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药品临床综合评价中真实世界数据质量控制的探讨和工作经验分享
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作者 尹文俊 谢悦良 +2 位作者 黄玉洁 朴慧玲 左笑丛 《中国药学杂志》 CAS CSCD 北大核心 2024年第4期369-374,共6页
目的探索药品临床综合评价中真实世界数据的质量控制,推动真实世界数据在药品临床综合评价中科学合理地应用。方法查阅国内外药品临床综合评价真实世界研究数据质量控制的文献,并结合笔者所在省份的药品临床综合评价中心开展的工作经验... 目的探索药品临床综合评价中真实世界数据的质量控制,推动真实世界数据在药品临床综合评价中科学合理地应用。方法查阅国内外药品临床综合评价真实世界研究数据质量控制的文献,并结合笔者所在省份的药品临床综合评价中心开展的工作经验,探讨药品临床综合评价真实世界研究数据质量控制的内容和流程。结果与结论真实世界研究数据质量控制一般分为内部质控和外部质控,评价方法包括定性评价,定量评价和综合评价,实施阶段可分为项目启动阶段和数据治理后阶段,并在这两阶段各开展一次数据质量控制。本研究归纳总结了药品临床综合评价真实世界研究数据质量控制的内容和流程,为研究者和决策者正确生产和使用基于真实世界数据药品临床综合评价证据提供参考。 展开更多
关键词 药品临床综合评价 真实世界数据 质量控制
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The Status Quo and Countermeasures of“4+7”Quantity Purchase in China
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作者 Zhou Yusheng Wei Xingchen +3 位作者 piao huiling Wang Nan Wang Xing Dong Li 《Asian Journal of Social Pharmacy》 2020年第2期89-96,共8页
Objective To understand the effectiveness and problems of centralized drug procurement in China by analyzing the implementation of the“4+7”pilot work for centralized drug procurement in China.Methods The current sit... Objective To understand the effectiveness and problems of centralized drug procurement in China by analyzing the implementation of the“4+7”pilot work for centralized drug procurement in China.Methods The current situation and existing problems of drug procurement in China were analyzed through the literature research method.Results and Conclusion At present,good social benefits have been achieved for China’s drug procurement through pilot projects in several cities,but there are some serious problems.The proposed countermeasures will help to improve the procurement of pharmaceuticals in China. 展开更多
关键词 quantity procurement 4+7 drug bidding
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Current Effect of“4+7”Drug Centralized Volume Procurement and Suggestions for Future Improvement
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作者 piao huiling Wei Xingchen +3 位作者 Wang Nan Wang Xing Zhou Yusheng Dong Li 《Asian Journal of Social Pharmacy》 2020年第4期198-212,共15页
Objective To explore the impact of the“4+7”city drug centralized procurement policy implemented from April 1st,2019 on China’s pharmaceutical market and the differences between this pilot scheme and the first volum... Objective To explore the impact of the“4+7”city drug centralized procurement policy implemented from April 1st,2019 on China’s pharmaceutical market and the differences between this pilot scheme and the first volume procurement,so as to put forward some suggestions for this policy and improve the drug price formation mechanism.Methods The characteristics of the“4+7”volume procurement policy and its improvements were summarized through literature research,and the distribution of the winning enterprises in volume procurement was shown by the chart.Then the overall situation of pharmaceutical enterprises in China was analyzed.Results and Conclusion According to the main distribution of enterprises in the alliance region,we can see that the first round of bid-winning enterprises with 25 varieties are mainly distributed in the eastern coastal cities of Jiangsu,Zhejiang,Shandong,and Guangdong,which shows a trend of developing to provinces of Sichuan,Hubei,and Hunan.With the increase of volume procurement inland cities will be included in the future.This pilot scheme of volume procurement is a reform of the entire pharmaceutical industry.It has improved the market structure and promoted the transformation and upgrading of regional medicine representatives.The most important thing is to enable the public to better enjoy the benefits brought by the low-priced drugs.However,for some pharmaceutical enterprises and drug retail industry,it is a challenge.Therefore,it is necessary to improve the policy and strengthen market supervision and management. 展开更多
关键词 volume procurement 4+7 drug bidding
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4种低分子肝素预防骨科大手术静脉血栓栓塞症的网状Meta分析及药物经济学评价 被引量:2
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作者 朴慧玲 谷旭瑞 +4 位作者 周凌云 周光亮 蒋安琪 谢悦良 左笑丛 《中国临床药学杂志》 CAS 2022年第10期746-755,共10页
目的 系统评价国内上市4种低分子肝素(依诺肝素、那屈肝素、达肝素和贝米肝素)预防骨科大手术静脉血栓栓塞症(VTE)的有效性、安全性及经济性。方法 检索PubMed、Embase、Cochrane Library、CNKI、VIP、Wanfang以及CMB等数据库,搜集相关... 目的 系统评价国内上市4种低分子肝素(依诺肝素、那屈肝素、达肝素和贝米肝素)预防骨科大手术静脉血栓栓塞症(VTE)的有效性、安全性及经济性。方法 检索PubMed、Embase、Cochrane Library、CNKI、VIP、Wanfang以及CMB等数据库,搜集相关的随机对照试验(RCTs)文献资料,按照纳入排除标准对文献资料进行筛选、提取和质量评价,采用Stata 15.0软件,以致死性肺栓塞(PE)发生率、非致死性PE发生率、主要出血发生率、VTE发生率、深静脉血栓(DVT)发生率以及全因死亡率为结局指标,进行网状Meta分析并评价低分子肝素的有效性和安全性。根据网状Meta分析的结果采用最小成本分析法(CMA)进行药物经济学评价。结果 共纳入26篇RCTs研究,包括6 939例患者。网状Meta分析结果显示:各低分子肝素在骨科大手术患者术后致死性PE发生率、非致死性PE发生率、主要出血发生率、VTE发生率、DVT发生率和全因死亡率的差异无统计学意义(P> 0.05)。最小成本分析结果显示:依诺肝素、那屈肝素、达肝素和贝米肝素按照药品说明书和指南推荐预防剂量和最短疗程(10 d)的平均药品成本分别为440.31、568.99、489.80、1 698.20元,依诺肝素的经济性最佳。结论 上市的4种低分子肝素的有效性和安全性基本相同,依诺肝素相比其他低分子肝素在预防骨科大手术后VTE更具经济学优势。 展开更多
关键词 低分子肝素 骨科大手术 静脉血栓栓塞症 网状Meta分析 经济学评价
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