Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, PR China.
Minda Hospital of Hubei Minzu University, Enshi, Hubei, 445000, PR China.
BMC Pharmacol Toxicol. 2023 Oct 12;24(1):52. doi: 10.1186/s40360-023-00694-7.
Botulinum toxin (BoNT) injection is an important adjunctive method to treat sialorrhea. The purpose of this systematic review was to analyze the effect and safety of BoNT injections in the intervention of sialorrhea with Parkinson's disease (PD).
We searched PubMed, Web Of Science (WOS), Scopus, Cochrane CENTRAL, and Embase from inception until April 2022. Randomized controlled trials or randomized crossover trials comparing BoNT with placebo in sialorrhea with PD were eligible. PRISMA guidelines were used to carry out the meta-analysis. The Drooling Severity Frequency Scale (DSFS) score and the number of adverse events (AEs) were the primary and secondary outcomes, respectively. Standardized mean differences (SMDs) and risk differences (RDs) are used to express continuous and categorical outcomes, respectively. Heterogeneity among these studies was evaluated using I tests. We used the GRADE tool to assess the certainty of evidence (COE).
Eight articles involving 259 patients compared BoNT injections with a placebo for PD with sialorrhea. This meta-analysis showed a significant reduction in DSFS scores between BoNT injections and placebo (SMD=-0.98; 95% CI, -1.27 to 0.70, p<0.001; COE: high). This meta-analysis showed a significant difference in AEs between BoNT injections and placebo (RD=0.15; 95% CI, 0.05 to 0.24, p=0.002; COE: low).
The pooled results suggest that BoNT injections have some effect on DSFS scores with sialorrhea caused by PD. There are also mild adverse events, which generally recover within a week or so. The results indicate that BoNT injection is one of the treatments for sialorrhea caused by PD, but we need to pay attention to adverse events. In addition, the follow-up time was extended to observe oral hygiene, ulceration or dental caries, and digestive function.
Our review protocol was registered on PROSPERO (42021288334).
肉毒毒素（BoNT）注射是治疗流涎症的重要辅助方法。本系统评价的目的是分析 BoNT 注射治疗帕金森病（PD）所致流涎症的效果和安全性。
我们检索了 PubMed、Web Of Science（WOS）、Scopus、Cochrane CENTRAL 和 Embase，检索时间从建库至 2022 年 4 月。纳入比较 BoNT 与安慰剂治疗 PD 伴流涎症的随机对照试验或随机交叉试验。采用 PRISMA 指南进行荟萃分析。流涎严重程度频率量表（DSFS）评分和不良事件（AE）的数量分别为主要和次要结局。使用标准化均数差（SMD）和风险差异（RD）分别表示连续性和分类结局。采用 I 检验评估这些研究之间的异质性。我们使用 GRADE 工具评估证据确定性（COE）。
八项涉及 259 例患者的研究比较了 BoNT 注射与安慰剂治疗 PD 伴流涎症。这项荟萃分析显示，BoNT 注射与安慰剂相比，DSFS 评分显著降低（SMD=-0.98；95%CI，-1.27 至 0.70，p<0.001；COE：高）。这项荟萃分析显示，BoNT 注射与安慰剂之间的 AE 差异具有统计学意义（RD=0.15；95%CI，0.05 至 0.24，p=0.002；COE：低）。
汇总结果表明，BoNT 注射对 PD 所致流涎症的 DSFS 评分有一定疗效。也有轻度不良反应，一般在一周左右恢复。结果表明，BoNT 注射是治疗 PD 所致流涎症的方法之一，但需注意不良反应。此外，延长随访时间观察口腔卫生、溃疡或龋齿以及消化功能。
我们的综述方案在 PROSPERO（42021288334）上进行了注册。
