新驴胶补血颗粒治疗气血两虚型月经过少的多中心、随机对照、临床等效性研究  

Clinical equivalence study of “Xinlvjiao Buxue Granules”on treating hypomenorrhea due to qi and blood deficiency: a multicenter-randomized controlled trial

作　　者：林洁[1] 张敏[2] 陈锦黎[3] 傅萍[4] 谢安 尹天雷[6] 

机构地区：[1]湖南中医药大学第一附属医院妇科,湖南长沙410000 [2]上海中医药大学附属曙光医院妇科,上海201203 [3]上海中医药大学附属龙华医院妇科,上海200032 [4]浙江中医药大学附属广兴医院妇科,浙江杭州310000 [5]九芝堂股份有限公司,湖南长沙410008 [6]湖南省中医药研究院附属医院信息科,湖南长沙410006

出　　处：《上海中医药杂志》2014年第12期52-55,共4页Shanghai Journal of Traditional Chinese Medicine

摘　　要：目的观察新驴胶补血颗粒治疗气血两虚型月经过少的临床疗效。方法采用多中心分层随机、双盲、原剂型药对照的方法,将320例病例分为治疗组和对照组。治疗组予新驴胶补血颗粒治疗,对照组予驴胶补血颗粒治疗。两组疗程均为3个月经周期(3个月),观察临床疗效、月经经量及中医证候积分,并评价用药的安全性。结果 1最终完成试验者286例,每组143例。2用药后各时点与治疗前比较,两组月经经量的差异均有统计学意义(P<0.05);组间治疗后比较,月经经量的差异无统计学意义(P>0.05)。3治疗组、对照组总有效率分别为94.41%和89.51%,组间临床疗效比较,差异无统计学意义(P>0.05)。双向单侧t检验等效合格(P<0.05),等效界值为10%。4治疗前后组内比较,两组中医证候积分比较,差异均有统计学意义(P<0.05);组间治疗前后差值比较,差异无统计学意义(P>0.05)。5两组均未出现不良反应。结论新驴胶补血颗粒治疗气血两虚型月经过少,与旧剂型颗粒疗效相当,可显著改善女性月经量少、色淡、神疲乏力等症状,且安全性较好,服用方便,不易受潮霉变。Objective This research is to evaluate clinical effects of ＂Xinlvjiao Buxue Granules＂on treating hypomenorrhea due to qi and blood deficiency.Methods The research adopted methods of multicenter stratified random,double blind,comparison of original drug formulation. The enrolled 320 patients were randomly divided into treat group and control group which were treated respectively with ＂Xinlvjiao Buxue Granules＂and ＂Lvjiao Buxue Granules＂,with the course of 3 months. Clinical efficacy,menstruation blood volume and TCM syndrome score were observed and the safety of the drug was evaluated. Results ① Two hundred and eighty-six patients were finished the experiment,with,143 in each group. ② Differences of patients＇ menstrual blood volume between the two groups have statistical significance（ P〈0. 05）; Differences of patients＇ menstrual blood volume in the group have no statistical significance（ P〉0. 05） after treatment.③ The total efficiency rate of test group and control group was 94. 41% and 89. 51%. The two-way unilateral equivalent t test is up to standard（ P〈0. 05）,and the equivalent dividing value is 10%. ④Differences of patients＇ TCM syndrome score between the two groups have statistical significance（ P〉0. 05） after treatment; Differences of patients＇ TCM syndrome scoring in the team have no statistical significance（ P〈0. 05） after treatment. ⑤ No untoward effect was observed in both groups. Conclusion Compared with＂Lvjiao Buxue Granules＂,＂Xinlvjiao Buxue Granules＂have the same effect on treating on hypomenorrhea due to qi and blood deficiency. It can improve symptoms such as hypomenorrhea due to qi and blood deficiency,light colored menstruation,fatigue. And unlikely to mildew due to dampness,the drug is easy to take with great security.

关 键 词：新驴胶补血颗粒 月经过少 气血两虚 絮凝澄清法 等效性试验 

分 类 号：R271.111[医药卫生—中医妇科学]