头孢吡肟治疗急性细菌性感染多中心随机双盲对照临床研究

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目的:评价国产头孢吡肟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、双盲、阳性药物平行对照研究,共入选142例,可评价疗效病例139例,其中试验组70例,对照组69例。呼吸系统感染采用国产和进口头孢吡肟均为每次2 g,而泌尿系统感染采用国产和进口头孢吡肟均为每次1 g,分别加入50~100 mL氯化钠注射液或5%葡萄糖注射液中,iv,gtt,bid,疗程均为7~14 d。结果:试验组和对照组痊愈率分别为50%和41%,有效率分别为93%和91%;2组细菌清除率均为100%;药物不良反应发生率分别为4%和9%,2组比较均无显著差异(P>0.05)。结论:国产头孢吡肟治疗急性细菌性感染安全、有效。 Objective: To evaluate the efficacy and safety of domestic cefepime in the treatment of acute bacterial infections. METHODS: A multicenter, randomized, double-blind, positive-drug parallel controlled study was enrolled. A total of 142 patients were enrolled in this study. 139 cases were evaluated for efficacy, including 70 in the test group and 69 in the control group. Respiratory infections using domestic and imported cefepime were 2 g each time, and urinary tract infection with domestic and imported cefepime were 1 g each, were added 50 ~ 100 mL sodium chloride injection or 5% glucose Injection, iv, gtt, bid, treatment are 7 ~ 14 d. Results: The cure rates were 50% and 41% in the test group and the control group respectively. The effective rates were 93% and 91% respectively. The bacterial clearance rate was 100% in both groups. The adverse drug reaction rates were 4% and 9% There was no significant difference between the two groups (P> 0.05). Conclusion: Domestic cefepime is safe and effective in the treatment of acute bacterial infections.
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