Choi Songie, Oh Dal-Seok, Jerng Ui Min
The K-herb Research Center, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
PLoS One. 2017 Aug 10;12(8):e0182794. doi: 10.1371/journal.pone.0182794. eCollection 2017.
The aim of this study was to systematically review data regarding pharmacokinetic (PK)-pharmacodynamic (PD) parameters from randomized controlled trials relating to interactions between herbal medicines and warfarin.
Three electronic databases were searched to identify relevant trials. Two reviewers independently performed the study selection and data extraction. The risk of bias and reporting quality were also assessed independently by two reviewers using the Cochrane risk of bias tool and the consolidated standards of reporting trials (CONSORT). Outcomes were measured for all reported PK-PD parameters and adverse events.
Nine randomized controlled trials met our inclusion criteria. Most of the included studies were unclear regarding the risk of bias and had a low quality of methodology. Using CONSORT, the reporting percentages for the articles ranged from 36.5% to 61.5% and the mean percentage for all articles was 45.6%. St John's wort and echinacea affected the PK parameters of warfarin. Ginseng, ginger, garlic, and cranberry had no significant effect on the PK parameters. American ginseng altered the PD parameters of warfarin. St John's wort, ginseng, Korea red ginseng, ginkgo, ginger, garlic, aged garlic, and echincea did not significantly alter the PD parameters. Studies of ginkgo and cranberry showed conflicting results on the PK parameters and PD parameters, respectively. The incidence of adverse events in all trials was low and no major adverse events were reported.
It was difficult to determine whether ten herbal medicines had significant effects on the PK-PD parameters of warfarin. Low quality of evidence, different compounds within and different compositions of the herbs, and methodological limitations of the crossover study, which is a clinical study in which subjects receive a sequence of different interventions, made it difficult to form conclusions. Additional studies that remedy these vulnerabilities are necessary to verify these results.
本研究旨在系统回顾有关草药与华法林相互作用的随机对照试验中的药代动力学（PK）-药效学（PD）参数数据。
检索三个电子数据库以识别相关试验。两名审阅者独立进行研究筛选和数据提取。两名审阅者还使用Cochrane偏倚风险工具和报告试验的统一标准（CONSORT）独立评估偏倚风险和报告质量。对所有报告的PK-PD参数和不良事件进行测量。
九项随机对照试验符合我们的纳入标准。大多数纳入研究的偏倚风险不明确，方法学质量较低。使用CONSORT，文章的报告百分比范围为36.5%至61.5%，所有文章的平均百分比为45.6%。圣约翰草和紫锥菊影响华法林的PK参数。人参、生姜、大蒜和蔓越莓对PK参数无显著影响。西洋参改变了华法林的PD参数。圣约翰草、人参、高丽参、银杏、生姜、大蒜、陈年大蒜和紫锥菊未显著改变PD参数。银杏和蔓越莓的研究分别在PK参数和PD参数上显示出相互矛盾的结果。所有试验中不良事件的发生率较低，未报告重大不良事件。
难以确定十种草药对华法林的PK-PD参数是否有显著影响。证据质量低、草药内部不同的化合物和不同的成分，以及交叉研究（一种受试者接受一系列不同干预措施的临床研究）的方法学局限性，使得难以得出结论。需要进行其他弥补这些缺陷的研究来验证这些结果。
