Raschetti R, Maggini M, Popoli P, Caffari B, Da Cas R, Menniti-Ippolito F, Spila-Alegiani S, Traversa G
Department of Epidemiology and Biostatistics, Istituto Superiore di Sanità, Rome, Italy.
J Clin Epidemiol. 1995 Nov;48(11):1399-405. doi: 10.1016/0895-4356(95)00557-9.
Cases of Guillain-Barré syndrome (GBS) associated with parenteral use of gangliosides have been reported in several European countries. To evaluate the hypothesis of association between ganglioside exposure and occurrence of GBS, a case-control study was conducted. GBS cases discharged during 1989 from public and private hospitals in three Italian provinces were identified: 42 GBS cases and 420 controls matched on age and gender were enrolled. Data of onset of symptoms of GBS was taken from clinical records. Exposure status of subjects was ascertained through the regional computerized drug prescription monitoring system. The odds ratio of association between ganglioside use, in the 30 days prior to onset of symptoms, and GBS was 9.1 (95% confidence interval 2.8-29.4). Although there are formidable difficulties in distinguishing prodromal therapy of GBS from drug causation, the association with ganglioside therapy is strong and supportive of the hypothesis of a role of ganglioside preparations in the occurrence of GBS.
在几个欧洲国家均报告了与肠胃外使用神经节苷脂相关的吉兰-巴雷综合征(GBS)病例。为评估神经节苷脂暴露与GBS发生之间存在关联的假说,开展了一项病例对照研究。确定了1989年期间从意大利三个省份的公立和私立医院出院的GBS病例:纳入了42例GBS病例以及按年龄和性别匹配的420名对照。GBS症状发作的数据取自临床记录。通过区域计算机化药物处方监测系统确定受试者的暴露状态。在症状发作前30天内使用神经节苷脂与GBS之间的关联优势比为9.1(95%置信区间2.8 - 29.4)。尽管在区分GBS的前驱治疗与药物因果关系方面存在巨大困难,但与神经节苷脂治疗的关联很强,支持了神经节苷脂制剂在GBS发生中起作用这一假说。