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De novo Inflammatory Bowel Disease in Kidney Transplant Recipients: A Single-Center Case Series Study. 肾移植受者新发炎症性肠病:单中心病例系列研究
Q2 Medicine Pub Date : 2024-03-18 eCollection Date: 2024-01-01 DOI: 10.1159/000538334
Masatomo Ogata, Masaki Kato, Takamasa Miyauchi, Marie Murata-Hasegawa, Yuko Sakurai, Kazunobu Shinoda, Hajime Yamazaki, Yugo Shibagaki, Masahiko Yazawa

Introduction: Gastrointestinal complications are common after solid organ transplantation. New-onset inflammatory bowel disease (IBD) after transplantation (de novo) is a major differential diagnosis of diarrhea after liver transplantation (LT) because of its high incidence in the field. However, the incidence of IBD after kidney transplantation (KT) remains unknown.

Methods: This case series comprised six de novo IBD patients who had undergone KT at our hospital from April 1998 to December 2020. In this period, 232 KT recipients were identified. Participants were analyzed based on their colonoscopy diagnoses. Detailed clinical information regarding both KT- and IBD-related symptoms or outcomes was obtained, and we calculated the incidence of de novo IBD from the date of KT.

Results: Of the 232 recipients in the median observation period of 6.1 (interquartile range: 2.6, 10.8) years, six recipients (one with Crohn's disease and five with ulcerative colitis) were diagnosed with de novo IBD. The incidence of de novo IBD after KT was 355.8/100,000 person-years (95% confidence interval, 159.8-791.9 per 100,000 person-years). Bloody stools and diarrhea did not always occur, with bloody stools occurring in three and diarrhea in 2 patients at the time of diagnosis. No recipient developed graft failure or extraintestinal complications (e.g., IBD-related nephritis or arthritis).

Conclusion: Despite a small sample size, this study's results indicate that the incidence of de novo IBD after KT may be similar to that after LT and higher than that in the general population. Larger studies are required to validate these preliminary findings.

简介胃肠道并发症是实体器官移植后的常见病。移植后新发的炎症性肠病(IBD)是肝移植(LT)后腹泻的主要鉴别诊断,因为它在该领域的发病率很高。然而,肾移植(KT)后IBD的发病率仍然未知:本病例系列包括 1998 年 4 月至 2020 年 12 月期间在我院接受 KT 的六名新发 IBD 患者。在此期间,共确认了 232 名 KT 受者。根据结肠镜诊断结果对参与者进行分析。我们获得了有关 KT 和 IBD 相关症状或结果的详细临床信息,并计算了自 KT 日起新发 IBD 的发病率:中位观察期为 6.1 年(四分位间范围:2.6-10.8 年),在 232 名受试者中,有 6 人(1 人患有克罗恩病,5 人患有溃疡性结肠炎)被诊断为新发 IBD。KT后新发IBD的发病率为355.8/100,000人年(95%置信区间为159.8-791.9/100,000人年)。血便和腹泻并不总是发生,在诊断时,3 名患者出现血便,2 名患者出现腹泻。没有受者出现移植失败或肠道外并发症(如与 IBD 相关的肾炎或关节炎):尽管样本量较小,但本研究结果表明,KT术后新发IBD的发病率可能与LT术后相似,但高于普通人群。需要更大规模的研究来验证这些初步发现。
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引用次数: 0
The Comprehensive Complication Index in Ulcerative Colitis: A Comparison with the Clavien-Dindo Classification. 溃疡性结肠炎综合并发症指数:与克拉维恩-丁多分类法的比较
Q2 Medicine Pub Date : 2024-03-08 eCollection Date: 2024-01-01 DOI: 10.1159/000538180
Yuki Horio, Motoi Uchino, Masataka Igeta, Kentaro Nagano, Kurando Kusunoki, Ryuichi Kuwahara, Toshiyuki Sato, Shinichiro Shinzaki, Hiroki Ikeuchi

Introduction: The comprehensive complication index (CCI), which weights all postoperative complications according to severity and integrates them into a single formula, has been reported as a new evaluation system. We aimed to compare the CCI with the Clavien-Dindo Classification (CDC) to patients with ulcerative colitis (UC).

Methods: Patients who underwent initial surgery for UC from April 2012 to March 2020 were included. The patients were classified into a length of stay (LOS) >30 days group or an LOS ≤30 days group. We performed a multivariate analysis of risk factors for LOS >30 days in the model with the factors identified in the univariate analysis plus the CCI (the CCI model) and plus CDC (the CDC model). An ROC curve was used to test the difference in the area under the curve (AUC) between the CCI model and the CDC model.

