Abstract：
OBJECTIVE: To determine the tolerability and safety of concurrent peripheral nerve blocks and onabotulinumtoxinA treatment during a single outpatient clinic procedure visit.
BACKGROUND: Procedural interventions are available for the treatment of headache disorders. OnabotulinumtoxinA and peripheral nerve blocks are used as alternatives or in addition to oral therapies to reduce the frequency and intensity of migraine attacks. There is currently a lack of safety data focusing on the sequential administration of local anesthetic via peripheral nerve blocks and onabotulinumtoxinA during a single clinical encounter for the treatment of headache. The primary aim of the study was to determine the safety and tolerability of concurrent peripheral nerve blockade and onabotulinumtoxinA injections during a single outpatient clinic procedure visit. We hypothesized that the dual intervention would be safe and well tolerated by patients with chronic migraine and other headache disorders.
METHODS: A retrospective chart review was performed using clinical data from patients seen by multiple providers over a 16-month timeframe at one outpatient headache clinic. Patients were identified by procedure codes and those receiving peripheral nerve block(s) and onabotulinumtoxinA injections during a single encounter within the study period were eligible for inclusion. Inclusion criteria were (1) patients 18 years and older who were (2) receiving both peripheral nerve blocks and onabotulinumtoxinA injections for the treatment of chronic migraine. Patients were excluded if they were under age 18, received their procedure outside of the clinic (emergency room, inpatient ward), or were receiving sphenopalatine ganglion blocks. Age- and sex-matched patients who received one procedure, either peripheral nerve blocks or onabotulinumtoxinA, were used for control. The primary outcome of this safety study was the number of adverse events that occurred in the dual intervention group compared to the single intervention control arms. Information regarding adverse events was gathered via retrospective chart review. If an adverse event was recorded, it was then graded by the reviewer utilizing the Common Terminology Criteria for Adverse Events ranging from Grade 1 Mild Event to Grade 5 Death. Additionally, it was noted whether the adverse event led to treatment discontinuation.
RESULTS: In total, 375 patients were considered eligible for inclusion in the study. After age and sex matching of controls, 131 patients receiving dual intervention were able to be compared to 131 patients receiving onabotulinumtoxinA alone and 104 patients receiving dual intervention were able to be compared to 104 patients receiving peripheral nerve block(s) alone. The primary endpoint analysis showed no significant difference in total adverse events between dual intervention compared to nerve blocks alone or onabotulinumtoxinA alone. The number of adverse events that led to treatment discontinuation approached but did not reach statistical significance for those receiving dual intervention versus onabotulinumtoxinA alone in the number of adverse events that led to treatment termination (4.6%, 6/131 vs. 0.8%, 1/131, p = 0.065); however, the number of patients who discontinued therapy was not significantly different between those groups (2.3%, 3/131 vs. 0.8%, 1/131; p = 0.314; odds ratio 0.3 [0-3.2]; p = 0.338).
CONCLUSIONS: In this retrospective chart review, there was no significant difference in adverse events or therapy discontinuation between patients receiving sequential peripheral nerve block(s) and onabotulinumtoxinA injections versus those receiving either peripheral nerve block(s) or onabotulinumtoxinA injections alone. As a result, we concluded that the combination procedure is likely safe and well tolerated in routine clinical practice.
BACKGROUND: Procedural interventions are available for the treatment of headache disorders. OnabotulinumtoxinA and peripheral nerve blocks are used as alternatives or in addition to oral therapies to reduce the frequency and intensity of migraine attacks. There is currently a lack of safety data focusing on the sequential administration of local anesthetic via peripheral nerve blocks and onabotulinumtoxinA during a single clinical encounter for the treatment of headache. The primary aim of the study was to determine the safety and tolerability of concurrent peripheral nerve blockade and onabotulinumtoxinA injections during a single outpatient clinic procedure visit. We hypothesized that the dual intervention would be safe and well tolerated by patients with chronic migraine and other headache disorders.
