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Morphometry of the Foramen Ovale in Adult Human Skulls from a Clinical Perspective. 从临床角度看成人头骨中卵圆孔的形态。
Q4 Medicine Pub Date : 2024-12-10 Epub Date: 2024-09-13 DOI: 10.2739/kurumemedj.MS7034010
Anupama Kodialbail, Radhika Paramesh Mudaliar, Jyothi Krishnarajanagar Chandrachari, Shailaja Shetty

Introduction: The foramen ovale (FO) is present in the posterior part of the greater wing of sphenoid. A trauma or space-occupying lesion in this area would result in clinical manifestations due to compression of the structures passing through it. This study was undertaken because of the clinical significance of the FO in radiological and neurological procedures. The aim is to study the morphometry of the FO and its bilateral variations.

Material and methods: Fifty adult dry human skulls of unknown age and sex were studied. The shape of the FO, presence of accessory foramina or abnormal bony outgrowths, if any, were noted. Maximum length and width of FO were measured.

Results: The FO was present bilaterally in all 50 skulls. Accessory foramen was present in 17 (34%) and 13 (26%) skulls on the right and left side, respectively. Bony out growths were present in 9 (18%) and 15 (30%) skulls on the right and the left side, respectively.

Conclusion: Understanding the exact topography, morphometry and variations of the FO is required to enable the clinician to correctly interpret radiographs and help in planning the surgical procedures. The findings presented here should be taken into account when neurological procedures of the middle cranial fossa are performed.

简介卵圆孔位于蝶骨大翼后部。该区域的外伤或占位性病变会导致通过该区域的结构受到压迫而出现临床表现。由于卵圆孔在放射学和神经学手术中的临床意义,因此开展了这项研究。目的是研究卵圆孔的形态测量及其双侧变异:研究对象为 50 个年龄和性别未知的成人干头骨。注意到卵圆孔(FO)的形状、是否存在附属孔或异常的骨性突起(如果有的话)。测量了卵圆孔的最大长度和宽度:结果:50 个头骨中均存在双侧卵圆孔。右侧和左侧分别有 17 个(34%)和 13 个(26%)头骨存在附属孔。右侧和左侧分别有 9 个(18%)和 15 个(30%)头骨出现骨质增生:结论:临床医生需要了解 FO 的确切地形、形态和变化,以便正确理解 X 光片并帮助规划手术程序。在进行中颅窝神经外科手术时,应将本文的研究结果考虑在内。
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引用次数: 0
Development and Psychometric Verification of a Self-Administered Scale for Family Needs in Japanese Critical Care Settings. 日本重症监护环境中家庭需求自控量表的开发与心理测量验证。
Q4 Medicine Pub Date : 2024-12-10 Epub Date: 2024-09-13 DOI: 10.2739/kurumemedj.MS7034008
Sayaka Fujimaru, Hiroki Inutsuka, Tatsuyuki Kakuma, Kimiko Morimoto, Mitsuyoshi Ayabe

Aim: We developed and evaluated the statistical reliability and validity of a family needs scale directly answerable by families in critical care settings.

Methods: In this qualitative study, 39 questions were drafted to capture family needs. These questions were then administered to the families of patients in emergency care settings. Exploratory factor analyses identified several needs factors and factor structures of the questions with oblique rotation. A confirmatory factor analysis examined internal consistency and criterion-related and construct validity.

Results: Three factors comprising 32 items were extracted from the exploratory factor analysis: "Needs for fulfilling family roles," "Needs for appropriate treatment and care," and "Needs for respecting family ties." Cronbach's α was 0.949 for the total score and 0.927, 0.914, and 0.896 for factors A-C, respectively, with cumulative variance of 50.0%. The three factors' confirmatory factor analysis revealed a relatively good model fit. A significant correlation was found between this scale and the assessment scale for the needs of families of patients in the intensive care unit.

Conclusions: A new scale assessing family needs was developed, and its reliability and validity were confirmed. The scale has acceptable psychometric properties and can be used to measure family needs in critical care settings, particularly in Japanese cultural contexts.