Results: The median LOS was 21 days (IQR: 16-29 days), and the rate of LOS >30 days was 119/588 (20.2%). In the CCI model, age at the time of surgery (odds ratio [OR] = 1.24, 95% confidence interval [CI] 1.07-1.45, p = 0.01), ASA score ≥3 (OR = 1.94, 95% CI:1.00-3.76, p = 0.04), and CCI (OR = 1.07, 95% CI: 1.05-1.09; p < 0.01) were identified as independent risk factors for LOS >30 days. The AUC value of the CCI model (0.86) was significantly better in relation to LOS >30 days than that of the CDC model (0.82) (p = 0.02).

Conclusion: The CCI was a better measure of LOS than was the CDC and was found to be a useful indicator in UC.

简介据报道,综合并发症指数(CCI)是一种新的评估系统,它根据严重程度对所有术后并发症进行加权,并将其整合到一个单一的公式中。我们旨在对溃疡性结肠炎(UC)患者进行 CCI 与 Clavien-Dindo 分类法(CDC)的比较:方法:纳入 2012 年 4 月至 2020 年 3 月期间因 UC 接受初次手术的患者。这些患者被分为住院时间(LOS)大于30天组和住院时间小于30天组。我们在单变量分析确定的因素加上 CCI(CCI 模型)和加上 CDC(CDC 模型)的模型中对 LOS >30 天的风险因素进行了多变量分析。采用 ROC 曲线检验 CCI 模型和 CDC 模型的曲线下面积(AUC)差异:中位 LOS 为 21 天(IQR:16-29 天),LOS >30 天的比例为 119/588(20.2%)。在CCI模型中,手术时的年龄(几率比[OR] = 1.24,95% 置信区间[CI] 1.07-1.45,P = 0.01)、ASA评分≥3(OR = 1.94,95% CI:1.00-3.76,P = 0.04)和CCI(OR = 1.07,95% CI: 1.05-1.09;P < 0.01)被确定为LOS >30天的独立风险因素。CCI模型的AUC值(0.86)明显优于CDC模型(0.82)(P = 0.02):结论:与 CDC 相比,CCI 能更好地衡量 LOS,是 UC 的一个有用指标。
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引用次数: 0
The Impacts of Laparoscopic Restorative Proctocolectomy for Ulcerative Colitis: Systematic Review and Meta-Analysis. 腹腔镜修复性直肠结肠切除术对溃疡性结肠炎的影响:系统回顾与元分析》。
Q2 Medicine Pub Date : 2024-03-05 eCollection Date: 2024-01-01 DOI: 10.1159/000535832
Motoi Uchino, Hiroki Ikeuchi, Yuki Horio, Ryuichi Kuwahara, Kurando Kusunoki, Kentaro Nagano, Kei Kimura, Kozo Kataoka, Naohito Beppu, Masataka Ikeda

Introduction: Laparoscopic surgery (LAP) is now recognized as the standard procedure for colorectal surgery. However, the standard surgery for ulcerative colitis (UC) is total proctocolectomy with ileal pouch anal anastomosis (IPAA), which may be an overly complex procedure to complete laparoscopically. We conducted this systematic review and meta-analysis to evaluate the efficacy as well as the advantages and disadvantages of LAP-IPAA in patients with UC stratified by the outcome of interest.

Method: We performed a systematic literature review by searching the PubMed/MEDLINE, the Cochrane Library, and the Japan Centra Reuvo Medicina databases from inception until January 2023. Meta-analyses were performed for surgical outcomes, including morbidity and surgical course, to evaluate the efficacy of LAP-IPAA.

Results: A total of 707 participants, including 341 LAP and 366 open surgery (OPEN) patients in 9 observational studies and one randomized controlled study, were included. From the results of the meta-analyses, the odds ratio (OR) of total complications in LAP was 1.12 (95% CI: 0.58-2.17, p = 0.74). The OR of mortality for LAP was 0.38 (95% CI: 0.08-1.92, p = 0.24). Although the duration of surgery was extended in LAP (mean difference (MD) 118.74 min (95% CI: 91.67-145.81), p < 0.01) and hospital stay were not shortened, the duration until oral intake after surgery was shortened in LAP (MD -2.10 days (95% CI: -3.52-0.68), p = 0.004).

Conclusions: During IPAA for UC, a similar morbidity rate was seen for LAP and OPEN. Although LAP necessitates extended surgery, there may be certain advantages to this procedure, including easy visibility during the surgical procedure or a shortened time to oral intake after surgery.

