单采自体红细胞回输技术在全髋关节置换术中的应用

Application of apheresis autologous red blood cell transfusion in total hip arthroplasty

目的探讨单采自体红细胞回输技术在全髋关节置换术（THA）中的应用。方法选择2016年2月至7月，于中国人民解放军总医院接受THA治疗的191例患者作为研究对象。采用简单随机抽样法将患者分为研究组（n=91）和对照组（n=100）。研究组患者于THA前，进行单采自体红细胞，而对照组患者THA前未进行自体血液采集。分别记录研究组患者单采自体红细胞前和对照组患者接受THA前，2组患者接受THA后第1、3天的血常规检查主要指标，包括红细胞计数、血红蛋白（Hb）水平、白细胞计数、血小板计数。并且记录2组患者接受THA过程中的出血量，THA当天的异体输血量、异体输血率、异体红细胞输注量、异体红细胞输注率、异体血浆输注量、异体血浆输注率等指标。采用Mann-WhitneyU检验、Wileoxon符号秩检验或y。检验等统计学方法，分别比较2组患者上述各项指标的差异。本研究遵循的程序符合2013年修订版《世界医学协会赫尔辛基宣言》的要求，分组征得受试者的知情同意，并与之签署临床研究知情同意书。研究组接受单采自体红细胞的患者于单采前，均签署单采自体红细胞的知情同意书。结果①本研究中，研究组患者单采自体红细胞前和对照组患者接受THA前、2组患者接受THA后第1、3天的红细胞计数中位数分别比较，差异均无统计学意义（P〉O．05）。研究组患者单采自体红细胞前的红细胞计数中位数分别较THA后第1、3天高，并且差异均有统计学意义（4．5×10^12／L比4．1×10^12／L，Z=-4．043、P〈0．001；4．5×10^12／L比3．7×10^12／L，Z=-6．754、P〈0．001）。对照组患者接受THA前的红细胞计数中位数分别较THA后第1、3天高，并且差异亦均有统计学意义（4．4×10^12／L比4．0×10^12／L，Z=-3．339、P〈O．001；4．4×10^12／L比3．7×10^12／L，Z=-5．018、P〈0．001）。②研究组患者单采自体红细胞前和对照组患者接受THA前、2组患者接受THA后第3天的Hb水平分别比较，差异均无统计学意义（P〉0．05）。THA后第1天，研究组患者的Hb水平中位数为125g／L（113～134g／L），高于对照组的115g／L（107～135g／L），并且差异有统计学意义（Z=-2．302，P=0．021）。研究组患者单采自体红细胞前的Hb水平中位数分别较THA后第1、3天高，并且差异均有统计学意义（137g／L比125g／L，X=-6．668、P〈0．001；137g／L比112g／L，Z=-8．146、P〈0．001）。对照组患者接受THA前的Hb水平中位数亦分别较THA后第1、3天高，并且差异亦均有统计学意义（135g／L比115g／L，Z=-7．397、P〈O．001；135g／L比106g／L，Z=-8．189、P〈O．001）。③研究组患者单采自体红细胞前和对照组患者接受THA前、2组患者接受THA后第3天的白细胞计数中位数分别比较，差异均无统计学意义（P〉O．05）。THA后第1天，研究组患者的白细胞计数中位数为11．34×10^9／L（9．75×10^9／L～12．76×10^9／L），高于对照组的10．20×10^9／L（8．50×10^9／L～12．39×10。／L），并且差异有统计学意义（Z=-2．399，P=0．016）。研究组患者接受THA后第1天的白细胞计数中位数分别较单采自体红细胞前和接受THA后第3天高，并且差异均有统计学意义（11．34×10^9／L比6．15×10^9／L，Z=-8．272、P〈0．001；11．34×10^9／L比7．38×10^9／L，Z=-6．170、P〈0．001）。对照组患者接受THA后第1天白细胞计数中位数亦分别较接受THA前及THA后第3天高，并且差异亦均有统计学意义（10．20×10^9／L比5．82×10^9／L，Z=-8．603、P〈0．001；10．20×10。／L比7．09×10^9／L，Z=-6．313、P〈0．001）。④研究组患者单采自体红细胞前和对照组患者接受THA前，2组患者接受THA后第1、3天的血小板计数中位数分别比较，差异均无统计学意义（P〉0．05）。研究组患者单采自体红细胞前的血小板计数中位数分别较THA后第1、3天高，并且差异均有统计学意义（229×10^9／L比183×10^9／L，Z=-7．796、P〈0．001；229×10^9／L比162×10^9／L，Z=-8．249、P〈0．001）。对照组患者接受THA前的血小板计数中位数分别较THA后第1、3天高，并且差异亦均有统计学意义（221×10^9／L比184×10^9／L，Z=-6．871、P〈0．001；221×10^9／L比166×10^9／L，Z=-7．828、P〈O．001）。⑤2组患者THA中出血量、手术当天总输血量和异体血浆输注量中位数分别比较，差异均无统计学意义（P〉O．05）。研究组患者手术当天的异体输血量中位数为2．6U（1．O～4．4U），低于对照组的5．3U（3．0～7．2U），并且差异有统计学意义（Z=-3．903，P〈0．001）；异体红细胞输注量中位数为1．0U（0～2．0U），亦低于对照组的3．0u（2．O～4．0U），并且差异亦有统计学意义（Z=-6．495，P〈0．001）。2组患者异体输m率和异体血浆输注率分别比较，差异均无统计学意义（P〉O．05）。研究组患者的异体红细胞输注率为52．7％，低于对照组的82．0％，并且差异有统计学意义（X^2=18．756，P〈o．001）。结论单采自体红细胞技术能满足接受THA患者的临床输血需求，安全有效，可以在外科手术中推广。

Objective To investigate the application of apheresis autologous red blood cell transfusion technology in total hip arthroplasty （THA）. Methods From February to July 2016, a total of 191 patients who received THA treatment in the Chinese PLA General Hospital were selected as the research subjects. All patients were randomly divided into study group （n = 91） and control group （n = 100） by simple random sampling method. Patients in the study group received autologous red blood cell apheresis before THA, while the control group did not collect any autologous blood before THA. The