2.The Safety Profiles of Biological Drugs for Rheumatoid Arthritis
Tetsu KOBAYASHI ; Kazushige MURAYAMA ; Yuki OHTA ; Nana KAWASAKI ; Satoshi TOYOSHIMA ; Akiko ISHII-WATABE
Japanese Journal of Pharmacoepidemiology 2017;21(2):63-76
To identify the most frequently reported preferred terms (PTs) in the cases of rheumatoid arthritis (RA) patients treated with immunosuppressive biological drugs as suspected drugs, we analyzed the cases in the Japanese Adverse Drug Event Report (JADER) database. We found that pneumonia, interstitial lung disease, Pneumocystis jiroveci pneumonia (PCP), cellulitis, sepsis, and herpes zoster were the most frequently reported PTs. We obtained the reporting odds ratio (ROR) and the time to onset of these six PTs and compared them in the cases reported for each immunosuppressant as a suspected drug. We focused on RA treatment, including five tumor necrosis factor (TNF) antagonists (infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol). For pneumonia, interstitial lung disease and sepsis, no specific correlation was observed for each immunosuppressant for RA. In the case of PCP, the highest ROR was observed in the patients treated with infliximab. The time to onset of PCP in the infliximab-treated patients (median, 0.19 yr) was significantly shorter than the onset time in the patients treated with tocilizumab, an interleukin-6 receptor blocker that is another type of drug for RA(0.32 yr, p<0.01, Mann-Whitney test). The onset time in the patients treated with golimumab (0.24 yr) was also significantly shorter than the onset time for tocilizumab(p<0.05), but the ROR was not as high. These results suggested a correlation between PCP and infliximab. In the cases of cellulitis and herpes zoster, a similar correlation was observed with tocilizumab and certolizumab pegol, respectively. We should consider these results when patients have a respiratory disorder or skin/subcutaneous tissue disorder.
3.Safety Evaluation of Extract from Cultured Lentinula edodes Mycelia; Study of Acute Toxicity, Genotoxicity and Inhibiting Effect of Drug-Metabolizing Enzyme, Cytochrome P-450 3A4
Yasuko YOSHIOKA ; Yasunori MATSUI ; Masakazu KOBAYASHI ; Yuki HONDA ; Makoto TAMESADA ; Toshio OONUMA ; Hironori TOMI
Japanese Journal of Complementary and Alternative Medicine 2010;7(1):51-57
Objective: Extract from cultured Lentinula edodes mycelia (L.E.M.) is a food ingredient possessing various pharmacologic actions such as immunomodulatory properties, antitumor and hepatoprotective effects. In Japan, it has been used as a health food for 30 years or more.
In the present study to evaluate the safety of L.E.M., a genotoxicity study and acute toxicity study were conducted. In addition, the inhibitory effect of drug-metabolizing enzyme by L.E.M. was tested in vitro, to gain insight on the interaction with medicines.
Methods: The genotoxicity study was performed using a bacterial reverse mutation assay and a in vivo mammalian bone marrow cell chromosomal mutation assay. The acute toxicity study was performed using a single-dose oral toxicity test in rats. Inhibitory activity of cytochrome P-450 3A4 (CYP3A4), one of the most important drug-metabolizing enzymes, by L.E.M. was tested using a baculovirus-expressed system.
Results: In the genotoxicity study, mutagenicity was negative for both bacterial reverse mutation assay and in vivo mammalian bone marrow cell chromosomal mutation assay. In the acute toxicity study, no toxic symptoms were observed by single dose oral administration of L.E.M. at a dose of 10,000 mg/kg BW in rats. This implies LD50>10,000 mg/kg BW. No inhibitory activity of CYP3A4 by L.E.M. was observed at in the in vitro screening system to investigate drug-L.E.M. interaction.
Conclusion: It is believed L.E.M. is a safety ingredient for foods used in complementary and alternative medicine, since it was toxicologically safe and showed no inhibitory activity of CYP3A4 in the studies conducted.