简介:腹腔镜手术(LAP)现已被公认为结直肠手术的标准程序。然而,溃疡性结肠炎(UC)的标准手术是全直肠切除术加回肠袋肛门吻合术(IPAA),这可能是一种过于复杂的腹腔镜手术。我们进行了这项系统性综述和荟萃分析,以评估腹腔镜肛门吻合术(LAP-IPAA)对 UC 患者的疗效和优缺点,并根据相关结果进行分层:我们通过检索 PubMed/MEDLINE、Cochrane 图书馆和日本 Centra Reuvo Medicina 数据库进行了系统性文献综述。对包括发病率和手术过程在内的手术结果进行了元分析,以评估LAP-IPAA的疗效:共纳入 707 名参与者,包括 9 项观察性研究和 1 项随机对照研究中的 341 名 LAP 和 366 名开放手术 (OPEN) 患者。荟萃分析结果显示,LAP总并发症的几率比(OR)为1.12(95% CI:0.58-2.17,P = 0.74)。LAP 的死亡率 OR 为 0.38(95% CI:0.08-1.92,p = 0.24)。虽然LAP的手术时间延长了(平均差(MD)118.74分钟(95% CI:91.67-145.81),p < 0.01),住院时间也没有缩短,但LAP术后口服药物的时间缩短了(MD -2.10天(95% CI:-3.52-0.68),p = 0.004):结论:在IPAA治疗UC期间,LAP和OPEN的发病率相似。虽然 LAP 需要延长手术时间,但这种手术可能有一定的优势,包括手术过程中的可视性或术后口服时间的缩短。
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引用次数: 0
Laparoscopy-Assisted Restorative Proctocolectomy with Ileal Pouch-Anal Anastomosis in Middle Colic Artery Ligation Immediately before Specimen Removal. 在腹腔镜辅助下进行直肠结肠切除术,并在切除标本前立即进行结肠中动脉结扎的回肠袋-肛门吻合术。
Q2 Medicine Pub Date : 2024-02-26 eCollection Date: 2024-01-01 DOI: 10.1159/000538025
Keiji Matsuda, Yojiro Hashiguchi, Tamuro Hayama, Kurara Hayashi, Toshiya Miyata, Kentaro Asako, Yoshihisa Fukushima, Ryu Shimada, Kensuke Kaneko, Keijiro Nozawa, Hiroki Ochiai, Takatsugu Yamamoto

Introduction: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical procedure for ulcerative colitis (UC). Intestinal ischemia may occur if the main blood vessels are ligated at an early stage of this surgery. Considering that the blood flow in the large intestine can be maintained by preserving the middle colic artery, we have used a new IPAA method: ligating the middle colic artery immediately before removal of the specimens ("M-method"). Here, we evaluated the M-method's clinical outcomes.

Methods: Between April 2009 and December 2021, 13 patients underwent a laparoscopy-assisted IPAA procedure at our institution. The conventional method was used for 6 patients, and the M-method was used for the other 7 patients. We retrospectively analyzed the cases' clinical notes.

Results: The M-method's rate of postoperative complications (Clavien-Dindo classification grade II or more) was significantly lower than that of the conventional method (14.2% vs. 83.3%). The M-method group's postoperative stay period was also significantly shorter (average 16.4 days vs. 55.5). There were significant differences in the albumin value and the ratio of the modified GPS score 1 or 2 on the 7th postoperative day between the M- and conventional methods (average 3.15 vs. 2.5, average 4/7 vs. 6/6). However, it is necessary to consider the small number of cases and the uncontrolled historical comparison.

Conclusion: Late ligation of the middle colic artery may be beneficial for patients' post-surgery recovery and can be recommended for IPAAs in UC patients.

