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The status of Helicobacter pylori infection related extraintestinal diseases in Myanmar 缅甸幽门螺杆菌感染相关肠外疾病的现状
Pub Date : 2021-07-06 DOI: 10.1002/ygh2.472
Than Than Aye, Thet Mar Win, Myint Naychi Tun

Background

Myanmar is the country where the prevalence of Helicobacter pylori (H. pylori) infection is high among Southeast Asia region. Many studies have demonstrated association of H. pylori infection with extraintestinal diseases as in pathogenic role.

Methods

This is narrative review article. Available studies regarding H. pylori and extraintestinal manifestations; both full texts and abstracts which appeared in the Union catalogue of Myanmar Health science link, were reviewed in this article.

Results

There were statistically significant association between H. pyloriinfection and autoimmune thrombocytopenia (P = .001), coronary artery disease (P = .001), Parkinson’s diseases (P = .001), chronic urticaria (P = .007) and psoriasis (P = .001). There were trend towards positive association with H. pylori infection and type 2 diabetes mellitus (0.544), ischemic stroke (P = .163) and pemphigus (58%) although statistically did not significant.

Conclusion

This is the first paper in Myanmar reviewing the prevalence of extraintestinal manifestation of H. pylori infection in Myanmar. Although the majority are descriptive in design and the results were heterogeneous , there are trend towards positive association of H. pylori infection and extraintestinal diseases in Myanmar.

背景缅甸是东南亚地区幽门螺杆菌感染率较高的国家。许多研究表明,幽门螺杆菌感染与肠外疾病的致病作用有关。方法本文为叙述性综述。关于幽门螺杆菌和肠外表现的现有研究;全文和摘要均出现在缅甸卫生科学链接的联邦目录中,本文进行了综述。结果幽门螺杆菌感染与自身免疫性血小板减少症(P=0.001)、冠状动脉疾病(P=0.001,缺血性中风(P=.163)和天疱疮(58%),尽管在统计学上并不显著。结论这是缅甸第一篇综述幽门螺杆菌感染肠道外表现的论文。尽管大多数设计是描述性的,结果是异质性的,但在缅甸,幽门螺杆菌感染和肠外疾病有正相关的趋势。
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引用次数: 2
SARS-CoV-2 vaccination in patients with inflammatory bowel disease 炎症性肠病患者的SARS-CoV-2疫苗接种
Pub Date : 2021-07-02 DOI: 10.1002/ygh2.473
Ralley E. Prentice, Clarissa Rentsch, Aysha H. Al-Ani, Eva Zhang, Douglas Johnson, John Halliday, Robert Bryant, Jacob Begun, Mark G. Ward, Peter J. Lewindon, Susan J. Connor, Simon Ghaly, Britt Christensen

Background

The current COVID-19 pandemic, caused by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), has drastically impacted societies worldwide. Vaccination against SARS-CoV-2 is expected to play a key role in the management of this pandemic. Inflammatory conditions such as inflammatory bowel disease (IBD) often require chronic immunosuppression, which can influence vaccination decisions.

Aim

This review article aims to describe the most commonly available SARS-CoV-2 vaccination vectors globally, assess the potential benefits and concerns of vaccination in the setting of immunosuppression and provide medical practitioners with guidance regarding SARS-CoV-2 vaccination in patients with IBD.

Methods

All published Phase 1/2 and/or Phase 3 and 4 studies of SARS-CoV-2 vaccinations were reviewed. IBD international society position papers, safety registry data and media releases from pharmaceutical companies as well as administrative and medicines regulatory bodies were included. General vaccine evidence and recommendations in immunosuppressed patients were reviewed for context. Society position papers regarding special populations, including immunosuppressed, pregnant and breast-feeding individuals were also evaluated. Literature was critically analysed and summarised.

Results

Vaccination against SARS-CoV-2 is supported in all adult, non-pregnant individuals with IBD without contraindication. There is the potential that vaccine efficacy may be reduced in those who are immunosuppressed; however, medical therapies should not be withheld in order to undertake vaccination. SARS-CoV-2 vaccines are safe, but data specific to immunosuppressed patients remain limited.

Conclusions

SARS-CoV-2 vaccination is essential from both an individual patient and community perspective and should be encouraged in patients with IBD. Recommendations must be continually updated as real-world and trial-based evidence emerges.