目的:我们开发并评估了可由危重症护理环境中的家庭直接回答的家庭需求量表的统计可靠性和有效性:在这项定性研究中,我们草拟了 39 个问题来反映家庭需求。然后对急诊患者家属进行了问卷调查。探索性因子分析确定了几个需求因子和问题的因子结构,并进行了斜向旋转。确认性因子分析检查了内部一致性、标准相关性和构建有效性:从探索性因子分析中提取了三个因子,共 32 个项目:"满足家庭角色的需要"、"适当治疗和护理的需要 "和 "尊重家庭纽带的需要"。总分的 Cronbach's α 为 0.949,A-C 因子的 Cronbach's α 分别为 0.927、0.914 和 0.896,累积方差为 50.0%。三个因子的确认性因子分析显示模型拟合度较好。该量表与重症监护病房患者家属需求评估量表之间存在明显的相关性:结论:我们开发了一个新的家庭需求评估量表,其信度和效度均得到了证实。该量表具有可接受的心理测量特性,可用于测量重症监护环境中的家庭需求,尤其是在日本文化背景下。
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引用次数: 0
Papillary Fibroelastoma of the Aortic Valve:Acute Coronary Syndrome Due to Dynamic Obstruction of the Right Coronary Artery Ostium. 主动脉瓣乳头状纤维母细胞瘤:右冠状动脉瓣膜动态阻塞导致的急性冠状动脉综合征。
Q4 Medicine Pub Date : 2024-12-10 Epub Date: 2024-08-05 DOI: 10.2739/kurumemedj.MS7034004
Hiroyuki Saisho, Satoru Tobinaga, Shigeaki Aoyagi, Yusuke Shintani, Hiroshi Yasunaga

A 59-year-old woman, who had a history of acute coronary syndrome (ACS) but without obstructive coronary lesions 2 years previously, presented with vertigo. MRI revealed a left cerebellar embolism. TEE detected a mobile aortic valve tumor, suggesting a papillary fibroelastoma (PFE). Reviewing previous echocardiograms, it was discovered that the tumor was present at the time of the ACS event. At surgery, the PFE was present on the right coronary cusp. When the aortic valve was opened, it was found that the tumor was obstructing the right coronary artery (RCA) ostium. ACS was probably caused by PFE's dynamic obstruction of the RCA ostium.

一名 59 岁的女性患者曾有急性冠状动脉综合征(ACS)病史,但 2 年前未发现冠状动脉阻塞性病变。磁共振成像显示左侧小脑栓塞。TEE 发现主动脉瓣有移动性肿瘤,提示为乳头状纤维瘤 (PFE)。复查之前的超声心动图发现,该肿瘤在发生 ACS 事件时就已存在。手术时,PFE 位于右冠状动脉尖。打开主动脉瓣后,发现肿瘤阻塞了右冠状动脉(RCA)的骨膜。急性冠状动脉综合征很可能是由 PFE 动态阻塞 RCA 管腔引起的。
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引用次数: 0
Hybrid Training System Consisting of Synchronized Neuromuscular Electrical Stimulation for Voluntary Exercise Using an Articular Motion Sensor. 利用关节运动传感器进行自主运动的同步神经肌肉电刺激混合训练系统。
Q4 Medicine Pub Date : 2024-12-10 Epub Date: 2024-08-05 DOI: 10.2739/kurumemedj.MS7034006
Hiroo Matsuse, Hiroshi Tajima, Eriko Baba, Sohei Iwanaga, Masayuki Omoto, Ryuki Hashida, Takeshi Nago, Naoto Shiba

