糖尿康片聯(lián)合六仙飲治療消渴�。�2型糖尿�。怅巸商撟C的臨床研究
發(fā)布時間：2018-07-24 08:47
【摘要】：目的:本課題系統(tǒng)觀察糖尿康片聯(lián)合六仙飲治療2型糖尿病(T2DM)的有效性和安全性,通過治療前后對比,觀察糖尿康片聯(lián)合六仙飲治療T2DM的臨床療效,并對其相關(guān)指標做出客觀評價。為糖尿康片聯(lián)合六仙飲治療T2DM的推廣作初步臨床研究,為中醫(yī)藥在T2DM治療中的運用提供一種安全有效的方法。方法:抽取河南中醫(yī)藥大學(xué)附屬開封市中醫(yī)院龐國明教授工作室及糖尿病區(qū)符合入選標準的2型糖尿病患者60例,治療2個療程(6個月)。在保證合理飲食和堅持適當運動的基礎(chǔ)上,本課題采用自身對照研究的方法進行設(shè)計,進行糖尿康片聯(lián)合六仙飲治療前后的對比,比較治療前后3個月、6個月癥狀積分變化,空腹血糖(FPG),餐后2小時血糖(2hPG),胰島素抵抗指數(shù)(HOMA-IR),胰島素敏感指數(shù)(HOMA-IS),C-肽,糖化血紅蛋白(HbA1C)及血脂的改變,同時進行療效評價。結(jié)果:(1)將符合標準的60例患者納入組,其中男32例,占53.33%,女28例,占46.67%,平均年齡50.25±5.23歲,將兩組性別、年齡等一般資料進行檢驗,差異均無顯著性意義(P0.05),具有可比性。(2)治療前后空腹血糖平均達標天數(shù)為100.23±65.85,餐后2小時血糖平均達標天數(shù)為98.03±69.58;(3)總有效率:治療3月總有效率為83.3%,治療6月總有效率為95%;(4)中醫(yī)癥狀積分:治療3月較治療前下降,差異有統(tǒng)計學(xué)意義(P0.05);治療6月較治療前明顯下降,差異有顯著性統(tǒng)計學(xué)意義(P0.01);治療3月與治療6月組間比較,后者較前者下降更明顯,差異有顯著性統(tǒng)計學(xué)意義(P0.01)。(5)FPG:治療3月較治療前下降,差異有統(tǒng)計學(xué)意義(P0.05);治療6月較治療前明顯下降,差異有顯著性統(tǒng)計學(xué)意義(P0.01);治療3月與治療6月組間比較,后者較前者下降更明顯,差異有顯著性統(tǒng)計學(xué)意義(P0.01);2h PG:治療3月、治療6月較治療前均明顯下降,差異有顯著性意義(P0.01);治療3月與治療6月組間比較,后者較前者下降更明顯,差異有顯著性統(tǒng)計學(xué)意義(P0.01)。(6)HbA1c:治療3月較治療前下降,差異有統(tǒng)計學(xué)意義(P0.05);治療6月較治療前明顯下降,差異有顯著性統(tǒng)計學(xué)意義(P0.01);治療3月與治療6月組間比較,后者較前者下降更明顯,差異有顯著性統(tǒng)計學(xué)意義(P0.01);(7)HOMA-IR、HOMA-IS:治療3月較治療前均改善,差異有統(tǒng)計學(xué)意義(P0.05),治療6月較治療前均明顯改善,差異有顯著性統(tǒng)計學(xué)意義(P0.01);HOMA-IR:治療3月與治療6月組間比較,后者較前者下降更明顯,差異有顯著性統(tǒng)計學(xué)意義(P0.01);HOMA-IS:治療3月與治療6月組間比較,后者較前者下降明顯,差異有顯著性統(tǒng)計學(xué)意義(P0.05)。(8)TC、LDL-C:在調(diào)節(jié)TC、LDL-C方面,治療3個月后TC、LDL-C均可得到明顯改善,比較有顯著性差異(P0.01);在調(diào)節(jié)TG、HDL-C方面:治療后3個月與治療后6個月較治療前均得到改善,其中治療后6個月較治療后3個月改善明顯,比較有顯著性差異(P0.01);(9)安全性分析:治療組和對照組血、尿、糞常規(guī),肝、腎功能,心電圖指標變化無統(tǒng)計學(xué)意義(P0.05),在臨床治療過程中所有病人均未出現(xiàn)不良反應(yīng)和過敏現(xiàn)象。結(jié)論:①有效性:治療3個月總有效率為83.3%,治療6個月總有效率為95%,證實糖尿康片聯(lián)合六仙飲治療2型糖尿病確實有一定療效;②糖尿康片和六仙飲聯(lián)合可明顯降低患者FPG、2h PG、Hb A1C相關(guān)指標,調(diào)節(jié)脂代謝紊亂,并可有效改善其臨床癥狀,初步判定其與增強胰島素敏感性,降低胰高血糖素水平,改善胰島素抵抗,促進胰島素分泌等機理有關(guān);③量效關(guān)系::在7≤FPG8mmol/L:糖尿康片5片日三次口服;8≤FPG11mmol/L糖尿康片8片日三次口服,11≤FPG≤15mmol/L糖尿康片10片日三次口服能較好降低空腹及餐后2小時血糖,初步判定其有一定的臨床量效關(guān)系;④時效性:在6個月療程內(nèi),隨著時間延長療效越確切;⑤安全性:在治療過程中,未發(fā)現(xiàn)藥物明顯毒副作用,值得臨床進一步深入研究及作進一步推廣及應(yīng)用。
[Abstract]:Objective: to systematically observe the efficacy and safety of diabetes combined with Liu Xian Yin in the treatment of type 2 diabetes (T2DM), and to observe the clinical efficacy of diabetes combined with Liu Xian Decoction in the treatment of T2DM through comparison before and after treatment, and to make an objective evaluation of its related indexes. A preliminary clinical study on the promotion of the combination of diabetes Kang Tablet and Liu Xian Yin in the treatment of T2DM is made. To provide a safe and effective method for the use of traditional Chinese medicine in the treatment of T2DM. Methods: to extract 60 cases of type 2 diabetic patients in the hospital of traditional Chinese medicine, Kaifeng University of Chinese medicine, Henan and the diabetes area, which conform to the standard of admission, and treat 2 courses of treatment (6 months). On the basis of ensuring reasonable diet and insisting on proper exercise, The subjects were designed with the method of self-control study, and compared before and after the treatment of the diabetes combined with six Xian Yin, compared with the 3 months, 6 months after the treatment, fasting blood glucose (FPG), 2 hours postprandial blood glucose (2hPG), insulin resistance index (HOMA-IR), insulin sensitivity index (HOMA-IS), C- peptide, glycosylated hemoglobin (HbA1C), The results were as follows: (1) 60 patients were included in the group, including 