摘要
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。
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 （0.5 g, iv, gtt, 30 min to 1 h, bid）, and the control group （group B, n = 120, M 50, F 70, average age （42 ± 13） a） were given levofloxacin （0.3 g, iv, gtt, 30 min to 1 h, bid） for 7 - 10 d. 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.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2007年第3期183-186,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
帕珠沙星
左氧氟沙星
细菌感染
随机对照试验
抗感染药
多中心研究
pazufloxacin
levofloxacin
bacterial infections
randomized controlled trials
antiinfectionagents
muhicenter studies
