探讨双盲设计在针刺治疗癌痛RCT中的可行性——一个小样本随机对照双盲试验  

Exploring the Feasibility of Applying Double Blind Design in Randomized Controlled Clinical Trial of Acupuncture Treating Carcinous Pain——A randomized controlled double blind trial in a small sample

作　　者：彭浩[1] 彭海东[1] 许玲[1] 

机构地区：[1]第二军医大学长征医院中医科,上海200003

出　　处：《江西中医学院学报》2010年第4期26-31,共6页Journal of Jiangxi College of Traditional Chinese Medicine

摘　　要：目的:探讨双盲设计在针刺治疗癌痛的随机对照临床试验(RCT)中的可行性,并根据试验过程中出现的现象,为以后同类RCT提供设计上的建议。方法:将22例癌痛患者根据疼痛程度分为3层,再把每层病人随机分配到针刺组和安慰组。用VAS量表评价疼痛缓解情况,用自评问卷了解盲法效果。结果:在安慰组的11名患者中,除2名因病情急剧恶化未完成问卷外,只有1名患者以"镇痛效果不明显"的理由认为自己接受的是安慰性治疗。结论:双盲设计在针刺治疗癌痛的临床研究中是可行的。此次研究对未来大规模RCT设计上的思考:(1)采取多中心合作的方式扩大研究病例数;(2)增加对针刺治疗癌痛即时效果的观察;(3)采用VAS与VRS-5相结合的疼痛评价方法。Objective： To explore the feasibility of applying double blind design in randomized controlled clinical trial（RCT） of acupuncture treating carcinous pain,and provide reference for future similar RCTs based on the observation of the trial.Method： 22 patients with carcinous pain were stratified into 3 groups,then randomized into acupuncture group and placebo group.VAS scale was used to evaluate the effect of pain alleviation.Result： Among the 11 patients of placebo group,only 1 patient thought that he was assigned into placebo group based on the reason that the ＂analgesic effect was not obvious＂.Also,there were another 2 patients couldn＇t complete the questionnaire due to sudden deterioration of their conditions.Conclusion： Double blind design is feasible in clinical trial of acupuncture treating patients with carcinous pain.This trail is of reference value to future large scale RCTs,in that：（1） multi-center cooperative mode should be employed to increase the number of cases;（2） the observation of the effect of acupuncture treating carcinous pain should be strengthened;（3） the combination of VAS and VRS-5 should be employed to evaluate patients with carcinous pain.

关 键 词：针刺疗法 癌痛 双盲试验 

分 类 号：R246.5[医药卫生—针灸推拿学]