CAJ | 학술논문

目的分析服用他汀类药物发生不同程度肌病的临床特点.方法收集并整理分析2007年1月至2012年12月期间,报告至北京市药品不良反应(ADR)监测中心数据完整的他汀类药物所致肌病病例.根据是否发生横纹肌溶解分别定义为一般程度肌病组及横纹肌溶解组,并比较两组临床特点、用药情况、转归等.率的比较使用x2检验,均值的比较用t检验,相关性分析使用Spearman分析.结果共收集160例服用他汀类药物所致肌病患者,平均年龄为(64.2±13.6)岁,男性82例(51.2％),女性78例(48.8％),肌病相关ADR发生时间从服药即刻至服药4年.临床表现为肌痛、肌炎、无症状肌酶升高或横纹肌溶解症表现.160例肌病相关ADR病例中,横纹肌溶解组54例(33.8％),一般程度肌病组106例(66.3％).横纹肌溶解组和一般程度肌病组的平均年龄分别为(68.5±15.4)岁和(62.0±12.4)岁,差异有统计学意义(P =0.004);男女比例分别为25∶29和57∶49,性别比较差异无统计学意义(P=0.406);服用高剂量他汀类药物的例数分别为24例(44.4％)及26例(16.5％)(x2=16.45,P ＜0.001);服用辛伐他汀的例数分别为38例(70.4％)及34例(32.1％) (x2 =21.20,P＜0.001).Spearman相关性分析显示:年龄、服用高剂量他汀及服用辛伐他汀均与肌病相关ADR严重程度呈正相关(r分别为0.305、0.290和0.364,P均＜0.001).死亡4例,年龄71～85岁,均有较高剂量他汀类药物的用药史,其中3例病史明确的患者均存在复杂合并疾病、急性病程或复杂合并用药史.结论发生肌病相关ADR中,高龄、服用高剂量他汀、服用辛伐他汀的患者ADR的严重程度更高.
목적 분석복용타정류약물발생불동정도기병적림상특점.방법 수집병정리분석2007년1월지2012년12월기간,보고지북경시약품불량반응(ADR)감측중심수거완정적타정류약물소치기병병례.근거시부발생횡문기용해분별정의위일반정도기병조급횡문기용해조,병비교량조림상특점、용약정황、전귀등.솔적비교사용x2검험,균치적비교용t검험,상관성분석사용Spearman분석.결과 공수집160례복용타정류약물소치기병환자,평균년령위(64.2±13.6)세,남성82례(51.2％),녀성78례(48.8％),기병상관ADR발생시간종복약즉각지복약4년.림상표현위기통、기염、무증상기매승고혹횡문기용해증표현.160례기병상관ADR병례중,횡문기용해조54례(33.8％),일반정도기병조106례(66.3％).횡문기용해조화일반정도기병조적평균년령분별위(68.5±15.4)세화(62.0±12.4)세,차이유통계학의의(P =0.004);남녀비례분별위25∶29화57∶49,성별비교차이무통계학의의(P=0.406);복용고제량타정류약물적례수분별위24례(44.4％)급26례(16.5％)(x2=16.45,P ＜0.001);복용신벌타정적례수분별위38례(70.4％)급34례(32.1％) (x2 =21.20,P＜0.001).Spearman상관성분석현시:년령、복용고제량타정급복용신벌타정균여기병상관ADR엄중정도정정상관(r분별위0.305、0.290화0.364,P균＜0.001).사망4례,년령71～85세,균유교고제량타정류약물적용약사,기중3례병사명학적환자균존재복잡합병질병、급성병정혹복잡합병용약사.결론 발생기병상관ADR중,고령、복용고제량타정、복용신벌타정적환자ADR적엄중정도경고.
Objective To analyze the clinical features of statin-induced myopathy.Method The statin-induced myopathy case reported as adverse drug reaction (ADR) to the Beijing Center for ADR Monitoring during January 2007 to December 2012 was summarized,patients were divided to myopathy group and rhabdomyolysis group,according to the absence or presence of rhabdomylysis.The clinical characteristics,medication history and outcome were compared between the two groups.Results A total of 160 statin-induced myopathy cases (54 in rhabdomyolysis group (33.8％) and 106 cases in myopathy group (66.3％)) were collected from the database (mean age:(64.22 ± 13.55) years old,51.2％ male,n =82).The ADR occurred immediately after the first medication and up to 4 years after medication.Observed clinical features were myalgia,myositis,asymptommatic creatine kinase (CK) elevation or rhabdomyolysis.The average age were (68.54 ± 15.41) years old in rhabdomylysis group and (62.02 ± 12.41) years old in myopathy group (P =0.004).There was no gender difference between the rhabdomylysis group and myopathy group (P =0.406).Twenty-four cases (44.4％) in rhabdomyolysis group and 26 cases (16.5％) in myopathy group were treated with high dose statin (P ＜ 0.001).Percent of simvastatin treatment was significantly higher in rhabdomyolysis group (70.4％ (38/54)) than in myopathy group (32.1％ (34/106),P ＜ 0.001).Spearman correlation analysis showed that age,high-dose statin treatment and simvastatin use were all positively correlated with rhabdomylysis (P ＜ 0.001),and the correlation coefficients (r value) were 0.305,0.290 and 0.364,respectively.Four patients (aged from 71 to 85 years) died because of ADR and all 4 cases received high-dose statin treatment,3 of them suffered from complex combined diseases,acute disease progression and complex multiple drug use history.Conclusions Severe statin-induced myopathy,like rhabdomyolysis,is more likely to occur in old patients,in patients taking high-dose statin,especially simvastatin.