头孢呋辛钠国产品与进口品随机对照治疗急性细菌性感染临床评价  

A randomized controlled clinical trial on domestic cefuroxime sodium versus imported cefuroxime sodium for the treatment of bacterial infections

作　　者：侯芳[1] 李家泰[1] 高磊[1] 郝凤兰[1] 缪竟智[2] 侯军[2] 郭胜祥[2] 胡云建[2] 宣天芝[2] 张秀珍[2] 陈楠[3] 任红[3] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]北京医院呼吸内科,北京100730 [3]上海第二医科大学附属瑞金医院,上海200025

出　　处：《中国抗生素杂志》2002年第7期413-418,共6页Chinese Journal of Antibiotics

摘　　要：采用随机对照试验方法评价国产头孢呋辛钠治疗细菌性感染的安全性及有效性。给药方法 :试验组头孢呋辛钠 0 .75～ 1.5 g,bid,静脉滴注 ;对照组进口头孢呋辛钠 (商品名 :西力欣 ) ,0 .75 g～ 1.5 g,bid静脉滴注 ,疗程均为 7～ 14 d。结果试验组及对照组分别有 70例及 71例可评价疗效 ,两组有效率分别为 94 .3%(6 6 /70 )及 90 .1% (6 4 /71) ,对各种致病菌感染有效率分别为 93.2 % (5 5 /5 9)和 91.4 % (5 3/5 8)。两组治疗前分离菌株均为 5 9株 ,治疗后细菌清除率分别为 94 .9% (5 6 /5 9)和 98.3% (5 8/5 9)。两组安全性评价分别为 86例及 79例 ,不良反应发生率分别为 10 .5 % (9/86 )与 15 .2 % (12 /79)。两组经统计学处理差异无显著性 (P>0 .0 5 )。结论 :头孢呋辛钠治疗急性细菌性感染疗效好 ,可安全耐受。Objective: To evaluate the efficacy and safety of domestic cefuroxime sodium, a randomized, open label, controlled clinical trial for the treatment of the patients with bacterial infections was conducted. Imported cefuroxime sodium (zinacef) was served as control. Method: 191 hospitalized patients enrolled in the study 100 patients received cefuroxime sodium 750mg～1500mg every 12 hours by intravenous infusion. 91 patients received Zinacef 750mg～1500mg every 12 hours by intravenous infusion. The duration was 7～14 days in two groups. Results 70 of 100 cases received cefuroxime sodium and 71 of 91 cases received Zinacef were assessable for clinical efficacy. The overall efficacy rates were 94.3% for the cefuroxime sodium group and 90.1% for the Zinacef group. The bacterial eradication rates were 94.9% and 98.3% respectively. The adverse reaction was evaluated in 86 cases of cefuroxime sodium group and 79 cases of Zinacef group. The adverse drug reaction rates were 10.5%(9/86) and 15.2%(12/79), respectively. Results showed that there were no statistical differences between these two groups ( P >0.05). Conclusion: Cefuroxime sodium was effective for the treatment of lower respiratory tract infections and urinary tract infections and other infections. Cefuroxime sodium displayed a good tolerance during the study.

关 键 词：治疗 临床评价 头孢呋辛钠 随机对照试验 细菌感染 

分 类 号：R978.11[医药卫生—药品] R969.4[医药卫生—药学]