泰脂安治疗高脂血症的临床疗效观察

目的：研究泰脂安对高脂血症病人血脂的调脂作用及安全性。方法：300例原发性高脂血症病人按中医辨证分型，肝肾阴虚159例，阴虚阳亢141例，口服泰脂安胶囊3粒（每粒0．3g)，每天3次，连服8周。服药前及服药4周和8周末，均做体格检查、记录证候积分、查血脂谱。服药前及服药后8周末查血尿粪常规、ALT、BUN、Cr、ECG及前庭功能。治疗期间每2周复诊1次，记录证候积分及副作用。结果：服药4周和8周末，TC分别降低18．2％和25．2％，TG降低26．2％和40．6％。LDL－C降低18．9％和20．6％，AI降低了27．1％和34．9％，HDL－C升高了81．2％和42．9％，分别与治疗前比较有统计学意义（P均＜0．01），治疗8周末TC、TG和AI下降程度明显大于4周（P均＜0．01），临床证候积分减少，与治疗前比较有统计学意义（P均＜0．01），总有效率为95．35％，其中肼肾阴虚为94．34％，阴虚阳亢为96．45％，但两组无可比性（P＞0．05）。该药对血尿粪常规、BUN、ALT、Cr、ECG及前庭功能均无不良影响。结论：泰脂安对高脂血症病人具有较好的调脂作用，其降低TC、TG、LDL－C、AI和升高HDL－C的作用，8周疗效更优，并能明显改善证候，无副作用，是安全、有效的调脂中药。

The Clinical Effects of Taizhian on Hyperlipidemia

Objective:To study the effects of Taizhian capsule on the patients with hyperlipidemia.Methods:According to TCM syndrome differention-type of(TCM-SDT),300 patients with primary hyperlipidemia were divided into deficiency of liver-yin and kidney-yin(n=159,DLYKY) and deficiency of yin leads to hyperactivity of yang(n=141,DYLHY).Whole patients had taken 3 capsules each time and 3 times daily for 8 weeks.Before treatment and later 8 weeks respectively,a series of examinations were performed,such as Blood,Urine and Stool routine,ALT,BUN,Cr,ECG and vestibular function,during this period physical examination and clinical symptoms scoring on alternate weeks.In addition,in the end of the fourth week,lipid profile and physical examination were performed,and symptoms were recorded.Results:4 weeks and 8 weeks after treatment,TC decreased by 18.2%and 25.2% respectively,TG decreased by 26.2% and 40.6%respectively,LDL-C decreased by 18.9% and 20.6% respectively,AI decreased by 27.1%and 34.9% respectively,HDL-C increased by 31.2%and 42.9%respectively,which compared with that before treatment.There was significant difference(P<0.01).Furthermore,TC,TG and AI in 8 weeks significantly decreased to that in 4 weeks(P<0.01).In the improvement of clinical symptoms scoring the effect of Taizhian capsule was significant difference than that before treatment,(P<0.01).The total effective rate was 95.35%.DLYKY was 94.34%,DYLHY was 96.45%.There was no significan difference.At the same time,there was no any side effect on body during administration of this medicine.Conclusion:Taizhian is a safe and effective Traditional Chinese Medicine to modulate lipid profile,which can decreasethe levels of TC,TG,LDL-C,AI and increased the level of HDL-C in the patients with hyperlipidmia.Moreover,there were evident improvement in clinical symptoms.