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阿莫西林钠/舒巴坦钠治疗急性细菌性感染疾病的多中心临床研究 被引量:6

Multicentre clinical trial on amoxicillin/sulbactam for treatment of acute bacterial infections
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摘要 目的 评价阿莫西林钠/舒巴坦钠治疗急性细菌感染疾病的安全性和有效性及药物不良反应。方法 用多中心随机对照的方法,比较了国产阿莫西林钠/舒巴坦钠轻度感染,每次1.5 g,每12 h 1次,中、重度感染每次3.0 g,每12 h或8 h 1次,与阿莫西林/克拉维酸轻度感染每次1.2 g,每12 h 1次;中、重度感染2.4 g,每12 h或8 h 1次,治疗急性细菌性感染的临床疗效和安全性。结果 试验组的痊愈率和有效率分别为80.88%和95.58%,细菌清除率为96.42%;对照组的痊愈率和有效率分别为75.36%和94.20%,细菌清除率为95.24%,两组差异无统计学意义。试验中未发现应用阿莫西林钠/舒巴坦钠的严重药物不良反应。结论 国产阿莫西林钠/舒巴坦钠对急性细菌性感染的临床疗效好,且药物不良反应少。 Objective To evaluate the clinical efficacy and safty and adverse drug reaction of amoxicillin/sulbactam for acute bacterial infections. Methods A randomized controlled multicentre clinical trial on efficacy and safety of domestic amoxicillin/sulbactan in 1.5 g every 12 hours (light), 3.0 g every 12 hours (middle) and 3.0 g every 8 hours (serious) compared with amoxicillin/clavulanate in 1.2g every 12 hours (light), 2.4 g every 12 hours (middle) and 2.4 g every 8 hours (serious) for treatment of acute bacterial infections was conducted. Results The results showed that the curerates and efficacy rates in the test group were 80.88% and 95.58%, while the cure rates and efficacy rates in the control group were 75.36% and 94.20%, and the bacterial clean rate was 95.24%. The difference between the two groups was no statistically significant.There no serious adverse drug reactions of amoxicillin/ sulbactam in the clinical trial. Conclusion It suggested that amoxicillin/sulbactam is an effective and safe drug or treatment acute bacterial infections.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2003年第5期323-329,共7页 The Chinese Journal of Clinical Pharmacology
关键词 阿莫西林钠 舒巴坦钠 治疗 急性细菌感染 不良反应 抗生素 amoxicillin/sulbactam amoxicillin/clavulanate bacterial infection
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