Abstract
目的
近年有研究报道大面积烧伤成年患者休克期使用血浆代用品的抗休克效果不佳，然而由于临床上冰冻血浆供应紧张，无法保障患者在休克期内都有冰冻血浆作为胶体液来进行抗休克治疗，本研究旨在探讨休克期冰冻血浆与血浆代用品输注比例对大面积烧伤成年患者预后的影响。
方法
回顾性分析2014年9月至2019年4月在我院烧伤科住院治疗的586例大面积烧伤成年患者临床资料。入院48 h冰冻血浆与血浆代用品输注比例≥2꞉1的患者纳入实验组，反之则纳入对照组。比较2组患者基本临床资料和预后转归指标，并采用logistic单因素回归分析筛选大面积烧伤成年患者30 d病死率的影响因素，对影响因素进一步行logistic多因素回归分析以得出独立危险因素及保护因素；采用Kaplan-Meier法绘制2组患者的生存曲线并运用log-rank检验比较2组患者30 d生存率。
结果
2组患者入院48 h冰冻血浆及血浆代用品输注量差异均有统计学意义(均P<0.05)。实验组机械通气时间短于对照组，接受连续性肾脏替代治疗(continuous renal replacement therapy，CRRT)百分比低于对照组，且住院死亡率及30 d病死率均低于对照组，差异均有统计学意义(均P<0.05)。烧伤面积/总体表面积(total body surface area，TBSA)是大面积烧伤成年患者30 d病死率的独立危险因素(OR=1.228，95% CI：1.010~1.439，P=0.039)，而入院48 h冰冻血浆与血浆代用品输注比是其独立保护因素(OR=0.016，95% CI：0.001~0.960，P=0.023)。实验组30 d生存率明显高于对照组(P<0.001)。
结论
入院48 h冰冻血浆与血浆代用品输注比例是大面积烧伤成年患者30 d病死率的独立保护因素。大面积烧伤成年患者应早期使用冰冻血浆作为胶体液(冰冻血浆与血浆代用品输注比≥2꞉1)进行抗休克治疗。
Keywords: 输注比例, 大面积烧伤, 30 d病死率, 冰冻血浆, 预后
Abstract
Objective
In recent years, it has been reported that the anti-shock effect of plasma substitutes in adult patients with major burn in shock stage is not good. However, due to the shortage of clinical frozen plasma supply, it is impossible to guarantee that frozen plasma is used as colloidal solution for anti-shock treatment. The purpose of this study is to explore the effect of the infusion ration between frozen plasma and plasma substitutes on the prognosis of adult patients with major burn in shock stage.
Methods
This study enrolled 586 adult patients with major burn by selecting the hospitalization burn patients, who had been hospitalized at the Jiangxi province burn center from September 2014 to April 2019. The patients with the infusion ratio of frozen plasma to plasma substitutes ≥2꞉1 at 48 hours after admission were included in the experimental group, otherwise they were included in the control group. The basic clinical data and clinical prognosis indicator in the 2 groups were compared. Logistic univariate regression analysis was used to screen the influential factors of 30-day mortality in adult patients with major burn, and logistic multivariate regression analysis was used to obtain independent risk and protective factors; Kaplan-Meier method was used to draw the survival curve of the 2 groups, and log-rank test was used to compare the 30-day survival rate of the 2 groups.
Results
There were significant differences in the infusion volume of frozen plasma and plasma substitutes between the 2 groups at 48 hours after admission (both P<0.05). The duration of mechanical ventilation in the experimental group was shorter than that in the control group, the percentage of continuous renal replacement therapy (CRRT) in the experimental group was lower than that in the control group, and the in-hospital mortality and 30-day mortality in the experimental group were lower than those in the control group, the differences were statistically significant (all P<0.05). The percentage of burn area and total body surface area (TBSA) was an independent risk factor for 30-day mortality of adult patients with major burn (OR=1.228, 95% CI 1.010 to 1.439, P=0.039), while the infusion ration between of frozen plasma and plasma substitutes 48 hours after admission was an independent protective factor (OR=0.016, 95% CI 0.001 to 0.960, P=0.023). The 30-day survival rate of the experimental group was significantly higher than that in the control group (P<0.001).