导言:带回肠袋-肛门吻合术(IPAA)的恢复性直肠切除术是治疗溃疡性结肠炎(UC)的手术方法。如果在手术早期结扎主要血管,可能会发生肠缺血。考虑到保留结肠中动脉可以维持大肠的血流,我们采用了一种新的 IPAA 方法:在切除标本前立即结扎结肠中动脉("M-方法")。在此,我们对 M 方法的临床效果进行了评估:2009年4月至2021年12月期间,13名患者在我院接受了腹腔镜辅助IPAA手术。其中 6 名患者采用传统方法,另外 7 名患者采用 M 方法。我们对病例的临床记录进行了回顾性分析:结果:M 法的术后并发症(Clavien-Dindo 分级 II 级或以上)发生率明显低于传统方法(14.2% 对 83.3%)。M 方法组的术后住院时间也明显缩短(平均 16.4 天对 55.5 天)。在术后第 7 天,白蛋白值和改良 GPS 评分 1 或 2 的比率方面,M-方法组和传统方法组存在明显差异(平均 3.15 对 2.5,平均 4/7 对 6/6)。然而,有必要考虑到病例数量较少以及历史对比的不可控性:结论:晚期结扎结肠中动脉可能有利于患者的术后恢复,可推荐用于 UC 患者的 IPAAs。
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引用次数: 0
Dietary Perceptions among Patients with Crohn's Disease in Clinical Remission: Comparison with an Era Preceding the Availability of Biologic Therapy. 临床缓解期克罗恩病患者的饮食观念:与生物疗法问世前的对比。
Q2 Medicine Pub Date : 2024-02-18 eCollection Date: 2024-01-01 DOI: 10.1159/000536281
Makoto Tanaka, Aki Kawakami, Kayoko Sakagami, Hiroaki Ito

Introduction: Dietary temperance significantly affects the quality of life of patients with Crohn's disease (CD) and remains a major concern. However, perceptions of diet in remission may have changed from the era when treatment options were limited. Therefore, we compared the dietary perceptions and treatment of patients with CD in remission with previously published data from the time biologic therapy was not introduced.

Methods: We compared the data of 254 patients with CD in remission who completed a questionnaire survey in 2022 with those of 76 patients with CD in remission collected in 2003, when biologics were not used for maintenance therapy in Japan. Remission was defined as a CD activity index of 150 or less in both studies. Perceptions of diet (degree of eating whatever one likes) were assessed using single-item nominal scale responses.

Results: The percentage of patients receiving enteral nutrition therapy had decreased (past vs. present: 43.4 vs. 12.6%), while the proportion of patients receiving biologic therapy increased (0 vs. 88.6%, respectively). The percentages of patients who responded "not at all," "sometimes," and "mostly" when asked if they could eat whatever they liked had changed, respectively, from 9.2%, 46.1%, and 44.7% in the past to 4.3%, 25.2%, and 70.5% in the present.

Conclusion: The proportion of those who ate whatever they liked and the mean body mass index increased in comparison with the corresponding values 20 years ago. With the advent of biologic therapies, the number of patients with CD who can enjoy eating has increased.

