enema

灌肠
  • 文章类型: Journal Article
    慢性便秘是全球儿科患者的常见病,与生活质量下降有关。当门诊治疗失败并且儿童出现便秘时,需要住院治疗便秘,无法通过粪便或气体。关于小儿便秘的不同管理策略的证据越来越多。本范围审查旨在绘制有关儿科便秘住院管理的现有文献,并确定知识差距。
    我们将遵循JoannaBriggsInstitute描述的方法,并在“系统评论和Meta分析扩展的首选报告项目”中概述。搜索策略将包括Embase,PubMed,CINAHL,Cochrane系统评价数据库,Cochrane中央控制试验登记册,WebofScience,Scopus,和灰色文献来源。两名独立审稿人将分两步完成对符合条件的研究的筛选:标题和摘要的扫描,然后是全文审查。关于儿科便秘住院管理的研究,通过实验或队列设计,并以英文提供全文将包括在内。还将包括系统审查。两名独立的审阅者将使用标准化表格提取数据。提取的数据将以视觉和叙事格式呈现,包括一个证据图,以满足这一范围审查的目标。该协议在开放科学框架中注册。
    在此范围审查中,我们将概述关于各种医院干预治疗小儿便秘的有效性和安全性的现有证据.
    UNASSIGNED: Chronic constipation is a common condition in pediatric patients worldwide and is associated with decreased quality of life. Inpatient management of constipation is required when outpatient therapy fails and a child becomes obstipated, and unable to pass stool or gas. There is a growing body of evidence regarding different management strategies for pediatric obstipation. This scoping review aims to map the existing literature regarding inpatient management of pediatric obstipation and identify gaps in knowledge.
    UNASSIGNED: We will follow the methodology described by the Joanna Briggs Institute and outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. The search strategy will include Embase, PubMed, CINAHL, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, and gray literature sources. Two independent reviewers will complete screening for eligible studies in two steps: a scan of the title and abstracts followed by a full-text review. Studies regarding inpatient management of pediatric obstipation, with experimental or cohort design, and with full text available in English will be included. Systematic reviews will also be included. Two independent reviewers will extract data using a standardized form. Extracted data will be presented in visual and narrative formats, including an evidence map to meet the objectives of this scoping review. This protocol is registered at Open Science Framework.
    UNASSIGNED: In this scoping review, we will outline the current evidence available regarding the efficacy and safety of various hospital interventions for the treatment of pediatric obstipation.
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  • 文章类型: Journal Article
    目的:本研究旨在评估延迟重复空气灌肠(DRE)镇静在小儿肠套叠中的临床应用。
    方法:回顾性评估首都医科大学附属北京儿童医院急诊科2016年1月至2019年8月空气灌肠整复治疗特发性肠套叠的病例。根据DRE镇静治疗的结果,将纳入的病例分为成功或失败组。一般患者信息,临床表现,测试结果,和手术情况进行比较分析。
    结果:共3052例初步诊断为肠套叠,行空气灌肠整复术。最终,包括211例,成功组162人,失败组49人。DRE镇静成功率为76.8%(162/211),总体复位成功率为97.8%(2984/3052)。单因素logistic回归分析显示,失败组患者年龄≤1岁的比例明显增高,血淋淋的凳子,与成功组相比,DRE前左侧肠套叠(OR=2.3,95CI:1.1~4.6,P=0.023;OR=3.4,95CI:1.6~7.2,P=0.002;OR=12.6,95CI:4.6~34.6,P<0.001)。基于这三个因素的多元logistic回归分析显示,DRE前左侧肠套叠患者的DRE失败风险高10.1倍。
    结论:DRE联合镇静可提高肠套叠的整体灌肠复位成功率,具有良好的可行性和安全性。DRE前左侧肠套叠是灌肠失败的独立危险因素。
    OBJECTIVE: This study aimed to evaluate the clinical application of delayed repeated air enema (DRE) with sedation in pediatric intussusception.
