Safety of Gliadel Implant for Malignant Glioma: Report of Postmarketing Surveillance in Japan.

Clinical trial data of Carmustine implant (Gliadel Wafer) in Japanese patients with malignant glioma are limited; thus, we conducted a postmarketing surveillance study to evaluate the safety of Gliadel in real-world clinical practice in Japan. In this postmarketing surveillance study, all patients who received Gliadel placement for malignant glioma surgeries from its market launch (January 9, 2013) to July 10, 2013 were enrolled from 229 institutions using a central registration system. Up to eight wafers of Gliadel (containing 61.6 mg of carmustine) were used to cover the site of brain tumor resection intraoperatively according to the size and shape of the tumor resection cavity. The observation period lasted 3 months after Gliadel placement. Patients were followed up for 1 year postoperatively. Safety was assessed by the incidence of adverse events (AEs) and adverse drug reactions (ADRs). In total, 558 patients were included. Most patients (66.7%) received eight Gliadel wafers. The percentage of patients with ADRs was 35.7% (365 ADR episodes in 199 patients). Of the AEs of special interest, the most common were cerebral edema (22.2%, 124/558 patients), convulsion (9.9%, 55/558 patients), impaired healing (4.8%, 27/558 patients), and infection (3.4%, 19/558 patients). This first all-case postmarketing surveillance report of the safety of Gliadel in real-world clinical practice in Japan suggests that the risk of toxicity with Gliadel placement is relatively tolerable. The survival benefits of Gliadel placement should be evaluated and considered carefully by the clinician taking into account possible toxicities.

Evaluation of tongue-, jaw-, and swallowing-related muscle coordination during voluntarily triggered swallowing.

PURPOSE: The prosthodontic treatment of dysphagic patients may preclude favorable treatment outcomes due to uncoordinated or discordant oral and pharyngeal functions. Since optimal treatment requires a full understanding of the mechanism of oropharyngeal swallowing, this study seeks to describe the normal temporal pattern of tongue-, jaw-, and swallowing-related muscle coordination during voluntarily triggered swallows in healthy patients. MATERIALS AND METHODS: Tongue pressure against the hard palate at seven measuring points, swallowing sounds, and surface electromyography (EMG) activity of the masseter, anterior digastric, and infrahyoid muscles during voluntarily triggered swallowing were recorded in seven healthy male volunteers. The order of onset and offset of these parameters was analyzed by repeated-measures two-way analysis of variance. RESULTS: The onset of anterior digastric muscle activity occurred first and was significantly earlier than the onset of the masseter or infrahyoid muscles and tongue pressure. The onset of masseter muscle activity was also significantly earlier than that of the infrahyoid muscle and tongue pressure. Offset of masseter activity was almost simultaneous with the swallowing sound and was significantly earlier than the offset of the anterior digastric and infrahyoid muscles as well as tongue pressure. The EMG burst of the anterior digastric muscle continued until the offset of tongue pressure, and was followed by the offset of infrahyoid muscle activity. CONCLUSIONS: The temporal coordination patterns of the tongue, jaw, and oropharyngeal muscles during voluntarily triggered swallowing appear to agree with known safe management of a bolus and offer criteria for evaluating the function of oropharyngeal swallowing.

Influence of bite force and tongue pressure on oro-pharyngeal residue in the elderly.

OBJECTIVE: To investigate the influence of maximal bite force, maximal tongue pressure, number of mastications and swallowing on the oro-pharyngeal residue in the elderly. BACKGROUND: Oro-pharyngeal residue in the elderly is an indication of dysphagia. Pharyngeal residue is especially critical as it may cause aspiration pneumonia, which is one of the major causes of death in elderly. MATERIALS AND METHODS: Videofluorographic recordings were performed on 14 elderly volunteers (six males, eight females, age range 65-93 years) without any history or symptoms of dysphagia. The subjects were instructed to consume 9 g of barium containing bread in two manners; free mastication and swallow (FMS: masticate and swallow freely), and limited mastication and swallow (LMS: swallow once after 30 chewing actions). The amount of oral and pharyngeal residue was evaluated using a 4-point rating scale. Maximal occlusal force was measured by a pressure sensitive sheet, and maximal tongue pressure using a handy probe. Multiple regression analysis was performed to examine the influence of these items on the amount of oral and pharyngeal residue in FMS and LMS. RESULTS: In FMS, age was found to be a factor which increased oral residue (p = 0.053), and the number of swallowing (p = 0.017) and the state of the prosthesis (p = 0.030) reduced the pharyngeal residue. In LMS, tongue pressure was a factor which reduced oral residue (p = 0.015) and increased pharyngeal residue (p = 0.008). CONCLUSION: It is suggested that in the elderly tongue pressure contributed to propulsion of the food bolus from oral cavity into the pharynx, and multiple swallowing contributed to the reduction in the amount of pharyngeal residue.

Tongue pressure against hard palate during swallowing in post-stroke patients.

OBJECTIVES: The tongue plays an important role in swallowing by contacting the palate. The aim of the present study was to investigate the characteristics of tongue pressure production during swallowing in post-stroke patients using a newly developed sensor sheet. MATERIALS AND METHODS: Ten post-stroke inpatients with hemiplegia and five healthy volunteers participated in this study. Magnitude of tongue pressure during a dry swallow was measured using a newly developed sensor sheet comprising five sensors applied directly to the palate or to the palatal surface of a maxillary denture using denture adhesive. Swallowing ability was evaluated by measuring the time taken to swallow 30 ml of water. The magnitude of tongue pressure was compared between the post-stroke patients and healthy subjects as well as between each measuring point in both groups. The relationship between tongue pressure and swallowing ability and that between tongue pressure and state of occlusal support were also examined. RESULTS: The magnitude of tongue pressure in the post-stroke patients was smaller than that of the healthy subjects at the measuring points along the median line (Welch test, p < 0.05), larger in the non-paralysed side than in the paralysed side (two-way ANOVA, p < 0.05), and was influenced by swallowing ability and occlusal support (Welch test, p < 0.05). CONCLUSIONS: Measurement of the magnitude of tongue pressure shows promise as a simple, non-invasive and quantitative method by which tongue activity in post-stroke patients, in whom swallowing ability is a concern, could be evaluated.