祛邪胶囊治疗晚期结直肠癌疗效及安全性的随机对照临床试验

Randomized Controlled Clinical Trial of Efficacy and Safety of Quxie Capsules in the Treatment of Metastatic Colorectal Cancer

目的:对前期祛邪胶囊临床随机对照试验(RCT)的数据进行更新,验证祛邪胶囊治疗晚期结直肠癌患者生存期的疗效和安全性。方法:选取2014年4月1日至2015年7月31日中国中医科学院西苑医院肿瘤科门诊和住院的有明确病理诊断的晚期结直肠癌患者60例作为研究对象,采用区组随机、双盲、安慰剂对照的方法将受试者分为观察组和对照组,每组30例。观察组采用祛邪胶囊联合常规治疗,对照组采用祛邪胶囊安慰剂联合常规治疗,治疗3个月后长期随访,观察2组的总生存期、无进展生存期、安全性指标和不良反应。随访至2021年2月20日,全部受试者均达到了临床终点,最长随访时间74个月。结果:观察组中位生存期较对照组延长了9.6个月(23.9比14.3,P=0.032),2组中位无进展生存均为6个月,差异无统计学意义(P=0.60)。在结肠亚组、左半结肠亚组、二线及二线以上治疗亚组、非靶向治疗亚组、RAS野生型亚组中,观察组与对照组的OS差异均有统计学意义(P=0.018,0.037,0.007,0.022,0.019);在化疗亚组中,观察组总生存期较对照组延长了9.7个月,临床获益明显,趋势有差异(P=0.072)。祛邪胶囊安全性良好。结论:祛邪胶囊可以延长晚期结直肠癌患者的生存期且安全性良好。

Objective:Update the RCT data of Quxie Capsules in early stage,and verify the efficacy and safety of Quxie Capsules in the treatment of patients with metastatic colorectal cancer(mCRC).Methods:From April 1,2014 to July 31,2015,a total of 60 patients with advanced colorectal cancer and clear pathological diagnosis in the outpatient and inpatient Department of Oncology Department of Xiyuan Hospital,China Academy of Chinese Medical Sciences were selected as the research objects.The subjects were divided into a treatment group and a control group by a randomized,double-blind,placebo-controlled method,with 30 cases in each group.The treatment group was treated with Quxie Capsules combined with conventional treatment,and the control group was treated with Quxie Capsules placebo combined with conventional treatment.Long-term follow-up was after 3 months of treatment,the overall survival,progression-free survival,safety indicators and adverse reactions of the 2 groups were observed.Results:Follow-up until February 20,2021,all subjects reached the clinical endpoint.The longest follow-up time was 74 months.The median survival time of the treatment group was 9.6 months longer than that of the control group(23.9 vs.14.3,P=0.032).The median progression-free survival in both groups was 6 months,and the difference was not statistically significant(P=0.60).In the colon subgroup,left colon subgroup,second-line and above second-line treatment subgroup,non-targeted therapy subgroup,and RAS wild-type subgroup,the difference in OS between the treatment group and the control group was statistically significant(P=0.018,0.037,0.007,0.022,0.019);in the chemotherapy subgroup,the overall survival of the treatment group was prolonged by 9.7 months compared with the control group,the clinical benefit was obvious,and the difference was trending(P=0.072).Quxie capsules are safe.Conclusion:Quxie Capsules can prolong the survival and safety of patients with advanced colorectal cancer with good safety.