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中华肝脏外科手术学电子杂志

中华肝脏外科手术学电子杂志 ›› 2013, Vol. 02 ›› Issue (04): 230 -234. doi: 10.3877/cma.j.issn.2095-3232.2013.04.006

所属专题： 文献；

临床研究

外科围手术期休克患者应用6%中分子羟乙基淀粉130/0.4的安全性初步研究
危敏1, 易述红2, 傅斌生2, 李敏如1, 安玉玲1, 熊亮1, 易慧敏1,†()   
  1. 1. 510630　广州，中山大学附属第三医院外科重症监护病房
    2. 510630　广州，中山大学附属第三医院肝移植中心
  • 收稿日期:2013-05-06 出版日期:2013-08-10
  • 通信作者: 易慧敏

Primary analysis of safety of 6% hydroxyethyl starch 130/0.4 for patients with shock during surgical perioperative period

Min WEI1, Shu-hong YI2, Bin-sheng FU2, Min-ru LI1, Yu-Ling AN1, Liang XIONG1, Hui-min YI1,†()   

  1. 1. Surgical Intensive Care Unit, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China
  • Received:2013-05-06 Published:2013-08-10
  • Corresponding author: Hui-min YI
  • About author:
    Corresponding author: YI Hui-min, Email:
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目的

探讨6%中分子羟乙基淀粉（HES）130/0.4在外科围手术期休克患者中应用的安全性。

方法

回顾性研究2009年3月至2012年12月在中山大学附属第三医院外科重症监护病房（ICU）收治的279例围手术期休克患者临床资料。所有患者均签署知情同意书，符合医学伦理学规定。根据患者发生休克48 h内有否应用6% HES 130/0.4，将患者分为HES组和白蛋白组。HES组患者168例，其中男109例，女59例；年龄（64±17）岁。白蛋白组患者111例，其中男72例，女39例；年龄（63±16）岁。所有患者进入外科ICU立即给予积极抗休克治疗。HES组患者以静脉输注6% HES 130/0.4作为主要补充的胶体液，白蛋白组以人血白蛋白作为主要补充的胶体液。观察两组患者病死率、急性肾损伤、新发的其他器官功能衰竭及皮肤不良事件的情况。计量资料两组间比较采用t检验或秩和检验；计数资料比较采用χ2检验。

结果

HES组病死率为17.9%（30/168），白蛋白组病死率为17.1%（19/111），差异无统计学意义（χ2=2.01，P>0.05）。HES组患者中肾损伤危险期者占54.8%（92/168），肾损伤期者占34.5%（58/168），肾衰竭期者占10.7%（18/168）；白蛋白组中分别占55.0%（61/111）、35.1%（39/111）、9.9%（11/111），差异均无统计学意义（χ2=1.98，1.82，1.04；P>0.05）。HES组中11.3%（19/168）患者需行肾脏替代治疗，白蛋白组相应为8.1%（9/111），差异有统计学意义（χ2=20.23，P<0.05）。HES组呼吸系统及血液系统衰竭发生率分别为26.8%（45/168）、5.4%（9/168），白蛋白组分别为25.2%（28/111）、5.4%（6/111），差异无统计学意义（χ2=1.07，2.30；P>0.05）。HES组的心血管系统衰竭发生率为36.3%（61/168），比白蛋白组的39.6%（44/111）明显降低，而肝衰竭发生率为2.4%（4/168），比白蛋白组的1.8%（2/111）明显升高（χ2=43.71，17.25；P<0.05）。两组患者的皮肤不良反应主要表现为皮肤红斑、皮疹、瘙痒。HES组皮肤不良反应发生率为4.8%（8/168），白蛋白组为4.5%（5/111），差异无统计学意义（χ2=1.78，P>0.05）。

结论

应用6% HES 130/0.4治疗外科围手术期休克患者并不能降低患者病死率，反而增加患者接受肾脏替代治疗的几率。

关键词: 羟乙基淀粉130/0.4, 休克，外科, 安全性, 急性肾损伤, 肝功能衰竭，急性, 疹
Objective

To investigate the safety of fluid resuscitation with 6% hydroxyethyl starch(HES 130/0.4) for patients with shock during surgical perioperative period.

