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静脉注射氨苄西林-舒巴坦联合雾化吸入多黏菌素与静脉注射多黏菌素联合雾化吸入多黏菌素治疗多重耐药菌所致呼吸机相关性肺炎的比较:随机开放标签试验

Comparison of Intravenous Ampicillin-sulbactam Plus Nebulized Colistin with Intravenous Colistin Plus Nebulized Colistin in Treatment of Ventilator Associated Pneumonia Caused by Multi Drug Resistant Randomized Open Label Trial.

作者信息

Pourheidar Elham, Haghighi Mehrdad, Kouchek Mehran, Miri Mir Mohammad, Shojaei Seyedpouzhia, Salarian Sara, Hassanpour Rezvan, Sistanizad Mohammad

机构信息

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Department of Infectious Diseases, Imam Hossein Teaching and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Iran J Pharm Res. 2019 Fall;18(Suppl1):269-281. doi: 10.22037/ijpr.2019.112466.13775.

Abstract

The purpose of this study was evaluating the efficacy and safety of intravenous (IV) ampicillin-sulbactam plus nebulized colistin in the treatment of Ventilator-Associated Pneumonia (VAP) caused by MDR (MDRA) in ICU patients as an alternative to IV plus nebulized colistin. In this single-blinded RCT, one group received IV colistin and another group IV ampicillin-sulbactam (16 and 12 patients from total 28 patients, respectively) for 14 days or since clinical response. Both groups received nebulized colistin by mesh nebulizer. There were no statistically significant differences between the 2 groups in baseline characteristics and previous antibiotic therapy. In follow up period, no significant difference was observed between 2 groups in rate of microbiological eradication, clinical signs of VAP improvement, survival rate and length of hospital as well as ICU stays. Although we have found no significant differences in Acute Kidney Injury (AKI) incidence between two groups, comparison of cumulative patient-days with stages 2 and 3 AKI with days with no or stage 1 AKI, according to AKIN criteria, revealed significant difference in IV colistin versus IV ampicillin-sulbactam group ( = 0.013). The results demonstrated that the high dose IV ampicillin-sulbactam plus nebulized colistin regimen has comparable efficacy with IV plus nebulized colistin in the treatment of VAP caused by MDRA, with sensitivity to colistin only, with probably lower incidence of kidney injury.

摘要

本研究的目的是评估静脉注射氨苄西林-舒巴坦联合雾化吸入多黏菌素治疗重症监护病房(ICU)患者中由多重耐药菌(MDRA)引起的呼吸机相关性肺炎(VAP)的疗效和安全性,作为静脉注射联合雾化吸入多黏菌素的替代方案。在这项单盲随机对照试验中,一组接受静脉注射多黏菌素,另一组接受静脉注射氨苄西林-舒巴坦(分别来自28例患者中的16例和12例),疗程为14天或至临床症状缓解。两组均通过网状雾化器接受雾化吸入多黏菌素治疗。两组在基线特征和既往抗生素治疗方面无统计学显著差异。在随访期,两组在微生物清除率、VAP改善的临床体征、生存率、住院时间以及ICU住院时间方面均未观察到显著差异。尽管两组之间急性肾损伤(AKI)发生率无显著差异,但根据AKIN标准,将2期和3期AKI的累积患者天数与无AKI或1期AKI的天数进行比较,结果显示静脉注射多黏菌素组与静脉注射氨苄西林-舒巴坦组存在显著差异(P = 0.013)。结果表明,高剂量静脉注射氨苄西林-舒巴坦联合雾化吸入多黏菌素方案在治疗由MDRA引起的VAP方面与静脉注射联合雾化吸入多黏菌素具有相当的疗效,仅对多黏菌素敏感,且可能肾损伤发生率较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f76/7393051/c42a90130b67/ijpr-18-269-g001.jpg

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