Kakia Aloysious, Wiysonge Charles S, Ochodo Eleanor A, Awotedu Abolade A, Ristic Arsen D, Mayosi Bongani M
Department of Family Medicine and Rural Health, Walter Sisulu University, Mthatha, South Africa.
Centre for Evidence-based Health Care, Stellenbosch University, Cape Town, South Africa Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa.
BMJ Open. 2016 Jan 5;6(1):e007842. doi: 10.1136/bmjopen-2015-007842.
Intrapericardial fibrinolysis has been proposed as a means of preventing complications of pericardial effusion such as cardiac tamponade, persistent and recurrent pericardial effusion, and pericardial constriction. There is a need to understand the efficacy and safety of this procedure because it shows promise.
We aim to assess the effects of intrapericardial fibrinolysis in the treatment of pericardial effusion. We will search PubMed, the Cochrane Library, African Journals online, Cumulative Index to Nursing and Allied Health Literature, Trip database, Clinical trials.gov and the WHO International Clinical Trials Registry Platform for studies that evaluate the efficacy and/or safety of complete pericardial fluid drainage by intrapericardial fibrinolysis irrespective of study design, geographical location, language, age of participants, aetiology of pericarditis or types of fibrinolytics. Two authors will do the search independently, screen the search outputs for potentially eligible studies and assess whether the studies meet the inclusion criteria. Discrepancies between the two authors will be resolved through discussion and arbitration by a third author. Data from the selected studies shall be extracted using a standardised data collection form which will be piloted before use. The methodological quality of studies will be assessed using the Cochrane Collaboration's tools for assessing risk of bias for experimental studies and non-randomised studies, respectively. The primary meta-analysis will use random effects models due to expected interstudy heterogeneity. Dichotomous data will be analysed using relative risk and continuous with data mean differences, both with 95% CIs.
Approval by an ethics committee is not required for this study as it is a protocol for a systematic review of published studies. The results will be disseminated through a conference presentation and peer-reviewed publication.
PROSPERO, CRD42014015238.
心包内纤维蛋白溶解术已被提议作为预防心包积液并发症的一种方法，如心脏压塞、持续性和复发性心包积液以及心包缩窄。由于该方法显示出前景，因此有必要了解其疗效和安全性。
我们旨在评估心包内纤维蛋白溶解术治疗心包积液的效果。我们将检索PubMed、Cochrane图书馆、非洲在线期刊、护理及相关健康文献累积索引、Trip数据库、ClinicalTrials.gov以及世界卫生组织国际临床试验注册平台，以查找评估心包内纤维蛋白溶解术完全引流心包积液的疗效和/或安全性的研究，无论研究设计、地理位置、语言、参与者年龄、心包炎病因或纤维蛋白溶解剂类型如何。两位作者将独立进行检索，筛选检索结果以查找潜在符合条件的研究，并评估这些研究是否符合纳入标准。两位作者之间的差异将通过讨论并由第三位作者进行仲裁来解决。将使用标准化数据收集表提取所选研究的数据，该表在使用前将进行预试验。将分别使用Cochrane协作网评估实验性研究和非随机研究偏倚风险的工具来评估研究的方法学质量。由于预期研究间存在异质性，主要的荟萃分析将使用随机效应模型。二分数据将使用相对风险进行分析，连续数据将使用数据均值差异进行分析，两者均带有95%置信区间。
本研究无需伦理委员会批准，因为这是一项对已发表研究进行系统评价的方案。研究结果将通过会议报告和同行评审出版物进行传播。
PROSPERO，CRD42014015238。
