Division of Oncology, Department of Pediatric Surgery, West China Hospital of Sichuan University, Chengdu, 610041, China.
Med-X Center for Informatics, Sichuan University, Chengdu, 610041, China.
Orphanet J Rare Dis. 2023 May 24;18(1):121. doi: 10.1186/s13023-023-02740-3.
Patients with vascular anomalies (VAs) who receive oral sirolimus may be at high risk of infectious complications. Antibiotic prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMZ) has been advocated. However, there have been few evidence-based analyses on this topic. This study assessed the effect of prophylactic TMP-SMZ on the incidence of infections in VA patients receiving sirolimus monotherapy.
A retrospective, multicenter chart review was performed on all VA patients receiving sirolimus treatment from August, 2013 to January, 2021.
Before January 2017, 112 patients were treated with sirolimus without antibiotic prophylaxis. In the subsequent period, 195 patients were treated with TMP-SMZ for at least 12 months during sirolimus therapy. The percentage of patients with at least one serious infection during the initial 12 months of sirolimus treatment did not differ between the groups (difference, 1.1%; 95% CI - 7.0-8.0%). We observed no difference in the incidence of individual infection or total adverse events between the groups. The rate of sirolimus discontinuation due to adverse events did not differ significantly between groups.
We demonstrated that prophylactic TMP-SMZ does not decrease the incidence of infection or improve tolerance in VA patients receiving sirolimus monotherapy.
接受口服西罗莫司治疗的血管异常(VA)患者可能存在发生感染并发症的高风险。已提倡使用复方磺胺甲噁唑(TMP-SMZ)进行抗生素预防。然而,针对这一主题的循证分析较少。本研究评估了预防性 TMP-SMZ 对接受西罗莫司单药治疗的 VA 患者感染发生率的影响。
对 2013 年 8 月至 2021 年 1 月期间接受西罗莫司治疗的所有 VA 患者进行了回顾性、多中心病历审查。
在 2017 年 1 月之前,112 例患者在未接受抗生素预防的情况下接受了西罗莫司治疗。在随后的时期,195 例患者在接受西罗莫司治疗期间至少接受了 12 个月的 TMP-SMZ 治疗。在西罗莫司治疗的最初 12 个月内,至少发生一次严重感染的患者比例在两组之间无差异(差异,1.1%;95%CI-7.0-8.0%)。我们未观察到两组之间在个别感染或总不良事件的发生率上存在差异。由于不良事件而停止使用西罗莫司的比率在两组之间也无显著差异。
我们证明了在接受西罗莫司单药治疗的 VA 患者中,预防性 TMP-SMZ 并不能降低感染发生率或改善耐受性。