Laxative

泻药
  • 文章类型: Journal Article
    肠道准备质量和患者依从性是评估结肠镜检查质量的最重要指标之一。探讨影响结肠镜检查患者肠道准备质量的独立因素及其对患者依从性的影响。
    共收集329份患者记录,分为肠道准备充足组(272例)和肠道准备不足组(57例),或顺从组(260例)和不顺从组(69例),基于肠道准备质量或依从性。使用波士顿肠道准备量表评价肠道准备的质量。使用Kolcaba一般舒适问卷(GCQ)评估受试者在肠道准备期间的舒适水平。根据自行制定的依从性问卷评估受试者的依从性。进行预测分析以确定与肠道准备质量和依从性相关的因素。
    年龄,肠道准备持续时间,肠不足的病史,肠道准备充足和不充足组之间的通便剂量和通便剂量差异有统计学意义(P<0.05)。年龄,肠道准备持续时间,通便用量是肠道准备质量的独立影响因素。相关分析显示,GCQ评分与年龄呈显著负相关,肠道准备持续时间,泻药剂量,排便频率,结肠镜检查时间(r<0,P<0.05),与睡眠时间呈正相关(r>0,P<0.05)。此外,年龄,性别,肠道准备持续时间,顺服组和非顺服组之间存在统计学差异(P<0.05)。Logistic回归分析显示,年龄,肠道准备持续时间,通便剂量是肠道准备依从性的独立影响因素。年龄和肠道准备时间是肠道准备充分性和依从性的独立影响因素。
    年龄,肠道准备持续时间,和泻药剂量是在第一附属医院接受结肠镜检查的患者肠道准备充分性和依从性的独立影响因素,医学院,浙江大学。建议将一天的低残留饮食与2000mL泻药剂量结合用作一般结肠镜检查人群的肠道准备方案。
    UNASSIGNED: Quality of bowel preparation and patient compliance are among the most important indicators to assess the quality of colonoscopy. To investigate the independent factors associated with the quality of bowel preparation in subjects undergoing colonoscopy and its impact on compliance.
    UNASSIGNED: A total of 329 patient records were collected and were divided into an adequate bowel preparation group (272 cases) and an inadequate bowel preparation group (57 cases), or a compliant group (260 cases) and a non-compliant group (69 cases), based on bowel preparation quality or compliance. The quality of bowel preparation is evaluated using the Boston Bowel Preparation Scale. The comfort level of subjects during bowel preparation is assessed using the Kolcaba General Comfort Questionnaire (GCQ). Subjects\' compliance was assessed according to a self-developed compliance questionnaire. Prediction analyses were conducted to identify factors associated with the quality of bowel preparation and compliance.
    UNASSIGNED: Age, bowel preparation duration, history of bowel inadequacy, and laxative dosage showed statistical differences between the adequate and inadequate bowel preparation groups (p < 0.05). Age, bowel preparation duration, and laxative dosage were independent influencing factors of bowel preparation quality. Correlation analysis showed that GCQ scores were significantly negatively correlated with age, bowel preparation duration, laxative dose, defecation frequency, and colonoscopy duration (r < 0, p < 0.05), and positively correlated with sleep duration (r > 0, p < 0.05). In addition, age, gender, bowel preparation duration, and laxative dosage showed statistical differences between the compliant and non-compliant groups (p < 0.05). Logistic regression analysis revealed that age, bowel preparation duration, and laxative dosage were independent influencing factors of bowel preparation compliance. Age and bowel preparation duration were independent influencing factors for bowel preparation adequacy and compliance.
    UNASSIGNED: Age, bowel preparation duration, and laxative dosage are independent influencing factors for bowel preparation adequacy and compliance among patients undergoing colonoscopy at the First Affiliated Hospital, School of Medicine, Zhejiang University. It is recommended that a one-day low-residue diet combined with a 2000 mL laxative dosage be used as the bowel preparation protocol for the general colonoscopy population.
