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_论文.docxVIP

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 【摘要】 目的 评价国产注射用盐酸头孢吡肟治疗中、重度急性细菌性感染的临床疗效与安全性。方法 采用双盲、随机对照试验设计，以进口盐酸头孢吡肟为对照药。两组的用量、用法、疗程均为～溶解于NS 100ml中，Q12h静脉滴注，疗程7～10d。结果 研究实际完成211例，其中国产头孢吡肟组纳入FAS分析109例，PPS分析104例；进口头孢吡肟组纳入FAS分析108例，纳入PPS分析107例。疗程结束时国产头孢吡肟组和进口头孢吡肟组的总痊愈率和有效率分别为%与%和%与%，两组细菌清除率分别为%和%。以上结果两组间比较无统计学差异(P)。国产头孢吡肟组和进口头孢吡肟组的不良反应发生率分别为%和%，主要表现为皮疹、嗜酸性粒细胞计数一过性增高及轻度转氨酶升高等。结论 国产注射用头孢吡肟治疗中、重度急性细菌性感染的临床疗效确切，安全性较好。 【关键词】 头孢吡肟 急性细菌性感染 随机双盲对照试验 A multicenter, doubleblind, randomized clinical trial of parenteral cefepime in the treatment of acute bacterial infections ABSTRACT Objective To evaluate the clinical efficacy and safety of domestic injectable cefepime for the treatment of acute moderate and severe bacterial infections. 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). Adverse reactions 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 transaminases (4/112; 2/111). Conclusion Domestic injectable cefepime is effective and safe for the treatment of acute moderate and severe bacterial infections. KEY WORDS Cefepime; Acute bacterial infections; 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