Yao Qin, Zhang Xinyue, Mu Yunnong, Liu Yajie, An Yu, Zhao Baixiao
Beijing University of Chinese Medicine, Beijing, China.
Medicine (Baltimore). 2019 Feb;98(7):e14541. doi: 10.1097/MD.0000000000014541.
Chronic urticaria is a common disease affecting patients' quality of life, and leading to substantial burden to both patients and society. Many trials have shown that bloodletting therapy is effective in treating chronic urticaria. There are currently no systematic reviews of bloodletting therapy for chronic urticaria. This protocol aims to present the methods used to assess the effectiveness and safety of bloodletting therapy for patients with chronic urticaria.
The following databases will be searched from their inception: the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP database), and Wan-Fang Database. Clinical randomised controlled trials related to bloodletting therapy for treating chronic urticaria will be included, regardless of publication status and languages. Study selection, data collection, and quality assessment will be independently conducted by 2 researchers. For data synthesis, we will select either the fixed-effects or random-effects model according to heterogeneity assessment. Disease activity control will be assessed as the primary outcomes. Response rate, recurrence rate and adverse events will be evaluated as secondary outcomes. If it is appropriate for meta-analysis, RevMan V.5.3 statistical software will be used. Otherwise, a systematic narrative synthesis will be conducted. The results will be presented as risk ratio (RR) with 95% confidence intervals (CIs) for dichotomous data and weight mean difference (WMD) or standard mean difference (SMD) 95% CIs for continuous data.
The protocol of this systematic review will be disseminated in a peer-reviewed journal and presented at relevant conferences. It is not necessary for a formal ethical approval because the data are not individualised.
PROSPERO CRD42018111143.
慢性荨麻疹是一种影响患者生活质量的常见疾病，给患者和社会都带来了沉重负担。许多试验表明，放血疗法在治疗慢性荨麻疹方面有效。目前尚无关于放血疗法治疗慢性荨麻疹的系统评价。本方案旨在介绍用于评估放血疗法治疗慢性荨麻疹患者有效性和安全性的方法。
将从各数据库建库起进行检索：Cochrane对照试验中心注册库（CENTRAL）、PubMed、EMBASE、中国知网（CNKI）、中国生物医学文献数据库（CBM）、中文科技期刊数据库（维普数据库）和万方数据库。纳入与放血疗法治疗慢性荨麻疹相关的临床随机对照试验，无论其发表状态和语言如何。研究筛选、数据收集和质量评估将由两名研究人员独立进行。对于数据合成，我们将根据异质性评估选择固定效应模型或随机效应模型。疾病活动控制将作为主要结局进行评估。缓解率、复发率和不良事件将作为次要结局进行评估。如果适合进行荟萃分析，将使用RevMan V.5.3统计软件。否则，将进行系统的叙述性合成。结果将以风险比（RR）及95%置信区间（CI）表示二分数据，以加权均数差（WMD）或标准化均数差（SMD）及95%CI表示连续数据。
本系统评价方案将在同行评审期刊上发表，并在相关会议上展示。由于数据不涉及个人化信息，无需正式伦理批准。
PROSPERO CRD42018111143。