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  • 文章类型: Journal Article
    在作者以前的报告中发现了功能性便秘(FC)相关口臭的特征。在这份报告中,作者旨在进一步探讨其治疗方法和疗效。这项回顾性研究回顾了100例FC患者,包括82例(82%)口臭患者和18例(18%)非口臭患者。他们接受了感官测试(OLT)来诊断口臭,感官评分(OLS)(0-5)用于评估口臭严重程度。克利夫兰临床便秘评分(CCCS)(0-30)用于评估FC严重程度。患者接受泻药聚乙二醇电解质粉(PGEP)治疗4周。这些测试在治疗之前和之后进行。作者发现,治疗前,所有患者的CCCS为20.00(18.00-23.00),21.00(19.00-24.00)口臭患者,非口臭患者为18.00(17.00-18.25)。口臭患者与非口臭患者之间存在显着差异(P<0.001)。口臭患者的OLS为3.00(3.00-4.00)。OLS与CCCS呈正相关(r=0.814,95%CI:0.732~0.872,P<0.001)。CCCS≥18预测口臭概率超过50%。治疗后,CCCS显著下降至11.50(6.00-14.75)(P<0.001),OLS显著降低至1.00(0.00-2.00)(P<0.001)。OLS和CCCS之间存在正相关(r=0.770,95%CI:0.673-0.841,P<0.001)。治疗前CCCS≥21预测治疗后口臭的概率超过50%,而治疗后CCCS≥12预测治疗后口臭的概率超过50%。作者得出结论,FC的严重程度与FC相关口臭的严重程度相似,并能预测口臭的概率.PGEP的泻药治疗可有效改善FC相关的口臭。
    The features of functional constipation (FC)-associated halitosis were identified in the author\'s previous report. In this report, the author aimed to further investigate its treatment and efficacy. This retrospective study reviewed 100 FC patients, including 82 (82%) halitosis patients and 18 (18%) non-halitosis patients. They underwent the organoleptic test (OLT) to diagnose halitosis, and the organoleptic score (OLS) (0-5) was used to evaluated halitosis severity. The Cleveland Clinical Constipation Score (CCCS) (0-30) was used to evaluate FC severity. Patients were treated with the laxative polyethylene glycol electrolyte powder (PGEP) for four weeks. These tests were performed before and after treatment. The author found that, before treatment, the CCCS was 20.00 (18.00-23.00) for all patients, 21.00 (19.00-24.00) for halitosis patients, and 18.00 (17.00-18.25) for non-halitosis patients. A significant difference was observed between halitosis patients and non-halitosis patients (P< 0.001). The OLS for halitosis patients was 3.00 (3.00-4.00). A positive correlation (r= 0.814, 95% CI: 0.732-0.872,P< 0.001) was found between OLS and CCCS. A CCCS ⩾18 predicted over 50% probability of halitosis. After treatment, the CCCS significantly decreased to 11.50 (6.00-14.75) (P< 0.001), and OLS significantly decreased to 1.00 (0.00-2.00) (P< 0.001). A positive correlation (r= 0.770, 95% CI: 0.673-0.841,P< 0.001) persisted between OLS and CCCS. A pre-treatment CCCS ⩾21 predicted over 50% probability of post-treatment halitosis, while a post-treatment CCCS ⩾12 predicted over 50% probability of post-treatment halitosis. The author concludes that the severity of FC parallels the severity of FC-associated halitosis, and can predict the probability of halitosis. Laxative treatment with PGEP is effective in improving FC-associated halitosis.
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  • 文章类型: Journal Article
    关于药物引起的便秘(DIC)的详细临床信息有限。本研究旨在调查DIC的实际情况。
    这项回顾性研究使用了2014年至2021年注册的日本索赔数据库的数据。便秘队列包括至少有一个治疗便秘记录的受试者,而非便秘队列是通过随机分层抽样方法选择的,按性别匹配便秘队列。使用倾向评分将具有至少一个已知致病药物(CD)病史的研究人群和对照进行1:1匹配。潜在DIC(PDIC)的比例,PDIC的诊断时机,计算了CD和泻药按药物类别划分的处方比例,同时进行logistic回归分析以探讨其他相关因素.
