五苓散治疗代谢综合征的理论和临床研究
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摘要
[目的]观察五苓散治疗代谢综合征的临床疗效,并探讨其部分作用机制。
     [方法]将纳入符合诊断标准的80例患者,随机分为治疗组40人,对照组40人,对照组采取以健康生活方式为基础的初级干预措施和以控制血糖、血压、血脂为基础的二级干预措施,治疗组在对照组基础上加以五苓散口服,12周为一疗程;观察并比较用药前后所有患者的中医证候、腰围、体重、体重指数、血压、血脂、血糖、胰岛功能、血清炎症指标(超敏C反应蛋白、白介素-6、肿瘤坏死因子-a)、脂肪细胞因子(脂联素、瘦素)、血管内皮功能(一氧化氮、内皮素、肱动脉血流介导的舒张内径)和毒副反应。
     [结果]改善中医证候方面,治疗组显效14例,有效20例,无效6例,总有效率85%;对照组显效11例,有效19例,无效10例,总有效率75%;治疗组在显效率、总有效率方面优于优于对照组(P<0.05或P<0.01)。降低腰围、体重、体重指数方面,两组组内比较,差异均有统计学意义(P<0.01或P<0.05);治疗组腰围、体重、体重指数下降程度分别为(8.65±4.82)cm、(7.46±4.72)kg、(4.39±1.87),与对照组腰围、体重、体重指数下降程度(分别为(7.93±0.81)cm、(6.29±2.88)kg、(3.19±2.48))相比,差异具有统计学意义(P均<0.01)。改善收缩压、舒张压方面,治疗组组内比较,差异有统计学意义(P<0.01),对照组组内比较,治疗前后无显著性差异(P>0.05)。降低血脂方面,两组均能明显降低TC、LDL-C水平,治疗前后比较,差异有统计学意义(P<0.01);治疗组治疗后HDL-C明显上升(P<0.01),对照组较治疗前未见明显改变(P=0.079),两组治疗后HDL-C水平比较,治疗组优于对照组,差异有统计学意义(P<0.01)。控制血糖方面,两组患者治疗后FBG、PG0.5h、PG1h, PG2h、PG3h, HbA1c的水平均显著降低,较组内治疗前水平比较,差异有统计学意义(P<0.01);其中治疗组降低FBG和PG0.5h的效果优于对照组(P<0.05)。改善胰岛素分泌水平方面,治疗组治疗后INS0.5h、INS2h水平减低,REISI水平升高,FINS、INS1h、INS3h、 HBCI、MBCI、REISI水平明显下降,与治疗前比较,差异均具有统计学意义(P<0.05、P<0.01);与治疗前比较,对照组患者INS0.5h、HBCI水平有所减低,/△I30/△G30值有所升高,差异具有统计学意义(P<0.05),FINS、INS1h、INS2h、INS3h、MBCI水平明显下降,差异有统计学意义(P<0.01);与对照组比较,治疗组在降低FINS、 MBCI水平方面疗效更显著,差异有统计学差异(P<0.05);同时,治疗组可升高REISI水平,而对照组REISI水平无明显变化,两组治疗后REISI水平比较,P<0.01。改善炎症指标方面,治疗后两组的IL-6、TNF-α和hs-CRP水平均较治疗前下降,三项指标治疗前后比较,差异均具有统计学意义(P<0.05);与对照组比较,治疗组IL-6、TNF-α和hs-CRP下降水平较更为显著,治疗组优于对照组(P<0.05)。改善脂肪细胞因子方面,两组治疗后LEP较治疗前均有显著降低,差异有统计学意义(P<0.01);治疗后,治疗组LEP下降水平较对照组LEP下降水平更明显,二者比较有显著性差异,P<0.01;两组治疗后APN均较治疗前显著上升,差异有统计学意义(对照组P<0.05,治疗组P<0.01);治疗后,治疗组APN升高水平较对照组APN升高水平更明显,二者比较有显著性差异(P<0.01)。改善血管内皮功能方面,治疗后治疗组NO、ET及NO/ET较治疗前均有改善,且优于对照组(P<0.05);治疗后实验组的FMD值明显增加(P<0.05),对照组FMD值无明显变化(P>0.05),两组差异有统计学意义(P<0.05)。治疗相关不良反应方面,治疗组的不良反应较少,安全性较高。
     [结论]五苓散治疗MS不仅可改善临床症状、体征,减少腰围、体重和体重指数,控制血压、血糖、血脂,同时对相关的重要实验室指标包括胰岛素分泌水平、血清炎症标志物(IL-6、TNF-α和hs-CRP)、脂肪细胞因子(LEP、APN)、血管活性物质(ET、NO、NO/ET)等均有良好的干预作用。五苓散通过改善胰岛素分泌,减轻胰岛素抵抗,降低炎症反应,纠正瘦素抵抗,改善低脂联素水平,调节血管活性物质等途径发挥其治疗代谢综合征的功效。该方用药安全,无毒副反应,值得临床推广和进一步研究。
[Objective] Observation of the clinical efficacy of the treatment of metabolic syndrome by the wuling powder and to explore some of its mechanism of action.
