Yu Ying, Zhang Gong, Han Tao, Li Jie, Huang Hai-Liang
College of Traditional Chinese Medicine,Shandong University of Traditional Chinese Medicine Ji'nan 250355,China.
Zhongguo Zhong Yao Za Zhi. 2019 Dec;44(23):5217-5224. doi: 10.19540/j.cnki.cjcmm.20190522.501.
To evaluate the clinical efficacy and safety of Shugan Jieyu Capsules,Jieyu Pills and Xiaoyao Pills in the treatment of liver-stagnation and spleen-deficiency depression by the network Meta-analysis( NMA),so as to provide evidence-based clinical practice. Chinese databases,including CNKI,VIP,Wan Fang Data,CBM as well as English databases including the Cochrane Library,PubMed,EMbase and Web of Science were retrieved from inception to October 30,2018,to collect randomized controlled trials( RCTs) about clinical study of the three kinds of Chinese patent medicines. The quality and bias risk of the included studies were assessed by 5. 1 standard in Cochrane Handbook,ADDIS software was applied in the statistical analysis,and the result were compared by NMA. A total of 37 studies involving 3 105 patients were included. The results of NMA showed that the adjuvant therapy with the three kinds of traditional Chinese patent medicines could improve the clinical efficacy. Jieyu Pills had the most significant effect( OR = 4. 59,95%CI[1. 94,12. 71],P<0. 05). In HAMD,Shugan Jieyu Capsules( MD = 3. 22,95%CI[2. 07,4. 39],P< 0. 05) and Xiaoyao Pills( MD= 2. 23,95%CI[0. 41,4. 03],P<0. 05) can effectively reduce the depression scale indicators. In the incidence of adverse reactions,the three kinds of Chinese patent medicines can reduce the incidence of adverse reactions. The three kinds of Chinese patent medicines can be combined with auxiliary Western medicine to treat liver-stagnation and spleen-deficiency depression,with complementary advantages in action mechanisms. In the clinical efficacy and safety,the Chinese patent medicines had good clinical manifestations. Although this study showed that Jieyu Pills may be the referred medicine for depression,this conclusion is still immature and needs to be further verified by high-quality RCTs studies,and the application shall be selective based on specific characteristics in clinic.
通过网状Meta分析（NMA）评价疏肝解郁胶囊、解郁丸和逍遥丸治疗肝郁脾虚型抑郁症的临床疗效和安全性，为临床实践提供循证依据。检索中国知网（CNKI）、维普（VIP）、万方数据、中国生物医学文献数据库（CBM）等中文数据库以及考克兰图书馆、PubMed、EMbase、Web of Science等英文数据库，检索时间从建库至2018年10月30日，收集三种中成药临床研究的随机对照试验（RCT）。采用考克兰手册5.1标准评估纳入研究的质量和偏倚风险，应用ADDIS软件进行统计分析，采用NMA比较结果。共纳入37项研究，涉及3105例患者。NMA结果显示，三种中成药辅助治疗均能提高临床疗效。解郁丸效果最为显著（OR=4.59，95%CI[1.94，12.71]，P<0.05）。在汉密尔顿抑郁量表（HAMD）评分方面，疏肝解郁胶囊（MD=3.22，95%CI[2.07，4.39]，P<0.05）和逍遥丸（MD=2.23，95%CI[0.41，4.03]，P<0.05）能有效降低抑郁量表指标。在不良反应发生率方面，三种中成药均能降低不良反应发生率。三种中成药可联合辅助西药治疗肝郁脾虚型抑郁症，作用机制优势互补。在临床疗效和安全性方面，中成药具有良好的临床表现。虽然本研究显示解郁丸可能是抑郁症的推荐用药，但该结论仍不成熟，需要高质量RCT研究进一步验证，临床应用应根据具体情况选择性使用。
