头孢呋辛钠治疗急性细菌性感染的多中心随机对照临床研究

A multicenter randomized controlled clinical trial on cefuroxime sodium in the treatment of acute bacterial infections

目的 评价国产头孢呋辛钠的临床疗效及安全性。方法 以进口分装注射用头孢呋辛钠为对照进行多中心随机对照临床研究。试验药与对照药均为每次 0 .75～ 1.5g、静脉滴注 ,Q8h ,疗程 7～ 14d。结果共治疗急性中、重度细菌性感染 12 0例 ,其中试验组 5 9例 ,对照组 6 1例。试验组和对照组的痊愈率分别为6 1.0 2 %与 5 4.0 9% ,有效率分别为 93.2 2 %与 93.44%。细菌培养阳性率分别为 84.75 %与 80 .33% ,细菌阴转率分别为 90 .0 0 %与 89.80 % ,细菌清除率均为 90 .0 0 %。安全性评价结果显示 ,试验组与对照组不良反应发生率分别为 15 .0 0 %与 8.2 0 %。以上结果两组比较差异均无统计学意义 (P >0 .0 5 )。结论 国产头孢呋辛钠注射液临床疗效确切 ,不良反应较少。

Objective: To compare the clinical efficacy and safety of domestic cefuroxime with that of imported in the treatment of moderate to severe bacterial infections. Methods: In a randomized controlled clinical trail, a total of 120 patients enrolled the study, 59 in domestic cefuroxime group and 61 in imported cefuroxime group. The dosage of both drugs was 0.75～1.5g q8h. The duration of treatment was 7～14days in both groups. Results: Results showed that the cure rates were 61.02% and 54.09%; the effective rates were 93.22% and 92.44%, whereas the bacterial clearance rates were 90.00% and 90.20%,respectively. The incidence of adverse reactions were 15.00% and 8.20%. Conclusion: The results showed that there was no statistical difference between the two groups ( P >0.05).