贝达喹啉治疗耐多药肺结核的疗效及安全性观察

The curative effects and safety of bedaquoline in treatment of multi drug resistant tuberculosis

目的观察贝达喹啉(Bdq)治疗耐多药肺结核(MDR-TB)患者的疗效及安全性情况。方法前瞻性纳入2019年2月至2020年5月收治的63例MDR-TB患者作为研究对象,根据门诊单双号顺序将患者分为对照组(32例)和观察组(31例),全部患者均接受常规MDR-TB治疗,在此基础上,对照组患者使用安慰剂,观察组患者使用Bdq治疗;于治疗24周时,比较2组病灶吸收总有效率、痰菌转阴率;记录并比较2组患者不良反应发生情况;于治疗前、治疗24周时,检测并比较2组血清学指标[干扰素-γ(IFN-γ)、白细胞介素-17(IL-17)]。结果观察组病灶吸收总有效率、痰菌转阴率高于对照组,差异有统计学意义(P<0.05);治疗24周,2组IFN-γ均较治疗前升高,观察组高于对照组,IL-17均较治疗前降低,且观察组低于对照组,差异有统计学意义(P<0.05);观察组QT间期延长发生率高于对照组(P<0.05);2组其他不良反应发生率比较,差异无统计学意义(P>0.05)。结论Bdq用于MDR-TB的治疗,可更好的帮助患者血清IL-17、IFN-γ水平改善,获得更理想的痰菌转阴率与病灶吸收率,且不会增加不良反应,安全性好。

Objective To investigate the curative effects and safety of bedaquoline(Bdq)in treatment of multi drug resistant tuberculosis(MDR-TB).Methods A total of 63 patients with MDR-TB who were treated in our hospital from February 2019 to may 2020 were enrolled in the study,who were divided into control group(n=32)and observation group(n=31)according to the odd and even number of outpatient service.The patients in both groups underwent conventional MDR-TB treatment,on this basis,the patients in control group were treated by placebo,however,the patients in observation group were treated by Bdq,with a treatment course of 24 weeks for both groups.The total effective rate of lesion absorption,sputum negative conversion rate,the incidence of adverse reactions as well as the changes of interferon-γ(IFN-γ),interleukin-17(IL-17)were observed and compared between the two groups.Results The total effective rate of focus absorption and sputum negative conversion rate in observation group were significantly higher than those in control group(P<0.05).After 24-week treatment,the levels of IFN-γin both groups were increased,moreover,which in observation group were significantly higher than those in control group(P<0.05).However the levels of IL-17 in both groups were decreased,moreover,which in observation group were significantly lower than those in control group(P<0.05).In addition the incidence of QT prolongation in observation group was significantly higher than that in control group(P<0.05).There was no significant difference in the incidence of other adverse reactions between the two groups(P>0.05).Conclusion The application of Bdq in treatment of MDR-TB can better improve the serum levels ofIL-17 and IFN-γ,and can improve sputum negative conversion rate and lesion absorption rate,which does not increase the incidence of adverse reactions,with better safety.