Neuromuscular electrical stimulation (NMES) is widely used for improving muscle strength, preventing muscle atrophy, and decreasing pain. Recently, NMES has become a substitute for exercise therapy for metabolism improvement and functional capacity improvement. However, NMES has several disadvantages. First, slow-twitch muscle contractions are insufficient because the recruitment pattern of NMES does not obey Henneman's size principle. Second, when using surface electrodes, it is difficult to contract deep skeletal muscles at the application site. Third, electrical stimulation causes discomfort. Therefore, we devised a simultaneous combination of NMES and voluntary muscle contractions to overcome the weak points of NMES. A hybrid training system (HTS) that resists the motion of a volitionally contracting agonist muscle with force generated by its electrically stimulated antagonist was developed as a technique to combine the application of NMES and volitional contractions. This motion sensor makes it possible to simultaneously combine voluntary movements with NMES. Our HTS synchronizes with voluntary movements, enhancing safety and reducing discomfort. This HTS enhances the exercise effect of even simple exercise. So far, our HTS has been reported to be effective for muscle strength enhancement, prevention of muscle atrophy, improvement of physical function, pain relief, enhancement of physical fitness, and improvement of metabolic function. HTS are expected to be useful methods in environments where sufficient exercise load is not available or for individuals with low exercise tolerance.

神经肌肉电刺激(NMES)被广泛用于提高肌肉力量、防止肌肉萎缩和减轻疼痛。最近,神经肌肉电刺激已成为运动疗法的替代疗法,用于改善新陈代谢和提高功能能力。然而,NMES 有几个缺点。首先,由于 NMES 的募集模式不符合海尼曼大小原则,因此慢肌腱收缩不足。其次,在使用表面电极时,很难收缩应用部位的深层骨骼肌。第三,电刺激会引起不适。因此,我们设计了一种同时结合 NMES 和肌肉自主收缩的方法,以克服 NMES 的弱点。我们开发了一种混合训练系统 (HTS),该系统利用电刺激拮抗剂产生的力来抵制自主收缩激动肌的运动,从而将 NMES 的应用与自主收缩结合起来。这种运动传感器使同时结合自主运动和 NMES 成为可能。我们的 HTS 与自主运动同步,提高了安全性并减少了不适感。即使是简单的运动,这种 HTS 也能增强运动效果。据报道,迄今为止,我们的 HTS 在增强肌肉力量、防止肌肉萎缩、改善身体功能、缓解疼痛、增强体质和改善新陈代谢功能方面非常有效。在没有足够运动负荷的环境中,或对于运动耐受力较低的人来说,半身运动疗法有望成为有用的方法。
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引用次数: 0
Extrahepatic Portal Venous Gas Is the Strongest Predictor of Mortality in Patients with Portal Venous Gas and Pneumatosis Intestinalis. 肝外门静脉积气是门静脉积气和肠道肺炎患者死亡率的最强预测因子
Q4 Medicine Pub Date : 2024-12-10 Epub Date: 2024-08-05 DOI: 10.2739/kurumemedj.MS7034005
Naohiro Yoshida, Yoshihiko Sadakari, Hiroyuki Nakane, Munehiro Yoshitomi, Kazuhito Tamehiro, Gentaro Hirokata, Takeshi Aoyagi, Toshiro Ogata, Masahiko Taniguchi

Background: Very few studies have examined the association between contrast-enhanced computed tomography (CT) findings observed in portal venous gas (PVG) and pneumatosis intestinalis (PI) and the underlying diseases in these conditions.

Objectives: In this study, we analyzed this association and report the findings for predicting mortality.

Materials and methods: Overall, 50 patients diagnosed with PVG or PI, observed on contrast-enhanced CT, underwent treatment at our hospital. Based on the underlying disease, we divided the patients into three groups, those with ischemic disease, infectious disease, or gastrointestinal dilatation. Furthermore, cases that underwent surgical treatment or needed surgery but were inoperable were assigned to the high risk group (n=16) and patients who received conservative treatment were assigned to the low risk group (n=34). We reviewed the patients' medical charts, laboratory data, and CT images retrospectively, and analyzed the relationship between CT findings, underlying disease, and association with the high risk or low risk group in each case.

Results: Poor enhancement of the intestinal wall, mesenteric fat stranding, extrahepatic PVG, advanced age, and renal disease were significantly associated with ischemic disease (p=0.02, p=0.02, p=0.005, p=0.008 and p=0.049, respectively). PI alone was strongly associated with gastrointestinal dilatation (p=0.009). Patients in the low risk group had more favorable outcomes with conservative treatment. In multivariate analysis, extrahepatic PVG was the only factor associated with the high risk group (p=0.002).

