头孢美唑治疗吸入性肺炎1522例的疗效与安全性

目的 评价头孢美唑治疗吸入性肺炎的临床疗效与安全性.方法 采用多中心、前瞻性、开放性临床研究.共入选1522例吸入性肺炎患者,静脉滴注头孢美唑2.0 g、2次/d,疗程7～14 d.记录观察期间出现的药物不良反应,评估治疗结束时的临床疗效、细菌学疗效及安全性.结果 33家医院参加了本研究,共入选1522例患者.符合意向性分析1522例,其中198例因违反试验方案、疗程资料缺失、患者依从性差及中途停药等原因剔除,最终符合方案集分析1324例.头孢美唑治疗1324例患者痊愈690例,显效366例,总有效率为79.8%(1056/1324).细菌学清除率为75.0%(342/456),头孢美唑对肺炎克雷伯杆菌、大肠埃希菌、甲氧西林敏感的金黄色葡萄球菌及厌氧菌的清除率分别是78.2%(97/124)、80.8%(80/99)、89.0%(81/91)和9/11.不良反应以肖化系统反应比较常见,主要有轻度恶心、呕吐、腹泻、头晕、皮疹、ALT一过性升高,停药后均好转.不良反应发生率为1.7%(26/1552).结论 头孢美唑治疗吸入性肺炎疗效好,安全性高.

Abstract：

Objective To evaluate the efficacy and safety of intravenous cefmetazole in the treatment of patients with aspiratory pneumonia. Methods A multicenter, prospective and open-labeled trial was conducted. A total of 1522 patients were enrolled at the beginning, and only 1324 were evaluabled at the endpoint. The duration of treatment was 7-14 days. During the treatment and follow-up periods, we recorded any unexpected symptoms and abnormal laboratory tests. At last,we evaluated its efficacy and safety. Results The total effective rate of cefmetazole was 79. 8% (1056/1324). The total bacterial eradication rate was 75.0% ( 342/456 ) . The bacterial eradication rates of klebsiellar pneumonia, escherichia, staphyloccocus aureus and anaerobic bacteria were 78.2% (97/124), 80.8% (80/99), 89.0% (81/91), 9/11,respectively. Conclusions Cefmetazole is effective and safe in the treatment of aspiratory pneumonia.

The clinical efficacy and safety of intravenous cefmetazole in treatment of 1,522 patients with aspiration pneumonia

Objective To evaluate the efficacy and safety of intravenous cefmetazole in the treatment of patients with aspiratory pneumonia. Methods A multicenter, prospective and open-labeled trial was conducted. A total of 1522 patients were enrolled at the beginning, and only 1324 were evaluabled at the endpoint. The duration of treatment was 7-14 days. During the treatment and follow-up periods, we recorded any unexpected symptoms and abnormal laboratory tests. At last,we evaluated its efficacy and safety. Results The total effective rate of cefmetazole was 79. 8% (1056/1324). The total bacterial eradication rate was 75.0% ( 342/456 ) . The bacterial eradication rates of klebsiellar pneumonia, escherichia, staphyloccocus aureus and anaerobic bacteria were 78.2% (97/124), 80.8% (80/99), 89.0% (81/91), 9/11,respectively. Conclusions Cefmetazole is effective and safe in the treatment of aspiratory pneumonia.