严重烧伤早期行连续性血液净化治疗的可行性及疗效随机对照临床试验

Clinical randomized controlled trial on the feasibility and validity of continuous blood purification during the early stage of severe burn

目的观察并初步评价在严重烧伤早期进行连续性血液净化治疗的可行性及临床疗效。方法选择笔者单位2013年1月-2015年7月收治且符合入选标准的41例严重烧伤患者，按随机数字表法并结合患者个人意愿分为常规治疗组21例和血液净化组20例。常规治疗组患者按照严重烧伤救治原则给予常规治疗；血液净化组患者在常规治疗基础上，人院后及时进行连续性静脉．静脉血液透析滤过模式的血液净化治疗，持续至伤后72h。伤后1、2、3d，观察并记录患者的生命体征、补液量、尿量；采集患者股动脉血，检测乳酸、碳酸氢根、剩余碱，并计算氧合指数。伤后12、24、48、72h，采集患者股静脉血，检测白细胞计数、血小板计数、中性粒细胞、心肌型肌酸激酶同工酶、肌酸激酶、乳酸脱氢酶、AST、ALT（计算AST／ALT比值）、肌酐、尿素氮、血糖。随访记录患者伤后2个月内感染、脓毒症、MODS发生率和病死率。对数据行X2检验、重复测量方差分析、t检验、Wilcoxon检验，并进行Bonferroni校正。结果41例患者均顺利完成试验，无脱落病例。（1）伤后1～3d，2组患者生命体征、补液量和尿量比较，差异均无统计学意义（t值为-1．64～1．48，P值均大于0．05）。（2）与常规治疗组比较，血液净化组患者乳酸水平仅于伤后2、3d显著降低（z值分别为-2．37、-2．46，P值均小于0．05），碳酸氢根、剩余碱水平仅于伤后3d显著降低（t值均为-2．51，P值均小于0．05）。血液净化组患者伤后3d氧合指数为（370±98）mmHg（1mmHg=0．133kPa），显著高于常规治疗组的（305±81）mmHg（t=2．27，P〈0．05）。（3）伤后12～72h，2组患者白细胞计数、血小板计数、中性粒细胞、肌酸激酶、乳酸脱氢酶、AST、ALT、AST／ALT比值比较，差异均无统计学意义（t值为-1．47～1．19，Z值为-1．58～-0．03，P值均大于0．05）。伤后24、48、72h，血液净化组患者心肌型肌酸激酶同工酶、血糖水平分别为（81±43）、（55±34）、（58±40）U／L及（7．9±2．0）、（6．7±0．9）、（6．9±1．8）mmol／L，显著低于常规治疗组的（179±184）、（124±71）、（103±57）U／L及（10．1±3．8）、（9．1±2．4）、（8．8±4．1）mmol／L（Z值为-3．73～-2．02，P〈0．05或P〈0．01）。与常规治疗组比较，血液净化组患者肌酐水平于伤后48h、尿素氮水平于伤后24～72h明显降低（t值为-4．23～-2．44，P〈0．05或P〈0．01）。（4）伤后2个月内，血液净化组患者感染率为60．0％（12／20），显著低于常规治疗组的95．2％（20／21），X2=5．51，P〈0．05；脓毒症、MODS发生率及病死率虽均较常规治疗组下降，但差异无统计学意义（X2值为0．22—2．93，P值均大于0．05）。结论严重烧伤早期进行连续性血液净化治疗不会明显影响患者生命体征、补液量、尿量及血小板数量等，是安全可行的，有助于保护重要脏器功能，且能控制应激性高血糖，降低感染率。

Objective To observe and primarily evaluate the feasibility and validity of continuous blood purification （CBP） during the early stage of severe burn. Methods Forty-one patients with severe burn admitted to our ward from January 2013 to July 2015, conforming to the study criteria, were divided into conventional treatment group （CT, n = 21 ） and blood purification group （BP, n = 20） according to the random number table and patient＇s personal consent. Patients in group CT received CT conforming to the traditional resuscitation principle for severe burn, while patients in group BP received CT and blood purification treatment in the mode of continuous venous-venous hemodiafihration in addition up to post injury hour （PIH） 72. On post injury day （PID） 1, 2, 3, the vital signs, volume of fluid input, and volume of the urine output were observed and recorded; femoral artery blood was drawn to determine lactate, bicarbonate radical, and base excess, and oxygen index was calculated. At PIH 12, 24, 48, 72, femoral vein blood was drawn to determine white cell count, platelet count, neutrophils, creatine kinase-MB, creatine kiuase, lactic dehydrogenase, aspartate transaminase （AST） , alanine aminotransferase （ALT） , creatinine, urea nitrogen, and blood glucose （the ratio of AST to ALT was calculated）. The incidence of infection, sepsis, and multiple organ dysfunction syndrome （MODS） and the mortality of patients were recorded during 2 months after injury. Data were processed with chi-square test, analysis of variance for repeated measurement, t test and Wilcoxon test, and the values of P were adjusted by Bonferroni. Results The observation was completed in the 41 patients without exclusion. （ 1 ） There were no statistically significant differences in vital signs, volume of fluid input, and volume of the urine output of patients between two groups on PID 1, 2, 3 （with t values from - 1.64 to 1.48, P values above 0.05 ）. （2） Compared with that in group CT, the level of lactate of patients in group BP declined significantly on PID 2 and 3 （ with Z values respectively - 2.37 and - 2.46, P values below 0. 05 ）. Compared with those in group CT, the levels of bicarbonate radical and base excess of patients in group BP declined significantly on PID 3 （with t values both as -2.51 , P values below 0.05）. The oxygen index of patients in group BP on PID 3 was （370 ±98） mmHg （ 1 mmHg =0. 133 kPa） , which was significantly higher than that in group CT [（305 ±81） mmHg, t =2.27,P 〈0.051. （3） There were no statistically significant differences in white cell count, platelet count, neutrophils, creatine kinase, lactic dehy- drogenase, AST, ALT, and AST to ALT ratio of patients between two groups at PIH 12, 24, 48, 72 （with t values from - 1.47 to 1.19, Z values from - 1.58 to -0.03, Pvalues above 0.05）. At PIH 24, 48, 72, the levels of creatine kinase-MB and blood glucose of patients in group BP were respectively （ 81 ± 43 ） , （55±34）, （58±40） U/L and （7.9 ±2.0）, （6.7 ±0.9）, （6.9±1.8） mmol/L, which were significantly lower than those in group CT [（179 ± 184）, （124 ±71）, （103 ±57） U/L and （10. 1 ±3.8）, （9.1 ±2.4）, （8.8±4.1） mmol/L, with Z values from -3.73 to -2.02,P 〈0.05 orP 〈0.011. Compared with those of patients in group CT, creatinine at PIH 48 and urea nitrogen at PIH 24, 48, 72 were obviously lower in group BP （withtvalues from -4.23 to -2.44, P 〈0.05 orP 〈0.01）. （4） During the two months after injury, the infection rate of patients in group BP was 60.0% （12/20） , which was significantly lower than that in group CT [ 95.2% （20/21） , X2 =5. 51, P 〈 0.05 ]. The incidence of sepsis and MODS and the mortality of patients in group BP were all lower than those in group CT, but there were no sta- tistically significant differences （ with X2 values from 0.22 to 2.93, P values above 0.05 ）. Conclusions Conducting CBP in the early stage of severe burn is safe and feasible, which does not obviously affect the vital signs, volumes of fluid input and urine output, or platelet count of patients, additionally, it could help protect the function of vital organs, eliminate stress hyperglycemia, and reduce infection rate.