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http://ir.cmu.edu.tw/ir/handle/310903500/23928
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| 題名: | 濟生腎氣丸對糖尿病併發慢性腎功能不全 病人的療效評估:使用雙盲,對照組試驗法;A double blind, placebo-controlled study of The Effect of Jisheng Shengi Wan on Diabetic Patients with Chronic Renal insufficiency |
| 作者: | 王子源;Tzu Yuan Wang |
| 貢獻者: | 中國醫藥學院中西醫結合研究所 |
| 關鍵詞: | 糖尿病腎功能不全;濟生腎氣丸;糖化血色素;臨床症狀;生活品質;Diabetes with chronic renal insufficiency;Jis-heng Shen-gi Wan;HbA1c;Clinical symptoms;Quality of life |
| 日期: | 1991 |
| 上傳時間: | 2009-12-01 20:14:37 (UTC+8) |
| 摘要: | 糖尿病慢性腎功能不全是末期腎臟疾病最常見原因，它是糖尿病人死亡最主要的病因，西醫預防和治療糖尿病慢性腎功能不全為嚴謹的血糖控制、維持正常血壓、限鹽及低蛋白飲食和高血脂的治療。腎氣丸是中醫治療糖尿病的著名方劑，許多治療經驗及研究均顯示對糖尿病併發慢性腎功能不全病人有一定的療效，且能改善臨床的不適症狀，提升生活品質。 為評估濟生腎氣丸對糖尿病腎功能不全病人的臨床療效。本研究採用雙盲安慰劑對照隨機試驗，病患依中醫辨證分型，排除熱症及陰虛火旺證型的患者，分為腎陽虛及非腎陽虛兩型。共有44位第二型糖尿病合併慢性腎功能不全病患加入本研究，隨機分成二組。實驗組有21位服用西藥加上「濟生腎氣丸」濃縮藥粉，每天三次，一次三公克，對照組服有23位服用西藥及安慰劑，療程為十二週。評估指標為實驗數值、臨床症狀及生活品質(SF 36)問卷分變化的比較。 結果顯示在第12週，實驗組糖化血色素平均下降0.76 %，而對照組平均上升0.16%，兩組比較有統計之顯著差異(P<0.05)。血糖、肌酸酐、每天尿液白蛋白、蛋白質排泄量、晨起尿液白蛋白與尿液肌酸酐比值，兩組之比較均未達統計之顯著差異。病患於治療前後鉀離子、膽固醇、三酸甘油脂、肝功能並沒有常變化；臨床症狀方面，實驗組在疲倦乏力、浮腫的平均分數改善為0.66、0.27，而對照組平均分數改善0.14、0.03，兩組比較有統計之顯著差異(P<0.05)；病患生活品質(SF36) ，實驗組在生理功能、自覺健康、活力狀態、社交情況及心理健康方面分數之變化分別為6.8、16.9、5.5、5.0，而對照組分數之變化為-2.1、3.4、-4.8、-0.7，兩組比較有統計之顯著差異(P<0.05)。就腎陽虛型病患而言，在實驗組糖化血色素平均下降0.88 %而對照組糖化血色素上升0.20 %，兩組比較有統計之顯著差異(P<0.05)，而腎陽虛型病患在實驗組的臨床症狀方面如疲倦乏力、畏寒肢冷、浮腫平均分數的改善皆優於對照組，且兩組比較有統計之顯著差異(P<0.05)。 本研究結果顯示對糖尿病腎功能不全病人，依中醫辨證論治原則，排除熱症及陰虛火旺證型的病人，在接受西藥治療的情況下，服用濟生腎氣丸十二週能使糖化血色素值下降，且能改善臨床症狀及提升生活品質。濟生腎氣丸對於腎陽虛型病患效果尤佳。; Diabetes with chronic renal insufficiency has become the major cause of end-stage renal disease in Taiwan. The prevention and treatment of diabetes with chronic renal insufficiency are tight glycemic control, maintain blood pressure in the normal range, low salt and low protein diet and treat for hyperlipidemia. “Jis-heng Shen-gi Wan” is the famous Fang-Chi for treatment of Diabetes in Chinese medicine. Many clinical experiences and researches revealed that they are effective on Diabetic patients with chronic renal insufficiency and could improve the clinical discomfort symptoms, promoted the quality of life. We undertook a double blind, placebo-controlled study to evaluate the effect of “Jis-heng Shen-gi Wan” on diabetes with chronic renal insufficiency. All the patients fall into the category of heat pattern and yin vacuity fire effulgence were excluded according to identify patterns and determine treatment. A total of 44 type 2 diabetic patients with chronic renal insufficiency were enrolled in this study. They will be divided into two type kidney-yang-vacuity, non kidney-yang-vacuity and then randomly divided into 2 groups. There were 21 patients in the experimental group. Therapeutic measures are conventional western drugs and Jisheng Shengi Wan power 3 gm in pack thrice daily for twelve weeks. Another 23 patients in control group are treated with conventional western drugs and placebo. The main outcome was changes of laboratory parameter, clinical symptom score and quality life score (SF36 questionnaire). The results revealed that the HbA1c reduced 0.76 % in the experimental group and increased 0.16 % in the control group after 12 weeks of treatment .The differences of HbA1c between the two groups were statistically significiant. But the differences of blood sugar, creatinine, daily urinary albumin excretion, daily urinary protein secretion and the ratio of urinary albumin to urinary creatinine from the first morning specimen were not statistically significiant. Serum potassium, total cholesterol, triglyceride and liver fucntion test showed no abnormal change. For clinical symptoms, changes of fatigue & weakness and edema score improved statistically significiant in the experimental group (0.66、0.27 vs 0.14、0.13). For quality of life, changes of physical functioning, general health, vitality, social functioning and mental health were 6.8、16.8、5.5、5.0 in the experimental group and -2.1、3.4、-4.8、0.7 in the control group. The differences between the two group were statistically significiant. HbA1c reduced 0.78 % in the experimental kidney-yang-vacuity group and increased 0.20 % in the control kidney-Yang-Vacuity group. The differences are statistically significiant. Clinical symptoms as changes of fatigue & weakness, cold intolerance and edema score improved statistically significiant in the experimental kidney-Yang-Vacuity group than that of control kidney-Yang-Vacuity group. In conclusion, “Jis-heng Sh |
| 顯示於類別: | [中西醫結合研究所] 博碩士論文
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