氨茶碱可治疗硬膜外穿刺后头痛：随机临床试验
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Aminophylline for treatment of postdural puncture headache：A randomized clinical trial
背景与目的
本试验主要探讨氨茶碱治疗硬膜外穿刺后头痛（PDPH）的疗效和安全性。
方 法
将患者随机分为两组：静脉注射氨茶碱250mg组及安慰剂组，两组均于症状发作后3小时内给药，每天一次，连续2天。主要指标为治疗后8小时患者的头痛严重程度，使用患者站位的视觉模拟量评分量表（VAS）评分评估主要指标。同时研究人员还记录了治疗后VAS评分的改变、患者总体印象改变（PGIC）评分和不良事件发生情况以及意愿治疗分析。
结 果
本研究共纳入中国5个医疗中心的126例PDPH患者（氨茶碱组62例，安慰剂组64例）。患者中位年龄为37岁，96例（76.2%）为女性；与安慰剂组比较，氨茶碱组患者治疗后8小时平均VAS评分显著降低（5.34 vs 2.98；p ＜0.001），PGIC明显改善（39.1% vs 72.6%；p ＜0.01）；该治疗效果在治疗后30分钟尤为明显，并持续2天；两组间不良事件发生率无显着性差异（4.8% vs 1.6%；p =0.589）。
结 论
静脉注射氨茶碱对于PDPH患者是一种有效且安全的早期治疗方法。
原始文献摘要
Wu C, Guan D, Ren M, et al. Aminophylline for treatment of postdural puncture headache: A randomized clinical trial[J]. Neurology, 2018.
Objective
To investigate the efficacy and safety of IV aminophylline for patients with postdural puncture
headache (PDPH).
Methods
We 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.
Results
We 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).
Conclusions
IV aminophylline is an effective and safe early-stage treatment for patients with PDPH.
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