延长美罗培南输液时间治疗ICU患者重症感染的随机对照临床研究

发布时间：2018-09-12 15:01

【摘要】：研究目的：比较延长美罗培南输液时间至3小时和常规输注30分钟两种给药方案治疗ICU患者重症感染的临床疗效和安全性差异。 研究方法：开放性随机对照研究。选取2012年9月1日至2013年9月31日期间在山东大学齐鲁医院综合ICU病房住院的危重病感染病患者120例,签署知情同意书,按照患者入组序号和随机数字表随机分入研究组(延长输液时间给药组/3h组)和对照组(单剂量间歇输液给药组/30min组)。研究组患者按照250mg/10min+750mg/180min给药,对照组按照1000mg/30min给药。记录用药开始前1天、用药第4天,第8天和停药后1天的临床信息,并详细记录不良反应、伴发疾病和合并用药情况,同时进行疾病严重程度(APACHE Ⅱ/SOFA)评分、临床肺部感染(CPIS)评分、并统计全身炎性反应综合征(SIRS)指标的个数等,随访第28天的存活情况。从临床疗效、细菌学疗效、危重病评分的改善度和药物的安全性等方面评价两种不同给药方式的差异。 研究结果：108例患者完整执行研究方案,其中研究组52例,对照组56例。研究组的临床治愈率(78.8%vs50%)、28天生存率(86.5%vs.66.1%)、ICU内的死亡率(9.6%vs.25%)、SOFA评分改善程度(2.31±2.58vs.1.09±2.27)明显优于对照组,差异有统计学意义；两组患者在细菌清除率(48.7%vs.47.7%)、影像学有效率(50%vs.32.1%)、械通气天数(10.85±10.44vs.12.06±7.37)、ICU住院日(19.98±12.35vs.20.61±9.44)以及临床症状(体温、白细胞)、感染性指标(PCT、SIRS)、危重病评分(APACHE Ⅱ/SOFA评分)的改善程度上未见明显差异；肺部感染亚组的临床治愈率、28天存活率、SIRS指标的改善以及SOFA评分、CPIS评分的改善程度明显优于对照组,腹腔感染亚组的临床治愈率明显过于对照组。两组患者观察到的主要不良反应为一过性肝酶升高,两组间无差异,均未给予特殊处理,停药后逐渐恢复正常。 研究结论：延长美罗培南输液时间给药方案可以提高ICU患者重症感染的临床治愈率、改善28天存活率,减轻器官功能的损伤,而且不增加药物的不良反应发生率。因此,针对危重病患者的严重细菌感染,延长输注时间为3小时的美罗培南给药方式值得推荐。
[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，

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