目的分析真实世界中榄香烯乳注射液肝癌患者联合用药特征。方法基于2003年1月1日至2019年7月31日医院信息系统(hospital information system,HIS)数据库中全国21家医院,对使用榄香烯乳注射液中441例肝癌患者进行描述分析,通过采用Aprior...目的分析真实世界中榄香烯乳注射液肝癌患者联合用药特征。方法基于2003年1月1日至2019年7月31日医院信息系统(hospital information system,HIS)数据库中全国21家医院,对使用榄香烯乳注射液中441例肝癌患者进行描述分析,通过采用Apriori算法建立模型和clementine12.0进行关联分析,分析肝癌患者人群特征和榄香烯乳注射液联合用药特征。结果肝癌患者人群特征结果为肝癌患者的西医诊断为肝恶性肿瘤760例次(合并患者各次诊断结果),占比最多(22.66%),无中医诊断病例;入院科室中肿瘤诊疗中心102例,占比最多(23.13%);使用榄香烯乳注射液的肝癌患者男性多于女性;平均年龄为58.39岁,46~65岁患者数206例,占比最多(46.71%);患者住院时间中位数为24 d,28 d患者数占比最多(40.36%);104例出现病危,病危持续时间在≤1 d者100例(22.68%),269例出现病重,病重持续时间中位数为11 d;给药途径为静脉滴注占比最多;单次用药剂量≤200 mg患者数390例,占比最多(99.49%)。榄香烯乳注射液联合用药特征为其合并用药品种主要有维生素类、地塞米松、谷胱甘肽、康艾注射液、氨基酸类等;合并用药类别主要为血液代用品和灌注液、抗肿瘤药、免疫促进药、抗菌药、矿物质补充剂。同时通过复杂网络分析结果验证,榄香烯乳注射液联合用药结果与用药特征分析结果一致性较好。榄香烯乳注射液联合用药规律主要为辅助抗肿瘤和平衡体内基本需求的作用。结论通过对使用榄香烯乳注射液的肝癌患者进行用药特征及复杂网络分析,均得出其一般与维生素类、地塞米松、谷胱甘肽、康艾注射液、氨基酸类等联合使用,根据联合用药的特征得出相关联合用药规律,可为药物的临床使用和深入分析提供指导。展开更多
Objective:To systematically evaluate the efficacy and safety of Longshengzhi Capsules(龙生蛭胶囊)in the treatment of cerebral infarction.Materials and methods:A randomized controlled trial of Longshengzhi Capsules(龙...Objective:To systematically evaluate the efficacy and safety of Longshengzhi Capsules(龙生蛭胶囊)in the treatment of cerebral infarction.Materials and methods:A randomized controlled trial of Longshengzhi Capsules(龙生蛭胶囊)for cerebral infarction was screened out by searching CNKI,Wanfang Data,VIP,Sino Med,Cochrane Library,Pub Med,Embase,Web of Science in a systematic way and was based on Handbook 5.1 evaluation criteria and tools and Rev Man 5.3 software for Meta-analysis of the final inclusion of the study.Results:A total of 12 studies were included,including 9 meta-analysis of studies and 3 other studies,with a total sample size of 1446 cases,including 746 cases in the experimental group and 700 cases in the control group.The results of Meta-analysis showed that the Chinese Stroke Chinical Neurological Deficit Scales Score(CSS)of Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction was better than that of conventional treatment alone(MD=–6.98,95%CI[–7.41,–6.55],P<0.00001).The National Institues of Health Sroke Scales(NIHSS)score of Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction was better than that of conventional treatment alone(MD=–1.49,95%CI[–1.78,–1.20],P<0.00001);The quality of life score of Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction was better than that of conventional treatment(MD=6.65,95%CI[3.97,9.33],P<0.00001).Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment in treating cerebral infarction was better than conventional treatment in Homocysteine(Hcy)(MD=–2.44,95%CI[–2.89,–1.99],P<0.00001).There was no significant difference in the incidence of adverse reactions between Longshengzhi Capsules(龙生蛭胶囊)and conventional treatment for cerebral infarction(RR=0.58,95%CI[0.31,1.06],P=0.08).The main adverse reactions were skin rash,gastrointestinal reaction,headache,dizziness,abdominal pain,irritability,chills,urticaria,blood pressure reduction,dyspnea,vomiting,fever and urinary tract infection,which did not affect the treatment.Due to the small sample size,a large sample is needed for further verification.Conclusion:Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction reduced CSS and NIHSS scores,improved quality of life scores,and reduced Hcy,without serious adverse reactions,and the incidence of adverse reactions was similar to that of conventional treatment.However,the quality of the study is not high,and it is necessary to improve the level of evidence quality by using clinical trial schemes with large samples,rigorous design and compliance with international standards.展开更多
基金The Ministry of Science and Technology,2018 National Key R&D Program"Research on Modernization of Traditional Chinese Medicine"project"Evidence-based evaluation of ten types of proprietary Chinese medicines and classic prescriptions for the treatment of major diseases after marketing and demonstration research on their effect mechanisms"(2018YFC1707400)。
文摘Objective:To systematically evaluate the efficacy and safety of Longshengzhi Capsules(龙生蛭胶囊)in the treatment of cerebral infarction.Materials and methods:A randomized controlled trial of Longshengzhi Capsules(龙生蛭胶囊)for cerebral infarction was screened out by searching CNKI,Wanfang Data,VIP,Sino Med,Cochrane Library,Pub Med,Embase,Web of Science in a systematic way and was based on Handbook 5.1 evaluation criteria and tools and Rev Man 5.3 software for Meta-analysis of the final inclusion of the study.Results:A total of 12 studies were included,including 9 meta-analysis of studies and 3 other studies,with a total sample size of 1446 cases,including 746 cases in the experimental group and 700 cases in the control group.The results of Meta-analysis showed that the Chinese Stroke Chinical Neurological Deficit Scales Score(CSS)of Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction was better than that of conventional treatment alone(MD=–6.98,95%CI[–7.41,–6.55],P<0.00001).The National Institues of Health Sroke Scales(NIHSS)score of Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction was better than that of conventional treatment alone(MD=–1.49,95%CI[–1.78,–1.20],P<0.00001);The quality of life score of Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction was better than that of conventional treatment(MD=6.65,95%CI[3.97,9.33],P<0.00001).Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment in treating cerebral infarction was better than conventional treatment in Homocysteine(Hcy)(MD=–2.44,95%CI[–2.89,–1.99],P<0.00001).There was no significant difference in the incidence of adverse reactions between Longshengzhi Capsules(龙生蛭胶囊)and conventional treatment for cerebral infarction(RR=0.58,95%CI[0.31,1.06],P=0.08).The main adverse reactions were skin rash,gastrointestinal reaction,headache,dizziness,abdominal pain,irritability,chills,urticaria,blood pressure reduction,dyspnea,vomiting,fever and urinary tract infection,which did not affect the treatment.Due to the small sample size,a large sample is needed for further verification.Conclusion:Longshengzhi Capsules(龙生蛭胶囊)combined with conventional treatment for cerebral infarction reduced CSS and NIHSS scores,improved quality of life scores,and reduced Hcy,without serious adverse reactions,and the incidence of adverse reactions was similar to that of conventional treatment.However,the quality of the study is not high,and it is necessary to improve the level of evidence quality by using clinical trial schemes with large samples,rigorous design and compliance with international standards.
