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国产与进口头孢呋辛钠随机对照治疗妊娠合并细菌性感染临床研究
Randomized controlled clinical trial on domestic and imported cefuroxime sodium in the treatment of bacterial infection during pregnancy
【摘要】 目的 评价国产头孢呋辛钠注射剂治疗妊娠合并敏感菌引起的呼吸和泌尿系统感染的有效性和安全性。方法 以进口头孢呋辛钠注射剂为对照,用随机对照多中心平行开放的试验设计,两组药物用量均为0.75~1.5g,tid,疗程均为7~10天。国产头孢呋辛钠组临床评价病例为64例,细菌学疗效评价例数为52例,药物不良反应评价例数为68例;进口头孢呋辛钠组分别为62,51,66例。结果 试验组和对照组的临床有效率分别为85.9%和83.9%;细菌清除率分别为86.8%和80.8%,药物不良反应发生率分别为5.8%和6.1%。结论 国产头孢呋辛钠注射剂是治疗妊娠合并细菌感染的安全有效药物。
【Abstract】 Objective To evaluate the efficacy and safety of domestic cefuroxime compared to imported cefuroxime. Methods A randomized comparative open multicenter trial was conducted. The dosage of both drugs was 0.75-1.5 g, tid.The duration of treatment was 7~10 days in both groups.The total number of final evaluated subject was 126 including 64 subjects in domestic cefuroxime group and 62 subjects for imported cefuroxime group.The bacterial evaluated subjects were 52 in domestic cefuroxime and 51 for imported cefuroxime. Results Clinical efficacy rate and bacterial eradication rate for domestic cefuroxime were 85.9% and 86.8%, respectively.Clinical efficacy rate and bacterial eradication rate for imported cefuroxime were separately 83.9% and80.8%. Both of the incidence of adverse drug reaction were 5.8% and 6.1%, respectively. Conclusion It was concluded that domestic cefuroxime had an excellent clinical efficacy and good safety profile in treating patients with bacterial infection during pregnancy.
- 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2004年02期
- 【分类号】R714.25
- 【被引频次】2
- 【下载频次】102