Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

OBJECTIVE: To evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension. METHODS: Patients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study. RESULTS: A total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected. CONCLUSION: Eculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population. CLINICALTRIALSGOV IDENTIFIER: REGAIN, NCT01997229; REGAIN open-label extension, NCT02301624. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo

Minimal Symptom Expression' in Patients With Acetylcholine Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis Treated With Eculizumab

The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension

Bladder Explosion during Transurethral Resection of the Prostate with Nitrous Oxide Inhalation

Bladder explosions are a rare complication of transurethral resection of the prostate. We report a patient who suffered a bladder rupture following transurethral resection of the prostate. Although explosive gases accumulate during the procedure, a high concentration of oxygen is needed to support an explosion. This rare phenomenon can be prevented by preventing the flow of room air into the bladder during the procedure to maintain a low concentration of oxygen inside the bladder

腹腔鏡下手術中に気胸および著明な皮下気腫を来たした症例

腹腔鏡下手術は,従来の開腹術にはみられない多彩な周術期合併症を引き起こす可能性がある.今回,鏡視下手術中経験した合併症を紹介する.(症例1)52歳女性.胆石・胆嚢炎に対し腹腔鏡下胆嚢摘出術が施行された.気腹20分後に経皮酸素飽和度が低下し血圧も低下した.胸部X線撮影で右気胸が確認された.胸腔ドレーンを挿入し呼吸状態は改善された.気胸の原因として,横隔膜の脆弱性が疑われた.(症例2)86歳女性.腹腔鏡下後腹膜到達法(retroperitoneal approach)で右腎癌に対して右腎臓摘出術が施行された.気腹後から呼気終末二酸化炭素分圧(PETCO_2)が急に上昇し換気条件を変更しても改善されなかった.皮下気腫を認め,徐々に広範となった.両側大腿部から頸部まで進展したため,手術後も皮下気腫が改善するまで気管内挿管下呼吸管理を行った.腹腔鏡下手術中は気胸,皮下気腫などの合併症が起こり換気障害を来たすことがあるので,早期発見につとめ,周術期も注意深く観察する必要がある.Laparoscopic surgery can cause various perioperative complications unassociated with conventional open surgery. We describe complications caused by laparoscopic surgery in 2 patients. Patient 1 was a 52-year-old woman who underwent a laparoscopic cholecystectomy for gallstones and cholecystitis. The percutaneous oxygen saturation and blood pressure decreased 20 minutes after the onset of pneumoperitoneum. A chest film confirmed a right-sided pneumothorax. Her respiratory status improved after placement of a drain in the thoracic cavity. Anatomical weakness of the diaphragm was suspected to have caused the pneumothorax. Patient 2 was an 86-year-old woman who underwent a laparoscopic nephrectomy via a retroperitoneal approach for cancer of the right kidney. After the induction of pneumoperitoneum, the end-tidal partial pressure of carbon dioxide (PETCO_2) rapidly increased and did not improve, even after altering the ventilation conditions. Subcutaneous emphysema developed and gradually extended from both thighs to the neck. After surgery, the patient received artificial ventilation through an endotracheal tube until the resolution of subcutaneous emphysema. Laparoscopic surgery can cause various complications, such as pneumothorax and subcutaneous emphysema, and result in ventilatory impairment. Patients who undergo laparoscopic surgery should be carefully monitored during the perioperative period to ensure early detection of potential complications

腹腔鏡下手術中に気胸および著明な皮下気腫を来たした症例

腹腔鏡下手術は,従来の開腹術にはみられない多彩な周術期合併症を引き起こす可能性がある.今回,鏡視下手術中経験した合併症を紹介する.(症例1)52歳女性.胆石・胆嚢炎に対し腹腔鏡下胆嚢摘出術が施行された.気腹20分後に経皮酸素飽和度が低下し血圧も低下した.胸部X線撮影で右気胸が確認された.胸腔ドレーンを挿入し呼吸状態は改善された.気胸の原因として,横隔膜の脆弱性が疑われた.(症例2)86歳女性.腹腔鏡下後腹膜到達法(retroperitoneal approach)で右腎癌に対して右腎臓摘出術が施行された.気腹後から呼気終末二酸化炭素分圧(PETCO_2)が急に上昇し換気条件を変更しても改善されなかった.皮下気腫を認め,徐々に広範となった.両側大腿部から頸部まで進展したため,手術後も皮下気腫が改善するまで気管内挿管下呼吸管理を行った.腹腔鏡下手術中は気胸,皮下気腫などの合併症が起こり換気障害を来たすことがあるので,早期発見につとめ,周術期も注意深く観察する必要がある.Laparoscopic surgery can cause various perioperative complications unassociated with conventional open surgery. We describe complications caused by laparoscopic surgery in 2 patients. Patient 1 was a 52-year-old woman who underwent a laparoscopic cholecystectomy for gallstones and cholecystitis. The percutaneous oxygen saturation and blood pressure decreased 20 minutes after the onset of pneumoperitoneum. A chest film confirmed a right-sided pneumothorax. Her respiratory status improved after placement of a drain in the thoracic cavity. Anatomical weakness of the diaphragm was suspected to have caused the pneumothorax. Patient 2 was an 86-year-old woman who underwent a laparoscopic nephrectomy via a retroperitoneal approach for cancer of the right kidney. After the induction of pneumoperitoneum, the end-tidal partial pressure of carbon dioxide (PETCO_2) rapidly increased and did not improve, even after altering the ventilation conditions. Subcutaneous emphysema developed and gradually extended from both thighs to the neck. After surgery, the patient received artificial ventilation through an endotracheal tube until the resolution of subcutaneous emphysema. Laparoscopic surgery can cause various complications, such as pneumothorax and subcutaneous emphysema, and result in ventilatory impairment. Patients who undergo laparoscopic surgery should be carefully monitored during the perioperative period to ensure early detection of potential complications