归龙汤治疗老年糖尿病下肢血管病变临床研究

Clinical Study on the Treatment of Senile Diabetes Mellitus Patients with Lower Extremity Vascular Disease with Gui Long Tang

目的:观察归龙汤治疗老年糖尿病下肢血管病变患者的中远期疗效。方法:94例老年糖尿病下肢血管病变患者按随机数表法均分为观察组与对照组各47例。两组均采取严格饮食控制、运动治疗及常规给予胰岛素控制血糖等基础治疗。对照组口服西洛他唑片,每次50 mg,2次·d-1,连续治疗3个月。观察组在对照组治疗基础上给予归龙汤干预治疗,水煎服,每日1剂,1个月为1个疗程,连续治疗3个疗程。随访12个月,全部随访成功。比较两组临床疗效,记录治疗前及治疗3个月、6个月、12个月后血糖指标、凝血指标、踝动脉-肱动脉血压比值(ankle-branchial index,ABI),并观察不良反应发生率。结果:观察组有效率(93.62%)显著高于对照组(76.60%)(P<0.05)。两组治疗3个月、6个月、12个月后均较治疗前空腹血糖(fasting blood-glucose,FBG)、餐后2小时血糖(2-hour post-meal blood glucose,2h FBG)水平显著降低;且随时间延长,观察组FBG、2h FBG水平呈降低趋势(P<0.05)。观察组治疗后各时间点FBG、2h FBG水平均显著低于对照组(P<0.05)。两组治疗后各时间点凝血酶原时间(prothrombin time,PT)、部分凝血活酶时间(activated partial thromboplastin time,APTT)长于治疗前,D-二聚体(d-dimer,DD)、纤维蛋白原水平低于治疗前,且观察组随时间延长,PT、APTT呈升高趋势,DD、纤维蛋白原水平呈降低趋势(P<0.05)。观察组治疗后各时间点PT、APTT长于对照组,DD、纤维蛋白原水平低于对照组(P<0.05)。两组治疗后各时间点ABI均较治疗前明显升高,且观察组高于对照组(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:归龙汤治疗老年糖尿病下肢血管病变疗效较好,可控制患者血糖水平,改善血液高凝状态及ABI值,且无严重不良反应。

Objective： To investigate the long and medium term efficacy of Gui Long Tang in elderly patients with diabetes mellitus with lower extremity vascular disease. Methods： 94 cases of elderly patients with diabetic lower extremity vascular disease were randomly divided into observation group and control group of 47 cases. The two groups were strictly given diet control,exercise therapy and routine insulin to control blood sugar and other basic treatment. The control group was treated with Cilostazol tablets for 3 months,50 mg per time,twice a day. On the basis of the control group,the observation group was given the treatment of Gui Long Tang for 3 months,and the decoction was decocted 1 time a day. All patients were followed up for 12 months. The clinical effects of the two groups were compared. The indexes of blood glucose,blood coagulation indexes,ankle brachial artery blood pressure rati-o（ ABI） and the incidence of adverse reactions were recorded before and 3,6 and 12 months after treatment. Results： The effective rate of observation group was significantly higher than that of the control group（ P〈0. 05）. The levels of FBG and 2 hF BG in the two groups were significantly lower than those before treatment at 3,6 and 12 months,and the FBG and 2 hF BG levels decreased in the observation group as time went on（ P〈0. 05）. The average water level of FBG and 2 hF BG in the observation group was significantly lower than that in the control group at each time point（ P〈0. 05）. The PT and APTT of the two groups were longer than before treatment,and the levels of DD and FBG were lower than those before treatment. The observation group increased with time,and PT and APTT showed an upward trend（ P〈0. 05）. The levels of DD and FBG showed a downward trend（ P〈0. 05）. The PT and APTT of the observation group were longer than that of the control group at each time point after treatment（ P〈0. 05）. The levels of DD and FBG were lower than those of the control group（ P〈0. 05）. At each time point after treatment,ABI of the two group was significantly higher than that before treatment,and the observation group was higher than that of the control group（ P〈0. 05）. The incidence of adverse reactions in the two groups was not statistically significant（ P〈0. 05）. Conclusion： The effect of Gui Long Tang treatment of senile diabetes with lower extremity vascular disease is better,which can control the blood glucose level,improve the hypercoagulable state and ABI value,and there is no serious adverse reaction.