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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。
Objective: To evaluate the efficacy and safety of gatifloxacin injection in patients with acute bacterial infection. Methods: Randomized double-blind controlled trial. A group with gatifloxacin injection 2g · L-1, iv, gtt, bid; B group levofloxacin injection 2g · L-1, iv, gtt, bid, treatment were 7 ~ 10d. Results: A group of 104 people, 7d after treatment, the cure rate was 90%, the effective rate was 98.1%; B group of 105 patients, the cure rate was 87.6%, the effective rate was 99.0%. In terms of etiology, the bacterial clearance rates in groups A and B were 92.7% and 95.6%, respectively, with similar results. The safety test results showed that there was no significant difference in the hematological and biochemical indexes before and after treatment in group A and group B. The incidence of adverse reactions in group A was 8.7% and in group B 3.8%, but there was no statistical significance (P = 0.139). CONCLUSION: Gatifloxacin injection is effective in treating respiratory tract infections caused by sensitive pathogens. The urinary tract infection is similar to levofloxacin injection with obvious effects and low adverse reactions, which is safe for patients.