Leng Yu-Xin, Yang Shu-Guang, Song Ya-Han, Zhu Xi, Yao Gai-Qi
Yu-Xin Leng, Shu-Guang Yang, Xi Zhu, Gai-Qi Yao, Department of Intensive Care Unit, Peking University Third Hospital, Beijing 100191, China.
World J Crit Care Med. 2014 Feb 4;3(1):34-41. doi: 10.5492/wjccm.v3.i1.34.
To investigate the efficacy and safety of ulinastatin for patients with acute lung injury (ALI) and those with acute respiratory distress syndrome (ARDS).
A systematic review of randomized controlled trials (RCTs) of ulinastatin for ALI/ARDS was conducted. Oxygenation index, mortality rate [intensive care unit (ICU) mortality rate, 28-d mortality rate] and length of ICU stay were compared between ulinastatin group and conventional therapy group. Meta-analysis was performed by using Rev Man 5.1.
Twenty-nine RCTs with 1726 participants were totally included, the basic conditions of which were similar. No studies discussed adverse effect. Oxygenation index was reported in twenty-six studies (1552 patients). Ulinastatin had a significant effect in improving oxygenation [standard mean difference (SMD) = 1.85, 95%CI: 1.42-2.29, P < 0.00001, I(2) = 92%]. ICU mortality and 28-d mortality were respectively reported in eighteen studies (987 patients) and three studies (196 patients). We found that ulinastatin significantly decreased the ICU mortality [I(2) = 0%, RR = 0.48, 95%CI: 0.38-0.59, number needed to treat (NNT) = 5.06, P < 0.00001], while the 28-d mortality was not significantly affected (I(2) = 0%, RR = 0.78, 95%CI: 0.51-1.19, NNT = 12.66, P = 0.24). The length of ICU stay (six studies, 364 patients) in the ulinastatin group was significantly lower than that in the control group (SMD = -0.97, 95%CI: -1.20--0.75, P < 0.00001, I(2) = 86%).
Ulinastatin seems to be effective for ALI and ARDS though most trials included were of poor quality and no information on safety was provided.
探讨乌司他丁对急性肺损伤(ALI)和急性呼吸窘迫综合征(ARDS)患者的疗效及安全性。
对乌司他丁治疗ALI/ARDS的随机对照试验(RCT)进行系统评价。比较乌司他丁组与传统治疗组的氧合指数、死亡率[重症监护病房(ICU)死亡率、28天死亡率]及ICU住院时间。采用Rev Man 5.1进行荟萃分析。
共纳入29项RCT,1726例参与者,其基本情况相似。无研究讨论不良反应。26项研究(1552例患者)报告了氧合指数。乌司他丁在改善氧合方面有显著效果[标准均差(SMD)=1.85,95%CI:1.42 - 2.29,P < 0.00001,I² = 92%]。18项研究(987例患者)和3项研究(196例患者)分别报告了ICU死亡率和28天死亡率。我们发现乌司他丁显著降低了ICU死亡率[I² = 0%,RR = 0.48,95%CI:0.38 - 0.59,需治疗人数(NNT)= 5.06,P < 0.00001],而28天死亡率未受到显著影响(I² = 0%,RR = 0.78,95%CI:0.51 - 1.19,NNT = 12.66,P = 0.24)。乌司他丁组的ICU住院时间(6项研究,364例患者)显著低于对照组(SMD = -0.97,95%CI:-1.20 - -0.75,P < 0.00001,I² = 86%)。
尽管纳入的大多数试验质量较差且未提供安全性信息,但乌司他丁似乎对ALI和ARDS有效。