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麻疹、腮腺炎和风疹疫苗接种后血小板减少性紫癜:法国地区药物警戒中心和巴斯德-梅里厄血清与疫苗公司的回顾性调查

Thrombocytopenic purpura after measles, mumps and rubella vaccination: a retrospective survey by the French regional pharmacovigilance centres and pasteur-mérieux sérums et vaccins.

作者信息

Jonville-Béra A P, Autret E, Galy-Eyraud C, Hessel L

机构信息

Department of Clinical Pharmacology, Hôpital Bretonneau, Tours, France.

出版信息

Pediatr Infect Dis J. 1996 Jan;15(1):44-8. doi: 10.1097/00006454-199601000-00010.

DOI:10.1097/00006454-199601000-00010
PMID:8684875
Abstract

BACKGROUND

Thrombocytopenic purpura (TP) after vaccination with measles, mumps and rubella has occasionally been reported.

OBJECTIVES

To evaluate the incidence and characteristics of thrombocytopenic purpura reported in France after measles, mumps or rubella vaccination with monovalent or multivalent vaccines.

METHODS

A retrospective epidemiologic survey was conducted. All confirmed cases of TP reported spontaneously either to the French Regional Pharmacovigilance Centres or to the manufacturer (Pasteur-Mérieux Sérums et Vaccins) between 1984 and June 30, 1992, were reviewed.

RESULTS

Sixty cases of TP in children between 1 and 11 years of age occurred 2 to 45 days after administration of 1 of 7 vaccines. The reported incidence of TP varied from 0.17 and 0.23/100,000 doses of measles or rubella vaccines, respectively, given alone to 0.87/100,000 doses of combined measles-rubella vaccines and 0.95/100,000 doses of the measles-mumps-rubella vaccine. The mean platelet count was 8000 +/- 6000/mm3 and was lower than 10,000/mm3 in 58% of cases. The immediate outcome was favorable in 89.5% of cases.

CONCLUSIONS

According to the clinical course and biologic findings, vaccine-associated TP appears to be similar to that occurring after natural measles or rubella infections and is not distinguishable from acute childhood idiopathic thrombocytopenic purpura not associated with vaccination. Such observations, combined with a clear temporal relationship between measles-mumps-rubella vaccination and the occurrence of TP, make a causal relationship highly plausible. Nevertheless the incidence of these events remains relatively low with a favorable immediate outcome.

摘要

背景

接种麻疹、腮腺炎和风疹疫苗后偶尔会报告出现血小板减少性紫癜(TP)。

目的

评估在法国接种单价或多价麻疹、腮腺炎或风疹疫苗后报告的血小板减少性紫癜的发病率及特征。

方法

开展了一项回顾性流行病学调查。对1984年至1992年6月30日期间自发报告给法国地区药物警戒中心或制造商(巴斯德 - 梅里厄血清与疫苗公司)的所有确诊TP病例进行了审查。

结果

1至11岁儿童中有60例TP病例在接种7种疫苗中的1种后2至45天出现。报告的TP发病率分别为:单独接种麻疹或风疹疫苗时,每100,000剂为0.17和0.23例;接种麻疹 - 风疹联合疫苗时为每100,000剂0.87例;接种麻疹 - 腮腺炎 - 风疹疫苗时为每100,000剂0.95例。平均血小板计数为8000 +/- 6000/mm3,58%的病例低于10,000/mm3。89.5%的病例近期预后良好。

结论

根据临床病程和生物学检查结果,疫苗相关的TP似乎与自然感染麻疹或风疹后发生的情况相似,且与未接种疫苗的急性儿童特发性血小板减少性紫癜无法区分。这些观察结果,再加上麻疹 - 腮腺炎 - 风疹疫苗接种与TP发生之间明确的时间关系,使得因果关系非常可信。然而,这些事件的发病率仍然相对较低且近期预后良好。

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Thrombocytopenic purpura after measles, mumps and rubella vaccination: a retrospective survey by the French regional pharmacovigilance centres and pasteur-mérieux sérums et vaccins.麻疹、腮腺炎和风疹疫苗接种后血小板减少性紫癜:法国地区药物警戒中心和巴斯德-梅里厄血清与疫苗公司的回顾性调查
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