Aminophylline for treatment of postdural puncture headache A randomized clinical trial
Aminophylline for treatment of postdural puncture headache A randomized clinical trial
复制标题
氨茶碱治疗硬膜穿刺后头痛：一项随机临床试验
DOI：
10.1212/wnl.0000000000005351
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发表时间：
2018-04-24
期刊：
影响因子：
9.9
通讯作者：
Xie, Nanchang
中科院分区：
文献类型：
--
作者：
Wu, Chuanjie;Guan, Dongsheng;Xie, Nanchang
目的探讨静脉注射氨茶碱治疗硬膜穿刺后头痛（PDPH）的有效性和安全性。主要终点是治疗后8小时头痛的严重程度。我们使用站立位患者的视觉模拟量表（VAS）评分进行评估。我们还记录了治疗后VAS评分变化、患者总体印象变化（PGIC）评分和不良事件。我们进行了意向治疗analysis.ResultsWe招募了126例PDPH患者在5个中心在中国（62分配到氨茶碱组和64安慰剂组）。中位年龄为37岁，96例（76.2%）患者为女性。与安慰剂治疗的患者相比，氨茶碱治疗的患者在治疗后8小时的平均VAS评分显著较低（5.34 vs 2.98，p < 0.001），并且更可能报告PGIC改善（39.1% vs 72.6%，p < 0.01）。这种治疗效果在30分钟的时间点已经很明显，并持续2天。不良事件的发生率无显著差异（4.8% vs 1.6%，p = 0.589）。结论静脉注射氨茶碱是PDPH.ClinicalTrials.gov标识符NCT 02522013患者有效且安全的早期治疗方法。证据分类本研究提供了I类证据，证明对于PDPH患者，静脉注射氨茶碱可减轻头痛严重程度。
ObjectiveTo investigate the efficacy and safety of IV aminophylline for patients with postdural puncture headache (PDPH).MethodsWe randomly assigned patients to groups receiving either 250 mg IV aminophylline or a placebo within 3 hours of symptom onset once daily for 2 consecutive days. The primary endpoint was headache severity 8 hours after treatment. We assessed this using visual analog scale (VAS) scores taken from patients in a standing position. We also recorded posttreatment VAS score changes, Patient Global Impression of Change (PGIC) scores, and adverse events. We performed an intention-to-treat analysis.ResultsWe enrolled 126 patients with PDPH at 5 centers in China (62 assigned to the aminophylline group and 64 to the placebo group). The median age was 37 years, and 96 (76.2%) patients were women. Compared to the placebo-treated patients, the aminophylline-treated patients had significantly lower mean VAS scores 8 hours after treatment (5.34 vs 2.98, p < 0.001) and were significantly more likely to report improvements on the PGIC (39.1% vs 72.6%, p < 0.01). This therapeutic effect was already evident at the 30-minute time point and persisted for 2 days. There was no significant difference in the incidence of adverse events (4.8% vs 1.6%, p = 0.589).ConclusionsIV aminophylline is an effective and safe early-stage treatment for patients with PDPH.ClinicalTrials.gov identifierNCT02522013.Classification of evidenceThis study provides Class I evidence that for people with PDPH, IV aminophylline reduces headache severity.