温胆汤加减方治疗精神分裂症不良反应/事件的Meta分析  

Adverse Drug Reactions/Events of Modified Wendan Decoction for Schizophrenias: a Meta-analysis

作　　者：李昂[1] 张冰[1,2] 张丹 张晓朦[1] 林志健[1] Li Ang;Zhang Bing;Zhan Dan;Zhang Xiaomeng;Lin Zhijian(School of Chinese Pharmacy,Beijing University of Chinese Medicine,Beijing 100029,China;Center for Pharmacovigilanceand Rational Use of Chinese Medicine,Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学中药学院,北京100029 [2]北京中医药大学中药药物警戒与合理用药研究中心

出　　处：《药物流行病学杂志》2020年第1期23-29,60,共8页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金项目(编号:81874349);中医药传承与创新“百千万”人才工程(岐黄工程)岐黄学者项目(国家中医药管理局项目)。

摘　　要：目的:系统评价温胆汤加减方治疗精神分裂症的临床安全性。方法:计算机检索CNKI、WanFang Data、VIP、SinoMed、PubMed、 Cochrane Library数据库,搜集有关温胆汤加减方治疗精神分裂症的随机对照试验(RCT),检索时限均为建库至2019年5月1日,由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,对药品不良反应/事件发生率采用RevMan 5.3软件进行Meta分析。结果:共纳入18个RCT,包括1 461例受试者。应用温胆汤加减方治疗精神分裂症的总药品不良反应/事件发生率小于常规西药。单独应用温胆汤加减方治疗精神分裂症会发生失眠、口干、视物模糊、心电图异常等不良反应。Meta分析结果显示,应用温胆汤加减方的锥体外系反应发生率小于常规西药[RR=0.26,95%CI(0.22,0.32),P<0.000 01]。以温胆汤组用药方案是否联用西药进行亚组分析,结果显示,单独应用温胆汤加减方治疗精神分裂症时的椎体外系反应发生率小于西药对照组[RR=0.02,95%CI(0.01,0.09),P<0.000 01],温胆汤加减方联用西药时的发生率也小于西药对照组[RR=0.34,95%CI(0.28,0.41),P<0.000 01];此外,应用温胆汤加减方的消化系统不良反应、头晕头痛、失眠发生率均小于仅用常规西药。结论:临床上,应用温胆汤加减方治疗精神分裂症的安全性良好,能够改善抗精神病药物引起的椎体外系反应等不良反应/事件,减轻患者痛苦。但本研究结果仍需高质量RCT进一步验证。Objective:To systematically evaluate the clinical safety of Wendan Decoction in the treatment of schizophrenia. Methods:CNKI, VIP, WanFang Data, SinoMed, PubMed and Cochrane Library were electronically searched to collect randomized controlled trial(RCT) regarding Wendan Decoction treating schizophrenia from inception to May 1, 2019. Two reviewers independently screened literatures, extracted data and assessed the risk of bias of included studies. Then the data were extracted and Meta-analyzed by RevMan 5.3 software.Results:A total of 18 RCTs involving 1 461 participants were included. The incidence of total adverse drug reactions/events(ADR/ADE) in the treatment of schizophrenia with Wendan Decoction was less than that of western medicine. Treatment of schizophrenia with Wendan Decoction alone may cause insomnia, dry mouth, blurred vision and abnormal electrocardiogram. Results of Meta-analysis showed that the incidence of extrapyramidal symptoms with Wendan Decoction was less than that of western medicine(RR=0.26, 95%CI 0.22 to 0.32, P<0.000 01). Subgroup analysis showed that the incidence of extrapyramidal symptoms in schizophrenia treated with Wendan Decoction alone was lower than that with western medicine(RR=0.02, 95%CI 0.01 to 0.09, P<0.000 01), and that with Wendan Decoction combined with western medicine was also lower than that of Western medicine only(RR=0.34, 95%CI 0.28 to 0.41, P<0.00 01). The incidence of ADR of digestive system, dizziness, headache and insomnia with Wendan Decoction was lower than that with western medicine only. Conclusion:Thus, our study showed that Wendan Decoction is safe in the treatment of schizophrenia, and can significantly reduce the incidence of extrapyramidal symptom and other ADR/ADE, while our conclusion should be confirmed by more well-designed and large-scale RCTs.

关 键 词：精神分裂症 温胆汤 药品不良反应 META分析 随机对照试验 

分 类 号：R289.56[医药卫生—方剂学]