Ghodsi Seyed Mohammad, Mohebbi Niayesh, Naderi Soheil, Anbarloie Mousareza, Aoude Ahmad, Habibi Pasdar Seyed Sohail
Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran.
Department of Clinical Pharmacy, Faculty of Pharmacy and Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2015 Winter;14(1):125-30.
Cerebral vasospasm considered to be a serious cause of morbidity and mortality following subarachnoid haemorrhage (SAH).Despite several available therapeutic options, current protocols do not prevent major consequences of vasospasm. Inflammation is believed to play an important role in post-haemorrhagic vasospasm. Meloxicam is a non-steroidal anti-inflammatory drug. The aim of this study was to compare the efficacy of meloxicam versus placebo on vasospasm in patients with SAH. In this randomized, double-blind, placebo-controlled trial, SAH patients randomly received 7.5 mg meloxicam or placebo twice daily for 7 days. End points were, middle cerebral artery velocity obtained with transcranial doppler, in-hospital mortality, hospital stay and discharge Glasgow Outcome Scale. Eighty-one patients enrolled in the study. (40 received meloxicam, 41 received placebo). Baseline characteristics were similar between the groups. There were no differences in length of hospitalization (17.4 ± 3.1 vs 18.6 ± 4.2 days; p = 0.145), in-hospital mortality rate (15 vs 22%; p-value=0.569), or GOS (p = 0.972) between the two groups. MCA velocity were slightly less in patients who had received meloxicam, but not to a significant degree (p-value=0. 564(. No side effect has been detected for meloxicam. This study did not prove meloxicam efficacy in vasospasm of SAH patients. But it demonstrated that clinical trial of meloxicam in these patients is feasible and probably safe. The effectiveness of meloxicam on cerebral vasospasm has to be studied in larger trials.
脑血管痉挛被认为是蛛网膜下腔出血(SAH)后发病和死亡的严重原因。尽管有几种可用的治疗选择,但目前的方案并不能预防血管痉挛的主要后果。炎症被认为在出血后血管痉挛中起重要作用。美洛昔康是一种非甾体抗炎药。本研究的目的是比较美洛昔康与安慰剂对SAH患者血管痉挛的疗效。在这项随机、双盲、安慰剂对照试验中,SAH患者随机接受每日两次7.5毫克美洛昔康或安慰剂,共7天。终点指标为经颅多普勒测得的大脑中动脉流速、住院死亡率、住院时间和出院时格拉斯哥预后评分。81名患者参与了该研究。(40名接受美洛昔康,41名接受安慰剂)。两组之间的基线特征相似。两组在住院时间(17.4±3.1天对18.6±4.2天;p = 0.145)、住院死亡率(15%对22%;p值=0.569)或格拉斯哥预后评分(p = 0.972)方面没有差异。接受美洛昔康的患者大脑中动脉流速略低,但差异不显著(p值=0.564)。未检测到美洛昔康的副作用。本研究未证明美洛昔康对SAH患者血管痉挛有效。但它表明美洛昔康在这些患者中的临床试验是可行的且可能是安全的。美洛昔康对脑血管痉挛的有效性必须在更大规模的试验中进行研究。