当前由严重急性呼吸综合征-冠状病毒-2 (SARS-CoV-2)引起的COVID-19大流行已严重影响了全球社会。预计针对SARS-CoV-2的疫苗接种将在本次大流行的管理中发挥关键作用。炎症性肠病(IBD)等炎症性疾病通常需要慢性免疫抑制,这可能影响疫苗接种的决定。目的本综述旨在描述全球最常见的SARS-CoV-2疫苗接种载体,评估免疫抑制背景下接种疫苗的潜在益处和关注问题,为IBD患者接种SARS-CoV-2疫苗提供指导。方法回顾所有已发表的SARS-CoV-2疫苗接种的1/2期和/或3期和4期研究。包括IBD国际协会的立场文件、安全注册数据和制药公司以及行政和药品监管机构的媒体发布。对免疫抑制患者的一般疫苗证据和建议进行了背景审查。社会立场文件关于特殊人群,包括免疫抑制,怀孕和哺乳的个人也进行了评估。对文献进行了批判性的分析和总结。结果支持所有成年、非妊娠IBD患者接种SARS-CoV-2疫苗,无禁忌症。在免疫抑制的人群中,疫苗效力可能会降低;但是,不应为了接种疫苗而停止医疗治疗。SARS-CoV-2疫苗是安全的,但针对免疫抑制患者的特异性数据仍然有限。结论无论从个体患者还是社区的角度来看,SARS-CoV-2疫苗接种都是必要的,应鼓励IBD患者接种。建议必须随着现实世界和试验证据的出现而不断更新。
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引用次数: 5
Sodium-glucose co-transporter 2 inhibitors reduce hepatic events in diabetic patients with chronic hepatitis B 钠-葡萄糖共转运蛋白2抑制剂减少糖尿病合并慢性乙型肝炎患者的肝事件
Pub Date : 2021-07-02 DOI: 10.1002/ygh2.471
Lilian Yan Liang, Vincent Wai-Sun Wong, Vicki Wing-Ki Hui, Terry Cheuk-Fung Yip, Yee-Kit Tse, Grace Chung-Yan Lui, Henry Lik-Yuen Chan, Grace Lai-Hung Wong

Background

Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are a novel class of anti-diabetic drugs that lower the blood glucose level by inhibiting the renal glucose reabsorption. We aimed to evaluate the effect of SGLT2i on the risk of hepatic events in diabetic patients with chronic hepatitis B (CHB).

Methods

This is a retrospective territory-wide cohort study. Nucleos(t)ide analogue (NA)-treated diabetic patients with CHB were included. Patients who used SGLT2i for more than 90 days were classified as SGLT2i users and those who had never used SGLT2i were defined as non-SGLT2i users. The primary endpoint was the cumulative incidence of hepatic events.

Results

Among 5276 NA-treated diabetic patients with CHB, 393 (7.4%) patients were SGLT2i users and 4883 (92.6%) patients were non-users. Ten (2.5%) SGLT2i users and 739 (15.1%) non-users developed hepatic events during the mean follow-up of 25 and 63 months respectively. SGLT2i treatment was significantly associated with a lower risk of hepatic events in univariate analysis (subdistribution hazard ratio (SHR): 0.43, 95% CI: 0.22-0.84, P = 0.013) and log-rank test (P = 0.01) before propensity score (PS) weighting. This association was also observed in Fine-Gray subdistribution hazard regression after PS weighting (weighted SHR: 0.42, 95% CI: 0.19-0.90, P = 0.026).

Conclusions

Use of SGLT2i may be linked with a lower risk of hepatic events in NA-treated diabetic patients with CHB. Larger cohort studies or randomised trials are warranted.

