在疟疾流行地区通过国家药物警戒系统对青蒿素联合疗法进行安全性监测。

Safety monitoring of artemisinin combination therapy through a national pharmacovigilance system in an endemic malaria setting.

机构信息

African Medical and Research Foundation, Nairobi, Kenya.

出版信息

Malar J. 2013 Feb 5;12:54. doi: 10.1186/1475-2875-12-54.

DOI:10.1186/1475-2875-12-54

PMID:23384036

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3598537/

Abstract

BACKGROUND

The National Malaria Control Programme in Senegal, introduced since 2006, artemisinin-based combination therapy (ACT administration) for the treatment of uncomplicated malaria cases. In this framework, an anti-malarial pharmacovigilance plan was developed and implemented in all public health services. This study investigated the occurrence of Adverse Drug Events (ADEs) after ACT.

METHODS

The study was conducted between January 2007 and December 2009. It was based on spontaneous reports of ADEs in public health facilities. Data on patient demographic characteristics, dispensing facility, adverse signs and symptoms and causality were collected from a total of 123 patients.

RESULTS

The age range of these patients was six months to 93 years with a mean of 25.9 years. Of the reported symptoms, 46.7% were related to the abdomen and the digestive system. Symptoms related to the nervous system, skin and subcutaneous tissue, circulatory and respiratory systems and general symptoms and signs were 7%, 9.7%, 3.5% and 31.3%, respectively. Causality results linked 14.3% of symptoms to Falcimon® (Artesunate-Amodiaquine) with certainty. Effects were classified as mild and severe in 69.1% and 7.3% of cases respectively while 23.6% were serious. All patients with serious ADEs were hospitalized. One death was reported in a patient who had taken 24 pills at once.

CONCLUSION

These results confirm the need to develop and implement pharmacovigilance systems in malaria endemic countries in order to monitor the safety of anti-malarial treatments.

摘要

背景

塞内加尔自 2006 年以来引入了国家疟疾控制规划，为治疗无并发症的疟疾病例提供了以青蒿素为基础的联合疗法（ACT 治疗）。在此框架内，制定并在所有公共卫生服务机构实施了抗疟药物警戒计划。本研究调查了 ACT 后不良药物事件（ADE）的发生情况。

方法

该研究于 2007 年 1 月至 2009 年 12 月进行。它基于公共卫生机构自发报告的 ADE 数据。共从 123 名患者中收集了患者人口统计学特征、配药机构、不良体征和症状以及因果关系的数据。

结果

这些患者的年龄范围为 6 个月至 93 岁，平均年龄为 25.9 岁。报告的症状中，46.7%与腹部和消化系统有关。神经系统、皮肤和皮下组织、循环和呼吸系统以及一般症状和体征相关的症状分别为 7%、9.7%、3.5%和 31.3%。因果关系结果将 14.3%的症状与 Falcimon®（青蒿琥酯-阿莫地喹）明确相关联。69.1%和 7.3%的病例分别归类为轻度和重度，而 23.6%的病例为严重。所有严重 ADE 患者均住院治疗。一名患者一次性服用 24 片后报告死亡。