Conclusion: Extrahepatic PVG associated with ischemic disease was the strongest predictive factor of mortality. Other CT findings, though useful in diagnosing the underlying disease, were not significant predictive factors.

背景:很少有研究探讨门静脉积气(PVG)和肠道积气(PI)的对比增强计算机断层扫描(CT)结果与这些疾病的潜在疾病之间的关联:在这项研究中,我们分析了这种关联,并报告了预测死亡率的结果:共有 50 名经造影剂增强 CT 观察确诊为 PVG 或 PI 的患者在我院接受了治疗。根据基础疾病,我们将患者分为三组,即缺血性疾病组、感染性疾病组或胃肠道扩张组。此外,接受手术治疗或需要手术但无法手术的病例被归入高风险组(16 例),接受保守治疗的患者被归入低风险组(34 例)。我们回顾性地查看了患者的病历、实验室数据和 CT 图像,并分析了每例患者的 CT 结果、潜在疾病以及与高风险组或低风险组之间的关系:结果:肠壁强化不佳、肠系膜脂肪绞窄、肝外 PVG、高龄和肾脏疾病与缺血性疾病显著相关(分别为 p=0.02、p=0.02、p=0.005、p=0.008 和 p=0.049)。单用 PI 与胃肠道扩张密切相关(p=0.009)。低风险组患者接受保守治疗的效果更佳。在多变量分析中,肝外静脉曲张是唯一与高风险组相关的因素(P=0.002):结论:与缺血性疾病相关的肝外PVG是预测死亡率的最强因素。结论:与缺血性疾病相关的肝外PVG是预测死亡率的最强因素,其他CT结果虽然有助于诊断潜在疾病,但不是重要的预测因素。
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引用次数: 0
Right Parasternal Approach for Aortic Valve Replacement After Presternal Gastropexy. 胸骨前胃切除术后主动脉瓣置换术的右侧胸骨旁入路
Q4 Medicine Pub Date : 2024-12-10 Epub Date: 2024-09-06 DOI: 10.2739/kurumemedj.MS7034009
Hiroyuki Otsuka, Hiroyuki Saisho, Tohru Takaseya, Hiromasa Fujita, Hiroyuki Tanaka, Eiki Tayama

Due to bicuspid aortic valve aortic stenosis, a 78-year-old man with a history of esophagectomy and presternal gastric tube reconstruction required aortic valve replacement (AVR). AVR with a bioprosthetic valve was performed through a right parasternal thoracotomy. Despite the unfavorable conditions for conventional median sternotomy, AVR was successfully performed through an alternate approach. The right parasternal approach was excellent for AVR in patients with presternal gastric tube reconstruction for esophageal cancer (EC).

一名 78 岁的男性因主动脉瓣二尖瓣主动脉瓣狭窄而需要进行主动脉瓣置换术(AVR),他曾进行过食管切除术和胸前胃管重建术。手术通过右胸骨旁切口,使用生物人工瓣膜进行了主动脉瓣置换术。尽管传统的胸骨正中切开术条件不佳,但还是通过另一种方法成功进行了主动脉瓣置换术。对于因食管癌(EC)而进行胸前胃管重建的患者来说,右胸骨旁入路是进行自体瓣膜置换术的绝佳途径。
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引用次数: 0
Effects of Cognitive Task During Unstable Walking on the Frontal Cerebral Blood Flow in Elderly Retirement Home Residents Leading an Independent Daily Life. 不稳定行走时的认知任务对独立生活的养老院老人额叶脑血流的影响
Q4 Medicine Pub Date : 2024-12-10 Epub Date: 2024-08-05 DOI: 10.2739/kurumemedj.MS7034003
Seigou Hashiguchi, Hiroo Matsuse, Kenichi Ito, Chika Kamura, Yoshio Takano

Objectives: This study aimed to examine the effects of cognitive tasks during walking with perturbation on the cerebral blood flow.

