Migliori Giovanni Battista, Pontali Emanuele, Sotgiu Giovanni, Centis Rosella, D'Ambrosio Lia, Tiberi Simon, Tadolini Marina, Esposito Susanna
World Health Organization Collaborating Centre for Tuberculosis and Lung Diseases, Maugeri Institute, IRCCS Tradate 21049, Italy.
Department of Infectious Diseases, Galliera Hospital, Genoa 16128, Italy.
Int J Mol Sci. 2017 Feb 7;18(2):341. doi: 10.3390/ijms18020341.
The new drugs delamanid and bedaquiline are increasingly being used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB). The World Health Organization, based on lack of evidence, recommends their use under specific conditions and not in combination. No systematic review has yet evaluated the efficacy, safety, and tolerability of delamanid and bedaquiline used in combination. A search of peer-reviewed, scientific evidence was carried out, aimed at evaluating the efficacy/effectiveness, safety, and tolerability of delamanid and bedaquiline-containing regimens in individuals with pulmonary/extrapulmonary disease, which were bacteriologically confirmed as M/XDR-TB. We used PubMed to identify any relevant manuscripts in English up to the 23 December 2016, excluding editorials and reviews. Three out of 75 manuscripts retrieved satisfied the inclusion criteria, whilst 72 were excluded for dealing with only one drug (three studies), being recommendations (one study) or identifying need for their use (one study), focusing on drug resistance aspects (six studies) or being generic reviews/other studies (61 papers). The studies retrieved reported two XDR-TB cases observed for six months and achieving consistent sputum smear and culture conversion. Case 2 experienced a short break of bedaquiline, which was re-started after introducing verapamil. After a transient and symptom-free increase of the QT interval from week 5 to 17, it then decreased below the 500 ms threshold.
新型药物地拉米胺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)。世界卫生组织基于证据不足,建议在特定条件下使用这两种药物,且不建议联合使用。目前尚无系统评价评估地拉米胺和贝达喹啉联合使用的疗效、安全性和耐受性。我们检索了同行评审的科学证据,旨在评估含地拉米胺和贝达喹啉的治疗方案对经细菌学确诊为M/XDR-TB的肺/肺外疾病患者的疗效/有效性、安全性和耐受性。我们使用PubMed检索截至2016年12月23日的所有英文相关手稿,不包括社论和综述。检索到的75篇手稿中有3篇符合纳入标准,72篇因仅涉及一种药物(3项研究)、为推荐意见(1项研究)或确定使用需求(1项研究)、关注耐药性方面(6项研究)或为一般性综述/其他研究(61篇论文)而被排除。检索到的研究报告了2例XDR-TB患者,观察6个月后痰涂片和培养结果持续转阴。病例2在使用贝达喹啉过程中有短暂中断,在加用维拉帕米后重新开始使用。在第5周至第17周QT间期短暂且无症状地延长后,又降至500毫秒阈值以下。