普伐他汀用序贯设计及期中分析法治疗高脂血症

Pravastatin in treating hyperlipidemia with group sequential design and interim analysis

目的：了解普伐他汀降血脂疗效。方法：用最小序贯设计及期中分析法将１０２例ＩＩａ，ＩＩｂ型高脂血症病人采用双盲法分为普伐他汀组５３例，给普代他汀 １０ ｍｇ，ｐｏ， ｑｎ×８ ｗｋ；对照组 ４９例，给服外观相同的淀粉片，服法疗程相同。结果：治疗４ｗｋ与 ８ ｗｋ普伐他汀组ＴＣ下降差值分别为（１．７±０．８）ｍｍｏｌ·Ｌ－１与（２．６±０．９）ｍｍｏｌ·Ｌ－１；ＴＧ下降差值为（０．６±０．６）ｍｍｏｌ·Ｌ－１与（１．０±０．５）ｍｍｏｌ·Ｌ－１，治疗８ｗｋ后ＴＣ，ＴＧ下降差值２组组问比较Ｐ＜０．０１；普伐他汀组治疗２ ｗｋ开始ＨＤ Ｌ－Ｃ开始升高（ Ｐ＜ ０． ０５），对照组治疗 ２～ ８ ｗｋ均未见显著升高。结论：普伐他汀组有显著降低ＴＣ，ＴＧ及升高ＨＤＬＣ作用。

AIM: To explore the therapeutic effects of pravastatin in Patients with primary hyperlipidemia. METHODS: Using the group sequential design and interim analysis, the 102 patients with IIa IIb primary hyperlipidemia were double-blind allocated into pravastatin group [M 24, F 29; age (51+- s 13) a]and control group [M 25, F 24; age (52 +- 11) a]. The pravastatin group were given pravastatin 10 mg, po, qn.8 wk; the control group were given the same looking starch tablet with the same dosage and treatment Periods RESULTS: Pravastatin group were after treatment at the 4 wk, 8 wk, the TC decreased (1. 7+- 0. 8) mmol. L^1 and (2. 6 +- 0. 9) mmol.L-1, respectively. After treatment 8 wk, the TC was decreased to the normal level (P < 0. 01). The TG decreased (0. 6 +- 0. 6) mmol. L-1 and(1. 0 +- 0. 5) mmol. L-1, respectively. After treatment of 2 wk, the HDL-C was initiated elevation. After treatment of 8 wk, there were significantly different of TC, TG between the two groups (P<0. 01). After treatment of 2 wk, the HDL-bC was initiated elevation (P<0. 05), but the control group after treatment Of 2-8 wk, the response remained constantly unimproved CONCLUSION: Pravastatin have markedly effects in reducing TC, TG and elevation of the HDL-C