS）和无进展生存期（PFS）。根据年龄、左右侧疾病及二线治疗进行亚组分析，以确定两组之间PFS和OS的差异。每3个月对患者进行随访，直至2016年12月31日。
治疗组的中位OS为23个月[95%置信区间（CI）：15-未计算]，而对照组为14个月（95%CI：11-22，P=0.060）。治疗组的OS有长于对照组的趋势（P>0.05）。在年龄<65岁、左侧结肠癌和二线治疗的亚组患者中，治疗组与对照组相比显示出显著的生存获益（分别为P=0.006、0.038、0.013）。两组之间的PFS无显著差异（P>0.05）。安全性分析显示治疗组无严重血液学毒性或肝肾功能损伤。
祛邪胶囊显示出良好的安全性和疗效，可延长mCRC患者的OS。（注册号：ChiCTR-IOR-16009733）
