针刺治疗面瘫临床试验的优化设计研究  

Study on Optimal Design of Clinical Trial of Acupuncture in Treatment of Facial Paralysis

作　　者：杨联胜 周丹凤[1] 张昆[1] 郑淑珍 庄子齐[2] YANG Liansheng;ZHOU Danfeng;ZHANG Kun;ZHENG Shuzhen;ZHUANG Ziqi(Department of Acupuncture and Moxibustion,The Third Affiliated Hospital of Sun Yat-sen University,Guangzhou 510630,China;The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405,China)

机构地区：[1]中山大学附属第三医院中医针灸科,广东广州510630 [2]广州中医药大学第一附属医院,广东广州510405

出　　处：《现代中医药》2022年第1期53-59,共7页Modern Chinese Medicine

基　　金：广东省中医药管理局科研项目(20203014)。

摘　　要：目的基于国际高质量RCT探讨针刺治疗面瘫临床研究设计优化方案。方法在PubMed上运用主题词检索筛选近5年来影响因子≥10的支持针刺有效性的临床随机对照研究,由双人提取试验设计相关因素,总结高质量针刺临床试验的设计特点并探讨针刺治疗面瘫的临床研究优化方案。结果检索符合条件的文献8篇。研究采用多中心区组随机化(8/8),受试者(6/8)和(或)结局评估者、数据收集者、统计者盲法(7/8),假针刺安慰对照(7/8)和(或)阳性对照(2/8),主要及次要结局指标相结合的评估方法(8/8),基于先导研究的样本量评估(8/8),意向治疗分析(8/8)的设计方案。结论借鉴高质量针刺临床研究设计,可从区组随机化设计,电针为主的标准化针刺干预方案,固定非穴位点进行不刺入皮肤的假针刺安慰对照,盲法的设计及实施,以面神经功能恢复时间为主要结局与以抑郁、焦虑自评量表为次要结局的综合疗效评价设计等方面优化试验设计方案,提高针刺临床研究水平。Objective To explore the optimal scheme of clinical research design of acupuncture in the treatment of facial paralysis based on international high-quality RCT.Methods The subject word search was used on PubMed to screen the clinical randomized controlled studies supporting the effectiveness of acupuncture with influencing factors≥10 in recent 5 years.The relevant factors of trial design were extracted by two people,the design characteristics of high-quality acupuncture clinical trials were summarized,and the clinical research optimization scheme of acupuncture in the treatment of facial paralysis was discussed.Results Eight eligible literatures were retrieved.The study used multicenter group randomization(8/8),subject(6/8)and/or outcome evaluator,data collector and statistician blind method(7/8),sham acupuncture comfort control(7/8)and/or positive control(2/8),evaluation method combining primary and secondary outcome indicators(8/8),sample size evaluation based on pilot study(8/8),intention to treat analysis(8/8).Conclusion Based on the high-quality clinical research design of acupuncture,we can use the randomized design of regional groups,the standardized acupuncture intervention scheme dominated by electroacupuncture,fixed non acupoint points for false acupuncture comfort control without penetrating the skin,the design and implementation of blind method,with the recovery time of facial nerve function as the main outcome,and the comprehensive efficacy evaluation design with self rating depression and anxiety scale as secondary outcomes.So as to improve the level of acupuncture clinical research.

关 键 词：针刺 面瘫 临床试验 随机对照试验 优化设计 

分 类 号：R245[医药卫生—针灸推拿学]