Wechwithan Sareeya, Suwankesawong Wimon, Sornsrivichai Vorasith, McNeil Edward B, Jiraphongsa Chuleeporn, Chongsuvivatwong Virasakdi
Health Product Vigilance Center, Food and Drug Administration, Ministry of Public Health, 11000, Thailand; Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110, Thailand.
Health Product Vigilance Center, Food and Drug Administration, Ministry of Public Health, 11000, Thailand.
Regul Toxicol Pharmacol. 2014 Oct;70(1):407-12. doi: 10.1016/j.yrtph.2014.06.007. Epub 2014 Jun 16.
Herbal containing medicine consumption has increased while the awareness of adverse drug reaction (ADR) was less than conventional medicine. Early detection of unexpected numbers of ADRs from herbal medicines' reports which are abnormal from the whole database needs quantification. Disproportionality analysis has been performed for signal detection by using reporting odds ratio (ROR) as measurement. The impact of having medicine as exposures in each ADR should be measured by using reported population attributable risks (RPAR). This study aimed to quantify the contribution of Thai traditional medicine (TTM) to ADR reports and to assess the association between TTMs and serious adverse drug reactions. Data were retrieved from the adverse drug reaction surveillance database, Thai-Food and Drug Administration from 2002 to 2013. Crude and adjusted RORs for each drug-ADR pair and RPARs were computed. TTM contributed only 0.001% of all serious ADRs reported. Out of 4208 TTM-ADR pairs were examined, three had the statistically significant RORs, namely Andrographis paniculata and anaphylactic shock (ROR 2.32, 95% CI 1.03, 5.21); green traditional medicine and Stevens-Johnson syndrome (ROR 13.04, 95% CI 5.4-31.51) and Derris scandens Benth and angioedema (ROR 2.71, 95% CI 1.05-6.95). Their RPARs ranged from 0.05% to 0.16%. We conclude that TTMs need more intensive surveillance.
含草药药品的消费量有所增加，而对药物不良反应（ADR）的认知却低于传统药品。需要对草药报告中与整个数据库相比异常的意外数量的ADR进行早期检测并进行量化。已通过使用报告比值比（ROR）作为测量指标进行不成比例分析以进行信号检测。每种ADR中作为暴露因素的药物影响应使用报告的人群归因风险（RPAR）来衡量。本研究旨在量化泰国传统医学（TTM）对ADR报告的贡献，并评估TTM与严重药物不良反应之间的关联。数据取自泰国食品药品管理局2002年至2013年的药物不良反应监测数据库。计算了每种药物 - ADR对的粗ROR和调整后ROR以及RPAR。TTM仅占所有报告的严重ADR的0.001％。在检查的4208对TTM - ADR中，有三对具有统计学意义的ROR，即穿心莲与过敏性休克（ROR 2.32，95％CI 1.03，5.21）；绿色传统药物与史蒂文斯 - 约翰逊综合征（ROR 13.04，95％CI 5.4 - 31.51）以及鱼藤与血管性水肿（ROR 2.71，95％CI 1.05 - 6.95）。它们的RPAR范围为0.05％至0.16％。我们得出结论，TTM需要更密集的监测。
