目的:磁共振引导聚焦超声(MRgFUS)是治疗药物难治性特发性震颤(ET)的新兴治疗方法。这项研究的目的是评估单侧MRgFUS治疗ET的长期(长达5年)安全性和有效性。
方法:作者在4个数据库中进行了系统搜索,以找到相关的临床研究。对二元结果进行分析,并报告为比值比和95%置信区间,同时对连续结局进行分析并报告为标准化均数差异(SMD)和95%置信区间.此外,本研究采用单变量meta回归评估各种协变量与结局之间的关联,包括震颤临床评定量表(CRST)评分和手震颤评分的平均差.进行敏感性分析以解决任何异质性。
结果:共43项研究,包括1818例接受MRgFUS的ET患者。在1539名有性别数据的患者中,1095(71.2%)为男性。这些研究的平均随访时间为3个月至8.4年。在MRgFUS后3、6和12个月,平均CRST总分显着降低(分别为SMD-4.5,p=0.0069;SMD-4.9,p=0.0045;和SMD-2.95,p=0.0039)。在MRgFUS后3、6、12、24和36个月,平均手震颤评分显着减轻(SMD-3.99,p=0.05;SMD-4.5,p=0.05;SMD-1.99,p<0.0001;SMD-2.07,p=0.0002;和SMD-2.1,p<0.0001)。此外,原发性震颤问卷评分的平均生活质量在3个月时有所改善(SMD-2.8,p=0.0025),6个月(SMD-4.1,p=0.04),12个月(SMD-1.57,p=0.0004),2年(SMD-1.64,p=0.0003),和3年(SMD-1.14,p=0.08)。我们的荟萃回归结果显示,性别(p=0.03),与年龄不同,用手,症状持续时间,在3个月时达到能量峰值,与震颤严重程度的平均差异显著相关。
结论:这项荟萃分析提供了强有力的证据,支持单侧MRgFUS治疗ET在震颤严重程度和生活质量方面的有效性和安全性,并伴有可接受的不良事件。
Magnetic resonance-guided focused ultrasound (MRgFUS) is an emerging treatment for medication-refractory essential tremor (ET). The objective of this study was to evaluate long-term (up to 5 years) safety and efficacy of unilateral MRgFUS in the treatment of ET.
The authors performed a systematic search through 4 databases to find relevant clinical studies. Binary outcomes were analyzed and reported as odds ratios and 95% confidence intervals, while continuous outcomes were analyzed and reported as standardized mean differences (SMDs) and 95% confidence intervals. Furthermore, a univariable meta-regression was performed to evaluate the association between various covariates and the outcomes including the mean difference in the Clinical Rating Scale for Tremor (CRST) score and hand tremor scores. Sensitivity analysis was performed to address any heterogeneity.
A total of 43 studies comprising 1818 patients with ET who underwent MRgFUS were identified. Of the 1539 patients with data on sex, 1095 (71.2%) were male. The mean follow-up duration ranged from 3 months to 8.4 years among the studies. The mean total CRST score significantly decreased at 3, 6, and 12 months post-MRgFUS (SMD -4.5, p = 0.0069; SMD -4.9, p = 0.0045; and SMD -2.95, p = 0.0039, respectively). The mean hand tremor scores significantly mitigated at 3, 6, 12, 24, and 36 months post-MRgFUS (SMD -3.99, p = 0.05; SMD -4.5, p = 0.05; SMD -1.99, p < 0.0001; SMD - 2.07, p = 0.0002; and SMD -2.1, p < 0.0001, respectively). Furthermore, the mean Quality of Life in Essential Tremor Questionnaire scores were improved at 3 months (SMD -2.8, p = 0.0025), 6 months (SMD -4.1, p = 0.04), 12 months (SMD -1.57, p = 0.0004), 2 years (SMD -1.64, p = 0.0003), and 3 years (SMD -1.14, p = 0.08). Our meta-regression findings showed that sex (p = 0.03), unlike age, handedness, symptom duration, and peak energy levels at 3 months, was associated with a significantly higher mean difference in tremor severity.
This meta-analysis provides strong evidence supporting the efficacy and safety of unilateral MRgFUS for the treatment of ET in terms of tremor severity and quality of life with acceptable adverse events.