A questionnaire survey of risk management systems for medical products was conducted with the cooperation of domestic and foreign pharmaceutical companies. As for the foreign companies, it was revealed that specialized safety management teams and data-management committees are established to formulate risk management plans in order to create systems that assure consistent risk management for each company. In addition, it was revealed that toxicologists are incorporated in the central decision making organization. As for domestic companies, it turned out that no less than half of the respondents pay attention to consistent risk management from the development stage through the post marketing stage. From now on, it will be essential to consolidate safety data, improve the accessibility of centralized safety data from the relevant departments, and establish systems to provide consistent risk management from the development stage to the post marketing stage.

We report 2 patients with Graves' disease and psychological disorders. In these patients, treatment did not relieve psychological disorders despite normalization of thyroid function, but kampo therapy was effective. Patient 1 was a 24-year-old female. In 2000, she was diagnosed as having Graves' disease. Treatment with an antithyroid drug normalized thyroid function, but did not relieve psychological disorders such as irritation, anxiety, or despair. In February 2005, the patient consulted our hospital. Patient 2 was a 26-year-old female. After graduating from a high school, she developed Graves' disease. Treatment with an antithyroid drug was started. However, thyroid function was unstable ; mild hyperthyroidism and hypothyroidism repeatedly occurred. During this period, irritation, fatigue, malaise, and alopecia deteriorated, and she consulted our hospital in January 2005. In the two patients, keishikanzoryukotsuboreitogohangekobokuto was prescribed (the regimen was changed during follow-up in Patient 1), and their conditions markedly subsided after 16 and 9 weeks of administration, respectively, suggesting the usefulness of kampo therapy in the treatment of Graves' disease associated with psychological disorders.
Therapeutic procedure ; Graves' Disease ; seconds ; Patients ; Mental disorders

Lynch syndrome (LS) is an autosomal dominant disorder caused by mutations in mismatch repair (MMR) genes and is also known to be associated with glioblastomas. The efficacy of immunotherapy for LS-associated glioblastomas remains unknown. Herein, we report a rare case of LS-associated glioblastoma, treated with chemotherapy using immune checkpoint inhibitors (ICI). A 41-year-old female patient presented with headaches and sensory disturbances in the right upper limb for 6 weeks. She had been treated for rectal cancer and had a family history of LS. MRI revealed two ring-enhancing lesions in the left precentral gyrus. She underwent subtotal resection, leading to a pathological diagnosis of isocitrate dehydrogenase wild-type glioblastoma. She received daily administration of (temozolomide, 75 mg/m 2 ) and concurrent radiotherapy (60 Gy) postoperatively. However, the tumor recurred 1 year after the initial treatment. A molecular genetic study showed high microsatellite instability (MSI), and she was treated with pembrolizumab therapy. Disease progression occurred despite six cycles of pembrolizumab therapy and radiotherapy at the dose of 40 Gy. She died due to glioblastoma progression 19 months after the initial treatment. The present case demonstrates that some LS-associated glioblastomas may be resistant to ICI despite high MSI, possibly because of intratumor heterogeneity related to MMR deficiency.

PURPOSE: Sialolithiasis is one of the most prevalent large obstructive disorders of the submandibular glands. The aim of this study was to investigate submandibular sialolithiasis with computed tomography (CT) and scintigraphy, with a particular focus on the relationship between CT values of the submandibular glands and their excretion rate. MATERIALS AND METHODS: Fifteen patients with submandibular sialolithiasis who underwent CT and salivary gland scintigraphy were included in this study. The relationship between the CT values of submandibular glands with and without sialoliths and salivary gland excretion measured using salivary gland scintigraphy was statistically analyzed. Dynamic images were recorded on the computer at 1 frame per 20 seconds. The salivary gland excretion fraction was defined as A (before stimulation test [counts/frame]) / B(after stimulation test [counts/frame]) using time-activity curves. RESULTS: The CT values in the submandibular glands with and without sialoliths was 9.9±44.9 Hounsfield units (HU) and 34.2±21.8 HU, respectively (P=.233). Regarding the salivary gland excretion fraction using scintigraphy, the A/B value in the submandibular glands with sialoliths (1.09±0.23) was significantly lower than in the submandibular glands without sialoliths (1.99±0.57, P=.000). CONCLUSION: Assessments of the CT values and the salivary gland excretion fraction using scintigraphy in the submandibular glands seem to be useful tools evaluating submandibular sialolithiasis.
Gamma Cameras ; Humans ; Multidetector Computed Tomography ; Radionuclide Imaging* ; Salivary Duct Calculi ; Salivary Gland Calculi* ; Salivary Glands* ; Submandibular Gland*

PURPOSE: The aim of this study was to evaluate the quantitative strain elastography of tongue carcinoma using intraoral ultrasonography. MATERIALS AND METHODS: Two patients with squamous cell carcinoma (SCC) who underwent quantitative strain elastography for the diagnosis of tongue lesions using intraoral ultrasonography were included in this prospective study. Strain elastography was performed using a linear 14 MHz transducer (Aplio 300; Canon Medical Systems, Otawara, Japan). Manual light compression and decompression of the tongue by the transducer was performed to achieve optimal and consistent color coding. The variation in tissue strain over time caused by the compression exerted using the probe was displayed as a strain graph. The integrated strain elastography software allowed the operator to place circular regions of interest (ROIs) of various diameters within the elastography window, and automatically displayed quantitative strain (%) for each ROI. Quantitative indices of the strain (%) were measured for normal tissues and lesions in the tongue. RESULTS: The average strain of normal tissue and tongue SCC in a 50-year-old man was 1.468% and 0.000%, respectively. The average strain of normal tissue and tongue SCC in a 59-year-old man was 1.007% and 0.000%, respectively. CONCLUSION: We investigated the quantitative strain elastography of tongue carcinoma using intraoral ultrasonography. Strain elastography using intraoral ultrasonography is a promising technique for characterizing and differentiating normal tissues and SCC in the tongue.
Carcinoma, Squamous Cell ; Clinical Coding ; Decompression ; Diagnosis ; Elasticity Imaging Techniques ; Humans ; Middle Aged ; Prospective Studies ; Tongue Neoplasms ; Tongue ; Transducers ; Ultrasonography