    METHODS: We retrospectively assessed cases of idiopathic intussusception treated with air enema reduction at the emergency department of Beijing Children\'s Hospital affiliated to Capital Medical University from January 2016 to August 2019. The included cases were assigned to the success or failure groups based on the outcomes of DRE with sedation. General patient information, clinical manifestations, test results, and surgical conditions were collected for comparative analysis.
    RESULTS: A total of 3052 cases were initially diagnosed with intussusception and underwent air enema reduction. Ultimately, 211 cases were included, with 162 in the success group and 49 in the failure group. The success rate of DRE with sedation was 76.8% (162/211), with an overall reduction success rate of 97.8% (2984/3052). Univariate logistic regression analysis showed that patients in the failure group had a significantly higher proportion of patients with age ≤1 year, bloody stools, and left-sided intussusception before DRE compared to the success group (OR = 2.3, 95%CI: 1.1∼4.6, P = 0.023; OR = 3.4, 95%CI: 1.6∼7.2, P = 0.002 and OR = 12.6, 95%CI: 4.6∼34.6, P < 0.001). Multiple logistic regression analysis based on these three factors revealed that the risk of DRE failure was 10.1 times higher in cases with the left-sided intussusception before DRE.
    CONCLUSIONS: DRE with sedation can improve the overall enema reduction success rate for intussusception and has good feasibility and safety profiles. Left-sided intussusception before DRE is an independent risk factor for enema failure.
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  • 文章类型: Journal Article
    背景:照顾常规治疗难以治疗的便秘儿童可能具有挑战性,管理实践差异很大。
    目的:回顾儿童难治性便秘的评估和治疗的最新进展,并提出一种结合最新证据和我们机构经验的算法。
    方法:我们对儿童难治性便秘的诊断试验和治疗方案进行了文献综述。
    结果:对儿童难治性便秘的评估旨在更好地了解影响儿童个体表现的因素。肛门直肠测压评估直肠排空障碍和结肠测压评估结肠运动障碍可以指导后续治疗。对于对常规治疗没有反应的孩子,对新的药物如利那洛肽的试验可能会有所帮助。经肛门冲洗为能够进行每日直肠治疗的家庭提供了安全有效的替代方案。尽管儿童的证据参差不齐,盆底生物反馈疗法可以帮助一些儿童盆底协同失调。对于无法配合盆底治疗的年幼儿童,或者有难治性症状的大龄儿童,肛门内括约肌注射肉毒毒素可有益。顺行失禁灌肠治疗对结肠运动正常或节段运动障碍的儿童有效。骶神经刺激通常保留用于尽管顺行失禁灌肠仍存在的症状,特别是如果大便失禁是突出的。在更严重的情况下,可能需要暂时性或永久性结肠改道及节段结肠切除术.
    结论:最近的进展为儿童难治性便秘提供了希望。
    BACKGROUND: Caring for children with constipation refractory to conventional treatment can be challenging and management practices vary widely.
    OBJECTIVE: To review recent advances in the evaluation and treatment of children with refractory constipation and to propose an algorithm that incorporates the latest evidence and our institutional experience.
    METHODS: We performed a literature review on diagnostic tests and treatment options for children with refractory constipation.
    RESULTS: Evaluation of a child with refractory constipation seeks to better understand factors contributing to an individual child\'s presentation. Anorectal manometry evaluating for a rectal evacuation disorder and colonic manometry evaluating for colonic dysmotility can guide subsequent treatment. For the child who has not responded to conventional treatment, a trial of newer medications like linaclotide can be helpful. Transanal irrigation offers a safe and effective alternative for families able to administer daily rectal treatment. Despite mixed evidence in children, pelvic floor biofeedback therapy can help some children with pelvic floor dyssynergia. For younger children unable to cooperate with pelvic floor therapy, or older children with refractory symptoms, internal anal sphincter botulinum toxin injection can be beneficial. Antegrade continence enema treatment can be effective for children with either normal colonic motility or segmental dysmotility. Sacral nerve stimulation is generally reserved for symptoms that persist despite antegrade continence enemas, particularly if faecal incontinence is prominent. In more severe cases, temporary or permanent colonic diversion and segmental colonic resection may be needed.
