CAJ | 학술논문

目的：完善肝胆疾病辅助用药的说明书，为合理使用肝胆疾病辅助用药提供参考。方法结合临床实际需要对103份肝胆疾病辅助用药说明书进行调查分析，进行综合分析。结果调查的103份说明书中，化学药品的项目标注率高于中药的项目标注率，进口药品的项目标注率高于国产药品的项目标注率。化学药品说明书项目较全，内容较详，质量明显优于中药说明书。而进口药品说明书更加详细。说明书中特殊人群用药项目及相互作用的标注率较低，中成药说明书中关于药理毒理标注少。结论肝胆疾病辅助用药说明书部分内容还不够完整，尤其是中成药说明书，使其不能发挥指导临床合理用药的作用。建议加强管理，补充完善说明书的内容，为临床合理使用提供强有力的支持。
목적：완선간담질병보조용약적설명서，위합리사용간담질병보조용약제공삼고。방법결합림상실제수요대103빈간담질병보조용약설명서진행조사분석，진행종합분석。결과조사적103빈설명서중，화학약품적항목표주솔고우중약적항목표주솔，진구약품적항목표주솔고우국산약품적항목표주솔。화학약품설명서항목교전，내용교상，질량명현우우중약설명서。이진구약품설명서경가상세。설명서중특수인군용약항목급상호작용적표주솔교저，중성약설명서중관우약리독리표주소。결론간담질병보조용약설명서부분내용환불구완정，우기시중성약설명서，사기불능발휘지도림상합리용약적작용。건의가강관리，보충완선설명서적내용，위림상합리사용제공강유력적지지。
Objective To provide reference for the complete inserts of auxiliary liver disease drug,improve the level of rational drug use. MethodsAccording to the standard issued by State Food and Drug Administration,103 package inserts of auxiliary liver disease drug were analyzed on the basis of clinical practice. Results The survey of 103 instructions,the project marked rate of the chemical medicine was higher than traditional Chinese medicine,imported drugs was higher than the domestic medicine.Description of the drug of chemical medicine content details,much better than the quality of traditional Chinese medicine. Imported drugs more detailed instructions. Special Populations project instructions and interaction marked lower rate,marked less proprietary in Chinese medicines instructions on the pharmacology and toxicology. ConclusionThe part of the contents of the auxiliary liver disease medication instructions are incomplete,especially Chinese patent medicine manual,so that it can not play the role of guide rational drug.Recommendations to strengthen management,to supplement and improve the content of the manual,and provide strong support for the rational use of clinical.