Yu Ying, Zhang Gong, Han Tao, Huang Hailiang
2018 Level Doctor's Degree Graduate Class.
2017 Level Doctor's Degree Graduate Class, College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine.
Medicine (Baltimore). 2020 Feb;99(7):e19142. doi: 10.1097/MD.0000000000019142.
Depression is a kind of chronic and recurrent mental disorder, the main clinical characteristics of the patients are marked and persistent depression. At the same time, it is often accompanied by chronic physical disease, cognitive impairment, and functional damage, which is one of the common diseases that seriously threaten human health. At present, 3 kinds of oral Chinese patent medicine have clinical comparability in the treatment of depression of liver stagnation and spleen deficiency, but there is no evidence for clinical efficacy and safety. Therefore, this study aims to integrate the clinical related syndromes of direct and indirect comparison by using systematic evaluation and network meta-analysis (NMA). According to the data, the different Chinese patent medicines with the same evidence body for the treatment of the disease are collected, analyzed, and sequenced in a quantitative and comprehensive way, and then the advantages and disadvantages of the efficacy and safety between different Chinese patent medicines are screened out to get the best choice scheme, thus providing reference value and evidence-based theoretical evidence for the clinical optimization of drug selection.
Comprehensive retrieval of China National Knowledge Infrastructure, Chinese scientific journal database (VIP), China biological feature database (CBM) and WANFANG Data Chinese electronic database and the Cochrane Library, PubMed, Web of Science, and EMBASE foreign database. Search and publish the clinical randomized controlled trials of these 3 Chinese patent medicines combined with fluoxetine compared with fluoxetine. The retrieval time is from the establishment of the database to October 31, 2019. The 2 first authors will screen the literatures that meet the inclusion criteria, extract the data independently according to the predesigned rules, and evaluate the literature quality and bias risk of the included research according to the Cochrane 5.1 manual standard. R and Aggregate Data Drug Information System software were used for data consolidation and NMA to evaluate the ranking probability of all interventions.
This result will show that the best oral Chinese patent medicine to assist the treatment of liver stagnation and spleen deficiency depression provides reliable evidence.
This study will provide systematic evidence-based medicine evidence for TCM assisted treatment of depression of liver stagnation and spleen deficiency type, and help clinicians, patients with depression and decision-makers to make more effective, safer, and economic optimal treatment plan in the decision-making process.
CRD42019115695.
抑郁症是一种慢性复发性精神障碍，患者的主要临床特征为显著而持久的抑郁情绪。同时，常伴有慢性躯体疾病、认知损害及功能损害，是严重威胁人类健康的常见疾病之一。目前，3种口服中成药在治疗肝郁脾虚型抑郁症方面具有临床可比性，但缺乏临床疗效及安全性证据。因此，本研究旨在运用系统评价和网状Meta分析（NMA）综合直接和间接比较的临床相关证候。依据数据，对治疗该疾病具有相同证据体的不同中成药进行收集、分析，并以定量和全面的方式排序，进而筛选出不同中成药之间疗效及安全性的优缺点，得出最佳选择方案，从而为临床优化选药提供参考价值和循证理论依据。
全面检索中国知网、维普中文科技期刊数据库、中国生物医学文献数据库和万方数据中文电子数据库以及Cochrane图书馆、PubMed、Web of Science和EMBASE外文数据库。检索并发表这3种中成药联合氟西汀与氟西汀比较的临床随机对照试验。检索时间为各数据库建库至2019年10月31日。由2位第一作者筛选符合纳入标准的文献，按照预先设计的规则独立提取数据，并依据Cochrane 5.1手册标准评估纳入研究的文献质量和偏倚风险。运用R软件和综合数据药物信息系统软件进行数据合并及NMA，以评估所有干预措施的排序概率。
该结果将显示辅助治疗肝郁脾虚型抑郁症的最佳口服中成药，提供可靠证据。
本研究将为中医辅助治疗肝郁脾虚型抑郁症提供系统的循证医学证据，有助于临床医生、抑郁症患者及决策者在决策过程中制定更有效、更安全且更经济的最佳治疗方案。
PROSPERO注册号：CRD42019115695。
