恒古骨伤愈合剂不良事件临床特点及影响因素分析  

Clinical Characteristics of Adverse Events and Influencing Factors of Osteoking

作　　者：董芃萱 全锐 周峻 林娜[3] 宓保宏 陈卫衡 DONG Pengxuan;QUAN Rui;ZHOU Jun;LIN Na;MI Baohong;CHEN Weiheng(The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100029,China;Engineering Research Center of Chinese Orthopaedic and Sports Rehabilitation Artificial Intelligent,Ministry of Education,Beijing 100029,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]北京中医药大学第三附属医院,北京100029 [2]中医骨伤治疗与运动康复智能化教育部工程研究中心,北京100029 [3]中国中医科学院中药研究所,北京100700

出　　处：《中国实验方剂学杂志》2024年第18期132-138,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：首都卫生发展科研专项重点攻关项目(2022-1-7032)。

摘　　要：目的:观察恒古骨伤愈合剂不良事件临床特点及影响因素,为临床合理用药提供依据。方法:采用前瞻性,多中心,大样本,队列研究方法,观察2020年5月1日至2021年12月31日来自20家医院就诊的922例膝骨关节炎患者的恒古骨伤愈合剂真实世界治疗情况,使用恒古骨伤愈合剂的患者设为暴露队列,未使用恒古骨伤愈合剂的患者为非暴露队列,记录患者的性别、年龄、身体质量指数、职业、过敏史、既往病史、就诊医院、用药信息、不良事件的发生情况,并分析不良事件的发生率、发生特征和影响因素等。结果:共收集膝骨关节炎患者922例,男性274例(29.72%),女性648例(70.28%),其中暴露队列617例和非暴露队列305例。所有病例共发生25例不良事件,占总病例数2.71%,其中暴露队列17例(2.76%),非暴露队列8例(2.62%),两组发生率差异无统计学意义(P=0.907)。暴露队列不良事件发生率最高的年龄段为50~59岁(4.61%);女性发生率为3.49%,略高于男性的1.07%,但差异无统计学意义(P=0.156);按不良事件发生的系统分类,5例为呼吸系统、胸及纵隔疾病,发生率为0.81%;感染及浸染类疾病、皮肤及皮下组织类疾病、心脏相关疾病、症状和体征(不另分类)、眼器官疾病各2例,发生率均为0.32%;全身性疾病、神经病类、心脏器官疾病、血管低血压疾病各1例,发生率均为0.16%。试验期间共发生7例不良反应,其中2例表现为咽干,2例表现为头晕,1例表现为困倦,1例表现为低血压,1例为眼分泌物,不良反应发生率为1.13%。通过二元Logistic回归分析,可能影响暴露队列不良事件发生的因素中,就诊医院为中医医院是不良事件发生的保护因素(OR=0.200,P=0.002),而尚不能认为性别、年龄、身体质量指数(BMI)、职业、过敏史、既往病史、就诊医院级别对不良事件的发生有影响。结论:恒古骨伤愈合剂治疗膝骨关节炎,偶见轻度不良事件发生,�Objective To observe the clinical characteristics and influencing factors of adverse events of Osteoking and provide a basis for its rational use in clinical practice.Method A prospective and multicenter Cohort study with large samples was conducted to observe the effects of Osteoking in the treatment of 922 patients with knee osteoarthritis from 20 hospitals from May 1,2020 to December 31,2021.Patients who were treated with Osteoking were set as the exposed cohort,and those who were not treated with Osteoking were set as the non-exposed cohort.The gender,age,body mass index(BMI),occupation,allergy history,past medical history,hospital information,medication,and the occurrence of adverse events of the patients were recorded,and the incidence of adverse events was analyzed,as well as its characteristics and factors.Result A total of 922 patients with knee osteoarthritis were involved,including 274 males(29.72%)and 648 females(70.28%),from which 617 cases were in the exposed cohort,and 305 cases were in the non-exposed cohort.A total of 25 adverse events occurred in both cases,accounting for 2.71%of the total number of cases,with 17 cases in the exposed cohort(2.76%)and eight cases in the non-exposed cohort(2.62%).There was no difference in the incidence rate between the two groups(P=0.907).The age group with the highest incidence of adverse events was between 50 and 59 years old in the exposed cohort(4.61%).The incidence rate in women was 3.49%,slightly higher than 1.07%in men,but there was no difference(P=0.156).According to the systematic classification of adverse events,five cases were respiratory,thoracic,and mediastinal diseases,with an incidence rate of 0.81%.There were two cases of infection and infection diseases,two cases of skin and subcutaneous tissue diseases,two cases of heart-related diseases,two cases of symptoms and signs(not otherwise classified),and two cases of eye organ diseases,and the incidence rate was 0.32%.There was one case of systemic disease,one case of neuropathy,one case of heart orga

关 键 词：恒古骨伤愈合剂 膝骨关节炎 不良事件 不良反应 

分 类 号：R2-0[医药卫生—中医学] R33R24R274