喜炎平注射液治疗社区获得性肺炎:1项基于多准则决策分析的临床证据与价值评估研究

Xiyanping Injection for community-acquired pneumonia:A clinical evidence and value evaluation study based on multi-criteria decision analysis

目的基于多准则决策分析综合评估喜炎平注射液治疗社区获得性肺炎的临床价值。方法采用定性与定量相结合的评价方式,基于循证医学、流行病学、临床医学、临床药学、循证药学、药物经济学、卫生技术评估等方法学,结合调查问卷与数据库资料,利用多准则层决策分析模型(multi-criteria level decision analysis model,MCDA),围绕喜炎平注射液治疗社区获得性肺炎,从安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色“6+1”个维度综合评估其临床价值。结果安全性方面:根据药品说明书、国家药品不良反应监测中心自发呈报系统(spontaneous reporting system,SRS)、登记注册研究、临床文献报道、真实世界研究、官方网站通知公告、药物警戒与风险管理等,现有研究证据充分;喜炎平注射液不良反应主要表现为皮疹、瘙痒、恶心、呕吐、发热寒战等,临床安全性风险较可控,评价为B级,表明基于现有临床研究安全性良好。有效性方面:选取Meta分析作为有效性证据,喜炎平注射液联合抗生素(氟喹诺酮类、头孢菌素类、大环内酯类、β-内酰胺类)治疗成人社区获得性肺炎的临床总有效率、咳嗽消失时间、退热时间及住院治疗时间、相关理化指标改善优于单用抗生素治疗;采用GRADE体系评价证据质量,根据PICO原则衡量证据价值,评价为B级,表明基于现有临床研究有效性较好。经济性方面:以住院时间作为指标,喜炎平注射液联合头孢菌素类、抗病毒药物更具成本-效果优势;对证据质量和经济价值进行评价,评为B级,表明经济性较好。创新性方面:喜炎平注射液联合抗生素可显著提高临床疗效,药材及原料安全充足,可扩展性较好;分子结构中引入亲水基团以增强水溶性,改善穿心莲内酯生物利用度;工艺及药学已拥有国内授权发明专利20余项,评价为B级,表明创新性较好。适宜性方面:配备及给药方便,配伍禁忌及注意事项明确,用药疗程合适,但需关注用药反应,可基本满足临床用药需求,评价为B级,表明适宜性较好。可及性方面:疗程费用占城镇/农村居民人均可支配年收入比低,药品销售范围广,药材资源充足,接受治疗人数多,评为B级,表明可及性较好。中医药特色方面:喜炎平注射液为源于穿心莲的中药注射剂,辨证使用疗效更佳,人用经验丰富。综合喜炎平注射液治疗社区获得性肺炎“6+1”维度的证据结果,评价为B类。结论喜炎平注射液治疗社区获得性肺炎具有较好的临床综合价值,中医药特色较突出,建议可按程序有条件转化为基本临床用药管理的相关政策结果。

Objective To comprehensively evaluate the clinical value of Xiyanping Injection in the treatment of community-acquired pneumonia based on multi-criteria decision analysis.Methods Based on evidence-based medicine,epidemiology,clinical medicine,clinical pharmacy,evidence-based pharmacy,pharmacoeconomics,health technology evaluation and other methodologies,combined with questionnaires and database data,and using multi-criteria level decision analysis model(MCDA),the clinical value of Xiyanping Injection(喜炎平注射液)in the treatment of community-acquired pneumonia was comprehensively evaluated from the“6+1”dimensions of safety,effectiveness,economy,innovation,suitability,accessibility,and characteristics of traditional Chinese medicine.Results Safety:According to the drug label,spontaneous reporting system(SRS)of the National Adverse Drug Reaction Monitoring Center,registration research,clinical literature reports,real-world research,official website notification announcement,pharmacovigilance and risk management,etc.,the existing research evidence was sufficient.The adverse reactions of Xiyanping Injection were mainly manifested as rash,itching,nausea,vomiting,fever and chills,etc.The clinical safety risk was relatively controllable,and the evaluation was grade B,indicating that the safety was good based on existing clinical studies.Effectiveness:Metaanalysis was selected as evidence of effectiveness,and the results showed that the total clinical response rate,cough disappearance time,antipyretic time and hospitalization time,and related physicochemical indexes of Xiyanping Injection combined with antibiotics(fluoroquinolones,cephalosporins,macrolides,β-lactams)in the treatment of community-acquired pneumonia in adults were better than those treated with antibiotics alone.The quality of the evidence was measured according to GRADE,and the value of the evidence was measured according to the PICO principle,and the evaluation was grade B,indicating that the validity was good based on existing clinical research.Economy:The results of pharmacoeconomic evaluation shown that taking the length of hospital stay as an indicator,Xiyanping Injection combined with cephalosporins and antiviral drugs had more cost-effect advantages.The evaluation of evidence quality and economic value was rated as grade B,and the economy was better.Innovation:Xiyanping Injection combined with antibiotics could significantly improve clinical efficacy,medicinal materials and raw materials were safe and sufficient,and the scalability was good.Hydrophilic groups were introduced into the molecular structure to enhance water solubility and improve andrographolide bioavailability.Technology and pharmacy had more than 20 domestic authorized invention patents,which were evaluated as grade B and have good innovation.Suitability:There was no special technical management and requirements for clinical use of this variety,medical staff allocation and administration were convenient,cautious use should be paid close attention to,the patient’s medication course was appropriate,could basically meet the needs of clinical medication,evaluated as grade B,and the suitability was better.Accessibility:The cost of treatment accounts for a low proportion of the per capita disposable annual income of urban/rural residents,the sales range of drugs was wide,the resources of medicinal materials were sufficient,the number of people receiving treatment was large,rated as grade B,and the accessibility was better.Characteristics of traditional Chinese medicine:The drug was derived from Chuanxinlian(Andrographis Herba)extract,the therapeutic effect of syndrome differentiation is better,with rich human experience.Based on the evidence results of Xiyanping Injection in the“6+1”dimension of community-acquired pneumonia,the evaluation was B.Conclusion Xiyanping Injection has good clinical comprehensive value in the treatment of community-acquired pneumonia,and the characteristics of traditional Chinese medicine are prominent,and it is suggested that it can be conditionally transformed into relevant policy results of basic clinical drug management according to the procedure.