导言:饮食节制严重影响克罗恩病(CD)患者的生活质量,仍然是一个主要问题。然而,与治疗方案有限的时代相比,缓解期患者的饮食观念可能已经发生了变化。因此,我们将处于缓解期的克罗恩病患者的饮食观念和治疗方法与之前公布的未引入生物疗法时的数据进行了比较:我们将 2022 年完成问卷调查的 254 名 CD 缓解期患者的数据与 2003 年收集的 76 名 CD 缓解期患者的数据进行了比较,当时日本尚未使用生物制剂进行维持治疗。在这两项研究中,缓解的定义都是 CD 活动指数达到或低于 150。对饮食的看法(喜欢吃什么就吃什么的程度)采用单项名义量表进行评估:结果:接受肠内营养治疗的患者比例有所下降(过去与现在:43.4% 与 12.6%),而接受生物治疗的患者比例有所上升(分别为 0 与 88.6%)。当被问及是否可以随意进食时,回答 "完全不能"、"有时 "和 "大部分 "的患者比例分别从过去的 9.2%、46.1% 和 44.7% 变为现在的 4.3%、25.2% 和 70.5%:结论:与 20 年前的相应数值相比,爱吃什么就吃什么的人群比例和平均体重指数都有所上升。随着生物疗法的出现,能够享受饮食的 CD 患者人数有所增加。
{"title":"Dietary Perceptions among Patients with Crohn's Disease in Clinical Remission: Comparison with an Era Preceding the Availability of Biologic Therapy.","authors":"Makoto Tanaka, Aki Kawakami, Kayoko Sakagami, Hiroaki Ito","doi":"10.1159/000536281","DOIUrl":"10.1159/000536281","url":null,"abstract":"<p><strong>Introduction: </strong>Dietary temperance significantly affects the quality of life of patients with Crohn's disease (CD) and remains a major concern. However, perceptions of diet in remission may have changed from the era when treatment options were limited. Therefore, we compared the dietary perceptions and treatment of patients with CD in remission with previously published data from the time biologic therapy was not introduced.</p><p><strong>Methods: </strong>We compared the data of 254 patients with CD in remission who completed a questionnaire survey in 2022 with those of 76 patients with CD in remission collected in 2003, when biologics were not used for maintenance therapy in Japan. Remission was defined as a CD activity index of 150 or less in both studies. Perceptions of diet (degree of eating whatever one likes) were assessed using single-item nominal scale responses.</p><p><strong>Results: </strong>The percentage of patients receiving enteral nutrition therapy had decreased (past vs. present: 43.4 vs. 12.6%), while the proportion of patients receiving biologic therapy increased (0 vs. 88.6%, respectively). The percentages of patients who responded \"not at all,\" \"sometimes,\" and \"mostly\" when asked if they could eat whatever they liked had changed, respectively, from 9.2%, 46.1%, and 44.7% in the past to 4.3%, 25.2%, and 70.5% in the present.</p><p><strong>Conclusion: </strong>The proportion of those who ate whatever they liked and the mean body mass index increased in comparison with the corresponding values 20 years ago. With the advent of biologic therapies, the number of patients with CD who can enjoy eating has increased.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"9 1","pages":"47-54"},"PeriodicalIF":0.0,"publicationDate":"2024-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10942792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rifaximin-treatment for collagenous colitis: A randomised, double-blind, placebo-controlled trial 利福昔明治疗胶原性结肠炎:随机、双盲、安慰剂对照试验
Q2 Medicine Pub Date : 2024-01-24 DOI: 10.1159/000536124
Sabine Becker, Louise B. Grode, O. Bonderup
Introduction: Collagenous colitis (CC) is a disabling disease primarily affecting elderly women. Sparse, well-documented treatment modalities exist, except for budesonide. Long term and repetitive treatment with budesonide is often necessary. Rifaximin is a poorly absorbed antibiotic with a positive modulatory effect on gut microbiota. In this randomised, double-blind, placebo-controlled single center trial, we test the effect of adding rifaximin in continuation to budesonide on relapse rates in collagenous colitis.Methods: Eligible patients with active, biopsy verified CC received oral budesonide during a 6-week open-label induction phase. Patients in clinical remission after four weeks of treatment were randomised to receive either rifaximin or placebo for four weeks. Results: Fifteen patients were randomised to receive either rifaximin (n=7) or placebo (n=8). At 12-week follow-up, two patients in the rifaximin group were still in remission and none in the placebo group (p = 0.2). The median number of days in remission in the rifaximin group was 42 (IQR 33-126) compared to 18.5 (IQR 10.5-51.5) in the placebo group (P = 0.189). At 12-week follow-up the relapse rate per 100 person-days in the placebo group was higher (3.25 (1.40-6.41)) than in the rifaximin group (1.33 (0.43-3.10)).Conclusion: Although not statistically significant (p = 0.0996), the study suggests a potential improvement in relapse rates within the rifaximin group compared to the placebo group. A major limitation in the study is the small sample size.
