他汀类药物致160例肌病相关不良反应的临床分析  

Clinical analysis of 160 cases of statin-induced myopathy

作　　者：江岳鑫[1] 娄莹[1] 刘玉清[1] 王莉[1] 庞会敏[1] 张俊[2] 周应群[2] 李一石[1] 

机构地区：[1]北京协和医学院中国医学科学院阜外心血管病医院卫生部心血管药物临床研究重点实验室,100037 [2]北京市药品不良反应监测中心

出　　处：《中华心血管病杂志》2014年第11期905-909,共5页Chinese Journal of Cardiology

基　　金：“重大新药创制”科技重大专项（2012ZX09303-008-001）;国家临床重点专科建设项目

摘　　要：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χ^2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％）（χ^2 =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％） （χ^2 =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.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

关 键 词：降血脂药 肌疾病 横纹肌溶解 药物不良反应 

分 类 号：R95[医药卫生—药学]