4.Abnormal ramification pattern of the renal and testicular vessels
Tetsuhito KIGATA ; Yuki AKAKABE ; Rei INOUE ; Yasushi KOBAYASHI
Anatomy & Cell Biology 2025;58(1):140-143
We demonstrate an aberrant ramification pattern of the renal and testicular vessels. On both sides, the anterior and posterior renal veins emerged from the renal. On the right side, the anterior renal vein collected the right testicular vein and drained into the inferior vena cava, while the posterior one directly drained into the inferior vena cava. Two retrocaval testicular arteries originated from the aorta. On the left side, the perinephric vein drained from the abdominal wall and adrenal gland and joined the anterior renal vein. The anterior renal vein also collected the testicular, suprarenal, and inferior phrenic veins. The posterior one received the other testicular vein and the first three lumbar veins. These renal veins converged, passed anteriorly to the aorta, and drained into the inferior vena cava. Knowledge of the varied anatomy of these vessels will contribute to safe surgical approach to the kidneys.
5.Abnormal ramification pattern of the renal and testicular vessels
Tetsuhito KIGATA ; Yuki AKAKABE ; Rei INOUE ; Yasushi KOBAYASHI
Anatomy & Cell Biology 2025;58(1):140-143
We demonstrate an aberrant ramification pattern of the renal and testicular vessels. On both sides, the anterior and posterior renal veins emerged from the renal. On the right side, the anterior renal vein collected the right testicular vein and drained into the inferior vena cava, while the posterior one directly drained into the inferior vena cava. Two retrocaval testicular arteries originated from the aorta. On the left side, the perinephric vein drained from the abdominal wall and adrenal gland and joined the anterior renal vein. The anterior renal vein also collected the testicular, suprarenal, and inferior phrenic veins. The posterior one received the other testicular vein and the first three lumbar veins. These renal veins converged, passed anteriorly to the aorta, and drained into the inferior vena cava. Knowledge of the varied anatomy of these vessels will contribute to safe surgical approach to the kidneys.
6.Abnormal ramification pattern of the renal and testicular vessels
Tetsuhito KIGATA ; Yuki AKAKABE ; Rei INOUE ; Yasushi KOBAYASHI
Anatomy & Cell Biology 2025;58(1):140-143
We demonstrate an aberrant ramification pattern of the renal and testicular vessels. On both sides, the anterior and posterior renal veins emerged from the renal. On the right side, the anterior renal vein collected the right testicular vein and drained into the inferior vena cava, while the posterior one directly drained into the inferior vena cava. Two retrocaval testicular arteries originated from the aorta. On the left side, the perinephric vein drained from the abdominal wall and adrenal gland and joined the anterior renal vein. The anterior renal vein also collected the testicular, suprarenal, and inferior phrenic veins. The posterior one received the other testicular vein and the first three lumbar veins. These renal veins converged, passed anteriorly to the aorta, and drained into the inferior vena cava. Knowledge of the varied anatomy of these vessels will contribute to safe surgical approach to the kidneys.
7.Abnormal ramification pattern of the renal and testicular vessels
Tetsuhito KIGATA ; Yuki AKAKABE ; Rei INOUE ; Yasushi KOBAYASHI
Anatomy & Cell Biology 2025;58(1):140-143
We demonstrate an aberrant ramification pattern of the renal and testicular vessels. On both sides, the anterior and posterior renal veins emerged from the renal. On the right side, the anterior renal vein collected the right testicular vein and drained into the inferior vena cava, while the posterior one directly drained into the inferior vena cava. Two retrocaval testicular arteries originated from the aorta. On the left side, the perinephric vein drained from the abdominal wall and adrenal gland and joined the anterior renal vein. The anterior renal vein also collected the testicular, suprarenal, and inferior phrenic veins. The posterior one received the other testicular vein and the first three lumbar veins. These renal veins converged, passed anteriorly to the aorta, and drained into the inferior vena cava. Knowledge of the varied anatomy of these vessels will contribute to safe surgical approach to the kidneys.
