调脂灵治疗高脂血症的临床和实验研究

Experimental and Clinical Study of Tiaozhiling in the Treatment of Hyperlipidemia

目的 研究灵芝制剂调脂灵的毒理、药效、对心脑血管的保护作用及治疗高脂血症的效果。方法 检测卫生指标、LD50、“三致”试验;用调脂灵对SHR-SP进行降压及卒中的疗效实验;按国家标准判定调脂灵的临床疗效。结果 重金属和细菌含量符合国家标准,LD50>10 g/kg体重,“三致”试验阴性,证明调脂灵无毒。SHR-SP实验证明,调脂灵可保护动脉内皮细胞的完整性,阻止血栓形成与出血,减少脑卒中的发生。治疗160例高脂血症患者,降TC、LDL-C和TG的总有效率分别为71.4%、71.4%和48.4%,升高HDL-C为82.5%,同时对部分患者有降血压、血糖和ALT的作用。未发现不良反应。结论 调脂灵安全有效,适用于冠心病、高血压、糖尿病等伴高脂血症的治疗。

Objective To study on toxicology, pharmacodynamics, protective effect on cardio-cerebral artery and clinical efficacy of Tiaozhiling (TZL), made from Lingzhi. Method The hygiene indices, determine of LD50, mutagenic tests (Ames test, micronuclei test and spermatozoon teratism test) were carried out. Experimental study on decreasing blood pressure and stroke rate in SHR-SP by TZL were performed. The clinical efficacy of TZL was evaluated by national criteria. Results The contents of heavy metals and bacterium in TZL accorded with the national criteria. The LD50 was more than 10 g/kg of body weight. The results of Ames test, micronuclei test and spermatozoon teratism test were negative. It documented that TZL is nontoxic. The results of experimental study of SHR-S showed that TZL protected the enterety of endotheliocyte of artery, prevented thrombosis and hemorrhage, decreased stroke rate. The results of clinical use of TZL in 160 cases with hyperlipidemia showed that the total effective rate of lowering TC, LDL-C and TG was 71.4%, 71.4% and 48.4% respectively. The total effective rate of increasing HDL-C was 87.5%. Meanwhile, TZL not only remarkably improved patient's general condition, but also decreased blood pressure, blood glucose and elevated ALT in part of patients. No side effect was found. Conclusion TZL is safe and effective. It is particularly suitable for those who suffer from coronary heart disrase, hypertension, diabetes complicated by hyperlipidemia.