背景钠-葡萄糖共转运蛋白2抑制剂(SGLT2i)是一类新型的抗糖尿病药物,通过抑制肾脏葡萄糖重吸收来降低血糖水平。我们旨在评估SGLT2i对糖尿病合并慢性乙型肝炎(CHB)患者肝事件风险的影响。方法这是一项回顾性的区域性队列研究。核苷酸类似物(NA)治疗的糖尿病慢性乙型肝炎患者也包括在内。使用SGLT2i超过90天的患者被归类为SGLT2i使用者,从未使用过SGLT2Ⅰ的患者被定义为非SGLT2Ⅱ使用者。主要终点是肝脏事件的累计发生率。结果5276例NA治疗的糖尿病CHB患者中,393例(7.4%)为SGLT2i使用者,4883例(92.6%)为非使用者。在25个月和63个月的平均随访中,10名(2.5%)SGLT2i使用者和739名(15.1%)非使用者分别发生了肝事件。在倾向评分(PS)加权前的单变量分析(亚分布危险比(SHR)=0.43,95%CI:0.22-0.84,P=0.013)和对数秩检验(P=0.01)中,SGLT2i治疗与较低的肝事件风险显著相关。在PS加权后的Fine Gray亚分布风险回归中也观察到了这种相关性(加权SHR:0.42,95%CI:0.19-0.90,P=0.026)。结论在NA治疗的糖尿病CHB患者中,使用SGLT2i可能与较低的肝事件风险有关。有必要进行更大规模的队列研究或随机试验。
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引用次数: 1
Re: Risk of extrahepatic cancer in a nationwide cohort of hepatitis C virus‐infected persons treated with direct‐acting antivirals: Public health impact amongst Swedish cohort in the Covid‐19 pandemic era 全国性丙型肝炎病毒感染者接受直接抗病毒药物治疗的肝外癌风险:Covid - 19大流行时期瑞典队列的公共卫生影响
Pub Date : 2021-07-01 DOI: 10.1002/ygh2.470
S. Pandey
To the Editor: The study by Lybeck et al1 focusing on riskassessment of extrahepatic cancer (EHC) in a nationwide Swedish cohort of hepatitis C virus (HCV) infected persons treated with direct acting antivirals (DAAs) provides critical insights in the patientfriendly, costeffective, timelinebased clinical management of HCVmediated EHC (eg nonHodgkin lymphoma/intrahepaticcholangiocarcinoma) for eventual design/development of novel immunomodulatory drugs and predictive/prognostic biomarkers in “atrisk” susceptible populations of varying genetic landscapes. Inclusion/exclusioncriteria were welldefined with a biasfree interpretation of complex statistical datasets; large sample size (N = 19 685 HCVpositive cases), a major study strength, added adequate statistical power (≥80%) reducing the possibility of potential selection bias in risk assessment amongst subgroups of HCVinfected persons: 4013 DAAtreated/3071 interferon (IFN)treated/12 601 untreated, with maximal 3 years’ clinical followup time. EHC risk was compared between treatment groups using Cox regression analyses, with adjustment for age/Charlson Comorbidity Index (CCI); matched case– control studyapproach wherein HCVinfected groups were stringently compared with matched cohorts without HCV from general Swedish population, reduced possibility of populationadmixture. Healthy/diseasefree, age/ethnicitymatched controls from random population significantly adds to statisticalpower of case– control association studies in “gastrohepatic diseaseweb”pathophysiology research2,3; Pandey has elegantly emphasized the significance of age/ethnicitymatched diseasefree controls from the general random population in multicentric epidemiology/ pharmacogenetics/genomics studies for demystifying the cellular/ molecular/genetic basis of inflammatory gastrohepatic ailments in susceptible cohorts.4 Overall, the findings of this study on HCVmediated EHC management in Swedish cohort(s) convincingly demonstrated that the HCVpositivity trend amongst 341 EHCs was appreciable: 84/43/214 EHC in DAA/IFN/untreatedgroup respectively; EHCrisk in DAAtreated compared with IFNtreated was doubled, but after adjustment for age/CCI, hazards ratio (HR) was 1.07 (95% CI 0.741.56). Cox regression analysis with controls revealed that EHCHR in DAAgroup = 1.45 (CI 1.131.86), with difference remaining statistically significant after adjusting for CCI. These findings may be successfully