Hua Zhen, Zhai Feng-Ting, Tian Jinhui, Gao Cheng-Fei, Xu Peng, Zhang Fan, Liu Si-Jia, Dong Kun, Du Xiao-Feng, Zhang Zhe, Yang Guanlin
Shandong Provincial Qianfoshan Hospital, The First Hospital Affiliated with Shandong First Medical University, Jinan, China.
The First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, China.
BMJ Open. 2019 Sep 20;9(9):e026136. doi: 10.1136/bmjopen-2018-026136.
Achieving efficacious and safe treatments for unstable angina pectoris (UAP) is still a challenging clinical problem. The availability of different oral Chinese patent medicines frequently poses a practical challenge to clinicians, namely, which one to choose as first-line regimen for treatment. This study aims to examine the comparative effectiveness and safety of oral Chinese patent medicines for UAP on the national essential drugs list of China.
We will conduct a network meta-analysis (NMA) of all randomised controlled trials to evaluate the use of oral Chinese patent medicines as adjuvant for the treatment of UAP. We will explore eight electronic databases from their inception to June 2018 and search for grey literature. Primary outcomes include mortality and the cardiovascular events. Secondary outcomes include: (1) symptom improvement; (2) ECG improvement; (3) frequency of acute angina attack; (4) duration of angina; (5) adverse effects. Two independent authors will screen titles and abstracts, review full texts, extract data, assess the risk of bias using the Cochrane risk of bias tool and assess the quality of evidence and strength of the recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). If adequate data are available, NMA will be performed with Bayesian analysis methods.
The NMA will help us to reduce the uncertainty of interventions and help clinicians to make optimal and more accurate therapeutic decisions for adults with UAP. Therefore, we will publish the findings of this study in a peer-reviewed journal. No ethics approval is necessary for this study based on the nature of its design.
CRD42018092822.
实现对不稳定型心绞痛(UAP)有效且安全的治疗仍是一个具有挑战性的临床问题。多种口服中成药的存在常常给临床医生带来实际挑战,即选择哪一种作为一线治疗方案。本研究旨在探讨中国国家基本药物目录中的口服中成药治疗UAP的相对有效性和安全性。
我们将对所有随机对照试验进行网状Meta分析(NMA),以评估口服中成药作为辅助药物治疗UAP的效果。我们将检索从建库至2018年6月的八个电子数据库,并搜索灰色文献。主要结局包括死亡率和心血管事件。次要结局包括:(1)症状改善;(2)心电图改善;(3)急性心绞痛发作频率;(4)心绞痛持续时间;(5)不良反应。两名独立作者将筛选标题和摘要、审阅全文、提取数据、使用Cochrane偏倚风险工具评估偏倚风险,并使用推荐分级的评估、制定与评价(GRADE)方法评估证据质量和推荐强度。如果有足够的数据,将采用贝叶斯分析方法进行NMA。
NMA将有助于我们减少干预措施的不确定性,并帮助临床医生为患有UAP的成年人做出最佳、更准确的治疗决策。因此,我们将在同行评审期刊上发表本研究的结果。基于本研究的设计性质,无需伦理批准。
CRD42018092822。