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普伐他汀用序贯设计及期中分析法治疗高脂血症
引用本文:杨雨田,武俊青,李保,刘卓敏.普伐他汀用序贯设计及期中分析法治疗高脂血症[J].中国新药与临床杂志,2000,19(2):93-95.
作者姓名:杨雨田  武俊青  李保  刘卓敏
作者单位:1. 上海市徐汇区大华医院,上海,200031
2. 上海市计划生育科学研究所,上海,200032
3. 山西省心血管疾病研究所,山西,太原,030001
基金项目:山西省自然科学基金资助项目!(9309)
摘    要: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。

关 键 词:普伐他汀  高脂血症  高胆固醇血症  双盲法

Pravastatin in treating hyperlipidemia with group sequential design and interim analysis
YANG Yu-Tian,WU Jun-Qing,LI Bao,LIU Zhuo-Min.Pravastatin in treating hyperlipidemia with group sequential design and interim analysis[J].Chinese Journal of New Drugs and Clinical Remedies,2000,19(2):93-95.
Authors:YANG Yu-Tian  WU Jun-Qing  LI Bao  LIU Zhuo-Min
Abstract: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
Keywords:pravastatin  hyperlipidemia  hypercholesterolemia  double-blind method
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