Preventive effects of betamethasone valerate ointment for radiation-induced severe oral mucositis in patients with oral or oropharyngeal cancer: protocol for a multicentre, phase II, randomised controlled trial (Bet-ROM study)

Introduction: This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in patients with head and neck cancer undergoing concomitant radiotherapy with cisplatin or cetuximab.Methods and analysis: The trial will take place at seven hospitals in Japan. Patients will be randomised (1:1) into betamethasone and control groups after the occurrence of grade 1 oral mucositis. In the betamethasone group, patients will use betamethasone valerate ointment five times a day, in addition to usual oral hygiene guidance. The primary endpoint is the incidence and onset time of grade 3 oral mucositis. The secondary endpoints are the incidence and onset time of grade 2 oral mucositis, incidence and onset time of oral candidiasis, completion of radiation therapy and adverse events. Target accrual is 102 patients with a two-sided type I error rate of 5% and 80% power to detect an 80% risk reduction in the incidence of grade 3 oral mucositis.Ethics and dissemination: This study was approved by the Clinical Research Review Board of Nagasaki University (No. CRB20-009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publication. The datasets generated during the study will be available from the corresponding author on reasonable request.Trial registration number: jRCTs071200013

速度論に基づくマウス脂肪細胞分化過程の解析

It is possible to determine rate kinetic constants for cell-differential processes in vivo through the measurement of the transcription-ratio of some genes by real-time PCR(1). In the previous paper, the differentiation of adipocytes was investigated and rate constants for the processes, at which PPARγ-expressing cells differentiated into AD(adiponectin)- or Re(resistin)-expressing cells, were determined in the thymus of BALB/c mouse(2). In this paper, the rate constant for the process of PPARγ-expressing cells changing to HSL(hormone sensitive lipase)-expressing cells. Considering both results, it was concluded that PPARγexpressing cells change to express HSL firstly, AD secondly and then Re in adipocytes-differential processBALB/cマウスの胸腺での脂肪細胞の分化過程を,PPARγ(PP)に対するホルモン感受性リパーゼ(HSL)の転写量を指標として,リアルタイムPCR法により検討した。　PPに対するHSLの転写量比は,生後直後は1より小さかったが,その後増大し一定値となった。この加齢変化を,遺伝子の転写量は,その転写細胞数に比例すると仮定することにより,また,脂肪細胞系列の幹細胞を考えることにより,速度論により説明することができた。この速度論に基づく方法は,細胞の分化過程で発現する遺伝子の発現順を決定することに応用できることを示した

Overexpression of a Maize SPS Gene Improves Yield Characters of Potato under Field Conditions

We analyzed the yield characters of field-grown transgenic potato plants (Solanum tuberosum) carrying a maize gene for sucrose-phosphate synthase (SPS), the key enzyme in sucrose synthesis. The SPS activity in the leaves of transgenic plants (line Ag1203) was 2 times that of the control (cv. May Queen). There was no difference in the photosynthetic CO2 uptake rates between Ag1203 and May Queen plants, and the leaf starch content of Ag1203 was lower. These observations indicate that the introduction of a foreign SPS gene improved the supply of photosynthate from source (leaves) to sink (tubers). Additionally, leaf senescence of the transgenic potato plants was delayed relative to that of May Queen. The average tuber weight and total yield of Ag1203 plants were at least 20% higher, and the tuber sucrose content, which is related to eating quality, was also higher. Increased translocation of photosynthate and longer period of photosynthetic activity in the leaves may have increased the yield of Ag1203. These results suggest that introduction of the SPS gene improved the yield characters and quality of potato tubers under field conditions

Factors affecting development of medication-related osteonecrosis of the jaw in cancer patients receiving high-dose bisphosphonate or denosumab therapy: Is tooth extraction a risk factor?

Methods for preventing medication-related osteonecrosis of the jaw (MRONJ) in cancer patients who have received high-dose bisphosphonate (BP) or denosumab (Dmab) have not yet been established. Tooth extraction after starting medication has been believed to be a major risk factor for MRONJ, and therefore this procedure tends to be avoided. This study investigated the risk factors for MRONJ, with a special reference to the correlation between tooth extraction and development of MRONJ. One hundred and thirty-five cancer patients who were administrated high-dose BP or Dmab were enrolled in the study. Demographic factors, general condition, treatment factors, and dental findings were examined retrospectively using medical records and panoramic X-ray findings. The cumulative occurrence rate of MRONJ was calculated using the Kaplan?Meier method, and the correlation between these variables and development of MRONJ was analyzed by univariate and multivariate Cox regression analysis. MRONJ developed in 18 of 135 patients. The 1-, 2-, and 3-year cumulative occurrence rates were 8.6%, 21.5%, and 29.2%, respectively. The duration of medication before first visit to the dental unit and the presence of a tooth with clinical symptoms were significantly correlated with the development of MRONJ. The rate of MRONJ occurrence in patients who had teeth with clinical symptoms, but who did not undergo tooth extraction, became higher 2 years later than that in patients who underwent extraction of teeth with symptoms, although not significant. Early dental examination and effective preventative care to avoid infection/inflammation are important for preventing MRONJ

Identifying the Timing of Swallowing Sounds Using Videoendoscopy Findings in Healthy Adults

Cervical auscultation is a useful tool for detecting dysphagia; however, the sites where swallowing sounds are produced are unknown. In this study, we investigated the relationship between swallowing sounds and videoendoscopy (VE) images in healthy adults to identify the timing of swallowing sounds. Fifteen healthy young adults participated in the study. Each participant was seated in an upright position while a stethoscope probe with an inserted microphone was placed at the center of his or her lower neck to detect swallowing sounds during the VE. The detected sounds were recorded simultaneously with the VE images while the subjects swallowed 4g of liquid or jelly. Swallowing duration, swallowing sound duration, and VE findings at the beginning and end of swallowing sounds were analyzed. One hundred and thirty-four sound samples produced by a single swallowed bolus were obtained and analyzed. The mean swallowing duration for each material ranged from 1.25 to 2.39s. Swallowing duration was significantly longer for jelly compared with liquids (p<0.01). Swallowing sound duration was approximately 0.5s in all samples, and there were no significant differences between materials. Most swallowing sounds started during velopharyngeal closure (109/134, 81.3%), and most swallowing sounds ended during velopharyngeal closure (98/134, 73.1%). For all materials, swallowing sounds did not start when the materials flowed into the pyriform sinuses, and very few sounds corresponded with epiglottic movements. These results show that many movements associated with physiologic events―including hyoid bone and laryngeal excursion, and opening of the upper esophageal sphincter―may be involved in the production of swallowing sounds