Liu Chang, Zhang Yu-Ting, Peng Zhi-Yong, Zhou Qing, Hu Bo, Zhou Hui, Li Jian-Guo
Department of Intensive Care Unit, Zhongnan Hospital of Wuhan University, Wuhan, Hubei 430071, China.
Chin Med J (Engl). 2017 May 20;130(10):1196-1201. doi: 10.4103/0366-6999.205846.
Aerosolized amikacin (AA) is a current option for the management of ventilator-associated pneumonia (VAP) caused by multidrug-resistant Gram-negative bacteria (MDR-GNB), as it is reported that AA could increase the alveolar level of the drug without increasing systemic toxicity. This study aimed to evaluate the efficacy and safety of AA as an adjunctive therapy for VAP caused by MDR-GNB.
In this single-center, double-blind study conducted in a 36-bed general Intensive Care Unit (ICU) in a tertiary hospital from June 2014 to June 2016, 52 ICU patients with confirmed MDR-GNB VAP were randomized to two groups (AA group, n = 27 and placebo group, n = 25). Amikacin (400 mg, q8h) or saline placebo (4 ml, q8h) was aerosolized for 7 days. The attending physician determined the administration of systemic antibiotics for VAP. Patients were followed up for 28 days. Bacteriological eradication, clinical pulmonary infection score (CPIS), and serum creatinine were assessed on day 7 of therapy. New resistance to amikacin, cure rate of VAP, weaning rate, and mortality were assessed on day 28.
The baseline characteristics of patients in both groups were similar. At the end of the treatment, 13 of the 32 initially detected bacterial isolates were eradicated in AA group, compared to 4 of 28 in placebo group (41% vs. 14%, P= 0.024). As for patients, 11 of 27 patients treated with AA and 4 of 25 patients treated with placebo have eradication (41% vs. 16%, P= 0.049). The adjunction of AA reduced CPIS (4.2 ± 1.6 vs. 5.8 ± 2.1, P= 0.007). New drug resistance to amikacin and the change in serum creatinine were not detected in AA group. No significant differences in the clinical cure rate in survivors (48% vs. 35%, P= 0.444), weaning rate (48% vs. 32%, P= 0.236), and mortality (22% vs. 32%, P= 0.427) were detected between the two groups on day 28.
As an adjunctive therapy of MDR-GNB VAP, AA successfully eradicated existing MDR organisms without inducing new resistance to amikacin or change in serum creatinine. However, the improvement of mortality was not found.
雾化吸入阿米卡星（AA）是目前用于治疗由多重耐药革兰氏阴性菌（MDR - GNB）引起的呼吸机相关性肺炎（VAP）的一种选择，因为据报道AA可提高药物在肺泡中的浓度而不增加全身毒性。本研究旨在评估AA作为MDR - GNB引起的VAP辅助治疗的疗效和安全性。
在2014年6月至2016年6月于一家三级医院的36张床位的综合重症监护病房（ICU）进行的这项单中心、双盲研究中，52例确诊为MDR - GNB VAP的ICU患者被随机分为两组（AA组，n = 27；安慰剂组，n = 25）。将阿米卡星（400mg，每8小时一次）或生理盐水安慰剂（4ml，每8小时一次）雾化吸入7天。主治医生确定针对VAP的全身抗生素给药。对患者进行28天的随访。在治疗第7天评估细菌清除情况、临床肺部感染评分（CPIS）和血清肌酐。在第28天评估对阿米卡星的新耐药性、VAP治愈率、脱机成功率和死亡率。
两组患者的基线特征相似。治疗结束时，AA组最初检测到的32株细菌分离株中有13株被清除，而安慰剂组28株中有4株被清除（41%对14%，P = 0.024）。就患者而言，接受AA治疗的27例患者中有11例和接受安慰剂治疗的25例患者中有4例细菌被清除（41%对16%，P = 0.049）。AA的辅助治疗降低了CPIS（4.2±1.6对5.8±2.1，P = 0.007）。AA组未检测到对阿米卡星的新耐药性和血清肌酐的变化。在第28天，两组在幸存者的临床治愈率（48%对35%，P = 0.444）、脱机成功率（48%对32%，P = 0.236）和死亡率（22%对32%，P = 0.427）方面未检测到显著差异。
作为MDR - GNB VAP的辅助治疗，AA成功清除了现有的MDR微生物，未诱导对阿米卡星的新耐药性或血清肌酐变化。然而，未发现死亡率有所改善。
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