加替沙星注射液治疗急性细菌感染性疾病104例的Ⅱ期临床试验

目的:评价加替沙星注射液对急性细菌感染病人的有效性及安全性。方法:随机双盲对照试验。A组用加替沙星注射液2g·L-1,iv,gtt,bid;B组用左氧氟沙星注射液2g·L-1,iv,gtt,bid,疗程均为7～10d。结果:A组104人,治疗结束后7d痊愈率为90%,有效率为98.1%;B组105人痊愈率为87.6%,有效率为99.0%。在病原学方面,A组和B组的细菌清除率分别为92.7%和95.6%,结果基本相同。安全性检查结果表明,A组与B组用药前后的血液学及生化指标无明显影响,A组不良反应发生率为8.7%,B组为3.8%,但无统计学意义(P=0.139)。结论:加替沙星注射液治疗由敏感病原体引起的呼吸道感染、泌尿系统感染疗效与左氧氟沙星注射液相近,有明显的效果,不良反应较低,对病人是安全的。

Phase Ⅱ clinical trial of gatifloxacin injection in treating acute bacterial infective disease

AIM: To evaluate the efficiency and safety of gatifloxacin injection in treating acute bacterial infection. METHODS: A rarndomized double-blind controlled clinical trial was conducted. A group members were treated with gatifloxacin injection 2 g·L -1, bid and B group members were given levofloxacin 2 g·L -1, bid, Two groups with all lasting were given for 7-10 d. RESULTS: The cured rates and efective rates were 90.3 % and 98.1 % in A group (104 patients); and 87.6 % and 99.0 % in B group (105 patients) respectively(P>0.05), after 7 d therapy finished. The clearance rates of bacteria and the adverse reaction rates were 92.7 % and 8.7 % in A group, 95.6 % and 3.8 % in B group, respectively(P=0.139). CONCLUSION: Gatifloxacin and levofloxacin have the similar efficiency and safety in the treatment of susceptible patogen infection.