     [Methods] The80patients corresponding with the diagnostic criteria were randomly divided into treating group of40patients and control group of40patients. The control group take a primary interventions of based on healthy lifestyle and regard controling blood sugar, blood pressure, blood fat as the secondary interventions. The treatment group added the wuling powder based on the interventions of the control group. The course of treatment was tweleve weeks. Compared with the Traditional Chinese Medicine syndrome, waist circumference, weight, body mass index, blood pressure, blood lipids, blood glucose, insulin function, serum inflammatory markers (high sensitivity C-reactive protein, interleukin-6, tumor necrosis factor-a), adipocytokines (adiponectin, leptin), vascular endothelial function (nitric oxide, endothelin, brachial artery flow-mediated dilation diameter) and toxicity before and after treatment of all patients.
     [Results] The aspect of improving TCM syndromes, as for the treatment group,14cases were significantly effective,20cases were effectual and6cases were unfruitful with a total effective rate of85%. In40cases of control group,11cases were significantly effective,19cases were effectual, the total effective rate was75%, The rate of excellent and total effective were superior to the control group (P<0.05或P<0.01). The aspect of decreasing the waist circumference, weight, body mass index, the differences were statistically significant comparing with the two groups (P<0.01or P<0.05). As for the treatment group, the fall degree of waist circumference, weight, body mass index were (8.65±4.82) cm,(7.46±4.72) kg,(4.39±1.87). As for the control group, the fall degree were (7.93±0.81) cm、(6.29±2.88) kg、(3.19±2.48), the differences were all statistically significant(P<0.01). There was statistically significant difference before and after treatment of treatment group with respect to improving systolic pressure and diastolic pressure(P <0.01), but there was no statistically significant difference in the control group (P>0.05). The aspect of decreasing blood fat, the two groups could significant decrease the level of TC、LDL-C, they all have statistically significant difference(P<0.01);After treatment, the level of HDL-C significant increased in treatment group (P<0.01), there was no obvious change in control group(P=0.079), the treatment group were superior to the control group (P<0.01). After treatment, there was statistically significant difference of two group with respect to decreasing the level of FBG、PGO.5h、 PGlh、PG2h、PG3h、HbAlc (P<0.01);Comparing with the control group, the treatment group were superior to the control group aspect to decreasing FBG and PGO.5h. After treatment, there was statistically significant difference in treatment group respect to decreasing the level of INS0.5h、INS2h, increasing the level of REISI, decreasing the level of FINS、INSlh、INS3h、 HBCI、MBCI (P<0.05or P<0.01). There was statistically significant difference in control group respect to decreasing the level of INSO.5h、HBCI, increasing the level of△I30/△G30, decreasing the level of FINS、INSlh、INS3h、HBCI、 MBCI (P<0.05or P<0.01). Comparing with the control group, the treatment group were superior to the control group aspect to decreasing FINS、MBCI(P <0.05), there was statistically significant difference aspect to increasing the level of REISI (P<0.01). After treatment, there were statistically significant difference in two groups respect to decreasing the level of IL-6、 TNF-α and hs-CRP (P<0.05). Comparing with the control group, the treatment group were superior to the control group aspect to decreasing the level of IL-6、TNF-α and hs-CRP (P<0.05). After treatment, there were statistically significant difference in two groups respect to decreasing the level of LEP and increasing the level of APN (P<0.05or P<0.01). Comparing with the control group, the treatment group were superior to the control group aspect to decreasing the level of LEP and increasing the level of APN (P<0.01). Comparing with the control group, the treatment group were superior to the control group aspect to imoprving the NO、ET、NO/ET and increasing the level of FMD (P<0.05). The treatment group had less side effects, the safety was higher.
     [Conclusion]The wuling powder could not only improve clinical symptoms and signs, decreased waist circumference, weight and body mass index, blood pressure control, blood sugar, blood lipids but also had better intervation of the important laboratory index including the level of insulin secretion, serum inflammatory markers (IL-6, TNF-α and hs-CRP), adipocytokines (LEP, APN), vasoactive substances (ET, NO, NO/ET). Through improving insulin secretion and relieving insulin resistance, decreasing inflammation, correcting leptin resistance, increasing the low-fat adiponectin levels and regulating vasoactive substances, the wuling powder play the effect of its treatment of metabolic syndrome. The wuling powder is worthy of popularization and further research because of the better effects and less side effects.
引文
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