Development of active-safety surveillance system for traditional Chinese medicine: an empirical study in treating climacteric women
Development of active-safety surveillance system for traditional Chinese medicine: an empirical study in treating climacteric women
复制标题
DOI：
10.1002/pds.1340
复制
发表时间：
2006-12-01
影响因子：
2.6
通讯作者：
Wang, Jung-Der
中科院分区：
文献类型：
--
作者：
Hsieh, Shu-Ching;Lai, Jung-Nien;Wang, Jung-Der
目的在台湾，医生开的中药由国民健康保险（NHI）定期报销。中药的安全性应该像大多数西药一样受到同样的审查。本研究是监测不良事件（AE）与一个新的混合物的中药，TMN-1，用于治疗更年期symptoms.Methods为这个多中心，前瞻性观察研究，我们招募了134名妇女更年期症状。在这项为期12周的研究中，受试者进行了9次访问，每天服用TMN-1三次，并在基线和开始用药4周和12周后接受常规血液学检查，生化检查和妇科相关激素检查。每次访视时，通过问卷询问受试者是否发生任何AE。结果共记录203例不良事件，发生率依次为咳嗽、咽炎、鼻炎、腹痛、腹胀、腹泻、瘙痒，发生率分别为2.57、2.47、1.88、1.78、1.68、1.58、1.68、1.78、1.88、1.8和1.58/10（3）人日。大多数AE可耐受。五个AE被判定为“可能的”药物不良反应（ADR）：腹泻和恶心，腹痛，腹部fullness.Conclusion本研究证明了使用主动安全性监测的有效性，以文件的安全性中药的两个事件。这一监测系统可能有助于记录其他替代或补充药物的安全性。版权所有（c）2006约翰威利父子有限公司。
Purpose Traditional Chinese medicines (TCM) prescribed by doctors are regularly reimbursed by the National Health Insurance (NHI) in Taiwan. The safety of TCM should undergo the same scrutiny that most western medicines do. This study was to monitor adverse events (AEs) associated with a new mixture of TCM, TMN-1, used to treat climacteric symptoms.Methods For this multi-center, prospective observational study, we recruited 134 women with climacteric symptoms. During this 12-week study, the subjects made nine visits, took TMN-1 three times a day, and received routine hematologic tests, biochemical tests, and tests for gynecologically relevant hormones at baseline and after 4 and 12 weeks of beginning medication. At every visit, the subjects were asked by questionnaire about any AEs. All AEs were examined through a process of causality assessment (CA) by a research team.Results In total, we recorded 203 AEs, in order of decreasing incidences-cough, pharyngitis, rhinitis, abdominal pain, abdominal fullness, diarrhea, and pruritus with incidence rates of 2.57, 2.47, 1.88, 1.78, 1.68, 1.58, and 1.58 per 10(3) person-days, respectively. Most AEs were tolerable. Five of the AEs were judged to be "probable" adverse drug reactions (ADRs): Two events of diarrhea and one event each of nausea, abdominal pain, and abdominal fullness.Conclusion This study demonstrates the effectiveness using active safety surveillance to document safety of TCMs. This surveillance system could probably be useful to document the safety of other alternative or complementary medicines. Copyright (c) 2006 John Wiley & Sons, Ltd.