main blood indicators, including red blood cell count, levels of hemoglobin （Hb）, white blood cell count, platelet count, were recorded before apheresis in study group or before THA in control group, as well as on the 1st and 3rd day after THA in the 2 groups, respectively. The amount of blood loss during THA, allogeneie transfusion volume on the day of THA, allogeneic blood transfusion rate, allogeneic red blood cell transfusion volume, allogeneic red blood cell transfusion rate, allogeneic plasma transfusion volume, and allogeneie plasma transfusion rate were also observed. Mann-Whitney U test, Wilcoxon signed rank test or X^2 test were used to compare the difference of the above indications between the patients of 2 groups. The procedure of this study is in accordance with the requirements of the revised World Medical Association Declaration of Helsinki in 2013. Informed consent was obtained from each patient. Results ① In this study, there were no statistically significant differences in median red blood cell count of patients between study group before apheresis and that of control group before THA, as well as those of patients between the 2 groups on the 1st and 3rd day after THA （P〉0.05）. In study group, the median red blood cell count of patients before apheresis was higher than that of patients on the 1st and 3rd day after THA, and the differences were statistically significant （4.5×10^12/L vs 4.1×10^12/L, Z=-4.043, P〈0.001; 4.5×10^12/L vs 3.7×10^12/L, Z=-6.754, P〈0.001）. In control group, the median red cell count of patients before THA was higher than that of patients on the 1st and 3rd day after THA, and the differences were also statistically significant （4.4×10^12/L vs 4.0 × 10^12/L, Z=-3.339, P〈0.001; 4.4 × 10^12/L vs 3.7 × 10^12/L, Z= 5. 018, P〈0. 001）. ② There were no statistically significant differences in median Hb level of patients between study group before apheresis and that of patients in control group before THA, as well as those of patients between the2 groups on the 3rd day after THA （P〉0.05）. On the 1st day after THA, the median Hb level of patients in study group was 125 g/L （113-134 g/I,）, which was higher than 115 g/L （107-135 g/L） of patients in control group, and the difference was statistically significant （Z=-2. 302, P=0. 021）. In study group, the median Hb level of patients before apheresis was higher than those of patients on the 1st and 3rd day after THA, and the differences were statistically significant （137 g/L vs 125g/L, Z= 6.668, P〈0.001; 137 g/L vsl12g/L, Z= 8.146, P〈0.001）. In control group, the median Hb level of patients before THA was higher than those of patients on the 1st and 3rd day after THA, and the differences were statistically significant （135 g/L vs 115 g/L, Z=-7. 397, P〈0. 001; 135 g/L vs 106 g/L, Z=-8. 189, P〈0. 001）. ③There were no statistically significant differences in the median white blood cell count of patients between study group before apheresis and that of patients in control group before THA, as well as those of patients between the 2 groups on the 3rd day after THA （P〉0.05）. On the 1st day after THA, the median white blood cell count of patients in study group was 11.34× 10^9/L （9.75×10^9/L-12.76×10^9/L）, which was higher than 10. 