脂必妥与安慰剂治疗高脂血症的随机双盲多中心研究

Zhi-bi-tuo vs placebo treatment of hyperlipidemia a double blind randomized and multicenter study

ｃｈ，总有效率分别为８０％及１６％；８２％及１７％；６９％及２８％。２组间疗效对比有非常显著差异（Ｐ＜０．０１），对ＴＣ，ＴＧ，ＨＤＬ－ｃｈ水平及ＴＣ－ＨＤＬ－ｃｈ／ＨＤＬ－ｃｈ比值均有显著改变，与对照组相比差异非常显著。２组对ＬＤＬ－ｃｈ，ＡｐｏＡＩ，ＡｐｏＢ１００，ＡｐｏＡＩ／ＡｐｏＢ１００，ＬＰ（ａ）水平则改变不明显。未见不良反应。结论：脂必妥是一种安全有效的调脂药物。

AIM: To study the antihyperlipidemia efficacy and safety with Zhi-bi-tuo. METHODS: The randomized, double-blind, placebo-control multicenter method was used, 3 tablets (0.35 g/tab) po, tid were used both in Zhi-bi-tuo group (104 patients, M 60, F 44, age 58±s 9 a) and in starch placebo group (101 patients, M 56, F 45, age 59±10 a). RESULTS: After 6 wk, the total effective rate of decreasing total cholesterol (TC), triglyceride (TG) and increasing high density lipoprotein-cholesterol (HDL-ch) in both group were 80% and 16%, 82% and 17%, 69% and 28% respectively. There were great differences between two groups (P<0.01). In the Zhi-bi-tuo group, TC, TG HDL-ch, TC-HDL-ch/HDL-ch also changed greatly, and there were great differences between two groups. Though LDL-ch, Apo AI, Apo B 100 , Apo AI/Apo B 100 , lipoprotein(a) changed slightly, but no statistical difference (P>0.05). There were no adverse reactions. CONCLUSION: Zhi-bi-tuo is a safe and effective antihyperlipidemic drug.