摘要
目的综合评价前列舒通胶囊治疗慢性前列腺炎湿热瘀阻证的临床价值。方法采用定性与定量相结合的评价方法,基于循证医学、流行病学、临床医学、药物经济学、卫生技术评估等方法学,通过对文献数据、企业资料、问卷调查、公开资料、真实世界数据及文献二次评价,利用多准则决策分析模型对前列舒通胶囊的安全性、有效性、经济性、创新性、适宜性、可及性和中医药特色6+1维度进行度量,综合评价其临床价值。各维度评价结果由好到差依次分为A、B、C、D四个等级。结果1)安全性维度:药品说明书、自发呈报系统(SRS)及文献报道表明已知风险较可控,证据较充分,安全性评为B级。2)有效性维度:前列舒通胶囊联合喹诺酮类抗生素治疗慢性前列腺炎可降低美国国立卫生研究院慢性前列腺炎症状评分(NIHCPSI)、疼痛症状评分、排尿障碍评分,GRADE证据质量低,证据价值高,有效性评为B级。3)经济性维度:前列舒通胶囊联合盐酸莫西沙星片治疗慢性前列腺炎在总有效率、前列腺液(EPS)白细胞计数减少、NIH-CPSI评分指标上更具经济性;经济学研究质量评价证据报告基本完整,结果较明确,经济性评为A级。4)创新性维度:针对慢性前列腺炎湿热瘀阻证,联合喹诺酮类抗生素可提高临床效果,市场占有率高,基层覆盖率广,荣获发明专利及中药大品种科技竞争力排行榜上榜品牌,创新性评为B级。5)适宜性维度:前列舒通为胶囊制剂,医护人员配制及给药方便,不良反应救治难度低,在个性化用药、药品信息宣传方面有待提高,无特殊技术和管理要求;患者用法用量较易掌握和接受,不受安全性、经济性及药品信息影响,无需特殊时间给药,贮运方便,适宜性评为B级。6)可及性维度:在同类中成药中日均价格具有较好的优势,销售范围广,医院配备率高,基层市场占有率高,药材资源可持续供应,疗程费用占城镇/农村居民人均可支配收入比低,可及性评为A级。7)中医药特色维度:组方有中医药基础理论,人用经验较丰富,中医药特色较突出。综合6+1维度证据,前列舒通胶囊治疗慢性前列腺炎的临床价值效用分数为0.67分,临床价值综合评价为B类。结论前列舒通胶囊治疗慢性前列腺炎湿热瘀阻证临床证据较充分,临床价值较好,且中医药特色较突出。
ObjectiveTo comprehensively evaluate the clinical value of Qianlie Shutong Capsule(前列舒通胶囊)i n the treatment of chronic prostatitis with damp-heat stasis obstruction syndrome.MethodsA combination of qualitative and quantitative evaluation methods was used,with methodologies of evidence-based medicine,epidemio-logy,clinical medicine,pharmacoeconomics,health technology assessment and others,to collect data from literature and pharmaceutical companies,questionnaire surveys,public files,real-world experience and literature review,and to evaluate the clinical value of Qianlie Shutong Capsule comprehensively by measuring the 6+1 dimensions from safe-ty,effectiveness,economy,innovation,suitability,accessibility to specific features of traditional Chinese medicine(T CM)with the aid of multi-criteria decision analysis model.Results1)Safety:package insert,spontaneous re-porting system(SRS)monitoring data and literature reports showed that as the known risks were controllable,and the evidence was sufficient,the safety was rated as level B.2)Effectiveness:Qianlie Shutong Capsule combined with quinolone antibacterial drugs can reduce the National Institutes of Health Chronic Prostatitis Symptom Index(NIH-CPSI),pain symptom score,urination disorder score in the treatment of chronic prostatitis,with GRADE evidence quality as low and evidence value as high;the effectiveness was rated as level B.3)Economy:Qianlie Shutong Cap⁃s ule combined with moxifloxacin hydrochloride tablets in the treatment of chronic prostatitis was more economical in terms of total effective rate,decrease in expressed prostatic secretions(EPS)leukocyte(WBC)count,and NIH-CPSI score.Quality evaluation of economic research was basically complete,and the results were clear,making the econo-my rated as level A.4)Innovation:for chronic prostatitis with damp-heat stasis obstruction syndrome,QianlieS hutong Capsule combined with quinolone antibacterial drugs can improve the clinical effect,with high market share and wide grassroots coverage,winning the grants for invention patent and the top rankings of scientific and technologi-cal competitiveness of large varieties of Chinese patent medicine Bbrands on the list;the innovation was rated as level B.5)Suitability:Qianlie Shutong as a capsule preparation is easily to be prepared and administered,and it is less difficult to deal with the adverse reactions.It needs to be improved in terms of individualized medication plans and drug promotion,and there are no special technical and management requirements.Moreover,it does not require spe-cial time for administration,and is characterized by convenient storage and transportation.The suitability was rated as level B.6)Accessibility:Qianlie Shutong Capsule has an advantage of average daily price over similar patent med-icines,with a wide range of sales,a high hospital procurement rate,a high grassroots market share,a sustainable sup-ply of medicinal materials,and low proportion of treatment cost in per capita disposable of urban/rural residents.Therefore,the accessibility was rated as level A.7)Specific features of TCM:the prescription is backed up by the ba-sic theory of TCM as well as the rich human experience,showing prominent TCM specific features.Based on the evi-dence from the 6+1 dimensions,the clinical value and utility score of Qianlie Shutong Capsule in the treatment of chronic prostatitis was 0.67,and the comprehensive evaluation was rated as Class B.Conclusion Qianlie ShutongC apsule has good clinical value in the treatment of chronic prostatitis(damp-heat and blood stasis syndrome).
作者
张强
王志飞
谢雁鸣
ZHANG Qiang;WANG Zhifei;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,100700)
出处
《中医杂志》
CSCD
北大核心
2022年第21期2037-2045,共9页
Journal of Traditional Chinese Medicine
基金
国家重点研发计划(2018YFC1707410)。
关键词
慢性前列腺炎
前列舒通胶囊
湿热瘀阻证
临床综合评价
chronic prostatitis
Qianlie Shutong Capsule(前列舒通胶囊)
damp-heat stasis obstruction syndrome
clinical comprehensive evaluation
