以修正型德菲法探討妊娠期中藥安全性分級之先導研究──以某醫療體系為例

Exploring the Safety Classification of Chinese Herbal Medicine During Pregnancy: A Pilot Study using Modified Delphi Method in a Specific Healthcare System

目的：臺灣衛生福利部目前對妊娠期中藥的使用並無明確規範。現今妊娠中藥安全性的研究多處於觀察性研究、細胞實驗、動物試驗等階段，但仍缺乏中醫師臨床經驗的彙整。此研究為一先導研究，目的為試驗以修正型德菲法彙集專家意見，先以長庚醫療體系各院區中醫藥專家為受訪對象，嘗試達成對妊娠期中藥安全性分級之共識，建立長庚電腦系統妊娠期中藥提醒制度，並為未來此主題更大範圍的共識研究方法提供可參考的基礎。方法：本研究透過修正型德菲法調查長庚醫療體系各院區中醫藥專業人員對妊娠期中藥安全性分級的意見，將妊娠期中藥安全性分級定義為三種：禁用、慎用與不用管制，讓受訪者依據自身專業經驗做出分類，試圖探討妊娠期中藥安全性分級之共識。結果：共計56種中藥（71.8%），包含23種「禁用」中藥、31種「慎用」、2種「不用管制」中藥，達到長庚體系內之專家共識。結論：透過修正型德菲法研究調查，部分妊娠期中藥藉由此方法於長庚體系取得初步共識，可將研究結果提交至長庚體系門診委員會，實施妊娠期使用中藥之提醒制度。希望可藉由此先導研究之經驗，為未來更大範圍的中醫專業人員對於此主題共識的調查奠定基礎，建立與推動妊娠期中藥安全性分級。

Objective: Currently, the Taiwan Ministry of Health and Welfare has no clear regulations regarding the use of Chinese Herbal Medicine (CHM) during pregnancy. Research on CHM safety during this period primarily remains at the observational studies, cellular experiments, and animal trials stages, with a notable lack of integration of clinical experience from Chinese Medicine (CM) practitioners. This pilot study employs the Modified Delphi Method to gather CM professional opinions within the Chang Gung Healthcare System (CGHS), aiming to achieve a consensus on the safety classification of CHM in pregnancy , establish a CHM alert system within the CGSH computer system for pregnant patients , and thereby provide a reference for future larger-scale consensus studies on this topic. Methods: This study utilized the Modified Delphi Method to investigate the opinions of CM professionals within the CGHS regarding the safety classification of CHM during pregnancy. Chinese herbs were categorized into three groups:“contraindicated”,“cautiously prescribed”, and“non-regulated’in pregnancy. Participants were asked to classify herbs based on their professional experience to explore consensus on safety classifications during pregnancy. Results: A total of 56 CHMs (71.8%) reached consensus among professionals, including 23 '' contraindicated'', 31 '' cautiously prescribed '', and 2 ''non-regulated'' herbs during pregnancy. Conclusion: This pilot study has facilitated a preliminary consensus on the use of certain Chinese herbs during pregnancy within the CGHS using the Modified Delphi Method. The findings can be submitted to the CGHS outpatient committee to implement a CHM alert system for use during pregnancy. This study provides foundational insights for future larger-scale surveys of CM professionals, aiming to establish and promote the safety classification of CHM during pregnancy.