导言:胶原性结肠炎(CC)是一种主要影响老年妇女的致残性疾病。除布地奈德外,现有的治疗方法很少,而且没有充分的文献记载。通常需要使用布地奈德进行长期和反复治疗。利福昔明是一种不易吸收的抗生素,对肠道微生物群有积极的调节作用。在这项随机、双盲、安慰剂对照的单中心试验中,我们测试了在布地奈德的基础上添加利福昔明对胶原性结肠炎复发率的影响:方法:符合条件的活动性活检证实结肠炎患者在为期 6 周的开放标签诱导阶段接受口服布地奈德治疗。治疗四周后临床缓解的患者随机接受利福昔明或安慰剂治疗四周。结果15名患者随机接受利福昔明(7人)或安慰剂(8人)治疗。随访 12 周时,利福昔明组仍有两名患者病情缓解,而安慰剂组则没有(P = 0.2)。利福昔明组缓解天数的中位数为 42 天(IQR 33-126),而安慰剂组为 18.5 天(IQR 10.5-51.5)(P = 0.189)。随访12周时,安慰剂组每百人天的复发率(3.25(1.40-6.41))高于利福昔明组(1.33(0.43-3.10)):尽管没有统计学意义(P = 0.0996),但研究表明利福昔明组的复发率可能比安慰剂组有所改善。该研究的一个主要局限是样本量较小。
{"title":"Rifaximin-treatment for collagenous colitis: A randomised, double-blind, placebo-controlled trial","authors":"Sabine Becker, Louise B. Grode, O. Bonderup","doi":"10.1159/000536124","DOIUrl":"https://doi.org/10.1159/000536124","url":null,"abstract":"Introduction: Collagenous colitis (CC) is a disabling disease primarily affecting elderly women. Sparse, well-documented treatment modalities exist, except for budesonide. Long term and repetitive treatment with budesonide is often necessary. Rifaximin is a poorly absorbed antibiotic with a positive modulatory effect on gut microbiota. In this randomised, double-blind, placebo-controlled single center trial, we test the effect of adding rifaximin in continuation to budesonide on relapse rates in collagenous colitis.\u0000Methods: Eligible patients with active, biopsy verified CC received oral budesonide during a 6-week open-label induction phase. Patients in clinical remission after four weeks of treatment were randomised to receive either rifaximin or placebo for four weeks. \u0000Results: Fifteen patients were randomised to receive either rifaximin (n=7) or placebo (n=8). At 12-week follow-up, two patients in the rifaximin group were still in remission and none in the placebo group (p = 0.2). The median number of days in remission in the rifaximin group was 42 (IQR 33-126) compared to 18.5 (IQR 10.5-51.5) in the placebo group (P = 0.189). At 12-week follow-up the relapse rate per 100 person-days in the placebo group was higher (3.25 (1.40-6.41)) than in the rifaximin group (1.33 (0.43-3.10)).\u0000Conclusion: Although not statistically significant (p = 0.0996), the study suggests a potential improvement in relapse rates within the rifaximin group compared to the placebo group. A major limitation in the study is the small sample size.","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"56 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139602041","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
Crosstalk between microRNAs and Oxidative stress in coeliac disease. 乳糜泻中微小 RNA 与氧化应激之间的相互影响
Q2 Medicine Pub Date : 2024-01-24 DOI: 10.1159/000536107
F. Pelizzaro, R. Cardin, Giulia Sarasini, M. Minotto, Chiara Carlotto, Matteo Fassan, Michela Palo, Fabio Farinati, Fabiana Zingone
MicroRNAs (miRNAs) are small, non-coding RNA molecules involved in regulating gene expression. Many studies, mostly conducted on pediatric patients, suggested that oxidative stress and several miRNAs may play an important role in coeliac disease (CeD) pathogenesis. However, the interplay between oxidative stress and miRNA regulatory functions in CeD remains to be clarified. In this review, we aimed to perform a literature review on the role of miRNAs and oxidative stress in adult CeD patients and to analyze their potential interactions. In this direction, we also reported the preliminary results of a pilot study we recently performed.
微小 RNA(miRNA)是一种参与调节基因表达的非编码 RNA 小分子。许多研究(大多针对儿科患者)表明,氧化应激和多种 miRNA 可能在乳糜泻(CeD)发病机制中扮演重要角色。然而,氧化应激与 miRNA 在 CeD 中的调控功能之间的相互作用仍有待澄清。在这篇综述中,我们旨在对 miRNAs 和氧化应激在成年 CeD 患者中的作用进行文献综述,并分析它们之间潜在的相互作用。为此,我们还报告了最近进行的一项试点研究的初步结果。
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引用次数: 0
Clinical utilization of generic drugs and biosimilars for ulcerative colitis treatment: Insights from a nationwide database study in Japan 治疗溃疡性结肠炎的仿制药和生物仿制药的临床使用情况:日本全国数据库研究的启示