Methods: The subjects were a total of 20 persons, consisting of 12 healthy adults aged 21-47 years (adult group) and 8 retirement home residents aged 67-85 years who led an independent daily life and could walk independently (elderly group). Oxyhemoglobin was measured using wireless functional near-infrared spectroscopy (fNIRS). An analysis was conducted using the Wilcoxon rank sum test to compare the variation of oxyhemoglobin between walking with perturbation (WP) and walking with perturbation and cognitive tasks (WPC) in each group. In addition, we compared the variation of oxyhemoglobin between groups by analysis of covariance adjusting for the value of WP.

Results: In the adult group, the left and right oxyhemoglobin significantly increased under WPC (p=0.0122, 0.0015, respectively). On the other hand, in the elderly group, the right and left oxyhemoglobin did not significantly change under WPC.

Conclusions: These results suggest that the effect of a cognitive task during unstable walking conditions differs between healthy adults and elderly persons, and that this may be important when considering postural control strategies, especially in the elderly.

研究目的本研究旨在探讨认知任务中的扰动行走对脑血流量的影响:受试者共 20 人,包括 12 名 21-47 岁的健康成人(成人组)和 8 名 67-85 岁、日常生活独立且能独立行走的养老院居民(老人组)。使用无线功能性近红外光谱(fNIRS)测量氧合血红蛋白。我们使用 Wilcoxon 秩和检验进行了分析,以比较各组在扰动行走(WP)和扰动行走及认知任务(WPC)之间氧合血红蛋白的变化。此外,我们还通过调整 WP 值的协方差分析比较了组间氧合血红蛋白的变化:结果:成人组的左氧血红蛋白和右氧血红蛋白在 WPC 条件下显著增加(p=0.0122,0.0015)。另一方面,在老年人组中,左右氧合血红蛋白在 WPC 下没有明显变化:这些结果表明,在不稳定的行走条件下,认知任务对健康成年人和老年人的影响是不同的,这在考虑姿势控制策略时可能很重要,尤其是对老年人。
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引用次数: 0
Optimized Axenic Culture Medium for Comprehensive Biological and Physiological Analysis of Naegleria Fowleri. 优化轴突状培养基,用于对奈格勒氏菌进行全面的生物学和生理学分析。
Q4 Medicine Pub Date : 2024-07-02 Epub Date: 2024-03-19 DOI: 10.2739/kurumemedj.MS7012007
Tatsuru Hara, Toshihide Fukuma
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引用次数: 0
Oral Colchicine and Low-Dose Aspirin Combination Therapy for Non-elderly, Non-severe, Early Time From Onset, Adult Outpatients with Coronavirus Disease 2019 (COVID-19) during "The Fifth Pandemic Wave" in Japan. 口服秋水仙碱和小剂量阿司匹林联合疗法治疗日本 "第五次大流行 "期间非老年、非重症、发病时间早的成人门诊冠状病毒病 2019(COVID-19)患者。
Q4 Medicine Pub Date : 2024-07-02 Epub Date: 2024-03-19 DOI: 10.2739/kurumemedj.MS7012003
Tetsuaki Inokuchi, Tomoki Homma, Yasuhiko Kitasato, Mayu Akiyama, Ayako Chikasue, Yuuya Nishii, Shigeki Ban, Takeki Adachi, Aya Sonezaki, Hiroshi Masuda, Hideki Kamei, Miki Takenaka, Maki Tanaka, Masaki Okamoto, Tomoaki Hoshino

Background: Treatment with antiviral drugs for non-severe, early time from onset, adult outpatients with Coronavirus Disease 2019 (COVID-19) had not been established in 2021. However, some new variants of SARS-CoV-2 had caused rapid exacerbation and hospitalization among non-elderly outpatients with COVID-19, contributing to widespread crises within healthcare systems.

