Basurto Ona Xavier, Osorio Dimelza, Bonfill Cosp Xavier
Emergency Department, Hospital de Figueres, Fundació Salut Empordà, Rda Rector Aroles s/n, Figueres, Girona-Catalunya, Spain, 17600.
Cochrane Database Syst Rev. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3.
This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post-dural puncture headache'.Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness.
To assess the effectiveness and safety of drugs for treating PDPH in adults and children.
The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions.
We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow-up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data.
Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta-analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention-to-treat (ITT) analysis.
We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH).Two RCTs reported data for PDPH persistence of any severity at follow-up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option.Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome.Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment.There were no clinically significant drug adverse events.The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect.
AUTHORS' CONCLUSIONS: None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment.There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin).These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s.
这是2011年第8期发表的关于“药物治疗硬膜穿刺后头痛”的原始Cochrane系统评价的更新版本。硬膜穿刺后头痛(PDPH)是腰椎穿刺最常见的并发症,腰椎穿刺是急诊室经常进行的侵入性操作。已经提出了许多药物来治疗PDPH,但它们的临床有效性仍存在一些不确定性。
评估药物治疗成人和儿童PDPH的有效性和安全性。
检索包括Cochrane对照试验中心注册库(CENTRAL 2014年第6期)、MEDLINE及MEDLINE在研数据库(1950年至2014年7月29日)、EMBASE(1980年至2014年7月29日)和CINAHL(1982年至2014年7月)。无语言限制。
我们纳入了评估任何用于治疗PDPH的药物有效性的随机对照试验(RCT)。本系统评价考虑的结局指标包括:随访时任何严重程度的PDPH持续存在(主要结局)、因头痛而受限的日常活动、提供的保守辅助治疗选择、进行硬膜外血贴、疼痛严重程度评分的变化、疼痛严重程度评分的改善、参与者住院天数、任何可能的不良事件及缺失数据。
系统评价作者独立选择研究、评估偏倚风险并提取数据。我们对二分类数据估计风险比(RR),对连续性结局估计均值差(MD)。我们为每个RR和MD计算95%置信区间(CI)。我们未进行Meta分析,因为纳入的研究评估了不同种类的药物或不同的结局。我们进行了意向性分析(ITT)。
本系统评价纳入了13项小型RCT(479名参与者)(至少274名参与者为女性,其中118名是在区域麻醉下进行腰椎穿刺后的产妇)。在本Cochrane系统评价的原始版本中,仅纳入了7项小型RCT(200名参与者)。评估的药物有口服和静脉注射咖啡因、皮下注射舒马曲坦、口服加巴喷丁、口服普瑞巴林、口服茶碱、静脉注射氢化可的松、静脉注射促肾上腺皮质激素释放激素和肌内注射促肾上腺皮质激素(ACTH)。两项RCT报告了随访时任何严重程度的PDPH持续存在的数据(主要结局)。与安慰剂相比,咖啡因在1至2小时时减少了PDPH参与者的数量。使用咖啡因治疗还减少了保守辅助治疗选择的需求。与安慰剂相比,以及在第2、3和4天与麦角胺加咖啡因相比,加巴喷丁治疗在第1、2、3和4天导致更好的视觉模拟评分(VAS)。与单独的传统治疗相比,以及与安慰剂相比,氢化可的松加传统治疗在第6、24和48小时显示出更好的VAS评分。与对乙酰氨基酚在第2、6和12小时相比,以及与保守治疗在第8、16和24小时相比,茶碱治疗显示出更好的VAS评分。与安慰剂相比,茶碱的平均“疼痛总和”也更低。舒马曲坦和ACTH对此结局未显示任何相关效果。与保守治疗相比,茶碱导致报告疼痛评分改善的参与者比例更高。未观察到具有临床意义的药物不良事件。纳入的RCT未报告其余结局或未显示任何相关效果。
新纳入的研究均未提供额外信息以改变原始Cochrane系统评价上一版发表时的结论。与安慰剂相比,咖啡因已显示出治疗PDPH的有效性,降低了PDPH持续存在的参与者比例以及需要辅助干预的参与者比例。加巴喷丁、氢化可的松和茶碱已显示出可降低疼痛严重程度评分。与传统治疗相比,茶碱还显示出报告疼痛评分改善的参与者比例更高。对于其他评估的药物(舒马曲坦、促肾上腺皮质激素、普瑞巴林和促肾上腺皮质激素释放激素)缺乏确凿证据。由于缺乏信息以正确评估偏倚风险、研究样本量小以及其普遍性有限,这些结论应谨慎解读,因为近一半的参与者是30多岁的产后女性。