replicated in future multicentric large sample sizebased case– control prospective studies adhering to core tenets of good practice ethical research with longterm patient satisfaction trends. Interestingly, data from the HCVinfected EHCcohort and matched comparisoncohort were linked to national registers with prospectively collected data (National Board of Health and Welfare: PrescriptionRegister (PrR)/PatientRegister (PR)/CancerRegister (CR)/CauseofDeathRegister (DR)), adding authenticity to the selectioncriteria of eligible studysubjects of Swedish ethnic
致编辑:Lybeck等人对瑞典全国丙型肝炎病毒(HCV)感染者接受直接作用抗病毒药物(DAAs)治疗的肝外癌(EHC)风险评估的研究,为患者友好、成本效益、基于时间线的hcv介导的EHC(如非霍奇金淋巴瘤/肝内胆管癌)临床管理,以最终设计/开发新的免疫调节药物和预测/预后生物标志物,用于不同遗传景观的“高危”易感人群。纳入/排除标准定义明确,对复杂统计数据集进行无偏倚解释;大样本量(N = 19 685例hcv阳性病例)是研究的主要优势,增加了足够的统计能力(≥80%),减少了hcv感染者亚组风险评估中潜在选择偏倚的可能性:4013例dav治疗/3071例干扰素(IFN)治疗/12 601例未治疗,最长临床随访时间为3年。采用Cox回归分析比较各组间EHC风险,调整年龄/Charlson合并症指数(CCI);匹配病例对照研究方法,将HCV感染组与瑞典普通人群中未感染HCV的匹配队列严格比较,减少了人群混合的可能性。来自随机人群的健康/无疾病、年龄/种族匹配的对照显著增加了“胃肝疾病网”病理生理学研究中病例-对照关联研究的统计效力2,3;Pandey优雅地强调了在多中心流行病学/药物遗传学/基因组学研究中,来自一般随机人群的年龄/种族匹配的无疾病对照对于揭开易感人群中炎症性胃肝疾病的细胞/分子/遗传基础的重要性总体而言,本研究在瑞典队列中对hcv介导的EHC管理的研究结果令人信服地表明,341例EHC患者中hcv阳性趋势明显:DAA/IFN/未治疗组分别为84/43/214;与ifn治疗组相比,dan治疗组的EHCrisk增加了一倍,但在调整年龄/CCI后,危险比(HR)为1.07 (95% CI 0.741.56)。与对照组进行Cox回归分析,daaggroup EHCHR = 1.45 (CI 1.131.86),校正CCI后差异仍有统计学意义。这些发现可能会在未来的多中心大样本量的病例对照前瞻性研究中成功复制,这些研究坚持良好实践伦理研究的核心原则,并具有长期患者满意度趋势。有趣的是,来自hcv感染的ehc队列和匹配的比较队列的数据与前瞻性收集数据的国家登记册(国家卫生和福利委员会:处方登记册(PrR)/患者登记册(PR)/癌症登记册(CR)/死因登记册(DR))相关联,增加了瑞典种族合格研究受试者的选择标准的真实性。精心提取pegylatedIFN (alfa2a/alfa2b)/第二波或第三波DAAs处方的药物治疗临床证据:(索非布韦/西莫普韦/daclatasvir/ombitasvir/paritaprevir/利托那韦/dasabuvir/ledipasvir/elbasvir/grazoprevir/velpatasvir/glecaprevir/pibrentasvir/voxilaprevir)形成特定治疗组;排除使用第一波daa治疗的个体(telaprevir/boceprevir/n = 697)。通过增加PR和DR的癌症(CR中未包括)和较短随访时间进行敏感性分析,研究随访12年后的hr;Kaplan - Meier曲线估计了不同治疗组的无EHC随访时间,按年龄组(随访开始时年龄:3549/5064/≥65岁)和匹配的瑞典普通人群分层,并使用logranktests比较这些组之间无EHC随访时间。数据集显示,在调整年龄/CCI后,daa治疗与EHC的风险没有增加,与普通人群相比,daa治疗的EHC风险增加。我想补充的是,缺氧/血管不足/炎症异质性肿瘤浸润不同表型的增生和/或坏死/凋亡/自噬细胞的异常“代谢通量”是hcv介导的EHC/相关胃肝癌的主要标志;“免疫原性细胞死亡级联”即自噬细胞凋亡的治疗靶向,为未来hcv介导的EHC干细胞在covid - 19大流行时代的转化研究提供了令人着迷的途径。
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引用次数: 0
Sodium‐glucose co‐transporter 2 inhibitors reduce hepatic events in diabetic patients with chronic hepatitis B 钠-葡萄糖共转运蛋白2抑制剂可减少慢性乙型肝炎糖尿病患者的肝脏事件
Pub Date : 2021-07-01 DOI: 10.1002/ygh2.471
L. Y. Liang, V. Wong, Vicki Wing-Ki Hui, T. Yip, Y. Tse, G. Lui, H. Chan, G. Wong
Sodium‐glucose co‐transporter 2 inhibitors (SGLT2i) are a novel class of anti‐diabetic drugs that lower the blood glucose level by inhibiting the renal glucose reabsorption. We aimed to evaluate the effect of SGLT2i on the risk of hepatic events in diabetic patients with chronic hepatitis B (CHB).
钠葡萄糖共转运蛋白2抑制剂(SGLT2i)是一类新型的抗糖尿病药物,通过抑制肾脏葡萄糖重吸收来降低血糖水平。我们的目的是评估SGLT2i对糖尿病合并慢性乙型肝炎(CHB)患者肝脏事件风险的影响。
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引用次数: 1
Oral simethicone tablets with PEG-ELS split-prep reduces frequency of inadequate bowel cleansing and decreases bubbles 含有PEG-ELS分体式制剂的西美酮口服片可减少肠道清洁不足的频率并减少气泡
Pub Date : 2021-06-23 DOI: 10.1002/ygh2.469
Jennifer K. Maratt, Alison E. Freeman, Philip Schoenfeld, Sameer D. Saini, Grace L. Su, Andrew W. Tai, Anoop Prabhu, Joel H. Rubenstein, Akbar K. Waljee, Lisa Glass, Duyen Dang, Neehar D. Parikh, Shail M. Govani, Swati G. Patel, Stacy B. Menees

