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肝泰舒胶囊治疗病毒性乙型肝炎的系统评价与Meta分析 被引量:9

Efficacy and safety of Gantaishu Capsules for viral B hepatitis:a systematic review and Meta-analysis
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摘要 该文评价肝泰舒治疗病毒性肝炎的疗效和安全性。通过计算机检索Cochrane Library,PubMed、万方数据库、维普、中国知网(CNKI)、中国生物医学文献数据库(Sino Med),检索时限为建库至2018年11月,纳入肝泰舒治疗病毒性肝炎的随机对照试验,采用Cochrane 5. 0推荐的偏倚风险评估工具对纳入的研究进行方法学质量评价,通过使用Rev Man 5. 3软件进行Meta分析,对于不能合并的研究采用描述性分析。利用GRADE软件对系统评价的结果进行证据分级。共纳入6项随机对照试验,Meta分析结果显示,在HBe Ag阴转率(RR=2. 09,95%CI[0. 90,4. 85],P=0. 09,I2=0%)、HBV-DNA阴转率(RR=1. 49,95%CI[0. 56,3. 95],P=0. 43,I2=0%)和治疗前后谷丙转氨酶(ALT)水平的变化(RR=-6. 28,95%CI[-72. 83,60. 27],P=0. 85,I2=99%)方面,肝泰舒胶囊与东宝甘泰片无统计学差异。在生活质量方面,肝泰舒胶囊能够明显改善乙肝患者的症状,且不良反应较少。GRADE证据等级为'低级别证据'。结果表明肝泰舒胶囊与东宝甘泰片在抗病毒方面无统计学差异,而相较于当飞利肝宁胶囊在抗病毒方面优势明显,能够明显改善慢性乙型肝炎患者的症状,临床安全性较好,可以考虑在辨证施治的情况下应用。鉴于纳入研究的质量偏低,需要更多高质量的临床试验进行证实。 To evaluate the efficacy and safety of Gantaishu Capsules in the treatment of viral B hepatitis.The randomized controlled trials(RCT)retrieved from Cochrane Library,PubMed,Sino Med,CNKI,Wan Fang and VIP were enrolled.The methodology quality of the included studies was evaluated,and a Meta-analysis was performed using Rev Man 5.3 software.A total of six randomized controlled trials were included.Meta-analysis results showed that the similarities in the negative conversion rate of HBe Ag(RR=2.09,95%CI[0.90,4.85],P=0.09,I2=0%),the HBV-DNA negative rate(RR=1.49,95%CI[0.56,3.95],P=0.43,I2=0%)and the changes in ALT levels before and after treatment(RR=-6.28,95%CI[-72.83,60.27],P=0.85,I2=99%),with no statistical difference.In terms of quality of life,Gantaishu Capsules can significantly alleviate the symptoms of hepatitis B patients,with less adverse reactions.Gantaishu Capsules and Dongbao Gantai Tablets were similar in antiviral effect.In this term,Gantaishu Capsules was superior to Dangfei Liganning Capsules.It can significantly alleviate the symptoms of chronic hepatitis B patients,with a good clinical safety.Therefore,it can be applied in the case of syndrome differentiation and treatment.In view of the low quality of the included studies,more high-quality clinical trials were required to confirm its efficacy.
作者 李德恒 黄坡 李博 李秀惠 LI De-heng;HUANG Po;LI Bo;LI Xiu-hui(Hainan West Central Hospital,Danzhou 571700,China;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing You'an Hospital Affiliated to Capital Medical University,Beijing 100069,China)
出处 《中国中药杂志》 CAS CSCD 北大核心 2019年第13期2858-2864,共7页 China Journal of Chinese Materia Medica
基金 国家自然科学基金项目(81774146)
关键词 肝泰舒胶囊 病毒性乙型肝炎 有效性 安全性 系统评价 Gantaishu Capsules viral B hepatitis efficacy safety systematic review
作者简介 通讯作者:李秀惠,主任医师,主要从事肝病研究,E-mail:lixiuhui@sohu.com;通讯作者:李博,副主任医师,主要从事消化系统和循证医学研究,E-mail:dr.libo@vip.163.com;李德恒,副主任医师,主要从事中西医结合防治肝胆病,E-mail:liuchun177@163.com
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