| 摘要: | 糖尿病是死亡和罹病的重要危險因子。在臺灣，相較於其他慢性病，糖尿病已成為標準死亡比增加最快的疾病，糖尿病也是中風、失明、末期腎臟病、神經病變和下肢截肢發生個案的主要因素。然而，台灣有關糖尿病相關死亡和併發症發生率的資料相當的缺乏。本研究為一個三年期的研究計畫，第一年主要研究目的為預估加入中部一醫學中心糖尿病疾病管理計畫之第二型糖尿病患者其死亡率和併發症發生率，第二研究目的為評估斷食飯前血糖和糖化血色素每年之變異與死亡率和併發症發生率間之相關；第二年之研究目的為探討糖尿病患者每年代謝症候群狀態和其組成因子異常與死亡率和併發症發生率之相關；第三年之研究目的為比較有加入及無加入糖尿病疾病管理計畫之糖尿病患者每年照護過程與中間結果指標、死亡率和併發症發生率之不同，並探討照護過程與中間結果指標與死亡率和併發症發生率之相關。本研究第一年和第二年為單一族群之回顧性追蹤研究設計，以加入中部一醫學中心糖尿病疾病管理計畫之第二型糖尿病患者為研究對象，納入準則為必須提供一年以上之追蹤且年齡18 歲以上之第二型糖尿病患者，此糖尿病疾病管理計畫設立於西元2002 年，研究追蹤結束時間為每年研究計畫開始前一個月，目前初步分析符合準則的加入疾病管理計畫病患有3358 人，而未加入疾病管理計畫之病患有6377 位。第三年增加另一個族群:未加入糖尿病疾病管理計畫之糖尿病患者，斷食飯前血糖和糖化血色素每年之變異將以一年中測量數值的標準差、變異係數及斜率為指標；代謝症候群與其組成因子異常之定義將採用國際衛生組織、NCEP-III 亞太版、國際糖尿病協會及美國心臟學會/國家心臟肺血液機構所訂定的準則；照護過程指標包括每年至少有一次或以上的糖化血色素檢測、至少有一次的低密度膽固醇檢測、至少有一次微尿蛋白檢測或已有腎病變的照護、一次的足部檢查及至少一次的眼底或視網膜檢查，中間照護結果指標包括是否血糖控制不良(HbA1c >9.0%)、低密度膽固醇低於130 mg/d 及血壓低於140/90 毫米汞柱。糖尿病併發症包括足部病變、視網膜病變、高血壓、腎病變、週邊神經病變、缺血性心臟病、心肌梗塞和中風。累積發生率將用來預估死亡之發生率，發生密度則將用來預估糖尿病併發症之發生率，卡方檢定和Cox 隨時間變動等比風險模式來探討斷食飯前血糖和糖化血色素每年之變異、不同定義代謝症候群、其組成因子異常和照護過程及中間結果指標，與糖尿病死亡與併發症發生之相關。
Diabetes is associated with substantial morbidity and mortality. In Taiwan, diabetes has become the most rapid increase in standard mortality ratio, compared to other chronic diseases. Diabetes is also a leading cause of incidence case for stroke, blindness, end-stage renal disease, neuropathy, and lower limb amputations. However, relevant data regarding mortality and morbidity from diabetes for Taiwan diabetes population is limited. This is a 3-year study proposal focusing on mortality and incidence of diabetic complications in patients with type II diabetes. The primary objective of the first year is to estimate the overall mortality and morbidity from diabetes in patients with type II diabetes enrolled in Share Care Disease Management (SCDM) program of a medical center. The secondary objective is to assess whether the annual variability of fasting plasma glucose and hemoglobin A1C (HbA1C) is associated with mortality and incidence rates of diabetic complication. The objective of the second year is to assess whether the annual status of metabolic syndrome and its components’ abnormalities are associated with mortality and incidence rates of diabetic complication. The objectives of the third year are to compare the annual measures of care quality for diabetes, mortality, and incidence rates of diabetic complication between patients enrolled and not enrolled in SCDM program, and to explore the relationship of measures of care quality with mortality and incidence rates of diabetic complication. SCDM, a nurse case management program, was set up by Bureau of National Health Insurance in 2002. The study design is a retrospective cohort study. The study cohort for the first and second year will be enrollee population of Share Care Disease Management (SCDM) program in China Medical University Hospital. From our preliminary data analysis up to date, there are 3358 men and women aged 18 years or older qualified our inclusion criteria. For the third year, another cohort will be built for those patients with type II diabetes not enrolled in SCDM program. There are 6377 patients not enrolled in SCDM program. Three measures of variability for fasting plasma glucose and HbA1C will be used: standard deviation (SD), coefficient of variation (CV), and slope of repeated measurements (S). Definitions of the MS and its components’abnormality will be defined according to the criteria of World Health Organization (WHO), National Cholesterol Education Program (NCEP)/Adult Treatment Panel III (ATP III), International Diabetes Federation (IDF), and American Heart Association and the National Heart Lung Blood Institute (AHA/NHLBI). Process measures of care quality includes one or more HbA1c tests annually, at least one LDL cholesterol test annually, at least one test for microalbuminuria or medical attention for existing nephropathy each year, at one foot examine annually and at a dilated eye exam or retinal photography. Intermediate outcome measures of care quality consist of most recent HbA1c level 9.0%, most recent LDL<130 mg/dl, and most recent blood pressure<140/90 mmHg. Diabetic complications consist of foot ulcer, retinopathy or macular edema, hypertension, nephropathy, ischemic heart disease, myocardial infarction, and stroke. Cumulative incidence and incidence density will be used to estimate mortality and diabetic complication incidence. Simple statistical analysis such as the Chi-square test will first be employed and time-dependent Cox’s proportional hazard models will be further applied to test the contribution or explanatory effects of variability for fasting plasma glucose and HbA1C, different definitions of metabolic syndrome and/or its components’abnormality, and process and intermediate outcome measures of quality care on the mortality and occurrence of diabetic complications. |