    在4533905个科目中,178852在研究人群和对照中均合格。pDIC组包括19485名患者,占所有治疗便秘受试者的10.9%,而非便秘型CD组有10430名受试者。记录的CD处方和治疗的便秘之间的中位持续时间为38.0天。最常用的CD是心血管药物(47.9%)。所有CD类,作为男性,一些合并症与pDIC的发生有关。
    pDIC受试者占所有治疗便秘病例的约11%。由于与其他便秘类型相比,DIC需要不同的治疗方案,医生应该认识到为患者提供优化的治疗方法。
    UNASSIGNED: Detailed clinical information regarding drug-induced constipation (DIC) is limited. This study aimed to investigate the real-world situation of DIC.
    UNASSIGNED: This retrospective study used data from a Japanese claims database registered from 2014 to 2021. The constipation cohort included subjects with at least one record of treated constipation, while the non-constipation cohort was selected through random stratified sampling method, to match the constipation cohort by gender. The study population and control with at least one history of a known causative drug (CD) were matched 1:1 using propensity scores. The proportion of potential DIC (pDIC), the timing of diagnosis for pDIC, and the proportion of prescriptions by drug class for both the CDs and the laxatives were calculated, while logistic regression analysis was performed to explore additional associated factors.
    UNASSIGNED: Of the 4 533 905 subjects, 178 852 were eligible in both the study population and the control. The pDIC group comprised of 19 485 patients, which accounted for 10.9% of all treated constipation subjects, while the non-constipation with CD group had 10 430 subjects. The median duration between the recorded CD prescription and treated constipation was 38.0 days. The most frequently prescribed CD was cardiovascular drugs (47.9%). All CD classes, being male, and some comorbidities were associated with the occurrence of pDIC.
    UNASSIGNED: The pDIC subjects accounted for about 11% of all treated constipation cases. Since DIC requires different treatment regimens compared to other constipation types, physicians should be cognizant to provide patients with optimized treatments.
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  • 文章类型: Observational Study
    Naldemedine用于治疗阿片类药物引起的便秘(OIC),但是关于其预防OIC功效的报道很少。因此,我们回顾性调查了影响纳地米定同步处方治疗OIC疗效的因素.开始服用羟考酮10mg/d的癌症门诊患者纳入研究。医生将符合条件的患者分为以下三组:A组在引入羟考酮之前使用常规泻药,并在羟考酮给药的同时开始纳地定治疗。B组在引入羟考酮之前不服用泻药,并在羟考酮给药的同时开始纳地米定,和C组在引入羟考酮之前一直定期服用泻药,并且不与羟考酮同时服用纳迪米定。支持团队评估时间表日文版便秘评分,排便频率,布里斯托尔凳子表格秤,感觉不完全的直肠排空,比较三组在羟考酮给药前后排便紧张的发展或恶化。B组,除了不完全的直肠排空感之外,四个参数都显着恶化,而A组和C组未出现任何变化。在逻辑回归分析中,体重≥51.8kg是显着降低纳地米定对OIC的预防作用的因素,定期使用泻药是显着增加纳地米定对OIC的预防作用的因素。因此,应根据体重和定期使用泻药考虑开始使用纳地米定。
    Naldemedine is indicated for the treatment of opioid-induced constipation (OIC), but reports on its efficacy in preventing OIC are few. Therefore, we retrospectively investigated factors affecting the efficacy of concurrent prescription of naldemedine on OIC. Outpatients with cancer who were started on oxycodone 10 mg/d were included in the study. The eligible patients were classified by their physicians into the following three groups: Group A used regular laxatives before the introduction of oxycodone and initiated naldemedine treatment simultaneously with oxycodone administration, Group B did not take laxatives before the introduction of oxycodone and started naldemedine simultaneously with oxycodone administration, and Group C had been administering regular laxatives before the introduction of oxycodone and were not prescribed naldemedine simultaneously with oxycodone treatment. The Support Team Assessment Schedule Japanese edition score for constipation, frequency of defecation, Bristol Stool Form Scale, sense of incomplete rectal evacuation, and development or worsening of straining to pass bowel movements were compared among the three groups before and after oxycodone administration. In Group B, there was significant worsening of the four parameters except for the sense of incomplete rectal evacuation, whereas Groups A and C did not present any changes. In logistic regression analysis, body weight ≥51.8 kg was a factor significantly decreasing the preventive effect of naldemedine on OIC, and regular use of laxatives was a factor significantly increasing the preventive effect of naldemedine on OIC. Thus, the initiation of naldemedine should be considered depending on the body weight and regular laxative use.
