目的评价超长疗程阿米卡星在治疗耐多药肺结核中的疗效与药物安全风险。方法将138例耐多药肺结核病例随机分组,治疗组77例,对照组61例。化疗方案:治疗组方案为12Am ZEPLv Th/12ZEPLv Th,对照组方案为6Am ZEPLv Th/18ZEPLv Th;2组于治疗前、治疗6月末、治疗12月末及治疗24月末分别进行X线、痰菌检查;对2组同期的肺部X线病灶吸收率、痰菌阴转率进行比较。监测阿米卡星不良反应发生率,同期进行比较。结果 2组共有105例完成化疗疗程,治疗组57例,对照组48例。治疗6月末,治疗组痰菌阴转率、肺部病灶X线吸收有效率分别与对照组比较差异均无统计学意义(P>0.05);治疗12月末,治疗组痰菌阴转率、肺部X线吸收有效率与对照组分别比较差异均有统计学意义(P<0.05);治疗24月末,治疗组与对照组痰菌阴转率、肺部X线吸收有效率比较差异均有统计学意义(P<0.05)。在完成疗程病例中,2组阿米卡星不良反应发生率比较差异有统计学意义(P<0.05);在退组病例中,因阿米卡星不良反应而发生的退组率比较差异无统计学意义(P>0.05)。结论阿米卡星注射剂的12个月超长疗程治疗耐多药肺结核的疗效优于6个月疗程的疗效;在严密监测下,超长疗程阿米卡星注射剂治疗是相对安全的。 Objective To evaluate the efficacy and drug safety risk of long course amikacin in the treatment of multidrug-resistant pulmonary tuberculosis. Methods 138 cases of MDR-TB cases were randomly divided into treatment group (77 cases) and control group (61 cases). The chemotherapy regimen: the treatment group plan was 12Am ZEPLv Th / 12ZEPLv Th, the control group plan was 6Am ZEPLv Th / 18ZEPLv Th; two groups before treatment, treatment at the end of 6, treatment at the end of 12 and treatment at the end of 24 were X-ray, sputum examination ; On the same period in the two groups of lung X-ray lesions absorption, sputum negative conversion rates were compared. The incidence of adverse reactions of amikacin was monitored over the same period. Results A total of 105 patients in two groups completed the chemotherapy regimen, 57 in the treatment group and 48 in the control group. Treatment at the end of 6, the treatment group sputum negative conversion rate, pulmonary lesions X-ray absorption efficiency respectively compared with the control group, no significant difference (P> 0.05); treatment end of 12 months, the treatment group sputum negative conversion rate, lung Department of X-ray absorption efficiency compared with the control group were statistically significant (P <0.05); treatment at the end of 24, the treatment group and the control group sputum negative conversion rate, pulmonary X-ray absorption efficiency differences were statistically significant Significance (P <0.05). In the completed course of treatment, there was significant difference in the incidence of adverse reactions between the two groups (P <0.05); in the withdrawal group, there was no difference in the rate of withdrawal due to the adverse reactions of amikacin Statistical significance (P> 0.05). Conclusions The 12-month long course of treatment with amikacin is superior to the 6-month course in the treatment of multidrug-resistant pulmonary tuberculosis. Long-term monitoring of amikacin injection is relatively safe.