贝达喹啉治疗耐多药、广泛耐药肺结核患者的疗效和安全性观察

Efficacy and Safety of Bedaquiline to Treat Patients with Multidrug-Resistant and Extensive Drug-Resistant Tuberculosis

目的评价贝达喹啉治疗耐多药、广泛耐药肺结核病的疗效和安全性。方法选取2018年3月至2020年3月我院80例耐多药、广泛耐药肺结核患者为研究对象,予含贝达喹啉的化疗方案治疗,观察其临床疗效及用药安全性。结果80例患者中62例(77.5%)完成了贝达喹啉24周治疗及抗痨疗程并治愈,治疗失败8例(10.0%),丢失6例(4.5%),不能评价1例(1.3%),死亡3例(3.8%)。完成治疗的62例患者,疗程结束时痰培养均阴转,阴转时间4~28周,中位阴转时间8周;治疗结束后复查CT肺部病变显吸33例(53.2%)、吸收27例(43.5%),不变2例(3.2%);42例肺部有空洞患者治疗后空洞闭合30例(71.4%,30/42),缩小10例(23.8%,10/42),不变2例(2.4%,2/42),增大1例(2.4%,1/42),肺部空洞增大患者余肺部病变明显吸收好转。80例患者治疗期间有1例(1.3%)出现明显心悸,发生时间为13 d,监测心电图均正常,停用贝达喹啉后缓解;33例(40.2%)QTcF延长幅度≥60 ms,9例(11.3%)同时出现QTcF≥500 ms,发生时间3~24周,中位时间16周。结论贝达喹啉可明显提高患者痰菌阴转,促进肺部病灶吸收和空洞闭合,提高治疗成功率,但应用含贝达喹啉方案治疗引起的Q-T间期延长比例较高,虽未出现严重心脏不良事件,仍需在密切监测心电图下使用。

Objective To evaluate the efficacy and safety of Bedaquiline in treatment of multidrug resistant-tuberculosis and extensive drug resistant-tuberculosis.Methods From March 2018 to March 2020,82 cases of MDR-TB and XDR-TB patients with using Bedaquiline were selected as objects.Clinical efficacy and safety were observed.Results Among all patients,62 cases(77.5%)completed 24w treatment and cured,8 cases(10.0%)failed,6 cases(4.5%)lost,1 cases(1.3%)could not be evaluated and 3 cases died(3.8%).When 62 patients who completed treatment,sputum culture was all negative,negative conversion time was 4~28 w,and median time was 8 w.CT lung lesions showed suction in 33 cases(53.2%),absorption in 27 cases(43.5%)and unchanged in 2 cases(3.2%).30 cases had cavity closure(71.4%,30/42),10 cases lessened(23.8%,10/42),2 cases unchanged(2.4%,2/42)and 1 case enlarged(2.4%,1/42).One cases(1.3%,1/80)had significant cardiopalmus and relieved after withdrawal of Bedaquiline.33 cases(40.2%,33/80)extended QTcF amplitude≥60 ms and 9 cases(11.3%,9/80)had QTcF≥500 ms.The onset time was 3~24 w and median time was 16 w.Conclusion Bedaquiline could significantly improve negative conversion of sputum bacteria,promote absorption of lung lesions and cavity closure,and improve success rate of treatment.Proportion of Q-T interval extension caused by treatment is high.Although there are no serious adverse cardiac events,it is still necessary to be used under close monitoring ECG.