Methods

Clinical data of 279 patients with shock during surgical perioperative period in Department of Surgical Intensive Care Unit (SICU), the Third Affiliated Hospital of Sun Yat-sen University from March 2009 to December 2012 were analyzed retrospectively. The informed consents of all patients were obtained and the ethical committee approval was received. The patients were divided into HES group and albumin group according to whether they were resuscitated with 6% HES 130/0.4 within 48 hours of shock. There were 168 patients in HES group [109 males and 59 females, age of(64±17) years old], and 111 patients in albumin group[72 males and 39 females, age of (63±16) years old]. All patients received anti-shock therapy immediately after they were admitted in SICU. In HES group, 6% HES 130/0.4 was administered by intravenous infusion as the main colloid supplement, while albumin was administered in albumin group. The mortality, acute renal injury, new-onset function failure of other organs and adverse events of skin in two groups were observed. The comparison of measurement data between two groups was conducted using t test or rank sum test, and comparison of enumeration data was conducted using Chi-square test.

Results

The mortality was 17.9%(30/168) in HES group, and 17.1%(19/111) in albumin group. There was no significant difference between two groups(χ2=2.01, P>0.05). In HES group, 54.8%(92/168) of the patients were in renal injury risk period, 34.5%(58/168) of the patients were in renal injury period and 10.7%(18/168) of the patients were in renal failure period, while those were 55.0%(61/111), 35.1%(39/111) and 9.9%(11/111) respectively in albumin group. There was no significant difference (χ2=1.98, 1.82, 1.04; P>0.05). Renal-replacement therapy was used in 11.3% of the patients(19/168) in HES group, and that was 8.1%(9/111) accordingly in albumin group. There was no significant difference between two groups(χ2=20.23, P<0.05). The incidences of respiratory system and hematologic system failure were 26.8%(45/168), 5.4%(9/168) respectively in HES group and 25.2%(28/111), 5.4%(6/111) accordingly in albumin group. There was no significant difference between two groups (χ2=1.07, 2.30; P>0.05) . Compared with albumin group, the incidence of cardiovascular system failure significantly decreased in HES group[39.6% (44/111) vs. 36.3% (61/168) ; χ2=43.71, P<0.05], while the incidence of liver failure significantly increased in HES group [1.8% (2/111) vs. 2.4% (4/168) ; χ2=17.25, P<0.05]. Erythema, rash and pruritus were the common adverse events in two groups. The incidence of skin adverse events was 4.8% (8/168) in HES group, and 4.5% (5/111) in albumin group. There was no significant difference between two groups(χ2=1.78, P>0.05).

Conclusion

Fluid resuscitation with 6% HES(130/0.4) for patients with shock during surgical perioperative period cannot reduce the mortality but can increase the probability of patients receiving the renal-replacement therapy.

Key words: Hydroxyethyl starch (130/0.4), Shock, surgical, Safety, Acute renal injury, Liver failure, acute, Exanthema
表1 HES组与白蛋白组患者入组时一般状况的比较
组别 例数 心率（次/min，±s） 平均动脉压（mm Hg，±s） CVP[cm H2O,M(QR)] 动脉血乳酸（mmol/L，±s） Scr（μmol/L，±s）
HES组 168 110±24 54±13 6(0～10) 4.3±2.0 105±57
白蛋白组 111 109±23 58±13 7(1～12) 4.2±1.5 104±58
检验值 ? t=1.700 t=1.907 Z=2300.500 t=1.898 t=1.891
P值 ? 0.20 0.12 0.10 0.08 0.09
表2 HES组与白蛋白组患者抗休克治疗6 d内尿量的变化（ml，±s）
组别 例数 治疗后
1d 2d 3d 4d 5d 6d
HES组 168 1600±650 1700±865 1780±982 2000±1230 2060±1027 2000±1252
白蛋白组 111 1520±730 1750±658 2080±942 2250±1321 2100±1268 2260±1201
t值 ? 1.96 1.89 11.16 7.84 1.91 6.27
P值 ? 0.06 0.10 0.01 0.02 0.12 0.01
表3 HES组与白蛋白组患者抗休克治疗6 d内血清肌酐水平的变化（μmol/L，±s）
组别 例数 治疗后
1d 2d 3d 4d 5d 6d
HES组 168 110±22 114±25 116±25 115±19 110±21 110±20
白蛋白组 111 108±25 106±25 105±28 103±21 101±21 100±21
t值 ? 1.67 4.02 5.23 10.79 6.83 4.65
P值 ? 0.170 0.030 0.009 0.008 0.030 0.010
表4 HES组与白蛋白组患者新发器官功能衰竭情况的比较
组别 例数 呼吸系统衰竭 心血管系统衰竭 肝衰竭 血液系统衰竭
例数 百分率(%) 例数 百分率(%) 例数 百分率(%) 例数 百分率(%)
HES组 168 45 26.8 61 36.3 4 2.4 9 5.4
白蛋白组 111 28 25.2 44 39.6 2 1.8 6 5.4
χ2值 ? 1.07 43.71 17.25 2.30
P值 ? 0.10 0.02 0.03 0.95
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