    CONCLUSIONS: Recent advances offer hope for children with refractory constipation.
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  • 文章类型: Journal Article
    背景:肠套叠患儿的典型一线治疗是灌肠复位;然而,失败需要手术干预。尝试的次数因临床医生而异,在实践中未常规考虑非手术治疗失败的预测因素。这项研究的目的是创建一个评分系统,以预测非手术失败的风险和手术干预的需要。
    方法:对2019年至2022年到三级儿童医院急诊科就诊后诊断为肠套叠的儿童进行回顾性分析。单变量逻辑回归确定了非手术失败的预测因子,用作多变量逻辑回归的起始协变量,最终模型由反向消除确定。使用最终预测因子的回归系数来创建评分系统,并描绘了最佳切点。
    结果:我们确定了143例超声记录的肠套叠,其中28例(19.6%)需要手术干预。非手术治疗失败的预测因素包括年龄≥4y(比值比[OR]32.83,95%置信区间[CI]:1.91-564.23),≥1次灌肠减少尝试失败(OR189.53,95%CI:19.07-1884.11),心率≥128(OR3.38,95%CI:0.74-15.36),收缩压≥115mmHg(OR6.59,95%CI:0.93-46.66),超声检查肠套叠环路之间的滞留液体(OR17.54,95%CI:0.77-397.51)。利用这些因素,我们开发了一种新的风险评分系统(曲线下面积0.96,95%CI:0.93~0.99).分数范围从0到8;≤2有低(1.1%),3-4中度(50.0%),和≥5高(100%)故障风险。
    结论:使用已知的灌肠失败的危险因素,我们为需要手术干预的肠套叠患儿建立了一个具有出色辨别能力的风险评分系统.在临床整合之前需要进行前瞻性验证。
    BACKGROUND: Typical first-line management of children with intussusception is enema reduction; however, failure necessitates surgical intervention. The number of attempts varies by clinician, and predictors of failed nonoperative management are not routinely considered in practice. The purpose of this study is to create a scoring system that predicts risk of nonoperative failure and need for surgical intervention.
    METHODS: Children diagnosed with intussusception upon presentation to the emergency department of a tertiary children\'s hospital between 2019 and 2022 were retrospectively identified. Univariable logistic regression identified predictors of nonoperative failure used as starting covariates for multivariable logistic regression with final model determined by backwards elimination. Regression coefficients for final predictors were used to create the scoring system and optimal cut-points were delineated.
    RESULTS: We identified 143 instances of ultrasound-documented intussusception of which 28 (19.6%) required operative intervention. Predictors of failed nonoperative management included age ≥4 y (odds ratio [OR] 32.83, 95% confidence interval [CI]: 1.91-564.23), ≥1 failed enema reduction attempts (OR 189.53, 95% CI: 19.07-1884.11), presenting heart rate ≥128 (OR 3.38, 95% CI: 0.74-15.36), presenting systolic blood pressure ≥115 mmHg (OR 6.59, 95% CI: 0.93-46.66), and trapped fluid between intussuscepted loops on ultrasound (OR 17.54, 95% CI: 0.77-397.51). Employing these factors, a novel risk scoring system was developed (area under the curve 0.96, 95% CI: 0.93-0.99). Scores range from 0 to 8; ≤2 have low (1.1%), 3-4 moderate (50.0%), and ≥5 high (100%) failure risk.
    CONCLUSIONS: Using known risk factors for enema failure, we produced a risk scoring system with outstanding discriminate ability for children with intussusception necessitating surgical intervention. Prospective validation is warranted prior to clinical integration.
