CAJ | 학술논문

目的：探讨不同剂量他汀类药物短期治疗后降脂疗效的差异,他汀类血药浓度与降脂疗效以及药物不良反应的关系。方法连续入选2010年8月至2011年4月于北京大学人民医院心内科住院治疗且近期未服用他汀类药物的高胆固醇血症患者153例,按随机数字表法分为4组,分别给予辛伐他汀20 mg、40 mg、阿托伐他汀10 mg、20 mg降脂治疗。测量治疗前及治疗1周后晨起空腹血脂水平及治疗1周后血药浓度血脂水平,同时观察治疗期间药物不良反应。结果不同剂量的辛伐他汀与阿托伐他汀用药1周均能有效降低TC及LDL-C水平(均为p<0.01）。与辛伐他汀10 mg组相比,辛伐他汀20 mg组的LDL-C及TC的下降幅度增加了7.1%和3.3%(p=0.156,p=0.104）；与阿托伐他汀10 mg组相比,阿托伐他汀20 mg组的LDL-C及TC的下降幅度增加了1.5%和0.5%(p=0.352,p=0.259）。所有高危患者组较极高危患者组的LDL-C达标率更高(71.0%比32.8%, p<0.001）。不同剂量的辛伐他汀与阿托伐他汀用药1周后血药浓度比较,差异均无统计学意义,阿托伐他汀10 mg组的血药浓度与LDL-C下降幅度相关(均为p<0.05）。辛伐他汀与阿托伐他汀的血药浓度与药物不良反应无相关性。结论临床常规剂量范围内,不同剂量的辛伐他汀及阿托伐他汀短期治疗均能有效降低血脂水平。辛伐他汀及阿托伐他汀的血药浓度与药物不良反应无相关性。
목적：탐토불동제량타정류약물단기치료후강지료효적차이,타정류혈약농도여강지료효이급약물불량반응적관계。방법련속입선2010년8월지2011년4월우북경대학인민의원심내과주원치료차근기미복용타정류약물적고담고순혈증환자153례,안수궤수자표법분위4조,분별급여신벌타정20 mg、40 mg、아탁벌타정10 mg、20 mg강지치료。측량치료전급치료1주후신기공복혈지수평급치료1주후혈약농도혈지수평,동시관찰치료기간약물불량반응。결과불동제량적신벌타정여아탁벌타정용약1주균능유효강저TC급LDL-C수평(균위p<0.01）。여신벌타정10 mg조상비,신벌타정20 mg조적LDL-C급TC적하강폭도증가료7.1%화3.3%(p=0.156,p=0.104）；여아탁벌타정10 mg조상비,아탁벌타정20 mg조적LDL-C급TC적하강폭도증가료1.5%화0.5%(p=0.352,p=0.259）。소유고위환자조교겁고위환자조적LDL-C체표솔경고(71.0%비32.8%, p<0.001）。불동제량적신벌타정여아탁벌타정용약1주후혈약농도비교,차이균무통계학의의,아탁벌타정10 mg조적혈약농도여LDL-C하강폭도상관(균위p<0.05）。신벌타정여아탁벌타정적혈약농도여약물불량반응무상관성。결론림상상규제량범위내,불동제량적신벌타정급아탁벌타정단기치료균능유효강저혈지수평。신벌타정급아탁벌타정적혈약농도여약물불량반응무상관성。
Objective To investigate the lipid-lowing efficacy of short-term statins therapy with different routine clinical dosages, and the association of plasma concentrations, lipid-lowing efficacy and safety of statins. Methods A total of 153 in-hospital patients with hypercholesterolemia were enrolled in the study from August 2010 to April 2011 in Peking University People's Hospital. The patients were randomly divided into 4 groups, which received 20 mg, 40 mg simvastatin, 10 mg or 20 mg atorvastatin orally daily. The lipid profiles before and after 1-week treatment, and plasma concentrations of statin after 1-week treatment were assessed. All adverse events of statins were also recorded. Results Different dosages of simvastatin and atorvastatin were able to reduce TC and LDL-C levels (p<0. 01) at one week. The percent reductions in LDL-C and TC levels were increased by 7. 1% and 3. 3% respectively after doubling the dosage of simvastatin from 20 mg to 40 mg (p=0. 156,p=0. 104), while 1. 5% and 0. 5% were observed after doubling the dosage of atorvastatin from 10 mg to 20 mg (p=0. 352,p=0. 259). More patients at high risk reached LDL-C target than those at very high risk ( 71. 0% vs. 32. 8%, p <0. 001 ) . There was no significant difference in plasma concentrations between different dosages. The plasma concentrations of atorvastatin 10 mg treatment group were correlated with the reduction of LDL-C ( all p < 0. 05 ) . No association was observed between the plasma concentrations and adverse events of statins. Conclusions Different routine clinical dosages of simvastatin and atorvastatin can effectively reduce the TC and LDL-C levels after short-term treatment. There is no association between plasma concentrations and adverse events of statins.