目的:系统评价温胆汤联合抗精神病药物治疗精神分裂症(Schizophrenia SZ)的临床疗效和安全性。方法:计算机检索中国期刊全文数据库(CNKI)、万方数字化期刊全文数据库(Wanfang data)、维普中文科技期刊数据库(VIP)、Pubmed、Annual Reviews、Special Sci等数据库温胆汤联合抗精神病药物治疗SZ的临床随机对照试验,应用Jadad评分法和Cochrane手册5.1标准对纳入文献进行质量评价,采用review manager 5.2软件进行Meta分析。结果:纳入9项研究,共993例受试者,文献质量较低。Meta分析显示,试验组治疗SZ较对照组能提高有效率、痊愈率[OR=2.56,95%CI(1.72,3.82),P〈0.000 01]、[OR=1.89,95%CI(1.40,2.54),P〈0.000 01],降低阳性与阴性症状量表(PANSS)评分、锥体外系不良反应发生率[MD=-9.70,95%CI(-12.34,-7.03),P〈0.000 01]、[OR=0.29,95%CI(0.18,0.46),P〈0.000 01]。结论:温胆汤联合抗精神病药物治疗SZ较单纯抗精神病药物有更好的临床疗效和安全性,但仍需高质量的临床随机对照试验进一步证实。
Objectives: To review the clinical therapeutic effects and safety about the combinated treatment in terms of Wendan Decoction and antipsychotic drugs in schizophrenia systemically. Methods: Use the internet to retrieve the clinical randomized controlled trials about the combinated treatment in terms of Wendan Decoction and antipsychotic drugs in schizophrenia in the database of CNKI, VIP, Wanfang data, Pubmed, Annual Reviews, SpecialSci and so on. Use the Jadad scoring method and the Cochrane handbook 5.1 standard to evaluate the quality about the included literature and use the Review manager 5.2 software to make the Meta analysis. Results : Totally 9 related studies, 993 cases of subjects, yet the included literature has general low quality. The Mate analysis shows that the effective rate and the cure rate of the trial group are both superior to those of the control group in the treatment of schizophrenia[ OR =2.56,95% CI( 1.72, 3.82) ,P 〈 0. 000 01 ], [ OR = 1.89,95% CI ( 1.40,2.54), P 〈 0.000 01 ], while the PANSS score and the adverse effects rate of the extrapyramidal system of the trial group are below those of the control group[ MD = -9.70,95% CI ( - 12.34, -7.03) , P 〈0. 000 01 ] , [ OR =0.29,95% CI(0.18,0.46) ,P 〈0. 000 01J. Conclusion: The clinical therapeutic effects and safety about the combinated treatment in terms of Wendan Decoction and antipsychotic drugs in schizophrenia are better than the pure antipsychotic drugs. But it still needs the high - quality clinical randomized controlled trials to confirm further.