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治疗性血液成分单采相关即刻不良反应的发生率

Frequency of immediate adverse effects associated with therapeutic apheresis.

作者信息

McLeod B C, Sniecinski I, Ciavarella D, Owen H, Price T H, Randels M J, Smith J W

机构信息

Apheresis Unit, Rush Medical Center, Chicago, Illinois 60612, USA.

出版信息

Transfusion. 1999 Mar;39(3):282-8. doi: 10.1046/j.1537-2995.1999.39399219285.x.

DOI:10.1046/j.1537-2995.1999.39399219285.x
PMID:10204591
Abstract

BACKGROUND

Therapeutic apheresis was found to be reasonably safe in prior studies using instruments that are now largely obsolete. The incidence of adverse effects with current instruments and techniques has not been assessed in a large multicenter study.

STUDY DESIGN AND METHODS

A survey was conducted in 1995 using a uniform questionnaire that asked about 32 specific events but excluded transient paresthesia and mild vasovagal events. Eighteen centers returned 3429 responses concerning 125 to 500 therapeutic apheresis procedures per center.

RESULTS

Two hundred forty-two adverse events were reported in 163 procedures (4.75% of all procedures; 6.87% of first-time procedures and 4.28% of repeat procedures). The numbers (incidence) of selected specific events were transfusion reaction, 56 (51 in plasma exchange [PE] with plasma replacement) (1.6%); citrate-related nausea and/or vomiting, 41 (1.2%); systolic blood pressure <80 mmHg, 34 (1.0%); vasovagal nausea and/or vomiting, 17 (0.5%); pallor and/or diaphoresis, 16 (0.5%); pulse >120, 14 (0.4%); respiratory distress, 9 (0.3%); tetany or seizure, 9 (0.2%); and chills or rigors, 6 (0.2%). Rates for other specific events were < or =0.1 percent. Vasovagal phenomena were more frequent in procedures done in neurologic patients than in those done in hematology or oncology patients (p = 0.011) or renal or rheumatic patients (p = 0.038). Procedure-specific rates were red cell exchange, 8 (10.26%) of 78; PE (plasma), 89 (7.81 %) of 1140; PE (no plasma), 42 (3.35%) of 1255; leukapheresis, 4 (5.71%) of 70; plateletpheresis, 0 of 18; and autologous peripheral blood progenitor cell collection, 11 (1.66%) of 664. Three deaths were reported; all were attributed to primary disease.

CONCLUSION

Therapeutic apheresis procedures are relatively safe, with a 4.75-percent overall incidence of mostly reversible adverse effects. Among the most commonly performed procedures, the risk is higher for blood component exchanges, especially if allogeneic red cell or plasma transfusion occurs, and lower for peripheral blood progenitor cell collection.

摘要

背景

在先前使用现已基本过时的仪器进行的研究中,发现治疗性血液成分单采相当安全。目前仪器和技术的不良反应发生率尚未在大型多中心研究中进行评估。

研究设计与方法

1995年进行了一项调查,使用统一问卷询问32种特定事件,但排除短暂性感觉异常和轻度血管迷走神经事件。18个中心返回了3429份问卷,每个中心涉及125至500例治疗性血液成分单采程序。

结果

在163例程序中报告了242起不良事件(占所有程序的4.75%;首次程序的6.87%,重复程序的4.28%)。选定特定事件的数量(发生率)为:输血反应,56例(血浆置换[PE]并进行血浆替代的有51例)(1.6%);枸橼酸盐相关的恶心和/或呕吐,41例(1.2%);收缩压<80 mmHg,34例(1.0%);血管迷走神经恶心和/或呕吐,17例(0.5%);面色苍白和/或出汗,16例(0.5%);脉搏>120次/分,14例(0.4%);呼吸窘迫,9例(0.3%);手足搐搦或癫痫发作,9例(0.2%);寒战或发冷,6例(0.2%)。其他特定事件的发生率≤0.1%。神经科患者进行的程序中血管迷走神经现象比血液科或肿瘤科患者(p = 0.011)或肾科或风湿科患者(p = 0.038)进行的程序更常见。特定程序的发生率为:红细胞置换,78例中有8例(10.26%);PE(血浆),1140例中有89例(7.81%);PE(无血浆),1255例中有42例(3.35%);白细胞单采,70例中有4例(5.71%);血小板单采,18例中为0例;自体外周血祖细胞采集,664例中有11例(1.66%)。报告了3例死亡;均归因于原发性疾病。

结论

治疗性血液成分单采程序相对安全,总体不良反应发生率为4.75%,大多为可逆性。在最常用的程序中,血液成分置换的风险较高,尤其是发生异体红细胞或血浆输血时,而外周血祖细胞采集的风险较低。

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