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在家中使用美罗培南静脉注射疗法联合含地拉曼德/贝达喹啉方案的“挽救方案”用于耐多药/广泛耐药儿童结核病治疗的可行性。

Feasibility of a "Salvage Regimen" Using Home-based Intravenous Meropenem Therapy With a Delamanid/Bedaquilline Containing Regimen in the Management of MDR/XDR Pediatric Tuberculosis.

作者信息

Shah Ira, Antony Sonu, Jaiswal Akanksha, Bodhanwala Minnie, Shah Daksha, Tipre Pranita, Salve Jyoti, Parmar Malik, Sachdeva K S

机构信息

From the Pediatric TB Clinic, Department of Pediatric Infectious Diseases, B J Wadia Hospital for Children, Mumbai, India.

B J Wadia Hospital for Children, Mumbai, India.

出版信息

Pediatr Infect Dis J. 2022 May 1;41(5):401-404. doi: 10.1097/INF.0000000000003486.

DOI:10.1097/INF.0000000000003486
PMID:35153288
Abstract

INTRODUCTION

The prevalence of multidrug resistant (MDR) tuberculosis (TB) with additional resistance to fluoroquinolones or second-line injectables (MDRFQ/SLI)/extensively drug-resistant TB (XDR-TB) in children is high in Mumbai. There are limited therapeutic options available in management of such children. Carbapenems, although approved for this indication, requires 2 to 3 daily injections, which are cumbersome. Bedaquilline (Bdq) and Delamanid (Dlm), the new antitubercular drugs still remain inaccessible to this subset of patients caused by conditional approvals. Hence, newer strategies to combat MDRFQ/SLI/XDR-TB needs to be explored.

OBJECTIVES

To study feasibility and interim outcomes of a "salvage regimen" using home-based carbapenem therapy through peripherally inserted central catheter as part of a longer (18-20 months) optimized background regimen including Dlm or Bdq or both in pediatric MDRFQ/SLI/XDR-TB patients who failed a standard MDR-TB regimen under the National Tuberculosis Elimination Programme in Mumbai, India.

DESIGN AND METHODS

Retrospective descriptive analysis study. National Tuberculosis Elimination Programme medical records of all MDRFQ/SLI/XDR-TB patients enrolled at the pediatric TB clinic at BJ Wadia Hospital for Children, Mumbai who were initiated on such "salvage regimen" during the period between April 2018 and December 2020 were retrospectively studied. Treatment outcomes and adverse events were described.

RESULTS

Of the 15 patients enrolled, mean age of the patient population was 12.53 ± 2.47 years and the female:male ratio was 13:2. Seven patients had XDR-TB while 8 patients had MDRFQ/SLI. Most common adverse event noted was dyselectrolytemia (3 patients). Catheter-related complications were reported in 5 patients and included catheter blockage, leak, and thrombosis. Sputum culture conversion was reported in all of the patients. One child mortality was reported and 2 patients were lost to follow up during study period.

CONCLUSIONS

Home-based meropenem therapy using peripherally inserted central catheter is feasible with few adverse effects. This can be a promising strategy in the management of MDRFQ/SLI/XDR-TB when an effective oral regimen cannot be otherwise constituted and needs to be explored further.

摘要

引言

在孟买,儿童耐多药(MDR)结核病(TB)且对氟喹诺酮类或二线注射剂(MDRFQ/SLI)/广泛耐药结核病(XDR-TB)具有额外耐药性的患病率很高。在治疗这类儿童时,可用的治疗选择有限。碳青霉烯类药物虽然已获批用于此适应症,但需要每日注射2至3次,操作繁琐。贝达喹啉(Bdq)和德拉马尼(Dlm)这两种新型抗结核药物由于有条件批准,这部分患者仍然无法使用。因此,需要探索对抗MDRFQ/SLI/XDR-TB的新策略。

目的

在印度孟买全国消除结核病计划下,对未通过标准耐多药结核病治疗方案的儿科MDRFQ/SLI/XDR-TB患者,研究使用外周静脉穿刺中心静脉导管进行家庭碳青霉烯类治疗作为更长(18 - 20个月)优化背景治疗方案(包括Dlm或Bdq或两者)一部分的“挽救方案”的可行性和中期结果。

设计与方法

回顾性描述性分析研究。对2018年4月至2020年12月期间在孟买BJ瓦迪亚儿童医院儿科结核病诊所开始接受此类“挽救方案”治疗的所有MDRFQ/SLI/XDR-TB患者的全国消除结核病计划医疗记录进行回顾性研究。描述治疗结果和不良事件。

结果

在纳入的15名患者中,患者群体的平均年龄为12.53±2.47岁,女性与男性比例为13:2。7名患者患有XDR-TB,8名患者患有MDRFQ/SLI。观察到的最常见不良事件是电解质紊乱(3例患者)。5例患者报告了与导管相关的并发症,包括导管堵塞、渗漏和血栓形成。所有患者均报告痰培养转阴。在研究期间报告了1例儿童死亡,2例患者失访。

结论

使用外周静脉穿刺中心静脉导管进行家庭美罗培南治疗是可行的,不良反应较少。当无法采用有效的口服治疗方案时,这可能是管理MDRFQ/SLI/XDR-TB的一种有前景的策略,需要进一步探索。

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