六味地黄胶囊治疗肝肾阴虚证疗效评价的单病例随机对照双盲试验  

N of One Randomized Controlled Double-Blind Trial of Liuwei Dihuang Capsule(六味地黄胶囊) in the Treatment of Liver and Kidney Yin Deficiency Syndrome

作　　者：刘玉[1] 黄彬[1] 陈生[1] 彭立生[1] 张竞超[1] 贾丹[1] 曾真[1] 秦秀德[1] LIU Yu;HUANG Bin;CHEN Sheng;PENG Lisheng;ZHANG Jingchao;JIA Dan;ZENG Zhen;QIN Xiude(Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, 518033)

机构地区：[1]深圳市中医院

出　　处：《中医杂志》2018年第11期947-951,共5页Journal of Traditional Chinese Medicine

基　　金：深圳市科技计划项目(JCYJ20150401163247240);广东省中医药强省项目(20151077);深圳市"医疗卫生三名工程"项目(SZSM201612081)

摘　　要：目的采用单病例随机对照双盲试验评价六味地黄胶囊治疗肝肾阴虚证的临床疗效,并评估该方法在证候疗效评价中的可应用性及可靠性。方法通过预试验确定六味地黄胶囊的观察期与洗脱期,采用单病例随机对照双盲试验方法,在同一个体进行两轮试验,共有24例受试者参与试验,以患者最关心的临床症状作为疗效评价指标。采用t检验、重复性测量方差分析和单病例Meta分析处理数据,以评估结果的可靠性。结果 19例完成临床试验的受试者中,5例受试者符合有效标准,10例受试者符合可能有效标准,4例受试者为无效。采用t检验、重复性测量方差分析和Meta分析进行试验结论外推,3种统计分析方法均证实六味地黄胶囊较安慰剂能降低患者临床症状评分(P<0.01)。结论单病例随机对照试验可应用于证候类中药的疗效评价,且具有可应用性及结果可靠性。Objective To evaluate the clinical efficacy of Liuwei Dihuang Capsule （六味地黄胶囊） in the treat-ment of liver-kidney yin deficiency syndrome in N of 1, randomized controlled, double-blinded trial and to evaluate the applicability and reliability of this method in the evaluation of syndrome response. Methods The observation period and the elution period of Liuwei Dihuang Capsule were determined by pre-test. The N of 1 randomized con-trolled double-blind test method was used to conduct two rounds of trials in the same individual. A total of 24 subjects participated in the trial and took the patients＇ clinical symptoms as their most concern as efficacy evaluation indica-tors. Data were processed using the t-test, repeated measures analysis of variance, and single case meta-analysis to assess the reliability of the results. Results Among the 19 subjects who completed the Clinical trial, 5 subjects met the effective criteria, 10 subjects met the possible effective criteria, and 4 subjects were ineffective. The t test, re-peated measures analysis of variance, and meta-analysis were used to extrapolate the trial results. Three statistical a-nalysis methods confirmed that Liuwei Dihuang Capsule can reduce clinical symptom scores (P 〈 0. 01) compared with placebo. Conclusion N of 1 randomized controlled trials can be used to evaluate the therapeutic effect of syn-drome-like Chinese medicines, and they are applicable and reliable.

关 键 词：六味地黄胶囊 肝肾阴虚证 单病例随机对照试验 双盲 疗效评价 

分 类 号：R259[医药卫生—中西医结合]