Background

Intraluminal bubbles may prevent the visualisation of mucosa during a colonoscopy. Simethicone minimises bubbles, but its impact on incomplete bowel preparation and optimal protocols for use are unclear.

Aim

To assess the impact of oral simethicone tablets when added to 2-litre, split-prep, polyethylene glycol electrolyte lavage solution + ascorbic acid on bubble score and frequency of incomplete bowel preparation.

Methods

This QA/QI project assessed outpatients who underwent colonoscopy at the Veterans Affairs Ann Arbor Healthcare System. After endoscopists were trained in intraluminal bubble scoring systems, data about bubble score, frequency of inadequate bowel preparation requiring early repeat colonoscopy, quality of bowel preparation using Boston Bowel Preparation Scale (BBPS), and patient tolerance were collected before and after addition of oral simethicone 160mg to each dose of 2-litre split-prep.

Results

There were no differences in patient characteristics between the baseline group (n = 348) and the simethicone group (n = 354). Simethicone improved the total mean intraluminal bubble score from 8.18 to 8.78 (P < 0.001). Early repeat colonoscopy due to inadequate bowel preparation was higher in the baseline group vs simethicone group: 8.7% vs 4.6%, P = 0.03 with an RRR = 0.5 (95% CI 0.26-0.95). Using BBPS, the frequency of having inadequate cleansing in any colon segment was higher in the baseline group vs simethicone group: 6.6% vs 3.1%; RRR = 0.55 (95% CI 0.21-0.94).

Conclusions

The addition of oral simethicone to each dose of 2-litre, split-prep of polyethylene glycol + ascorbic acid decreased intraluminal bubbles and reduced the frequency of inadequate bowel preparation.

