中国抽动障碍患者西药治疗随机对照试验证据现状与趋势分析  

Trends and quality assessment of randomized controlled trials of western medicine for tic disorders in China

作　　者：杨静[1] 王平平 俞丹[3,4] 黄亮 张伶俐[3,5] 杨春松[3,5] YANG Jing;WANG Ping-ping;YU Dan;HUANG Liang;ZHANG Ling-li;YANG Chun-song(The Fourth People＇s Hospital of Chengdu,Chengdu 610031,China;The 401^th Hospital of PLA,Chengdu 610041,China;Department of Pharmacy,Evidence-based Pharmacy Center,West China Second Hospital,Sichuan University,Chengdu 610041,China;Department of Pediatric,West China Second Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Ministry of Education,Chengdu 610041,China)

机构地区：[1]成都市第四人民医院药学部,四川成都610031 [2]解放军401医院,四川成都610041 [3]四川大学出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041 [4]四川大学华西第二医院儿科,四川成都610041 [5]四川大学华西第二医院药学部/循证药学中心,四川成都610041

出　　处：《中国药物应用与监测》2018年第3期181-185,共5页Chinese Journal of Drug Application and Monitoring

基　　金：国家自然科学基金项目(81373381)

摘　　要：目的:评价中国抽动障碍(TDs)患者西药治疗随机对照试验(RCTs)的现状与发展趋势,为未来国内临床研究提供参考依据。方法:计算机检索国内外6个数据库,纳入国内外发表的西药治疗TDs的RCT,记录基线情况,采用Cochrane偏倚风险评价工具对其进行质量评价。结果:共纳入84篇文献,总共6562例患者,其中男性4640例。纳入研究中,仅2.4%(2/84)研究进行了样本量计算,4.8%(4/84)为多中心研究,研究中心数2~8个。29.8%(25/84)研究在教学医院完成;干预措施中,14.3%(12/84)为典型抗精神病药、45.2%(38/84)为非典型抗精神病药,28.6%(24/84)为抗癫痫药,6.0%(5/84)为α受体激动剂。对照措施中,3.6%(3/84)采用安慰剂对照,96.4%(81/84)采用阳性药物对照。20.3%(17/84)研究报告了正确的随机分配方法,仅3.6%(3/84)报告了完善的分配方案隐藏,7.1%(6/84)采用了正确的盲法。结论:近年中国发表抽动障碍药物治疗RCT数量不多,其中非典型的抗精神病药物(利培酮,阿立哌唑,喹硫平)和抗癫痫药物(托吡酯)是研究热点药物。研究样本量偏低,缺乏多中心研究,整体报告质量不理想,提高抽动障碍中治疗试验的设计与实施质量需引起更多重视。Objective： To systematically evaluate the current status of randomized controlled trials（RCTs） focusing on drug therapy for tic disorders in China and provide evidences for the development of clinical trails in China. Methods： A comprehensive and systematic literature search was carried out to collect all RCTs focusing on TDs drug therapy in 6 databases including the Pub Med, Embase and four Chinese Databases. The quality of the literature was evaluated by the Cochrane bias risk assessment tool. Results： A total of 84 RCTs and 6562 patients were included in this study, among which male patients were totally 4640. A small quantity of RCTs had been published in the past 19 years. Among all the enrolled RCTs, only 2.4%（2/84） of RCTs involved sample size. 4.8%（4/84） of RCTs were multicenter studies involving two to eight centers. 29.8%（25/84） of RCTs were performed in teaching hospitals. For drug therapy, typical antipsychotics, atypical antipsychotics, antiepileptic drugs and alpha-2 adrenergic agonists were involved in 14.3%（12/84） of RCTs, 45.2%（38/84） of RCTs, 28.6%（24/84） of RCTs and 6.0%（5/84） of RCTs respectively. Only 3.6%（3/84） of RCTs used a placebo control while 96.4%（81/84） of RCTs used a positive drug control. 20.3%（17/84） of RCTs correctly stated random grouping methods, in which only 3.6%（3/84） of RCTs stated complete blind allocation plans. 7.1%（6/84） of RCTs was correctly blinded. Conclusion： In recent years, the number of high-quality RCTs remains scarce in China, which were mainly focusing on atypical antipsychotic agonists（risperidone, aripiprazole and quetiapine） and antiepileptic drugs（topiramate）. Most published RCTs had small samples, no multicenters and low quality. We must pay more attentions to improve the study design and quality of RCTs on drug therapy for tic disorders in China.

关 键 词：抽动障碍 药物治疗 随机对照试验 质量评价 

分 类 号：R969.3[医药卫生—药理学]