8.Abnormal ramification pattern of the renal and testicular vessels
Tetsuhito KIGATA ; Yuki AKAKABE ; Rei INOUE ; Yasushi KOBAYASHI
Anatomy & Cell Biology 2025;58(1):140-143
We demonstrate an aberrant ramification pattern of the renal and testicular vessels. On both sides, the anterior and posterior renal veins emerged from the renal. On the right side, the anterior renal vein collected the right testicular vein and drained into the inferior vena cava, while the posterior one directly drained into the inferior vena cava. Two retrocaval testicular arteries originated from the aorta. On the left side, the perinephric vein drained from the abdominal wall and adrenal gland and joined the anterior renal vein. The anterior renal vein also collected the testicular, suprarenal, and inferior phrenic veins. The posterior one received the other testicular vein and the first three lumbar veins. These renal veins converged, passed anteriorly to the aorta, and drained into the inferior vena cava. Knowledge of the varied anatomy of these vessels will contribute to safe surgical approach to the kidneys.
9.Effectiveness of Solution with 5% Detergent for Cleaning Transnasal Esophagogastroduodenoscopy Lens
Yoshinori KOMAZAWA ; Mika YUKI ; Nobuhiko FUKUBA ; Yoshiya KOBAYASHI ; Hitomi ISHITOBI ; Sayaka NAKASHIMA ; Makoto NAGAOKA ; Yoshiko TAKAHASHI ; Toshihiro SHIZUKU
Clinical Endoscopy 2021;54(2):236-241
Background/Aims:
Unsedated transnasal esophagogastroduodenoscopy (EGD) is affected by a poor scope lens-cleaning function. We have previously reported good, albeit limited, effects of an oolong tea washing solution; here, we evaluated the effectiveness of a 5% lens cleaning solution for cleaning an EGD lens.
Methods:
Five percent lens cleaning solution (C), 5% dimethicone solution (D), and distilled water (W) were prepared. Study I: Lenses were soiled with pork grease, washed with each washing solution, and their image quality was judged. Study II: Patients (n=996) scheduled for transnasal EGD were randomly assigned to the C- or W-group. Lens cleanliness level, washing solution volume used, and endoscopist stress due to lens contamination were determined.
Results:
Study I: The image quality of the lenses washed with (C) was significantly superior. (D) was clinically unsuitable because of spray nozzle clogging. Study II: Lens cleaning in the C-group was significantly superior (p<0.0001) and the solution volume required was significantly reduced (p<0.0001), while endoscopist stress was also lower (p<0.0001).
Conclusions
For transnasal small-caliber EGD, the present 5% lens cleaning solution provided good visibility. It features a high detergency level and is simple to formulate for therapeutic endoscopy applications, such as endoscopic submucosal dissection.
10.Effectiveness of Solution with 5% Detergent for Cleaning Transnasal Esophagogastroduodenoscopy Lens
Yoshinori KOMAZAWA ; Mika YUKI ; Nobuhiko FUKUBA ; Yoshiya KOBAYASHI ; Hitomi ISHITOBI ; Sayaka NAKASHIMA ; Makoto NAGAOKA ; Yoshiko TAKAHASHI ; Toshihiro SHIZUKU
Clinical Endoscopy 2021;54(2):236-241
Background/Aims:
Unsedated transnasal esophagogastroduodenoscopy (EGD) is affected by a poor scope lens-cleaning function. We have previously reported good, albeit limited, effects of an oolong tea washing solution; here, we evaluated the effectiveness of a 5% lens cleaning solution for cleaning an EGD lens.
Methods:
Five percent lens cleaning solution (C), 5% dimethicone solution (D), and distilled water (W) were prepared. Study I: Lenses were soiled with pork grease, washed with each washing solution, and their image quality was judged. Study II: Patients (n=996) scheduled for transnasal EGD were randomly assigned to the C- or W-group. Lens cleanliness level, washing solution volume used, and endoscopist stress due to lens contamination were determined.
Results:
Study I: The image quality of the lenses washed with (C) was significantly superior. (D) was clinically unsuitable because of spray nozzle clogging. Study II: Lens cleaning in the C-group was significantly superior (p<0.0001) and the solution volume required was significantly reduced (p<0.0001), while endoscopist stress was also lower (p<0.0001).
Conclusions
For transnasal small-caliber EGD, the present 5% lens cleaning solution provided good visibility. It features a high detergency level and is simple to formulate for therapeutic endoscopy applications, such as endoscopic submucosal dissection.