治糖尿病中醫方藥對第二型糖尿病患者的臨床研究

Assessment on Type 2 Diabetes Mellitus with Chinese Medicine Formulas

趙家瑩(Chia-Ying Chao)

指導教授 ： 詹道明

高雄醫學大學/藥學院/藥學研究所/碩士(2003年)

摘要

研究背景：糖尿病是威脅國人健康的重大慢性疾病，民國九十年共奪走9113條台灣人民的寶貴生命，而民國九十一年糖尿病更成為台灣地區十大死因的第四名，在目前的治療模式之下，糖尿病患者的血糖控制及糖尿病的諸多慢性併發症的處理上，仍有相當大的改善空間，因此，本研究嚐試在目前治療模式的基礎上，加上中醫方藥的治療，希望能對糖尿病患者的病情控制，有更好的效果。
研究目的：藉由實驗室檢驗，來評估中醫方藥的確實療效，以及中醫方藥的副作用。
研究方法：以前瞻性的收集個案，依照中醫辨証論治的方法，將門診糖尿病患者分為DM1，DM2及DM3三組，每組給與濃縮科學中藥每日劑量20公克，分四次服用，連續服用十六週，患者皆維持原來的治療模式，即如果患者原來有服用降血糖西藥，仍囑其繼續維持原藥物及劑量服用，而與中藥服用間隔二小時以上。DM1主要用於中醫肺胃燥熱證型的患者，證見口乾、口渴、口唇發紅、舌質紅、舌苔黃燥、脈洪大等證時使用；DM2主要用於中醫腎陰虧虛證型的患者，證見多尿、煩渴、頭暈、腰酸、肢痠痛麻、目糊、舌質紅、舌苔甚少、脈沉細數等證時使用；DM3主要用於中醫氣陰兩虛證型的患者，證見多尿、煩渴、困倦氣短、舌質淡紅、舌苔薄白、脈細弱等證時使用。
研究結果：本研究共收案31人，平均年齡52.3±11歲，平均BMI 為24.2±3.6(kg/m2)，平均病程為6.4±6.1年。
DM1這組患者，治療前糖化血色素（HbA1C）的數值為9.22±2.80 ﹪，在治療16週後降為7.43±1.88 ﹪，有達到統計上的意義（p＜0.05）。全部患者治療前糖化血色素（HbA1C）的數值為8.73±2.63 ﹪，治療後12及16週降為7.31±1.61 ﹪及7.25±1.63 ﹪，有達到統計上的意義（p＜0.05）。
DM2這組患者，在治療前空腹血糖的值為185.2±91.9 mg/dl，在治療後14週及16週降為130.6±10.1 mg/dl及122.3±13.0 mg/dl，有達到統計上的意義（p＜0.05）。全部患者治療前空腹血糖的值為193.3±86.1 mg/dl，在治療後10週之後降為159.1±50.4 mg/dl、158.1±51.3 mg/dl、145.3±34.1 mg/dl及145.3±49.0 mg/dl，有達到統計上的意義（p＜0.05）。
全部患者的LDL及VLDL治療前及16週後的治療期間，所有數據皆在正常值之內。DM2這組患者，胆固醇數值治療前為207.4±61.7 mg/dl，在治療16週後，胆固醇的下降到204.2±54.4 mg/dl，有達到統計上的意義（p＜0.05）。DM2這組患者，三酸甘油酯（TG）數值治療前為216.7±201.4 mg/dl，在治療12及16週後，三酸甘油酯（TG）的下降到99.0±53.5mg/dl及53.0±6.2 mg/dl，有達到統計上的意義（p＜0.05）。
全部患者BUN、Creatinine、Uric acid、 GOT、 GPT與?GT經過16週的中藥治療後，並沒有惡化的跡象。
結論：第二型糖尿病患者在原有的治療模式下，再加上中醫方藥對患者具有一定程度的幫助，DM1這組患者，糖化血色素的改善較為明顯；DM2這組患者在空腹血糖、膽固醇與三酸甘油酯的改善較為明顯。由研究患者的肝功能與腎功能來看，在16週的治療期間看不出有不良的反應產生，可說中藥是有其安全性存在。在本研究的初步成果之上，再設計一個隨機、雙盲、對照的研究方法，如將中藥作成鋁箔包的型式，外觀一樣，但內容不同，再收案更多的患者，在方法學方面將更為適當。