Methods: From July to October 2021, we urgently assessed a therapeutic program using oral colchicine (1.0 mg loading dose, followed approximately half a day later by 0.5 mg twice daily for 5 days, and then 0.5 mg once daily for 4 days) and low-dose aspirin (100 mg once daily for 10 days), for non-elderly, non-severe, early time from onset, adult outpatients with COVID-19. To verify its effectiveness, we set loxoprofen as a control arm, and com parison of these two arms was performed. The primary outcomes were hospitalization, criticality, and death rates.

Results: Thirty-eight patients (23 receiving colchicine and low-dose aspirin [CA]; 15 receiving loxoprofen [LO]) were evaluated. Hospitalization rate was lower in the CA group (1/23; 4.3%) than in the LO group (2/15; 13.3%); however, no significant difference was found between the two groups (p=0.34). No critical cases, deaths, or severe adverse events were found in either group.

Conclusions: Our CA regimen did not show superiority over LO treatment. However, our clinical experience should be recorded as part of community health care activities carried out in Kurume City against the unprece dented COVID-19 pandemic.

背景:2021 年尚未确立对非重症、发病时间早的 2019 年冠状病毒病(COVID-19)成人门诊患者的抗病毒药物治疗。然而,SARS-CoV-2的一些新变种导致COVID-19非老年门诊患者病情迅速恶化并住院治疗,在医疗系统内造成了广泛的危机:从 2021 年 7 月到 10 月,我们对口服秋水仙碱(1.0 毫克负荷剂量,约半天后改为 0.5 毫克,每天两次,持续 5 天,然后改为 0.5 毫克,每天一次,持续 4 天)和小剂量阿司匹林(100 毫克,每天一次,持续 10 天)的治疗方案进行了紧急评估,该方案适用于非老年、非重症、发病时间早的 COVID-19 成人门诊患者。为了验证其有效性,我们将洛索洛芬设为对照组,并对这两个对照组进行了比较。主要结果为住院率、危重率和死亡率:评估了 38 名患者(23 名接受秋水仙碱和小剂量阿司匹林[CA];15 名接受洛索洛芬[LO])。CA组的住院率(1/23;4.3%)低于LO组(2/15;13.3%),但两组间无显著差异(P=0.34)。两组均未发现危重病例、死亡或严重不良事件:结论:我们的 CA 方案并未显示出优于 LO 治疗。然而,我们的临床经验应作为久留米市开展的社区医疗保健活动的一部分记录下来,以应对 COVID-19 这一前所未有的大流行。
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引用次数: 0
A Phase II Clinical Trial to Study the Safety of Triamcinolone after Endoscopic Radial Incision and Cutting Dilatation for Benign Stenosis of the Lower Gastrointestinal Tract: A Study Protocol. 研究下消化道良性狭窄的内窥镜径向切开和切割扩张术后曲安奈德安全性的 II 期临床试验:研究方案。
Q4 Medicine Pub Date : 2024-07-02 Epub Date: 2024-03-19 DOI: 10.2739/kurumemedj.MS7012005
Rintaro Moroi, Hisashi Shiga, Kotaro Nochioka, Hirofumi Chiba, Yusuke Shimoyama, Motoyuki Onodera, Takeo Naito, Masaki Tosa, Yoichi Kakuta, Yuichiro Sato, Shoichi Kayaba, Seichi Takahashi, Satoshi Miyata, Yoshitaka Kinouchi, Atsushi Masamune

Background: Lower gastrointestinal tract stenosis is commonly diagnosed and is typically treated with surgery or endoscopic balloon dilation (EBD). Radial incision and cutting (RIC) is a novel treatment approach that has several benefits compared with EBD and surgery. Although RIC has demonstrated a high technical success rate and has been shown to improve subjective symptoms, previous studies revealed that restenosis after RIC remain unsolved. Herein, we report the design of a prospective, multicenter, single-arm, interventional, phase II trial to evaluate the safety of local triamcinolone acetonide (TA) administration and its feasibility in preventing restenosis after RIC for lower gastrointestinal tract stenosis.

