补肾健脾方治疗2型糖尿病合并骨质疏松症的临床观察  

Clinical Observation on Type 2 Diabetes Mellitus Complicated with Osteoporosis Treated by Bushen Jianpi Prescription

作　　者：李东玲 潘凯瑶 潘梓珊 刘峰 季兵 LI Dong-Ling;PAN Kai-Yao;PAN Zi-Shan;LIU Feng;JI Bing(Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China;The Third Affiliated Hospitol of Guangzhou University of Chinese Medicine,Guangzhou 510170 Guangdong,China;Guangdong Clifford Hospital,Guangzhou 511400 Guangdong,China)

机构地区：[1]广州中医药大学,广东广州510405 [2]广州中医药大学第三附属医院,广东广州510170 [3]广东祈福医院,广东广州511400

出　　处：《广州中医药大学学报》2023年第10期2465-2471,共7页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：广东省中医药局科研项目(编号:20231259);广州市卫健委资助项目(编号:20202A011031)。

摘　　要：【目的】探讨补肾健脾方治疗脾肾两虚型2型糖尿病合并骨质疏松症患者的临床疗效及其作用机制。【方法】将60例脾肾两虚型2型糖尿病合并骨质疏松症患者随机分为观察组和对照组,每组各30例。2组患者均给予糖尿病基础治疗,在此基础上,对照组给予碳酸钙D3口服治疗,观察组在对照组的基础上给予补肾健脾方治疗,疗程为12周。观察2组患者治疗前后血糖指标、骨转换指标以及生长激素(GH)、胰岛素样生长因子(IGF-1)及疼痛程度视觉模拟量表(VAS)评分的变化情况,并评价2组患者的中医证候疗效及安全性。【结果】(1)研究过程中,观察组无失访脱落病例,30例患者均完成全部疗程的治疗;对照组失访脱落1例,有29例患者完成全部疗程的治疗。(2)治疗12周后,观察组的总有效率为90.00%(27/30),对照组为55.17%(16/29),组间比较(χ2检验),观察组的中医证候疗效明显优于对照组(P<0.05)。(3)治疗后,2组患者的空腹血糖(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(Hb A1c)水平均较治疗前明显下降(P<0.05),且观察组对FPG、2hPG、HbA1c水平的下降作用均明显优于对照组(P<0.05)。(4)治疗后,2组患者血清骨钙素(OC)水平均较治疗前明显升高(P<0.05),血清β胶原降解产物(β-CTX)、总Ⅰ型胶原氨基端延长肽(PINP)、碱性磷酸酶(ALP)水平均较治疗前明显下降(P<0.05),且观察组对血清OC水平的升高作用及血清PINP、ALP水平的下降作用均明显优于对照组(P<0.05),而对血清β-CTX水平的下降作用有优于对照组趋势,但差异无统计意义(P>0.05)。(5)治疗后,2组患者血清GH、IGF-1水平均较治疗前明显升高(P<0.05),VAS评分均较治疗前明显下降(P<0.05),且观察组对血清GH、IGF-1水平的升高作用及对VAS评分的下降作用均明显优于对照组(P<0.05)。(6)治疗过程中,除对照组1例患者出现恶心欲呕(症状较轻,经对症治疗后好转,不影响研究进展)外,其余患Objective To investigate the clinical efficacy and therapeutic mechanism of Bushen Jianpi Prescription(mainly with the action of tonifying kidney and invigorating spleen)in the treatment of type 2 diabetes mellitus(T2DM)complicated with osteoporosis differentiated as the syndrome of deficiency of both spleen and kidney.Methods Sixty T2DM patients complicated with osteoporosis differentiated as the syndrome of deficiency of both spleen and kidney were randomly divided into the observation group and the control group,30 patients in each group.Both groups were given the basic treatment of diabetes mellitus.Additionally,the control group was given oral use of calcium carbonate D3 and the observation group was given Bushen Jianpi Prescription and calcium carbonate D3 orally.Both groups were treated for 12 weeks.The changes in blood glucose indicators,indicators of bone turnover,levels of growth hormone(GH)and insulin-like growth factor(ICF-1),and pain visual analogue scale(VAS)scores in the two groups were observed before and after treatment.After treatment,the traditional Chinese medicine(TCM)syndrome efficacy and clinical safety in the two groups were evaluated.Results(1)During the trial,there were no patients falling off in the observation group,and all of the 30 patients completed the whole course of treatment;there was one case falling off in the control group,and 29 patients completed the whole course of treatment.(2)After 12 weeks of treatment,the total effective rate of the observation group was 90.00%(27/30)and that of the control group was 55.17%(16/29).The intergroup(tested by chi-square test)comparison showed that the efficacy of the TCM syndromes in the observation group was significantly superior to that in the control group(P<0.05).(3)After treatment,the levels of fasting plasma glucose(FPG),2-hour postprandial blood glucose(2hPG)and glycosylated hemoglobin(HbAlc)in the two groups were significantly decreased compared with those before treatment(P<0.05),and the effect of the observation group on decreas

关 键 词：补肾健脾方 2型糖尿病 骨质疏松症 血糖 骨转换标志物 生长激素(GH) 胰岛素样生长因子(IGF-1) GH/IGF-1轴 

分 类 号：R259.872[医药卫生—中西医结合]