Rheumatology Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
PhD in Experimental Medicine, University of Pavia, Pavia, Italy.
Rheumatology (Oxford). 2021 Aug 2;60(8):3553-3564. doi: 10.1093/rheumatology/keab267.
To assess available evidence from randomized controlled trials (RCTs) and observational studies including a control group regarding the role of trimethoprim/sulfametoxazole (TMP/SMX) in reducing the relapse rate in patients with granulomatosis with polyangiitis (GPA) and the risk of infections in patients with ANCA-associated vasculitis (AAV).
MEDLINE, EMBASE, The Cochrane Library databases, Scopus, Web of Science and ClinicalTrials.gov were searched from inception until 15 January 2020 to identify controlled studies assessing the role of TMP/SMX in reducing the rate of relapse in patients with GPA (primary outcome) and the number and/or severity of infections in patients with AAV (secondary outcome). Two reviewers independently selected eligible studies and extracted data. Cumulative risk ratios (RRs) with 95% CI were calculated using a random effect meta-analysis.
Eight studies were selected out of 2907 records. Seven studies (520 patients) (of which two were RCTs) assessed the role of TMP/SMX in the relapse rate in patients with GPA. TMP/SMX was not associated with a reduced risk of relapse (RR = 1.15, 95% CI: 0.51, 2.55; I2 = 78.5%; P < 0.001). Sensitivity analysis according to the dose of TMP/SMX (960 mg twice daily vs three times/week) confirmed the results. One retrospective cohort study (192 patients) was identified demonstrating a significant reduction of severe infections in patients with AAV receiving prophylaxis with TMP/SMX in association with rituximab.
TMP/SMX was not associated with a reduced risk of relapse in patients with GPA. TMP/SMX might be useful in the reduction of infectious complications.
CRD42019118983.
评估随机对照试验（RCT）和包括对照组的观察性研究中关于复方磺胺甲噁唑（TMP/SMX）在降低肉芽肿性多血管炎（GPA）患者复发率和抗中性粒细胞胞浆抗体（ANCA）相关性血管炎（AAV）患者感染风险中的作用的现有证据。
从建库至 2020 年 1 月 15 日，我们在 MEDLINE、EMBASE、The Cochrane Library 数据库、Scopus、Web of Science 和 ClinicalTrials.gov 中检索了评估 TMP/SMX 降低 GPA 患者复发率（主要结局）和 AAV 患者感染数量和/或严重程度（次要结局）的对照研究。两位评审员独立选择合格研究并提取数据。使用随机效应荟萃分析计算累积风险比（RR）及其 95%置信区间。
从 2907 条记录中筛选出 8 项研究。其中 7 项研究（520 例患者）（其中 2 项为 RCT）评估了 TMP/SMX 在 GPA 患者复发率中的作用。TMP/SMX 与降低复发风险无关（RR=1.15，95%CI：0.51，2.55；I2=78.5%；P<0.001）。根据 TMP/SMX 剂量（960mg 每日两次与每周三次）的敏感性分析结果证实了这一结果。一项回顾性队列研究（192 例患者）表明，与单独使用利妥昔单抗相比，在接受 TMP/SMX 预防治疗的 AAV 患者中，严重感染显著减少。
TMP/SMX 与 GPA 患者的复发风险降低无关。TMP/SMX 可能有助于减少感染并发症。
PROSPERO 数据库注册码：CRD42019118983。
