發(fā)布時(shí)間：2018-07-29 07:52

【摘要】：目的通過(guò)臨床觀察蓯歸益腎顆粒治療2型糖尿病合并骨質(zhì)疏松癥(腎虛血瘀型)患者的相關(guān)指標(biāo)變化情況,客觀評(píng)價(jià)蓯歸益腎顆粒臨床治療效果和藥物安全性,為蓯歸益腎顆粒運(yùn)用于臨床治療2型糖尿病合并骨質(zhì)疏松癥的推廣提供有力依據(jù)。方法符合本研究疾病診斷標(biāo)準(zhǔn)、納入標(biāo)準(zhǔn)的62例2型糖尿病合并骨質(zhì)疏松癥患者,采用隨機(jī)、平行、對(duì)照的方法,按1:1的對(duì)照原則,隨機(jī)分為治療組31例和對(duì)照組31例。在飲食、運(yùn)動(dòng)和糖尿病常規(guī)降糖治療的基礎(chǔ)上,對(duì)照組予阿侖膦酸鈉每周三1片(70mg),早晨空腹口服;治療組在對(duì)照組的基礎(chǔ)上加用蓯歸益腎顆粒,每日1劑,早晚各1次沖服。兩組均治療2個(gè)療程(6個(gè)月)。監(jiān)測(cè)患者的血、尿、糞及肝腎功能等常規(guī)指標(biāo);觀察治療前后兩組患者的中醫(yī)證候積分、空腹血糖(FPG)、餐后2h血糖(2h PBG)、糖化血紅蛋白(Hb A1c)、空腹胰島素(FINS)、餐后2小時(shí)胰島素(2h PINS)、胰島素抵抗指數(shù)(IRI),血清鈣(Ca)、血清磷(P)、血清堿性磷酸酶(ALP)、雌二醇(E2)、睪酮(T)、各部位骨密度(BMD)、血清I型前膠原氨基端前肽(PINP)、血清I型膠原交聯(lián)羧基末端肽(CTX-I)、血清抗酒石酸酸性磷酸酶(TRACP-5b),采用SPSS23.0對(duì)所得結(jié)果進(jìn)行統(tǒng)計(jì)學(xué)分析,客觀評(píng)價(jià)蓯歸益腎顆粒的臨床療效和藥物安全性。結(jié)果1.臨床研究結(jié)果表明,經(jīng)2個(gè)療程治療后,治療組疾病治療總有效率達(dá)86.2%,對(duì)照組疾病治療總有效率為64.3%,治療組優(yōu)于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。2.兩組相對(duì)治療前的中醫(yī)證候總積分均有所降低(P0.05或P0.01),且治療組優(yōu)于對(duì)照組(P0.01)。兩組的癥狀和體征相比治療前均有不同程度改善,治療組臨床癥狀改善總有效率是93.1%;對(duì)照組總有效率是72.4%。經(jīng)統(tǒng)計(jì)學(xué)分析處理,治療組神疲乏力、頭暈耳鳴、自汗盜汗、夜尿頻多癥狀較對(duì)照組有顯著改善(P0.01);在腰背疼痛、腰膝酸軟、口渴多飲、心煩失眠上,治療組也較對(duì)照組改善明顯,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。3.治療組FPG、2h PBG、Hb Alc水平均明顯降低,較治療前相比差異有統(tǒng)計(jì)學(xué)意義(P0.05或P0.01),且FINS、2h PINS均明顯降低,IRI得到改善,較治療前相比差異有統(tǒng)計(jì)學(xué)意義(P0.05或P0.01);組間比較,治療組FPG、2h PBG、Hb Alc、FINS、2h PINS、IRI改善程度優(yōu)于對(duì)照組(P0.05或P0.01)。4.兩組患者腰椎L1-4、股骨頸、股骨大粗隆及Ward三角區(qū)骨密度值均較治療前改善(P0.05或P0.01),且治療組的改善幅度明顯優(yōu)于對(duì)照組(P0.05或P0.01)。5.治療后兩組對(duì)血清鈣、血清磷、血清堿性磷酸酶有一定的改善作用,但與同組治療前及組間比較均無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。6.治療組患者血清PINP、血清CTX-I水平均較治療前明顯下降(P0.05);治療組與對(duì)照組相比降低明顯(P0.05)。兩組患者血清TRACP-5b水平較治療前均明顯下降(P0.05或P0.01);組間比較,治療組相比對(duì)照組降低顯著(P0.01)。7.治療組男性患者血清雌二醇雖有改善,但與同組治療前及對(duì)照組比較無(wú)意義(P0.05);血清睪酮較治療前升高(P0.05),且優(yōu)于對(duì)照組(P0.01)。治療組女性患者血清雌二醇較治療前顯著上升(P0.01),升高程度大于對(duì)照組(P0.01);血清睪酮較治療前下降(P0.05);但較對(duì)照組差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。8.兩組患者血常規(guī)、尿常規(guī)、糞常規(guī)、肝腎功能等檢查指標(biāo)均未見(jiàn)明顯異常,未發(fā)現(xiàn)有過(guò)敏反應(yīng)和嚴(yán)重的不良反應(yīng)。結(jié)論通過(guò)本研究發(fā)現(xiàn),運(yùn)用蓯歸益腎顆粒治療2型糖尿病合并骨質(zhì)疏松癥患者(腎虛血瘀型),可以明顯改善中醫(yī)臨床癥狀,降低中醫(yī)證候積分,控制血糖水平,改善胰島素抵抗,提高骨密度,調(diào)節(jié)骨代謝。蓯歸益腎顆粒采用傳統(tǒng)中藥濃縮顆粒劑,具有服用方便的優(yōu)點(diǎn),并且無(wú)明顯的不良反應(yīng)和毒副作用,值得推廣運(yùn)用于治療2型糖尿病合并骨質(zhì)疏松癥。
[Abstract]:Objective to evaluate the clinical therapeutic effect and drug safety of Cistanche GUI Yishi granules by clinical observation of Cistanche GUI Yishen granules in patients with type 2 diabetes combined with osteoporosis (kidney deficiency and blood stasis), and to provide a powerful way for the application of Cistanche GUI Yishen granules in the promotion of clinical treatment of type 2 diabetes and osteoporosis. Methods 62 patients with type 2 diabetes combined with osteoporosis were randomly, parallel and controlled, according to the control principle of 1:1, randomly divided into 31 cases of treatment group and 31 cases of control group. On the basis of diet, exercise and diabetic regular glucose treatment, the control group was given alendronate sodium per group. 1 tablets (70mg) on Wednesday were taken orally on empty stomach in the morning; the treatment group was added with cistanche to Yishen granules on the basis of the control group, 1 doses per day and 1 times in every morning and evening. The two groups were treated for 2 courses (6 months). The blood, urine, feces and liver and kidney function of the patients were monitored. The TCM syndrome score, fasting blood glucose (FPG), and postprandial 2H blood in two groups of patients were observed. 