Decompression with or without Duraplasty for Chiari I and Syringomyelia.

Methods

We conducted a multicenter, cluster-randomized, controlled trial of PFD with duraplasty (PFD-D) as compared with PFD alone.

我们进行了一项多中心、群组随机、对照试验，比较了后颅窝减压术联合硬脑膜成形术（PFD-D）与单纯后颅窝减压术的效果。

Persons 21 years of age or younger with cerebellar tonsillar ectopia of at least 5 mm and a maximum syrinx diameter of 3.0 to 9.9 mm were enrolled at 38 centers.

招募了年龄为21岁或更小，小脑扁桃体下疝至少5毫米，最大脊髓空洞直径为3.0至9.9毫米的患者，共在38个中心进行研究。

Centers were cluster-randomized: all the participants within each center underwent the same intervention.

中心进行了群组随机化：每个中心的所有参与者接受了相同的干预措施。

The primary outcome was surgical complications within 6 months.

主要结果是6个月内手术并发症。

Secondary outcomes were clinical improvement, syrinx reduction, and repeat decompression at 10 to 24 months and the change in overall health-related quality of life at 6 to 24 months.

次要结果是10至24个月的临床改善、脊髓空洞缩小以及再次减压情况，以及6至24个月整体健康相关生活质量的变化。

Results

A total of 162 participants were included in the trial, of whom 78 were assigned to undergo PFD-D and 84 to undergo PFD alone.

共有162名参与者被纳入试验，其中78人被分配接受PFD-D治疗，另外84人仅接受PFD治疗。

The percentage of participants with complications within 6 months was 14% with PFD-D and 6% with PFD (adjusted odds ratio, 2.59; 95% confidence interval[CI], 0.86 to 7.84; P = 0.11).

在6个月内，接受PFD-D治疗的参与者中出现并发症的比例为14%，而仅接受PFD治疗的参与者中这一比例为6%（调整后的优势比为2.59；95%置信区间[CI]，0.86至7.84；P = 0.11）。

At 24 months, the percentage of participants with clinical improvement was 58% with PFD-D and 46% with PFD; the mean (±SD) syrinx reduction was 3.08±2.33 mm and 1.22±1.79 mm, respectively; and the percentage of participants with repeat decompression was 3% and 14%.

在24个月时，使用PFD-D的参与者中有58%表现出临床改善，而使用PFD的参与者中这一比例为46%；平均（±标准差）脊髓空洞缩小程度分别为3.08±2.33毫米和1.22±1.79毫米；需要再次减压的参与者比例分别为3%和14%。

Changes in health-related quality of life were similar in the two groups.

两组在健康相关生活质量的变化上相似。

Conclusions

The percentage of participants with surgical complications did not differ significantly between those who underwent PFD-D and and those who underwent PFD alone.

接受PFD-D和仅接受PFD的参与者之间，手术并发症的百分比没有显著差异。

Larger trials are needed to determine the relative benefits and risks of these two procedures.

需要更大规模的试验来确定这两种手术的相对益处和风险。

(Funded by the Patient-Centered Outcomes Research Institute and others; ClinicalTrials.gov number, NCT02669836.).

(由患者为中心的结果研究研究所和其他机构资助；ClinicalTrials.gov编号，NCT02669836。)