盐酸头孢吡肟多中心随机对照治疗急性细菌感染的临床观察_论文.docxVIP

盐酸头孢吡肟多中心随机对照治疗急性细菌感染的临床观察 作者：闫喜荣 贾利宁 桂保松 王婷 孙秀珍 杨岚 石志红 何辉 韩雪芳 【关键词】 头孢吡肟；,,,急性细菌性感染；,,,随机单盲对照 摘要： 目的 评估盐酸头孢吡肟治疗各种中、重度细菌性感染的临床疗效和安全性。方法 采用多中心随机单盲对照临床试验，241例患者纳入该研究，治疗组121例，给予盐酸头孢吡肟；对照组120例，给予头孢吡肟。两药的剂量均为10～20g/次，静脉滴注，Q12h；疗程均为7～10d。结果 盐酸头孢吡肟组和头孢吡肟组的临床痊愈率分别为544%和542%，临床有效率分别为895%和869%，细菌阴转率分别为934%和895%，细菌清除率分别为923%和895%；不良反应发生率分别为42%与42%。以上结果经统计学处理均无显著性差异(P005)。两组不良反应主要是消化道反应，少数患者可有皮疹、肝酶学升高、白细胞和血红蛋白下降等反应。结论 注射用盐酸头孢吡肟治疗各种中、重度急性细菌性感染疗效确切，安全性好。 关键词： 头孢吡肟； 急性细菌性感染； 随机单盲对照 A multicenter randomized control clinical trial of cefepime hydrochloride　injection in the treatment of acute bacterial infections ABSTRACT Objective To evaluate the clinical efficacy and safety of cefepime hydrochloride for injection in the treatment of moderate and serious acute bacterial infections. Methods A multicenter singleblind randomized control clinical trial was conducted and 241 patients were enrolled for this study. One hundred and twenty one patients of test group were treated with cefepime hydrochloride and 120 patients of control group were treated with cefepime, and both groups were administrated intravenously at a dose of 10～20g twice daily for 10～14 days. Results The rate of cure, effectiveness, bacterial clearance, bacterial negative and adverse reactions is 5439%, 8947%, 9231%, 9342% and 4166% in cefepime hydrochloride groups and 5421%, 8692%, 8947%, 8947% and 4237% in cefepime groups, respectively. There were no statistically significant differences between the two groups. Adverse reactions are primarily digestive reactions, occasionally rash, elevation of hepatic enzyme, and decrease of leukocyte and hemoglobin. Conclusion Cefepime hydrochloride is effective and safe in the treatment of moderate and serious acute bacterial infections. KEY WORDS Cefepime; Acute bacterial infections; Singleblind randomized control 头孢吡肟(cefepime，CPE)为新型第四代头孢菌素类抗生素。本品具有抗菌谱广，抗菌活性强，不仅对肠杆菌属、克雷伯菌属、变形菌属、嗜血菌属、沙门菌属、不动杆菌属及假单胞菌属等革兰阴性菌具有良好的体外抗菌活性，对葡萄球菌属、链球菌属等革兰阳性菌也具有较强的抗菌作用。本品能快速透过革兰阴性杆菌细胞膜，对多种重要的青