背景在结肠镜检查过程中,管腔内气泡可能会阻碍粘膜的可视化。Simethicone可最大限度地减少气泡,但其对不完全肠道准备的影响和最佳使用方案尚不清楚。目的评估口服西美酮片加入2升、拆分制剂、聚乙二醇电解质灌洗液+抗坏血酸对气泡评分和肠道不完全准备频率的影响。方法该QA/QC项目评估了在安阿伯退伍军人事务医疗系统接受结肠镜检查的门诊患者。在内镜医生接受腔内气泡评分系统、气泡评分数据、需要早期重复结肠镜检查的肠道准备不足的频率、使用波士顿肠道准备量表(BBPS)的肠道准备质量、,并在每次剂量的2-升拆分-prep中添加160mg口服西美酮之前和之后收集患者耐受性。结果基线组(n=348)和西美酮组(n=354)的患者特征没有差异。Simethicone将总平均管腔内气泡评分从8.18提高到8.78(P<;0.001)。由于肠道准备不足,基线组的早期重复结肠镜检查高于Simethicon组:8.7%vs 4.6%,P=0.03,RRR=0.5(95%CI 0.26-0.95)。使用BBPS,在任何结肠节段进行不充分清洁的频率,基线组高于西美酮组:6.6%vs 3.1%;RRR=0.55(95%可信区间0.21-0.94)。结论在每次2升、聚乙二醇+抗坏血酸的分次制备中加入口服西美酮,可减少管腔内气泡,降低肠道准备不足的频率。
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引用次数: 0
Lenvatinib for unresectable hepatocellular carcinoma: the first Indian experience Lenvatinib治疗不可切除的肝细胞癌:第一个印度经验
Pub Date : 2021-06-09 DOI: 10.1002/ygh2.477/v1/review2
A. Kulkarni, S. Fatima, Mithun Sharma, P. Kumar, Rajesh Gupta, N. Padaki, N. Reddy
The AsiaPacific region contributes to nearly 73% of global deaths due to hepatocellular carcinoma (HCC).1 The ageadjusted annual HCC incidence rate (per 100,000 persons) in India ranges between 0.7 and 7.5 for men and 0.2 and 2.2 for women.2 Most patients present in the advanced stage when definitive therapies are not possible.3 Lenvatinib was a breakthrough in the treatment of unresectable HCC (uHCC).4 However, there is no Indian data on lenvatinib therapy. In this report, we describe the outcomes of uHCC patients treated with lenvatinib. We retrospectively analysed the data of patients who were treated with lenvatinib as firstline systemic therapy at our tertiary care centre from January 2019 to February 2021. The data were analysed using SPSS software 25 version. Descriptive statistics have been expressed as mean (±SD) for continuous data. For categorical data, we have expressed the results as a percentage (n). KaplanMeier analysis was used to assess the median overall survival (OS) and progressionfree survival (PFS). A total of 63 patients received lenvatinib. The mean age was 60.24 ± 9.57 years. Males were predominant (93.7%). Viral hepatitis (50%) was the most common cause of liver disease, followed by nonalcoholic steatohepatitis (44.5%) and alcohol (6.3%). Twentytwo percent (14/63) of patients were noncirrhotic HCC. The mean αfetoprotein (AFP) before initiation of lenvatinib was 1120.71 ± 2369.55 ng/mL. All the patients had ≤1 Eastern Cooperative Oncology Group performance status. Thirtyfive percent of patients had received a prior radiological intervention (Table 1). Sixtytwo percent (39/63) of patients were initiated on 8 mg dose and the rest on 12 mg dose based on the weight. Fiftysix percent (35/63) of patients developed adverse events. The median tolerated dose was 8 mg/d in the whole cohort. The median duration of therapy was 4.1 months. Adverse events noted were hypertension (13/63, 21%), nausea (6/63, 10%), diarrheoa (5/63, 8%), palmarplantar erythrodysesthesia syndrome (4/63, 6.35%), fatigue (3/63, 5%), skin rash (2/63, 3.17%) and abdominal pain (1/63, 1.6%). One patient developed tumour rupture (size 10.3 × 7.1 cm) after 27 days of therapy. Treatment was discontinued in 20% (12/63) of patients due to adverse events. Seven patients were started on regorafenib, given the progressive disease. On KM analysis, the median PFS was 5 (95% CI, 4.275.72) months, and the median OS was 10.4 (95% CI, 8.2412.56) months. Fiftytwo patients were evaluated by modified Response Evaluation Criteria in Solid Tumors (mRECIST). While none of the patients achieved complete response, 27% (14/52) achieved partial response, 44.2% (23/52) had stable disease, and the disease progressed in 29% (15/52) of patients. Lenvatinib is a multikinase inhibitor which is now one of the firstline therapy recommended for uHCC. The first study by Kudo et al demonstrated noninferiority of lenvatinib compared to sorafenib.4 The median PFS was significantly better with lenva
亚太地区占全球肝细胞癌(HCC)死亡人数的近73%在印度,年龄调整后的HCC年发病率(每10万人)男性为0.7 - 7.5,女性为0.2 - 2.2大多数患者出现在晚期,此时无法进行明确的治疗Lenvatinib是治疗不可切除HCC (uHCC)的一个突破然而,没有印度关于lenvatinib治疗的数据。在这篇报道中,我们描述了lenvatinib治疗uHCC患者的结果。我们回顾性分析了2019年1月至2021年2月在三级护理中心接受lenvatinib作为一线全身治疗的患者的数据。采用SPSS软件25版对数据进行分析。描述性统计用连续数据的平均值(±SD)表示。对于分类数据,我们将结果表示为百分比(n)。KaplanMeier分析用于评估中位总生存期(OS)和无进展生存期(PFS)。共有63名患者接受lenvatinib治疗。平均年龄60.24±9.57岁。男性居多(93.7%)。病毒性肝炎(50%)是肝脏疾病最常见的原因,其次是非酒精性脂肪性肝炎(44.5%)和酒精(6.3%)。22%(14/63)的患者为非肝硬化HCC。lenvatinib起始前α胎蛋白(AFP)平均值为1120.71±2369.55 ng/mL。所有患者的成绩均为≤1分。35%的患者先前接受过放射干预(表1)。62%(39/63)的患者开始服用8mg剂量,其余患者根据体重服用12mg剂量。56%(35/63)的患者出现不良事件。整个队列的中位耐受剂量为8mg /d。中位治疗持续时间为4.1个月。不良事件包括高血压(13/ 63,21%)、恶心(6/ 63,10%)、腹泻(5/ 63,8%)、掌跖红觉不良综合征(4/ 63,6.35%)、疲劳(3/ 63,5%)、皮疹(2/ 63,3.17%)和腹痛(1/ 63,1.6%)。1例患者治疗27天后出现肿瘤破裂(10.3 × 7.1 cm)。20%(12/63)的患者因不良事件而停止治疗。考虑到病情进展,7名患者开始服用瑞非尼。KM分析中,中位PFS为5 (95% CI, 4.275.72)个月,中位OS为10.4 (95% CI, 8.2412.56)个月。采用改良的实体瘤应答评价标准(mRECIST)对52例患者进行评价。没有患者达到完全缓解,27%(14/52)患者达到部分缓解,44.2%(23/52)患者病情稳定,29%(15/52)患者病情进展。Lenvatinib是一种多激酶抑制剂,目前是推荐用于uHCC的一线治疗之一。Kudo等人的第一项研究表明lenvatinib与sorafenib相比无劣效性lenvatinib的中位PFS明显优于sorafenib最近,Goh等人评估了111例使用lenvatinib治疗原发性肝癌的患者。在现实世界中,OS为10.5个月,PFS为6.2个月。我们的研究结果与Koh等人的经验相似。5我们研究的主要局限性是对数据的回顾性评价和缺乏与接受索拉非尼的患者的比较。然而,这是印度第一个关于Lenvatinib治疗uHCC安全性和有效性的数据。
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引用次数: 6
Dried blood spot-based detection of serological profiles of hepatitis B and C infections and their prevalence in Cambodia 基于干血点的乙型肝炎和丙型肝炎血清学特征检测及其在柬埔寨的流行情况
Pub Date : 2021-06-02 DOI: 10.1002/ygh2.468
Bunthen E, Ko Ko, Shintaro Nagashima, Serge Ouoba, Md Razeen Ashraf Hussain, Aya Sugiyama, Tomoyuki Akita, Masayuki Ohisa, Channarena Chuon, Bunsoth Mao, Md Shafiqul Hossain, Vichit Ork, Junko Tanaka

