Objective：To verify the efficacy and safety of Quxie Capsule（祛邪胶囊） in patients with metastatic colorectal cancer（mC RC）.Methods：The present study was a randomized,double-blind,placebo-controlled trial.Sixty ...Objective：To verify the efficacy and safety of Quxie Capsule（祛邪胶囊） in patients with metastatic colorectal cancer（mC RC）.Methods：The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC 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 31 st 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 2 nd-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 mC RC.展开更多
Objective:To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer(m CRC).Methods:It was a block randomized,double-blind,placebo-controlled trial.Sixty patients with m CRC were randomized ...Objective:To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer(m CRC).Methods:It was a block randomized,double-blind,placebo-controlled trial.Sixty patients with m CRC were randomized into 2 groups at a 1:1 ratio.The patients in the treatment group received conventional therapy including chemotherapy,radiotherapy,targeted therapy and supportive care,and Chinese herbal medicine combined with Quxie Capsule(each capsule of 0.4 g was orally administered at 50 mg/kg,twice daily,day 1–20,in a 30-day course)for 3 months.The patients in the control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months.Main outcome measures were overall survival(OS)and progression-free survival(PFS).Subgroup analysis was performed according to therapy lines,right or left-sided colon,targeted therapy and RAS gene status to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until December 31st,2018.Results:Median follow-up time was 19.4 months.The median OS was 23.9 months in the treatment group[95%confidence interval(CI)15.9-28.5]vs.14.3 months in the control group(95%CI 11.3-21.4,P<0.05).Hazard ratio(95%CI)was 0.55(0.31-0.95,P=0.040).There were no significant differences between the two groups in PFS(P>0.05).In the subgroups of second-line therapy,non-targeted therapy,RAS gene wild type and left-sided colon,the treatment group showed a significant survival benefit compared with the control group(P<0.05 or P<0.01),respectively.Conclusion:Quxie Capsule can reduce the risk of death and prolong the OS of patients with m CRC.(Registration No.Chi CTR-IOR-16009733).展开更多
目的评价祛邪胶囊对晚期结直肠癌患者中位生存期和生活质量的影响。方法采用随机对照临床研究方法,纳入晚期结直肠癌患者40例,可评价37例,治疗组18例,对照组19例,两组均采用化疗(FOLFOX、FOLFRI方案)等西医治疗,治疗组在此基础上加用祛...目的评价祛邪胶囊对晚期结直肠癌患者中位生存期和生活质量的影响。方法采用随机对照临床研究方法,纳入晚期结直肠癌患者40例,可评价37例,治疗组18例,对照组19例,两组均采用化疗(FOLFOX、FOLFRI方案)等西医治疗,治疗组在此基础上加用祛邪胶囊,治疗3个月后,进行长期随访,观察患者的病死率、生存期、中位生存期、疾病进展期(time to progression,TTP)及生活质量。结果治疗组和对照组的病死率分别为11.1%(2/18)和42.1%(8/19);生存期分别为(22.63±7.34)个月和(19.76±8.28)个月,中位生存期分别为17个月和13个月;TTP分别为(17.76±5.62)个月和(12.68±9.26)个月,经统计分析均有统计学意义(P<0.05)。中医症状积分、生活质量及KPS评分治疗组治疗前分别为15.59±3.78、54.06±3.96、64.71±6.24,治疗后分别为10.53±5.57、58.65±4.03、69.41±4.29,治疗前后比较差异均有统计学意义(P<0.05);对照组治疗前分别为16.11±3.99、54.06±4.39及64.44±5.11;治疗后分别为19.61±7.78、50.17±8.26、60.00±9.70,治疗前后生活质量及KPS评分比较差异有统计学意义(P<0.05),但趋势是向差的方向。结论晚期结直肠癌患者加用祛邪胶囊,能减少病死率,延长生存期、中位生存期和TTP,提高生活质量。展开更多
基金Supported by National Natural Science Foundation of China(No.81373824)Science and Technology Program of Beijing(No.Z131107002213101)Project of the Chinese Academy of Traditional Chinese Medicine(No.ZZ070854)
文摘Objective：To verify the efficacy and safety of Quxie Capsule（祛邪胶囊） in patients with metastatic colorectal cancer（mC RC）.Methods：The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC 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 31 st 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 2 nd-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 mC RC.
基金Supported by National Natural Science Foundation of China(No.81573958)。
文摘Objective:To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer(m CRC).Methods:It was a block randomized,double-blind,placebo-controlled trial.Sixty patients with m CRC were randomized into 2 groups at a 1:1 ratio.The patients in the treatment group received conventional therapy including chemotherapy,radiotherapy,targeted therapy and supportive care,and Chinese herbal medicine combined with Quxie Capsule(each capsule of 0.4 g was orally administered at 50 mg/kg,twice daily,day 1–20,in a 30-day course)for 3 months.The patients in the control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months.Main outcome measures were overall survival(OS)and progression-free survival(PFS).Subgroup analysis was performed according to therapy lines,right or left-sided colon,targeted therapy and RAS gene status to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until December 31st,2018.Results:Median follow-up time was 19.4 months.The median OS was 23.9 months in the treatment group[95%confidence interval(CI)15.9-28.5]vs.14.3 months in the control group(95%CI 11.3-21.4,P<0.05).Hazard ratio(95%CI)was 0.55(0.31-0.95,P=0.040).There were no significant differences between the two groups in PFS(P>0.05).In the subgroups of second-line therapy,non-targeted therapy,RAS gene wild type and left-sided colon,the treatment group showed a significant survival benefit compared with the control group(P<0.05 or P<0.01),respectively.Conclusion:Quxie Capsule can reduce the risk of death and prolong the OS of patients with m CRC.(Registration No.Chi CTR-IOR-16009733).
文摘目的评价祛邪胶囊对晚期结直肠癌患者中位生存期和生活质量的影响。方法采用随机对照临床研究方法,纳入晚期结直肠癌患者40例,可评价37例,治疗组18例,对照组19例,两组均采用化疗(FOLFOX、FOLFRI方案)等西医治疗,治疗组在此基础上加用祛邪胶囊,治疗3个月后,进行长期随访,观察患者的病死率、生存期、中位生存期、疾病进展期(time to progression,TTP)及生活质量。结果治疗组和对照组的病死率分别为11.1%(2/18)和42.1%(8/19);生存期分别为(22.63±7.34)个月和(19.76±8.28)个月,中位生存期分别为17个月和13个月;TTP分别为(17.76±5.62)个月和(12.68±9.26)个月,经统计分析均有统计学意义(P<0.05)。中医症状积分、生活质量及KPS评分治疗组治疗前分别为15.59±3.78、54.06±3.96、64.71±6.24,治疗后分别为10.53±5.57、58.65±4.03、69.41±4.29,治疗前后比较差异均有统计学意义(P<0.05);对照组治疗前分别为16.11±3.99、54.06±4.39及64.44±5.11;治疗后分别为19.61±7.78、50.17±8.26、60.00±9.70,治疗前后生活质量及KPS评分比较差异有统计学意义(P<0.05),但趋势是向差的方向。结论晚期结直肠癌患者加用祛邪胶囊,能减少病死率,延长生存期、中位生存期和TTP,提高生活质量。
