D'Ambrosio Lia, Centis Rosella, Tiberi Simon, Tadolini Marina, Dalcolmo Margareth, Rendon Adrian, Esposito Susanna, Migliori Giovanni Battista
World Health Organization Collaborating Centre for Tuberculosis and Lung Diseases, Maugeri Care and Research Institute, IRCCS, Tradate, Italy.
Public Health Consulting Group, Lugano, Switzerland.
J Thorac Dis. 2017 Jul;9(7):2093-2101. doi: 10.21037/jtd.2017.06.16.
The new drugs delamanid and bedaquiline are increasingly used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB). As evidence is lacking, the World Health Organization recommends their use under specific conditions in adults, delamanid only being recommended in children ≥6 years of age. No systematic review has yet evaluated the efficacy, safety and tolerability of the new drugs in children. A search of peer-reviewed, scientific evidence was performed, to evaluate the efficacy/effectiveness, safety, and tolerability of delamanid or bedaquiline-containing regimens in children with confirmed M/XDR-TB. We used PubMed and Embase to identify any relevant manuscripts in English until 31 December 2016, excluding editorials and reviews. Three out of 96 manuscripts retrieved satisfied the inclusion criteria, while 93 were excluded because dealing exclusively with adults (12: 4 on delamanid and 8 on bedaquiline), being recommendations or guidelines (8 manuscripts), reviews (17 papers) or other studies (56 papers). One of the studies retrieved reported evidence on 19 M/XDR-TB children, 16 of them treated under compassionate use with delamanid (13 achieving consistent bacteriological conversion) and 3 candidates for the drug. Two studies reported details on the first paediatric case treated (and cured) with a delamanid-containing regimen. Eight trials including children were also retrieved (clinicaltrials.gov). Although the methodology used in the study was rigorous, the results are limited by the paucity of the studies available in the literature on the use of new anti-TB drugs in children. In conclusion, more evidence is needed on the use of delamanid and bedaquiline in paediatric patients.
新药地拉曼德和贝达喹啉越来越多地用于治疗耐多药（MDR-）和广泛耐药结核病（XDR-TB）。由于缺乏证据，世界卫生组织建议在特定条件下用于成人，地拉曼德仅推荐用于≥6岁的儿童。尚无系统评价评估这些新药在儿童中的疗效、安全性和耐受性。我们检索了同行评审的科学证据，以评估含地拉曼德或贝达喹啉方案对确诊的M/XDR-TB儿童的疗效/有效性、安全性和耐受性。我们使用PubMed和Embase检索截至2016年12月31日的所有英文相关手稿，不包括社论和综述。检索到的96篇手稿中有3篇符合纳入标准，93篇被排除，原因是仅涉及成人（12篇：4篇关于地拉曼德，8篇关于贝达喹啉）、是推荐或指南（8篇手稿）、综述（17篇论文）或其他研究（56篇论文）。检索到的一项研究报告了19例M/XDR-TB儿童的证据，其中16例在同情用药下接受地拉曼德治疗（13例实现持续细菌学转阴），3例为该药物的候选者。两项研究报告了首例接受含地拉曼德方案治疗（并治愈）的儿科病例的详细情况。还检索到八项包括儿童的试验（clinicaltrials.gov）。尽管研究中使用的方法很严格，但结果受到文献中关于儿童使用新型抗结核药物的研究匮乏的限制。总之，关于地拉曼德和贝达喹啉在儿科患者中的使用需要更多证据。
