Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Copenhagen Ø, 2100, Denmark.
Syst Rev. 2024 Oct 12;13(1):257. doi: 10.1186/s13643-024-02674-2.
Salivary hypofunction leads to debilitating oral symptoms and has major complications for overall quality of life. Two of the most frequent causes of xerostomia are radiotherapy in the head and neck and Sjögren's syndrome. Only symptomatic treatment is available today. An increasing number of both preclinical and clinical studies have suggested that mesenchymal stem cell (MSC) transplantation treatment can increase the salivary flow rate and ameliorate symptoms of xerostomia. However, both adipose-derived and bone marrow-derived MSCs are used, although they differ in important ways. The primary objective of this study is an indirect comparison of the change in the unstimulated salivary flow rate after intervention between patients treated with adipose-derived or bone marrow-derived MSCs.
This systematic review and network meta-analysis will search for eligible studies in the MEDLINE, EMBASE, and Cochrane CENTRAL register of Controlled Trials. Eligible studies are as follows: clinical studies including human patients with salivary hypofunction due to either radiotherapy or Sjogren's syndrome who were subsequently treated with either adipose-derived MSCs or bone marrow-derived MSCs. Studies with no control group will be excluded. The search phrase has been peer-reviewed following the PRESS guidelines. The primary outcome is the change in the unstimulated salivary flow rate after treatment with either adipose-derived or bone marrow-derived MSCs. Secondary outcomes are as follows: change in patient reported outcomes, methods of intervention administration, number of injected MSCs, and safety. Data from included studies will be pooled and compared with a fixed-effects or random effects model dependent on signs of heterogeneity, presented with a forest plot, and indirectly compared with a meta-regression in a network meta-analysis. Risk of bias will be assessed with the tools ROBINS-I or RoB-2 depending on type of study.
Both adipose-derived and bone marrow-derived MSCs are used today for experimental treatment of salivary hypofunction in humans as no direct or indirect comparisons have been made. Therefore, an evaluation of the effect of adipose-derived vs bone marrow-derived MSC treatment is needed to support future decision-making on the type of MSC used in a clinical trial.
PROSPERO ID CRD42024527183.
唾液分泌减少会导致令人虚弱的口腔症状，并对整体生活质量造成重大影响。口干症的两个最常见原因是头颈部放疗和干燥综合征。目前只有对症治疗。越来越多的临床前和临床研究表明，间充质干细胞（MSC）移植治疗可以增加唾液流量并改善口干症状。然而，目前使用的是脂肪来源和骨髓来源的 MSC，尽管它们在重要方面存在差异。本研究的主要目的是间接比较接受脂肪来源或骨髓来源 MSC 治疗的患者干预后未刺激唾液流量的变化。
本系统评价和网络荟萃分析将在 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库中搜索合格的研究。合格的研究如下：包括因放疗或干燥综合征导致唾液分泌减少的人类患者的临床研究，随后接受脂肪来源的 MSC 或骨髓来源的 MSC 治疗。将排除没有对照组的研究。搜索词已经过同行评审，遵循 PRESS 指南。主要结局是治疗后未刺激唾液流量的变化，使用脂肪来源或骨髓来源的 MSC。次要结局如下：患者报告结果的变化、干预管理方法、注射的 MSC 数量和安全性。纳入研究的数据将进行汇总，并使用固定效应或随机效应模型进行比较，具体取决于异质性的迹象，以森林图呈现，并在网络荟萃分析中进行元回归间接比较。根据研究类型，使用 ROBINS-I 或 RoB-2 工具评估偏倚风险。
目前，脂肪来源和骨髓来源的 MSC 都用于人类唾液分泌减少的实验治疗，因为没有直接或间接的比较。因此，需要评估脂肪来源与骨髓来源 MSC 治疗的效果，以支持未来在临床试验中使用哪种 MSC 类型的决策。
PROSPERO ID CRD42024527183。