METHODS: A retrospective chart review was performed using clinical data from patients seen by multiple providers over a 16-month timeframe at one outpatient headache clinic. Patients were identified by procedure codes and those receiving peripheral nerve block(s) and onabotulinumtoxinA injections during a single encounter within the study period were eligible for inclusion. Inclusion criteria were (1) patients 18 years and older who were (2) receiving both peripheral nerve blocks and onabotulinumtoxinA injections for the treatment of chronic migraine. Patients were excluded if they were under age 18, received their procedure outside of the clinic (emergency room, inpatient ward), or were receiving sphenopalatine ganglion blocks. Age- and sex-matched patients who received one procedure, either peripheral nerve blocks or onabotulinumtoxinA, were used for control. The primary outcome of this safety study was the number of adverse events that occurred in the dual intervention group compared to the single intervention control arms. Information regarding adverse events was gathered via retrospective chart review. If an adverse event was recorded, it was then graded by the reviewer utilizing the Common Terminology Criteria for Adverse Events ranging from Grade 1 Mild Event to Grade 5 Death. Additionally, it was noted whether the adverse event led to treatment discontinuation.
RESULTS: In total, 375 patients were considered eligible for inclusion in the study. After age and sex matching of controls, 131 patients receiving dual intervention were able to be compared to 131 patients receiving onabotulinumtoxinA alone and 104 patients receiving dual intervention were able to be compared to 104 patients receiving peripheral nerve block(s) alone. The primary endpoint analysis showed no significant difference in total adverse events between dual intervention compared to nerve blocks alone or onabotulinumtoxinA alone. The number of adverse events that led to treatment discontinuation approached but did not reach statistical significance for those receiving dual intervention versus onabotulinumtoxinA alone in the number of adverse events that led to treatment termination (4.6%, 6/131 vs. 0.8%, 1/131, p = 0.065); however, the number of patients who discontinued therapy was not significantly different between those groups (2.3%, 3/131 vs. 0.8%, 1/131; p = 0.314; odds ratio 0.3 [0-3.2]; p = 0.338).
CONCLUSIONS: In this retrospective chart review, there was no significant difference in adverse events or therapy discontinuation between patients receiving sequential peripheral nerve block(s) and onabotulinumtoxinA injections versus those receiving either peripheral nerve block(s) or onabotulinumtoxinA injections alone. As a result, we concluded that the combination procedure is likely safe and well tolerated in routine clinical practice.
摘要：
目的：确定在一次门诊就诊过程中，并发周围神经阻滞和鼻甲毒素A治疗的耐受性和安全性。
背景：程序性干预措施可用于治疗头痛疾病。作为口服治疗的替代或补充，可以使用促性腺激素A和周围神经阻滞来减少偏头痛发作的频率和强度。目前缺乏安全性数据，重点是在一次临床治疗头痛期间通过周围神经阻滞和局部麻醉药A的顺序给药。该研究的主要目的是确定在一次门诊就诊过程中同时注射周围神经阻滞和抑瘤霉素A的安全性和耐受性。我们假设慢性偏头痛和其他头痛患者的双重干预是安全且耐受性良好的。
方法：使用来自一家门诊头痛诊所16个月内多个医疗服务提供者所见患者的临床数据进行回顾性图表回顾。通过程序代码确定患者，并且在研究期间的单次相遇期间接受周围神经阻滞和脑啡肽A注射的患者符合纳入条件。纳入标准为（1）18岁及以上的患者（2）同时接受周围神经阻滞和注射乙酰丙酸钠毒素A治疗慢性偏头痛。如果患者未满18岁，则将其排除在外，在诊所外接受手术（急诊室，住院病房)，或者正在接受蝶腭神经节阻滞。年龄和性别匹配的患者接受了一次手术，无论是周围神经阻滞，还是脑啡肽A，用于控制。该安全性研究的主要结果是与单干预对照组相比，双重干预组发生的不良事件数量。通过回顾性图表审查收集有关不良事件的信息。如果记录了不良事件，然后由审稿人使用不良事件通用术语标准对其进行分级,范围从1级轻度事件到5级死亡.此外,观察到不良事件是否导致治疗中止.
