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糖尿病肾病治疗用中成药临床综合评价

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目的 为临床合理选择治疗糖尿病肾病的中成药提供参考。方法 以国家卫生健康委员会《药品临床综合评价管理指南(2021 年版试行)》为依据,参考中成药临床综合评价技术规范和报告规范及《中成药临床综合评价管理指南(2022 年版试行)》,在安全性、有效性、经济性、创新性、适宜性、可及性和传承性 7 个维度对渴络欣胶囊、肾炎康复片、糖脉康胶囊/颗粒/片、苁蓉益肾颗粒、百令胶囊、金水宝胶囊/片、六味地黄丸、黄葵胶囊、通心络胶囊、尿毒清颗粒、肾衰宁片/胶囊、雷公藤多苷片、参芪降糖颗粒、益肾化湿颗粒评分,并进行临床综合评价。结果 安全性,黄葵胶囊、肾炎康复片和金水宝胶囊/片较好,雷公藤多苷片、益肾化湿颗粒较差;有效性,黄葵胶囊、参芪降糖颗粒疗效较好;经济性,肾炎康复片、渴络欣胶囊、雷公藤多苷片较有优势;创新性和传承性,14 种中成药均展现出了良好的创新性和强烈的中医药优势特色;适宜性,14 种中成药均为口服制剂,药品技术特点适宜性和药品使用适宜性均无明显差异;可及性,六味地黄丸和雷公藤多苷片更具有优势。14 种中成药的综合评分分别为 74。5 分、76。5 分、56。5 分、62。8 分、70。5 分、79。5 分、72 分、78。5 分、79。5 分、64 分、64。5 分、65 分、69。5 分、68。5 分。结论 综合 7 个维度的评价结果,金水宝胶囊/片、通心络胶囊和黄葵胶囊治疗糖尿病肾病的临床综合价值较高。
Clinical Comprehensive Evaluation of Chinese Patent Medicines for the Treatment of Diabetic Nephropathy
Objective To provide a reference for clinical rational selection of Chinese patent medicines for the treatment of diabetes nephropathy(DN).Methods Based on the Guidelines for Clinical Comprehensive Evaluation of Pharmaceuticals(2021 Version,trial)issued by the National Health Commission,technical standards and report standards for clinical comprehensive evaluation of Chinese patent medicines and Guidelines for Clinical Comprehensive Evaluation of Chinese Patent Medicines(2022 Version,trial),the Keluoxin Capsules,Shenyan Kangfu Tablets,Tangmaikang Capsules/Granules/Tablets,Congrong Yishen Granules,Bailing Capsules,Jinshuibao Capsules/Tablets,Liuwei Dihuang Pills,Huangkui Capsules,Tongxinluo Capsules,Niaoduqing Granules,Shenshuaining Tablets/Capsules,Leigongteng Duogan Tablets,Shenqi Jiangtang Granules and Yishen Huashi Granules were scored from the safety,effectiveness,economy,innovation,suitability,accessibility and inheritance,and the clinical comprehensive evaluation was conducted.Results The safety of Huangkui Capsules,Shenyan Kangfu Tablets and Jinshuibao Capsules/Tablets was better,while that of Leigongteng Duogan Tablets and Yishen Huashi Granules was poorer.Huangkui Capsules and Shenqi Jiangtang Granules were more effective.Shenyan Kangfu Tablets,Keluoxin Capsules and Leigongteng Duogan Tablets were more economical.All 14 kinds of Chinese patent medicines showed good innovation and strong advantages of traditional Chinese medicine;they were all oral preparations,and there was no significant difference in the suitability of drug technical characteristics and drug use.Liuwei Dihuang Pills and Leigongteng Duogan Tablets were more accessible.The comprehensive scores of the above 14 kinds of Chinese patent medicines were 74.5 points,76.5 points,56.5 points,62.8 points,70.5 points,79.5 points,72 points,78.5 points,79.5 points,64 points,64.5 points,65 points,69.5 points,68.5 points.Conclusion Based on the comprehensive evaluation from seven aspects,Jinshuibao Capsules/Tablets,Tongxinluo Capsules and Huangkui Capsules have a higher clinical comprehensive value in the treatment of DN.

diabetes nephropathyChinese patent medicineclinical comprehensive evaluationrational drug use

曾祥仲、胡紫微、陈举亮

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广州中医药大学第二附属医院珠海医院,广东 珠海 519000

糖尿病肾病 中成药 临床综合评价 合理用药

广东省珠海市社会发展领域科技计划医疗卫生项目

2320004000259

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(14)
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