莫西沙星治疗慢性阻塞性肺疾病急性加重期疗效和安全性的评价

The efficacy and safety of moxifloxacin in the treatment of patients with acute exacerbation of chronic obstructive pulmonary disease

目的探讨奠西沙星治疗慢性阻塞性肺疾病（COPD）急性加重期的疗效和安全性。方法采用前瞻性、随机对照方法，收集2013年10月至2015年05月山东省阳谷县人民医院呼吸内科COPD急性加重期需抗生素治疗的患者共202例。按照随机数字表分为2组：（1）莫西沙星治疗组102例，男58例，女44例，年龄为（67．9±4．7）岁，给予莫西沙星注射液0．4g qd静脉滴注，（2）对照组100例，男55例，女45例，年龄为（67．4±4．6）岁，给予头孢哌酮／舒巴坦注射液3g q8h静脉滴注。评价两组临床疗效、细菌清除率及药物不良反应。两组间率比较采用X2检验，均数比较采用t检验。结果莫西沙星组临床治疗有效率为92．1％（94／102），对照组临床治疗有效率为92％（92／100）；奠西沙星组细菌清除率为58．1％（18／31），对照组细菌清除率为55．2％（16／29），两组临床有效率及细菌清除率比较差异无统计学意义（均P〉0．05）；奠西沙星组抗生素使用时间及平均住院天数[（7．1±2．7）和（9.5±2.2）d]比对照组[（9．2±3．2）和（12．5±3．1）d]短，两组比较差异有统计学意义均（P〈0．01）。两组均未发生严重药物不良反应。结论莫西沙星治疗COPD急性加重期的疗效与头孢哌酮／舒巴坦相似，但住院时间和抗生素使用天数明显缩短，安全性好。

Objective To compare the effectiveness and safety of rnoxifloxacin and cefoperazone-sulbactam therapy in acute exacerbation of chronic obstructive pulmonary disease（COPD）. Methods A total of 202 patients with AECOPD requiring antibiotic therapy in YangGta Xian People＇s Hospital of ShanDong Province from October 2013 to May 2015 were enrolled. Of these patients randomized to either treatments, 102 patients [male 58, female 44, （67.9±4.7） y] received moxifloxacin （0.4 mg qd） and 100 [male 55, female 45, （67.4±4.6） y] received cefoperazone-sulbactam （3.0g q8h）. Clinical effectiveness, bacterial eradication and drug safety were evaluated. Results The clinical effectiveness rate was 92.1% （94/102） in the moxifloxacin group and 92%（92/100） in the cefoperazone-sulbactam group. The bacterial eradication rate was 58. 1%（18/31） and 55.2% （16/29） in the 2 groups respectively. The differences between groups were not statistically significant in terms of clinical and microbiological effectiveness （both P〉0.05）. The antibiotic-days and length of hospital stay were shorter in the moxifloxaein group [（7. 1± 2.7） vs （9. 2±3.2）d; （9.5±2.2） vs （12.5 ± 3.1）d], the differences being significant between the 2 arms （P〈0.05）. Both drugs were well tolerated with no significant differences in numbers of drug-related adverse events（P〉0.05）. Conclusion Moxifloxaein was equivalent to cefoperazone-sulbactam therapy for clinical success, bacteriologic eradication and showed superiority over the control group in shortening the length of hospital stay and antibiotic-days. Ad- ditionally, the drug safety of moxifloxacin was good.