1997-2008 年間的台灣糖尿病患者服用中藥相關性研究 台灣健保資料庫之分析

Prescription pattern of Chinese herbal products for Diabetes Mellitus in Taiwan: a population-based study

黃中瑀(Chung-Yu Huang)

指導教授 ： 徐鳳麟

共同指導教授 ： 賴榮年

臺北醫學大學/藥學院/生藥學研究所/碩士(2013年)

https://doi.org/10.6831/TMU.2013.00092

摘要

研究目的：第二型糖尿病是快速增長的疾病，而它所造成的併發症，更是受世人所矚目。同樣地，第二型糖尿病在台灣是普遍並快速增長的疾病之一。在台灣，利用中醫藥來治療各種疾病已有數百年的歷史，而中醫藥產品的使用也呈現快速增加的趨勢。但是有關詳第二型糖尿病病患中醫藥使用的藥物流行病學資訊以及相關的實證科學研究卻相對的不足。此項研究的主要目的即是探討台灣第二型糖尿病族群在罹患糖尿病後，尋求中西醫藥療法的使用概況與影響，以及最常與降血糖西藥藥物併用的中藥處方。相信本研究結果將可以作為未來降血糖西藥與中藥交互作用研究的參考。研究方法：本研究以1997-2008 年間100 萬健保抽樣歸人檔中，以西醫之主次診斷碼為糖尿病的患者為對象做描述型分析，同時，針對年齡、投保地區、投保金額及主要診斷疾病別描述其中醫藥療法的使用情形，並探討糖尿病患者的人口特質及社經特性對其接受中醫藥療法的影響，並分析其常合併使用中西醫之藥品種類及處方開立之模式。除此之外，更進一步利用個案對照(case-control)研究設計做因果型分析，分析末期腎病變與服用中藥之因果關係。研究結果：本研究共收入了40,163 位第二型糖尿病病患，其中百分之77.9 (31,289人)曾採用中醫療法。而大部分的第二型糖尿病病人都有接受西藥治療，僅有百分之8.4 (3,370人)未曾使用過西藥。其中，女性、居住在台灣中部及高雄地區的糖尿病患者比較接受中醫藥的治療。在這些合併中西藥治療糖尿病的民眾中，以症狀、體徵及不明狀況為主診斷者而就診中醫為最多數，並且產生了612,380 的門診診次。這些第二型糖尿病病人中大部分同時使用兩種西藥降血糖藥(共13,609人，占33.9％)，Metformin與Sulfonylureas為最常合併使用的降血糖西藥(共11,636人，占29.0％)；而六味地黃丸為最常與西藥併用的中藥處方。與對照組相比較下，使用中藥的族群中，有較低的糖尿病末期腎病變的發生率：未曾使用中醫者為14.5 (ESRDs/ 1,000 person-years)；男性患者有15.6，女性患者有12.6。曾使用中醫者為3.9；男性患者有5.0，女性患者有2.8。討論：台灣成年的糖尿病病人對中醫藥的利用率高於先前的研究調查的結果，可以用以下原因來解釋：首先，臺灣人民運用中醫、藥來治療疾病已經有數百年以上的歷史，中醫、藥可以被臺灣人民普遍接受；其次，中醫醫療在臺灣已被中央健保局接受並且提供醫療給付，所以中醫藥能被民眾廣泛運用。在1998 到2008 的11 年間的第二型糖尿病病人，在受困於糖尿病以及其併發症的同時，大多希望得到中醫師的協助，但是利用中藥來治療糖尿病，只是一種輔助治療，而非取代性療法。再作進一步的分析，臺灣的的中醫師對於所處方的中藥，最主要希望用來治療糖尿病以及有關於因為降血糖藥所造成的腸胃不適，針灸對臺灣的糖尿病患者是用來治療肌肉關節的不適疾病(Diseases of the musculoskeletal system and connective tissue ICD-9 code 710-739)。與對照組相比較下，服用中藥對於糖尿病腎病變的發生具有保護與預防的效果。但是，是什麼中藥處方或是中藥藥物具有這種保護或預防作用，則需要更進一步的研究與探討。結論：本研究發現在1998 到2008 的11 年間臺灣第二型糖尿病民眾在求診於西醫的同時也使用中醫療法來治療糖尿病的相關疾病，77.9％曾採用中醫療法，而僅有百分之8.4％未曾使用過西藥。由此推論，臺灣糖尿病病患在尋求中醫治療糖尿病的態度上，是以輔助治療為主，而非取代性治療。服用中藥對於糖尿病腎病變的發生具有潛在保護的效果，在糖尿病末期腎病變的發生率(ESRDs/ 1,000 person-years)上，未曾使用中醫者為14.5，曾使用中醫者為3.9。然而，對於中藥療效與安全性以及中藥與降血糖西藥之間併用的安全性及療效評估，是急需要被了解的。因此，希望未來能累積更大量的研究族群，以提供進一步的中藥療效與安全性以及中西藥的交互作用的研究探討。

