摘要
目的从安全性、有效性、经济性、创新性、适宜性、可及性6个维度对人参健脾片治疗功能性胃肠病(FGIDs)进行综合临床评价,为国家基本药物遴选提供依据。方法采用名义群体法、访谈法和调查问卷法等多种方式构建临床综合评价指标体系,通过文献检索、问卷调查、企业资料搜集等方法获取人参健脾片及3个同类药物(参苓白术颗粒、补中益气颗粒、人参健脾丸)临床证据。采用多准则决策分析模型对药物的临床价值进行综合评估,采用层次分析法计算准则层、指标层、备选方案权重。采用等频离散化原则对评价结果进行分级。结果安全性证据表明,人参健脾片不良反应主要表现为轻微腹胀和头晕,无严重不良反应,基于现有研究,认为安全性证据较充分,风险较可控,安全性评为A级;临床研究表明,人参健脾片治疗FGIDs在改善腹泻症状方面较布拉氏酵母菌效果好,在改善餐后饱胀不适感、腹部疼痛和慢性腹泻症状体征方面较马来酸曲美布汀片效果好,有效性评为A级;人参健脾片与参苓白术颗粒、补中益气颗粒、人参健脾丸相比,日用药费最低,经济性评为A级;人参健脾片能改善FGIDs的多种临床症状,并且在药品制备工艺方面有多项专利,创新性强,评为A级;在药品的临床使用和患者依从性等方面,人参健脾片问卷调查得分较高,适宜性评为A级;药品药材供应可持续,价格低廉,疗程费用低,销售范围广,购买方便,可及性评为A级。结论人参健脾片治疗FGIDs的临床价值评A类,建议该药可按程序转化为基本药物目录用药。
Objective To assess the clinical value of Renshen Jianpi Tablets comprehensively in aspects of safety,effectiveness,economic value,innovativeness,suitability,and accessibility;To provide basis for the selection of national essential drugs.Methods The clinical comprehensive evaluation index system was constructed by means of nominal group method,interview method and questionnaire method,and the clinical evidence of Renshen Jianpi Tablets and three similar drugs(Shenling Baizhu Granules,Buzhong Yiqi Granules,Renshen Jianpi Pills)was obtained through literature search,questionnaire survey,enterprise data collection and other methods.Multi-criteria decision analysis model was used to comprehensively evaluate the clinical value of the drug,and analytic hierarchy process was used to calculate the weight of criteria,indicators and alternatives.The evaluation results were classified using the equal-frequency discretization rule.Results The safety evidence showed that the main adverse reactions of Renshen Jianpi Tablets were mild abdominal distension and dizziness,without serious adverse reactions.Based on the existing research,it was considered that the safety evidence was sufficient,the risk was relatively controllable,and the safety was rated as Grade A;clinical research showed that Renshen Jianpi Tablets was better than Saccharomyces boulardii in improving the symptoms of diarrhea,and better than trimebutine maleate in improving the symptoms and signs of postprandial fullness,abdominal pain and chronic diarrhea,and the effectiveness was rated as Grade A;compared with Shenling Baizhu Granules,Buzhong Yiqi Granules and Renshen Jianpi Pills,the daily drug cost of Renshen Jianpi Tablets was the lowest,and thus the economic value of the formula was at Grade A;Renshen Jianpi Tablets could improve a variety of clinical symptoms of FGIDs,and had a number of patents in drug preparation technology,thus the innovativeness was rated as Grade A;in terms of clinical use of drugs and patient compliance,Renshen Jianpi Tablets scored higher in the questionnaire survey,and its suitability was rated as Grade A;the supply of the drug and medicines was sustainable,the price was low,the cost of treatment was low,the scope of sales was wide,the purchase was convenient,and the accessibility was rated as Grade A.Conclusion The clinical value of Renshen Jianpi Tablets in treating FGIDs is graded A.It is suggested that the drug can be converted into the essential drug list according to the procedure.
作者
祖雅琪
唐旭东
于琦
李国祥
石文艳
李敬华
ZU Yaqi;TANG Xudong;YU Qi;LI Guoxiang;SHI Wenyan;LI Jinghua(Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国中医药信息杂志》
CAS
CSCD
2023年第10期178-185,共8页
Chinese Journal of Information on Traditional Chinese Medicine
基金
国家自然科学基金面上项目(81873200)。
关键词
人参健脾片
功能性胃肠病
临床综合评价
多准则决策分析
Renshen Jianpi Tablets
functional gastrointestinal disorders
clinical comprehensive evaluation
multi-criteria decision analysis
