养正消积胶囊辅助介入化疗治疗原发性肝癌的随机双盲多中心临床研究

目的观察养正消积胶囊辅助介入化疗治疗脾肾两虚、瘀毒内阻型原发性肝癌的临床疗效和安全性。方法采用随机双盲多中心对照,通过NDST统计软件按3∶1比例分成试验组300例和对照组100例。试验组给予介入化疗+养正消积胶囊,每次4粒,每日3次,饭后30 min温开水送服。对照组单用介入化疗,方法同试验组。疗程均为4周。结果实体瘤近期疗效:试验组缓解率23.3%,对照组缓解率14.0%,2组比较差异有统计学意义(P<0.01);中医证候疗效:试验组总有效率65.3%,对照组33.0%,2组比较差异有统计学意义(P<0.01);生存质量及体质量:试验组分别升高54.3%和34.4%,对照组分别升高38.0%和22.2%,二者比较差异有统计学意义(P<0.05,P<0.01)。免疫功能:试验组治疗前后无显著变化,对照组治疗后NK细胞下降(P<0.05)。结论养正消积胶囊配合介入化疗辅助治疗脾肾两虚、瘀毒内阻型原发性肝癌安全有效。

A randomly,double-blinded,and multicentre study of chemotherapy assisted with Yangzhengxiaoji capsule on treating primary hepatic carcinoma

Objective To observe the therapeutic effect and safety of chemotherapy assisted with Yangzhengxiaoji capsule on primary hepatic carcinoma （ PHC）, which explained by the TCM with syndrome of asthenia of both the spleen and kidney, yu and du internal resistance. Methods As a randomly, double,blinded, and muhi- center study, the enrolled patients with PHC were divided into experiment group （ n = 300） and control group （ n = 100）, according to 3：1 proportion by NDST statistical software. The chemotherapy was used to all of the patients,and the patients in experiment group orally Yangzhengxiaoji capsule （4 pills once and 3 times per day）, while the control group orally placebo. The course of treatment lasted 4 weeks, Results The remission rate in experiment group （23.3%） was obviously higher than control group（ 14. 0% ） in the short-time therapeutic effect of solid tumor （ P 〈 0.01 ）. For the therapeutic effect of the traditional Chinese medicine syndrome, total effective rate was 65.3% in experiment group, while 33.0% in control group （ P 〈0. 01 ）. The survival quality and body weight were improved respectively with the 54.3% and 43.8% in experiment group, while 38.0% and 22.2% respectively in control group （ P 〈0.05 orP 〈0.01 ）. For the immune function, there was no changes pre and post therapy in experiment group, while the NK cell decreased obviously in control group （ P 〈 0.05 ）. Conclusion It provided that the chemotherapy assisted with Yangzhengxiaofi capsule had better therapeutic effect on PHC, which explained by the TCM with syn- drome of asthenia of both the spleen and kidney, yu and du internal resistance.