From the Department of Anesthesiology, Perioperative and Pain Medicine (I.C., L.H., M.J.B., J.M.H.), Stanford Headache Clinic (I.C.), Department of Neurology (N.Z., M.J.B., A.P., L.M., O.O., C.B.), Departments of Neurology and Neurosciences and (by courtesy) Anesthesia (R.P.C.), and Department of Radiology (B.L., S.H.), Stanford University, Palo Alto, CA; Headache Neurology (N.H.), Metrodora Institute, West Valley City, UT; Department of Biomedical Informatics (S.B.), Emory University, Atlanta, GA; Department of Medicine (Biomedical Informatics) (T.H.-B.), Stanford University, Palo Alto, CA; and Department of Radiology (A.L.C.), University of Colorado Anschutz Medical Campus, Aurora.
Neurology. 2024 Jun 25;102(12):e209449. doi: 10.1212/WNL.0000000000209449. Epub 2024 May 31.
Spinal CSF leaks lead to spontaneous intracranial hypotension (SIH). While International Classification of Headache Disorders, Third Edition (ICHD-3) criteria necessitate imaging confirmation or low opening pressure (OP) for SIH diagnosis, their sensitivity may be limited. We offered epidural blood patches (EBPs) to patients with symptoms suggestive of SIH, with and without a documented low OP or confirmed leak on imaging. This study evaluates the efficacy of this strategy.
We conducted a prospective cohort study with a nested case-control design including all patients who presented to a tertiary headache clinic with clinical symptoms of SIH who completed study measures both before and after receiving an EBP between August 2016 and November 2018.
The mean duration of symptoms was 8.7 ± 8.1 years. Of 85 patients assessed, 69 did not meet ICHD-3 criteria for SIH. At an average of 521 days after the initial EBP, this ICHD-3-negative subgroup experienced significant improvements in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health score of +3.3 (95% CI 1.5-5.1), PROMIS Global Mental Health score of +1.8 (95% CI 0.0-3.5), Headache Impact Test (HIT)-6 head pain score of -3.8 (95% CI -5.7 to -1.8), Neck Disability Index of -4.8 (95% CI -9.0 to -0.6) and PROMIS Fatigue of -2.3 (95% CI -4.1 to -0.6). Fifty-four percent of ICHD-3-negative patients achieved clinically meaningful improvements in PROMIS Global Physical Health and 45% in HIT-6 scores. Pain relief following lying flat prior to treatment was strongly associated with sustained clinically meaningful improvement in global physical health at an average of 521 days (odds ratio 1.39, 95% CI 1.1-1.79; < 0.003). ICHD-3-positive patients showed high rates of response and previously unreported, treatable levels of fatigue and cognitive deficits.
Patients who did not conform to the ICHD-3 criteria for SIH showed moderate rates of sustained, clinically meaningful improvements in global physical health, global mental health, neck pain, fatigue, and head pain after EBP therapy. Pre-treatment improvement in head pain when flat was associated with later, sustained improvement after EBP therapy among patients who did not meet the ICHD-3 criteria.
This study provides Class IV evidence that epidural blood patch is an effective treatment of suspected CSF leak not conforming to ICHD-3 criteria for SIH.
脊柱脑脊液漏会导致自发性颅内低血压（SIH）。尽管《国际头痛疾病分类，第三版》（ICHD-3）标准需要影像学证实或低开口压力（OP）来诊断 SIH，但它们的敏感性可能有限。我们为有 SIH 症状的患者提供了硬膜外血贴（EBP），无论其 OP 记录值是否较低或影像学是否证实有漏。本研究评估了这一策略的疗效。
我们进行了一项前瞻性队列研究，采用嵌套病例对照设计，纳入了 2016 年 8 月至 2018 年 11 月期间在三级头痛诊所就诊、有 SIH 临床症状并完成 EBP 前后研究评估的所有患者。
症状平均持续时间为 8.7±8.1 年。在 85 名评估的患者中，有 69 名不符合 ICHD-3 标准的 SIH。在初次 EBP 后平均 521 天，该 ICHD-3 阴性亚组在患者报告的结局测量信息系统（PROMIS）总体身体健康评分上有显著改善，增加了+3.3（95%CI，1.5-5.1），PROMIS 总体心理健康评分增加了+1.8（95%CI，0.0-3.5），头痛影响测试（HIT-6）头痛评分降低了-3.8（95%CI，-5.7 至-1.8），颈部残疾指数降低了-4.8（95%CI，-9.0 至-0.6），PROMIS 疲劳评分降低了-2.3（95%CI，-4.1 至-0.6）。54%的 ICHD-3 阴性患者在 PROMIS 总体身体健康方面达到了有临床意义的改善，45%的患者在 HIT-6 评分方面达到了有临床意义的改善。治疗前平卧时头痛缓解与治疗后 521 天的总体身体健康有持续的临床意义改善显著相关（优势比 1.39，95%CI，1.1-1.79；<0.003）。ICHD-3 阳性患者显示出高反应率和以前未报告的、可治疗的疲劳和认知缺陷水平。
不符合 ICHD-3 标准的 SIH 患者在接受 EBP 治疗后，总体身体、心理健康、颈部疼痛、疲劳和头痛方面均有中度、持续的临床意义改善。治疗前平卧时头痛改善与不符合 ICHD-3 标准的患者 EBP 治疗后持续改善有关。
本研究提供了 IV 级证据，表明硬膜外血贴是一种有效的治疗方法，适用于不符合 ICHD-3 标准的疑似 CSF 漏的患者。