Q2 Medicine Pub Date : 2024-01-08 DOI: 10.1159/000536146
Rintaro Moroi, Y. Kakuta, Hiroshi Nagai, Yusuke Shimoyama, Takeo Naito, H. Shiga, Y. Kinouchi, Atsushi Masamune
Introduction: Limited data exist regarding the prevalence and clinical practice involving generic drugs and biosimilars for treating ulcerative colitis (UC) in Japan. We aimed to clarify the clinical usage of these generic drugs and biosimilars for UC treatment in Japan using a nationwide database.Methods: We collected data from 30,675 UC cases, along with their prescriptions for both generic drugs or biosimilars and their original counterparts, using a medical claims database provided by DeSC Healthcare, Inc. We calculated the prescription and penetration rates of generic drugs and biosimilars and demonstrated the transition of these rates. Additionally, the cumulative retention rates between infliximab originator and biosimilar were compared using the Kaplan–Meier method.Results: The prescription rate of generic mesalazine increased from approximately 10% in 2015 to over 30% in 2021. Although the prescription rate of generic molecular targeting drugs (MTDs) also increased from approximately 0.15% in 2014 to 2.5% in 2021, the increment was lower than that of generic mesalazine. The penetration rates of generic 5-aminosalicylic acid and tacrolimus ranged from over 30% to approximately 50%. Infliximab biosimilar achieved an approximate 20% penetration rate, whereas adalimumab achieved< 5%. The cumulative retention rates did not differ between infliximab originator and biosimilar.Conclusions: The penetration rates of generics and biosimilars for UC treatment are relatively low compared with those for treatment in other fields and the goal of Ministry of Health, Labor, and Welfare. Several countermeasures are necessary for the widespread use of generics and biosimilars, ultimately contributing to cost-effective and sustainable healthcare delivery.
简介:有关日本治疗溃疡性结肠炎(UC)的非专利药和生物仿制药的流行程度和临床实践的数据有限。我们的目的是利用一个全国性数据库,明确这些治疗溃疡性结肠炎的仿制药和生物仿制药在日本的临床使用情况:我们利用 DeSC Healthcare, Inc. 提供的医疗索赔数据库收集了 30,675 例 UC 病例的数据,以及他们对仿制药或生物仿制药及其原研药的处方。我们计算了仿制药和生物仿制药的处方率和渗透率,并展示了这些比率的过渡情况。此外,我们还使用 Kaplan-Meier 法比较了英夫利西单抗原研药和生物仿制药的累积保留率:结果:美沙拉嗪仿制药的处方率从 2015 年的约 10%增至 2021 年的 30%以上。虽然分子靶向药物(MTDs)仿制药的处方率也从2014年的约0.15%增至2021年的2.5%,但增幅低于美沙拉嗪仿制药。5-氨基水杨酸和他克莫司仿制药的渗透率从30%以上到50%左右不等。英夫利西单抗生物仿制药的渗透率约为 20%,而阿达木单抗的渗透率低于 5%。英夫利西单抗原研药和生物仿制药的累积保留率没有差异:结论:与其他领域的治疗相比,仿制药和生物仿制药在治疗 UC 方面的渗透率相对较低,这也是厚生劳动省的目标。为了广泛使用仿制药和生物仿制药,有必要采取一些对策,最终为提供具有成本效益和可持续的医疗服务做出贡献。
{"title":"Clinical utilization of generic drugs and biosimilars for ulcerative colitis treatment: Insights from a nationwide database study in Japan","authors":"Rintaro Moroi, Y. Kakuta, Hiroshi Nagai, Yusuke Shimoyama, Takeo Naito, H. Shiga, Y. Kinouchi, Atsushi Masamune","doi":"10.1159/000536146","DOIUrl":"https://doi.org/10.1159/000536146","url":null,"abstract":"Introduction: Limited data exist regarding the prevalence and clinical practice involving generic drugs and biosimilars for treating ulcerative colitis (UC) in Japan. We aimed to clarify the clinical usage of these generic drugs and biosimilars for UC treatment in Japan using a nationwide database.\u0000Methods: We collected data from 30,675 UC cases, along with their prescriptions for both generic drugs or biosimilars and their original counterparts, using a medical claims database provided by DeSC Healthcare, Inc. We calculated the prescription and penetration rates of generic drugs and biosimilars and demonstrated the transition of these rates. Additionally, the cumulative retention rates between infliximab originator and biosimilar were compared using the Kaplan–Meier method.\u0000Results: The prescription rate of generic mesalazine increased from approximately 10% in 2015 to over 30% in 2021. Although the prescription rate of generic molecular targeting drugs (MTDs) also increased from approximately 0.15% in 2014 to 2.5% in 2021, the increment was lower than that of generic mesalazine. The penetration rates of generic 5-aminosalicylic acid and tacrolimus ranged from over 30% to approximately 50%. Infliximab biosimilar achieved an approximate 20% penetration rate, whereas adalimumab achieved< 5%. The cumulative retention rates did not differ between infliximab originator and biosimilar.