Objective To Compare the clinical efficacy and safety of meropenem with a 3-hour extended infusion or conventional 30-minute infusion regimen in treatment of hospital acquired pneumonia (HAP) in intensive care unit (ICU) patients.Methods An open-label randomized controlled clinical trial was conducted.100 HAP patients,admitted to ICU of Qilu Hospital of Shandong University,who needed meropenem therapy were enrolled from September 1st,2012 to September 30th,2013.The patients were randomly divided into two groups.Patients who did not conform to the study protocol were excluded.A total of 78 patients were included for the study of clinical efficacy evaluation,with 38 cases in study group,and 40 in control group.The patients in study group received intravenous 1 g of meropenem (dissolved in 40 mL saline) within 10 minutes,and followed by the remaining 750 mg by continuous intravenous infusion for 3 hours,and the treatment was repeated every 8 hours.The patients in control group received meropenem by injection of 1 g (dissolved in 40 mL saline),i.e.by intravenous infusion within 30 minutes every 8 hours.This regime was carried out for at least 7 days.Clinical efficacy,bacterial clearance rate,improvement of critical illness scoring,and safety were observed and compared after meropenem withdrawal between two groups.Results Compared with control group,the clinical cure rate and 28-day survival rate in study group were significantly increased [clinical cure rate:71.1％ (27/38) vs.42.5％ (17140),x2=6.461,P=0.011; survival rate:81.6％ (31/38) vs.60.0％ (24/40),x2=4.364,P=0.037].The improvement of clinical pulmonary infection score (CPIS) and sequential organ failure assessment (SOFA) score in study group were more marked than those in control group (difference of CPIS score:-3.47 ± 2.48 vs.-1.50 ± 2.48,t=-3.513,P=0.001 ; difference of SOFA score:-2.10 ± 2.38 vs.-1.00 ± 2.21,t=-0.800,P=0.037).There were no significant differences in duration of meropenem treatment,acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score,procalcitonin (PCT),duration of mechanical ventilation,ICU stay days,secondary infection,and bacterial clearance rate between two groups.The main adverse reactions observed were transient elevation of liver enzymes and diarrhea in bothgroups,but no significant difference in their incidence was found between study and control groups [elevated liver enzymes:28.9％ (11/38) vs.30.0％ (12/40),x2=0.010,P=0.919;diarrhea:7.9％ (3/38) vs.10.0％ (4/40),x2=0.000,P=1.000].Conclusions Compared with conventional regime of 30-minute infusion of meropenem in the treatment of HAP in ICU patients,the clinical efficacy can be improved,the severity of the disease can be reduced,the recovery of organ failure and long-term prognosis can be improved with 3 hour extended infusion of meropenem.%目的 比较美罗培南延长输注时间(3 h)和常规输注(30 min)两种给药方法治疗重症监护病房(ICU)医院获得性肺炎(HAP)患者的临床疗效和安全性.方法 采用开放性随机对照临床单盲研究.以2012年9月1日至2013年9月30日入住山东大学齐鲁医院ICU经临床评估需要给予美罗培南治疗的100例HAP患者为研究对象,按随机数字表法均分为两组,剔除不合格病例,最终纳入研究组38例、对照组40例.研究组给药方案为美罗培南1g溶于40 mL生理盐水中,10 min内给予250 mg负荷剂量,余750 mg匀速静脉泵入3h,每8h给药1次;对照组给药方案为美罗培南1 g溶于40 mL生理盐水中,30 min内静脉输注完成,每8h给药1次;两组至少用药7d.比较两组患者的临床疗效、细菌学疗效、病情严重度评分的改善程度和药物安全性等.结果 与对照组比较,研究组临床治愈率和28 d生存率均明显升高[治愈率:71.1％(27/38)比42.5％(17/40),x2=6.461,P=0.011;生存率:81.6％ (31/38)比60.0％(24/40),x2=4.364,P=0.037],临床肺部感染评分(CPIS)、序贯器官衰竭评分(SOFA)明显改善[CPIS差值(分):-3.47±2.48比-1.50±2.48,t=-3.513,P=0.001;SOFA差值(分):-2.10±2.38比-1.00±2.21,t=-0.800,P=0.037];两组美罗培南治疗天数、急性生理学与慢性健康状况评分系统Ⅱ(APACHEⅡ)评分、降钙素原(PCT)、机械通气时间、ICU住院时间、二重感染率及病原学清除率差异均无统计学意义.主要观察到的不良反应为一过性肝酶升高和腹泻,研究组与对照组比较差异均无统计学意义[肝酶升高:28.9％(11/38)比30.0％(12/40),x2=0.010,P=0.919;腹泻:7.9％(3/38)比10.0％(4/40),x2=0.000,P=1.000].结论 与30 min常规输注给药方法相比,3h延长美罗培南输液时间给药可以提高ICU内HAP患者的临床治愈率,减轻疾病严重程度,促进器官功能的好转,改善长期预后.
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