贝达喹啉治疗耐多药结核病的疗效和安全性  

Efficacy and safety of Bedaquiline in the treatment of multidrug-resistant tuberculosis

作　　者：常瑞霞[1] 可春梅 CHANG Rui-xia;KE Chun-mei(Department of Respiratory,the Sixth People's Hospital of Zhengzhou,Zhengzhou 450000,China)

机构地区：[1]河南省郑州市第六人民医院呼吸科,郑州450000

出　　处：《临床药物治疗杂志》2021年第3期57-60,共4页Clinical Medication Journal

摘　　要：目的观察贝达喹啉治疗耐多药结核病的有效性和安全性。方法选择2018年1月至2019年6月于郑州市第六人民医院结防门诊就诊的90例耐多药结核病患者作为研究对象,根据患者意愿选择分组,分为观察组(45例)和对照组(45例)。对照组接受阿米卡星(Am)、对氨基水杨酸钠(Pas)、丙硫异烟胺(Pto)、吡嗪酰胺(Z)和左氧氟沙星(Lfx)的联合治疗;观察组在对照组基础上加用富马酸贝达喹啉片,治疗24周。观察两组患者的治疗效果和不良反应发生情况,比较治疗前后患者体液免疫及细胞免疫水平。结果观察组总有效率为91.1%,显著高于对照组的66.7%(P<0.05);治疗后观察组痰菌转阴率(95.6%)、空洞闭合有效率(88.9%)高于对照组(分别为80.0%和68.9%),痰菌转阴时间[(4.1±0.4)d]短于对照组[(6.6±0.4)d],差异均有统计学意义(P<0.05);治疗后,两组患者CD4^(+)、CD4^(+)/CD8^(+)、免疫球蛋白A(IgA)、免疫球蛋白G(IgG)及免疫球蛋白M(IgM)水平均升高,观察组高于对照组;CD8^(+)水平较治疗前降低,且观察组低于对照组,差异均有统计学意义(P<0.05)。观察组不良反应发生率为8.9%,对照组为13.3%,差异无统计学意义(P>0.05)。结论贝达喹啉与常规抗结核药物联用可加速耐多药结核病患者病灶吸收,改善耐多药结核病患者免疫功能。Objective To analyze the efficacy and safety of Bedaquiline in the treatment of multidrug-resistant tuberculosis(MDR-TB).Methods A total of 90 patients with MDR-TB who were admitted to the Outpatient Department of the Sixth People’s Hospital of Zhengzhou from January 2018 to June 2019 were selected as the research subjects.The patients were divided into observation group(45 cases)and control group(45 cases)according to their intentions.The control group received a combination regimen of Amicacin(Am),Sodium Aminosalicylate(Pas),Propanethionotinamide(Pto),Pyrazinamide(Z),and Levofloxacin(Lfx).Observation group was additively treated with Bedaquiline Fumarate tablets for 24 weeks.The therapeutic effect and adverse reactions of the two groups were observed,and the humoral immunity and cellular immunity levels were compared before and after treatment.Results The total effective rate of observation group was 91.1%,significantly higher than that of control group(66.7%,P<0.05).After treatment,the sputum negative conversion rate(95.6%)and cavity shrinkage effective rate(88.9%)of the observation group were higher than those of the control group(80.0%and 68.9%,respectively).The sputum negative conversion time of(4.1±0.4)days was shorter than that of the control group(6.6±0.4)days,the differences were statistically significant(P<0.05).After treatment,CD4^(+),CD4^(+)/CD8^(+),IgA,IgG and IgM levels in the two groups were all increased,observation group was higher than control group;CD8^(+)in the observation group was lower than that in the control group,with statistical significance(P<0.05).The incidence of adverse drug reaction(ADR)was 8.9%in the observation group and 13.3%in the control group,and the difference was not statistically significant(P>0.05).Conclusion The combination of Bedaquiline and conventional anti-tuberculosis drugs can accelerate the absorption of lesions and improve the immune function of patients with MDR-TB.

关 键 词：耐多药结核病 贝达喹啉 体液免疫 细胞免疫 安全性 

分 类 号：R978.3[医药卫生—药品]