针灸治疗颈型颈椎病临床试验疗效与不良事件的期中分析  

Interim Analysis of Therapeutic Effects and Adverse Events of Clinical Trial in Neck Type of Cervical Spondylosis with Acupuncture

作　　者：李慧[1] 符文彬[1] 梁伟雄[2] 欧爱华[1] 朱晓平[1] 

机构地区：[1]广州中医药大学第二附属医院(广东省中医院),广东广州510120 [2]广州中医药大学,广东广州510405

出　　处：《中华中医药学刊》2017年第7期1665-1669,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：国家"十一五"科技支撑计划项目(2006BAI12B04);广东省自然基金项目(S2013010015427)

摘　　要：目的:根据临床试验前期病例纳入情况,结合灵活性较强的适应性设计方法,观察干预方案的主要疗效指标与不良事件情况。方法:采用条件概率法、α消耗函数法进行主要结局指标(Northwick Park颈痛量表)、次要结局指标(Mc Gill疼痛量表、SF-36量表)的期中分析,并进行不良事件的观察分析。结果:Northwick Park颈痛量表组间比较的早期终止概率和早期接受概率Pr分别为:0.005 2、0.001 97,0.001 97、0.004 5(治疗后);0.003 5、0.021 2,0.551 7、0.017 4(随访3个月);Mc Gill疼痛量表、SF-36量表各观察时点组间差异无显著性;3例不良事件判定为轻度不良反应。结论:主要、次要结局指标组间疗效差异无显著性。尚不能早期结束临床试验;针灸治疗具有较好安全性,应进一步规范穴位压豆治疗的操作。Objective ： According to the situation of included cases in the prophase of clinical trial and combining with the flexible adaptable design, the indexes for therapeutic effects and adverse events were observed. Methods ： The condition- al probability method and α- consumption function method were used in interim analysis of the primary outcome index （ Northwick Park cervicodynia scale） and the minor outcome indexes （ McGill pain questionnaire and SF - 36 scale） and the adverse events were observed and analyzed. Results：The early reliability probability and acceptance probability in Northwiek Park cervicodynia scale group were respectively 0. 005 2, 0. 001 97, 0. 001 97, 0. 004 5 （ after treatment ） ; 0. 003 5,0.021 2,0. 551 7,0. 017 4 （ after 3 months follow - up study）. There was no significant difference between two groups in the Northwick Park cervicodyuia scale group and SF -36 scale group at all time points. Three adverse events were regarded as mild adverse reaction. Conclusions：There was no significant difference between two groups in the primary outcome index and the minor outcome indexes. The test can not be terminated early. The operation of acupuncture is safe in clinic and the treatment of pressure at points with bean should be further standardized.

关 键 词：条件概率法 α消耗函数法 临床试验 期中分析 

分 类 号：R681.55[医药卫生—骨科学]