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  • 文章类型: Observational Study
    目的:纳洛谢醇已被证明是治疗阿片类药物引起的便秘(OIC)的有效替代品。本研究旨在描述纳洛昔果使用者的特征,并评估纳洛昔果的使用模式和相关因素。
    方法:这项药物利用队列研究使用了四个欧洲国家新处方纳洛舍醇患者的观察性登记数据。描述了患者使用纳洛舍醇的特征和模式以及相关因素。
    结果:在全国范围内确定了17254名纳洛舍戈尔用户。他们的平均年龄是56-71岁,每个国家都有大多数女性(57.5%-62.9%)。多种合并症,包括癌症,很常见。天然鸦片生物碱和渗透作用的泻药(不包括盐水)是最常用的阿片类药物和泻药。阿片类药物的总体先前使用范围为91.9%至99.6%,轻泻药的总体先前使用范围为69.9%至92.4%。高达77.7%的人以前使用过具有相互作用潜力的药物,高达44.5%的人将它们与纳洛谢戈尔同时使用。Naloxegol被55.1%-90.9%的用户停产,通常在前30天。大约10%-30%的人在停药后改用或增加了其他便秘药物的治疗或重新开始了纳洛舍。用另一种便秘药物增强是相对常见的,提示纳洛克醇用于多因素便秘。
    结论:本研究反映了纳洛舍醇的实际临床应用,包括弱势患者群体。一些纳洛昔果使用者在索引日期前六个月内缺乏泻药或常规阿片类药物使用,或者与具有相互作用潜力的药物同时使用纳洛昔果。
    OBJECTIVE: Naloxegol has been shown to be an efficient alternative to treat opioid-induced constipation (OIC). This study aimed at describing the characteristics of naloxegol users and assessing patterns of naloxegol use and associated factors.
    METHODS: This drug utilization cohort study used observational registry data on patients newly prescribed naloxegol in four European countries. Patient characteristics and patterns of naloxegol use and associated factors were described.
    RESULTS: A total of 17 254 naloxegol users were identified across the countries. Their median age was 56-71 years, and each country had a majority of women (ranging 57.5%-62.9%). Multiple comorbidities, including cancer, were common. Natural opium alkaloids and osmotically acting laxatives (excluding saline) were the most frequently used opioids and laxatives. Overall prior use of opioids ranged from 91.9% to 99.6% and overall prior use of laxatives ranged from 69.9% to 92.4%. Up to 77.7% had prior use of medications with interaction potential, and up to 44.5% used them concurrently with naloxegol. Naloxegol was discontinued by 55.1%-90.9% of users, typically during the first 30 days. Approximately 10%-30% switched to or augmented the treatment with another constipation medication or restarted naloxegol after discontinuation. Augmentation with another constipation medication was relatively common, suggesting that naloxegol was used for multifactorial constipation.
    CONCLUSIONS: The present study reflects real-world clinical use of naloxegol, including in vulnerable patient groups. Some naloxegol users lacked laxative or regular opioid use within six months before index date or used naloxegol concomitantly with medications presenting an interaction potential.
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  • 文章类型: Journal Article
    背景:便秘是抗精神病药的常见不良反应,但是很少进行调查。我们的目的是在20年的时间内解决与精神分裂症患者开始使用泻药相关的因素。
    方法:我们招募了2021年4月1日在每家医院就诊的精神分裂症患者(n=14),并回顾性检查了截至2016年4月1日、2011年、2006年和2001年的所有处方,从2021年开始每5年一次。716名具有完整数据的参与者被纳入分析。使用CochranQ检验以及Bonferroni校正和Cochran-Armitage趋势检验来确定每种泻药频率的差异和趋势。进行了多因素logistic回归分析,以评估20年内开始使用泻药的因素。
    结果:在患者中,2001年有25.1%的人接受了泻药治疗,2021年有34.1%的人接受了泻药治疗。在过去的20年中,接受任何泻药治疗的患者数量显着不同,有显著的增长趋势。在所有泻药中,接受氧化镁治疗的患者数量,lubiprostone和elobixibat有显著的增长趋势。女性性别,年龄,总DZP等效剂量,和马来酸左甲丙嗪的剂量,奥氮平,喹硫平,zotepine,锂,2021年的卡马西平和卡马西平是20年期间开始使用泻药的重要因素.
