养正消积胶囊配合介入化疗治疗原发性肝癌随机双盲多中心临床研究

目的：观察养正消积胶囊对原发性肝癌介入化疗术后患者的疗效和安全性。方法：采用随机双盲、安慰剂对照,利用SAS统计软件将604例病例分成治疗组402例和对照组202例,2组均采用化学疗法,治疗组加服养正消积胶囊,1次4粒,3次/d,饭后30min温开水送服,对照组加服安慰剂,观察比较两组实体肿瘤疗效及中医证候、生存质量、体重、免疫功能等相关指标的变化。疗程为4周。结果：实体肿瘤的疗效,治疗组缓解率22.4%,对照组15.3%,两组比较,差异有统计学意义（P〈0.01）。中医症状和体征疗效,治疗组总有效率为65.2%,对照组总有效率36.1%,两组比较,差异有统计学意义（P〈0.01）。生存质量疗效,治疗组升高稳定率为85.0%,对照组升高稳定率为76.7%,两组比较,差异有统计学意义（P〈0.01）。体重疗效,治疗组升高稳定率为78.3%,对照组升高稳定率为70.8%,两组比较,差异有统计学意义（P〈0.01）。免疫学指标变化比较,治疗组治疗前后无明显变化,NK细胞均数比较,对照组治疗前后差异有统计学意义（P〈0.05）。结论：养正消积胶囊对介入化疗术后原发性肝癌安全,有效。

A Randomized,Double-blind and Multicentre Study of Interventional Chemotherapy Combined with Yangzhengxiaoji Capsule in Treating Primary Hepatic Carcinoma

Objective：To observe the curative effect and safety of Yangzhengxiaoji capsule on primary hepatic carcinoma patients treated by interventional chemotherapy.Methods：As a randomized double-blind and placebo controlled trial,the 604 patients were divided into treatment group（n = 402） and control group（n = 202） by SAS statistical software.The chemotherapy was applied to all of the patients,and the patients in treatment group took extra Yangzhengxiaoji capsule 4 pills each time and 3 times per day with warm water 30 minutes after each meal.And patients in the control group took placebo.The solid tumor,traditional Chinese medicine syndrome,survival quality,weight and immunologic function of the patients in both groups were observed and compared.The course of treatment lasted 4 weeks.Results：The remission rate of solid tumor in treatment group（22.4%） was obviously higher than that of the control group（15.3%）（P ＆lt; 0.01）.As for the therapeutic effect of the traditional Chinese medicine syndrome,the total effective rate was 65.2% in treatment group,and 36.1% in control group（P ＆lt; 0.01）.As for the therapeutic effect of survival quality,the rise stability rate of treatment group was 85.0%,while that of the control group was 76.7%（P ＆lt; 0.01）.The rise stability rate of weight was 78.3% in treatment group,and 70.8% in control group on（P ＆lt; 0.01）.For the immune function,there was no obvious change before and after therapy in treatment group,while the mean change of NK cell was obvious before and after in control group（P ＆lt; 0.05.Conclusion：Interventional chemotherapy assisted with Yangzhengxiaoji capsule on treating primary hepatic carcinoma was safe and effective.