\u0000Conclusions: The penetration rates of generics and biosimilars for UC treatment are relatively low compared with those for treatment in other fields and the goal of Ministry of Health, Labor, and Welfare. Several countermeasures are necessary for the widespread use of generics and biosimilars, ultimately contributing to cost-effective and sustainable healthcare delivery. \u0000","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139445108","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
White blood cell counts and future relapse in ulcerative colitis under low-dose thiopurine treatment in real-world practice: a three year Japanese multi-center retrospective cohort study. 白细胞计数与小剂量硫嘌呤治疗下溃疡性结肠炎未来复发的实际情况:一项为期三年的日本多中心回顾性队列研究。
Q2 Medicine Pub Date : 2023-12-28 DOI: 10.1159/000535889
H. Kiyohara, H. Yamazaki, Kei Moriya, Naohiko Akimoto, S. Kawai, Kento Takenaka, Tomohiro Fukuda, Keiichi Tominaga, Junji Umeno, S. Shinzaki, Yusuke Honzawa, Tomohisa Takagi, Hitoshi Ichikawa, Toshiyuki Endo, R. Ozaki, Akira Andoh, K. Matsuoka, Toshifumi Hibi, Taku Kobayashi
Introduction Whether white blood cell (WBC) counts are predictors for the effectiveness of thiopurine treatment in ulcerative colitis (UC) has been inconclusive in previous studies with small sample sizes. We investigated the association between WBC counts and future relapses in UC patients in a large-scale multi-center study. Methods This retrospective cohort study enrolled a total of 723 UC patients in remission from 33 hospitals and followed up for three years. Relapse was defined as a need for treatment intensification. The risk of relapse was compared among patients with the baseline WBC counts<3000/µL (N=31), 3000–4000/µL (N=167), 4000–5000/µL (N=241), and ≥5000/µL (N=284) using a Cox regression model analysis. Moreover, exploratory analyses were conducted to identify other factors predicting relapse. Results During a median follow-up period of 1095 (interquartile range, 1032–1119) days, relapse occurred in 17.2% (125/723). In a crude analysis, WBC counts were not associated with relapse; hazard ratios (HRs) [95% confidence interval (CI)] were 1.50 [0.74–3.06], 1.02 [0.66–1.59] and 0.67 [0.43–1.05] in WBC<3000/µL, 3000–4000/µL, and 4000–5000/µL groups, respectively (WBC≥5000/µL group, as reference). Multivariable-adjusted analyses showed similar results; HRs [95% CI] were 1.21 [0.59–2.49], 1.08 [0.69–1.69], and 0.69 [0.44–1.07], in <3000/µL, 3000–4000/µL, and 4000–5000/µL group, respectively. In the exploratory analyses, thiopurine use <1 year and a mean corpuscular volume <90 fL were predictors for relapse. Discussion/Conclusion WBC counts were not predictors for future relapses in patients with UC treated with thiopurine as a maintenance therapy.
导言:白细胞(WBC)计数是否能预测硫嘌呤治疗溃疡性结肠炎(UC)的疗效,以往样本量较小的研究尚无定论。我们在一项大规模多中心研究中调查了白细胞计数与 UC 患者未来复发之间的关系。方法 这项回顾性队列研究共纳入了来自 33 家医院的 723 名处于缓解期的 UC 患者,并进行了为期三年的随访。复发被定义为需要加强治疗。采用Cox回归模型分析比较了基线白细胞计数<3000/μL(31人)、3000-4000/μL(167人)、4000-5000/μL(241人)和≥5000/μL(284人)的患者的复发风险。此外,还进行了探索性分析,以确定预测复发的其他因素。结果 在中位 1095 天(四分位间范围 1032-1119)的随访期间,17.2% 的患者(125/723)出现复发。在粗略分析中,白细胞计数与复发无关;白细胞<3000/μL组、3000-4000/μL组和4000-5000/μL组的危险比(HRs)[95%置信区间(CI)]分别为1.50[0.74-3.06]、1.02[0.66-1.59]和0.67[0.43-1.05](白细胞≥5000/μL组作为参考)。多变量调整分析显示了相似的结果;HRs [95% CI] 分别为 1.21 [0.59-2.49]、1.08 [0.69-1.69]和 0.69 [0.44-1.07],<3000/µL、3000-4000/µL 和 4000-5000/µL 组分别为 1.21 [0.59-2.49]、1.08 [0.69-1.69]和 0.69 [0.44-1.07]。在探索性分析中,使用硫嘌呤<1年和平均血球容积<90 fL是预测复发的因素。讨论/结论 在使用硫嘌呤作为维持疗法的 UC 患者中,白细胞计数不是未来复发的预测因素。
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引用次数: 0
Contents Vol. 8, 2023 目录 第 8 卷,2023 年
Q2 Medicine Pub Date : 2023-12-01 DOI: 10.1159/issn.2296-9365
M. Takahashi, Nishinomiya, Kobe, M. Nunotani, Nishinomiya Aoyama, N. Kobe, D’Haens, Amsterdam Safroneeva, E. Thorne, H. Laoun
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引用次数: 0
期刊
Inflammatory Intestinal Diseases
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