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水平半规管良性阵发性位置性眩晕的治疗——一项比较两种不同速度治疗手法的随机假手术对照试验

Treatment of horizontal canal BPPV-a randomized sham-controlled trial comparing two therapeutic maneuvers of different speeds.

作者信息

Martens Camilla, Goplen Frederik Kragerud, Aasen Torbjørn, Gjestad Rolf, Nordfalk Karl Fredrik, Nordahl Stein Helge Glad

机构信息

Norwegian National Advisory Unit on Vestibular Disorders, Department of Otorhinolaryngology & Head Neck Surgery Haukeland University Hospital Bergen Norway.

Department of Clinical Medicine University of Bergen Bergen Norway.

出版信息

Laryngoscope Investig Otolaryngol. 2020 Jun 29;5(4):750-757. doi: 10.1002/lio2.420. eCollection 2020 Aug.

Abstract

OBJECTIVES

To compare the effect of a high-speed barbecue maneuver with the modified Lempert maneuver and sham in patients with benign paroxysmal positional vertigo (BPPV) of the horizontal canal.

METHODS

Randomized sham-controlled, single blinded multicenter clinical trial in two university hospitals investigating consecutive patients with horizontal canal BPPV.Patients were randomly assigned to high-speed barbecue (HSB), modified Lempert maneuver (ML), or sham maneuver (SM). All treatments were performed in a biaxial rotational chair with weekly follow-up to a maximum of three treatment sessions. The final follow-up was 3 months after the last treatment.

RESULTS

Primary outcome: 2-week recovery rate per protocol. Secondary outcome: Cumulative recovery rate and Dizziness Handicap Inventory (DHI) scores after 3 months per protocol (HSB and ML) and intention to treat (all groups).Fifty-four patients were analyzed after 2 weeks (HSB = 17; ML = 20; SM = 17). Two-week recovery rate was 14/17 after HSB, 11/20 after ML, and 4/17 after SM, with significantly better recovery in HSB [OR 15.17, 95% CI (1.85, 124.63), = .001] using sham as base level. Recovery rate after 3 months was 15/17 after HSB and 15/19 after ML. Cumulative recovery rate showed no significant differences between the two treatment groups [95% CI (0.30, 13.14), = .46] in cure rate DHI [95% CI (-16.56, 15.02), = .92]. No unexpected adverse events were observed.

CONCLUSION

Velocity change in horizontal canal BPPV treatment gives a faster initial recovery. Rapid recovery could reduce the disease burden.

TRIAL REGISTRATION

Clinicaltrials.gov. Identifier: NCT01905800.

LEVEL OF EVIDENCE

1b.

摘要

目的

比较高速烧烤手法与改良Lempert手法及假手法对水平半规管良性阵发性位置性眩晕(BPPV)患者的疗效。

方法

在两家大学医院进行的随机、假对照、单盲多中心临床试验,研究连续的水平半规管BPPV患者。患者被随机分配至高速烧烤手法组(HSB)、改良Lempert手法组(ML)或假手法组(SM)。所有治疗均在双轴旋转椅上进行,每周随访一次,最多进行三次治疗。最后一次治疗后3个月进行最终随访。

结果

主要结局:按方案计算的2周恢复率。次要结局:按方案计算(HSB和ML)及意向性分析(所有组)3个月后的累积恢复率和眩晕残障量表(DHI)评分。2周后分析了54例患者(HSB = 17例;ML = 20例;SM = 17例)。HSB组2周恢复率为14/17,ML组为11/20,SM组为4/17,以假手法组为对照,HSB组恢复情况明显更好[比值比15.17,95%可信区间(1.85,124.63),P = 0.001]。3个月后HSB组恢复率为15/17,ML组为15/19。两组治疗组的累积恢复率在治愈率方面无显著差异[95%可信区间(0.30,13.14),P = 0.46],DHI评分方面也无显著差异[95%可信区间(-16.56,15.02),P = 0.92]。未观察到意外不良事件。

结论

水平半规管BPPV治疗中的速度变化可使初始恢复更快。快速恢复可减轻疾病负担。

试验注册

Clinicaltrials.gov。标识符:NCT01905800。

证据级别

1b。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da76/7444789/7336069ed996/LIO2-5-750-g001.jpg

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