“消疲怡神”配方颗粒干预肝郁脾虚型疲劳性亚健康状态的前瞻性随机双盲安慰剂对照试验  

Effects of Xiaopi Yishen herbal extract granules in treatment of fatigue-predominant subhealth due to liver-qi stagnation and spleen-qi deficiency:a prospective,randomized,placebo-controlled and double-blind clinical trial

作　　者：王天芳[1] 薛晓琳[1] 张雅静[1] 韩萍 李真[3] 王文萍[4] 邢建民[5] 王庆波[6] 汤宇[7] 李力[8] 王佳佳[1] 李冠儒[1] 季绍良[1] 武留信[9] 赵燕[1] 吴秀艳[1] 赵润栓 

机构地区：[1]北京中医药大学基础医学院中医诊断系,北京100029 [2]北京小汤山医院体检中心,北京102211 [3]河南中医学院第一附属医院内分泌科,河南郑州450000 [4]辽宁中医药大学附属医院国家药物临床试验机构,辽宁沈阳110032 [5]北京中医药大学基础医学院循证医学中心,北京100029 [6]河南中医学院第一附属医院针灸科,河南郑州450000 [7]辽宁中医药大学附属医院康复医学科,辽宁沈阳110032 [8]河南中医学院第一附属医院治未病健康管理中心,河南郑州450000 [9]中国人民解放军空军航空医学研究所,北京100142

出　　处：《中西医结合学报》2011年第5期515-524,共10页Journal of Chinese Integrative Medicine

基　　金："十一五"国家科技支撑计划项目(No .2006BAI13B05)

摘　　要：背景:亚健康对人们生活、工作的影响及其高发生率使得对其有效干预措施的需求日益突显,而如何发挥中医药在调治亚健康方面的优势及评价中医药干预亚健康的效果,是今后亚健康干预研究的一个重要研究方向。目的:评价"消疲怡神"配方颗粒干预肝郁脾虚型疲劳性亚健康状态的有效性及安全性。设计、场所、受试者和干预措施:采用多中心、随机、双盲、安慰剂对照试验,观测时间为18周,其中干预6周,随访12周。将来自北京小汤山医院、河南中医学院第一附属医院及辽宁中医药大学附属医院的体检中心及门诊的200例肝郁脾虚型疲劳性亚健康状态的受试者随机分为"消疲怡神"配方颗粒组(简称消疲怡神组,n=100)和安慰剂组(n=100),分别给予"消疲怡神"配方颗粒和安慰剂干预6周。主要结局指标:运用疲劳量表-14(Fatigue Scale14,FS-14)总分来判断疲劳状况,并进行中医证候(肝郁脾虚证)积分评价。结果:消疲怡神组有3例失访,最后200例进入全分析集(full analysisset,FAS),197例进入符合方案集"(per-protocol set,PPS)。消疲怡神组与安慰剂组疲劳状态的疗效(FS-14分值)显示,完全缓解率分别为14.0%和9.0%(FAS)与14.4%和9.0%(PPS),显效率分别为19.0%和15.0%(FAS)与19.6%和15.0%(PPS),有效率分别为39.0%和26.0%(FAS)与39.2%和26.0%(PPS),总有效率分别为72.0%和50.0%(FAS)与73.2%和50.0%(PPS)。Ridit分析显示"消疲怡神"配方颗粒改善疲劳状态的疗效优于安慰剂(P<0.05)。消疲怡神组与安慰剂组肝郁脾虚证候的疗效比较显示,完全缓解率分别为1.0%和0.0%(FAS)与1.0%和0.0%(PPS),显效率分别为20.0%和7.0%(FAS)与19.6%和7.0%(PPS),有效率分别为29.0%和24.0%(FAS)与29.9%和24.0%(PPS),总有效率分别为50.0%和31.0%(FAS)与50.5%和31.0%(PPS)。Ridit分析显示"消疲怡神"配方颗粒改善肝郁脾虚证候的疗效优于安慰剂(P<0.05)。第12周和18周随访表明,消疲怡神组的FS-14分�The demand for effective intervention for subhealth conditions is growing with increasing numbers of people being in a state of subhealth with a poor quality of life. Future research and evaluation of the treatment methods for subhealth conditions from the perspective of traditional Chinese medicine （TCM） may provide an important direction for developing effective management of these conditions.Objective：To evaluate the efficacy and safety of Xiaopi Yishen herbal extract granules （XPYS-HEG）,a compound traditional Chinese herbal medicine for relieving fatigue and promoting a cheerful spirit for the treatment of people with fatigue-predominant subhealth due to liver-qi stagnation and spleen-qi deficiency. Design,setting participants and interventions：A multi-center,randomized,double-blinded,placebo-controlled clinical study was undertaken. The study period was 18 weeks,including 6 weeks for intervention and 12 weeks for follow-up. Participants were recruited from medical center and outpatient clinics of three hospitals in China,i.e. Xiaotangshan Hospital of Beijing,the First Affiliated Hospital of Henan University of TCM and the Affiliated Hospital of Liaoning University of TCM. Two hundred participants who met the criteria of fatigue-predominant subhealth and liver-qi stagnation and spleen-qi deficiency in TCM were allocated randomly to the treatment group （XPYS,n=100） and control group （placebo,n=100）. Main outcome measures：The total score of Fatigue Scale-14 （FS-14） was used to evaluate the fatigue status of subjects and the extent of liver-qi stagnation and spleen-qi deficiency syndrome was also recorded. Results：Three cases in the XPYS group withdrew from the trial. There were 200 subjects who entered to full analysis set （FAS） analysis and 197 subjects fitted in the per-protocol set （PPS） analysis. （1） According to the score changes of FS-14,the effectiveness rates in the XPYS and placebo group were as follows：14.0% vs 9.0% （FAS） and 14.4% vs 9.0% （PPS） for co

关 键 词：中草药 疲劳 亚健康 证候 随机对照试验 双盲法 安慰剂 前瞻性研究 

分 类 号：R259[医药卫生—中西医结合]