摘要
目的评价国产盐酸加替沙星片剂治疗急性细菌性呼吸道感染与泌尿道感染的有效性和安全性。方法采用区组随机化、双盲、平行对照临床试验设计,试验药盐酸加替沙星与对照药乳酸左氧氟沙星片剂用法均为每次200m g,一日2次,疗程均为7-14d。结果本试验共入选74例,因各种原因淘汰12例,最终列入疗效评价的病例数为62例,盐酸加替沙星组32例,乳酸左氧氟沙星组30例。治疗结束后盐酸加替沙星与乳酸左氧氟沙星痊愈率分别为75.0%与73.3%,有效率分别为93.8%与90.0%,细菌清除率分别为86.7%与88.5%;在试验期间,盐酸加替沙星组有1例发生皮疹,乳酸左氧氟沙星组有2例发生不良反应(1例转氨酶升高,1例恶心、食欲差);上述结果经统计学检验无显著性差异。结论盐酸加替沙星与乳酸左氧氟沙星片剂治疗临床常见细菌性呼吸道、泌尿道感染均有效、安全。
Objective To evaluate the efficacy and safety of gatifloxacin and levofloxacin in the treatment of bacterial infections. Methods A randomized double-blind labeled controlled clinical trial was conducted for the treatment of respiratory tract and urinary tract infections. The dosage of both drugs was 200 rag, twice daily orally. The duration of treatment was 7-14 days in both groups. Results A total of 74 patients enrolled in the study, 12 patients withdrew due to various reasons. Sixty-two patients were assessed clinical evaluation, 32 were in gatifloxacin group, 30 were in levofloxacin group. The results showed that the overall cure rates were 75. 0% for gatifloxacin group and 73. 3% for levofloxacin group; the efficacy rates were 93.8% and 90.0%% the bacterial clearance rates were 86. 7% and 88.5%, respectively. One patient had rash in gatifloxacin group, 2 patients in levofloxacin group had adverse reactions, one with ALT and AST elevation, and one with nausea and low appetite. The resuhs showed that there was no statistical difference between two groups （P〉0.05）. Conclusion Gatifloxacin is as effective and safe as levofloxacin in the treatment of respiratory tract and urinary tract infections.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2007年第2期108-112,共5页
Chinese Journal of Antibiotics