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  • 文章类型: Journal Article
    目的:为了表征调查,新生儿远端肠梗阻的治疗和最终诊断。
    方法:对入院诊断为远端肠梗阻超过10年(2012-2022年)的足月(>37周)新生儿进行回顾性回顾。确定了患者的路径以及演示文稿之间的关联,对治疗和结果的反应。
    结果:共确定了124例新生儿,全部纳入。最初的管理是108例结肠冲洗,4例造影剂灌肠和12例剖腹手术。在那些对灌溉有反应的人中,没有人进行对比灌肠。最终,22例新生儿进行剖腹手术。总的来说,106进行了直肠抽吸活检,41进行了囊性纤维化的基因检测。最终诊断为Hirschsprung病(HD)67例,胎粪肠梗阻伴囊性纤维化(CF)9例,胎粪堵塞综合征19例(其中CF3例),肠闭锁10例,无正式诊断17例。新生儿单元住院时间的中位数为11天(7-19)。
    结论:新生儿远端肠梗阻的初始治疗应该是结肠冲洗,因为这在大多数情况下是治疗性的,并且显著减少了对比剂灌肠的需要。这些婴儿都应该进行直肠活检以检查HD,除非另一种诊断是明显的。如果通过了胎粪塞,建议进行CF测试。评估和治疗是多模式和耗时的,给资源和家庭带来负担。
    OBJECTIVE: To characterise the investigations, management and ultimate diagnosis of neonates with distal intestinal obstruction.
    METHODS: Retrospective review of term (> 37 weeks) neonates with admission diagnosis of distal intestinal obstruction over 10 years (2012-2022). Patient pathways were identified and associations between presentations, response to treatments and outcome investigated.
    RESULTS: A total of 124 neonates were identified and all included. Initial management was colonic irrigation in 108, contrast enema in 4, and laparotomy in 12. Of those responding to irrigations none underwent contrast enema. Ultimately, 22 neonates proceeded to laparotomy. Overall, 106 had a suction rectal biopsy and 41 had genetic testing for cystic fibrosis. Final diagnosis was Hirschsprung disease (HD) in 67, meconium ileus with cystic fibrosis (CF) in 9, meconium plug syndrome in 19 (including 3 with CF), intestinal atresia in 10 and no formal diagnosis in 17. Median length of neonatal unit stay was 11 days (7-19).
    CONCLUSIONS: Initial management of neonates with distal bowel obstruction should be colonic irrigation since this is therapeutic in the majority and significantly reduces the need for contrast enema. These infants should all have suction rectal biopsy to investigate for HD unless another diagnosis is evident. If a meconium plug is passed, testing for CF is recommended. Evaluation and therapy are multimodal and time consuming, placing burden on resources and families.
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  • 文章类型: Case Reports
    肠套叠发生在所有肠套叠病例的5%以下。演示时的中位年龄为4.4岁。通常表现为肠梗阻的特征。常见的原因包括像幼年息肉这样的病理性导点,Meckel憩室和淋巴瘤。然而,很少在没有有机原因的情况下发生,如索引案例中所示。
    方法:我们介绍了一个5岁男孩结肠肠套叠的病例,临床上有血染粘液样粪便的证据,腹胀和餐后呕吐。CT扫描证实了临床诊断。手术探查显示左侧结肠肠套叠没有病理导点。
    大多数结肠肠套叠病例具有病理导联点。临床特征无特异性,但大多表现为肠梗阻,因此,CT扫描有助于建立诊断。
    结论:肠套叠是儿科年龄组中一种罕见的肠套叠亚型,尤其是在没有病理导联的情况下。该病例报告介绍了一例罕见的结肠肠套叠,但没有病理导点,强调先进的成像方式,如CT扫描在建立诊断和指导管理的重要性。
    UNASSIGNED: Colocolic intussusception occur in less than 5 % of all cases of intussusception. Median age at presentation is 4.4 years. Usually presents with features of intestinal obstruction. Common causes include pathological lead points like juvenile polyps, Meckel\'s diverticulum and lymphoma. However, rarely occurs without an organic cause as presented in the index case.
    METHODS: We present a case of colocolic intussusception in a 5-year-old boy with clinical evidence of blood-stained mucoid stools, abdominal distention and post prandial vomiting. CT-scan confirmed the clinical diagnosis. Surgical exploration revealed left-sided colocolic intussusception without a pathological lead point.