32 men, 53.33%, 28 women, 46.67%, and the average age of 50.25 + 5.23 years. There was no significant difference between the two groups of sex and age (P0.05). (2) the average level of fasting blood glucose before and after treatment was reached. The number of standard days was 100.23 + 65.85, the average number of blood glucose in 2 hours after meal was 98.03 + 69.58; (3) total effective rate: the total effective rate in March was 83.3%, the total effective rate in June was 95%; (4) the TCM symptom integral: the treatment March was lower than before the treatment (P0.05); the treatment June was significantly lower than before the treatment, the difference has significant statistics. Learning significance (P0.01); compared with the June treatment group in March and the treatment group, the latter was more obvious than the former, and the difference had significant statistical significance (P0.01). (5) the difference was statistically significant (P0.05) in March compared with before the treatment (P0.05); the treatment in June was significantly lower than before the treatment (P0.01); the treatment between March and June treatment group was between the two groups. Compared with the former, the latter was more obvious than the former, and the difference had significant statistical significance (P0.01); the treatment of 2H PG: in March, the treatment June was significantly lower than before the treatment, the difference was significant (P0.01); the treatment of March and the treatment June group was more obvious than the former, the difference was significant statistically significant (P0.01). (6) HbA1c: treatment in March compared with treatment. Before treatment, the difference was statistically significant (P0.05); the treatment was significantly decreased in June compared with that before treatment (P0.01); the treatment between March and June group was more obvious than the former, and the difference was significant (P0.01); (7) HOMA-IR, HOMA-IS: was improved in March compared with before treatment, and the difference was statistically significant Significance (P0.05), the treatment was significantly improved in June than before the treatment, the difference was significant statistical significance (P0.01); HOMA-IR: treatment in March and the treatment of June group, the latter was more obvious than the former, the difference was significant statistical significance (P0.01); HOMA-IS: treatment in March and June group compared, the latter was significantly lower than the former, the difference was significant. Statistical significance (P0.05) (8) (8) TC, LDL-C: in the regulation of TC, LDL-C, 3 months after treatment, TC, LDL-C can be significantly improved, there is a significant difference (P0.01); in the regulation of TG, HDL-C: 3 months after treatment and 6 months after treatment were better than before the treatment, 6 months after treatment improved significantly compared with the 3 months after the treatment, more significant. Difference (P0.01); (9) safety analysis: there was no significant difference in blood, urine, fecal routine, liver, kidney function and electrocardiogram in the treatment group and the control group (P0.05). No adverse reactions and allergies were found in all patients during the clinical treatment. Conclusion: (1) the effectiveness: the total effective rate of treatment for 3 months was 83.3%, and the total effective rate was 95% for the treatment of 6 months. Solid diabetes combined with Liu Xian decoction has certain effect in the treatment of type 2 diabetes, and the combination of diabetic and six Xian Yin can obviously reduce