苁归益肾颗粒治疗2型糖尿病合并骨质疏松症患者的临床研究

发布时间：2018-07-29 07:52

【摘要】：目的通过临床观察苁归益肾颗粒治疗2型糖尿病合并骨质疏松症(肾虚血瘀型)患者的相关指标变化情况,客观评价苁归益肾颗粒临床治疗效果和药物安全性,为苁归益肾颗粒运用于临床治疗2型糖尿病合并骨质疏松症的推广提供有力依据。方法符合本研究疾病诊断标准、纳入标准的62例2型糖尿病合并骨质疏松症患者,采用随机、平行、对照的方法,按1:1的对照原则,随机分为治疗组31例和对照组31例。在饮食、运动和糖尿病常规降糖治疗的基础上,对照组予阿仑膦酸钠每周三1片(70mg),早晨空腹口服;治疗组在对照组的基础上加用苁归益肾颗粒,每日1剂,早晚各1次冲服。两组均治疗2个疗程(6个月)。监测患者的血、尿、粪及肝肾功能等常规指标;观察治疗前后两组患者的中医证候积分、空腹血糖(FPG)、餐后2h血糖(2h PBG)、糖化血红蛋白(Hb A1c)、空腹胰岛素(FINS)、餐后2小时胰岛素(2h PINS)、胰岛素抵抗指数(IRI),血清钙(Ca)、血清磷(P)、血清碱性磷酸酶(ALP)、雌二醇(E2)、睾酮(T)、各部位骨密度(BMD)、血清I型前胶原氨基端前肽(PINP)、血清I型胶原交联羧基末端肽(CTX-I)、血清抗酒石酸酸性磷酸酶(TRACP-5b),采用SPSS23.0对所得结果进行统计学分析,客观评价苁归益肾颗粒的临床疗效和药物安全性。结果1.临床研究结果表明,经2个疗程治疗后,治疗组疾病治疗总有效率达86.2%,对照组疾病治疗总有效率为64.3%,治疗组优于对照组,差异有统计学意义(P0.05)。2.两组相对治疗前的中医证候总积分均有所降低(P0.05或P0.01),且治疗组优于对照组(P0.01)。两组的症状和体征相比治疗前均有不同程度改善,治疗组临床症状改善总有效率是93.1%;对照组总有效率是72.4%。经统计学分析处理,治疗组神疲乏力、头晕耳鸣、自汗盗汗、夜尿频多症状较对照组有显著改善(P0.01);在腰背疼痛、腰膝酸软、口渴多饮、心烦失眠上,治疗组也较对照组改善明显,差异有统计学意义(P0.05)。3.治疗组FPG、2h PBG、Hb Alc水平均明显降低,较治疗前相比差异有统计学意义(P0.05或P0.01),且FINS、2h PINS均明显降低,IRI得到改善,较治疗前相比差异有统计学意义(P0.05或P0.01);组间比较,治疗组FPG、2h PBG、Hb Alc、FINS、2h PINS、IRI改善程度优于对照组(P0.05或P0.01)。4.两组患者腰椎L1-4、股骨颈、股骨大粗隆及Ward三角区骨密度值均较治疗前改善(P0.05或P0.01),且治疗组的改善幅度明显优于对照组(P0.05或P0.01)。5.治疗后两组对血清钙、血清磷、血清碱性磷酸酶有一定的改善作用,但与同组治疗前及组间比较均无统计学意义(P0.05)。6.治疗组患者血清PINP、血清CTX-I水平均较治疗前明显下降(P0.05);治疗组与对照组相比降低明显(P0.05)。两组患者血清TRACP-5b水平较治疗前均明显下降(P0.05或P0.01);组间比较,治疗组相比对照组降低显著(P0.01)。7.治疗组男性患者血清雌二醇虽有改善,但与同组治疗前及对照组比较无意义(P0.05);血清睾酮较治疗前升高(P0.05),且优于对照组(P0.01)。治疗组女性患者血清雌二醇较治疗前显著上升(P0.01),升高程度大于对照组(P0.01);血清睾酮较治疗前下降(P0.05);但较对照组差异无统计学意义(P0.05)。8.两组患者血常规、尿常规、粪常规、肝肾功能等检查指标均未见明显异常,未发现有过敏反应和严重的不良反应。结论通过本研究发现,运用苁归益肾颗粒治疗2型糖尿病合并骨质疏松症患者(肾虚血瘀型),可以明显改善中医临床症状,降低中医证候积分,控制血糖水平,改善胰岛素抵抗,提高骨密度,调节骨代谢。苁归益肾颗粒采用传统中药浓缩颗粒剂,具有服用方便的优点,并且无明显的不良反应和毒副作用,值得推广运用于治疗2型糖尿病合并骨质疏松症。
[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.
【学位授予单位】：安徽中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259

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