Conclusion
Infusion ration between frozen plasma to plasma substitutes at 48 hours after admission is an independent protective factor for 30-day mortality of adult patients with major burn. In the early stage of adult patients with major burn, frozen plasma should be used as the anti-shock therapy as far as possible (frozen plasma꞉plasma substitute ≥2꞉1) to improve the prognosis and reduce the of 30-day mortality.
Keywords: infusion ration, major burn, 30-day mortality, frozen plasma, prognosis
大面积烧伤患者由于皮肤的保护作用受损引起组织液外流导致血容量减少、组织受损等全身性变化，入院时往往已处于休克期。患者烧伤48 h内的抗休克治疗应积极补液，以恢复血液灌注，减轻细胞、组织及器官的缺血、缺氧性损伤，而胶体液使用对大面积烧伤成年患者抗休克补液治疗而言是必不可少的环节[1-4]。目前临床常使用的胶体液包括冰冻血浆及血浆代用品。
大面积烧伤成年患者休克期胶体液的补液量已有统一标准[5-7]。研究[8]报道大面积烧伤成年患者休克期使用羟乙基淀粉等血浆代用品的抗休克效果不佳。然而由于临床冰冻血浆供应紧张，无法保证患者在休克期内都能有冰冻血浆作为胶体液来进行抗休克治疗。因此笔者对南昌大学第一附属医院(以下简称我院)烧伤科住院治疗的586名大面积烧伤成年患者进行回顾性研究，旨在探讨休克期冰冻血浆与血浆代用品输注比例对大面积烧伤成年患者预后的影响。
1. 对象与方法
1.1. 对象
利用我院自行开发的临床用血管理与评价信息系统，检索2014年9月至2019年4月在我院烧伤科住院治疗的烧伤输血患者病历资料。纳入标准：1)年龄≥18岁；2)烧伤后12 h内送达我院治疗；3)入院时已处于休克期；4)入院48 h内有输注冰冻血浆抗休克史；5)烧伤面积/总体表面积(total body surface area，TBSA)≥45%的大面积烧伤患者[9]。排除标准：1)年龄<18岁；2)烧伤后送达我院治疗时已超出12 h或在外院已接受过液体复苏；3)烧伤面积/TBSA<45%；4)总住院时间少于72 h；5)合并妊娠；6)无法交流和患者本人或家属拒绝参与。根据以上标准，最终纳入586名大面积烧伤成年患者作为研究对象。其中男357名，女229名，年龄18~66(41.6±15.5)岁。本研究已通过我院医学伦理委员会批准。
1.2. 方法
1.2.1. 分组
自行设计患者信息表，通过查阅电子病历收集各项资料，并采取查阅电子病历和电话随访相结合方式对患者30 d病死率进行随访调查。586例大面积烧伤成年患者入院48 h内均未输注红细胞、血小板及冷沉淀，且均未发生输血不良反应。入院48 h冰冻血浆与血浆代用品输注比例≥2꞉1的患者纳入实验组(n=281)，反之则纳入对照组(n=305)。冰冻血浆(200 mL全血制备成100 mL冰冻血浆)均由江西省血液中心提供。
1.2.2. 抗休克基础治疗
患者入院后立即建立静脉通道，快速输入等渗生理盐水。根据国内外统一的成人烧伤补液公式[5-7]，按患者体重和烧伤面积计算补液量。烧伤后第1个24 h补液量=体重×1.5×(II°+III°烧伤面积/TBSA)+2000，其中日生理水分补充量为2 000 mL，晶体液与胶体液的补充体积比除广泛深度烧伤为1꞉1外其他均为2꞉1，晶体液为乳酸林格液、0.9%氯化钠溶液，胶体液为冰冻血浆、血浆代用品(低分子量右旋糖酐和羟乙基淀粉)，生理水分补充液为5%葡萄糖溶液；第1个24 h补液量的一半在烧伤后8 h内输入。烧伤后第2个24 h晶体液与胶体液补液量为第1个24 h的一半，日生理水分补充量不变。
1.2.3. 观察指标
1)患者临床基本资料：性别、年龄、体重、烧伤面积/TBSA、III°烧伤面积、入院时急性生理与慢性健康评估II(acute physiology and chronic health evaluation II，APACHE II)评分、序贯器官衰竭评估(sequential organ failure assessment，SOFA)评分、烧伤原因(火焰伤、烫伤、化学烧伤、电击伤)、是否伴吸入性损伤、入院24 h和48 h的尿量及补液量，入院48 h冰冻血浆输注量及血浆代用品输注量。2)主要结局指标：30 d病死率及30 d生存率。3)次要结局指标：烧伤科ICU住院时间、总住院时间、机械通气时间、接受连续性肾脏替代治疗(continuous renal replacement therapy，CRRT)患者百分比、住院死亡率。
