龙金通淋胶囊的临床综合评价

Clinical Comprehensive Evaluation of Longjintonglin Capsules

关键词:  龙金通淋胶囊  前列腺炎  临床综合评价

Key words:  longjintonglin capsules  prostatitis  clinical comprehensive evaluation

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，龙金通淋胶囊联合化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化药治疗慢性前列腺炎对比单用化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 Tongling 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. And the safety is rated as grade A. Efficacy evaluation showed that Longjintonglin Capsules had curative effect in treating chronic prostatitis, prostatic hyperplasia and male dysfunction, which had been recommended by 3 guidelines and 4 experts. Literature research shows that combination chemotherapy showed more effectively in treating prostatitis, compared with the control grouph (other positive drugs alone). Longjintonglin Capsules demonstrated significant efficacy in treating chronic prostatitis, evidenced by marked reductions in prostatic fluid white blood cell count, pain scores, urinary symptom scores, and quality of life impact scores. The effectiveness is rated as grade A. Economic evaluation showed that Longjintonglin capsules combined with conventional western medicine treatment of chronic prostatitis compared with conventional western medicine alone has cost-effective advantage. The economic performance is rated as grade A.The inheritance and innovation evaluation shows that Longjintonglin Capsules originates from the folk prescription of Yi nationality in Yunnan Province, which has the effects of dispelling damp-heat, removing blood stasis and clearing shower. Longjintonglin Capsules which has inheritance and innovation, was granted a patent. innovation is 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 is rated as grade A. The accessibility evaluation shows that the raw material resources of Longjintonglin Capsules are sustainable, the drug sales spread to many provinces, autonomous regions and municipalities directly under the Central Government, and belong to Class B drugs of medical insurance.The accessibility is rated as grade A. CONCLUSION Longjintonglin capsules are safe and effective in clinical practice, which provides reference for drug selection and management.