摘要
目的:系统评价舒肝宁注射液联合西药治疗病毒性肝炎的有效性和安全性。方法:计算机检索the Cochrane Library、PubMed、Embase、Web of Science、中国生物医学文献服务系统、万方数据库、中国知网、维普数据库等8个数据库,收集舒肝宁注射液联合西药治疗病毒性肝炎的随机对照试验(RCT),检索时限为建库至2022年6月。按照纳入与排除标准筛选文献、提取文献特征并以Cochrane偏倚风险评估工具评价文献质量,采用RevMan 5.3软件和R语言进行Meta分析。结果:共纳入18项RCT,合计1423例患者(观察组728例,对照组695例)。Meta分析结果显示,舒肝宁注射液联合西药治疗病毒性肝炎,其总有效率显著高于单纯使用西药,差异有统计学意义(RR=1.21,95%CI=1.15~1.28,P<0.00001);并能降低结合胆红素(DBIL)、丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)和碱性磷酸酶(ALP)水平,与单纯使用西药比较,差异均有统计学意义(P<0.05);且在降低不良反应发生率方面具有优势,但与单纯使用西药比较,差异无统计学意义(RR=0.82,95%CI=0.37~1.83,P=0.63)。报告总胆红素(TBIL)的各研究间异质性较大,仅进行组间比较,除1篇文献中两组患者TBIL水平的差异无统计学意义(P>0.05)外,其余文献中两组患者TBIL水平的差异均有统计学意义(P<0.05),从整体来看,舒肝宁注射液联合西药在降低TBIL水平方面较单纯使用西药有明显优势。结论:舒肝宁注射液联合西药治疗病毒性肝炎,可以提高治疗总有效率,降低TBIL、ALT、AST、ALP及DBIL水平,在一定程度上改善病毒性肝炎患者的肝功能,减少不良反应的发生。但仍需开展高质量的多中心、大样本、随机临床研究来进一步验证。
OBJECTIVE:To systematically evaluate the efficacy and safety of Shuganning injection combined with Western medicine in the treatment of viral hepatitis.METHODS:Randomized controlled trials(RCT)of Shuganning injection combined with Western medicine in the treatment of viral hepatitis were collected by retrieving 8 databases including the Cochrane Library,PubMed,Embase,Web of Science,SinoMed,Wanfang Data,CNKI and VIP from establishment of the database to Jun.2022.According to the inclusion and exclusion criteria,literature screening and characteristics extracting were conducted,and literature quality was evaluated by Cochrane risk of bias assessment tool,Meta-analysis was performed by using RevMan 5.3 software and R software.RESULTS:A total of 18 RCTs were enrolled,including 1423 patients(728 cases in the observation group and 695 cases in the control group).Results of Meta-analysis showed that the total effective rate of Shuganning injection combined with Western medicine in the treatment of viral hepatitis was significantly higher than that of Western medicine alone,with statistically significant difference(RR=1.21,95%CI=1.15-1.28,P<0.00001);which can reduce the direct bilirubin(DBIL),alanine aminotransferase(ALT),aspartate aminotransferase(AST)and alkaline phosphatase(ALP),and the differences were statistically significant compared with using Western medicine alone(P<0.05);which also had advantages in reducing the incidence of adverse drug reactions,while the difference was not statistically significant compared with using Western medicine alone(RR=0.82,95%CI=0.37-1.83,P=0.63).Heterogeneity among studies reporting total bilirubin(TBIL)was large,and only inter-group comparisons were made,which indicated that except for the difference of TBIL levels between two groups in one study was not statistically significant(P>0.05),the differences of TBIL levels between two groups in the rest studies were statistically significant(P<0.05),and from an overall point of view,the combination of Shuganning injection with Western
作者
张佳楠
杨玉晴
李春晓
郭静
张丽
凌霄
王盼盼
ZHANG Jianan;YANG Yuqing;LI Chunxiao;GUO Jing;ZHANG Li;LING Xiao;WANG Panpan(School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China;Dept.of Pharmacy,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;Henan Province Engineering Research Center for Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine/Henan Province Engineering Laboratory for Clinical Evaluation Technology of Chinese Medicine,Zhengzhou 450000,China;Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan province&Education Ministry of P.R.China,Henan University of Chinese Medicine,Zhengzhou 450046,China)
出处
《中国医院用药评价与分析》
2023年第12期1489-1495,共7页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
河南省中医药拔尖人才培养项目(No.2022ZYBJ05)
河南省中医管理局项目(No.2022ZY1049)。
