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分析

Analysis of multi-drug resistant pulmonary tuberculosis curative effect and drug safety risk in long-term therapy of amikacin

目的：分析超长疗程阿米卡星治疗耐多药肺结核的疗效及安全性。方法选择2010年1月至2014年3月共纳入符合研究条件的86例耐多药肺结核患者，按就诊顺序编号，均分为对照组与观察组2组，每组43例。均采用吡嗪酰胺（PZA）＋盐酸乙胺丁醇（EMB）＋对氨基水杨酸钠（PAS）＋左氧氟沙星（LVFX）＋丙硫异烟胺（PTH）化疗24个月，对照组加用阿米卡星6个月，观察组则采用超长疗程阿米卡星治疗12个月，共治疗24个月，观察治疗不同时间两组病灶吸收情况，统计痰菌阴转率，监测血常规、肝肾功能，观察药物安全性。结果①治疗6个月，两组治疗痰菌阴转率、病灶吸收率、治疗有效率对比差异无统计学意义（P 〉0.05），治疗12个月、18个月，观察组痰菌阴转率分别为68.29%、73.17%，均高于对照组（P 〈0.05）；病灶吸收率分别为73.17%、78.05%，明显高于对照组的50.00%、52.50%（P 〈0.05）；且其有效率分别为87.80%、85.37%，明显高于对照组的70.00%、70.00%，但仅治疗12个月对比差异有统计学意义（P 〈0.05）。②观察组治疗期间耳毒性发生率高于对照组（P 〈0.05），其肾毒性、肝毒性发生率略高于对照组，但对比差异无统计学意义（P 〉0.05）。结论超长疗程阿米卡星可提高耐多药肺结核患者痰菌阴转率，促进病灶吸收，改善疗效，虽长程用药患者耳毒性、肾毒性发生率高，但大部分均可逆。

Objective To analysis multi-drug resistant pulmonary tuberculosis curative effect and safety in long-term therapy of amikacin.Methods 86 cases of patients with multi-drug resistant pulmonary tuberculosis fitting for the demands from January 2010 to March 2014 were selected as the research objects,according to visiting sequence number.They were divided into the control group and the observation group （each 43 cases）.All patients underwent pyrazinamide （PZA） ＋ ethambutol hydrochloride（EMB）＋ sodium aminosalicylate（PAS）＋ levofloxacin（LVFX）＋ protionamide（PTH） chemotherapy,amikacin was added to the control group for 6 months,the observation group was treated with long-term therapy of amikacin for 12 months,totally 24 months,lesions absorption situation in the two groups at different time segment in the treatment were observed,the sputum negative conversion rate was recorded,blood routine,hepatic and renal function were monitored,drug safety was observed.Results①There was no significant difference in the sputum negative conversion rate,lesions absorption rate, effective rate of treatment between the two groups in the treatment of 6 months （P 〉 0.05）,in the treatment of 12 months,18 months,the sputum negative conversion rate of observation group were 68.29%,73.1 7%,which were significantly higher than the control group （P 〈 0.05）;the lesions absorption rate （73.1 7%,78.05%） were significantly higher than that of the control group （50.00% 52.50%）（P 〈0.05）;The effective rate （87.80%,85.37%） were significantly higher than that of the control group （70.00%,70.00%）,but only difference in the treatment of 12 months had statistical significance（P 〈 0.05）;② Ototoxicity occuring rate of the observation group was higher than the control group during the treatment（P 〈0.05）,the prevalence of nephrotoxicity and hepatotoxicity were slightly higher than the control group （P 〉 0.05）.Conclusions Long-term therapy of amikacin can improve the sputum negative conversion rate of patients with mult-i drug resistant pulmonary tuberculosis,promote lesions absorption,and improve the curative effect,although the prevalence of nephrotoxicity and ototoxicity of patients who received long-term therapy are high,most are reversible.