贝达喹啉治疗耐多药结核的临床综合评价  

Comprehensive clinical evaluation of bedaquiline in the treatment of multidrug-resistant tuberculosis

作　　者：耿鑫 杨莹 文小桐 龙虹霏 李颖霞 刘雨欣 毛宗福[1] Geng Xin;Yang Ying;Wen Xiaotong;Long Hongfei;Li Yingxia;Liu Yuxin;Mao Zongfu(School of Public Health,Wuhan University,Wuhan 430071,China;Dong Fureng Institute for Economic and Social Development,Wuhan University,Wuhan 430071,China)

机构地区：[1]武汉大学公共卫生学院,武汉430071 [2]武汉大学董辅礽经济社会发展研究院,武汉430071

出　　处：《中华结核和呼吸杂志》2023年第6期572-579,共8页Chinese Journal of Tuberculosis and Respiratory Diseases

基　　金：比尔和梅琳达盖茨基金会“中国耐多药结核药品定价与多方分摊机制研究”(250000206)。

摘　　要：目的从有效性、安全性、经济性、适宜性和社会效益五个维度评估贝达喹啉的临床价值,以期为医疗和医保相关决策提供参考。方法纳入2018年1月至2020年12月在武汉市肺科医院、赣州市第五人民医院、江西省胸科医院住院治疗的耐多药结核患者共计792例为研究对象,基于病例资料回顾性调查,以利奈唑胺为参照药,采用析因分析或卡方检验的方法对贝达喹啉各评价维度进行统计分析。结果有效性方面,贝达喹啉能显著提高23.9%(95%CI:4.8%~43.0%)的治疗成功率,显著减少64 d(95%CI:18~109 d)治疗时间;安全性方面,贝达喹啉不良反应发生率及不良反应停药率(5.11%、4.55%)显著低于利奈唑胺(22.49%、15.24%),差异均有统计学意义(χ^(2)=27.50,P<0.001;χ^(2)=14.09,P<0.001);经济性方面,使用贝达喹啉治疗的患者抗结核药物疗程费用明显增加48209.4元(95%CI:28336.0~68082.8元);适宜性方面,在2020年观测样本中,患者初次治疗方案中贝达喹啉的使用比例低于利奈唑胺(16.7%比86.5%),差异有统计学意义(χ^(2)=238.96,P<0.001);社会效益方面,使用贝达喹啉的患者传染控制率显著增加了27.8%(95%CI:8.2%~47.5%)。结论贝达喹啉在有效性、安全性及社会效益维度上具有较好的表现,但经济性较差且目前临床中贝达喹啉实际使用比例低于利奈唑胺,未来需要进一步降低价格以提高贝达喹啉在临床中的使用。Objective To assess the clinical value of bedaquiline in five dimensions:effectiveness,safety,economics,appropriateness,and social benefits,to provide a reference for medical and health insurance-related decisions.Methods A total of 792 patients with multidrug-resistant tuberculosis who were hospitalized at Wuhan Pulmonary Hospital,Ganzhou Fifth People′s Hospital and Jiangxi Chest Hospital between January 2018 and December 2020 were included in the study.Based on a retrospective survey of case data,and each evaluation dimension of bedaquiline was statistically analyzed by causal analysis or chi-square test,using linezolid as the reference drug.Results In terms of effectiveness,bedaquiline significantly increased treatment success by 23.9%(95%CI:4.8%-43.0%)and shortened treatment duration by 64 days(95%CI:18-109 days).In terms of safety,the incidence of adverse reactions to bedaquiline and the discontinuation rate of adverse reactions(5.11%,4.55%)were significantly lower than those for linezolid(22.49%,15.24%),with statistically significant differences(χ^(2)=27.50,P<0.001;χ^(2)=14.09,P<0.001).In terms of economics,patients treated with bedaquiline had a significantly higher anti-TB drug course cost of RMB 48209.4 Yuan(95%CI:28336.0-68082.8 Yuan).In terms of appropriateness,the proportion of bedaquiline in patients′initial treatment regimens was lower than that of linezolid(16.7%vs.86.5%)in the 2020 observation sample,with a statistically significant difference(χ^(2)=238.96,P<0.001).In terms of social benefits,the infection control rate was significantly increased by 27.8%(95%CI:8.2%-47.5%)in patients using bedaquiline.Conclusions Bedaquiline performed well in terms of efficacy,safety,and social benefits.However,it was less economical and the actual use rate of bedaquiline in clinical practice was lower than that of its counterpart drug,linezolid.Price reductions might be needed to increase the clinical use and performance of bedaquiline in the future.

关 键 词：结核 抗多种药物性 药物评价 贝达喹啉 利奈唑胺 

分 类 号：R52[医药卫生—内科学]