Methods: The major inclusion criteria are age 20-80 years and the presence of benign stenosis in the lower gastrointestinal tract accessible by colonoscope. We will perform RIC followed by local administration of TA to 20 participants. The primary outcome is the safety of local TA administration, which will be assessed by determining the frequency of adverse events of special interest. The secondary outcomes are the technical success rate of RIC, duration of procedure, improvement in subjective symptoms, and duration of hospitalization. The outcomes, improvement in subjective symptoms, and long-term results will be evaluated using descriptive statistics, Student's t-test, and Kaplan-Meier curve, respectively.

Discussion: This explorative study will provide useful information regarding the safety of TA administration after RIC, which may contribute to further investigations.

背景:下消化道狭窄是常见的诊断方法,通常采用手术或内窥镜球囊扩张术(EBD)治疗。桡侧切开术(RIC)是一种新型治疗方法,与 EBD 和手术相比具有多种优势。虽然 RIC 的技术成功率很高,并能改善主观症状,但以往的研究表明,RIC 后的再狭窄问题仍未得到解决。在此,我们报告了一项前瞻性、多中心、单臂、介入性 II 期试验的设计,以评估局部应用曲安奈德(TA)预防下消化道狭窄 RIC 后再狭窄的安全性和可行性:主要纳入标准为年龄在 20-80 岁之间,结肠镜下可触及的下消化道良性狭窄。我们将为 20 名参与者进行 RIC,然后在局部注射 TA。主要结果是局部应用 TA 的安全性,将通过确定特别关注的不良事件发生频率来评估。次要结果是 RIC 的技术成功率、手术持续时间、主观症状改善情况和住院时间。将分别使用描述性统计、学生 t 检验和 Kaplan-Meier 曲线对结果、主观症状改善情况和长期效果进行评估:讨论:这项探索性研究将为 RIC 后使用 TA 的安全性提供有用信息,有助于进一步研究。
{"title":"A Phase II Clinical Trial to Study the Safety of Triamcinolone after Endoscopic Radial Incision and Cutting Dilatation for Benign Stenosis of the Lower Gastrointestinal Tract: A Study Protocol.","authors":"Rintaro Moroi, Hisashi Shiga, Kotaro Nochioka, Hirofumi Chiba, Yusuke Shimoyama, Motoyuki Onodera, Takeo Naito, Masaki Tosa, Yoichi Kakuta, Yuichiro Sato, Shoichi Kayaba, Seichi Takahashi, Satoshi Miyata, Yoshitaka Kinouchi, Atsushi Masamune","doi":"10.2739/kurumemedj.MS7012005","DOIUrl":"10.2739/kurumemedj.MS7012005","url":null,"abstract":"<p><strong>Background: </strong>Lower gastrointestinal tract stenosis is commonly diagnosed and is typically treated with surgery or endoscopic balloon dilation (EBD). Radial incision and cutting (RIC) is a novel treatment approach that has several benefits compared with EBD and surgery. Although RIC has demonstrated a high technical success rate and has been shown to improve subjective symptoms, previous studies revealed that restenosis after RIC remain unsolved. Herein, we report the design of a prospective, multicenter, single-arm, interventional, phase II trial to evaluate the safety of local triamcinolone acetonide (TA) administration and its feasibility in preventing restenosis after RIC for lower gastrointestinal tract stenosis.</p><p><strong>Methods: </strong>The major inclusion criteria are age 20-80 years and the presence of benign stenosis in the lower gastrointestinal tract accessible by colonoscope. We will perform RIC followed by local administration of TA to 20 participants. The primary outcome is the safety of local TA administration, which will be assessed by determining the frequency of adverse events of special interest. The secondary outcomes are the technical success rate of RIC, duration of procedure, improvement in subjective symptoms, and duration of hospitalization. The outcomes, improvement in subjective symptoms, and long-term results will be evaluated using descriptive statistics, Student's t-test, and Kaplan-Meier curve, respectively.</p><p><strong>Discussion: </strong>This explorative study will provide useful information regarding the safety of TA administration after RIC, which may contribute to further investigations.</p>","PeriodicalId":39559,"journal":{"name":"Kurume Medical Journal","volume":" ","pages":"53-60"},"PeriodicalIF":0.0,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140177013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Kurume Medical Journal
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