1.3. 统计学处理
采用SPSS 22.0统计学软件进行数据分析。正态分布的计量资料采用均数±标准差( ±s)表示，偏态分布的计量资料以中位数(四分位间距)[M(P 25，P 75)]表示；计数资料采用例(%)表示。计量资料比较用t检验或Mann-Whitney U检验；计数资料比较用χ 2检验，当理论频数小于5，改用Fisher确切概率法；用logistic单因素回归分析筛选大面积烧伤成年患者30 d病死率的影响因素，并进一步对影响因素进行logistic多因素回归分析以得出独立危险因素和保护因素；采用Kaplan-Meier法绘制2组患者的生存曲线并运用log-rank检验，P<0.05为差异有统计学意义。
2. 结 果
2.1. 基本临床资料比较
2组患者性别、年龄、体重、烧伤面积/TBSA、III°烧伤面积、入院时APACHE II评分、入院时SOFA评分、入院24 h和48 h尿量及补液量、烧伤原因构成及伴吸入性损伤人数占比差异均不具有统计学意义(均P>0.05)，而入院48 h冰冻血浆输注量及血浆代用品输注量差异均具有统计学意义(均P<0.05，表1)。
表1.
2组患者基本临床资料比较
Table 1 Comparison of basic clinical data of patients between the 2 groups
| 组别 | n | 男性/[例(%)] | 年龄/岁 | 体重/kg | 烧伤面积/TBSA/% | Ⅲ°烧伤面积/% | 入院时APACHE II评分 |
|---|---|---|---|---|---|---|---|
| 实验组 | 281 | 164(58.4) | 45(24, 53) | 53.36±20.29 | 61.95±3.28 | 45(7, 67) | 24(16, 28) |
| 对照组 | 305 | 193(63.3) | 44(28, 54) | 52.89±17.99 | 61.12±15.89 | 42(10, 73) | 22(19, 26) |
| t/χ2 | 0.361 | -0.111 | -0.128 | ||||
| P | 0.548 | 0.514 | 0.912 | 0.893 | 0.103 | 0.102 |
| 组别 | 入院时SOFA评分 | 尿量/mL | 补液量/mL | |||
|---|---|---|---|---|---|---|
| 入院24 h | 入院48 h | 入院24 h | 入院48 h | |||
| 实验组 | 8(6, 10) | 860(582, 1 375) | 2 055(1 910, 2 882) | 5 854(3 005, 8 365) | 6 094(3 287, 8 554) | |
| 对照组 | 9(7, 11) | 1 210(621, 1 820) | 2 170(1 955, 2 793) | 7 149(4 011, 11 765) | 7 041(5 243, 9 538) | |
| t/χ2 | ||||||
| P | 0.221 | 0.192 | 0.065 | 0.087 | 0.237 | |
| 组别 | 烧伤原因/例 | 伴吸入性损伤/[例(%)] | 入院48 h冰冻血浆输注量/mL | 入院48 h血浆代用品输注量/mL | |||
|---|---|---|---|---|---|---|---|
| 火焰伤 | 烫伤 | 化学烧伤 | 电击伤 | ||||
| 实验组 | 120 | 61 | 54 | 46 | 108(38.4) | 4 800(3 600, 5 000) | 2 250(2 100, 3 000) |
| 对照组 | 116 | 72 | 62 | 55 | 102(33.4) | 3 100(2 600, 3 800) | 1 800(1 100, 1 900) |
| t/χ2 | 1.351 | 0.748 | |||||
| P | 0.853 | 0.387 | 0.035 | 0.047 | |||
2.2. 临床预后转归指标比较
2组患者烧伤科ICU住院时间及总住院时间差异均无统计学意义(均P>0.05)；实验组机械通气时间短于对照组，接受CRRT患者百分比低于对照组，且住院死亡率及30 d病死率均低于对照组，差异均有统计学意义(均P<0.05，表2)。
表2.
