更美宁胶囊治疗更年期综合征的多中心临床研究  

Multi-center Clinical Study of Gengmeining Capsules for Treatment of Menopausal Syndrome

作　　者：薛赛琴[1] 张琼[1] 姜羡华[1] 金哲[1] 

机构地区：[1]中国中医科学院西苑医院国家药品临床研究基地,北京100091

出　　处：《中药新药与临床药理》2011年第1期117-120,共4页Traditional Chinese Drug Research and Clinical Pharmacology

摘　　要：目的评价更美宁胶囊治疗更年期综合征(肝肾阴虚、心肝火旺证)临床疗效和安全性。方法采用区组随机、双盲、阳性药平行对照、多中心临床研究方法,共观察病例231例,其中试验组116例,服用更美宁胶囊,对照组115例,服用更年宁心胶囊。结果对更年期综合征的治疗,试验组总有效率为99.1%,愈显率为65.5%;对照组总有效率为94.8%,愈显率为44.3%,两组比较差异有显著性(P<0.05)。对肝肾阴虚、心肝火旺的中医证候疗效,试验组总有效率为99.1%,控显率为69.8%;对照组总有效率为94.8%,控显率为45.2%,两组比较差异有显著性(P<0.05)。结论更美宁胶囊治疗更年期综合征(肝肾阴虚、心肝火旺证)具有明显的临床疗效,且未发现明显的不良反应。Objective To evaluate the efficacy and safety of Gengmeining Capsule in the treatment of menopausal syndrome with liver-kidney Yin deficit and hyperactive heart-liver fire. Methods A randomized, double-blind, positive parallel controlled, multi-center clinical trial was carried out in 231 patients. One hundred and sixteen patients in trial group took Gengmeining Capsules, and 115 in the control group took Gengnian Ningxin Capsules. Results For the treatment of menopausal syndrome, the total effective rate was 99.1%, and cure and markedly effective rate was 65.5 % in the trial group; in the control group, the total effective rate was 94.8 %, and cure and markedly effective rate was 44.3 %, the difference being statistically significant between the two groups （P〈 0.05）. For traditional Chinese medical syndromes of liver-kidney Yin deficit and hyperactive heart-fiver fire, the total effective rate was 99.1%, and controlled and markedly effective rate was 69.8 % in the trial group; in the control group, the total effective rate was 94.8 %, and controlled and markedly effective rate was 45.2 %.There was significant difference between two groups （P 〈 0.05）. Conclusion Gengmeining Capsules is safe and effective in the treatment of menopausal syndrome with liver-kidney Yin deficit and hyperactive heart-liver fire.

关 键 词：更美宁胶囊 肝肾阴虚 心肝火旺 更年期综合征 中药疗法 

分 类 号：R285.6[医药卫生—中药学]