睡眠障礙治療藥物與安神類科學中藥處方併用之副作用流行病學研究

王榮德
台灣大學職業醫學與工業衛生研究所
失眠是所有睡眠問題中最普遍的，在美國一項失眠的流行病學研究當中，近1/3的成年人一年中至少體驗過一次失眠。在台灣失眠也是一個相當重要的議題，根據台灣睡眠醫學會的調查，國內有超過四分之一的人口有睡眠的問題。
有不少的文獻研究指出，安眠藥的使用會會影響駕駛能力以及增加交通意外的發生率，但是併用西藥安眠藥與中醫方藥中的安神類藥物其安全性如何? 對於交通事件的發生率是否會增加或是減少，到目前為止未有證據充足的流行病學研究。台灣由於健保給付中藥，而台灣地區民眾同時併用中西藥的情形也十分普遍。故本研究希望可以對西藥安眠藥與中藥安神類藥物併用模式，提供一些安全性的線索。
本計劃利用全民健康保險研究資料庫中1997-2004年的20萬及100萬健保抽樣歸人檔所有健保承保資料檔，進行下列三方面研究:
1.失眠族群的描述：
對於台灣曾經因為失眠而就醫的族群，分別就其年齡層、性別，逐年描述失眠的群族。
2.藥物使用分析：
針對西藥安眠藥以及中藥安神類藥物的使用情況，分析藥物種類、處方頻率、劑量，以及西藥的安眠藥與中藥安神類藥物併用模式等資料。
3.藥物合併使用風險分析：
利用100萬健保抽樣歸人檔中住院記錄的診斷碼，找出交通事件相關的事件，並利用病例對照的方式(case-crossover study)進行分析不同西藥安眠藥以及中藥使用及併用模式下對於交通事件發生率的改變，藉此評估西藥安眠藥與中藥併用的安全性。
關鍵字：

The pharmacoepidemiologic analysis of the potential drug-herb interaction between finished herbal products and conventional medicines used in the treatment of insomnia

Jung-Der Wang
Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University
Insomnia is the most prevalent sleep disorder. As approximately estimated in the United States, one third of the adult population experienced insomnia at least once a year and ten percent of them were persistently afflicted with the problem, In Taiwan, people suffereing from insomnia accounted for one fourth of the totally population, according to the survey of Taiwan Society of Sleep Medicine. 
Although hypnotics has been widely proved to improve insomnia, it is also found to increase the incidences of accident, including the traffic accidents caused by decreased driving ability and varied injureies associated with decreased concentration . Accordingly, the combined use of hypnotics and finished herbal products to treat insomnia with less traffic accidents was hypothesized to be a better option. However, the related pharmaco-epidemiologic evidences for such kind are lacking. The effective and safety information are especially important for Taiwan where the co-use of hypnotics and finished herbal products are common. This study aims to determine the potential interaction of finished herbal products and conventional medicines used in the treatment of insomnia, taking the incidences of traffic accidents and injuriers as outcome variables.
關鍵字：hypnotics , drug-herb interaction, traffic accident