2组患者临床预后转归指标比较
Table 2 Comparison of prognostic indicators of patients between the 2 groups
| 组别 | 烧伤科ICU住院时间/d | 总住院时间/d | 机械通气/d | CRRT/[例(%)] | 住院死亡/[例(%)] | 30 d病死率/% |
|---|---|---|---|---|---|---|
| 实验组 | 0(0, 23) | 40(19, 55) | 0(0, 2) | 66(23.4) | 54(22.42) | 13.52 |
| 对照组 | 8(0, 17) | 26(11, 46) | 1(0, 8) | 129(42.3) | 118(31.80) | 35.08 |
| χ2 | 11.792 | 14.780 | 22.347 | |||
| P | 0.881 | 0.144 | 0.032 | 0.001 | <0.001 | <0.001 |
2.3. 30 d病死率的logistic单因素回归分析
Logistic单因素回归分析结果显示：烧伤面积/TBSA、III°烧伤面积、入院时APACHE II评分、入院时SOFA评分、伴吸入性损伤、机械通气时间、入院48 h冰冻血浆与血浆代用品输注比例均为大面积烧伤成年患者30 d病死率的影响因素(均P<0.05)；而性别、年龄、体重、烧伤原因、烧伤科ICU住院时间和总住院时间均不是大面积烧伤成年患者30 d病死率影响因素(均P>0.05，表3)。
表3.
30 d病死率的logistic单因素回归分析
Table 3 Logistic univariate regression analysis of 30-day mortality
| 因素 | b | Wald χ 2 | P | OR | 95% CI |
|---|---|---|---|---|---|
| 性别 | -0.435 | 2.467 | 0.351 | 0.647 | 0.259~1.618 |
| 年龄 | 0.029 | 5.315 | 0.052 | 1.029 | 1.000~1.059 |
| 体重 | 0.027 | 4.413 | 0.061 | 1.027 | 1.002~1.053 |
| 烧伤面积/TBSA | 0.186 | 13.035 | <0.001 | 1.205 | 1.125~1.291 |
| Ⅲ°烧伤面积 | 0.096 | 12.017 | <0.001 | 1.101 | 1.064~1.139 |
| 入院时APACHE II评分 | 0.116 | 11.238 | 0.002 | 1.017 | 1.008~1.108 |
| 入院时SOFA评分 | 0.083 | 10.036 | 0.001 | 1.154 | 1.043~1.202 |
| 烧伤原因 | -0.058 | 3.261 | 0.823 | 0.943 | 0.565~1.574 |
| 伴吸入性损伤 | -1.144 | 11.462 | 0.013 | 0.319 | 0.129~0.787 |
| 烧伤科ICU住院时间 | -0.003 | 2.011 | 0.765 | 0.997 | 0.975~1.019 |
| 总住院时间 | -0.046 | 2.012 | 0.161 | 0.955 | 0.933~0.978 |
| 机械通气时间 | 0.267 | 10.091 | 0.003 | 1.306 | 1.092~1.516 |
| 入院48 h冰冻血浆与血浆代用品输注比例 | -2.011 | 11.488 | <0.001 | 0.134 | 0.051~0.348 |
2.4. 30 d病死率的logistic多因素回归分析
Logistic多因素回归分析结果显示：烧伤面积/TBSA是大面积烧伤成年患者30 d病死率的独立危险因素[比值比(odds ratio，OR)为1.228，95%置信区间(confidence interval，CI)为1.010~1.439，P=0.039]，而入院48 h冰冻血浆与血浆代用品输注比例是独立保护因素(OR=0.016，95% CI：0.001~0.960，P=0.023；表4)。
表4.
30 d病死率的logistic多因素回归分析
Table 4 Logistic multivariate regression analysis of 30-day mortality
| 因素 | b | Wald χ 2 | P | OR | 95% CI |
|---|---|---|---|---|---|
| 烧伤面积/TBSA | 0.205 | 11.100 | 0.039 | 1.228 | 1.010~1.439 |
| III°烧伤面积 | 0.016 | 2.043 | 0.719 | 1.016 | 0.933~1.106 |
| 入院时APACHE II评分 | 1.031 | 3.201 | 0.102 | 1.307 | 1.004~1.434 |
| 入院时SOFA评分 | 0.156 | 5.021 | 0.202 | 1.235 | 1.056~1.311 |
| 机械通气时间 | 0.217 | 4.121 | 0.074 | 1.242 | 0.979~1.575 |
| 伴吸入性损伤 | 1.729 | 3.363 | 0.205 | 0.637 | 0.390~1.505 |
| 入院48 h冰冻血浆与血浆代用品输注比例 | -4.121 | 9.082 | 0.023 | 0.016 | 0.001~0.960 |
2.5. 生存曲线分析
Kaplan-Meier生存曲线分析结果显示：实验组和对照组患者30 d生存率分别为86%和64%，差异有统计学意义(χ2=38.821，P<0.001；图1)。
图1.
