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大剂量静脉注射免疫球蛋白后的不良反应:83例特发性血小板减少性紫癜(ITP)患者的发生率及文献综述

Adverse reactions after high-dose intravenous immunoglobulin: incidence in 83 patients treated for idiopathic thrombocytopenic purpura (ITP) and review of the literature.

作者信息

Schiavotto C, Ruggeri M, Rodeghiero F

机构信息

Department of Hematology, San Bartolo Hospital, Vicenza, Italy.

出版信息

Haematologica. 1993 Nov-Dec;78(6 Suppl 2):35-40.

PMID:8039756
Abstract

BACKGROUND

High dose intravenous immunoglobulin (h.d. Ig) is increasingly used in several hematological diseases. There are few data on the safety and no review of side effects after this treatment is available. We review here the literature on reported adverse reactions after h.d. Ig and report our own experience in the management of 83 patients with idiopathic thrombocytopenic purpura (ITP).

PATIENTS AND METHODS

Computer assisted (Medline) and manual searches of the cumulative Index Medicus were undertaken to retrieve articles reporting side effects after infusion of h.d. Ig, published between 1981 and August 1993. Our own experience is based on clinical records of 83 patients, 56 females, 27 male, with a median age of 61 years (range 8-84), treated with h.d. Ig for acute or chronic ITP between 1985 and June 1993.

RESULTS AND DISCUSSION

Major adverse reactions included aseptic meningitis (14 cases), hemolytic anemia (8 cases) and renal dysfunction (12 cases). The most frequently reported mild side effect was headache. We have had 2 cases of severe skin reactions, 1 case of acute renal failure, 3 cases of severe headache and 1 case of chills and fever. For other 3 cases, an anaphylactic/oid reaction, caused by a too rapid infusion rate, occurred. Thus, 10/83 (12%) patients, 7 female and 3 male, developed side effects, but they were unpredictable and severe in only 3 cases (4%). Side effects developed only in 21/480 (4%) infusions.

摘要

背景

大剂量静脉注射免疫球蛋白(h.d. Ig)在多种血液系统疾病中的应用日益广泛。关于其安全性的数据较少,且尚无该治疗后副作用的综述。我们在此回顾有关h.d. Ig治疗后报告的不良反应的文献,并报告我们在83例特发性血小板减少性紫癜(ITP)患者管理中的经验。

患者与方法

通过计算机辅助(Medline)及人工检索《医学索引累积本》,以检索1981年至1993年8月间发表的关于输注h.d. Ig后副作用的文章。我们自己的经验基于83例患者的临床记录,其中女性56例,男性27例,中位年龄61岁(范围8 - 84岁),于1985年至1993年6月间接受h.d. Ig治疗急性或慢性ITP。

结果与讨论

主要不良反应包括无菌性脑膜炎(14例)、溶血性贫血(8例)和肾功能不全(12例)。最常报告的轻度副作用是头痛。我们有2例严重皮肤反应、1例急性肾衰竭、3例严重头痛和1例寒战发热。另外3例因输注速度过快发生过敏样反应。因此,83例患者中有10例(12%)出现副作用,其中女性7例,男性3例,但只有3例(4%)副作用不可预测且严重。副作用仅在480次输注中的21次(4%)出现。

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