【作者】 李兴龙；

【导师】 王旭；

【作者基本信息】 南京中医药大学 ， 中医西医结合临床， 2013， 博士

【摘要】 目的：探讨中医学对老年糖尿病合并骨质疏松症的认识,采用补肾化瘀壮骨法治疗老年糖尿病合并骨质疏松症,客观评价补肾化瘀壮骨法对老年糖尿病合并骨质疏松症肾虚血瘀证患者的治疗效果,尤其是对临床症状、血清钙、磷、性激素水平、骨密度测定、细胞因子等方面所产生的影响,并评价其安全性,为临床应用提供客观依据。方法：采用随机、对照的研究方法,将符合老年糖尿病合并骨质疏松症的患者50例,按1：1对照原则,随机分为对照组和治疗组。在基础治疗和西药常规降糖治疗的基础上,对照组给予钙尔奇D片600mg,每日1次；治疗组给予补肾化瘀壮骨方中药水煎剂,每日1剂,分早晚两次服用。以4周为1个疗程,观察3个疗程。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测血糖、糖化血红蛋白,骨密度、血清钙、磷,雌二醇、睾酮,白介素-6等指标。全部数据以SPSS16.0统计软件进行统计学分析。结果：治疗前两组的性别、年龄、病程等基线数据经统计学处理无显着性差异,有可比性(P>0.05)。①对症状体征的改善作用：治疗组患者治疗后中医证候有明显改善,且治疗组改善情况明显优于对照组,有显著性差异(P<0.01)。②降糖效果：治疗后两组患者空腹血糖、餐后血糖均明显降低,与治疗前比较均有显着性差异(P<0.01)；组间比较治疗组空腹血糖改善较对照组有显著性差异(P<0.01),治疗组餐后血糖、糖化血红蛋白改善较对照组有差异(P<0.05)。③改善骨密度(BMD)：治疗后治疗组患者BMD均明显升高,较治疗前有显著性差异(P<0.01)；对照组较治疗前无明显差异(P>0.05)。组间比较治疗组BMD的改善较对照组有差异(P<0.05)。④对血钙、血磷的影响：治疗前两组血钙、血磷比较,无明显差异(P>0.05),具有可比性。治疗后两组患者血钙均有所升高,但差异无统计学意义(P>0.05)；治疗后两组患者血磷均有所降低,但差异无统计学意义(P>0.05)；治疗组血钙、血磷的变化较对照组无显著性差异(P>0.05)。⑤性激素水平：治疗后治疗组男性患者雌二醇(E2)水平下降,雄激素(T)水平升高,较治疗前有显著性差异(P<0.01)。组间比较,治疗组E2水平改善较对照组有差异(P<0.05)；治疗组T水平升高较对照组无差异(P>0.05)。治疗后治疗组女性患者E2水平升高,T水平降低,较治疗前均有显著性差异(P<0.01)。组间比较,治疗组E2水平升高较对照组有差异(P<0.05),T水平降低较对照组无显著性差异(P>0.05)。⑥对白介素-6(IL-6)的影响：治疗后治疗组患者IL-6较治疗前改善有显著性差异(P<0.01)；组间比较治疗组IL-6改善较对照组有差异(P<0.05)。⑦安全性指标：治疗组患者血、尿、粪常规及肝肾功能检查均在正常范围。两组均未见不良反应。结论：从初步临床研究来看,补肾化瘀壮骨法治疗2型糖尿病骨质疏松症肾虚血瘀证,可明显改善患者的临床症状；在西医学指标方面,可以降低血糖、糖化血红蛋白,改善骨密度,调节性激素水平,且无肝肾功能损害,治疗本病安全、有效,有广泛的应用前景。但由于本人为境外学生,能力和条件限制,本研究病例数相对较少,今后需进一步深入研究。更多还原

【Abstract】 Purpose:To discuss the understanding of Traditional Chinese Medicine about type-2diabetes with osteoporosis, using the therapy of renal-vital-reinforce and bone-vital-strong prescription to treat type-2diabetes with osteoporosis.To observe the therapeutic efficacy of this prescription in treating type-2diabetes with osteoporosis liver-kidney deficiency symptoms by the indexes such as clinical symptoms,hormones,cytokines,bone mineral density.Then evaluate its curative effect and safety, so as to guide its clinical applicationMethods:A randomized,controlled trial was conducted.The patients of type-2diabetes with osteoporosis were randomly classified into two groups according to1:1paired matched.On the basic of normal treatment and western medicine, the patients of treated group were treated by Chinese medicine while the patients of controlled group were treated by Calcium Carbonate and Vitamin D3chewable tablets, observing for3month and four weeks made up of a course of treatment.The observed indexes included curative effect indexes,such as clinical symptoms, blood glucose,HbAlc,serum Calcium and Phosphate, Estradiol, Testosterone, IL-6, urinary calcium, BMD and so on.The complete data carries on statistics analysis by the SPSS16.0statistics software.Results:The study included type-2diabetic patients with50cases.25cases of treated group, while25cases of controlled group. Prior treatment,the gender, age, course of disease of the two groups patients had no differeces.1. Symptoms and signs improvement:the treated group after treatment had a significant improvement. The symptoms improvement of the treated group was better than the controlled group (P<0.01).2.Blood glucose:The FBG, PBG of treated group and controlled group were significantly lower(P<0.01); After treatment, the FBG of the treated group had a significant difference than controlled group(P<0.01).The PBG of treated group also had a significant difference than controlled group (P<0.05), The HbAlc of treated group also had a significant difference than controlled group (P<0.05).3. Bone mineral density:After treatment,the BMD of the treated group were significantly higher than controlled group(P <0.01).while the controlled group had no statistically significance(P>0.05).The BMD of the treated group had a significant difference than controlled group(P<0.05).4.Calcium and Phosphate:Serum calcium of the two groups were higher, but had no statistically significance(P>0.05).Serum phosphate of the two groups were lower, but had no statistically significance difference.Serum calcium and phosphate of the controlled group had no statistically significance difference(P>0.05).5.Hormone:In the male sufferer,after treatment,the E2of the treated group was visibly lower, had a significantly difference than controlled group(P<0.05), the T of the treated group was visibly higher, had a significantly difference than controlled group(P<0.01).The improvement of E2of the treated group had a significant difference than controlled group(P<0.05).the improvement of T of the treated group was better than the controlled group, but had no statistically significance difference(P>0.05).In the female sufferer, the E2of the treated group was visibly higher(P＜0.01), the T was visibly lower(P<0.01).The improvement of E2of the treated group was better than the controlled group(P<0.05), the improvement of T of the treated group was better than the controlled group, but had no statistically significance difference(P>0.05).6.IL-6:The IL-6of the treated group were also significantly improved(P<0.01), and had a significant difference than controlled group(P <0.05).7.Safety index:The routine blood/urine/feces test, and the liver and kidney function tests of treated group were within the normal range. Both groups had no unhealthy response.Conclusion:Through the preliminary clinical study, Bone-vital-strong prescription has obvious curative effected in treating type-2diabetes with osteoporosis liver-kidney deficiency symptoms. From the angle of western medicine, it can reduced blood sugar and HbAlc, improve BMD, decrease the excretion of urinary calcium, and adjust hormone.And, most importantly,be safe and effective.lt is worth studying deeply and developing further.Remarkable results have been achieved by bone-vital-strong prescription that reducing blood and improved BMD.But because of my ability and conditions limited as an overseas student, there were small number of cases and simple observational items in this study. And further investigations is required.更多还原