تحليل "دليل المراقبة الدوائية للتطبيقات السريرية للأدوية الصينية الفموية المعالجة"

  • role: First author第一作者
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

  • Email:pengwenxi@163.com
  • Introduction:彭文茜,在读硕士,从事中药上市后评价研究,E-mail:pengwenxi@163.com
PENG Wenxi1,  
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

QIAO Meng1,  
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

WANG Lianxin1,  
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

LI Yuanyuan1,  
  • Affiliation:

    Beijing You'an Hospital,Capital Medical University,Beijing 100069,China

LI Xiuhui2,  
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

CUI Xin1,  
  • Affiliation:

    Xiyuan Hospital,China Academy of Chinese Medical Science,Beijing 100091,China

CHEN Zijia3,  
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

CHEN Xinyi1,  
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

DENG Yi1,  
  • role: Corresponding author通信作者
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

  • Email:ktzu2018@163.com
  • Introduction:谢雁鸣,首席研究员,博士生导师,从事中药上市后评价研究,E-mail:ktzu2018@163.com
XIE Yanming1*,  
  • role: Corresponding author通信作者
  • Affiliation:

    Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

  • Email:wzhftcm@163.com
  • Introduction:王志飞,研究员,博士生导师,从事中药上市后评价研究,E-mail:wzhftcm@163.com;
WANG Zhifei1*

ملخص

"دليل المراقبة الدوائية للتطبيقات السريرية للأدوية الصينية الفموية المعالجة" (المشار إليه فيما بعد بـ"الدليل") هو أول دليل متخصص في مجال المراقبة الدوائية للأدوية الصينية الفموية في الصين، يعتمد على ظروف الصين الوطنية، ويركز على خصائص استخدام الأدوية الصينية الفموية والمخاطر المرتبطة بها، ويملأ الفراغ في تنظيم هذا المجال. لضمان الفهم الصحيح والتنفيذ الفعال للدليل، وتعزيز بناء تنظيم مراقبة الأدوية الصينية الفموية، يقوم هذا المقال بتحليل شامل حول 3 محاور رئيسية في الدليل. في جانب الرصد والتقارير، يشرح الدافع العملي لاختيار دمج معلومات المخاطر من مصادر متعددة، ويوضح أيضًا أساس اختيار الأصناف والفئات السكانية المهمة للرصد؛ في جانب تقييم المخاطر، يحلل إطار تقييم المخاطر من ثلاثة جوانب: المكونات، السلوك، والفئات السكانية، للتعامل مع المخاطر المعقدة الناتجة عن تركيبة الدواء، المخاطر السلوكية، والاختلافات السكانية؛ في جانب التحكم في المخاطر، يركز على مفهوم التدخل في سيناريوهات المخاطر ومسار الإدارة الديناميكي المغلق، ويناقش كيفية التحول من الاستجابة السلبية إلى التدخل الإيجابي في الممارسة. بالإضافة إلى ذلك، يقوم المقال بتحليل قيمة تطبيق الدليل ويقترح مسارات تحسين بما في ذلك تحسين آلية التحديث الديناميكي، تعزيز التدريب الأساسي، ودفع تمكين المراقبة الدوائية بواسطة الذكاء الاصطناعي لمواجهة الصعوبات الحالية مثل ضعف التقنية الأساسية ونقص البنية التحتية المعلوماتية في القاعدة. يهدف هذا المقال إلى توفير مرجع قرارات ودعم تنفيذ للعاملين في حاملي رخص تسويق الأدوية (بما في ذلك شركات الأدوية)، وشركات توزيع الأدوية، والمؤسسات الطبية، والمعاهد البحثية وغيرها من الجهات ذات الصلة، لدفع إنشاء وتحسين نظام مراقبة الدواء طوال دورة حياة الأدوية الصينية الفموية.

مفهوم

الأدوية الصينية الفموية;التطبيقات السريرية;المراقبة الدوائية;تحليل الدليل

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