Department of Critical Care Medicine, University Hospital of Larissa, Larissa, Greece.
Crit Care Med. 2011 Nov;39(11):2440-6. doi: 10.1097/CCM.0b013e318225742c.
To investigate whether the use of pravastatin reduces the frequency of ventilator-associated pneumonia and whether it is related to favorable outcomes in critical care patients.
Two-center, two-arm, randomized, open-label, controlled trial.
University Hospital and General Hospital of Larissa, Greece.
Consecutive patients were recruited from the intensive care units of the two hospitals. Patient inclusion criteria included mechanical ventilation and intensive care unit stay of >48 hrs.
The two arms consisted of treatment plus oral pravastatin sodium (40 mg) (n = 71 patients, pravastatin group) and treatment without pravastatin (n = 81 patients, control group). Treatment was started after randomization and ended 30 days later.
Ventilator-associated pneumonia frequency and intensive care unit mortality at 30 days and at the end of intensive care unit stay were measured. Adverse events related to statin treatment in the intensive care unit were documented. Sixteen patients (22.5%) in the pravastatin group and 28 (34.5%) in the control group (p = .11) presented pneumonia during the 30-day treatment period in the intensive care unit. There was an indication for increased probability of being free from ventilator-associated pneumonia during the 30-day treatment period in the pravastatin group compared to the control group (p = .06) and significantly increased probability during the whole intensive care unit period of stay (p = .04) in the pravastatin group compared to the control group in the subgroup of patients with Acute Physiology and Chronic Health Evaluation scores of ≥ 15. Six patients (8.45%) in the pravastatin group and 16 (19.85%) in the control group died during the 30-day treatment period (p = .06), whereas 10 (14.1%) patients in the pravastatin group and 24 (29.1%) patients in the control group died during the whole period of intensive care unit stay (p = .03). Pravastatin group patients with Acute Physiology and Chronic Health Evaluation scores of ≥ 15 had significantly increased probability of survival compared to controls during the 30-day treatment period (p = .04). Creatine kinase and hepatic function enzyme levels during the whole study period were not significantly different between the pravastatin group and control group.
This study provides evidence that pravastatin may favorably affect the outcome of critical care patients.
研究普伐他汀是否能降低呼吸机相关性肺炎的发生率，并观察其是否与重症监护患者的良好预后相关。
两中心、双臂、随机、开放标签、对照试验。
希腊拉里萨大学医院和综合医院。
连续入选两所医院重症监护病房的患者。患者纳入标准为机械通气和重症监护病房入住时间＞48 小时。
两组分别为治疗加口服普伐他汀钠（40mg）（n = 71 例，普伐他汀组）和治疗不加普伐他汀（n = 81 例，对照组）。随机分组后开始治疗，30 天后结束。
测量呼吸机相关性肺炎的发生率、重症监护病房 30 天病死率和重症监护病房结束时病死率。记录重症监护室他汀类药物治疗相关的不良事件。普伐他汀组 16 例（22.5%）和对照组 28 例（34.5%）（p =.11）在重症监护病房 30 天治疗期间发生肺炎。与对照组相比，普伐他汀组在 30 天治疗期间发生呼吸机相关性肺炎的可能性显著增加（p =.06），且在整个重症监护病房住院期间的可能性也显著增加（p =.04）。在急性生理学和慢性健康评估评分≥15 的患者亚组中，普伐他汀组的可能性更高。普伐他汀组 6 例（8.45%）和对照组 16 例（19.85%）在 30 天治疗期间死亡（p =.06），而普伐他汀组 10 例（14.1%）和对照组 24 例（29.1%）在整个重症监护病房住院期间死亡（p =.03）。急性生理学和慢性健康评估评分≥15 的普伐他汀组患者在 30 天治疗期间的生存率显著高于对照组（p =.04）。整个研究期间，普伐他汀组和对照组的肌酸激酶和肝酶水平无显著差异。
本研究表明，普伐他汀可能对重症监护患者的预后产生有利影响。
