CAJ | 학술논문

目的考察广泛使用条件下匹伐他汀用于中国高胆固醇血症患者调脂的安全性和有效性.方法以多中心、非盲、不设平等对照的方式开展为期12周的Ⅳ期临床试验.结果安全集427例受试者的不良事件主要有呕吐、肌痛以及天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、肌酸激酶(CK)升高等,与试验药物相关的不良事件发生率为4.22％.受试对象用药前后肾功能和血常规指标的差异均无统计学意义(均P＞0.05),未出现AST、ALT值超过3倍医学参考值上限(3×ULN)或CK值超过10×ULN的受试者.符合方案集397例受试者治疗12周时,无入组前调脂治疗组的总胆固醇和低密度脂蛋白胆固醇(LDL-C)水平分别下降24.6％和31.0％,基线高密度脂蛋白胆固醇(HDL-C)＜1.04 mmol/L组的HDL-C水平上升60.1％,基线甘油三酯(TG)＞1.70 mmol/L组的TG水平下降22.5％ (P＜0.05)；207例(92.3％)低危患者、46例(76.1％)中危患者、134例(47.8％)高危患者和10例(40.0％)极高危患者的LDL-C值达到治疗目标值；由其他调脂药物转换为匹伐他汀的受试者的LDL-C达标率显著高于转换前(P＜0.05).结论匹伐他汀具有良好的安全性和有效性,可用于我国高胆固醇血症患者的治疗.
목적 고찰엄범사용조건하필벌타정용우중국고담고순혈증환자조지적안전성화유효성.방법 이다중심、비맹、불설평등대조적방식개전위기12주적Ⅳ기림상시험.결과 안전집427례수시자적불량사건주요유구토、기통이급천동안산전안매(AST)、병안산전안매(ALT)、기산격매(CK)승고등,여시험약물상관적불량사건발생솔위4.22％.수시대상용약전후신공능화혈상규지표적차이균무통계학의의(균P＞0.05),미출현AST、ALT치초과3배의학삼고치상한(3×ULN)혹CK치초과10×ULN적수시자.부합방안집397례수시자치료12주시,무입조전조지치료조적총담고순화저밀도지단백담고순(LDL-C)수평분별하강24.6％화31.0％,기선고밀도지단백담고순(HDL-C)＜1.04 mmol/L조적HDL-C수평상승60.1％,기선감유삼지(TG)＞1.70 mmol/L조적TG수평하강22.5％ (P＜0.05)；207례(92.3％)저위환자、46례(76.1％)중위환자、134례(47.8％)고위환자화10례(40.0％)겁고위환자적LDL-C치체도치료목표치；유기타조지약물전환위필벌타정적수시자적LDL-C체표솔현저고우전환전(P＜0.05).결론 필벌타정구유량호적안전성화유효성,가용우아국고담고순혈증환자적치료.
Objective To evaluate the safety and efficacy of pitavastatin in patients with hypercholesterolemia in China under conditions of extensive usage.Methods This was a 12-week,multicenter,open-label,without parallcl-group comparison,phase Ⅳ clinical trial.Results There were 427 subjects in the safety set.The adverse events mainly included vomiting,myalgia and the elevations of aspartate transaminasc (AST),alanine transaminase (ALT) and creatine kinase (CK),etc.The incidence of drug-related adverse events was 4.22％.There were no significant differences between pre-exposure and post-exposure average levels of renal function indicators and blood routine examination item (all P＞0.05).None of them had a high AST/ALT value,i.e.＞3 times upper limits of normal (ULN),or had a high CK value,i.e.＞10 times ULN.There were 397 subjects in the per protocol set.At week 12 post-treatment,the blood levels of total cholesterol and low density lipoprotein cholcsterol(LDL-C) in subjects without previous treatment decreased 24.6％ and 31.0％ respectively,that of high density lipoprotein cholesterol (HDL-C) in subjects with HDL-C ＜1.04 mmol/L increased 60.1％ while that of triglyceride (TG) in subjects with TG ＞1.70 mmol/L decreased 22.5％ (P＜0.05).And 207 (92.3％) subjects were at a low risk,46(76.1％) subjects at an intermediate risk,134(47.8％) subjects at a high risk and 10(40.0％) of subjects at a very high risk had achieved a LDL-C target value; the LDL-C goal achievement rate after switching from previous medication to pitavastatin was significant higher than that of pre-switching.Conclusion Pitavastatin demonstrates positive safety and efficacy.It may be used for the treatment of patients with hypercholesterolemia in China.