扶正消癌Ⅰ号方治疗晚期结直肠癌疗效观察

目的 研究扶正消癌Ⅰ号方对体能评分不适合放化疗的晚期结直肠癌的作用.方法 选择我科2005-01～2006-12住院的转移性结直肠癌患者50例,按随机设计分为研究组和对照组,每组25例,研究组给予扶正消癌Ⅰ号方,主要由茯苓10g, 白术10 g, 山药10 g,黄芪15 g, 太子参15 g, 蛇舌草30 g, 山慈姑15 g, 蜈蚣2条等组成, 1剂/d,连服14d为1个周期,同时给予必要的对症处理,至少完成2个周期治疗的病例进入统计学处理,对照组给予最佳支持治疗(BSC),观察近期疗效, 毒副反应, 生存质量和中位生存期.结果 进入统计学处理的病例数研究组与对照组分别为23例和22例,研究组在中医症状疗效方面显著优于对照组(χ2=6.706, P=0.01),生存质量(QOL)较对照组为优(P<0.05),在中位生存时间(MST)和总生存时间(OS)方面无显著性差异(P>0.05).结论 扶正消癌Ⅰ号方对不适合放化疗的晚期结直肠癌有一定治疗效果,且能提高生存质量,较单纯BSC效果为佳,具有一定的临床应用价值.

A Clinical Trial of Fuzhengxiaoai Decoction I on Late Stage Colorectal Cancer Patients

Objective To investigate the efficacy of Fuzhengxiaoai Decoction I on advanced colorectal cancer patients without adequate performance status (PS). Methods 50 advanced colorectal cancer patients were enrolled in the study, and randomly divided into research group and control group, 25 cases in each group. In research group, patients were treated with Fuzhengxiaoai Decoction I on dayl to day 14, the regimen was performed every 2 weeks; in control group, patients were treated only with best supportive care (BSC) , after at least two cycles treatment, the efficacy, toxicity and quality of life (QOL), median survival time (MST), overall survival (OS) in both groups were assessed. Results There were 23 and 22 patients into statistics in research group and control respectively, the difference of efficacy on symptoms of traditional Chinese medicine ( TCM ) between research group and control were significant ( x~2=6.706, P =0.01) , QOL was higher than in control (P<0.05) , however, the incidence of toxicity between two groups was not significant (P>0.05) , MST and OS were also not significant between two groups (P>0.05). Conclusion Fuzhengxiaoai Decoction I is efficient on symptoms of TCM. It can enhance QOL suggesting its value in advanced colorectal cancer patients without adequate PS.