注射用盐酸头孢吡肟多中心随机双盲对照治疗急性细菌性感染的临床评价.docVIP

注射用盐酸头孢吡肟多中心随机双盲对照治疗急性细菌性感染的临床评价 目录 TOC \o 1-9 \h \z \u 目录 1 正文 1 文1：注射用盐酸头孢吡肟多中心随机双盲对照治疗急性细菌性感染的临床评价 1 1 材料与方法 3 2 结果 5 3 讨论 6 文2：法罗培南钠片治疗细菌性感染的随机双盲对照临床研究 8 1 病例与方法 9 2 结果 11 3 讨论 13 参考文摘引言： 14 原创性声明（模板） 15 文章致谢（模板） 16 正文 注射用盐酸头孢吡肟多中心随机双盲对照治疗急性细菌性感染的临床评价 文1：注射用盐酸头孢吡肟多中心随机双盲对照治疗急性细菌性感染的临床评价 A multicenter, doubleblind, randomized clinical trial of parenteral cefepime in the treatment of acute bacterial infectio ABSTRACT Objective To evaluate the clinical efficacy and safety of domestic injectable cefepime for the treatment of acute moderate and severe bacterial infectio. Methods A multicenter doubleblind randomized clinical trial was conducted comparing the efficacy and safety of domestic injectable cefepime with maxipime. Cefepime was administered intravenously at a dose of 1～2 gram twice daily for 7 to 14 days. Results A total of 211 patients were enrolled in the study. There were 109 patients enrolled in FAS analysis and 104 in PPS analysis in treatment group, while 108 patients were enrolled in FAS analysis and 107 patients were eligible for PPS analysis in control group. At the end of treatment, the cure rate and effective rate were % % in trial group; while % and % in control group. The bacterial eradication rates were % and %, respectively. There was no statistical difference between the two groups (P). Advee reactio were observed in % and % of patients in the two groups, dominated by skin rash (1/112), temporary acidophilia (2/112; 2/111) and mild elevated traaminases (4/112; 2/111). Conclusion Domestic injectable cefepime is effective and safe for the treatment of acute moderate and severe bacterial infectio. KEY WORDS Cefepime; Acute bacterial infectio; Doubleblind randomized clinical trial 注射用盐酸头孢吡肟(cefepime hydrochloride for injection)为第四代头孢菌素类抗菌药物，其作用机制为抑制细菌细胞壁合成，导致细菌无法繁殖而死亡。本品在抗菌谱、对β内酰胺酶的稳定性、对细菌细胞膜的穿透性等方面均明显优于第三代头孢菌素，与第三代头孢菌素相比较，本品对革兰阳性细菌的抗菌作用增强。 头孢吡肟对很多革兰阳性细菌和革兰阴性细菌，包括肠杆菌科细菌、铜绿假单胞菌和其他非发酵革兰阴性杆菌、流感嗜血菌、奈瑟球菌属、葡萄球菌及