    UNASSIGNED: Most cases of colonic intussusception have a pathological lead point. Clinical features are unspecific but mostly present with intestinal obstruction, hence, a CT-scan aids in establishing the diagnosis.
    CONCLUSIONS: Colocolic intussusception is a rare subtype of intussusception in the paediatric age group especially in the absence of a pathological lead point. This case report presents a rare case of colocolic intussusception without pathological lead point, highlighting the importance of advanced imaging modalities like CT-scan in establishing the diagnosis and guiding management.
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  • 文章类型: Journal Article
    目的:顺行结肠灌肠(ACE)可以成为排便障碍的有效管理选择,并改善生活质量。关于通道放置的最佳实践尚不清楚,并且在首选的初始通道类型周围可能存在变化,安置年龄,和潜在的诊断。我们旨在描述ACE通道放置的实践模式和患者特征。
    方法:我们在2017年至2022年参加儿科结肠直肠和盆腔学习联盟(PCPLC)的研究中心对患有ACE通道的儿童进行了多中心回顾性研究。使用Kruskal-Wallis检验以0.05的显著性水平按部位测试手术时的年龄。
    结果:纳入了500例ACE通道患者。293例(58.6%)患者在PCPLC中心进行了ACE手术。整个队列的手术年龄中位数为7.6[IQR5.3-11.0]岁,PCPLC中心的手术年龄中位数为8.1[IQR5.3-11.5]岁。对于PCPLC中心,不同中心的中位安置年龄差异显著(p=0.009).371例(74.2%)患者接受马龙阑尾造口术,116例(23.2%)接受盲肠造口术,13例(2.6%)接受了新马龙阑尾造口术。按通道类型划分的患者年龄中位数为7.7[IQR5.3-11.0],7.5[IQR5.7-11.0],9.8[IQR4.2-11.6]年,分别。盲肠造口术最常见的适应症是特发性/难治性便秘(52.6%),而肛门直肠畸形是马龙(47.2%)和新马龙(61.5%)最常见的适应症。在PCPLC中心的ACE通道中,在首选的初始渠道类型中,各机构之间存在差异。4个最高容量的中心更喜欢马龙阑尾造口术,而不是盲肠造口术。
    结论:ACE通道放置的实践存在差异。在儿科结直肠专科中心,安置时的年龄和安置渠道的类型因机构而异。需要进一步的工作来更好地表征诊断和以年龄为中心的患者结局,以阐明对受益于这些程序的患者的建议。
    方法:回顾性对比研究。
    方法:三级。
    OBJECTIVE: Antegrade colonic enemas (ACE) can be an effective management option for defecation disorders and improve quality of life. Best practice regarding channel placement is unclear and variation may exist around preferred initial type of channel, age at placement, and underlying diagnoses. We aimed to describe practice patterns and patient characteristics around ACE channel placement.
    METHODS: We conducted a multicenter retrospective study of children with an ACE channel cared for at sites participating in the Pediatric Colorectal and Pelvic Learning Consortium (PCPLC) from 2017 to 2022. Kruskal-Wallis test was utilized to test the age at surgery by site with significance level of 0.05.
    RESULTS: 500 patients with ACE channel were included. 293 (58.6%) patients had their ACE procedure at a PCPLC center. The median age at surgery was 7.6 [IQR 5.3-11.0] years for the overall cohort and 8.1 [IQR 5.3-11.5] years for placement at PCPLC centers. For PCPLC centers, median age at placement varied significantly across centers (p = 0.009). 371 (74.2%) patients received Malone appendicostomy, 116 (23.2%) received cecostomy, and 13 (2.6%) received Neo-Malone appendicostomy. Median age of patients by channel type was 7.7 [IQR 5.3-11.0], 7.5 [IQR 5.7-11.0], and 9.8 [IQR 4.2-11.6] years, respectively. The most common indication for cecostomy was idiopathic/refractory constipation (52.6%), whereas anorectal malformation was the most common indication for Malone (47.2%) and Neo-Malone (61.5%). Among ACE channels placed at PCPLC centers, there was variation across institutions in preferred initial channel type. The 4 highest volume centers favored Malone appendicostomy over cecostomy.