關鍵字

第二型糖尿病 ； 六味地黃丸 ； 糖尿病腎病變 ； 中西藥交互作用 ； 中醫藥 ； 健保資料庫

並列摘要

Objective：Type 2 diabetes is becoming a pandemic disorder and its alarming increase in prevalence of either microvascular or macrovascular disease raises significant concerns. As the same in Taiwan, type 2 diabetes mellitus (DM) is one of the most prevalent and fastest growing diseases. Traditional Chinese medicine (TCM) as a unique traditional therapy for various ailments has been used in Taiwan for over hundreds of years. The consumption of Chinese herbal products (CHPs) is increasing exponentially in Taiwan. However, the scientific evidence is lacking and there is an urgent requirement for detailed pharmacoepidemiological information on CHP usage. The aim of the study is to explore the demographics and utilization patterns between Chinese herbal products (CHPs) users and non-users among people with diabetes and to determine how frequent the concurrent use of hypoglycemic drugs with CHPs on a nationwide level in real practice. We believe that this study provides evidence-based information for formulating appropriate management strategies of drug safety and integrative medicine. Methods：The usage, frequency of services, and CHP prescribed among diabetic patients using hypoglycemic drugs were evaluated, recruited from a randomly sampled cohort of 1,000,000 beneficiaries from the National Health Insurance Research Database. The logistic regression method was employed to estimate the odds ratios (ORs) for the co-prescription of a CHP and hypoglycemic drugs. In addition, to investigate the incidence rate of consuming traditional Chinese medicine among diabetic patients with newly diagnosed end-stage renal disease (ESRD) from 1998 to 2008 in Taiwan. Result: 77.9 percent (n = 31,289) of diabetic patients utilized traditional Chinese medicine (TCM) during the 11-year study period. Most type 2 diabetic patients also received western medicine (WM) treatment, and only 8.4 percent (n = 3,370 ) never used WM. Females, regular salary earners, and living in Central and Kaohsiung city were more likely to consume CHPs and hypoglycemic drugs concurrently. Among concurrent users, “symptoms, signs, and ill-defined conditions” (612,380 visits) was the most frequent major disease category for concurrent use hypoglycemic drugs and CHPs. Most type 2 diabetes diabetes patients took two hypoglycaemic agents (n = 13,609, 33.9％) in WM treatment. Metformin plus Sulfonylureas (n = 11,636, 29.0％) and Liu-Wei-Di-Huang-Wan were the most prescribed hypoglycemic drugs and Chinese formula, respectively. In comparison with control group, there was a lower incidence rate (ESRDs/ 1,000 person-years) of the traditional Chinese medicine users (TCM nonusers, n = 14.5, male, n = 15.6, female, n = 12.6; TCM users, n = 3.9, male, n = 5.0, female, n = 2.8). Discussion: the utilization of TCM among adults with type 2 diabetes in Taiwan during the study period appeared to be high compared with previous findings. TCM as a unique traditional therapy for various ailments which has been used in Taiwan for over hundreds of years may be the main contributor to the high prevalence of TCM usage among type 2 diabetic subjects. Moreover, TCM treatment has been covered by the NHI system. Unsurprisingly, the prevalence of CHP for treating type 2 diabetes among adults is comparatively higher in Taiwan than in other countries. However, we inferred that TCM for type 2 diabetes in Taiwan was generally used as adjuncts to diabetes treatment, rather than as replacements for it. Further analysis found that TCM doctors tended to use Chinese herbal medicine (CHMs) to deal with diabetes and gastrointestinal disorders which might be the uncomfortable side effects of diabetes drugs. And the present study indicated that acupuncture in Taiwan was used by this population mainly for diseases of the musculoskeletal system and connective tissue (Diseases of the musculoskeletal system and connective tissue ICD-9 code 710-739). In comparison with control group, utilization of traditional Chinese medicine had the protective effect and lowing inducing diabetic nephropathy, but the active components need to be determined accurately. Conclusions：During the 11-year study period, 77.9 percent of type 2 diabetic patients utilized traditional Chinese medicine (TCM), and only 8.4 percent never used WM in Taiwan. Hence, we inferred that TCM for type 2 diabetes in Taiwan was generally used as adjuncts to diabetes treatment, rather than as replacements for it. Liu-Wei-Di-Huang-Wan and its derivatives are the most frequent prescribed formulas by TCM doctors in Taiwan for type 2 diabetic patients. Utilization of traditional Chinese medicine had the protective effect and lowing inducing diabetic nephropathy (incidence rate: TCM nonusers, n = 14.5; TCM users, n = 3.9). Although some evidence does support the use TCM to treat diabetes, the results from the current study could have been confounded by placebo effect, emphasizing the need for well conducted, double-blind, randomized, placebo-controlled studies to further evaluate the efficacy of TCM on patients with type 2 diabetes.

並列關鍵字

Liu-Wei-Di-Huang-Wan ； type 2 diabetes ； ESRD ； herbal medicine-drug interaction ； Chinese medicine ； health care database

參考文獻

11 林宏達，論述血糖控制與糖尿病合併症，中華民國內分泌暨糖尿病學會會訊，12 卷，1999 年 5 月，1-4頁。

19 高建仁、高東煒、陳永煌、周稚傑、劉紹興、羅慶徽，從全民健保資料分析糖尿病病患之流行病學與用藥情形。中華職業醫學雜誌 2005，12，(3)，87-195頁。

58 Cheng-Ching Lin, Mei-Shu Lai, Ci-Yong Syu, Shuan-Chuan Chang, and Fen-Yu Tseng Accuracy of diabetes Diagnosis in Health Insurance Claims Data in Taiwan. J Formos Med Assoc 2005, 104, (3).

1. Chen, F. P., Chen, T. J., Kung, Y. Y., Chen, Y. C., Chou, L. F., Chen, F. J., Hwang,S. J., Use frequency of traditional Chinese medicine in Taiwan. BMC health services research 2007, 7, 26-36.

2. Hsiao-yun Annie Chang, MarianneWallis, and Evelin Tiralongo.Use of complementary and alternative medicine among people with type 2 diabetes in Taiwan: a cross-sectional survey. Evidence-Based Complementary and Alternative Medicine 2011, Article ID 983792.