加替沙星注射液治疗呼吸道细菌性感染的临床随机对照研究

Clinical randomized controlled trials of gatifloxacin injection in treatment of bacterial infections of respiratory tract

目的 :评价国产加替沙星注射液治疗呼吸道感染的临床疗效与安全性。方法 :6 3例病人 ,其中急性化脓性扁桃体炎 16例 ,急性支气管炎 2 5例 ,社区获得性肺炎 2 1例 ,支气管扩张 1例。随机分为试验组 [32例 ,男性 2 9例 ,女性 3例 ;年龄 (2 5±s10 )a]用加替沙星注射液 4 0 0mg·次 - 1,iv ,gtt ,qd ;对照组 [31例 ,男性 2 8例 ,女性 3例 ;年龄 (2 7± 10 )a]用左氧氟沙星注射液 2 0 0mg·次 - 1,iv ,gtt,q 12h ;疗程均为 7～ 14d。结果 :试验组和对照组有效率分别为 94 % (2 6 / 32 )和 10 0 % (31/ 31) ,P>0 .0 5。细菌清除率分别为 92 % (2 3/ 2 5 ) ,96 %(2 3/ 2 4 ) ,P >0 .0 5。不良反应发生率分别为 3%(1/ 32 ) ,16 % (5 / 31) ,P >0 .0 5。结论 :加替沙星注射液治疗呼吸道细菌性感染疗效好、使用安全、方便。

AIM: To evaluate the efficacy and safety of domestic gatifloxacin injection in the treatment of respiratory tract bacterial infections. METHODS: A total of 63 patients (16 with acute purulent tonsillitis,25 with acute bronchitis,21 with community acquired pneumonia and 1 with bronchiectasis) were randomly divided into treatment group and control group. Thirty-two patients of the treatment group were (M 29,F 3;age(25± s 10)a) of the treatment group were treated with gatifloxacin injection 400mg,iv,gtt,qd for 7-14 d. Thirty-one patients(M 28,F 3,age(27±10)a) were treated with levofloxacin injection 200mg,iv,gtt,q12h for 7-14 d. RESULTS: The total clinical effectine rate was 94%(26/32) in treatment group and 100%(31/31) in control group. There was no significant difference ( P >0.05) between two group in the clinical efficacy. There was also no significant difference(92% to 96%, P >0.05) between gatifloxacin group and levofloxacin group in the bacterial clearance rate. The incidence rate of adverse reactions was 3 % in the treatment group and 16% in the control group ( P > 0.05 ). No severe adverse reactions were found. CONCLUSION: Gatifloxacin injection is an effective and safe antibiotics for the treatment of respiratory tract bacterial infections.