特利加压素治疗脓毒性休克的研究：单中心随机对照双盲临床试验  

The role of terHpressin in treatment of septic shock： a single center randomized controlled double- blind clinical trial

作　　者：刘韶华[1] 李亚辉[1] 张曙光[1] 王海旭[1] 段晓光[1] 罗永刚[1] 秦翠红[1] 王振华[1] 张晓娟[1] 王静[2] 管向东[3] 孙同文[1] 

机构地区：[1]郑州大学第一附属医院综合ICU,河南省重症医学重点实验室,郑州450052 [2]郑州大学第一附属医院呼吸内科,郑州450052 [3]中山大学附属第一医院外科ICU,广州510000

出　　处：《中华急诊医学杂志》2018年第3期289-294,共6页Chinese Journal of Emergency Medicine

基　　金：河南省教育厅科技创新团队支持计划（161RTSTHN021）;河南省卫生计生科技创新型人才“51282”工程领军人才（豫卫科2016-32号）

摘　　要：目的 评价特利加压素治疗脓毒性休克的有效性与安全性。方法 采用随机双盲对照研究方法，将2015年6月1日至2016年5月31日入住郑州大学第一附属医院综合ICU的经充分液体复苏后平均动脉压仍小于65 mmHg的脓毒性休克患者随机（随机数字法）分为两组，试验组给予持续静脉泵入特利加压素[0.6~2.6 μg/（kg·h）]，对照组给予持续泵入去甲肾上腺素（7~30μg/min），目标为使平均动脉压维持于65 mmHg以上。如不能则加用开放标签去甲肾上腺素或其他儿茶酚胺类药物。研究终点为休克纠正、死亡或退出研究。主要研究指标为休克纠正率，次要观察目标是开放标签去甲肾上腺素需要量、28 d 生存率及不良事件发生率。两组定量资料的比较采用t 检验或Wilcoxon 秩和检验，计数资料比较采用χ2 检验或Fisher确切概率法。生存资料分析采用Kaplan-Meier 法。结果 共入选患者28例。全分析集人群为28例，符合方案集人群为25例，安全集人群为28例。两组患者基线资料差异无统计学意义（均P〉0.05）。符合方案集中，用药结束时试验组与对照组的休克纠正率分别为9/11和8/14，差异无统计学意义（P=0.190）；试验组与对照组在入院时、第6 小时、第12 小时、第24 小时、第48 小时的开放标签去甲肾上腺素需要量[μg/（kg · min）] 分别为0.661 vs. 0.921、1.583 vs. 1.241、2.143 vs. 1.371、1.071 vs. 1.261、0.370 vs.1.001，其差异均无统计学意义（均P〉0.05）。试验组与对照组的28 d 生存率分别为7/11和7/14，经Fisher确切概率法检验，差异无统计学意义（P=0.393）；采用Kaplan-Meier 法分析显示两组患者28 d生存曲线差异无统计学意义（P=0.470）。试验组不良事件发生率为4/13，包括2例指端缺血，1例低钠血症，1例并发低钠血症及肠缺血，对照组不良事件发生率为1/15，仅1例发生指端缺血，其差异无统计学意�Objective To evaluate the efficacy and safety of terlipressin for septic shock. Methods A randomized double-blind placebo-controlled pilot study was carried out in the general ICU of the First Affiliated Hospital of Zhengzhou University from June 1st 2015 to May 31 st 2016. The septic shock patients with a mean arterial pressure below 65 mmHg despite adequate volume resuscitation were enrolled. Patients were randomized （random number） to give continuous infusions of either terlipressin[0.6-2.6μg/（kg·h）] or norepinephrine（7-30μg/min）. Open label norepinephrine or other catecholamines were additionally infused if the mean arterial pressure failed to reach 65 mmHg. Treatment was continued until shock corrected, death or withdrawn from this study. Correcting rate of shock was the primary end point, the secondary end points included open labeled norepinephrine requirements, the 28 d survival rate and adverse events. The quantitative data of the two groups were compared by t test or Wilcoxon rank sum test. The enumeration data were compared by chi square test or Fisher exact probability method, and the survival data were analyzed by Kaplan-Meier method. Results A total of 28 patients were enrolled. The full analysis set was 28, the per-protocol set was 25, and the safety set was 28. The key demographics and baseline characteristics were similar between the two groups（P〉0.05）. The results for the per-protocol set were followed up. The correcting rate of shock between the two groups were similar at the end of treatment[81.82%（9/11）vs. 57.14%（8/14）, P=-0.190]. The open label norepinephrine requirements of the trial group and control group for the 0, 6, 12, 24, 48 h time point were 0.661, 0.921, 1.583, 1.241, 2.143, 1.371, 1.071, 1.261, 0.370, 1.001 lag/（kg.min）, respectively with no significant difference（P〉0.05）. The 28 d survival rate of the trial group and control group were 63.64%（7/11）and 50.00%（7/14） respectively with no statistical significance（P〉0.05）.There was

关 键 词：脓毒性休克 特利加压素 去甲肾上腺素 休克纠正 

分 类 号：R459.7[医药卫生—急诊医学]