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张文高,吴敏,王红霞,刘龙涛.降脂红曲微粉治疗血脂异常合并颈动脉粥样硬化的随机对照研究[J].,2011,31(9):1196-1200
降脂红曲微粉治疗血脂异常合并颈动脉粥样硬化的随机对照研究
Clinical Study on the Treatment of Abnormal Blood Lipids Complicated with Carotid Atherosclerosis with Lipid-reducing Red Rice Minute Powder:A Randomized Controlled Trial
  
DOI:
中文关键词:  血脂异常  颈动脉粥样硬化  降脂红曲  微粉中药  随机对照试验
英文关键词:abnormal blood lipid  carotid atherosclerosis  lipid-reducing red rice  minute powder of Chinese herbs  randomized controlled trail
基金项目:国家中医药管理局科技计划项目(No.04-05LP30)
Author NameAffiliation
ZHANG Wen-gao 山东省临沂市交通医院 
WU Min 中国中医科学院西苑医院 
WANG Hong-xia 中国中医科学院广安门医院 
LIU Long-tao 山东中医药大学 
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中文摘要:
      目的观察经超微粉碎处理的降脂红曲对血脂异常合并颈动脉粥样硬化患者的血脂水平、颈动脉内膜-中膜厚度(IMT)以及斑块总积分的影响。方法按纳入标准选择2005年4月—2006年4月济南机床二厂社区血脂异常合并颈动脉粥样硬化患者60例,随机分为治疗组20例、中药对照组20例和西药对照组20例。治疗组给予降脂红曲微粉胶囊口服,每次1粒(175mg/粒),每日2次;中药对照组给予血脂康胶囊口服,每次2粒(300mg/粒),每日2次;西药对照组给予洛伐他汀片口服,每次1片(20mg/片),每日1次。各组患者均连续治疗6个月,治疗期间避免服用影响血脂代谢和抗动脉粥样硬化(AS)的其他药物。观察各组患者治疗前后中医证候积分、血清总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)和高密度脂蛋白胆固醇(HDL-C)水平以及颈动脉IMT和斑块总积分的变化。结果治疗6个月后,各组中医证候总积分均显著减少(P<0.05,P<0.01),且治疗组优于西药对照组(P<0.05);各组血清TC、TG、LDL-C水平显著降低(P<0.05,P<0.01),组间比较,差异无统计学意义(P>0.05),各组血清HDL-C水平变化无统计学意义(P>0.05);各组颈动脉IMT与斑块总积分显著减小(P<0.05,P<0.01),组间比较无统计学意义;治疗期间西药对照组1例患者因转氨酶升高退出试验,其他两组均未出现严重的与药物相关不良反应。结论降脂红曲微粉具有肯定的调脂、抗动脉粥样硬化作用,与血脂康和洛伐他汀疗效相当,且安全性高,节省药材,值得进一步研究。
英文摘要:
      Objective To observe the clinical effects of lipid-reducing red rice minute powder(LRRMP) on the levels of blood lipids,carotid arery intima-media thickness(IMT),and the plaque integral of hyperlipidemia patients complicated with carotid atherosclerosis.Methods This study was conducted from April 2005 to April 2006 according to inclusion criteria.Sixty hyperlipidemia patients complicated with carotid atherosclerosis were randomly assigned to the treatment group(20 cases),the Chinese medicine control group(CM control group,20 cases),and the Western medicine control group(WM control group,20 cases).They were recruited from the community of secondary machine tool factory of Jinan.Patients in the treatment group took LRRMP(175 mg/pill),one pill each time,twice daily.Patients in the CM control group took Xuezhikang Capsule(300 mg/pill),2 pills each time,twice daily.Patients in the WM control group took Lovastatin Tablet(20 mg/tablet),1 tablet each time,once daily.The course of treatment was 6 successive months for all.They avoided taking any lipid-regulating or anti-atherosclerotic drugs during the therapeutic course.The changes of Chinese medicine symptom scores,serum TC,TG,LDL-C,and HDL-C levels,IMT of the carotid artery,and the plaque integral before and after treatment were observed.Results After 6 months of treatment the Chinese medicine symptom scores reduced in each group(P<0.05 or P<0.01),and the treatment group was superior to WM control group(P<0.05).Serum TC,TG and LDL-C levels were significantly lowered(P<0.05 or P<0.01),showing no significant difference in inter-group comparison(P>0.05).There was no statistical significance of the serum HDL-C level in each group(P>0.05).The IMT and the plaque integral significantly reduced(P<0.05,P<0.01),showing no statistical difference among all groups.One patient in the WM control group dropped out because of transaminase elevation.No serious adverse reaction correlated with the drugs occurred during the therapeutic course in the rest two groups.Conclusions LRRMP showed definite effects on lipid-regulating and anti-atherosclerosis.Its effects were equivalent to Xuezhikang Capsule and Lovastatin Tablet.Besides,it was safe and economic,and deserved further studies.
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