Mills Edward, Montori Victor M, Wu Ping, Gallicano Keith, Clarke Mike, Guyatt Gordon
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada L8N 3Z5.
BMJ. 2004 Jul 3;329(7456):27-30. doi: 10.1136/bmj.329.7456.27.
To determine the methodological quality of clinical trials that examined possible interactions of St John's wort with conventional drugs, and to examine the results of these trials.
Systematic review.
Electronic databases from inception to April 2004, reference lists from published reports, and experts in the field.
Eligible studies were prospective clinical trials evaluating the pharmacokinetic effect of St John's wort on the metabolism of conventional drugs.
Two reviewers selected studies for inclusion and independently extracted data.
22 pharmacokinetic trials studied an average of 12 (SD 5) participants; 17 trials studied healthy volunteers and five studied patients. Most (17) studies used a "before and after" design; four studies used control groups other than the active group. Three studies randomised the sequence of administration or the participants to study arms or periods; three studies blinded participants or investigators. In 15 trials, investigators independently assayed the herb. Of 19 trials with available plasma data, three found no important interaction (change in area under the curve < 20%) and 17 found a decrease in systemic bioavailability of the conventional drug; in seven studies the 95% confidence interval excluded a decrease of < 20%.
Clinicians and patients should beware of possible decreases in the systemic bioavailability of conventional drugs when taken concomitantly with St John's wort.
确定检验圣约翰草与传统药物之间可能相互作用的临床试验的方法学质量,并审查这些试验的结果。
系统评价。
从数据库建立至2004年4月的电子数据库、已发表报告的参考文献列表以及该领域的专家。
符合条件的研究为评估圣约翰草对传统药物代谢的药代动力学效应的前瞻性临床试验。
两名评审员选择纳入研究并独立提取数据。
22项药代动力学试验平均研究了12名(标准差5)参与者;17项试验研究了健康志愿者,5项试验研究了患者。大多数(17项)研究采用“前后”设计;4项研究使用了除活性组之外 的对照组。3项研究将给药顺序或参与者随机分配至研究组或研究阶段;3项研究对参与者或研究者实施了盲法。在15项试验中,研究者独立分析草药。在19项有可用血浆数据的试验中,3项未发现重要相互作用(曲线下面积变化<20%),17项发现传统药物的全身生物利用度降低;在7项研究中,95%置信区间排除了<20%的降低。
临床医生和患者应注意,传统药物与圣约翰草同时服用时,其全身生物利用度可能会降低。