摘要
目的：探讨中医学对肥胖2型糖尿病的认识,采用开郁清胃化瘀法治疗肥胖2型糖尿病肝胃郁热夹瘀证。通过随机对照临床试验,观察开郁清胃化瘀法对肥胖2型糖尿病肝胃郁热夹瘀证的治疗效果,探讨其防治本病的机理。
方法：采用随机对照的研究方法,将符合肥胖2型糖尿病肝胃郁热夹瘀证诊断标准的患者60例,随机分为治疗组和对照组各30例。在生活方式干预和西药常规治疗的基础上,治疗组加用中药。3个月为一个疗程。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测肥胖相关指标、血糖、糖化血红蛋白、胰岛素、胰岛素抵抗指数、胰岛β细胞功能指数、血脂、血液流变学等指标,以及安全性指标。全部数据以SPSS15.0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著性差异,有可比性(P>0.05)。①对中医证候的改善作用：治疗组患者治疗后中医证候有明显改善,总有效率为93.33%,证候积分由治疗前20.77±3.43降至治疗后8.73±2.75；对照组总有效率50.00%,证候积分由治疗前20.174±2.29降至治疗后12.67±2.58。治疗组中医症状改善情况明显优于对照组(P<0.01)。②降糖效果：治疗后两组患者空腹血糖、餐后血糖、糖化血红蛋白均明显降低,与治疗前比较均有显著性差异(P<0.01)；治疗组治疗后空腹血糖、餐后血糖、糖化血红蛋白改善较对照组有显著差异(P<0.01)。③肥胖相关指标：治疗后治疗组患者体重、BMI、腰围、臀围、腰臀比均有所降低,与治疗前比较均有显著性差异(P<0.01)；治疗后对照组患者体重、腰围、腰臀比有所降低,与治疗前比较均有显著性差异(P<0.01),治疗后对照组在BMI上有差异(P<0.05),治疗后对照组在臀围方面无明显差异(P>0.05),治疗后治疗组与对照组体重、BMI、腰围、腰臀比比较差异显著(P<0.01),在臀围上无明显差异(P>0.05)。④胰岛素相关指标：治疗后两组患者空腹胰岛素、HOMA2-IR均有所降低,治疗后两组患者HOMA2-%B指数有所升高,与治疗前比较均有显著性差异(P<0.01)；治疗组空腹胰岛素、HOMA2-IR及HOMA2-%B的改善较对照组均有显著性差异(P<0.01)。⑤调脂效果：治疗组患者治疗后TG、TC、LDL-C水平下降,HDL-C水平升高,与治疗前比较有显著性差异(P<0.01)；对照组患者治疗后TG、TC、LDL-C水平下降,HDL-C水平升高,与治疗前比较有差异(P<0.05)。组间比较治疗组TG、TC、HDL-C、LDL-C水平改善均较对照组具有显著性差异(P<0.01)。⑥血液流变学：治疗组治疗后全血粘度(高切、中切、低切5/s、低切1/s)、血浆粘度较治疗前均下降,有显著性差异(P<0.01),对照组全血粘度(低切5/s)和血浆粘度较治疗前下降,有显著性差异(P<0.01),全血粘度(高切、中切、低切1/s)较治疗前下降,有差异(P<0.05)。组间比较治疗组全血粘度(高切、中切、低切5/s、低切1/s)、血浆粘度的改善均显著性较对照组有差异(P<0.01)。⑦安全性指标：肝。肾功能检查均在正常范围。两组均未见严重的不良反应。
结论：从初步临床研究来看,开郁清胃化瘀法结合二甲双胍治疗效果优十单纯西药治疗,中药治疗既可改善肥胖2型糖尿病患者的临床症状,改善肥胖相关指标,降低血糖、糖化血红蛋白,降低胰岛素,增加胰岛素敏感性,改善胰岛素抵抗,调节血脂,还能改善血液流变学指标,且安全、有效,具有广泛的应用前景,值得进一步深入研究。
Purpose:To discuss the understanding of traditional Chinese medicine about obese type2diabetes mellitus by using prescription of expelling stagnation clearing stomach、eliminating blood stasis. To observe the therapeutic efficacy of this method in treating the syndrome of stagnated heat of liver and stomach with blood stasis of obese T2DM and to investigate the mechanism of this method.
Methods:A randomized, controlled trial was conducted.60patients with the syndrome of stagnated heat of liver and stomach with blood stasis of obese T2DM were randomly classified into two groups. Besides the intervention of living behavior and western medicine, the patients of the treatment group (n=30) were treated by Chinese medicine whlie the patients of control group (n=30) were not. Three months was a course of treatment. The observed indexes included both change in the clinical symptoms and signs, index about obesity, FBG, PBG, HbAlC, HOMA2-IR, HOMA2-%B, blood-fat, hemorheology and safety indexes. All data were analyzed by the SPSS15.0statistics software.
Results:Before treatment, the gender, age, course of disease of the two groups had no differeces.①The total curative effect of treatment group was93.33%, the score of TCM symptom were decreased from20.77±3.43to8.73±2.75; while total curative effect of control group was50,00%, the score of TCM symptom were decreased from20.17±2.29to12.67±2.58. The treatment group gained an advantage over the control group (P<0.05).②The FBG, PBG, HbA1C of the two groups were decreased, compared with pre-treatment there is statistically significant (P<0.01). And the treatment group had an advantage over the control group(P<0.01).③The weight, BMI, WC, HC, WHR of treatment group were decreased, compared with pre-treatment there is statistically significant (P<0.01). The weight, WC, WHR of control group were decreased, compared with pre-treatment there is a remarkable statistically significant (P<0.01). The descent of BMI in control group had a statistically significant compared with pre-treatment(P<0.05) while HC did not(P>0.05). The treatment group had an advantage over the control group in weight, BMI, WC, WHR(P<0.01). The HC of the two groups after treatment had no obvious difference (P>0.05).④The FINS, HOMA2-IR of the two groups were both decreased, the HOMA2-%B of them were elevated, compared with pre-treatment there is statistically significant (P<0.01). And the treatment group had an advantage over the control group(P<0.01).⑤The TG, TC, LDL-C of the treatment group were decreased, the HDL-C of them were elevated, compared with pre-treatment there is a remarkable statistically significant (P<0.01). The TG, TC, LDL-C of the control group were decreased, the HDL-C of them were elevated, compared with pre-treatment there is a statistically significant (P<0.05).And the treatment group had an advantage over the control group(P<0.01).⑥Hemorheology:After treatment, the WHole blood viscosity (highly cuts, middle cuts, lowly cuts5/s, lowly cuts1/s), the blood plasma viscosity of the treatment group decreased, compared with pre-treatment there is a remarkable statistically significant (P<0.01). the WHole blood viscosity (highly cuts, middle cuts, lowly cuts5/s, lowly cuts1/s), the blood plasma viscosity of the control group dropped, compared with pre-treatment there is a remarkable statistically significant in blood viscosity (lowly cuts5/s), the blood plasma viscosity (P<0.01) and a statistically significant in blood viscosity (highly cuts, middle cuts, lowly cuts1/s)(P<0.05). Compared between the two groups, the treated one was better than the other (P<0.01).⑦Safety indicators:Liver and kidney function tests were in the normal range. Both groups were no severe adverse reactions.
Conclusion:From the preliminary clinical research, the prescription of expelling stagnation, clearing stomach, eliminating blood stasis combined with metformin can not only improve the clinical symptoms, but also can reduce weight, blood glucose, insulin resistance, lipid, viscosity of blood plasma. It is safe and effective has a broad prospect of application. It is worth studying deeply and developing further.
引文
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