    结论:对于用马来酸左旋美丙嗪治疗的患者,需要仔细监测,奥氮平,喹硫平和佐替平.根据治疗指南优化处方可以减少抗精神病药物引起的便秘。
    BACKGROUND: Constipation is a common adverse effect of antipsychotics, but little investigation has been conducted. We aimed to address the factors associated with the initiation of laxative use in the same patients with schizophrenia over a 20-year period.
    METHODS: We enrolled patients with schizophrenia attending each hospital (n = 14) from April 1, 2021, and retrospectively examined all prescriptions as of April 1, 2016, 2011, 2006, and 2001, every 5 years starting in 2021, for this population. 716 participants with complete data were included in the analysis. The Cochran Q test followed by Bonferroni correction and the Cochran-Armitage trend test were used to determine the differences and trends of the frequency of each laxative. Multivariate logistic regression analysis was performed to assess the factors on the initiation of laxative use over a 20-year period.
    RESULTS: Of the patients, 25.1% were treated with laxatives in 2001, and 34.1% were treated in 2021. The numbers of patients treated with any laxatives significantly differed over the 20-year period, with a significant increasing trend. In all laxatives, the numbers of patients treated with magnesium oxide, lubiprostone and elobixibat differed with a significant increasing trend. Female sex, age, the total DZP equivalent dose, and the doses of levomepromazine maleate, olanzapine, quetiapine, zotepine, lithium, and carbamazepine in 2021 were significant factors associated with the initiation of laxative use over the 20-year period.
    CONCLUSIONS: Careful monitoring is needed for patients treated with levomepromazine maleate, olanzapine, quetiapine and zotepine. Optimizing prescriptions according to treatment guidelines could reduce antipsychotic-induced constipation.
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  • 文章类型: Clinical Trial Protocol
    背景:阿片类药物引起的便秘(OIC)是接受阿片类药物治疗的癌症患者的常见症状,患病率高达59%。国际指南推荐标准泻药,如聚乙二醇/电解质和氢氧化镁,以防止OIC,尽管大量缺乏随机对照试验的证据.我们研究的目的是比较氢氧化镁与聚乙二醇/电解质在预防无法治愈的癌症患者中的OIC,并比较副作用,耐受性和成本效益。
    方法:我们的研究是一个开放标签,随机化,多中心研究,以检查氢氧化镁在预防OIC方面是否不劣于聚乙二醇/电解质。总的来说,330名无法治愈的癌症患者,从用于疼痛管理的阿片类药物开始,将随机接受聚乙二醇/电解质或氢氧化镁治疗。主要结果指标是肠功能指数(BFI)评分<30的患者比例,在第14天测量。罗马四世便秘标准,泻药的副作用和满意度,疼痛评分,生活质量(使用EQ-5D-5L),每天使用泻药和逃避药物,成本效益也将进行评估。
    结论:在这项研究中,我们旨在检查氢氧化镁在预防OIC方面是否不劣于聚乙二醇/电解质。我们研究的结果将有助于预防OIC和(阿片类药物引起的)便秘指南的科学证据。
    背景:该试验在clinicaltrials.gov:NCT05216328和荷兰试验注册:NTR80508中注册。EudraCT编号2022-000408-36。
    BACKGROUND: Opioid-induced constipation (OIC) is a common symptom in cancer patients treated with opioids with a prevalence of up to 59%. International guidelines recommend standard laxatives such as macrogol/electrolytes and magnesium hydroxide to prevent OIC, although evidence from randomized controlled trials is largely lacking. The aim of our study is to compare magnesium hydroxide with macrogol /electrolytes in the prevention of OIC in patients with incurable cancer and to compare side-effects, tolerability and cost-effectiveness.