the related indexes of FPG, 2h PG, Hb A1C, regulate the disorder of lipid metabolism, and can effectively improve the clinical symptoms, and preliminarily determine its sensitivity to the enhancement of insulin, the lowering of the glucagon level and the improvement of insulin. Anti -, promote insulin secretion and other mechanisms; (3) the dose effect relationship: three oral administration of 5 tablets on 7 < FPG8mmol/L: diabetic tablets; three oral administration of 8 tablets on 8 tablets of 8 < < < < < < < 15mmol/L >; 11 < < FPG < < 15mmol/L diabetes mellitus, three oral administration can lower the fasting and 2 hours postprandial blood glucose, and preliminarily determine that there is a certain clinical effect relationship. Timeliness: within 6 months of treatment, the more accurate the effect is prolonged with time; 5. Safety: in the course of treatment, no obvious toxic and side effects have been found. It is worth further in-depth study and further application.
【學(xué)位授予單位】：河南中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：R255.4
本文編號：2140843
[Abstract]:Objective: to systematically observe the efficacy and safety of diabetes combined with Liu Xian Yin in the treatment of type 2 diabetes (T2DM), and to observe the clinical efficacy of diabetes combined with Liu Xian Decoction in the treatment of T2DM through comparison before and after treatment, and to make an objective evaluation of its related indexes. A preliminary clinical study on the promotion of the combination of diabetes Kang Tablet and Liu Xian Yin in the treatment of T2DM is made. To provide a safe and effective method for the use of traditional Chinese medicine in the treatment of T2DM. Methods: to extract 60 cases of type 2 diabetic patients in the hospital of traditional Chinese medicine, Kaifeng University of Chinese medicine, Henan and the diabetes area, which conform to the standard of admission, and treat 2 courses of treatment (6 months). On the basis of ensuring reasonable diet and insisting on proper exercise, The subjects were designed with the method of self-control study, and compared before and after the treatment of the diabetes combined with six Xian Yin, compared with the 3 months, 6 months after the treatment, fasting blood glucose (FPG), 2 hours postprandial blood glucose (2hPG), insulin resistance index (HOMA-IR), insulin sensitivity index (HOMA-IS), C- peptide, glycosylated hemoglobin (HbA1C), The results were as follows: (1) 60 patients were included in the group, including 32 men, 53.33%, 28 women, 46.67%, and the average age of 50.25 + 5.23 years. There was no significant difference between the two groups of sex and age (P0.05). (2) the average level of fasting blood glucose before and after treatment was reached. The number of standard days was 100.23 + 65.85, the average number of blood glucose in 2 hours after meal was 98.03 + 69.58; (3) total effective rate: the total effective rate in March was 83.3%, the total effective rate in June was 95%; (4) the TCM symptom integral: the treatment March was lower than before the treatment (P0.05); the treatment June was significantly lower than before the treatment, the difference has significant statistics. Learning significance (P0.01); compared with the June treatment group in March and the treatment group, the latter was more obvious than the former, and the difference had significant statistical significance (P0.01). (5) the difference was statistically significant (P0.05) in March compared with before the treatment (P0.05); the treatment in June was significantly lower than before the treatment (P0.01); the treatment