The role of trimethoprim/sulfamethoxazole in preventing opportunistic infections in systemic lupus erythematosus patients receiving low-level immunosuppressive treatment: an open-label, randomized, controlled trial.

IF 3.2 4区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Paopat Munthananuchat, Pintip Ngamjanyaporn, Prapaporn Pisitkun, Porpon Rotjanapan
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引用次数: 0

Abstract

Objective: Systemic lupus erythematosus (SLE) patients receiving immunosuppressive therapy are at risk for opportunistic infections (OIs), particularly Pneumocystis pneumonia (PCP). This study aimed to evaluate the effectiveness of trimethoprim/sulfamethoxazole (TMP/SMX) as primary prophylaxis against OIs and its adverse effects in SLE patients receiving low-level immunosuppressive treatment in a real-world setting.

Methods: This open-label randomized controlled trial enrolled SLE patients receiving low-level immunosuppressive treatment at Ramathibodi Hospital between May 2021 and December 2022. Patient demographics and relevant clinical data were collected. Participants were randomized 1:1 to receive TMP/SMX or no prophylaxis, with dose adjustments according to renal function. The incidences of TMP/SMX-sensitive OIs and adverse events were monitored for 12 months post-enrollment.

Results: The trial was terminated early due to a high rate of adverse drug reactions (ADRs) associated with TMP/SMX. In total, 138 SLE patients receiving low-level immunosuppressive treatment were enrolled. Most patients (98.4%) were in disease remission. No TMP/SMX-sensitive OIs were observed in either group during the 12-month follow-up period. Among individuals receiving TMP/SMX, 10/70 (14.3%) developed ADRs. Of these 10 patients, eight experienced grade 1 ADRs, and two had grade 3 ADRs; all declined to resume prophylaxis. There were no deaths in the study.

Conclusions: During the 12-month follow-up period, no TMP/SMX-sensitive OIs occurred in SLE patients receiving low-level immunosuppressive therapy, suggesting that primary prophylaxis with TMP/SMX may not significantly benefit this population. The high rate of ADRs observed underscores the need for clinicians to carefully consider the risks and benefits of TMP/SMX prophylaxis in these patients.

三甲氧苄氨嘧啶/磺胺甲噁唑在预防接受低水平免疫抑制治疗的系统性红斑狼疮患者机会性感染中的作用:一项开放标签、随机对照试验。
目的:接受免疫抑制治疗的系统性红斑狼疮(SLE)患者有机会性感染(OIs)的风险,尤其是肺孢子菌肺炎(PCP)。本研究旨在评估三甲双胍/磺胺甲噁唑(TMP/SMX)在实际环境中作为接受低水平免疫抑制治疗的系统性红斑狼疮患者的OIs一级预防的有效性及其不良反应:这项开放标签随机对照试验招募了2021年5月至2022年12月期间在拉玛铁博迪医院接受低水平免疫抑制治疗的系统性红斑狼疮患者。试验收集了患者的人口统计学特征和相关临床数据。参与者按 1:1 随机分配接受 TMP/SMX 或不接受预防治疗,并根据肾功能调整剂量。在加入后的12个月内,对TMP/SMX敏感的OI发生率和不良事件进行监测:由于与TMP/SMX相关的药物不良反应(ADRs)发生率较高,试验提前终止。共有138名接受低水平免疫抑制治疗的系统性红斑狼疮患者参加了试验。大多数患者(98.4%)病情缓解。在12个月的随访期间,两组患者均未观察到对TMP/SMX敏感的OIs。在接受 TMP/SMX 治疗的患者中,10/70(14.3%)人出现了 ADR。在这10名患者中,8人出现了1级不良反应,2人出现了3级不良反应;所有患者都拒绝重新接受预防治疗。研究中无死亡病例:结论:在为期12个月的随访期间,接受低水平免疫抑制治疗的系统性红斑狼疮患者没有发生对TMP/SMX敏感的OIs,这表明使用TMP/SMX进行一级预防可能不会使这一人群明显受益。观察到的高ADR发生率突出表明,临床医生需要仔细考虑对这些患者进行TMP/SMX预防性治疗的风险和益处。
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来源期刊
Clinical and Experimental Medicine
Clinical and Experimental Medicine 医学-医学:研究与实验
CiteScore
4.80
自引率
2.20%
发文量
159
审稿时长
2.5 months
期刊介绍: Clinical and Experimental Medicine (CEM) is a multidisciplinary journal that aims to be a forum of scientific excellence and information exchange in relation to the basic and clinical features of the following fields: hematology, onco-hematology, oncology, virology, immunology, and rheumatology. The journal publishes reviews and editorials, experimental and preclinical studies, translational research, prospectively designed clinical trials, and epidemiological studies. Papers containing new clinical or experimental data that are likely to contribute to changes in clinical practice or the way in which a disease is thought about will be given priority due to their immediate importance. Case reports will be accepted on an exceptional basis only, and their submission is discouraged. The major criteria for publication are clarity, scientific soundness, and advances in knowledge. In compliance with the overwhelmingly prevailing request by the international scientific community, and with respect for eco-compatibility issues, CEM is now published exclusively online.
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