20×10^9/L （8. 50×10^9/L-12.39×10^9/L） in control group, and the difference was statistically significant （Z=-2.399, P=0. 016）. In study group,the median white blood cell count of patients on the 1st day after THA was higher than those of patientsbefore THA and on the 3rd day after THA, and the differences were statistically significant （11.34× 10^9/Lvs 6.15×10^9/L, Z=-8. 272, P〈0. 001; 11.34×10^9/L vs 7.38×10^9/L, Z=-6. 170, P〈0. 001）. Incontrol group, the median white blood cell count of patients on the 1st day after THA was higher than thoseof patients before THA and on the 3rd day after THA, and the differences were statistically significant（10.20×10^9/L vs 5.82×10^9/L, Z=-8. 603, P.〈0.001, 10.20×10^9/L vs 7.09× 10^9/L, Z=-6. 313,P〈0.001）. ④ There were no statistically significant differences in median platelet count of patients between study group before apheresis and that of patients in control group before THA , as well as those of patients between the 2 groups on the 1st and 3rd day after THA （P〉0.05）. In study group, the median platelet count of patients before apheresis was higher than those of patients on the 1st and 3rd day after THA, and the differences were statistically significant （229× 10^9/L vs 183 × 10^9/L, Z=- 7. 796, P〈 0.001; 229×10^9 /L vs 162×10^9/L, Z=-8.249, P〈0.001）. In control group, the median platelet count of patients before THA was higher than those of patients on the 1st and 3rd day after THA, and the differences were also statistically significant （221×10^9/L vs 184 × 10^9/L, Z=- 6. 871, P〈0. 001, 221×10^9/L vs 166×10^9/L, Z=-7. 828, P〈0. 001）. ⑤ Comparison of the median amount of blood loss during THA, median total blood transfusion volume and median allogeneic plasma transfusion volume on the day of THA of patients between the 2 groups indicated no statistically significant differences （P〉0. 05）. The median volume of allogeneic blood transfusion of patients in study group was 2.6 U （1.0-4.4 U）, which was lower than 5.3 U （3.0-7.2 U） of patients in control group, and the difference was statistically significant （Z=-3. 903, P〈0. 001）. The median volume of allogenic red blood cell transfusion was 1.0 U （0-2.0 U）, which was also lower than 3.0 U （2.0-4.0 U） of patients in control group, and the difference was also statistically significant （Z=-6. 495, P〈0. 001）. The rate of allogeneic blood transfusion and allogeneie plasma transfusion had no statistically significant differences between the 2 groups （P〉0.05）. The rate of allogenic red blood cell transfusion of patients in study group was 52.7%, which was lower than 82.0% of patients in control group, with a statistically significant difference （X^2= 18. 756, P〈0. 001）. Conclusions The apheresis autologous red blood cell transfusion could meet the needs of clinical blood transfusion in patients with THA, which is safe and effective, and could be promoted during surgery.