    METHODS: Our study is an open-label, randomized, multicenter study to examine if magnesium hydroxide is non-inferior to macrogol/electrolytes in the prevention of OIC. In total, 330 patients with incurable cancer, starting with opioids for pain management, will be randomized to treatment with either macrogol/electrolytes or magnesium hydroxide. The primary outcome measure is the proportion of patients with a score of < 30 on the Bowel Function Index (BFI), measured on day 14. The Rome IV criteria for constipation, side effects of and satisfaction with laxatives, pain scores, quality of life (using the EQ-5D-5L), daily use of laxatives and escape medication, and cost-effectiveness will also be assessed.
    CONCLUSIONS: In this study we aim to examine if magnesium hydroxide is non-inferior to macrogol/electrolytes in the prevention of OIC. The outcome of our study will contribute to prevention of OIC and scientific evidence of guidelines on (opioid-induced) constipation.
    BACKGROUND: This trial is registered at clinicaltrials.gov: NCT05216328 and in the Dutch trial register: NTR80508. EudraCT number 2022-000408-36.
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  • 文章类型: Randomized Controlled Trial
    Background: Human milk does not meet the nutritional needs to support optimal growth of very preterm infants during the first weeks of life. Nutrient fortifiers are therefore added to human milk, though these products are suspected to increase gut dysmotility. The objective was to evaluate whether fortification with bovine colostrum (BC) improves bowel habits compared to a conventional fortifier (CF) in very preterm infants. Methods: In an unblinded, randomized study, 242 preterm infants (26−31 weeks of gestation) were randomized to receive BC (BC, Biofiber Damino, Gesten, Denmark) or CF (FM85 PreNAN, Nestlé, Vevey, Switzerland) as a fortifier. Stools (Amsterdam Stool Scale), bowel gas restlessness, stomach appearance score, volume, and frequency of gastric residuals were recorded before each meal until 35 weeks post-menstrual age. Results: As intake of fortifiers increased, stools became harder in both groups (p < 0.01) though less in BC infants (p < 0.05). The incidence of bowel gas restlessness increased with laxative treatments and days of fortification in both groups (p < 0.01), but laxatives were prescribed later in BC infants (p < 0.01). With advancing age, stomach appearance scores improved, but more so in BC infants (p < 0.01). Conclusions: Although there are limitations, a minimally processed, bioactive milk product such as BC induced similar or slightly improved bowel habits in preterm infants.
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  • 文章类型: Multicenter Study
    背景:便秘是慢性肾脏病(CKD)患者的常见并发症,与CKD的菌群失调和进展有关。然而,关于其与CKD患者骨-心血管轴紊乱的相关性知之甚少。
    方法:我们使用福冈肾病注册研究的基线数据集,对3878例CKD患者进行了横断面分析。作为一个多中心,透析前CKD患者的前瞻性队列研究.感兴趣的主要暴露是定义为使用至少一种类型的泻药的便秘。主要结果是骨折和心血管疾病(CVD)的病史,是骨-心血管轴疾病的表现。
    结果:随着肾功能下降,轻泻药的使用和骨折和心血管疾病的病史增加。在3878名患者中,532名(13.7%)患者使用泻药,235(6.1%)患者先前有骨折,1001例(25.8%)患者既往有CVD。骨折和CVD的历史在通便使用者中明显更普遍(P<0.05)。多变量调整逻辑回归分析显示,服用泻药的患者骨折和心血管病史的比值比明显高于没有服用泻药的患者[调整比值比(95%置信区间)1.67(1.20-2.31)和1.70(1.30-2.22),分别,P<0.05]。
    结论:这些结果表明,在透析前CKD患者中,使用泻药表明的便秘与历史骨折和心血管疾病的患病率增加有关。
    BACKGROUND: Constipation is a common complication in patients with chronic kidney disease (CKD) and is involved in the pathogenesis of dysbiosis and progression of CKD. However, little is known about its association with disorders of the bone-cardiovascular axis in patients with CKD.
