摘要
目的:评价国产注射用头孢美唑钠治疗中、重度呼吸系统细菌感染的临床有效性和安全性。方法:采用随机、双盲、平行对照临床研究。将48例呼吸系统感染患者随机分入试验组(n=24)和对照组(n=24),分别静脉滴注国产或进口注射用头孢美唑钠,剂量均为4 g·d^(-1),bid,疗程5～12 d。结果:试验组和对照组的痊愈率分别为27．3%和33．3%;有效率分别为72．7%和76．2%;细菌清除率分别为87．5%和76．9%;对G^+球菌的清除率分别为81．8%和80．0%,对G^-杆菌的清除率分别为100．0%和75．0%。两组各项指标比较差异均无显著性(P＞0．05)。两组均未发生不良事件。结论:国产注射用头孢美唑钠治疗中、重度呼吸系统感染疗效好,安全性高,与进口头孢美唑钠相近。
Objective：To evaluate the efficacy and safety of the domestic cefmetazole sodium for injection in the treatment of moderate to severe respiratory tract infections. Methods： A randomized,double blind and parallel control phase Ⅱ clinical study enrolled 48 patients with repiratory tract infections, who were equally randomized intravenously to receive 2 grams of either domestic cefmetazole or imported cefmetazole twice daily for 5 -12 days. Results：The cure rate and response rate of domestic and imported cefmetazole were 27.3% vs. 33.3% and 72. 7% vs. 76. 2% ,respectively;the total bacterial eradication rate was87.5% vs. 76.9%（81.8% vs. 80.0% for G^＋ germs and 100.0% and 75.0% forG germs）;the P values were no significantly different （P 〉 0. 05）. No adverse events were reported in both treatment groups. Conclusions：The domestic cefmetazole is therapeutic equivalent to the imported cefmetazole in the treatment for moderate to severe respiratory tract infections.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2006年第4期298-300,共3页
Chinese Journal of New Drugs
关键词
头孢美唑纳
呼吸道感染
细菌感染
Ⅱ期临床试验
cefmetazole
respiratory tract infections
bacterial infections
phase Ⅱ clinical trial
