摘要
目的以临床常用药物双歧杆菌四联活菌片为例,探索微生态制剂综合评价的内容和方法,为微生态制剂的临床合理使用、微生态制剂的研究开发和药品相关决策提供依据,推动合理用药。方法基于系统检索文献获得的研究资料,利用循证医学和药物经济学等卫生技术评估基本方法,从安全性、有效性、经济性、适宜性、可及性和创新性等方面对双歧杆菌四联活菌片进行评价。结果有效性方面,双歧杆菌四联活菌片治疗小儿腹泻、抗生素相关性腹泻、腹泻型肠易激综合征、溃疡性结肠炎等疾病继发腹泻,便秘,以及功能性消化不良均有显著疗效;且可应用于幽门螺杆菌相关性胃炎、肝硬化、非酒精性脂肪肝等多种疾病的治疗。安全性方面,该药的不良反应发生率低,且常为轻中度、一过性的症状。经济性方面,相对于单用美沙拉秦治疗溃疡性结肠炎,双歧杆菌四联活菌片联合美沙拉秦的增量成本效果比为1743.2,双歧杆菌四联活菌片相对日治疗费用低于双歧杆菌三联活菌制剂与地衣芽孢杆菌制剂联用(1.87~2.80元比2.08~5.78元)。创新性方面,该药有多项专利,并被认定为浙江省高新技术产品。适宜性方面,该药的使用适宜性和药品技术特点适宜性整体良好,在剂型、体系适应性等方面可进一步改善。可及性方面,该药的价格水平稳定,对于一般民众而言可负担且可及。结论从现有证据而言,双歧杆菌四联活菌片临床有效性得到支持,安全性良好,可及性良好,适宜性可进一步优化,创新性良好,但在不同临床应用中的经济性、创新性等方面需要更深入和更针对性的研究,在药品适宜性方面也有优化空间。
Objective To explore the contents and methods of clinical comprehensive evaluation of microecologics,with the example of Bifidobacterium quadruple viable tablet,in order to provide evidence for clinical rational use of microecologics,and microecologics research,development and related decision-making,and to promote rational use of medications.Methods Based on the research data collected from systematic literature search,health technology assessment methods such as evidence-based medicine and pharmacoeconomics evaluation were used to estimate the safety,efficacy,economics,suitability,accessibility and innovation of Bifidobacterium quadruple viable tablet.Results In terms of efficacy,Bifidobacterium quadruple viable tablet showed significant therapeutic effects in the treatment of pediatric diarrhea,antibiotic-related diarrhea,diarrhea-predominant irritable bowel syndrome,and secondary diarrhea caused by diseases such as ulcerative colitis,as well as constipation and functional dyspepsia.It can also be used in the treatment of various diseases such as Helicobacter pylori related gastritis,liver cirrhosis,non-alcoholic fatty liver disease.In terms of safety,the incidence of adverse effects of this medication was low,and most were mild to moderate and transient symptoms.In terms of economics,compared with mesalazine alone in the treatment of ulcerative colitis,the incremental cost-effectiveness ratio of combination of Bifidobacterium quadruple viable tablet and mesalazine was 1743.2.Besides,the daily treatment cost of Bifidobacterium quadruple viable tablet was lower than that of combination of Bifidobacterium triple viable and Bacillus licheniformis(1.87 to 2.80 yuan vs.2.08 to 5.78 yuan).In terms of innovation,this medication had multiple patents and had been identified as a high-tech product in Zhejiang Province.In terms of suitability,the overall suitability of use and technical characteristics of medication were good.It could be further improved in the aspects of dosage form and system.In terms of accessibility,the price of the medication was stable,affordable and accessible to the general public.Conclusions Based on the existing evidence,Bifidobacterium quadruple viable tablet presented effective with supported evidences,good safety,accessibility and innovation.The suitability can be further optimized.However,more in-depth and targeted research is needed in terms of economics and innovation in different clinical applications,and there is space for optimization in medication suitability.
作者
田杨
胡文
卢云
王璇璇
冯佳佳
高苏钰
李科标
黄安琪
张晶
程虹
刘巍
Tian Yang;Hu Wen;Lu Yun;Wang Xuanxuan;Feng Jiajia;Gao Suyu;Li Kebiao;Huang Anqi;Zhang Jing;Cheng Hong;Liu Wei(Hospital Management Institute of Wuhan University,Wuhan 430064,China;Department of Pharmacy,Zhongnan Hospital of Wuhan University,Wuhan 430071,China)
出处
《中华消化杂志》
CAS
CSCD
北大核心
2023年第9期612-625,共14页
Chinese Journal of Digestion
关键词
临床综合评价
双歧杆菌四联活菌片
微生态制剂
肠道菌群
Clinical comprehensive evaluation
Bifidobacterium quadruple viable tablet
Probiotic formulation
Intestinal flora
