摘要
目的 :评价国产头孢泊肟酯片治疗急性细菌性感染的有效性和安全性。方法 :采用多中心、随机对照研究方法 ,以进口头孢泊肟酯片为对照 ,2组的用量、用法及疗程均为 10 0mg ,po ,bid ,疗程 7～14d。结果 :本研究共入组 175例病人 ,可进行临床疗效评价分析的病例 15 8例 ,试验组 77例 ,对照组81例。试验组总痊愈率和有效率分别为 70 %和92 % ;对照组总痊愈率和有效率分别为 79%和94 % ,2组细菌清除率分别为 98%和 98% ,2组比较差异均无显著意义 (P >0 .0 5 )。试验组和对照组的不良反应发生率分别为 9%和 2 % ,主要表现为口干、恶心、腹部不适及转氨酶增高等。结论 :国产头孢泊肟酯片治疗急性细菌性感染临床疗效确切 ,安全性较好。
AIM: To evaluate the clinical efficacy and safety of domestic cefpodoxime proxetil tablets in the treatment of acute bacterial infections. METHODS: A randomized multicenter clinical study was conducted for comparing domestic cefpodoxime proxetil tablets with inported cefpodoxime proxetil tablets. Both were administered orally at a dose of 100 mg twice daily for 7 to 14 days. RESULTS: Altogether, 175 patients were enrolled in the study. Among them 158 patients were eligible for clinical efficacy analysis inclnding 77 in domestic cefpodoxime proxetil proxetil group, 81 in control group. The cure rates and effective rates were 70 % and 92 %in domestic cefpodoxime proxetil group; and 79 % and 94 %in control group, respectively. The bacterial eradication rates were 98 % and 98 %, respectively. There were no statistically significant difference between the two treatment groups. Adverse reactions were observed for 9 % and 2 % of patients in the two groups, dominated by thirsty, nausea, abdominal discomfort and elevated transaminases. CONCLUSION: Domestic cefpodoxime proxetil tablet is effective and safe for the treatment of acute bacterial infections.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2004年第11期739-741,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
细菌感染
随机对照试验
多中心研究
头孢泊肟
bacterial infections
randomized controlled trials
multicenter studies
cefpodoxime
