CAJ | 학술논문

目的：观察降脂胶囊治疗高脂血症的降脂疗效和安全性，为其临床应用和开发提供科学依据。方法：按纳入标准选择2011年4-9月我院治未病中心高脂血症患者120例，随机分为治疗组和对照组，各60例。治疗组给予降脂胶囊，2 g/次（0.5 g/粒），餐后口服， bid；对照组60例给予洛伐他汀口服，1片/次（20 mg/片）， qn。各组均连续治疗3个月，治疗期间避免服用影响血脂代谢的其他药物。观察各组患者治疗前后中医证候积分、血脂总胆固醇（TC）、三酰甘油（TG）、低密度脂蛋白胆固醇（LDL-C）和高密度脂蛋白胆固醇（HDL-C）水平的变化。结果：治疗3个月后，各组中医证候总积分均显著降低，且治疗组优于对照组（P ＜0.05）；两组血清TC、TG、LDL-C水平显著降低，组间差异无统计学意义（P ＞0.05），两组血清 HDL-C 水平变化无统计学意义（P＞0.05）；治疗期间对照组有1例因氨基转移酶升高退出试验，治疗组未出现明显与该药物相关的不良反应。结论：降脂胶囊具有肯定的调脂作用，与洛伐他汀疗效相当，且安全性好，值得推广应用。
목적：관찰강지효낭치료고지혈증적강지료효화안전성，위기림상응용화개발제공과학의거。방법：안납입표준선택2011년4-9월아원치미병중심고지혈증환자120례，수궤분위치료조화대조조，각60례。치료조급여강지효낭，2 g/차（0.5 g/립），찬후구복， bid；대조조60례급여락벌타정구복，1편/차（20 mg/편）， qn。각조균련속치료3개월，치료기간피면복용영향혈지대사적기타약물。관찰각조환자치료전후중의증후적분、혈지총담고순（TC）、삼선감유（TG）、저밀도지단백담고순（LDL-C）화고밀도지단백담고순（HDL-C）수평적변화。결과：치료3개월후，각조중의증후총적분균현저강저，차치료조우우대조조（P ＜0.05）；량조혈청TC、TG、LDL-C수평현저강저，조간차이무통계학의의（P ＞0.05），량조혈청 HDL-C 수평변화무통계학의의（P＞0.05）；치료기간대조조유1례인안기전이매승고퇴출시험，치료조미출현명현여해약물상관적불량반응。결론：강지효낭구유긍정적조지작용，여락벌타정료효상당，차안전성호，치득추엄응용。
Objective: To observe the clinical efficacy and safety of antihyperlipidemia capsules so as to provide a scientific basis for the clinical use and development of the drugs . Methods: According to the selection standard , 120 patients with hyperlipidemia were chosen from Preventive Treatment of Disease Center of our hospital during Apr . to Sep . of 2011 . They were divided into treatment and control groups randomly , 60 in every group . Patients in treatment group were given antihyperlipidemia capsules,2 g(0.5 g/pill) each time,2 times a day(po,after meal). Those in control group were given lovastatin , 1 tablet (20 mg/tablet ) each time , qn . The medication lasted for 3 months . During the treatment , no other drugs which affect lipid metabolism were taken . The patients in each group were observed before and after treatment of TCM syndrome integral , total cholesterol ( TC ) , triglyceride ( TG ) , low density lipoprotein choles-terol ( LDL-C ) and high density lipoprotein cholesterol ( HDL-C ) levels . Results: After 3 month treatment , the TCM syndrome integral decreased significantly and the treatment group was better than control group ( P<0 . 05 ) . TC , TG , LDL-C levels of both groups reduced greatly , no statistically significant difference was showed between the two groups ( P>0 . 05 ) and the differences of HDL-C level of each group were not statistically significant ( P>0 . 05 ) . A patient in control group withdrew from the study because of elevated aminotransferase . The treatment group had no obvious ad-verse reactions related to the drug . Conclusion: It was proved that antihyperlipidemia capsules had the effect of lipid regulating , its effectiveness is comparable with lovastatin , and good in safety and worthwhile for extensive application .