香菊胶囊治疗鼻-鼻窦炎的临床综合评价

Clinical comprehensive evaluation of Xiangju Capsules in treatment of rhinosinusitis

通过系统检索和收集香菊胶囊的文献信息,定性与定量研究相结合,对药品安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色(“6+1”维度)梳理临床证据,采用多准则决策分析(MCDA)模型及中成药临床证据和价值评估(CSC v2.0)软件,对香菊胶囊治疗鼻-鼻窦炎的临床价值进行综合评价,明确临床精准定位。各维度评价结果分为A、B、C、D 4个等级。多源安全性证据显示,不良反应主要有胃肠道反应,皮疹、瘙痒,头晕、头痛,基于现有研究,风险可控,安全性评为A级。Meta分析证据表明,香菊胶囊+常规西药可改善Lund-Kennedy评分、Lund-Mackay评分、鼻窦计算机断层扫描(CT)疗效评分,缓解头痛、鼻塞、嗅觉障碍及面部胀痛症状,有效性评为B级。香菊胶囊+常规西药治疗慢性鼻-鼻窦炎与单用常规西药相比,增量成本-效果比为263.71元,占人均可支配收入的0.82%,敏感性分析支持结果稳健性,香菊胶囊+常规西药更具有经济性。该药属于国家医保甲类,日均费用3.06元,经济性评为B级。香菊胶囊由经典方和特色验方化裁组成,能提升免疫力,兼顾疾病不同时期的病证特点,用于急、慢性鼻-鼻窦炎,异病同治,预防反复发作。适用性较广泛,特别对伴有头面部压痛者疗效显著,临床创新性鲜明;保障供应、产能及可扩展性、覆盖基层销售渠道等体现了服务创新性;通过药材资源管理、制药工业和生产工艺、质量控制、科技研发提升产业创新性,创新性评为B级。全国20个省份的188名医护人员和196例患者问卷调查显示,该药便于配制及给药、个体化用药、技术和管理,方便患者用药及储运,不良反应易于救治,适宜性评为B级。香菊胶囊治疗急、慢性鼻-鼻窦炎疗程费用分别为45.9、275.4元,可负担性良好。全国各省份的35000家医疗机构均有销售。剂型适合运输、贮藏及基层应用。药材资源丰富、可持续,可获得性良好,可及性评为A级。香菊胶囊兼顾急、慢性鼻-鼻窦炎,清热排脓与固表防复并用,上市后研究病例数超过4000例,积累了丰富的人用经验,中医药特色较突出,评为B级。综合评价后,香菊胶囊的临床价值评为B类,建议按照基本临床用药管理的相关政策继续发挥作用。

The articles involving Xiangju Capsules were retrieved,and qualitative research and quantitative research methods were combined to evaluate the evidence of the safety,effectiveness,economy,innovation,suitability,accessibility,and characteristics of traditional Chinese medicine("6+1"dimensions)of this drug.Multi-criteria decision analysis(MCDA)model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Xiangju Capsules in the treatment of rhinosinusitis and clarify the precise clinical positioning.The dimensions are graded A,B,C,or D.Multi-source safety evidence showed that the main adverse reactions were gastrointestinal reactions,rash,itching,dizziness,and headache.Based on the available studies,the risk is controllable and the safety is grade A.Meta-analysis showed that Xiangju Capsules+conventional western medicine could recover the Lund-Kennedy score,Lund-Mackay score,and CT score,relieve headache,nasal congestion,olfactory disturbance,and facial pain,with the effectiveness is grade B.The incremental cost-effectiveness ratio of Xiangju Capsules+conventional western medicine compared with conventional western medicine alone in the treatment of chronic rhinosinusitis was 263.71 yuan,about 0.82%of the per capita disposable income.The results of sensitivity analysis showed that the research results were relatively robust.Based on the assumption that the per capita disposable income in 2020 will be the threshold of patients′willingness to pay,it is more economical to use Xiangju Capsules+conventional western medicine.The drug belongs to grade A of the national medical insurance,with an average daily cost of 3.06 yuan,and the economy is grade B.This formula is modified from classic formulas and characteristic empirical formulas,be capable of improving immunity and preventing repeated attacks.It can be used for acute and chronic rhinitis-rhinosinusitis.It had a wide range of applicability,especially for the patients with head and face tenderness.Service innovation was reflected in the measures to guarantee supply,capacity,scalability,and coverage of grass-roots sales channels.The industrial innovation was improved through the management of medicinal resources,pharmaceutical industry,production technology,quality control,scientific research and development,and this formula won three national invention patents.Comprehensively,the innovation of Xiangju Capsules is grade B.According to the survey of 188 medical practitioners and 196 patients in 20 provinces,municipalities,and autonomous regions of China,the drug was characterized by easy preparation and administration,individualized medication,simple technology and management,convenient use,storage,and transport,and controllable adverse reactions,with the suitability is grade B.Xiangju Capsules showed the cost of 45.9 and 275.4 yuan for treatment of acute and chronic rhinitis-rhinosinusitis,respectively,being well affordable.It was sold in 35000 medical institutions in China.The dosage form was suitable for transportation,storage,and grass-root application.With rich,sustainable,and available medicinal resources,the accessibility of Xiangju Capsules is grade A.This drug can be used for both acute and chronic rhinitis-rhinosinusitis,clearing heat and expelling pus,and strengthening the exterior to prevent relapse.After this drug was available on the market,over 4000 cases were studied,with rich experience in human use accumulated,and characteristics of traditional Chinese medicine is grade B.Overall,the clinical value of Xiangju Capsules is class B.It is suggested that Xiangju Capsules should be used in accordance with the relevant policies of basic clinical drug administration to play its role.