【摘要】：研究目的：比較延長美羅培南輸液時間至3小時和常規(guī)輸注30分鐘兩種給藥方案治療ICU患者重癥感染的臨床療效和安全性差異。 研究方法：開放性隨機對照研究。選取2012年9月1日至2013年9月31日期間在山東大學齊魯醫(yī)院綜合ICU病房住院的危重病感染病患者120例,簽署知情同意書,按照患者入組序號和隨機數(shù)字表隨機分入研究組(延長輸液時間給藥組/3h組)和對照組(單劑量間歇輸液給藥組/30min組)。研究組患者按照250mg/10min+750mg/180min給藥,對照組按照1000mg/30min給藥。記錄用藥開始前1天、用藥第4天,第8天和停藥后1天的臨床信息,并詳細記錄不良反應、伴發(fā)疾病和合并用藥情況,同時進行疾病嚴重程度(APACHE Ⅱ/SOFA)評分、臨床肺部感染(CPIS)評分、并統(tǒng)計全身炎性反應綜合征(SIRS)指標的個數(shù)等,隨訪第28天的存活情況。從臨床療效、細菌學療效、危重病評分的改善度和藥物的安全性等方面評價兩種不同給藥方式的差異。 研究結(jié)果：108例患者完整執(zhí)行研究方案,其中研究組52例,對照組56例。研究組的臨床治愈率(78.8%vs50%)、28天生存率(86.5%vs.66.1%)、ICU內(nèi)的死亡率(9.6%vs.25%)、SOFA評分改善程度(2.31±2.58vs.1.09±2.27)明顯優(yōu)于對照組,差異有統(tǒng)計學意義；兩組患者在細菌清除率(48.7%vs.47.7%)、影像學有效率(50%vs.32.1%)、械通氣天數(shù)(10.85±10.44vs.12.06±7.37)、ICU住院日(19.98±12.35vs.20.61±9.44)以及臨床癥狀(體溫、白細胞)、感染性指標(PCT、SIRS)、危重病評分(APACHE Ⅱ/SOFA評分)的改善程度上未見明顯差異；肺部感染亞組的臨床治愈率、28天存活率、SIRS指標的改善以及SOFA評分、CPIS評分的改善程度明顯優(yōu)于對照組,腹腔感染亞組的臨床治愈率明顯過于對照組。兩組患者觀察到的主要不良反應為一過性肝酶升高,兩組間無差異,均未給予特殊處理,停藥后逐漸恢復正常。 研究結(jié)論：延長美羅培南輸液時間給藥方案可以提高ICU患者重癥感染的臨床治愈率、改善28天存活率,減輕器官功能的損傷,而且不增加藥物的不良反應發(fā)生率。因此,針對危重病患者的嚴重細菌感染,延長輸注時間為3小時的美羅培南給藥方式值得推薦。
[Abstract]:Objective: to compare the clinical efficacy and safety of prolonged meropenem infusion time to 3 hours and routine infusion of 30 minutes in the treatment of severe infection in patients with ICU. Methods: open randomized controlled trial. From September 1, 2012 to September 31, 2013, 120 critically ill infectious patients in the ICU ward of Qilu Hospital, Shandong University, were selected, and informed consent was signed. According to the serial numbers and random numbers of the patients, they were randomly divided into the study group (prolonging the time of infusion) and the control group (single dose intermittent infusion group / 30 min group). The patients in the study group were treated with 250mg/10min 750mg/180min and the patients in the control group were treated with 1000mg/30min. The clinical information was recorded on the first day, the 4th day, the 8th day and the first day after the drug withdrawal, and the adverse reactions, associated diseases and combined medication were recorded in detail. The severity of the disease (APACHE 鈪，

本文編號：2239400