Luan Shuo, Wu Shao-Ling, Xiao Ling-Jun, Yang Hai-Yun, Liao Mei-Xin, Wang Shao-Ling, Fan Sheng-Nuo, Ma Chao
Department of Rehabilitation, Sun Yat-sen Memorial Hospital, Guangzhou, People's Republic of China.
Department of Ultrasonic, Sun Yat-sen Memorial Hospital, Guangzhou, People's Republic of China.
NeuroRehabilitation. 2021;49(4):629-639. doi: 10.3233/NRE-210113.
Cricopharyngeal muscle dysfunction (CPD) management has been challenging in clinical practice.
To compare the efficacy and safety of ultrasound-guided botulinum toxin injection and balloon catheter dilatation in treating CPD.
Forty patients with CPD were randomly divided into two groups, namely the botulinum toxin injection group (BTX group) and balloon dilatation group (BD group). Patients in the BTX group received a single ultrasound-guided injection of 50 units of botulinum toxin type A, while the BD group received dilatation therapy five times per week, consecutively for two weeks. Relative opening percentage of the upper esophageal sphincter (UES), the penetration-aspiration scale (PAS), and the Dysphagia Outcome Severity Scale (DOSS) were evaluated by a videofluoroscopic swallowing study (VFSS) at baseline, 1-month, and 3-months posttreatment. The Functional Oral Intake Scale (FOIS) and Standardized Swallowing Assessment (SSA) were also used to evaluate participants' swallowing function at baseline and the 1-week, 2-week, 1-month, and 3-month follow-ups.
A generalized estimating equation (GEE) model revealed the significant main effect for time in UES, PAS, DOSS, FOIS, and SSA compared to baseline (P <0.05), while no group-by-time interactions (except for the PAS assessment) or main effect for treatment was detected among the above multiple variances. No systematic complications or severe adverse effects were noted.
Both ultrasound-guided botulinum toxin type A injections and balloon dilatation therapy have been proven as safe and effective treatments for CPD patients. Future clinical trials with longer follow-up periods and more participants are warranted.
环咽肌功能障碍(CPD)的管理在临床实践中一直具有挑战性。
比较超声引导下肉毒杆菌毒素注射和球囊导管扩张术治疗CPD的疗效和安全性。
40例CPD患者随机分为两组,即肉毒杆菌毒素注射组(BTX组)和球囊扩张组(BD组)。BTX组患者接受一次超声引导下50单位A型肉毒杆菌毒素注射,而BD组患者每周接受5次扩张治疗,连续2周。在基线、治疗后1个月和3个月时,通过视频荧光吞咽造影检查(VFSS)评估食管上括约肌(UES)的相对开放百分比、渗透-误吸量表(PAS)和吞咽困难结果严重程度量表(DOSS)。还使用功能性经口摄入量表(FOIS)和标准化吞咽评估(SSA)在基线以及1周、2周、1个月和3个月随访时评估参与者的吞咽功能。
广义估计方程(GEE)模型显示,与基线相比,UES、PAS、DOSS、FOIS和SSA在时间上有显著的主效应(P<0.05),而在上述多个变量中未检测到组间时间交互作用(PAS评估除外)或治疗的主效应。未发现系统性并发症或严重不良反应。
超声引导下A型肉毒杆菌毒素注射和球囊扩张治疗均已被证明是治疗CPD患者的安全有效方法。未来有必要进行随访期更长、参与者更多的临床试验。