摘要
目的:探索痰热清注射液在真实世界应用中的辨证用药情况。方法:自"痰热清注射液上市后安全性再评价的真实世界研究"课题数据库中筛选中医诊断项非空的数据2 837例。数据进行标准化处理后分析真实世界中的痰热清注射液辨证用药与超适应证用药情况。结果:痰热清注射液临床主要用于咳(咯)痰不爽、发热、咽喉肿痛,占全部临床治疗症状的77.90%。临床多用于风温肺热病,证候多见于痰热阻肺证及其同类证名(50.65%)。有30.03%的患者存在不适宜病证用药,包含痰热清注射液用于禁忌病证、无关病证。与无医疗保险覆盖人群相比,被医疗保险覆盖的患者有可能被处方痰热清注射液用于其不适宜病证的趋势(OR=1.18,P=0.077 8,χ2=3.11)。与辨证不适宜组相比,辨证适宜组的住院时间更短(P<0.000 1,Z=143.88),住院总花费更低(P<0.000 1,Z=154.97),差异有显著性。结论:痰热清注射液中医临床主要治疗的症状、疾病、证候多符合说明书中标注的功能主治,仍存不适宜病证用药等情况,应建立相关中医诊疗规范。
OBJECTIVE To explore the prescription pattems of Tanreqing Injection in real world. METHODS 2 837 cases with non-empty data of Traditional Chinese Medicine(TCM) diagnosis items were screened from the database of "A Real World Study on Post-marketing surveillance of Tanreqing Injection".The data were normalized and analyzed for the real world use of Tanreqing Injection based on syndrome differentiation and off-label use. RESULTS Tanreqing injection was mainly for the treatment of cough with difficulty in expectoration, fever and swollen sore throat, accounting for 77.90% of total symptoms.It was widely used in the wind-warm pulmonary diseases, especially presenting syndromes as retention of phlegm-heat in the lung and its synonymous diagnosis(50.65%). There were 30.03% of the patients being not suitable for the disease, including Tanreqing injection for contraindications and unrelated disease.Compared with the population without health insurance coverage, there was a trend that patients covered by health insurance were likely to be prescribed Tanreqing Injection for their inappropriaten syndrome(OR=1.18,P=0.077 8,χ2=3.11). Compared with the patients being diagnosed appropriately, those with inappropriate diagnosis had a prolonged length of stay(P<0.000 1,Z=143.88)and a higher total cost(P<0.000 1,Z=154.97). CONCLUSION Tanreqing Injection is predominately used for approved TCM symptoms, diseases and syndromes;however, the fact of diagnosing without accurate syndrome differentiation or off-label use still exists. The standard of TCM diagnosis and treatment should be established.
作者
李潇潇
殷杰
朱昊如
郑虎占
杨毅恒
翟所迪
LI Xiao-Xiao;YIN Jie;ZHU Hao-ru;ZHENG Hu-zhan;YANG Yi-heng;ZHAI Suo-di(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Department of Pharmacy Administration and Clinical Pharmacy,School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《中国医院药学杂志》
CAS
北大核心
2019年第23期2412-2416,共5页
Chinese Journal of Hospital Pharmacy
基金
国家中医药管理2013年度科技项目(编号:国中医药科2013ZX04)
关键词
痰热清注射液
上市后再评价
中医
诊断
Tanreqing injection
post-marketing evaluation
Traditional Chinese medicine
diagnosis
