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| 慢性前列腺炎/慢性盆腔疼痛综合征中药新药临床试验设计的思考 | |
| 引用本文： | 贾志超,吕佳康,曾银. 慢性前列腺炎/慢性盆腔疼痛综合征中药新药临床试验设计的思考[J]. 中国临床药理学杂志, 2022, 0(3): 281-284 |
| 作者姓名： | 贾志超 吕佳康 曾银 |
| 作者单位： | 1. 国家药品监督管理局药品审评中心;2. 首都医科大学附属北京中医医院男科 |
| 摘 要： | 慢性前列腺炎/慢性盆腔疼痛综合征(CP/CPPS)是中医治疗的优势特色之一.随着对疾病认识的深入,在中药新药的临床研究方面,国内2002年《中药新药临床研究指导原则(试行)》中CP/CPPS部分尚不能完全覆盖对本病的最新认识,目前国内外监管机构亦缺少CP/CPPS较新的指导原则,笔者通过梳理CP/CPPS中西医认识、治... |
| 关 键 词： | 慢性前列腺炎/慢性盆腔疼痛综合征 中药新药 临床试验设计 |
Consideration on clinical trial design of traditional Chinese medicine for chronic prostatitis/chronic pelvic pain syndrome |
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| JIA Zhi-chao,Lü Jia-kang,ZENG Yin. Consideration on clinical trial design of traditional Chinese medicine for chronic prostatitis/chronic pelvic pain syndrome[J]. The Chinese Journal of Clinical Pharmacology, 2022, 0(3): 281-284 | |
| Authors: | JIA Zhi-chao Lü Jia-kang ZENG Yin |
| Affiliation: | (Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Department of Andrology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China) |
| Abstract: | The treatment of chronic prostatitis/chronic pelvic pain syndrome( CP/CPPS) is one of the advantages and characteristics of traditional Chinese medicine. However, with the deepening of the understanding of the disease,the CP/CPPS part of the guiding principles for clinical research of new traditional Chinese medicine( trial) in 2002 can not fully cover the latest understanding of the disease. At present,domestic and foreign regulators also lack the relatively new guiding principles of CP/CPPS. By combing the understanding,treatment and clinical trials of CP/CPPS Chinese and western medicine,the author discusses the relevant contents of the traditional Chinese medicine clinical trials of this disease. |
| Keywords: | chronic prostatitis/chronic pelvic pain syndrome traditional Chinese medicine new drug clinical trial design |
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