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Objectives: To assess the effectiveness of remimazolam against normal saline (placebo) as a sedative agent for endoscopy in a multicenter, randomized, double‐blind, investigator‐initiated phase III controlled trial. Methods: We included 48 Japanese patients undergoing upper gastrointestinal endoscopy. For the procedure, an initial remimazolam dose of 3 mg and additional doses of 1 mg were administered, as determined in the phase II clinical study. The primary study end‐point was the successful sedation rate during gastrointestinal endoscopy, determined as a Modified Observer's Assessment of Alertness/Sedation score ≤4 before the start of endoscopy, the completion of gastrointestinal endoscopy, and two or fewer additional doses per 6 min. Results: The successful endoscopy sedation rates were 91.9% and 9.1% in the remimazolam and placebo groups, respectively (P < 0.01). The time from the end of endoscopy to arousal was 0.0 (0.0–0.0) min for both groups. The number of additional doses required to achieve sedation was lower in the remimazolam group than that in the placebo group (P < 0.01). Conclusions: Remimazolam demonstrated a significantly higher sedation effect during upper gastrointestinal endoscopy in Japanese patients with safe and fast recovery compared with placebo. [ABSTRACT FROM AUTHOR]

The ganglioside expression of various human leukemia lines and uncultured or short-term cultured leukemia cells from patients were investigated. The resultsshowed that GD2 ganglioside is highly and specifically expressed in human T-cell lymphotropic type I-infected T-cells and in adult T-cell leukemia cells.This pattern of GD2 expression correlated with the expression of p40-tax and beta-1,4-N-acetylgalactosaminyltransferase (GM2/GD2 synthase). It is proposed that GD2 is synthesized by the action of p40-tax-induced GM2/GD2 synthase.

It is well known that cell-mediated immunity is suppressed in patients with neoplastic diseases. We have reported that soluble receptors for interleukin-2 (sIL-2R) and tumor necrosis factor (sTNF-R1) are elevated in the serum of patients with advanced colorectal cancer. The presence of these soluble receptors and immunosuppressive cytokines, including interleukin-10 (IL-10), might be important in the mechanisms of immunosuppression. cis-Diaminedichloroplatinum (cisplatin) has been reported to immunomodulate, especially when used in low dose in combination with 5-Fluorouracil (5-FU). In this study, cisplatin and UFT, a form of uracil and tegafur which is a prodrug of 5-FU, were administered with immunomodulator Polysaccharide K (PSK) to ten patients with colorectal cancer, who showed distant metastasis in the liver or lung, and the serum levels of sIL-2R and sTNF-R1 and the production of gamma-interferon (gamma-INF) and interleukin-10 by peripheral blood mononuclear cells were measured. The serum concentrations of sIL-2R and the production of IL-10 were reduced (p < 0.05) after 2 months of treatment. Thus, this combination appeared to have immunomodulative potential in patients with advanced colorectal cancer. [ABSTRACT FROM AUTHOR]

Utilizing the polymerase chain reaction (PCR), we studied the presence and pattern of mutations in the Kirsten (Ki)-ras oncogene, using paraffin-embedded sections of pancreatic carcinoma tissue from 53 patients. Mutations in the Ki-ras oncogene were evident in 46 of the 53 patients (87%) in codon 12. The predominant mutation was from glycine (GGT) to aspartic acid (GAT). Among the 46, one had an additional mutation in Ki-ras codon 13, and no mutation was found in codon 61. These oncogenetic mutations were observed even in early stage pancreatic carcinoma, and there was no statistically significant difference in the rate or positivity of mutations among the stages of the disease. With regard to patient survival, statistical analysis comparing 37 patients with mutations in the Ki-ras oncogene and four patients without mutations revealed no significant difference. These results suggest that mutations in the Ki-ras oncogene may be related to the initiation of carcinogenesis, but are not linked to malignant potential or promotion of human pancreatic cancer. [ABSTRACT FROM AUTHOR]

Introduction: We conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopies., Methods: This multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation with remimazolam (initial dose: 3 mg; additional dose: 1 mg) or normal saline (placebo). The primary endpoint of the study was the successful sedation rate during colonoscopy, defined as achieving a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤4 before the procedure, maintaining this score throughout colonoscopy, and requiring no more than five additional drug doses per 15 min., Results: The sedation success rate was 95.0% (38/40 patients) in the remimazolam group and 0.0% (0/11 patients) in the placebo group (p &lt; 0.01). The time from the end of procedure to regaining consciousness was 0.0 (interquartile range: 0.0-0.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 (interquartile range: 0.0-10.0) min in the remimazolam group and 0.0 (interquartile range: 0.0-0.0) min in the placebo group (p = 0.02). Serious adverse events were not observed., Conclusion: The use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than placebo., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Objectives: To compare the efficacy and safety of sedation with midazolam and remimazolam for colorectal endoscopy., Methods: This single-center, two-arm, post-hoc analysis of the REM-IICTJP01 study investigated the efficacy and safety of remimazolam for gastrointestinal endoscopic sedation. We enrolled 40 and 208 patients who underwent colonoscopy under remimazolam and midazolam sedation, respectively, during the same period. The primary outcome was the time from the end of the colonoscopy until discharge. The secondary outcomes included the time from the end of the colonoscopy until awakening, dosage, and adverse events. Propensity score matching was employed to eliminate the effect of confounding factors., Results: Thirty-seven patients in each group were matched. After propensity matching, the time to awakening after colonoscopy was 28.0 (13.0-37.0) min in the midazolam group and 0 (0-0) min in the remimazolam group; moreover, the time till discharge was 40.0 (35.0-46.5) min in the midazolam group and 0 (0-5.0) min in the remimazolam group, both of which were significantly shorter in the remimazolam group ( p < 0.01). The number of additional doses was 0 (0-0) and 2 (1-3) in the midazolam and remimazolam groups, respectively. The total dose was 2.0 (2.0-3.5) and 6.0 (5.0-7.0) mg in the midazolam and remimazolam groups, respectively., Conclusions: Remimazolam yielded significantly faster times to awakening and discharge safely compared to midazolam., Competing Interests: Author Hisatomo Ikehara received honoraria for his lectures from FUJIFILM Corporation, Mitsubishi Tanabe Pharma Corporation, and Olympus Corporation., (© 2024 The Author(s). DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)