含贝达喹啉新方案治疗耐药肺结核的疗效与安全性研究

Bedaquiline in the treatment of pulmonary drug-resistant tuberculosis:safety and efficacy

目的评价含贝达喹啉方案治疗耐药肺结核的疗效与安全性,为临床合理安全用药提供指导。方法回顾性分析2020年1月至2020年8月深圳市第三人民医院收治的使用含贝达喹啉方案治疗的44例耐药结核病患者的临床资料,包括耐多药结核(MDR-PTB)和广泛耐药结核(XDR-TB)患者,对含贝达喹啉方案的有效性和安全性进行评价。结果 44例患者含贝达喹啉方案治疗24周,抗酸杆菌涂片转阴率97.4%(38/39);结核分枝杆菌培养转阴率为92.9%(26/28)。不良事件共计49件,其中,心电图QT间期(代表心室去极化和复极化过程总时间)延长18件,占36.7%,肝脏毒性10件,占20.4%;在18件QT间期延长的不良事件中,明确与贝达喹啉单因素相关的3件,占总不良事件中6.1%;4例患者因QT间期延长中断治疗,其中1例与贝达喹啉单因素相关。结论含贝达喹啉的方案治疗耐多药、广泛耐药结核病疗效良好,有较高的安全性,但使用过程中仍需密切监测不良反应,特别需要关注QT间期延长的发生。

Objective To evaluate the efficacy and safety of bedaquiline (BDQ)in patients with drug resistant pulmonary tuberculosis (DR-PTB)and to provide guidance for clinical rational and safe drug use.Methods We retrospectively reviewed 44 DR-TB patientsincluding multi-drug resistant pulmonary tuberculosis,MDR-PTB and extensively-drug-resistant TB (XDR-TB) treated with bedaquiline-containing regimen between January 2020 and August 2020 in The Third People’s Hospital of Shenzhen.Results The conversion rate of acid-fast bacilli smear was 97.4%(38/39) and the culture conversion rates was 92.9%(26/28) at 24 weeks.There were 49 adverse events in total,including 18 cases of prolonged QT interval (36.7%) and 10 cases of liver toxicity (20.4%).Among the 18 QT prolonged adverse events,3 were clearly related to bedaquiline,accounting for 6.1% of the total adverse events.Treatment was halted in four patients because of prolonged corrected QT interval,one of which was associated with a single factor of bedaquiline.Conclusion Bedaquiline-containing regimen was effective and safe for patients with pulmonary DR-TB.But it was still necessary to closely monitor adverse reactions,especially the occurrence of prolonged QT interval.