2H PBG, glycosylated hemoglobin (Hb A1c), fasting insulin (FINS), 2 hour post meal insulin (2H PINS), insulin resistance index (IRI), serum calcium (Ca), serum phosphorus (P), serum alkaline phosphatase (ALP), estradiol (E2), testosterone, bone mineral density in various parts, serum procollagen amino end propeptide, serum collagen crosslinked carboxyl terminus Peptide (CTX-I), serum anti tartaric acid phosphatase (TRACP-5b), the results of SPSS23.0 were statistically analyzed, and the clinical efficacy and drug safety of Cistanche GUI Yishi granules were evaluated objectively. Results 1. clinical results showed that after 2 courses of treatment, the total effective rate of treatment group was 86.2%, and the control group was always effective for disease treatment. The rate of 64.3%, the treatment group was better than the control group, the difference was statistically significant (P0.05).2. two groups before the relative treatment of TCM syndrome total scores were reduced (P0.05 or P0.01), and the treatment group was better than the control group (P0.01). The symptoms and signs of the two groups were improved before treatment, and the total effective rate of clinical symptoms in the treatment group was 93.1%; The total effective rate of the group was 72.4%. by statistical analysis. The treatment group was tired, dizziness, tinnitus, sweating and sweating, and the frequency of night urination was better than the control group (P0.01); in the waist and back pain, the waist and the knees were soft, the thirst and the drink and the insomnia, the treatment group was also better than the control group, the difference was statistically significant (P0.05) FPG, 2h P in the.3. treatment group. BG, Hb Alc level decreased significantly, compared with before treatment (P0.05 or P0.01), and FINS, 2h PINS decreased significantly, IRI improved, compared with before treatment (P0.05 or P0.01). The BMD values of lumbar L1-4, femoral neck, femur great trochanter and Ward triangle were better than before treatment (P0.05 or P0.01), and the improvement of the treatment group was significantly better than that of the control group (P0.05 or P0.01).5. treatment. The two groups had a certain improvement on serum calcium, serum phosphorus and serum alkaline phosphatase, but compared with the same group before and between the groups. No statistically significant (P0.05).6. treatment group patients' serum PINP, serum CTX-I level was significantly lower than before the treatment (P0.05), the treatment group was significantly lower than the control group (P0.05). The serum TRACP-5b level in the two groups was significantly lower than before the treatment (P0.05 or P0.01); compared with the control group, the treatment group was significantly lower than the control group (P0.01).7. treatment group male. Although the serum estradiol was improved, the serum estradiol in the same group was not significant (P0.05), the serum testosterone was higher than that before the treatment (P0.05) and was better than that of the control group (P0.01). The serum estradiol in the treatment group was significantly higher than that before the treatment (P0.01), and the level of serum testosterone was higher than that of the control group (P0.01), and the serum testosterone was lower than that before the treatment (P0.05). But there was no significant difference between the control group and the control group (P0.05).8. two group of patients with blood routine, urine routine, fecal routine, liver and kidney function, no obvious abnormal abnormalities, no allergic reactions and serious adverse reactions were found. Conclusion through this study, the use of Cistanche GUI Yishi granule in the treatment of type 2 diabetes with osteoporosis patients (kidney deficiency blood) The blood stasis type) can obviously improve the clinical symptoms of TCM, reduce the score of TCM syndrome, control the level of blood sugar, improve the insulin resistance, improve the bone mineral density and regulate the bone metabolism. The Cistanche GUI Yishi granule has the advantages of using traditional Chinese medicine to concentrate the granules, and has no obvious adverse reactions and side effects. It is worth popularizing in the treatment of 2. Type 2 diabetes combined with osteoporosis.
【學(xué)位授予單位】：安徽中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R259

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