中新网11月21日电 据国家食品药品监督管理局网站消息，近日，国家食品药品监督管理局发布第51期药品不良反应信息通报，提醒医务人员和患者警惕他汀类药品血糖异常不良反应及与HIV蛋白酶抑制剂的相互作用。

Beijing on November 21, according to the state food and drug administration website news,recently,State food and drug administration issued period of 51 adverse drug reaction information bulletin,Remind the medical personnel and patient alert statin drug adverse reaction and abnormal blood glucose with HIV protease inhibitor interaction.

　　他汀类药物，即3-羟-3甲戊二酰辅酶A(HMG-CoA)还原酶抑制剂，为一类临床广泛使用的口服降脂药，主要作用为降低血液中低密度脂蛋白胆固醇水平，达到预防和治疗心血管疾病(如高胆固醇血症、冠心病)的目的。国内上市的产品包括：辛伐他汀、洛伐他汀、普伐他汀、瑞舒伐他汀、阿托伐他汀、氟伐他汀、匹伐他汀。

statins,Namely 3 - hydroxyl - 3 armour glutaryl coenzyme A(HMG - CoA)Reductase inhibitors,For a class of clinical widely used oral cholesterol-lowering drugs,The main function is to reduce the blood low-density lipoprotein cholesterol levels,To achieve the prevention and treatment of cardiovascular disease(Such as high cholesterol/Coronary heart disease)purpose.Domestic listed products include:simvastatin/lovastatin/praastatin/Red easy cutting statin/atorvastatin/Fluorine cutting statin/Horse cutting statin.

　　HIV蛋白酶抑制剂是治疗HIV感染的抗病毒药物，国内上市的产品包括：洛匹那韦、达芦那韦、沙奎那韦、阿扎那韦、利托那韦。

HIV protease inhibitor is the treatment of HIV infection of antiviral drugs,Domestic listed products include:Los horse that wei/Reed canary to the wei/ShaKui that wei/Aza that wei/The holder that wei.

　　研究发现他汀类药品可引起患者血糖异常，表现为空腹血糖水平升高、糖化血红蛋白水平升高、新发糖尿病、糖尿病血糖控制恶化等。此外，他汀类药品与HIV蛋白酶抑制剂同时服用，可能会使他汀类药物的血药浓度增高，增加包括横纹肌溶解在内的严重不良反应的发生风险。

The study found that the statin drugs can cause patients with abnormal blood sugar,For the performance of the fasting blood sugar levels/Glycated hemoglobin levels/New-onset diabetes/Diabetes blood sugar control deterioration.In addition,Statin drug and HIV protease inhibitors also take,May make statins blood concentration increased,Increase including rhabdomyolysis, the risk of serious adverse events.

　　根据他汀类药品安全性研究和监测结果，欧盟和美国等已经修订了他汀类药品的产品说明书，增加相关风险警示。我国药品监督管理部门也开展了他汀类药品安全性监测和评估工作。

According to the statin drug safety research and monitoring results,The European Union and the United States have revised the statin drug product specification,Is associated with increased risk warning.Our drug supervision and administration department also began statin drug safety monitoring and evaluation.

　　国家食品药品监督管理局建议：

State food and drug administration suggested:

　　1.建议医护人员在用药前应询问患者的既往病史(如肝肾功能障碍、糖尿病)和联合用药情况，将可能存在的安全性隐患告之患者，在增加剂量或调整治疗方案时，应密切关注患者的不良反应发生情况。

1. Suggest medical personnel in the drug should be asked before the patient past history(Such as liver and kidney dysfunction/diabetes)And the combined use situation,The possible existence of safety hidden trouble that patients,On the increase dose or adjust the treatment plan,Patients should pay close attention to the adverse reactions occur.

　　2、建议患者如果出现多尿、多饮、多食、疲乏等怀疑与糖尿病或血糖紊乱有关的症状，立即向医生咨询，以明确病因并采取适当的处理措施。建议使用他汀类药品的糖尿病患者密切监测血糖状况，如果出现血糖控制恶化，应立即就诊。

2/Patients are advised if appear diuresis/polydipsia/Feed more/Fatigue doubt and diabetes or glucose disorders related symptoms,To consult a doctor immediately,In order to make clear the cause and take appropriate measures.Suggest using statin drugs diabetes closely monitoring the blood sugar condition,If appear blood sugar control deterioration,Should see a doctor immediately.

　　3、建议患者在治疗前将所有正在使用的药品告之医生，并认真阅读药品说明书，与医生就用药的安全性问题进行有效地的交流，保护自身健康利益。

3/Patients are advised in the before treatment will all are using drugs that the doctor,Reading carefully and medicines,And the doctor drug safety problems are effectively communication,To protect their own health benefits.

　　4、建议药品生产企业加强对药品安全性的研究，进一步完善药品说明书和标签中不良反应、相互作用等信息。加强药品不良反应监测力度，加强与医生的信息沟通，采取有效措施最大限度地保障患者的用药安全。

4/Suggest a pharmaceutical production enterprise to strengthen the safety of drug research,To further improve drug instruction and tag adverse reaction/Information such as the interaction.Strengthen the adverse drug reaction monitoring dynamics,Strengthen and the doctor's information communication,Take effective measures to maximize ensuring patients' medical security.