關鍵字

中藥 ； 第二型糖尿病 ； 臨床研究

並列摘要

Background: Diabetes mellitus is the fourth leading cause of death in Taiwan (2002). We had focused on the needs of people with type 2 diabetes— the rapidly increasing prevalence of which should be a major concern for health- care providers. Traditional Chinese medicine, used in Taiwan for centuries, was used for many diseases, including type 2 diabetes mellitus. Because the morbidity and mortality remained terrible in the modern treating model, the benefits of Chinese formulas in preventing and delaying the development and progression of diabetic complications had been well expected. We used three Chinese medicine formulas (DM1, DM2 and DM3) to the type 2 diabetic outpatients in this study.
Objective: The purpose of this study was to investigate the effects and side effects of Chinese medicine formulas on type 2 diabetic outpatients with laboratory examinations.
Methods: All of the diabetic patients took a formula of Chinese medicine, concentrated powder 20 g/day, divided by four times for 16 weeks in this study.
DM1 was used for dryness and heat of lung and stomach, marked by extreme thirst and excessive drinking, dry mouth and tongue, red tongue with yellow- dry coating and rapid- strong pulse.
DM2 was used for deficiency of kidney- yin, marked by polyuria, extreme thirst and excessive drinking, dizziness, waist- soreness, soreness and numbness of extremities, blurred vision, red tongue with little coating, deep and thready pulse.
DM3 was used for deficiency of qi and yin, marked by polyuria, extreme thirst and excessive drinking, fatigue, red tongue with little and white coating, deep and thin pulse.
Results: 31 type 2 diabetic outpatients 16-76 years old participated in the study. The mean age of the patients was 52.7?11.2 (17-76) years. The mean BMI was 24.2?3.6 (Kg/m2). The mean duration of diabetes was 6.4±6.1 years.
Before treatment, the mean glycosylated A1C (HbA1C normal 4.4-6.4%) of group DM1 was 9.22±2.80% (week 0). After treatment 16 weeks, the mean HbA1C was 7.43±1.88%. There was a significant decreasing trend in HbA1C after treatment 16 weeks (p< 0.05). Before treatment, the mean HbA1C of all patients was 8.73±2.63% (week 0). After treatment 12 and 16 weeks, the mean HbA1C was 7.31±1.61% and 7.25±1.63% respectively. There were significant decreasing trends in HbA1C After treatment 12 and 16 weeks (p< 0.05).
Before treatment, the mean fasting plasma glucose (FPG normal 70-110 mg/dl) of group DM2 was 185.2±91.9 mg/dl (week 0). After treatment 14 and 16 weeks, the mean was 130.6±10.1 mg/dl and 122.3±13.0 mg/dl respectively. There were significant decreasing trends in FPG after treatment 14 and 16 weeks (p< 0.05). Before treatment, the mean fasting plasma glucose of all patients was 193.3±86.1 mg/dl (week 0). After treatment 10, 12, 14 and 16 weeks, the mean was 159.1±50.4 mg/dl, 158.1±51.3 mg/dl, 145.3±34.1 mg/dl, 145.3±49.0 mg/dl respectively. There were significant decreasing trends in FPG after treatment 10 weeks (p< 0.05).
The plasma LDL and VLDL were in the normal range in the 16 weeks period. Before treatment, the mean cholesterol (normal 140- 200 mg/dl) of group DM2 was 207.4±61.7 mg/dl (week 0). After treatment 16 weeks, the mean was 164.5±23.9 mg/dl. There was a significant decreasing trend in cholesterol after treatment 16 weeks (p< 0.05).
Before treatment, the mean triglyceride (normal 50-150 mg/dl) of group DM2 was 216.7±201.4 mg/dl (week 0). After treatment 12 and 16 weeks, the mean was 99.0±53.5 mg/dl and 53.0±6.2 mg/dl respectively. There were significant decreasing trends in TG after treatment 12 and 16 weeks (p< 0.05).
The renal function tests and the liver function tests of all patients were not elevated in the 16-week treating period.
Conclusion: There were several beneficial effects of traditional Chinese medicine observed. There was better decreased in HbA1C in the group DM1. There were better decreased in FPG, cholesterol and TG in the group DM2. There were no elevated liver function tests and renal function tests in the 16- week treating period. We will design a randomized, placebo- controlled study and collected more patients in the future to determine the effects and side effects of Chinese medicine.

並列關鍵字

Chinese Medicine ； Type 2 Diabetes Mellitus ； Clinical study

參考文獻

1. 行政院衛生署，台灣地區主要死亡原因，http://www.doh.gov.tw/statistic/data/死因摘要/90年/表1.xls

2. 行政院衛生署，台灣地區主要死亡原因，http://www.doh.gov.tw/statistic/data/死因摘要/91年/表1.xls

3. 行政院衛生署，全民健康保險醫療統計，http://www.doh.gov.tw/statistic/data/全民健康保險統計年報/90醫療統計年報/9002.xls

4. Amos AF, Mc Carty, Zimmetp PJ. The rising global burden of diabetes and its complications. Estimates and projections to the year 2010, Diabet Med, 7: 85,1997.

5. 蔡文惠，全民健康保險北區分局糖尿病人醫療利用及照護結果，國立陽明大學衛生福利研究所碩士論文，1999。