补肾益心片改善高血压病患者胰岛素抵抗的临床研究
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摘要
本文通过大量的文献回顾,得出如下结论:
     ※胰岛素抵抗是多种代谢性疾病的发病机制。
     ※通过对胰岛素抵抗致高血压病的机理及各类降压药对胰岛素抵抗影响的回顾,认为胰岛素抵抗是高血压病的一个独立因素。对降压药的评价不仅要看其降压的效果,更重要的是看其对胰岛素抵抗的改善情况。
     ※高血压病不同证型之间胰岛素抵抗不同,胰岛素抵抗可作为高血压病辨证分型的客观指标。中医药对胰岛素抵抗有一定的改善作用,有待进一步深入发掘。
     研究目的:评价补肾益心片对高血压病患者胰岛素抵抗的影响,并探讨其部分机理。
     研究方法:在临床研究之前,随机选取30名健康人,观察其空腹胰岛素水平及胰岛素敏感指数,以确定本研究中诊断高胰岛素血症的空腹胰岛素水平。认为空腹胰岛素大于17.02μIU/ml时可诊为高胰岛素血症,存在胰岛素抵抗。在临床研究中,选取高血压病存在胰岛素抵抗的患者50例,随机分为治疗组26例,对照组24例,两组均同时参照HOT研究方案,以尼群地平10mg Tid、倍他乐克25mg Bid、HCT12.5mg Qd为基础用药,以135/85mmHg以下为目标水平逐步控制血压,治疗组加用补肾益心片4~# Tid,对照组仅用基础治疗,治疗3周。治疗前后分别测定OGTT或空腹血糖、IRT或空腹胰岛素值、血脂、血尿酸进行比较;将50例患者辨证分型为肝火亢盛、痰湿壅盛、阴虚阳亢、阴阳两虚、瘀血阻络五型,观察不同证型间ISI、血脂、血尿酸的不同;将50例患者按血压分级不同分为高血压病1级、高血压病2级、高血压病3级三组,观察不同血压分级之间ISI、血脂、血尿酸的不同;将治疗组26例患者亦辨证分为上述五型,观察治疗前后不同证型间ISI、血脂、血尿酸的改善情况。
     观察结果:补肾益心片治疗前后,治疗组与对照组比较空腹胰岛素水平、ISI、血脂、血尿酸均有明显改善(P<0.05),在改善脂质代谢方面,可降低TG、LDL,升高HDL、ApoA,对TC无明显影响。高血压病不同证型之间ISI均数的顺序为:阴阳两虚>瘀血阻络>痰湿壅盛>阴虚阳亢>肝火亢盛,但在统计学上无明显差异。补肾益心片可改善五种不同证型高血压病的胰岛素抵抗,而不偏重于某一型。另外,不同血压分级之间IR不同,分级越高IR越明显。
     结论:补肾益心片可提高高血压病胰岛素抵抗患者的胰岛素敏感指数,改善胰岛素抵抗。
The clinical study on the medicine which to improve hypertension patient's IR
    Following conclusions are made after reviewing a great deal of documents: IR (insulin resistance) is the mechanism of various metabolism diseases. To explore the reasons that IR can lead to hypertension and depressed affect IR. It is thought that IR is an independent factor of hypertension. The evaluation of depresses TK& tm\y depends on the decrease of blood pressure but the improvement of IR.
    There are various IR among hypertension's different syndromes. IR can be treated as an objective index while different syndromes. The Chinese herbal can in some degree improve the IR which have to be explore further.
    Objective: to evaluate the effect of Bu Shen Yi Xin Pian to the IR of hypertension patients, and also to inqure the mechanism.
    Methods: Before clinical study, select 30 healthy persons randomly, observe the fasting insulin level while dialouge hypertension. It is concluded that when fasting insulin level >17.02uIU/ml, can be dialogued hyperinsulin and ER. In clinical study, chose 50 hypertension patients combined with IR, divided into two groups randomly, control group which was treated with Nitrendipine lOmg Tid, Betaloc 25mg Bid, HCT 12.5mg Qd, and treated group which was treated with Bu Shen Yi Xin Pian additional. Before and after treated, survey OGTT or fasting blood, IRT or fasting insulin, blood-lipid, blood uric acid. Divided the 50 samples into such 5 groups as flaming-up of liver-fire, sputum and dampness, hyperactivity of yang due to deficiency of yin, deficiency of both yin and yang, blood stasis blocking collateral, at the same time, divided them into 3 groups according to the blood pressure, so it is with the treated group of 26 samples.
    Result: Contrasted before and after treatment, the treated group was improved greatly(p<0.05), In addition, different blood pressure has different IR, the higher rank of pressure, the higher IR level.
    Conclusion: Bu Shen Yi Xin Pian can improve the insulin sensitization index, alleviate insulin resistance.
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