Aims

This study aims to examine the diagnostic accuracy of dried blood spot (DBS) samples contrast to serum samples for detection of hepatitis B virus (HBV) and hepatitis C virus (HCV) sero-markers in large scale epidemiological study in the resource limited settings and then to determine the prevalence of each sero-marker from DBS samples collected during 2017 Cambodia nationwide study.

Methods

This study included 921 paired DBS and serum samples. HBsAg, HBsAg-HQ, anti-HBs, anti-HBc and anti-HCV were detected in all DBS/serum pairs but HBeAg and anti-HBe in 109 DBS/serum pairs using chemiluminescent enzyme immunoassay (CLEIA). Thereafter, the individual DBS's diagnostic accuracy was calculated. Additionally, the prevalence of each sero-marker was calculated in 4541 DBS samples from nationwide study in Cambodia.

Results

The sensitivity of DBS for detection of HBsAg, HBsAg-HQ, HBeAg and antiHBe were high (≥90%) with 100% specificity. Anti-HBc and anti-HBs showed low sensitivity (70.73% and 69.25% respectively) than other sero-markers, but their diagnostic accuracies were 94.58% and 89.32%. Therefore, the overall prevalence of HBsAg, HBsAg-HQ, anti-HBc, anti-HBs and anti-HCV using DBS samples in Cambodia were 2.38%, 2.53%, 14.27%, 31.84% and 0.15%, respectively. HBeAg and anti-HBe positivity among HBsAg positives were 31.48% and 53.7%.

Conclusion

Our study indicates that DBS has high diagnostic accuracy for HBsAg, HBsAg-HQ, HBeAg and anti-HBe. Having the benefit of simple procedure, easy and compact transportation and storage, it is considered as an alternative to serum samples in examining the serological profiles of HBV infection through a large-scale epidemiological study in the resource limited settings.

