替加环素治疗烧伤继发感染的疗效和安全性的多中心开放研究

A non-controlled,multicenter open-label study to evaluate the safety and efficacy of tigecycline in the treatment of infections secondary to burn injury

目的观察替加环素治疗烧伤继发感染的疗效和安全性,探索其治疗烧伤继发感染的应用策略。方法本研究为非对照、多中心、开放性临床研究。静脉滴注,给药方案为首剂100 mg,然后每12 h 50 mg。替加环素的静脉滴注时间每12 h给药一次,每次30~60 min。通过对其初始治疗效果、临床疗效、细菌学疗效、安全性4个方面对药物进行评价。结果共入选77例患者,初始疗效有效率为81.82%,临床疗效有效率为84.42%(其中痊愈9.09%,显效50.65%,进步24.68%),发生与药物可能有关的不良事件1例,不良反应发生率为1.31%,细菌清除率为46.75%。结论替加环素治疗烧伤继发感染的临床不良反应发生率较低,且患者可耐受。替加环素可有效治疗烧伤继发感染。

Objective To explore the usage of the treatment and evaluate the safety and efficacy of tigecycline in the treatment of infections secondary to burn injury. Methods This was a non-controlled,multicenter,open-label clinical tria1. Intravenous tigecycline was administered with a loading dose of100 mg for the first time followed by 50 mg/12 hours during the remaining treatment,which lasted for 30-60 minutes every time. The drug was evaluated by 4 aspects： initial treatment effect,clinical efficacy,bacteriological efficacy,and safety. Results A total of 77 patients were recruited,the initial effective rate was 81. 82%,and the clinical effective rate was 84. 42%（ cured 9. 09%,markedly effective 50. 65%,improved 24. 68%）. There was one adverse event related to the drug,the incidence of adverse reaction was1. 31%. The bacterial clearance rate was 46. 75%. Conclusions Tigecycline is mostly mild in the treatment of infections secondary to burn injury and the clinical incidence of adverse reactions is low.Tigecycline can be an effective and safe treatment for infections secondary to burn injury.