Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.
Department of Radiosurgery and Stereotactic Radiotherapy, MediClin Robert Janker Clinic and MediClin MVZ Bonn, Bonn, Germany.
Syst Rev. 2022 Dec 12;11(1):265. doi: 10.1186/s13643-022-02118-9.
Vestibular schwannomas are benign tumours for which various treatments are available. We performed a systematic review of prospective controlled trials comparing the patient-relevant benefits and harms of single-fraction stereotactic radiosurgery (sfSRS) with microsurgical resection (MR) in patients with vestibular schwannoma.
We searched for randomized controlled trials (RCTs) and non-randomized prospective controlled trials in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and study registries (last search: 09/2021) and also screened reference lists of relevant systematic reviews. Manufacturers were asked to provide unpublished data. Eligible studies investigated at least one patient-relevant outcome. We assessed the risk of bias (high or low) at the study and outcome level. If feasible, meta-analyses were performed. We graded the results into different categories (hint, indication, or proof of greater benefit or harm).
We identified three non-randomized prospective controlled trials of generally low quality with evaluable data on 339 patients with unilateral vestibular schwannoma. There was an indication of greater benefit of sfSRS compared with MR for facial palsy (OR 0.06, 95% CI 0.02-0.21, p < 0.001, 2 studies), hearing function (no pooled estimate available, 2 studies), and length of hospital stay (no pooled estimate available, 2 studies). We found no clinically relevant differences for mortality, vertigo, headaches, tinnitus, balance function, work disability, adverse events, and health-related quality of life.
Our systematic review indicates that sfSRS has greater benefits than MR in patients with unilateral vestibular schwannoma. However, it is unclear whether this conclusion still holds after 2 years, as long-term studies are lacking. It is also unclear whether the effects of sfSRS are similar in patients with bilateral vestibular schwannomas. Long-term prospective studies including patients with this condition would therefore be useful.
The full (German language) protocol and report (Commission No. N20-03) are available on the institute's website: www.iqwig.de/en/projects/n20-03.html.
前庭神经鞘瘤是一种良性肿瘤，有多种治疗方法。我们对比较单次分割立体定向放射外科（sfSRS）与显微切除术（MR）治疗前庭神经鞘瘤患者的患者相关获益和危害的前瞻性对照试验进行了系统评价。
我们在 MEDLINE、Embase、Cochrane 中央对照试验注册库和研究登记处（最后一次检索：2021 年 9 月）中搜索了随机对照试验（RCT）和非随机前瞻性对照试验，并筛选了相关系统评价的参考文献列表。制造商被要求提供未发表的数据。合格的研究调查了至少一个患者相关的结局。我们评估了研究和结局层面的偏倚风险（高或低）。如果可行，我们进行了荟萃分析。我们将结果分为不同的类别（提示、适应证或更大获益或危害的证据）。
我们确定了三项非随机前瞻性对照试验，质量普遍较低，共有 339 例单侧前庭神经鞘瘤患者的可评估数据。与 MR 相比，sfSRS 对面神经麻痹（OR 0.06，95%CI 0.02-0.21，p < 0.001，2 项研究）、听力功能（无汇总估计值，2 项研究）和住院时间（无汇总估计值，2 项研究）有更大获益的提示。我们未发现死亡率、眩晕、头痛、耳鸣、平衡功能、工作能力丧失、不良事件和健康相关生活质量的临床相关差异。
我们的系统评价表明，sfSRS 对单侧前庭神经鞘瘤患者的获益大于 MR。然而，由于缺乏长期研究，尚不清楚 2 年后这一结论是否仍然成立。sfSRS 的效果在双侧前庭神经鞘瘤患者中是否相似也不清楚。因此，包括此类患者的长期前瞻性研究将是有用的。
完整的（德语）方案和报告（编号 N20-03）可在研究所网站上查阅：www.iqwig.de/en/projects/n20-03.html。
Zotero 插件
