重组人生长激素对重度烧伤低龄患儿免疫功能影响的随机对照临床试验

梅爱莲; 邱林; 张栎; 袁心刚; 刘燕; 李天武; 丁雄辉

doi:10.3760/cma.j.issn.1009-2587.2019.10.005

重组人生长激素对重度烧伤低龄患儿免疫功能影响的随机对照临床试验

doi: 10.3760/cma.j.issn.1009-2587.2019.10.005

重庆医科大学附属儿童医院烧伤整形外科,儿童发育疾病研究教育部重点实验室,国家儿童健康与疾病临床医学研究中心,儿童发展重大疾病国家国际科技合作基地,儿科学重庆市重点实验室 400014

基金项目:

重庆市卫生和计划生育委员会2016年医学科研计划（2016MSXM044）

重庆医科大学附属儿童医院2015年度临床研究项目（lcyj2015－11）

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出版历程
- 收稿日期: 2019-06-24
- 网络出版日期: 2021-10-28
- 刊出日期: 2019-10-20

Clinical randomized controlled trial on influence of recombinant human growth hormone on the immune function of younger children with severe burn injuries

Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Reasearch Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing Key Laboratory of Pediatrics, Department of Burns and Plastic Surgery, Children′s Hospital of Chongqing Medical University, Chongqing 400014, China

