目的 观察消渴丸联合二甲双胍及胰岛素治疗2型糖尿病(T2DM)的效果及对患者血糖、血脂、氧化应激的影响。方法 前瞻性选取60例T2DM患者，根据随机数字表法将其分为观察组(采用消渴丸+胰岛素+二甲双胍治疗)和对照组(采用二甲双胍+胰岛素治疗)，各30例，均治疗12周。比较两组患者治疗前后的中医证候积分、血糖指标[空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)]、血脂指标[总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)]以及氧化应激指标[超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶(GSH-Px)、丙二醛(MDA)]水平，治疗效果，不良反应发生情况。结果 治疗后，两组患者口干多饮、多食易饥、小便频数、乏力倦怠、认知受损积分均显著低于治疗前，且观察组患者口干多饮、多食易饥、小便频数、乏力倦怠、认知受损积分分别为(0。61±0。17)、(0。54±0。18)、(0。40±0。28)、(0。59±0。14)、(0。54±0。12)分，低于对照组的(1。13±0。26)、(1。05±0。37)、(1。06±0。36)、(1。04±0。12)、(1。02±0。15)分(P<0。05)。治疗后，两组患者FBG、2 h PG、HbA1c均低于治疗前，且观察组患者FBG、2 h PG、HbA1c分别为(7。33±1。04)mmol/L、(9。15±1。56)mmol/L、(6。42±1。14)％，低于对照组的(8。26±1。02)mmol/L、(10。17±1。38)mmol/L、(7。26±1。09)％(P<0。05)。治疗后，两组患者TC、TG、LDL-C均低于治疗前，且观察组患者TC(3。66±1。03)mmol/L、TG(1。46±0。53)mmol/L、LDL-C(2。48±0。63)mmol/L低于对照组的(4。27±1。25)、(1。78±0。67)、(3。06±0。87)mmol/L;HDL-C高于治疗前，且观察组HDL-C(1。42±0。12)mmol/L高于对照组的(1。36±0。04)mmol/L(P<0。05)。治疗后，两组患者SOD与GSH-Px高于治疗前，且观察组SOD(88。43±16。84)U/ml、GSH-Px(31。01±4。03)U/ml明显高于对照组的(78。48±16。37)、(28。06±3。18)U/ml;MDA低于治疗前，且观察组MDA(7。17±2。16)μmol/L低于对照组的(8。42±2。64)μmol/L(P<0。05)。观察组总有效率为90。00％(27/30)，高于对照组的66。67％(20/30)(P<0。05)。两组患者在治疗过程中均未发生贫血、心率失调、低血糖等明显不良反应。结论 消渴丸联合二甲双胍及胰岛素治疗T2DM可有效改善患者中医证候，调节血糖、血脂，其机制可能与抑制氧化应激反应有关，临床疗效确切，且该治疗方案较为安全。
The effect of Xiaoke Pill combined with metformin and insulin in the treatment of type 2 diabetes mellitus and its impact on blood glucose,blood lipids and oxidative stress
Objective To observe the effect of Xiaoke Pill combined with metformin and insulin in the treatment of type 2 diabetes mellitus (T2DM) and its impact on blood glucose,blood lipids and oxidative stress.Methods A prospective study was conducted on 60 patients with T2DM were included in the study.They were divided into an observation group (treated with Xiaoke Pill combined with insulin and metformin) and a control group (treated with metformin and insulin) by random number table method,each consisting of 30 cases.All patients were given 12 weeks of treatment.Patients in both groups were compared in terms of traditional Chinese medicine syndrome score,blood glucose indicators[fasting blood glucose (FBG),2-h postprandial glucose (2 h PG) and glycated hemoglobin (HbA1c)],blood lipid indicators[total cholesterol (TC),triacylglycerol (TG),low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)]and oxidative stress indicators[superoxide dismutase (SOD),glutathione peroxidase (GSH-Px) and malondialdehyde (MDA)],therapeutic effect,and occurrence of adverse reactions.Results After treatment,the scores of dry mouth and polydipsia,hyperphagia and swift hungering,frequent urination,fatigue and cognitive impairment in both groups were significantly lower than those before treatment;in the observation group,the scores of dry mouth and polydipsia,hyperphagia and swift hungering,frequent urination,fatigue and cognitive impairment were (0.61±0.17),(0.54±0.18),(0.40±0.28),(0.59±0.14) and (0.54±0.12) points,which were lower than (1.13±0.26),(1.05±0.37),(1.06±0.36),(1.04±0.12) and (1.02±0.15) points in the control group (P<0.05).After treatment,FBG,2 h PG and HbA1c in both groups were lower than those before treatment;FBG,2 h PG and HbA1c were (7.33±1.04) mmol/L,(9.15±1.56) mmol/L and (6.42±1.14)％ in the observation group,which were lower than (8.26±1.02) mmol/L,(10.17±1.38) mmol/L and (7.26±1.09)％ in the control group (P<0.05).After treatment,TC,TG and LDL-C in both groups were lower than those before treatment,while HDL-C was higher than that before treatment;the observation group had TC of (3.66±1.03) mmol/L,TG of (1.46±0.53) mmol/L and LDL-C of (2.48±0.63) mmol/L,which were lower than (4.27±1.25),(1.78±0.67) and (3.06±0.87) mmol/L in the control group;HDL-C of (1.42±0.12) mmol/L in the observation group was higher than (1.36±0.04) mmol/L in the control group (P<0.05).After treatment,SOD and GSH-Px in both groups were higher than those before treatment,and MDA was lower than that before treatment;the observation group had SOD of (88.43±16.84) U/ml and GSH-Px of (31.01±4.03) U/ml,which were significantly higher than (78.48±16.37) and (28.06±3.18) U/ml in the control group;MDA of (7.17±2.16) μmol/L in the observation group was lower than (8.42±2.64) μmol/L in the control group (P<0.05).The total effective rate of 90.00％ (27/30) in the observation group was higher than 66.67％ (20/30) in the control group (P<0.05).No obvious adverse reactions such as anemia,heart rate disorder and hypoglycemia occurred in both groups during treatment.Conclusion Xiaoke Pill combined with metformin and insulin can effectively improve traditional Chinese medicine syndromes,and regulate blood glucose and blood lipids of patients with T2DM.The mechanism may be related to the inhibition of oxidative stress response,and this treatment plan is effective and relatively safe.
万方数据
维普
