Liu Jianping, Zhu Minghui, Shi Rui, Yang Min
The West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Am J Chin Med. 2003;31(3):337-54. doi: 10.1142/S0192415X03001107.
To evaluate the effects of radix Sophorae fiavescentis for chronic hepatitis B, a systematic review of randomized clinical trials was conducted. Randomized trials comparing extract of radix Sophorae flavescentis versus placebo, no intervention, non-specific treatment, other active medicines, or interferon for chronic hepatitis B were identified by electronic and manual searches. Trials of Sophorae herb plus other drugs versus other drugs alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assessed by the Jadad scale plus allocation concealment. Meta-analysis was performed where data was available. Twenty-two randomized trials (n = 2409) were included. Methodological quality of the trials was generally low. The combined results showed that matrine (aqueous extract of Sophorae flavescentis) had antiviral activity, positive liver biochemical effects, and improved symptoms and signs compared with non-specific treatment and other herbal medicines. The combination of matrine and interferon-alpha (IFN-alpha), thymosin, or basic treatment showed better effects on viral and liver biochemical responses. The antiviral and biochemical responses were not significantly different between matrine and IFN-alpha. No serious adverse event was reported. Based on the review, Sophorae flavescentis extract (matrine) may have antiviral activity and positive effects on liver biochemistry in chronic hepatitis B. However, the evidence is not sufficient to recommend matrine for routine clinical use due to the generally low methodological quality of the studies. Further rigorous trials are needed.
为评估苦参治疗慢性乙型肝炎的效果,我们进行了一项随机临床试验的系统评价。通过电子检索和手工检索,确定了比较苦参提取物与安慰剂、无干预措施、非特异性治疗、其他活性药物或干扰素治疗慢性乙型肝炎的随机试验。还纳入了苦参与其他药物联合使用与单独使用其他药物的试验。未设定盲法和语言限制。采用Jadad量表加分配隐藏来评估试验的方法学质量。在数据可用时进行荟萃分析。共纳入22项随机试验(n = 2409)。试验的方法学质量普遍较低。综合结果显示,与非特异性治疗和其他草药相比,苦参碱(苦参水提取物)具有抗病毒活性、对肝脏生化指标有积极影响,并能改善症状和体征。苦参碱与α-干扰素(IFN-α)、胸腺肽或基础治疗联合使用对病毒和肝脏生化反应显示出更好的效果。苦参碱与IFN-α之间的抗病毒和生化反应无显著差异。未报告严重不良事件。基于该综述,苦参提取物(苦参碱)可能对慢性乙型肝炎具有抗病毒活性和对肝脏生化指标的积极影响。然而,由于研究的方法学质量普遍较低,证据不足以推荐苦参碱用于常规临床应用。需要进一步进行严格的试验。