2组患者Kaplan-Meier生存曲线
Figure 1 Kaplan-Meier survival curves of the 2 groups
3. 讨 论
输注胶体液是大面积烧伤成年患者休克期抗休克治疗不可或缺的手段之一[10-13]，然而胶体液中冰冻血浆与血浆代用品的输注比例是否会影响患者预后目前尚不明确。已有研究[11-15]发现：影响大面积烧伤成年患者临床预后的因素包括年龄、烧伤面积/TBSA、III°烧伤面积、机械通气时间和吸入性损伤等。本研究通过对586例大面积烧伤成年患者的临床预后转归指标进行分析，结果发现：实验组患者住院死亡率及30 d病死率均低于对照组，提示入院48 h冰冻血浆与血浆代用品的输注比例可能也是影响大面积烧伤成年患者预后的因素，同时实验组接受CRRT患者百分比低于对照组，这与Haase等[16]与Zarychanski等[17]认为输注血浆代用品会增加肾损伤发生率的报道相符。
本研究亦通过logistic单因素回归分析筛选出大面积烧伤成年患者30 d病死率的影响因素，再对影响因素进行logistic多因素回归分析，结果显示：III°烧伤面积、机械通气时间和伴吸入性损伤是大面积烧伤成年患者30 d病死率的危险因素，但非独立危险因素。Wu等[15]认为大面积烧伤成年患者年龄越大预后不良概率增高。本研究结果却显示年龄不是大面积烧伤成年患者30 d病死率的独立危险因素，这可能与两次研究的排除、纳入标准及年龄分布不均有关。
本研究发现：烧伤面积/TBSA是大面积烧伤成年患者30 d病死率的独立危险因素，而入院48 h冰冻血浆与血浆代用品输注比例是独立保护因素，提示大面积烧伤成年患者烧伤面积/TBSA越大，入院48 h冰冻血浆输注量越少，患者30 d病死率越高；进一步分析2组患者生存曲线，结果显示实验组患者30 d生存率高于对照组，说明大面积烧伤成年患者入院48 h加大冰冻血浆与血浆代用品输注比例(≥2꞉1)可能会改善其预后。分析原因有两点：1)大面积烧伤成年患者休克期因体液的急性丢失血液呈浓缩、高凝状态，而冰冻血浆中含有抗凝血酶III、蛋白C和蛋白S等抗凝物质，扩容的同时还能纠正早期血液高凝状态，这一作用是血浆代用品所不具备的。2)降低冰冻血浆与血浆代用品输注比例会增加需接受CRRT的人数占比，考虑与血浆代用品的使用影响患者肾功能有关[16-17]。
综上，本研究通过对586例大面积烧伤成年患者的临床资料进行回顾性分析，证实烧伤面积/TBSA是大面积烧伤成年患者30 d病死率的独立危险因素，而入院48 h冰冻血浆与血浆代用品输注比例是大面积烧伤成年患者30 d病死率的独立保护因素。这一研究结果对大面积烧伤成年患者早期尽可能使用冰冻血浆作为胶体液(冰冻血浆与血浆代用品输注比例≥2꞉1)进行抗休克治疗提供了理论依据，对指导烧伤科医生科学合理使用冰冻血浆进行大面积烧伤成年患者抗休克治疗具有重要的临床意义。由于本研究只做了回顾性分析，下一步我们将需进行多中心前瞻性队列研究来进一步验证本研究的结果。
基金资助
江西省科技计划重大项目(20144BBG70001)。
This work was supported by the Science and Technology Major Project of Jiangxi Province, China (20144BBG70001).
利益冲突声明
作者声称无任何利益冲突。
原文网址
http://xbyxb.csu.edu.cn/xbwk/fileup/PDF/202104393.pdf
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