    CONCLUSIONS: There is variation in practice of ACE channel placement. At specialty pediatric colorectal centers, age at time of placement and type of channel placed varied across institutions. Further work is needed to better characterize diagnosis- and age-focused patient centered outcomes to clarify recommendations for our patients who benefit from these procedures.
    METHODS: Retrospective comparative study.
    METHODS: Level III.
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  • 文章类型: Journal Article
    本研究的目的是评估胃内给药少量含磷的钠灌肠液作为磷替代疗法对需要持续肠内营养的危重创伤患者的疗效和安全性。评估血清磷浓度<3mg/dL(0.97mmol/L)的成年患者(>17岁)。排除血清肌酐浓度>1.4mg/dL(124μmol/L)的患者。患者胃内给予20mL生理盐水灌肠液,含有34mmol磷并在240mL水中混合。接受一次(n=22)或两次(n=11)的患者中,分别有55%和73%的血清磷浓度有所改善。分别。血清磷浓度从2.5[2.1,2.8]mg/dL(0.81[0.69,0.90]mmol/L)增加到2.9[2.2,3.0]mg/dL(0.94[0.71,0.97mmol/L)。排除两名血清磷明显下降1.3mg/dL(0.32mmol/L)的患者,导致血清磷浓度从2.3[2.0,2.8]mg/dL(0.74[0.65,0.90]mmol/L)增加到2.9[2.5,3.2]mg/dL(0.94[0.81,1.03]mmol/L;n=9;p=0.012)。没有发现明显的不良反应。我们的数据表明,使用少量盐水灌肠溶液的胃内磷酸盐可改善大多数患者的血清磷浓度。
    The purpose of this study was to evaluate the efficacy and safety of intragastric administration of small volumes of sodium enema solution containing phosphorus as phosphorus replacement therapy in critically ill patients with traumatic injuries who required continuous enteral nutrition. Adult patients (>17 years of age) who had a serum phosphorus concentration <3 mg/dL (0.97 mmol/L) were evaluated. Patients with a serum creatinine concentration >1.4 mg/dL (124 µmol/L) were excluded. Patients were given 20 mL of saline enema solution intragastrically, containing 34 mmol of phosphorus and mixed in 240 mL water. A total of 55% and 73% of patients who received one (n = 22) or two doses (n = 11) had an improvement in the serum phosphorus concentration, respectively. The serum phosphorus concentration increased from 2.5 [2.1, 2.8] mg/dL (0.81 [0.69, 0.90] mmol/L) to 2.9 [2.2, 3.0] mg/dL (0.94 [0.71, 0.97 mmol/L) for those who received two doses (p = 0.222). Excluding two patients with a marked decline in serum phosphorus by 1.3 mg/dL (0.32 mmol/L) resulted in an increase in the serum phosphorus concentration from 2.3 [2.0, 2.8] mg/dL (0.74 [0.65, 0.90] mmol/L) to 2.9 [2.5, 3.2] mg/dL (0.94 [0.81, 1.03] mmol/L; n = 9; p = 0.012). No significant adverse effects were noted. Our data indicated that intragastric phosphate administration using a small volume of saline enema solution improved the serum phosphorus concentrations in most patients.
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  • 文章类型: Case Reports
    背景:放射性直肠炎(RP)是骨盆放射的重要并发症。目前缺乏对慢性RP的有效治疗。我们报告了一例通过二甲双胍和丁酸盐(M-B)灌肠和栓剂治疗成功治疗慢性RP的病例。
    方法:一名70岁的亚洲男性被诊断为双侧叶前列腺癌,接受了38次76Gy前列腺的确定性放疗和6个月的雄激素剥夺治疗。尽管放疗后10个月PSA最低点稳定在0.2ng/mL,他出现了间歇性直肠出血,并被诊断为慢性RP。尽管口服美沙拉嗪两个月,症状仍然存在,美沙拉嗪灌肠和氢化可的松灌肠治疗。过渡到每日2%二甲双胍和丁酸盐(M-B)灌肠一周导致显着改善,然后每日使用2.0%M-B栓剂维持治疗3周,导致直肠出血持续减少。内镜检查和活检显示了良好的治疗效果。
    结论:M-B灌肠和栓剂可能是治疗慢性RP的有效方法。
    BACKGROUND: Radiation proctitis (RP) is a significant complication of pelvic radiation. Effective treatments for chronic RP are currently lacking. We report a case where chronic RP was successfully managed by metformin and butyrate (M-B) enema and suppository therapy.
