黄连治疗溃疡性结肠炎：一项随机临床试验的系统评价与Meta分析方案
Huang Lian for ulcerative colitis: A protocol of systematic review and meta-analysis of randomized clinical trials.
作者信息
Li Tinglin, Wu Mengzhu, Wang Lizhen, Song Xiaohan, Feng Peimin
机构信息
Hospital of Chengdu University of Traditional Chinese Medicine.
Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
出版信息
Medicine (Baltimore). 2020 Oct 2;99(40):e22457. doi: 10.1097/MD.0000000000022457.
INTRODUCTION
Ulcerative Colitis is a chronic nonspecific inflammatory disease of the colon and rectum, which is of global concern. It has the characteristics of a long course of disease and repeated attacks, which seriously affects the quality of life and economic and social development of the affected population. The treatment of UC by herb Huanglian and compound prescription contain Huanglian have been proved. However, due to the lack of evidence, there is no specific method or suggestion, it is necessary to systematically evaluate coptidis so as to provide effective evidence for further research.
METHODS AND ANALYSIS
The following databases will be searched from their inception to June 2020: Electronic databases included PubMed, Embase, Cochrane Library, Web of Science, Nature, Science Online, WanFang China Biomedical Database, VIP Medical Information, CNKI (Knowledge Infrastructure of China).
MAIN OUTCOMES
Colonoscopy, improved condition (tenesmus), stool routine. Additional outcomes: Electrocardiogram (ECG), erythrocyte (RBC), leukocyte (WBC), platelet (PLT). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0.
RESULTS
The results of this study will systematically evaluate the efficacy and safety of rhizoma coptidis intervention in patients with Ulcerative Colitis.
CONCLUSION
Through the systematic review of this study, the published evidence of rhizoma coptidis on the treatment of UC is summarized so as to further guide its promotion and application.
ETHICS AND COMMUNICATION
This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations.
OPEN SCIENCE FRA MEWORK (OSF) REGISTRATION NUMBER: August 27, 2020. osf.io/7nh3k (https://osf.io/7nh3k).
引言
溃疡性结肠炎是一种结肠和直肠的慢性非特异性炎症性疾病，受到全球关注。它具有病程长和反复发作的特点，严重影响患者的生活质量以及受影响人群的经济和社会发展。黄连及含黄连复方对溃疡性结肠炎的治疗已有相关证明。然而，由于缺乏证据，尚无具体方法或建议，有必要对黄连进行系统评价，以便为进一步研究提供有效证据。
方法与分析
检索以下数据库自建库至2020年6月的数据：电子数据库包括PubMed、Embase、Cochrane图书馆、科学引文索引、自然、科学在线、中国万方生物医学数据库、维普医药信息、中国知网。
主要结局指标
结肠镜检查、病情改善（里急后重）、大便常规。附加结局指标：心电图、红细胞、白细胞、血小板。数据将由两名研究人员独立提取，基于Cochrane干预措施系统评价手册评估Meta分析的偏倚风险。所有数据分析将使用数据统计软件Review Manager V.5.3和Stata V.12.0进行。
结果
本研究结果将系统评价黄连干预溃疡性结肠炎患者的疗效和安全性。
结论
通过本研究的系统评价，总结黄连治疗溃疡性结肠炎的已发表证据，以进一步指导其推广应用。
伦理与传播
本研究为系统评价，结局基于已发表证据，因此本研究无需伦理委员会审查和批准。我们打算在期刊上发表研究结果或在会议上进行展示。
开放科学框架（OSF）注册号：2020年8月27日。osf.io/7nh3k（https://osf.io/7nh3k）
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