含贝达喹啉方案治疗老年耐多药肺结核病患者的有效性及安全性评价

Efficacy and safety evaluation of the regimen containing Bedaquiline in elderly patients with drug-resistant pulmonary tuberculosis

目的评价含贝达喹啉方案治疗老年耐多药肺结核病的疗效及不良反应。方法2019年3月至2022年6月,对安徽省胸科医院收治的耐多药肺结核患者随机分组,观察组采用包含贝达喹啉的治疗方案,对照组采用不包含贝达喹啉的治疗方案,另外将患者按年龄分为老年患者(年龄≥60岁)及非老年患者(年龄<60岁)。分别比较总体、老年及非老年观察组与对照组患者的痰菌阴转、病灶吸收及不良反应等情况。结果共收集病例170例,包括观察组79例和对照组91例。(1)痰菌阴转:3个月末总体、非老年及老年观察组患者阴转率均好于对照组(总体96.2%和75.8%,χ^(2)=14.001,P<0.001;非老年94.9%和82.1%,χ^(2)=4.675,P=0.031;老年100.0%和65.7%,χ^(2)=8.771,P=0.003),6个月末总体观察组患者阴转率好于对照组(98.7%和92.3%,χ^(2)=3.895,P=0.048)。(2)病灶吸收:总体和非老年观察组患者3个月末及6个月末病灶吸收率均好于对照组(3个月末总体84.8%和68.1%,χ^(2)=12.962,P=0.002;3月末非老年88.1%和71.4%,χ^(2)=9.832,P=0.007;6月末总体88.6%和76.9%,χ^(2)=14.888,P=0.001;6个月末非老年89.8%和82.1%,χ^(2)=8.618,P=0.013);老年观察组患者3个月末、6个月末的病灶吸收率(75.0%和85.0%)比较差异无统计学意义(P>0.05)。(3)不良反应:总体及非老年观察组患者QT间期延长均多于对照组(P<0.05),但无患者因此停用贝达喹啉,老年两组患者QT间期延长差异无统计学意义(P>0.05)。结论老年耐多药肺结核患者使用含贝达喹啉方案早期痰菌阴转快,治疗效果良好,耐受性好,不良反应可控。

Objective To evaluate the efficacy and adverse reactions of the regimen containing Bedaquiline in elderly patients with multi-drug resistant tuberculosis.MethodsFrom March 2019 to June 2022,patients with multi-drug resistant pulmonary tuberculosis admitted to Anhui Chest Hospital were randomly divided into two groups:the observation group was given a treatment containing Bedaquiline,and the control group was given a treatment without Bedaquiline.Patients were also divided into elderly patients(age≥60 years old)and non-elderly patients(age<60 years old)according to age.Sputum culture conversion,lesion absorption and adverse reactions were compared between the observation group and the control group in general,elderly and non-elderly patients,respectively.ResultsA total of 170 cases were collected,including 79 in the observation group and 91 in the control group.Sputum culture conversion:The sputum culture conversion rates of observation groups in general,non-elderly and elderly patients were better than that of control groups at the 3rd month after treatment(the general,96.2%vs.75.8%,χ^(2)=14.001,P<0.001;the non-elderly,94.9%vs.82.1%,χ^(2)=4.675,P=0.031;the elderly,100.0%vs.65.7%,χ^(2)=8.771,P=0.003),and at the 6th month,the rates of overall observation group was better than that of control group(98.7%vs.92.3%,χ^(2)=3.895,P=0.048);the rates of non-elderly and elderly observation group and control group were all greater than 90%,with no statistical significance(P>0.05).Lesion absorption:Overall and non-elderly observation groups were better than control group in lesion absorption at the 3rd month(the general,84.8%vs.68.1%,χ^(2)=12.962,P=0.002;the non-elderly,88.1%vs.71.4%,χ^(2)=9.832,P=0.007;and the 6th month(the general,88.6%vs.76.9%,χ^(2)=14.888,P=0.001;the non-elderly,89.8%vs.82.1%,χ^(2)=8.618,P=0.013).The focal absorptivity of senile observation group at the end of March and June were 75.0%and 85.0%,respectively,both better than control group,but the difference was not statistically significant(P>0.05).Adverse reactions:Overall and non-senile observation groups had longer QT interval than control groups(P<0.05),but no patients stopped bedaquiline because of this,and there was no significant difference in QT interval between the two groups(P>0.05).ConclusionsIn elderly patients with multi-drug resistant pulmonary tuberculosis,early sputum culture conversion turns fast after treatment with Bedaquiline,which has good therapeutic effect,good tolerance and controllable adverse reactions.