止喘灵口服液治疗哮喘的临床综合评价及高价值专利培育思考

摘要:目的 本研究对止喘灵口服液治疗哮喘的现有研究进行了“6+1”维度的临床综合评价，旨在明确止喘灵口服液治疗哮喘的临床优势及临床精准定位，为止喘灵口服液的进一步研究和学术推广提供基础，并为专利培育提供新的方向。方法 从安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色的“6+1”维度出发，采用定性与定量相结合的评价方法，通过专家会议法投票获得相关权重，使用CSC_v2.0软件对各维度进行计算后并转化为相应的等级评分。结果 基于现有资料，①止喘灵口服液说明书对不良反应、禁忌以及注意事项进行说明，自上市前后临床研究、自发呈报系统等多源数据表明，该药风险较可控，安全性较好，安全性评为B级。②上市前临床研究、临床有效性系统评价与Meta分析等多源数据表明，该药有效性较好，临床意义较大，有效性评为B级。③对止喘灵口服液联合常规治疗进行成本-效果分析表明，该药经济性较好，经济性评为B级。④止喘灵口服液创新性好，创新性评为A级。⑤问卷调查结果表明，该药可基本满足临床用药需求，适宜性较好，适宜性评为B级。⑥止喘灵口服液可及性好，可及性评为A级。⑦止喘灵口服液中医药理论丰富，人用经验较欠缺，中医药特色评为C级。综合“6+1”维度得出止喘灵口服液治疗哮喘（寒证、热证）的临床综合评价为B类。结论 止喘灵口服液治疗哮喘（寒证、热证）临床价值较好，创新性与可及性突出，建议可按程序转化为基本临床用药管理的相关政策结果，同时建议积极培育有中医药特色的专利。

Abstract:Objective This study conducted a "6 + 1" clinical comprehensive evaluation of the existing research on Zhichuanling oral liquid （ZOL） in the treatment of asthma，so as to clarify the clinical advantages and precise clinical positioning of ZOL in the treatment of asthma， lay a foundation for further research and academic promotion of ZOL， and provide new directions for patent cultivation.Method An evaluation method featuring a qualitative and quantitative combination was used， which considered the dimensions of safety，effectiveness，economy，innovation，suitability，accessibility， and traditional Chinese medicine （TCM） characteristics. According to Expert Meeting Law， relevant weights were obtained through voting. CSC_v2.0 software was used to calculate each dimension and convert it into the corresponding grade score.Result Based on the existing materials，① ZOL instruction indicates the adverse reactions，taboo， and notes. Multiple data of clinical research before and after marketing and spontaneous reporting system shows that ZOL has controllable risk and good safety. Safety is rated as B grade. ② Multiple data of clinical research before marketing， systematic evaluation of clinical effectiveness， and Meta-analysis shows that ZOL has good effectiveness and clinical significance. Effectiveness is rated as a B grade. ③ Analysis of the cost-effectiveness of ZOL combined with conventional treatment shows that the economy of the drug is good and rated as a B grade. ④ ZOL has better innovation， which is rated as an A grade. ⑤ ZOL can basically meet the clinical drug needs based on the result of the questionnaire survey and has good suitability， which is rated as a B grade. ⑥ ZOL has better accessibility， and accessibility is rated as A grade. ⑦ ZOL involves a rich theory of TCM but insufficient experience of human usage. It is thus rated as a C grade in terms of TCM characteristics. Based on the results of "6 + 1" dimension，the clinical comprehensive evaluation of ZOL in the treatment of asthma （cold syndrome and heat syndrome）is rated as B category.Conclusion ZOL has good clinical value and outstanding innovation and accessibility in the treatment of asthma （cold syndrome and heat syndrome）. It is recommended that ZOL be transformed into the relevant policy results of basic clinical drug management procedurally. At the same time，it is recommended to actively cultivate patents with TCM characteristics.