龙金通淋胶囊的临床综合评价

    Clinical Comprehensive Evaluation of Longjin Tonglin Capsules

    • 摘要:
      目的 开展龙金通淋胶囊临床综合评价,探索其临床优势,以推进临床合理用药。
      方法 应用循证医学、流行病学、医学统计学等方法,对本品治疗前列腺炎的有效性、安全性、经济性、传承与创新性、适宜性、可及性等方面进行评价。
      结果 龙金通淋胶囊临床前研究以及国家不良反应监测中心上报情况主要集中在胃肠系统,安全性评级为A类。有效性评价显示,龙金通淋胶囊在治疗慢性前列腺炎等方面疗效较优,已被 3 部指南、4 部专家共识推荐。文献研究显示,龙金通淋胶囊联合西药可以有效治疗慢性前列腺炎,与对照组相比,能够显著降低前列腺液白细胞数、减少疼痛评分、减少排尿症状评分、改善生活质量影响评分,有效性评级为A类。经济学评价显示,龙金通淋胶囊联合常规西药治疗慢性前列腺炎对比单用西药具有成本效果优势,经济性评级为A类。传承与创新性评价显示,龙金通淋胶囊源于云南彝族民间验方,具有祛湿热、化瘀、通淋的功效,且申请专利 1 项,具有传承与创新性,创新性评级为A类。适宜性评价显示,该药为胶囊剂,患者依从性好,其药品说明书符合现行规定,适宜性较好,适宜性评级为A类。可及性评价显示,龙金通淋胶囊原药材资源可持续,药品销售遍及30多个省自治区直辖市特别行政区,且属医保乙类药品,可及性较高,可及性评级为A类。
      结论 龙金通淋胶囊来源于民族验方,临床应用安全有效,该研究为药品遴选及管理提供参考依据。

       

      Abstract:
      OBJECTIVE  To evaluate clinical effectiveness of Longjin Tonglin capsules, aiming to explore their clinical advantages and promote rational drug use in clinical practice.
      METHODS Evidence-based medicine, epidemiology and medical statistics were used to evaluate the efficacy, safety, economy, inheritance and innovation, suitability and accessibility of this product in treating prostatitis.
      RESULTS  All the adverse reactions detected in the preclinical study and National Adverse Reaction Monitoring Center, were general and mainly concentrated in gastrointestinal system, the safety was rated as grade A. Efficacy evaluation showed that Longjin Tonglin capsules had curative effect in treating chronic prostatitis, which had been recommended by 3 guidelines and 4 experts. Literature research had showed that Longjin Tonglin capsules, in combination with western medicine were more effectively in treating prostatitis. Compared with the control group, the combination therapy significantly reduced the white blood cell count, pain scores, urinary symptom scores, and improved the quality of life impact scores. The effectiveness was rated as grade A. Economic evaluation showed that Longjin Tonglin capsules combined with conventional western medicine treatment of chronic prostatitis compared with conventional western medicine alone had cost-effective advantage. The economic performance was rated as grade A. The inheritance and innovation evaluation showed that Longjin Tonglin capsules originated from the folk prescription of Yi nationality in Yunnan Province, which had the effects of dispelling damp-heat, removing blood stasis and clearing shower. Longjin Tonglin capsules granted a patent, and had inheritance and innovation, innovation was rated as grade A. Suitability evaluation showed that the drug was capsule, patient compliance was good, its package insert met the current regulations, and the suitability was rated as grade A. The accessibility evaluation showed that Longjin Tonglin capsules had sustainable raw material resources, were sold in more than 30 provinces, autonomous regions, municipalities, and special administrative regions, and belonged to Class B drugs of medical insurance.The accessibility was rated as grade A.
      CONCLUSION Longjin Tonglin capsules are derived from an ethnic folk prescription and have proven safe and effective clinically, which provides reference for drug selection and management.

       

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