脊損患者の膀胱機能回復 --急性期無菌間歇導尿管理法の違いによる尿路予後の検討--

1979年6月から1981年12月の間に総合脊損センターで急性期収容治療された外傷性脊髄麻痺90例につき, 急性期無菌間歇導尿管理法の違いによる膀胱の回復状況と治療効果を検討した.急性尿閉期に, 球海綿体筋反射と冷水テストを行なって膀胱回復の関係を調べたところ, 球海綿体筋反射が亢進または存在する例は, 膀胱を急伸展しない限り, 膀胱反射(冷水テスト陽性化)することが判明した.過伸展すると膀胱の回復が遅れる.膀胱反射(冷水テスト陽性化)の出現する時期に一致して, 尿失禁が発現する.過伸展により自己導尿管理がしやすくなる.自己導尿でも感染の危険は少ない.過伸展による水腎症, 膀胱尿管逆流等の合併症は認めなかった.以上の結果より, 将来反射性失禁排尿になる可能性が高い脊損完全麻痺(仙髄領域の知覚が無く, 球海綿体筋反射が亢進または存在する例)に限り, 尿失禁の少ない自己導尿向きの膀胱にする為, 過伸展で行なう急性期無菌歇導尿法も尿路管理法として意義があると考えるNinety patients with spinal cord injury were managed by aseptic intermittent catheterization program I (preventing the over-distension of the bladder) and program II (allowing overdistension) in which recovery of bladder function and the clinical effects were comparatively investigated. Using program I, cases with positive BCR restored the automaticity of the bladder on average 8 weeks after injury. When urinary incontinence first occurs during aseptic intermittent catheterization, urinary training may be commenced since the bladder has then recovered from spinal shock. Cases with no BCR do not restore automatic bladder contraction. Program II delayed or weakened the recovery of bladder function considerably. Patients with incomplete lesions and sacral sparing, particularly those with urinary sensation, should be managed by program I which does not impair recovery of the bladder. It is possible to prevent urinary incontinence and infection, if paraplegics with complete lesions are managed by program II. The percentage of urinary infection was 22.6 +/- 16.0% (N = 90) during aseptic intermittent catheterization (non-touch technic) among whom no statistically significant difference between those with trigger voiding (22.2 +/- 17.2%, N = 57) and those with self-catheterization (23.2 +/- 14.0%, N = 33) was found

NEXUS trial: a multicenter phase II clinical study evaluating the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab in patients with previously untreated surgically resectable BRAF V600E mutant colorectal oligometastases

Abstract Background The optimal treatment strategy for resectable BRAF V600E mutant colorectal oligometastases (CRM) has not been established due to the rarity and rapid progression of the disease. Since the unresectable recurrence rate is high, development of novel perioperative therapies are warranted. On December 2020, the BEACON CRC triplet regimen of encorafenib, binimetinib, and cetuximab was approved for unresectable metastatic colorectal cancer in Japan. Methods The NEXUS trial is a multicenter phase II clinical study evaluating the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab in patients with previously untreated surgically resectable BRAF V600E mutant CRM. The key inclusion criteria are as follows: histologically diagnosed with colorectal adeno/adenosquamous carcinoma; RAS wild-type and BRAF V600E mutation by tissue or blood; and previously untreated resectable distant metastases. The triplet regimen (encorafenib: 300 mg daily; binimetinib: 45 mg twice daily; cetuximab: 400 mg/m2, then 250 mg/m2 weekly, 28 days/cycle) is administered for 3 cycles each before and after curative resection. The primary endpoint of the study is the 1-year progression-free survival (PFS) rate and the secondary end points are the PFS, disease-free survival, overall survival, and objective response rate. The sample size is 32 patients. Endpoints in the NEXUS trial as well as integrated analysis with the nationwide registry data will be considered for seeking regulatory approval for the perioperative use of the triplet regimen. Discussion The use of the triplet regimen in the perioperative period is expected to be safe and effective in patients with resectable BRAF V600E mutant CRM. Trial registration jRCT2031220025, April. 16, 2022