胚宝胶囊治疗女性更年期综合征肾阳虚证多中心临床研究  

Multi-Center clinical study of Peibao Capsule in treating female climacteric syndrome of kidney-yang deficiency

作　　者：王华[1] 王国华 

机构地区：[1]湖南中医药大学第一附属医院,湖南长沙410007 [2]北京远博康惠医药信息咨询有限公司,北京100161

出　　处：《湖南中医药大学学报》2013年第9期67-69,共3页Journal of Hunan University of Chinese Medicine

摘　　要：目的评价胚宝胶囊治疗女性更年期综合征肾阳虚证的有效性及临床应用的安全性。方法将96例患者随机分为治疗组72例、对照组24例。治疗组口服胚宝胶囊+右归胶囊模拟剂,对照组口服右归胶囊+胚宝胶囊模拟剂,疗程8周。观察比较两组用药后的临床疗效。结果两组的中医证侯疗效差异有统计学意义(P<0.05),单项症状中的自汗、腰膝酸软、烦躁易怒、失眠多梦等方面两组差异有统计学意义(P<0.05);不良反应发生率比较,差异无统计学意义(P>0.05)。结论胚宝胶囊治疗女性更年期综合征(肾阳虚证)具有较好疗效,在中医证候疗效及单项症状自汗、腰膝酸软、烦躁易怒、失眠多梦改善方面,优于对照组右归胶囊,且临床使用安全。Objective To evaluate the effectiveness and safety of Peibao Capsule in treating female climacteric syndrome of kidney-yang deficiency. Methods 96 patients were randomly divided into treatment group （n=72） and control group （n=24）. Treatment group was treated with 4 pills of Peibao Capsule and 3 pills of mimetic Yougui Capsule as placebo while controls were treated with 4 pills of Yougui Capsule and 3 pills of mimetic Peibao Capsule as placebo, 3 times a day for 8 weeks. The effectiveness and safety of Peibao Capsule in treating female climacteric syndrome of kidney-yang deficiency were evaluated and compared between 2 groups. Results Curative effects of TCM syndrome had statistics differences between 2 groups（P〉0.05）. Improvement of individual symp- toms including spontaneous sweating, soreness and weakness of waist and knees, irritability and in- somnia between 2 groups showed statistics differences （P〈0.05）. The incidence rates of adverse effect between 2 groups had no statistics differences （P〉0.05）. Conclusion To treat female climacteric syn- drome of kidney-yang deficiency Peibao Capsule is better than Yougui Capsule especially in treating TCM syndrome and individual symptoms including spontaneous sweating, soreness and weakness of waist and knees, irritability and insomnia, also it is safe in clinic.

关 键 词：更年期综合征 肾阳虚证 胚宝胶囊 多中心临床研究 

分 类 号：R271.116[医药卫生—中医妇科学]