清肺排毒汤治疗新型冠状病毒肺炎：一项随机对照试验的Meta分析和系统评价方案
Qingfei Paidu decoction for treating COVID-19: A protocol for a meta-analysis and systematic review of randomized controlled trials.
作者信息
Zhang Yuan, Xie Hongyan, Li Yan, Li Tianhao, Yuan Haipo, Fu Xiaoxu, Xie Chunguang
机构信息
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.
出版信息
Medicine (Baltimore). 2020 Sep 4;99(36):e22040. doi: 10.1097/MD.0000000000022040.
BACKGROUND
Coronavirus disease 2019 (COVID-19) is one of the infectious diseases that have seriously threatened global public health since its outbreak in 2019. Due to the complicated Pathogenesis, high infectivity and high fatality rate of COVID-19, there is currently no effective treatment for such epidemic disease. Traditional Chinese medicine has a long clinical history for the prevention and treatment of this kind of acute infectious disease. Qingfei Paidu Decoction (QFPD) is widely used in treating COVID-19 in China. However, there is still a lack of comprehensive and systematic evidence on the effectiveness and safety of Qingfei Paidu Decoction.
METHODS
We will search each database from the built-in until May 2020. The English literature mainly searches Cochrane Library, PubMed, EMBASE, and Web of Science, while the Chinese literature comes from CNKI, CBM, VIP, and Wangfang database. Simultaneously we will retrieval clinical registration tests and grey literatures. This study only screen the clinical randomized controlled trials (RCTs) about QFPD for COVID-19 to assess its efficacy and safety. The two researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on whether or not heterogeneity exists. Total clinical effective rate, improvement rate of lung CT, adverse events were evaluated as the main outcomes. Effective rate of clinical symptoms, treatment time were secondary outcomes. Finally, meta-analysis was conducted by RevMan software version 5.3.
RESULTS
The results of our research will be published in a peer-reviewed journal.
CONCLUSION
This systematic review aims to provide new evidence of QFPD for COVID-19 in terms of its efficacy and safety.
PROSPERO REGISTRATION NUMBER
CRD42020200894.
背景
2019年冠状病毒病（COVID-19）自2019年爆发以来，是严重威胁全球公共卫生的传染病之一。由于COVID-19发病机制复杂、传染性高且病死率高，目前针对这种流行病尚无有效的治疗方法。中医在预防和治疗这类急性传染病方面有着悠久的临床历史。清肺排毒汤（QFPD）在中国被广泛用于治疗COVID-19。然而，关于清肺排毒汤有效性和安全性仍缺乏全面系统的证据。
方法
我们将检索截至2020年5月的各数据库。英文文献主要检索Cochrane图书馆、PubMed、EMBASE和科学网，中文文献来自中国知网、中国生物医学文献数据库、维普数据库和万方数据库。同时检索临床注册试验和灰色文献。本研究仅筛选关于清肺排毒汤治疗COVID-19的临床随机对照试验（RCT）以评估其疗效和安全性。两名研究人员独立进行文献筛选、数据提取和质量评估。二分数据用相对危险度（RR）表示，连续数据用均数差（MD）或标准化均数差（SMD）表示，最终根据是否存在异质性，使用固定效应模型（FEM）或随机效应模型（REM）对数据进行合成。以总临床有效率、肺部CT改善率、不良事件作为主要结局进行评估。临床症状有效率、治疗时间为次要结局。最后，采用RevMan 5.3版软件进行荟萃分析。
结果
我们的研究结果将发表在同行评审期刊上。
结论
本系统评价旨在为清肺排毒汤治疗COVID-19的疗效和安全性提供新的证据。
国际前瞻性系统评价注册编号
CRD42020200894。
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