摘要
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.
作者
SU Xin-xin
LV Jian
XIE Yan-ming
苏鑫鑫;吕健;谢雁鸣(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
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)。
