CAJ | 학술논문

目的探讨改良白膜法手工浓缩血小板临床应用的疗效及安全性.方法选择2012年10月至2014年2月于郑州市某医院住院并拟输注血小板的89例患者为研究对象,按输注血小板制剂不同,将其分为研究组(n=49)和对照组(n=40).其中,研究组输注改良白膜法手工浓缩血小板,对照组输注单采血小板.检测两组患者血小板输注前与输注后第1及24小时血小板计数,计算校正血小板计数增加值(CCI).观察和记录两组患者血小板输注前、后出血改善情况及输血不良反应发生情况.统计学比较两组患者血小板计数、CCI、输注疗效及不良反应发生率.本研究遵循的程序符合郑州市某医院人体试验委员会制定的伦理学标准,得到该委员会批准,征得受试对象的知情同意,并签署临床研究知情同意书.两组患者年龄、性别构成比、疾病类型及输血前血小板计数等比较,差异均无统计学差异(P＞0.05).结果 ①改良白膜法手工浓缩血小板与单采血小板制剂中血小板含量、血小板容量、白细胞及红细胞混入量相比较,差异均无统计学差异(P＞0.05).②血小板输注前、输注后第1及24小时,两组患者血小板计数组间比较,差异均无统计学意义(P＞0.05);两组患者组内血小板输注后第1及24小时血小板计数均较输注前明显升高,且差异均有统计学意义(P＜0.05).③血小板输注后第1及24小时,两组患者CCI值相比,差异均无统计学意义(P＞0.05);两组患者输注有效率比较,差异亦无统计学意义(P＞0.05).④两组患者血小板输注后不良反应发生率比较,差异无统计学意义(P＞0.05).结论改良白膜法制备的手工浓缩血小板是一种安全、有效的血小板制剂,但是否值得临床推广应用,仍需更多大样本、多中心随机对照试验证实.
목적 탐토개량백막법수공농축혈소판림상응용적료효급안전성.방법 선택2012년10월지2014년2월우정주시모의원주원병의수주혈소판적89례환자위연구대상,안수주혈소판제제불동,장기분위연구조(n=49)화대조조(n=40).기중,연구조수주개량백막법수공농축혈소판,대조조수주단채혈소판.검측량조환자혈소판수주전여수주후제1급24소시혈소판계수,계산교정혈소판계수증가치(CCI).관찰화기록량조환자혈소판수주전、후출혈개선정황급수혈불량반응발생정황.통계학비교량조환자혈소판계수、CCI、수주료효급불량반응발생솔.본연구준순적정서부합정주시모의원인체시험위원회제정적윤리학표준,득도해위원회비준,정득수시대상적지정동의,병첨서림상연구지정동의서.량조환자년령、성별구성비、질병류형급수혈전혈소판계수등비교,차이균무통계학차이(P＞0.05).결과 ①개량백막법수공농축혈소판여단채혈소판제제중혈소판함량、혈소판용량、백세포급홍세포혼입량상비교,차이균무통계학차이(P＞0.05).②혈소판수주전、수주후제1급24소시,량조환자혈소판계수조간비교,차이균무통계학의의(P＞0.05);량조환자조내혈소판수주후제1급24소시혈소판계수균교수주전명현승고,차차이균유통계학의의(P＜0.05).③혈소판수주후제1급24소시,량조환자CCI치상비,차이균무통계학의의(P＞0.05);량조환자수주유효솔비교,차이역무통계학의의(P＞0.05).④량조환자혈소판수주후불량반응발생솔비교,차이무통계학의의(P＞0.05).결론 개량백막법제비적수공농축혈소판시일충안전、유효적혈소판제제,단시부치득림상추엄응용,잉수경다대양본、다중심수궤대조시험증실.
Objective To explore the clinical efficacy and safety of platelet concentrates prepared by improved buffy-coat method.Methods From October 2012 to February 2014,a total of 89 cases of hospitalized patients in a certain hospital in Zhengzhou City who needed platelet transfusion were collected into this study,they were divided into study group (n=49) and control group (n =40) according to different kinds of platelet preparations they transfused.Patients in study group were transfused with platelet concentrates prepared by improved buffy-coat method,and patients in control group were transfused with apheresis platelets.Platelet counts were detected at pre-transfusion,1 hour after transfusion and 24 hours after transfusion,then corrected count increment (CCI) was calculated.The improvement of bleeding in patients and transfusion adverse events were observed and recorded before and after transfusion.The platelet counts,CCI,transfusion efficacy and the incidence of adverse reactions in two groups were compared with each other by statistical methods.The study protocol was approved by the Ethical Review Board of Investigation in a certain hospital in Zhengzhou City.Informed consent was obtained from all participants.There were no significant differences of the age,gender ratio,type of diseases and platelet counts before blood transfusion between two groups (P＞0.05).Results ①There were no significant differences in platelet content,capacity and the residual of white blood cells and red blood cells between apheresis platelets and platelet concentrates prepared by improved buffy-coat method (P＞0.05).②Platelet counts were significantly increased 1 hour and 24 hours after transfusion compared with the platelet counts before transfusion in two groups,and the differences were statistically different (P＜0.05).But there were no significant differences in platelet counts between two groups before transfusion,1 hour after transfusion and 24 hours after transfusion (P＞0.05).③There was no significant difference in rate of adverse reactions after platelet transfusion between two groups (P＞0.05).Conclusions Platelet concentrates prepared by improved buffy-coat method are safety and efficacy for patients,whether it is worth of clinical promotion and application,still needs large sample and multicenter randomized controlled trials to confirm.