高龄患者应用异帕米星的疗效及安全性

Efficacy and safety of isepamicin in the treatment of patients with advanced age

目的评价异帕米星对革兰阴性杆菌严重感染高龄患者的疗效和安全性。方法收集2008年3月至2010年12月入住北京军区总医院并因革兰阴性杆菌严重感染应用异帕米星治疗的高龄患者的临床资料,进行回顾性分析。给药方法:异帕米星200～400 mg,1次/d,缓慢静脉滴注给药,疗程一般为3～7 d。主要分析指标为临床有效率、病原菌清除率、治疗前后外周血白细胞计数(中性粒细胞比例)、肾功能和用药后不良反应发生率。结果共收集到33例患者,男性31例,女性2例,年龄80～100岁,平均(93±4)岁。肺部感染31例,泌尿系感染2例。患者以感染铜绿假单胞菌为主。均因临床效果不佳、细菌培养检出耐药革兰阴性杆菌而改为应用或联合应用异帕米星。经3～10 d治疗后,临床有效率为97.0%(32/33),细菌清除率为90.9%(30/33);患者外周血白细胞计数和中性粒细胞比例治疗前分别为(14.0±4.2)×109/L和0.81±0.06,治疗后分别为(11.0±3.3)×109/L和0.74±0.08;治疗前后差异有统计学意义(均P=0.00);肌酐和尿素氮水平治疗前后差异无统计学意义(均P>0.05)。用药期间有19例患者出现尿量减少,停药后2～3 d恢复正常,未见其他不良反应。结论异帕米星联合其他抗菌药治疗80岁以上的革兰阴性杆菌严重感染患者疗效肯定;在严格掌握用药指征、剂量、用法、疗程和定期监测下,一般比较安全。

ABSTRACT Objective To evaluate the efficacy and safety of isepamicin in the treatment of patients with advanced age and severe infection caused by Gram negative bacilli. Methods From March 2008 to December 2010, the clinical data of treatment with isepamiein in the patients with advanced age and severe infection caused by Gram negative bacilli in the Military General Hospital of Beijing PLA was collected and analyzed with retrospective method. An IV infusion of isepamicin 200-400 mg once daily was given. The treatment course was 3-7 days. The major indexes were effective rate, pathogens clearance rate, peripheral white blood cell count （ the proportion of neutrophils ） before and after the treatment, renal function, and the incidence of adverse reactions after isepamicin treatment. Results A total of 33 patients were collected. Of them, 31 were men and 2 were women with average age of （93 -＋ 4） years （from 80 to 100 ）. Thirty-one patients had lung infections, 2 patients had urinary system infections. The main pathogens in patients were Pseudomonas aeruginosa. All patients were treated with isepamicin alone or in combination with other drugs due to the poor treatment outcome in clinical practice and appearance of resistant Gram negative bacilli during bacterial culture. After 3-10 days of treatment, the effective rate was 97.0% （32/33） ; bacterial clearance rate was 90.9% （30/33） ; the peripheral white blood cell count and the proportion of neutrophils were （ 14.0 ±4.2） × 109/L and 0.81± 0.06 before treatment, （ 11.0 ± 3.3） × 109/L and 0.74 ±0.08 after treatment, respectively ; the differences were statistically significant （ both P = 0.00）. There were no significant differences before and after the treatment in the levels of creatinine and urea nitrogen （P 〉0.05）. During the treatment, 19 patients＇ urine volume decreased and returned to normal 2-3 days after drug discontinuation. No other adverse reactions were observed. Conclusion Isepamicin treatment in combination with other antimicrobials is effective in patients older than 80 years of age with severe infection caused by Gram negative bacilli. Application of isepamiein is safe under strict control of drug indications, dosage, administration, treatment course, and regular monitoring.