摘要
目的基于多维度证据全面评价卤米松/三氯生乳膏治疗感染性湿疹性皮肤病的临床价值。方法依据《药品临床综合评价管理指南》,从安全性、有效性、经济性、创新性、适宜性及可及性六个维度,整合药品说明书、不良反应监测数据、临床试验、药物经济学研究及指南共识等证据,采用循证医学方法进行综合评价。结果安全性:国家药品不良反应监测系统(2019至2024年)累计报告不良反应51例/78例次,均为轻度局部刺激症状(瘙痒、红斑等),无严重不良反应;有效性:治疗感染性急性湿疹性皮肤病满意有效率92.6%(治愈率69.6%),获多个国内外指南共识推荐;经济性:日均治疗费用5.83~8.75元,增量成本效果比(ICER)优于丙酸倍他米松/硫酸庆大霉素乳膏;创新性:国内唯一强效糖皮质激素(卤米松)与广谱抗菌剂(三氯生)复方制剂;适宜性:覆盖全国10196家医疗机构,剂型稳定,用法简便(每日1~2次外用);可及性:纳入国家医保乙类目录,2周治疗费用占全国居民可支配收入0.56%。结论卤米松/三氯生乳膏在治疗感染性湿疹性皮肤病中展现出显著的临床综合价值。
Objective To comprehensively evaluate the clinical value of Halometasone/Triclosan Cream for infected eczematous dermatitis based on multi-dimensional evidence.Methods Following the Guidelines for Clinical Comprehensive Evaluation of Drugs,evidence from six dimensions(safety,efficacy,economy,innovation,suitability,accessibility)was synthesized.Evidence such as drug labeling,adverse reaction monitoring data,clinical trials,pharmacoeconomic studies,and guideline recommendations were integrated and comprehensively evaluated by avidence-based medicine.Results Safety:51 cases(78 incidents)of mild local adverse reactions(e.g.,pruritus,erythema)were reported in the national adverse drug reaction monitoring system(2019-2024),with no severe events.Efficacy:The satisfactory response rate was 92.6%(cure rate 69.6%)for infected acute eczematous dermatitis,supported by some clinical guidelines.Economy:Daily cost was 5.83-8.75 yuan,with a favorable incremental cost-effectiveness ratio(ICER)versus betamethasone dipropionate/gentamicin sulfate cream.Innovation:The only compound preparation in China combining a potent corticosteroid(halometasone)and broad-spectrum antimicrobial(triclosan).Suitability:Widely available in 10196 medical institutions;Stable dosage form and simple administration(1-2 times daily).Accessibility:Covered by national medical insurance category B directory;The two-week treatment cost accounts for 0.56%of the disposable income of all residents in the country.Conclusion Halometasone/Triclosan Cream demonstrates significant clinical value in treating infected eczematous dermatitis.
作者
黄正明
杨新波
张建中
顾恒
陶娟
洪舟
HUANG Zhengming;YANG Xinbo;ZHANG Jianzhong(China Medical Education Association,Beijing 100071,China;不详)
出处
《中国处方药》
2025年第21期72-77,共6页
Journal of China Prescription Drug
关键词
卤米松/三氯生乳膏
感染性湿疹性皮肤病
安全性
有效性
临床综合评价
Halometasone/Triclosan Cream
Infected eczematous dermatitis
Safety
Effectiveness
Clinical comprehensive evaluation