结果：总计，375名患者被认为符合纳入研究的条件。在对照组的年龄和性别匹配之后，131名接受双重干预的患者能够与131名接受单独的乙酰磺胺醇毒素A的患者进行比较，104名接受双重干预的患者能够与104名接受单独的周围神经阻滞的患者进行比较。主要终点分析显示，与单独的神经阻滞或单独的促性腺激素A相比，双重干预之间的总不良事件没有显着差异。在导致治疗终止的不良事件数量中，与接受双重干预的患者相比，接受双重干预的患者与单独使用单药磺胺醇钠的患者的不良事件数量接近但未达到统计学意义（4.6％，6/131vs.0.8%,1/131，p=0.065)；然而，两组之间停止治疗的患者数量没有显着差异（2.3％，3/131vs.0.8%,1/131；p=0.314；比值比0.3[0-3.2]；p=0.338)。
结论：在这篇回顾性图表综述中，序贯接受外周神经阻滞和单用单用外周神经阻滞或单用单用单用外周神经阻滞的患者,在不良事件或治疗停止方面无显着差异.因此,我们得出的结论是,在常规临床实践中,联合治疗可能是安全且耐受性良好的.
背景：程序性干预措施可用于治疗头痛疾病。作为口服治疗的替代或补充，可以使用促性腺激素A和周围神经阻滞来减少偏头痛发作的频率和强度。目前缺乏安全性数据，重点是在一次临床治疗头痛期间通过周围神经阻滞和局部麻醉药A的顺序给药。该研究的主要目的是确定在一次门诊就诊过程中同时注射周围神经阻滞和抑瘤霉素A的安全性和耐受性。我们假设慢性偏头痛和其他头痛患者的双重干预是安全且耐受性良好的。
方法：使用来自一家门诊头痛诊所16个月内多个医疗服务提供者所见患者的临床数据进行回顾性图表回顾。通过程序代码确定患者，并且在研究期间的单次相遇期间接受周围神经阻滞和脑啡肽A注射的患者符合纳入条件。纳入标准为（1）18岁及以上的患者（2）同时接受周围神经阻滞和注射乙酰丙酸钠毒素A治疗慢性偏头痛。如果患者未满18岁，则将其排除在外，在诊所外接受手术（急诊室，住院病房)，或者正在接受蝶腭神经节阻滞。年龄和性别匹配的患者接受了一次手术，无论是周围神经阻滞，还是脑啡肽A，用于控制。该安全性研究的主要结果是与单干预对照组相比，双重干预组发生的不良事件数量。通过回顾性图表审查收集有关不良事件的信息。如果记录了不良事件，然后由审稿人使用不良事件通用术语标准对其进行分级,范围从1级轻度事件到5级死亡.此外,观察到不良事件是否导致治疗中止.
结果：总计，375名患者被认为符合纳入研究的条件。在对照组的年龄和性别匹配之后，131名接受双重干预的患者能够与131名接受单独的乙酰磺胺醇毒素A的患者进行比较，104名接受双重干预的患者能够与104名接受单独的周围神经阻滞的患者进行比较。主要终点分析显示，与单独的神经阻滞或单独的促性腺激素A相比，双重干预之间的总不良事件没有显着差异。在导致治疗终止的不良事件数量中，与接受双重干预的患者相比，接受双重干预的患者与单独使用单药磺胺醇钠的患者的不良事件数量接近但未达到统计学意义（4.6％，6/131vs.0.8%,1/131，p=0.065)；然而，两组之间停止治疗的患者数量没有显着差异（2.3％，3/131vs.0.8%,1/131；p=0.314；比值比0.3[0-3.2]；p=0.338)。
结论：在这篇回顾性图表综述中，序贯接受外周神经阻滞和单用单用外周神经阻滞或单用单用单用外周神经阻滞的患者,在不良事件或治疗停止方面无显着差异.因此,我们得出的结论是,在常规临床实践中,联合治疗可能是安全且耐受性良好的.
