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題 名 | 血府逐瘀湯對糖尿病周邊神經病變效用之研究:一個隨機、雙盲、安慰劑--對照組的臨床試驗=A Study of the Effects of Xie-Fu-Zhu-Yu-Tang on Diabetic Peripheral Neuropathy: A Randomized, Double Blind, Placebo-Controlled Clinical Trial |
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作 者 | 陳世爵; 謝慶良; 江東樺; 周思源; 李孟智; 賴金蓮; 江烈欽; 廖雅玲; | 書刊名 | 澄清醫護管理雜誌 |
卷 期 | 4:2 2008.04[民97.04] |
頁 次 | 頁38-51 |
分類號 | 414.52 |
關鍵詞 | 糖尿病周邊神經病變; 血府逐瘀湯; 神經傳導速度; 生活品質; Diabetic peripheral neuropathy; Xie-Fu-Zhu-Yu-Tang; Nerve conduction velocity; Quality of life; |
語 文 | 中文(Chinese) |
中文摘要 | 代謝異常和血管病變已被認為是引起糖尿病 周邊神經病變的主要因素,糖尿病周邊神經病變 屬於傳統中醫血瘀證的範園,血府逐瘀湯是活血 化瘀的代表方劑之一。因此本研究的目的是為了 探討血府逐瘀湯對糖尿病周邊神經病變的療效, 選擇86位糖尿病的忠者,他們的正中神經感覺和 運動、深排神經的運動,以及Mf腸神經的感覺神 經的最大傳導速度中,其中至少有一項低於正常 值下限的80%%以下,根據有無中醬辨證分成無 辨證組和氣血瘀阻型組。我們設計一個隨機、雙 育、placebo-controlled'十二星期的臨床試驗, 分別施于血府逐瘀湯、Gabapentin、methycobal 和Placebo(大麥楚)。療效評估是根據試驗前後 body mass index (BMI) 、空腹血糖(FBG) 糖化血色素(HbAIC)、Alanineaminotransferase (SGPT)、Creatinine (Cr)、Triglyceride (TG)、Total cholesterol (TC)、High density lipoprotein-cholesterol (HDL-C)、收縮血壓 (SBP)、舒張血壓(DBP)、神經傳導速度 (NCV)、神經症狀(手足麻木、手足無力、 疼痛、冰冷、頭暈眼花、全部症狀)、生活品質 量表(生理功能、身體疼痛、自覺健康、活力狀 態、社會功能、心理健康)。結果顯示血府進瘀 湯和Gabapentin相似,兩者都能改善糖尿病周邊 神經病變的正中神經感覺、運動和深Mf神經的運 動神經,和Mf腸神經的最大神經傳導速度。血府 逐瘀湯和Gabapentin兩者也能有改善手足麻木和 疼痛。血府逐瘀湯對生理功能和心理健康有改善 作用,Gabapentin則無,但兩者對於自覺健康和 活力狀態都有改善的作用。對於氣血瘀阻型糖尿 病周邊神經病變,血府進瘀湯和Gabapentin能改 善手足麻木,但對於手足無力、冰冷、疼痛、頭 暈眼花、全部症狀,兩者和Methycobal、Placebo 相似都沒有作用。血府逐瘀湯對自覺健康有改善 作用,但對生理功能、身體疼痛、活力狀態、社 會功能,以及心理健康則沒有作用。 結論是血府逐瘀湯能改善糖尿病周邊神經 病變的神經傳導速度、改善手足麻木和疼痛,以 及改善生活品質。又血府進瘀湯連續服用十二星 期,對血糖、血壓、肝、腎功能沒有影響,因此 我們認為血府逐瘀湯用來治療糖尿病的周邊神經 病變是有效而且安全的。糖尿病周邊神經病變在 本質上屬於血瘀,因此可用活血化瘀的藥物或方 劑來治療如血府逐瘀湯。 |
英文摘要 | It is believed that both metabolic and vascular factors contribute to development of peripheral neuropathy in diabetes.traditional Chinese Medicine believes that diabetic peripheral neuropathy involves blood stasis; Xie-Fu-Zhu-Yu-Tang (Xi) is one ofrepresentativeformulae used to quicken the blood and dispel such stasis. Therefore the aim of the present study and all investigate effects of Xi on diabetic peripheral neuropathy. A total of 86 diabetic patients were involved in the study and all patients had at least one maximal nerve conduction velocity in the right median nerve, deep peroneal nerve or sural nerve at <80% of the normal value We designed a randomized, double blind, placebo-controlled, 12 weeks clinical trial. Xi, Gabapentin (Ga), Methycobal (Me) and a control group consisting of powdered barley (Co) were administrated to the 4 various groups. The effect of the various treatments were measured by analyzing changes in body mass index (BMI)fasting blood sugar (FBS), glycosolated hemoglobin (HbAIC), GPT, Cretinine (Cr), Triglycerides (TG), total cholesterol (TC), high density lipoprotein-cholesterol (HDL-C), systolic blood pressure, diastolic blood pressure, nerve conduction velocity, nerve related symptoms including numbness of the hands or feet, weakness of hands or feet,pain cold sensations, dizziness and finally the overall effect of the symptoms on the patient's quality of life including physiological function, body pain, self health, activily social functionality and psychological health. The results indicated that the Xi,Ga, Me and Co groups sJωwed no significant changes in BMI, FBG, HbAIC, GPT, Cr, HDL-C, SBp, DBP. However, both Xi and Ga increased maximal nerve conduction velocity and improved the patients' symptoms in terms of numbness and pain. Xi also improved the patients' physiological and psychological health, but this did not occur with the Ga group. When diabetic peripheral neuropathy is considered in terms of the Qi-Blood stasis block pattern, both Xi and Ga improved numbness of hands and feet, but did not improve weakness of hands and feet pain cold sensations, body pain, dizziness, and overall symptoms, which were similar across all four groups. Nonetheless, Xi did improved self health, but did not improve physiological functioning body pain, activily social nctioning and psychological functioning. |
本系統中英文摘要資訊取自各篇刊載內容。