CAJ | 학술논문

目的建立利用ACD-B抗凝的不足量血制备MAP悬浮红细胞的技术标准和工艺路线,临床评价该血液制剂的安全性和有效性.方法将34份实际采血量≥66％标示量的不足量血,按采血后不同储存时间分成3组,分别制备MAP(含氯化钠-腺嘌呤-葡萄糖-甘露醇-磷酸盐的红细胞添加液)悬浮红细胞,在35 d的保存期内检测相关理化指标；临床观察56例不足量血制剂的疗效和有无输血不良反应.结果在35 d的保存期内,采血后不同的储存时间对于相关制剂的K+浓度、血浆游离血红蛋白(FHb)和游离红细胞膜蛋白(EMP)含量比较差异均有统计学意义(P值分别为0.041、0.007和0.002).在14 d的保存时间内4h组较正常的重要理化指标,除了K+在第14 d显著降低外,pH、Na+、FHb、2,3-二磷酸甘油(2,3-PPG)和EMP等指标的差异,均无统计学意义(P＞0.05)；保存期超过21 d的不足量血制剂的K+、FHb和EMP与正常对照组相比,4h组与正常对照组的差异最小.结论利用实际采血量≥66％标示量的不足量血,在采血后4h内制备的悬浮红细胞,其35 d保存期末的红细胞理化和功能指标与足量全血制备的悬浮红细胞的差异是可以接受的；临床研究资料表明,输注采血后4h内制备、储存7d内的该血液制品是安全和有效的.
목적 건립이용ACD-B항응적불족량혈제비MAP현부홍세포적기술표준화공예로선,림상평개해혈액제제적안전성화유효성.방법 장34빈실제채혈량≥66％표시량적불족량혈,안채혈후불동저존시간분성3조,분별제비MAP(함록화납-선표령-포도당-감로순-린산염적홍세포첨가액)현부홍세포,재35 d적보존기내검측상관이화지표；림상관찰56례불족량혈제제적료효화유무수혈불량반응.결과 재35 d적보존기내,채혈후불동적저존시간대우상관제제적K+농도、혈장유리혈홍단백(FHb)화유리홍세포막단백(EMP)함량비교차이균유통계학의의(P치분별위0.041、0.007화0.002).재14 d적보존시간내4h조교정상적중요이화지표,제료K+재제14 d현저강저외,pH、Na+、FHb、2,3-이린산감유(2,3-PPG)화EMP등지표적차이,균무통계학의의(P＞0.05)；보존기초과21 d적불족량혈제제적K+、FHb화EMP여정상대조조상비,4h조여정상대조조적차이최소.결론 이용실제채혈량≥66％표시량적불족량혈,재채혈후4h내제비적현부홍세포,기35 d보존기말적홍세포이화화공능지표여족량전혈제비적현부홍세포적차이시가이접수적；림상연구자료표명,수주채혈후4h내제비、저존7d내적해혈액제품시안전화유효적.
Objective To establish technical standards and process protocol for MAP erythrocyte concentrates(RBCs),which were prepared from ACD-B anticoagulated under-collected whole blood(UC-WB) and assess its security and efficacy.Methods Thirty-four samples with UC-WB of minimum 66％ volume of the labeled collection(UC-RBCs) were prepared and were divided into three groups according to store time.The indices related clinical application were analyzed during 35 days storage.The effect of UC-RBCs and the occurring of adverse reactions in 56 patients with blood transferrion were observed.Results At 35 days storage group,the differences were seen regarding of K + concentration,free Hb and free erythrocyte member protein (P =0.041,0.007 and 0.002 respectively).At 14 days storage group,except for the K + decreased significantly,the normal important physical and chemical indices of 4 h group,such as pH,Na+,FHb,2,3-PPG and EMP index,were no significant difference compared with normal control (P ＞ 0.05).At 21-days storage group,there was a big difference between control group and 24 h group regarding of K+,FHb and free EMP; Whereas,the difference was less between 4 h group and the comparable controls.Fifty-six clinical data showed that the transfusion of UC-RBCs was satisfactory and no adverse reactions were occurred.Conclusion It is feasible to prepare RBCs with ACD-B anticoagulated UC-WB of minimum 66％ volume of the labeled collection.It was effective and safety to transfuse the UC-RBCs prepared within 4 h after the collection and stored within 1 week.The recovery of the UC-WB would be a welcome addition to our limited blood resource.