Shamon Sandy D, Perez Marco I
Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada, V6T 1Z3.
Cochrane Database Syst Rev. 2009 Oct 7(4):CD007655. doi: 10.1002/14651858.CD007655.pub2.
Many antihypertensive agents exist today for the treatment of primary hypertension (systolic blood pressure >/=140 mmHg and/or diastolic blood pressure >/=90 mmHg). Randomised controlled trials have been carried out to investigate the evidence for these agents.There is, for example, strong RCT evidence that thiazides reduce mortality and morbidity. Reserpine has been used as a second-line therapy in some of those trials. However, the dose-related blood pressure reduction with this agent is not known.
To investigate the dose-related effect of reserpine on blood pressure, heart rate and withdrawals due to adverse events.
The databases CENTRAL, EMBASE, and MEDLINE were searched. We also traced citations in the reference sections of the retrieved studies.
Included studies were truly randomised controlled trials comparing reserpine monotherapy to placebo or no treatment in patients with primary hypertension.
Methods of randomization and concealment were assessed. Data on blood pressure reduction, heart rate,and withdrawal due to adverse effects were extracted and analysed.
Four RCTs (N =237) were found that met the inclusion criteria. The overall pooled effect demonstrates a statistically significant systolic blood pressure (SBP) reduction in patients taking reserpine compared to placebo (WMD -7.92, 95% CI -14.05, -1.78). Due to significant heterogeneity across trials, a significant effect in diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) could not be found. The SBP effects were achieved with 0.5 mg/day or greater. However, the dose-response pattern could not be determined because of the small number of trials. Data from the trial that investigated Rauwiloid against placebo was not combined with reserpine data from the remaining three trials. This is because Rauwiloid is a different alkaloid extract of the plant Rauwolfia serpentina and the dose used is not comparable to reserpine. None of the included trials reported withdrawals due to adverse effects.
AUTHORS' CONCLUSIONS: Reserpine is effective in reducing SBP roughly to the same degree as other first-line antihypertensive drugs. However, we could not make definite conclusions regarding the dose-response pattern because of the small number of included trials. More RCTs are needed to assess the effects of reserpine on blood pressure and to determine the dose-related safety profile before the role of this drug in the treatment of primary hypertension can be established.
目前有多种抗高血压药物用于治疗原发性高血压(收缩压≥140 mmHg和/或舒张压≥90 mmHg)。已开展随机对照试验来研究这些药物的证据。例如,有强有力的随机对照试验证据表明噻嗪类药物可降低死亡率和发病率。在其中一些试验中,利血平被用作二线治疗药物。然而,该药物与剂量相关的血压降低情况尚不清楚。
研究利血平对血压、心率及因不良事件导致的撤药情况的剂量相关效应。
检索了Cochrane系统评价数据库(CENTRAL)、荷兰医学文摘数据库(EMBASE)和美国国立医学图书馆医学索引数据库(MEDLINE)。我们还在检索到的研究的参考文献部分追踪了引文。
纳入的研究为真正的随机对照试验,比较利血平单药治疗与安慰剂或不治疗在原发性高血压患者中的疗效。
评估随机化和隐匿方法。提取并分析有关血压降低、心率及因不良反应导致撤药的数据。
发现四项符合纳入标准的随机对照试验(N = 237)。总体汇总效应显示,与安慰剂相比,服用利血平的患者收缩压有统计学意义的降低(加权均数差 -7.92,95%可信区间 -14.05,-1.78)。由于各试验间存在显著异质性,未发现舒张压、平均动脉压和心率有显著效应。收缩压效应在每日剂量0.5 mg及以上时出现。然而,由于试验数量较少,无法确定剂量反应模式。研究萝芙木碱与安慰剂对照的试验数据未与其余三项试验的利血平数据合并。这是因为萝芙木碱是蛇根木植物的一种不同生物碱提取物,其使用剂量与利血平不可比。纳入的试验均未报告因不良反应导致的撤药情况。
利血平在降低收缩压方面的效果与其他一线抗高血压药物大致相同。然而,由于纳入试验数量较少,我们无法就剂量反应模式得出明确结论。在确定该药物在原发性高血压治疗中的作用之前,需要更多随机对照试验来评估利血平对血压的影响并确定其剂量相关的安全性。