between March and June treatment group was between the two groups. Compared with the former, the latter was more obvious than the former, and the difference had significant statistical significance (P0.01); the treatment of 2H PG: in March, the treatment June was significantly lower than before the treatment, the difference was significant (P0.01); the treatment of March and the treatment June group was more obvious than the former, the difference was significant statistically significant (P0.01). (6) HbA1c: treatment in March compared with treatment. Before treatment, the difference was statistically significant (P0.05); the treatment was significantly decreased in June compared with that before treatment (P0.01); the treatment between March and June group was more obvious than the former, and the difference was significant (P0.01); (7) HOMA-IR, HOMA-IS: was improved in March compared with before treatment, and the difference was statistically significant Significance (P0.05), the treatment was significantly improved in June than before the treatment, the difference was significant statistical significance (P0.01); HOMA-IR: treatment in March and the treatment of June group, the latter was more obvious than the former, the difference was significant statistical significance (P0.01); HOMA-IS: treatment in March and June group compared, the latter was significantly lower than the former, the difference was significant. Statistical significance (P0.05) (8) (8) TC, LDL-C: in the regulation of TC, LDL-C, 3 months after treatment, TC, LDL-C can be significantly improved, there is a significant difference (P0.01); in the regulation of TG, HDL-C: 3 months after treatment and 6 months after treatment were better than before the treatment, 6 months after treatment improved significantly compared with the 3 months after the treatment, more significant. Difference (P0.01); (9) safety analysis: there was no significant difference in blood, urine, fecal routine, liver, kidney function and electrocardiogram in the treatment group and the control group (P0.05). No adverse reactions and allergies were found in all patients during the clinical treatment. Conclusion: (1) the effectiveness: the total effective rate of treatment for 3 months was 83.3%, and the total effective rate was 95% for the treatment of 6 months. Solid diabetes combined with Liu Xian decoction has certain effect in the treatment of type 2 diabetes, and the combination of diabetic and six Xian Yin can obviously reduce the related indexes of FPG, 2h PG, Hb A1C, regulate the disorder of lipid metabolism, and can effectively improve the clinical symptoms, and preliminarily determine its sensitivity to the enhancement of insulin, the lowering of the glucagon level and the improvement of insulin. Anti -, promote insulin secretion and other mechanisms; (3) the dose effect relationship: three oral administration of 5 tablets on 7 < FPG8mmol/L: diabetic tablets; three oral administration of 8 tablets on 8 tablets of 8 < < < < < < < 15mmol/L >; 11 < < FPG < < 15mmol/L diabetes mellitus, three oral administration can lower the fasting and 2 hours postprandial blood glucose, and preliminarily determine that there is a certain clinical effect relationship. Timeliness: within 6 months of treatment, the more accurate the effect is prolonged with time; 5. Safety: in the course of treatment, no obvious toxic and side effects have been found. It is worth further in-depth study and further application.
【學(xué)位授予單位】：河南中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：R255.4
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