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呋喃唑酮方案治疗感染的安全性:系统评价和荟萃分析。

Safety of furazolidone-containing regimen in infection: a systematic review and meta-analysis.

机构信息

Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shangdong, China.

Laboratory of Translational Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

出版信息

BMJ Open. 2020 Oct 19;10(10):e037375. doi: 10.1136/bmjopen-2020-037375.

Abstract

OBJECTIVES

Furazolidone containing regimen is effectivefor () infection, but its safetyremains controversial. To assess the safety of furazolidone containing regimenin infection.

DESIGN

A systematic review and meta-analysis.

DATA SOURCES

PubMed, Embase, Cochrane Library, Web of Science and Scopus databases were systematically searched for eligible randomised controlled trials.

ELIGIBILITY CRITERIA

Studies comparing furazolidone with non-furazolidone-containing regimen, variable durations or doses of furazolidone were included.

DATA EXTRACTION AND SYNTHESIS

Two reviewers independently selected studies and extracted data. Primary outcomes were the risk of total adverse events (AEs), serious AEs and severe AEs, expressed as relative risk (RR) with 95% CI. Secondary outcomes contained the incidence of individual adverse symptoms, AE-related treatment discontinuation and compliance.

RESULTS

Twenty-six articles were identified from 2039 searched records, of which 14 studies (n=2540) compared furazolidone with other antibiotics. The eradication rates of furazolidone-containing regimen were higher than those of other antibiotics in both intention-to-treat (RR 1.06, 95% CI 1.01 to 1.12) and per-protocol analysis (RR 1.05, 95% CI 1.00 to 1.10). Only two serious AEs were reported in furazolidone group (2/1221, 0.16%). No significant increased risk was observed for the incidence of total AEs (RR 1.04, 95% CI 0.89 to 1.21) and severe AEs (RR 1.81, 95% CI 0.91 to 3.60). Twelve studies (n=3139) compared different durations of furazolidone, and four studies (n=343) assessed variable doses. Elevated risk of total AEs and severe AEs were only found in a high daily dose of furazolidone rather than prolonged duration. The incidence of AE-related treatment discontinuation and compliance of patients were all similar, irrespective of dose and duration adjustments.

CONCLUSION

Furazolidone-containing regimen has a similar risk of AEs and compliance as non-furazolidone-containing regimen. A low daily dose of 200 mg is well-tolerated for 14 day regimen and should be first considered.

PROSPERO REGISTRATION NUMBER

CRD42019137247.

摘要

目的

含呋喃唑酮方案对幽门螺杆菌感染有效,但安全性仍存在争议。本研究旨在评估含呋喃唑酮方案治疗幽门螺杆菌感染的安全性。

设计

系统评价和荟萃分析。

数据来源

通过 PubMed、Embase、Cochrane 图书馆、Web of Science 和 Scopus 数据库系统地检索了合格的随机对照试验。

入选标准

比较呋喃唑酮与非呋喃唑酮方案、不同呋喃唑酮疗程或剂量的研究。

数据提取和综合

两位评审员独立选择研究并提取数据。主要结局是总不良反应(AE)、严重 AE 和重度 AE 的风险,以相对风险(RR)和 95%置信区间(CI)表示。次要结局包括个别不良反应症状的发生率、AE 相关治疗中断和依从性。

结果

从 2039 条检索记录中确定了 26 篇文章,其中 14 项研究(n=2540)比较了呋喃唑酮与其他抗生素。意向治疗分析(RR 1.06,95%CI 1.01 至 1.12)和方案分析(RR 1.05,95%CI 1.00 至 1.10)中,含呋喃唑酮方案的根除率均高于其他抗生素。仅在呋喃唑酮组报告了 2 例严重不良事件(2/1221,0.16%)。总 AE(RR 1.04,95%CI 0.89 至 1.21)和重度 AE(RR 1.81,95%CI 0.91 至 3.60)的发生率未见显著增加。12 项研究(n=3139)比较了不同疗程的呋喃唑酮,4 项研究(n=343)评估了不同剂量。仅在高剂量(RR 1.04,95%CI 0.89 至 1.21)而非延长疗程时发现总 AE 和重度 AE 的风险增加。AE 相关治疗中断和患者依从性的发生率均相似,无论剂量和疗程调整如何。

结论

含呋喃唑酮方案与非呋喃唑酮方案的 AE 发生率和依从性相似。低剂量(200mg/d)呋喃唑酮 14 天方案耐受性良好,应首先考虑。

PROSPERO 注册号:CRD42019137247。

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