帕珠沙星治疗急性细菌感染性疾病的Ⅱ期临床试验

目的:评价帕珠沙星对急性细菌感染病人的有效性和安全性。方法:采用多中心随机单盲对照试验设计。选择细菌性感染病人240例,试验组(A组)120例,年龄(44±s 12)a,男性46例,女性74例;对照组(B组)120例,年龄(42±13)a,男性50例,女性70例。A组用帕珠沙星0．5 g,加入氯化钠注射液100 mL,iv,gtt,30 min～1 h,bid;B组用左氧氟沙星0．3 g,加入氯化钠注射液100 mL, iv,gtt,30 min～1 h,bid。疗程均为7～10 d。结果:A组120例,痊愈率为77．5％,总有效率98．3％; B组120例,痊愈率为74．2％,总有效率为96．7％,A组痊愈率和总有效率95％可信区间分别为70％～85％和96％～100％;B组痊愈率和总有效率95％可信区间分别为66％～82％和93％～100％,2组无显著差异。A组和B组的细菌清除率分别为97．1％和96％,2组比较无显著差异(P＞0．05),A组不良反应发生率为4．2％,B组为3．3％,差异无显著意义(P＞0．05)。结论:帕珠沙星治疗由敏感病原体引起的呼吸道感染、泌尿道感染,疗效与左氧氟沙星相近,不良反应较低。

Phase Ⅱ clinical trial of pazufloxacin mesilate for injection in treatment of acute bacterial infection

AIM:To evaluate the efficacy and safety of pazufloxacin mesilate for injection in the treatment of acute bacterial infection.METHODS:A multi-center,single blind,randomized controlled trial was conducted among 240 patients with bacterial infections(118 patients with respiratory tract infections and 122 patients with urinary tract infections).The treatment group(group A,n=120,M 46,F 74,average age 44±12)a were treated with pazufloxacin mesilate(0.5g,iv,gtt,30min to 1h,bid),and the control group(group B,n=120,M 50,F 70,average age(42±13)a)were given levofloxacin(0.3g,iv,gtt, 30min to 1h,bid)for 7-10d.RESULTS:The recovery rate and effective rate were 77.5% and 98.3% in group A,and 74.2% and 96.7% in group B respectively(P＞0.05).The bacterial eradication rate in group A and B were 97.1% and 96%,and the adverse drug reaction rate in group A and B were 4.2% and 2.5% respectively(P＞0.05).CONCLUSION:Pazufloxain mesilate and levofloxacin have the similar efficacy and safety in the treatment of susceptible pathogen infection.