PURPOSE: To evaluate the usefulness of shear wave elastography in the diagnosis of oral and maxillofacial diseases. MATERIALS AND METHODS: Ten patients with oral and maxillofacial diseases and 28 volunteers drawn from our student doctors were examined by shear wave elastography with a 14-MHz linear transducer using an Aplio 300 apparatus (Canon Medical Systems, Otawara, Japan). A statistical analysis of the shear elastic modulus (kPa) of healthy tissue (the sublingual gland, submandibular gland, anterior belly of the digastric muscle, and geniohyoid muscle) in the 28 volunteers was performed using 1-way repeated measures analysis of variance with the Tukey honest significant difference test. The maximum shear elastic modulus (kPa) of 8 patients with squamous cell carcinoma (SCC) and 2 patients with benign lesions was evaluated with the Mann-Whitney U test. The analysis used a 5% significance level. RESULTS: The mean shear elastic modulus of the sublingual gland (9.4±3.7 kPa) was lower than that of the geniohyoid muscle (19.2±9.2 kPa, P=.000) and the anterior belly of the digastric muscle (15.3±6.1 kPa, P=.004). The maximum shear elastic modulus of the SCCs (109.6±14.4 kPa) was higher than that of the benign lesions (46.4±26.8 kPa, P=.044). CONCLUSION: Our results demonstrated the usefulness of shear wave elastography in the diagnosis of oral and maxillofacial diseases. Shear wave elastography has the potential to be an effective technique for the objective and quantitative diagnosis of oral and maxillofacial diseases.
Carcinoma, Squamous Cell ; Diagnosis ; Elastic Modulus ; Elasticity Imaging Techniques ; Humans ; Neck ; Sublingual Gland ; Submandibular Gland ; Transducers ; Ultrasonography ; Volunteers

PURPOSE: To present characteristic findings of Tc-99m hydroxymethylene diphosphonate (HMDP) scintigraphy, computed tomography (CT), and magnetic resonance (MR) imaging for osteonecrosis in the mandible, especially osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). MATERIALS AND METHODS: Thirteen patients with MRONJ and 7 patients with ORN in the mandible underwent Tc-99m HMDP scintigraphy, CT, and MR imaging (T1-weighted images [T1WI], T2-weighted images [T2WI], short inversion time inversion recovery images [STIR]), diffusion-weighted images [DWI], and apparent diffusion coefficient [ADC] mapping). The associations of scintigraphy, CT, and MR imaging findings with MRONJ and ORN were analyzed using the chi-square test with the Pearson exact test. RESULTS: Thirteen patients with MRONJ and 7 patients with ORN in the mandible showed low signal intensity on T1WI and ADC mapping, high signal intensity on STIR and DWI, and increased uptake on scintigraphy. Periosteal bone proliferation on CT was observed in 69.2% of patients with MRONJ (9 of 13) versus 14.3% of patients with ORN (1 of 7) (P=0.019). CONCLUSION: This study presented characteristic imaging findings of MRONJ and ORN on scintigraphy, CT, and MR imaging. Our results suggest that CT can be effective for detecting MRONJ and ORN.
Diffusion ; Humans ; Jaw ; Magnetic Resonance Imaging ; Mandible ; Osteonecrosis ; Osteoradionecrosis ; Radionuclide Imaging ; Tomography, X-Ray Computed

Postoperative pancreatic fistulas (POPFs) are common adverse events that occur after pancreatic surgery. Endoscopic ultrasonography (EUS)-guided drainage (EUS-D) is a first-line treatment, similar to that for pancreatic fluid collection (PFCs) after acute pancreatitis. However, some POPFs do not develop fluid collections depending on the presence or location of the surgical drain, whereas others develop fluid collections, such as postoperative fluid collections (POPFCs). Although POPFCs are similar to PFCs, the strategy and modality for POPF management need to be modified according to the presence of fluid collections, surgical drains, and surgical type. As discussed for PFCs, the indications, timing, and selection of interventions or stents for EUS-D have not been fully elucidated for POPFs. In this review, we discuss the management of POPFs and POPFCs in comparison with PFCs due to acute pancreatitis and summarize the topics that should be addressed in future studies.

Postoperative pancreatic fistulas (POPFs) are common adverse events that occur after pancreatic surgery. Endoscopic ultrasonography (EUS)-guided drainage (EUS-D) is a first-line treatment, similar to that for pancreatic fluid collection (PFCs) after acute pancreatitis. However, some POPFs do not develop fluid collections depending on the presence or location of the surgical drain, whereas others develop fluid collections, such as postoperative fluid collections (POPFCs). Although POPFCs are similar to PFCs, the strategy and modality for POPF management need to be modified according to the presence of fluid collections, surgical drains, and surgical type. As discussed for PFCs, the indications, timing, and selection of interventions or stents for EUS-D have not been fully elucidated for POPFs. In this review, we discuss the management of POPFs and POPFCs in comparison with PFCs due to acute pancreatitis and summarize the topics that should be addressed in future studies.