    METHODS: We performed a cross-sectional analysis of 3878 patients with CKD using the baseline dataset of the Fukuoka Kidney disease Registry study, as a multicenter, prospective cohort study of pre-dialysis CKD patients. The main exposure of interest was constipation defined as use of at least one type of laxative. The main outcomes were the histories of bone fractures and cardiovascular diseases (CVDs) as manifestations of disorders of the bone-cardiovascular axis.
    RESULTS: The prevalences of laxative use and histories of bone fractures and CVDs increased as kidney function declined. Among the 3878 patients, 532 (13.7%) patients used laxatives, 235 (6.1%) patients had prior bone fractures, and 1001 (25.8%) patients had prior CVDs. Histories of bone fractures and CVDs were significantly more prevalent among laxative users (P < 0.05). Multivariable-adjusted logistic regression analysis revealed that patients with laxatives had a significantly higher odds ratios for histories of bone fractures and CVDs than those without laxatives [adjusted odds ratios (95% confidence intervals) 1.67 (1.20-2.31) and 1.70 (1.30-2.22), respectively, P < 0.05].
    CONCLUSIONS: These results suggest that constipation indicated by laxative use is associated with increased prevalences of historical bone fractures and CVDs in pre-dialysis patients with CKD.
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  • 文章类型: Clinical Study
    评价依必西巴特对糖尿病合并慢性便秘患者的疗效和安全性。
    这是一个单一的中心,单臂研究。33例糖尿病和慢性便秘患者,根据罗马四世标准的定义,用elobixibat(10毫克/天)治疗8周。患者记录粪便特性,包括自发性排便(SBMs)和大便稠度,根据布里斯托尔粪便形态量表(BSFS)。使用日本版本的便秘患者生活质量评估(JPAC-QOL)评估便秘的生活质量。
    在33名符合条件的患者中,30人完成了研究。Elobixibat显着增加了每周SBM的中位数(四分位距)频率,从基线时的5.0(3.0-7.0)到第8周的6.0(4.0-7.0)(p=0.030)。8周后,BSFS评分接近4分;正常大便稠度评分和JPAC-QOL评分从基线时的1.05±0.40显著提高至0.94±0.53(p=0.048);糖化白蛋白和血脂谱显著改善.分层分析显示,SBM增加,特别是在低SBM频率的患者中,尤其是女性,老年人,没有超重的患者,长期便秘的患者,和糖尿病神经病变患者。无严重不良事件发生。
    在符合罗马IV便秘标准的糖尿病患者中,elobixibat是有效的,尤其是那些基线时很少的SBM。与其他泻药相比,脂质分布的改善可能是elobixibat的优势。
    日本临床试验注册登记号:jRCTs031190092。
    To evaluate the efficacy and safety of elobixibat in patients with diabetes and concomitant chronic constipation.
    This was a single-center, single-arm study. Thirty-three patients with diabetes and chronic constipation, as defined by the Rome IV criteria, were treated with elobixibat (10 mg/day) for 8 weeks. Patients recorded stool properties, including spontaneous bowel movements (SBMs) and stool consistency, according to the Bristol Stool Form Scale (BSFS). Quality of life for constipation was evaluated with the Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC-QOL).
    Of the 33 eligible patients, 30 completed the study. Elobixibat significantly increased the median (interquartile range) frequency of SBMs per week, from 5.0 (3.0-7.0) at baseline to 6.0 (4.0-7.0] at week 8 (p = 0.030). After 8 weeks, the BSFS score approached 4; the score for normal stool consistency and the JPAC-QOL score significantly improved from 1.05 ± 0.40 at baseline to 0.94 ± 0.53 (p = 0.048); and glycated albumin and serum lipid profiles significantly improved. Stratified analysis revealed that SBMs increased especially in patients with low SBM frequency, in particular in women, older adults, patients without overweight, patients with a long duration of constipation, and patients with diabetic neuropathy. No serious adverse events occurred.
    Among patients with diabetes who met the Rome IV criteria for constipation, elobixibat was effective, especially in those with few SBMs at baseline. Improvements in lipid profiles could be an advantage of elobixibat compared with other laxatives.
    Japan Registry of Clinical Trials registration number: jRCTs031190092.
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