改良全口服短程化疗方案治疗耐多药肺结核的有效性及安全性分析  

Efficacy and safety of modified all-oral short course chemotherapy in the treatment of multidrug-resistant pulmonary tuberculosis

作　　者：金龙 王利华 张晓磊 蒋怀龙 李晓南 刘玉琴 Jin Long;Wang Lihua;Zhang Xiaolei;Jiang Huailong;Li Xiaonan;Liu Yuqin(Drug-resistant Tuberculosis Ward,Infectious Hospital of Heilongjiang Province,Harbin 150500,China)

机构地区：[1]黑龙江省传染病防治院,哈尔滨150500

出　　处：《中国防痨杂志》2022年第12期1321-1326,共6页Chinese Journal of Antituberculosis

摘　　要：目的:分析改良全口服短程化疗方案治疗耐多药肺结核(multidrug-resistant pulmonary tuberculosis,MDR-PTB)的有效性及安全性。方法:采用前瞻性研究方法,按照入组标准选取2020年4月至2021年4月黑龙江省传染病防治院确诊为MDR-PTB的22例患者,给予改良全口服短程化疗方案[6Lfx(Mfx)-Bdq-Lzd-Cfz-Cs/3Lfx(Mfx)-Lzd-Cfz-Cs;Lfx:左氧氟沙星,Mfx:莫西沙星,Bdq:贝达喹啉,Lzd:利奈唑胺,Cfz:氯法齐明,Cs:环丝氨酸]治疗。观察痰抗酸杆菌涂片、分枝杆菌培养,以及影像学变化和不良事件。以痰培养阴转率及治疗成功率为主要结局指标,以痰培养阴转时间为次要结局指标。结果:共纳入22例患者,男性15例(68.2%),平均年龄为(40±11)岁。所有患者均完成了9个月的治疗,总体治疗成功率为100.0%,无治疗失败、失访及死亡患者。治疗期间,痰抗酸杆菌涂片和痰分枝杆菌培养累计阴转率及胸部病灶累计吸收有效率和空洞改善率均随治疗时间的延长而逐渐增高。治疗12周时,病灶吸收总有效率和空洞改善率即达到100.0%(分别为22/22和10/10);治疗16周时,痰抗酸杆菌涂片阴转率达到100.0%(22/22);治疗20周时,痰培养阴转率达到100.0%(22/22)。在21例(95.5%)患者中观察到61例次不良事件,但无严重不良事件发生,且均未影响治疗结局。前三位不良事件发生率分别为周围神经病变[18例(81.8%)]、胃肠道反应[15例(68.2%)]和QTc延长[14例(63.6%)]。结论:改良的全口服短程化疗方案疗程短、治疗成功率高、安全性良好,值得在临床推广应用。Objective:To analyze the effectiveness and safety of modified all-oral short course chemotherapy in the treatment of multidrug-resistant pulmonary tuberculosis(MDR-PTB).Methods:A prospective study was conducted in 22 MDR-PTB patients diagnosed in the Infectious Disease Hospital of Heilongjiang Province from April 2020 to April 2021 according to the inclusion criteria.The patients were treated with a modified short all-oral course chemotherapy regimen(6Lfx(Mfx)-Bdq-Lzd-Cfz-Cs/3Lfx(Mfx)-Lzd-Cfz-Cs).The changes of sputum smear,sputum culture,chest CT and adverse events were assessed during treatment.The main outcome indicators were culture negative conversion rate and treatment success rate and the secondary outcome indicator was the time of sputum culture negative conversion.Results:Of the 22 enrolled patients,15 patients(68.2%)were male and the average age was(40±11)years old.All of the patients completed the 9-month therapy.The total success rate of treatment was 100.0%with no failure,lost to follow up or death at the end of treatment.During treatment,the cumulative sputum smear negative conversion rate,culture negative conversion rate,effective rate of chest lesions absorption and the improvement rate of cavities all increased gradually with the extension of treatment time.The effective rate of chest lesions absorption and the improvement rate of cavities both reached 100.0%(22/22 and 10/10,respectively)after 12-week treatment;the sputum smear negative conversion rate reached 100.0%(22/22)after 16-week treatment;the culture negative conversion rate reached 100.0%(22/22)after 20-week treatment.A total of 61 adverse events were reported in 21 patients(95.5%).However,no serious adverse event was observed and the treatment outcomes were not influenced.The most frequently reported adverse events were peripheral neuropathy(18 patients,81.8%),gastrointestinal discomfort(15 patients,68.2%)and QTc prolongation(14 patients,63.6%).Conclusion:The modified short all-oral course chemotherapy regimen achieved a high treatment

关 键 词：结核 抗多种药物性 药物疗法 临床方案 可行性研究 治疗结果 

分 类 号：R52[医药卫生—内科学] R453[医药卫生—临床医学]