    METHODS: A 70-year-old Asian male was diagnosed with prostate cancer of bilateral lobes, underwent definitive radiotherapy to the prostate of 76 Gy in 38 fractions and six months of androgen deprivation therapy. Despite a stable PSA nadir of 0.2 ng/mL for 10 months post-radiotherapy, he developed intermittent rectal bleeding, and was diagnosed as chronic RP. Symptoms persisted despite two months of oral mesalamine, mesalamine enema and hydrocortisone enema treatment. Transition to daily 2% metformin and butyrate (M-B) enema for one week led to significant improvement, followed by maintenance therapy with daily 2.0% M-B suppository for three weeks, resulting in continued reduction of rectal bleeding. Endoscopic examination and biopsy demonstrated a good therapeutic effect.
    CONCLUSIONS: M-B enema and suppository may be an effective treatment for chronic RP.
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  • 文章类型: Clinical Trial Protocol
    背景:在新生儿重症监护病房(NICU)内,采用了各种方法来加快早产儿胎粪的通过,甘油灌肠是最常用的。由于高渗透压对肠粘膜造成伤害的潜在风险,稀释的甘油灌肠溶液通常用于临床实践。挑战在于目前缺乏关于最安全和最有效的甘油灌肠剂浓度的知识。本研究旨在确定不同浓度的甘油灌肠溶液在早产儿中的安全性。
    方法:本研究方案是针对单中心,双臂,平行组,双盲和非劣效性随机对照试验。参与者将从中国一家三级甲等医院的NICU招募,符合条件的婴儿将被随机分配到甘油(mL):盐水(mL)组,比例为3:7或1:9。灌肠程序将遵守标准化的操作协议。主要结局包括坏死性小肠结肠炎和直肠出血,而次要结果包括喂养参数,胎粪通过结果和内脏区域氧饱和度。分析将根据意向治疗分配比较两个试验组。
    背景:本试验经四川大学华西第二医院医学伦理委员会伦理委员会批准。结果将发表在同行评审的期刊上。
    背景:ChiCTR2300079199。
    BACKGROUND: Various approaches are employed to expedite the passage of meconium in preterm infants within the neonatal intensive care unit (NICU), with glycerine enemas being the most frequently used. Due to the potential risk of high osmolality-induced harm to the intestinal mucosa, diluted glycerine enema solutions are commonly used in clinical practice. The challenge lies in the current lack of knowledge regarding the safest and most effective concentration of glycerine enema. This research aims to ascertain the safety of different concentrations of glycerine enema solution in preterm infants.
    METHODS: This study protocol is for a single-centre, two-arm, parallel-group, double-blind and non-inferiority randomised controlled trial. Participants will be recruited from a NICU in a teriary class A hospital in China, and eligible infants will be randomly allocated to either the glycerine (mL): saline (mL) group in a 3:7 ratio or the 1:9 ratio group. The enema procedure will adhere to the standardised operational protocols. Primary outcomes encompass necrotising enterocolitis and rectal bleeding, while secondary outcomes encompass feeding parameters, meconium passage outcomes and splanchnic regional oxygen saturation. Analyses will compare the two trial arms based on an intention-to-treat allocation.
    BACKGROUND: This trial is approved by the ethics committee of the Medical Ethics Committee of West China Second University Hospital of Sichuan University. The results will be published in a peer-reviewed journal.
    BACKGROUND: ChiCTR2300079199.
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