摘要
[目的]通过前瞻性、多中心病例注册登记研究,探讨中、西医院安宫牛黄丸(ANP)临床实际应用情况。[方法]采用电子数据采集(EDC)系统提取符合纳入排除标准的使用ANP的106家医院3573例病例,根据就诊医院性质分为中医院组(38家)和西医院组(68家)。应用Excel和SPSS 25.0对两组患者一般资料、临床治疗情况等信息进行描述性分析。运用卡方检验及非参检验对两组ANP使用情况和服ANP前后的患者病情评估进行比较。[结果]人口学特征方面,两组中位年龄为67岁,中位身体质量指数(BMI)为24.44 kg/m^(2),工作以非体力为主,男性居多。就诊科室中医院组主要为重症医学科(30.83%),西医院组主要为神经外科(49.34%),接诊医师两组均以主治医师最多。两组脑出血与急性缺血性脑卒中患者的占比大致相同,约39%。ANP用法方面,从服用方式来看,两组患者主要有口服和鼻饲两种方法,鼻饲稍多,差异无统计学意义(P=0.742)。从服用时机来看,两组患者超过98%遵医嘱服用。从每日服药频次来看,两组患者每日服用1次最多,最多每日服用5次。ANP用量方面,单次使用有0.75,1,1.5,2,3,6 g,其中3 g最多,即1丸。ANP使用疗程方面,中医院组中位数为2 d,西医院组中位数为3 d。ANP用药时点方面,中医院组发病后平均(5.13±10.93)d服药,西医院组发病后平均(3.42±7.01)d服药。合并西药方面,两组患者均以神经保护剂使用最多。其他治疗方面,中医院组针灸、物理治疗较多,而西医院组手术治疗较多。在改善患者病情方面,两组患者服ANP后改良Rankin评分(m RS)和美国国立卫生研究院卒中评分(NIHSS)均降低,Barthel指数(BI)均升高(P<0.05)。对于意识障碍的患者,两组服ANP后格拉斯哥昏迷评分(GCS)均升高(P<0.05)。对于认知障碍的患者,两组服ANP后简易精神状态评分(MMSE)均升高(P<0.05)。对于高热的患者,中医院组退热时间为(5.27±3.11)d,西医院组为(5.12±4.18)d。在整个治疗过程中,两组患者有8例发生不良事件,但是均未出现严重不良事件。[结论]本研究基于ANP临床实际诊疗数据,发现中、西医院两组患者以老年男性患者居多,体型大多偏胖。ANP临床应用以中风病为主,应用基本符合药品说明书,亦存在超说明书情况。中、西医院使用ANP均能取得一定疗效。
[Objective]To observe the clinical application of Angong Niuhuang Pill(ANP)in the hospital of traditional Chinese medicine(TCM)and Western medicine hospital through a prospective multi-center case registration study.[Methods]This study extracted 3573 cases from 106 hospitals using ANP that met the inclusion and exclusion criteria in the EDC system,and divided them into TCM hospital group(38 hospitals)and Western medicine hospital group(68 hospitals)according to the nature of the hospitals.Excel and SPSS 25.0 were used to conduct a descriptive analysis of the general data and clinical treatment of the two groups of patients.Chi-square test and non-parametric test were used to compare the use of ANP and the condition assessment of patients before and after ANP.[Results]In terms of demographic characteristics,the median age of the two groups was 67 years old,the median BMI was 24.44 kg/m^(2),and the work was mainly non-physical,and most of them were male.In the TCM hospital group,the department of intensive care medicine was mainly(30.83%),and in the Western medicine hospital group,the department of neurosurgery was mainly(49.34%).The attending physicians were the most in both groups.The proportion of patients with cerebral hemorrhage and acute ischemic stroke was about the same in the two groups,about 39%.In terms of ANP usage,from the perspective of administration methods,patients in the two groups mainly had oral and nasal feeding,with slightly more nasal feeding,and the difference was not statistically significant(P=0.742).From the perspective of taking time,more than 98%of patients in both groups took it as prescribed by doctors.From the daily frequency of medication,two groups of patients took once a day accounted for the most,up to 5 times a day.In terms of ANP dosage,a single use was 0.75,1,1.5,2,3,6 g,of which 3 g is the most,that is,1 pill.In terms of the duration of ANP use,the median number of days in the TCM hospital group was 2 d,and the median number of days in the Western medicine hospital group was 3 d.In terms of ANP administration time,the average time after the onset of ANP was(5.13±10.93)days in TCM hospital group and(3.42±7.01)days in Western medicine hospital group.In combination with Western medicine,the proportion of neuroprotective agents in both groups were the highest.In terms of other treatments,acupuncture and physical therapy were more common in the TCM hospital group,while surgery was more common in the Western medicine hospital group.In terms of improving patients’condition,mRS scores and NIHSS scores were decreased and BI scores were increased in both groups after taking ANP(P<0.05).For the patients with consciousness disorder,GCS scores were increased in both groups after taking ANP(P<0.05).For patients with cognitive impairment,MMSE scores were increased in both groups after taking ANP(P<0.05).For the patients with high fever,the duration of fever remission was(5.27±3.11)days in the TCM hospital group and(5.12±4.18)days in the Western medicine hospital group.During the whole course of treatment,8 patients in both groups had adverse events,but no serious adverse events occurred.[Conclusion]Based on the actual clinical diagnosis and treatment data of ANP,this study finds that most patients in the two groups of TCM hospital and Western medicine hospital are elderly males,and most of them are overweight.The clinical application of ANP is mainly for apoplexy,and the application basically conforms to the drug instructions,and there are off-instructions.The use of ANP in both TCM and Western medicine hospitals can achieve certain curative effects.
作者
孟祥然
朱雪松
刘波
曹雪
王馨
何丽云
刘佳
MENG Xiangran;ZHU Xuesong;LIU Bo;CAO Xue;WANG Xin;HE Liyun;LIU Jia(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Qingdao Hospital of Traditional Chinese Medicine,Qingdao 266001,China;Beijing Massage Hospital,Beijing 100035,China)
出处
《天津中医药》
2025年第5期560-567,共8页
Tianjin Journal of Traditional Chinese Medicine
基金
中国中医科学院科技创新工程项目(CI2021A00702-2)
北京市中医药科技基金(BJZYYB-2023-74)。
关键词
安宫牛黄丸
真实世界研究
临床应用
Angong Niuhuang Pill
real-world study
clinical application
作者简介
孟祥然(1993-),男,博士,主治医师,研究方向为中医临床评价方法研究;通讯作者:何丽云,E-mail:hely3699@163.com;刘佳,E-mail:marie_liujia@sina.cn。