摘要

摘要: 目的初步探讨重组人生长激素(rhGH)对重度烧伤低龄患儿免疫功能的影响。方法 2016年7月—2018年7月笔者单位收治符合入选标准的重度烧伤低龄患儿30例，按随机数字表法分为rhGH组[15例，男10例、女5例，年龄(22±10)个月]、对照组[15例，男8例、女7例，年龄(21±7)个月]，行前瞻性随机双盲对照试验。对照组患儿入院后行抗休克、抗感染、创面护理等治疗。rhGH组患儿在上述治疗基础上，伤后第3天开始皮下注射rhGH 0.2 IU·kg^－1·d^－1，每晚睡前1次，连续治疗7 d。rhGH治疗前及治疗3、7 d，分别抽取2组患儿空腹外周静脉血，采用血糖仪检测血糖水平，流式细胞仪检测CD4^＋T淋巴细胞比例、CD8^＋T淋巴细胞比例、CD4^＋/CD8^＋T淋巴细胞比值、CD3^＋T淋巴细胞比例、CD19^＋B淋巴细胞比例，酶联免疫吸附测定法检测血清IgA、IgG、补体C3质量浓度。对数据行Fisher确切概率法检验、独立样本t检验、重复测量方差分析并行Bonferroni校正、Mann－Whitney U检验。结果 (1)2组患儿rhGH治疗前及治疗3、7 d血糖水平均相近(t＝0.474、1.652、1.997，P>0.05)。rhGH组患儿rhGH治疗3、7 d血糖水平[(6.9±1.0)、(7.7±1.1)mmol/L]均明显高于rhGH治疗前[(5.9±0.9)mmol/L，P<0.05]。对照组患儿rhGH治疗7 d血糖水平明显高于rhGH治疗前(P<0.05)。(2)rhGH组患儿rhGH治疗前、治疗3 d CD4^＋T淋巴细胞比例为(35.1±2.0)%、(38.5±2.2)%，分别与对照组的(36.2±2.0)%、(33.6±2.2)%相近(t＝0.371、1.553，P>0.05)；rhGH组患儿rhGH治疗7 d CD4^＋T淋巴细胞比例[(44.7±2.2)%]明显高于对照组[(36.5±2.2)%，t＝2.624，P<0.05]。rhGH组患儿rhGH治疗7 d CD4^＋T淋巴细胞比例明显高于rhGH治疗前(P<0.05)，对照组患儿rhGH治疗3、7 d CD4^＋T淋巴细胞比例均与rhGH治疗前相近(P>0.05)。(3)rhGH组患儿rhGH治疗3 d CD8^＋T淋巴细胞比例明显低于对照组(t＝2.107，P<0.05)。(4)rhGH组患儿rhGH治疗7 d CD4^＋/CD8^＋T淋巴细胞比值(2.36±0.20)明显高于对照组(1.72±0.20，t＝2.285，P<0.05)，rhGH组患儿rhGH治疗7 d CD4^＋/CD8^＋T淋巴细胞比值较rhGH治疗前(2.04±0.19)升高(P<0.05)。(5)2组患儿rhGH治疗前及治疗3、7 d CD3^＋T淋巴细胞比例、CD19^＋B淋巴细胞比例均相近(t＝1.913、0.552、1.327，1.465、1.587、0.407，P>0.05)，rhGH组患儿rhGH治疗3、7 d CD3^＋T淋巴细胞比例均明显高于rhGH治疗前(P<0.05)。(6)2组患儿rhGH治疗前及治疗3、7 d血清IgA、补体C3、IgG质量浓度均相近(t＝－1.596、－0.100、1.263，－0.220、1.378、1.631，Z＝0.228、0.519、1.182，P>0.05)。rhGH组患儿rhGH治疗3、7 d血清IgA、补体C3质量浓度明显高于rhGH治疗前(P<0.05)。结论 rhGH对重度烧伤低龄患儿CD19^＋B淋巴细胞及血清IgA、IgG、补体C3质量浓度影响小，因而对体液免疫的作用小；可能主要通过促进CD4^＋T淋巴细胞释放、减少CD8^＋T淋巴细胞释放，改善细胞免疫功能。rhGH可用于临床治疗重度烧伤低龄患儿。
- 烧伤 /
- 免疫调节 /
- 生长激素
Abstract: Objective To preliminarily investigate the influence of recombinant human growth hormone (rhGH) on the immune function of younger children with severe burn injuries. Methods A total of 30 younger children with severe burn injuries, conforming to the study criteria, were admitted to our hospital from July 2016 to July 2018. They were enrolled in the prospective, randomized, double-blinded, controlled trial and divided into group rhGH [n=15, 10 boys and 5 girls, aged (22±10) months] and control group [n=15, 8 boys and 7 girls, aged (21±7) months] according to the random number table. The patients in control group received anti-shock, anti-infection, and wound caring therapies, etc. On the basis of above-mentioned treatment, the patients in group rhGH were subcutaneously injected with rhGH once every night before bedding, with a dosage of 0.2 IU·kg^-1·d^-1, from the 3rd day post injury for 7 consecutive days. Before and on the 3rd and 7th day of rhGH treatments, the fasting peripheral venous blood was collected from patients in both groups. Blood glucose level was detected by glucometer. Percentages of CD4⁺ T lymphocytes, CD8⁺ T lymphocytes, CD3⁺ T lymphocytes, CD19⁺ B lymphocytes, and ratio of CD4⁺ T lymphocytes to CD8⁺ T lymphocytes were determined by flow cytometer. Mass concentration of serum immune globulin (Ig) A, IgG, and complement C3 were detected by enzyme-linked immunosorbent assay. Data were processed with Fisher′s exact probability test, independent sample t test, analysis of variance for repeated measurement and Bonferroni correction, and Mann-Whitney U test. Results (1) The blood glucose levels of children in the two groups were similar before and on the 3rd and 7th day of rhGH treatment (t=0.474, 1.652, 1.997, P>0.05). The glucose levels of children in group rhGH on the 3rd and 7th day of rhGH treatment [(6.9±1.0) and (7.7±1.1) mmol/L] were significantly higher than (5.9±0.9) mmol/L before rhGH treatment (P<0.05). The glucose level of children in control group on the 7th day of rhGH treatment was significantly higher than that before rhGH treatment (P<0.05). (2) The percentages of CD4⁺ T lymphocytes of children in group rhGH before rhGH treatment and on the 7th day of rhGH treatment were (35.1±2.0)% and (38.5±2.2)%, which were close to (36.2±2.0)% and (33.6±2.2)% in control group, respectively (t=0.371, 1.553, P>0.05). The percentages of CD4⁺ T lymphocytes of children in group rhGH on the 7th day of rhGH treatment[(44.7±2.2)%] was significantly higher than (36.5±2.2)% in control group (t=2.624, P<0.05). The percentage of CD4⁺ T lymphocytes of children in group rhGH on the 7th day of rhGH treatment was significantly higher than that before rhGH treatment (P<0.05). The percentages of CD4⁺ T lymphocytes of children in control group on the 3rd and 7th day of rhGH treatment were both close to the percentage before rhGH treatment (P>0.05). (3) The percentage of CD8⁺ T lymphocytes of children in group rhGH on the 3rd day of rhGH treatment was significantly lower than that in control group (t=2.107, P<0.05). (4) The ratio of CD4⁺ T lymphocytes to CD8⁺ T lymphocytes of children in group rhGH on the 7th day of rhGH treatment (2.36±0.20) was significantly higher than 1.72±0.20 in control group (t=2.285, P<0.05). The ratio of CD4⁺ T lymphocytes to CD8⁺ T lymphocytes of children in group rhGH on the 7th day of rhGH treatment was significantly higher than 2.04±0.19 before rhGH treatment (P<0.05). (5) The percentages of CD3⁺ T lymphocytes and CD19⁺ B lymphocytes of children in the two groups were similar before and on the 3rd and 7th day of rhGH treatment (t=1.913, 0.552, 1.327, 1.465, 1.587, 0.407, P>0.05). The percentages of CD3⁺ T lymphocytes of children in group rhGH on the 3rd and 7th day of rhGH treatment were significantly higher than the percentage before rhGH treatment (P<0.05). (6) The mass concentration of serum IgA, complement C3, and IgG of children in the two groups was similar before and on the 3rd and 7th day of rhGH treatment (t=-1.596, -0.100, 1.263, -0.220, 1.378, 1.631, Z=0.228, 0.519, 1.182, P>0.05). The mass concentration of serum IgA and complement C3 of children in group rhGH on the 3rd and 7th day of rhGH treatment was significantly higher than that before rhGH treatment(P<0.05). Conclusions rhGH has little effect on humoral immunity of younger children with severe burn injuries with limited influence on CD19⁺ B lymphocyte, mass concentration of serum IgA, IgG, and complement C3. It may improve the cellular immunity function mainly through promoting the release of CD4⁺ T lymphocyte, reducing the release of CD8⁺ T lymphocyte. It can be used in clinical treatment of younger children with severe burn injuries.
- Burns /
- Immunomodulation /
- Growth hormone