目的本研究旨在在资源有限的环境下,在大规模流行病学研究中,检验干血点(DBS)样本与血清样本对比检测乙型肝炎病毒(HBV)和丙型肝炎病毒(HCV)血清标志物的诊断准确性,然后确定2017年收集的干血点样本中每种血清标记物的流行率柬埔寨全国性研究。方法本研究包括921份配对DBS和血清样本。化学发光酶免疫测定法(CLEIA)在所有DBS/血清对中均检测到HBsAg、HBsAg-HQ、抗-HBs、抗-HBc和抗-HCV,但在109对DBS/血液对中检测到HBeAg和抗-HBe。然后,计算个体DBS的诊断准确性。此外,在柬埔寨全国研究的4541个DBS样本中计算了每种血清标志物的流行率。结果DBS检测HBsAg、HBsAg HQ、HBeAg和抗HBe的敏感性高(≥90%),特异性达100%。抗-HBc和抗-HBs的敏感性较低(分别为70.73%和69.25%),但其诊断准确率分别为94.58%和89.32%。HBsAg阳性者中HBeAg和抗-HBe阳性率分别为31.48%和53.7%。它具有程序简单、运输和储存方便紧凑的优点,被认为是在资源有限的环境中通过大规模流行病学研究来检测HBV感染血清学特征的血清样本的替代品。
{"title":"Dried blood spot-based detection of serological profiles of hepatitis B and C infections and their prevalence in Cambodia","authors":"Bunthen E,&nbsp;Ko Ko,&nbsp;Shintaro Nagashima,&nbsp;Serge Ouoba,&nbsp;Md Razeen Ashraf Hussain,&nbsp;Aya Sugiyama,&nbsp;Tomoyuki Akita,&nbsp;Masayuki Ohisa,&nbsp;Channarena Chuon,&nbsp;Bunsoth Mao,&nbsp;Md Shafiqul Hossain,&nbsp;Vichit Ork,&nbsp;Junko Tanaka","doi":"10.1002/ygh2.468","DOIUrl":"https://doi.org/10.1002/ygh2.468","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>This study aims to examine the diagnostic accuracy of dried blood spot (DBS) samples contrast to serum samples for detection of hepatitis B virus (HBV) and hepatitis C virus (HCV) sero-markers in large scale epidemiological study in the resource limited settings and then to determine the prevalence of each sero-marker from DBS samples collected during 2017 Cambodia nationwide study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study included 921 paired DBS and serum samples. HBsAg, HBsAg-HQ, anti-HBs, anti-HBc and anti-HCV were detected in all DBS/serum pairs but HBeAg and anti-HBe in 109 DBS/serum pairs using chemiluminescent enzyme immunoassay (CLEIA). Thereafter, the individual DBS's diagnostic accuracy was calculated. Additionally, the prevalence of each sero-marker was calculated in 4541 DBS samples from nationwide study in Cambodia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The sensitivity of DBS for detection of HBsAg, HBsAg-HQ, HBeAg and antiHBe were high (≥90%) with 100% specificity. Anti-HBc and anti-HBs showed low sensitivity (70.73% and 69.25% respectively) than other sero-markers, but their diagnostic accuracies were 94.58% and 89.32%. Therefore, the overall prevalence of HBsAg, HBsAg-HQ, anti-HBc, anti-HBs and anti-HCV using DBS samples in Cambodia were 2.38%, 2.53%, 14.27%, 31.84% and 0.15%, respectively. HBeAg and anti-HBe positivity among HBsAg positives were 31.48% and 53.7%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Our study indicates that DBS has high diagnostic accuracy for HBsAg, HBsAg-HQ, HBeAg and anti-HBe. Having the benefit of simple procedure, easy and compact transportation and storage, it is considered as an alternative to serum samples in examining the serological profiles of HBV infection through a large-scale epidemiological study in the resource limited settings.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12480,"journal":{"name":"GastroHep","volume":"3 4","pages":"247-253"},"PeriodicalIF":0.0,"publicationDate":"2021-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/ygh2.468","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71936433","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: 3
A ‘real-world’ retrospective multi-centre cohort study comparing infliximab and adalimumab for the maintenance of remission in ulcerative colitis 一项比较英夫利昔单抗和阿达木单抗维持溃疡性结肠炎缓解的“真实世界”回顾性多中心队列研究
Pub Date : 2021-06-02 DOI: 10.1002/ygh2.467
Victoria Tatiana Kronsten, Michael J. Colwill, Shadab Nayeemuddin, Jimmy K. Limdi, Christian Selinger, Glyn Scott, Lulia Al-Hillawi, Shayon Salehi, Paul Blaker, Guy Chung-Faye, Alexandra J. Kent, Patrick Dubois, Bu Hayee

Background

Anti-tumour necrosis factor therapy is an established treatment for moderate-to-severely active ulcerative colitis (UC). Recent network meta-analyses of controlled trial data have indicated a superiority of intravenous drugs (infliximab) over subcutaneous (adalimumab). We conducted a retrospective multi-centre cohort study to determine the comparative effectiveness of these two drugs.

Methods

Patients with UC administered infliximab or adalimumab as their first biologic, identified from the therapy databases of five UK hospitals, were included, if they had completed induction and were on maintenance treatment. Patients receiving infliximab as ‘rescue’ therapy for acute severe UC were excluded. The primary end-points for comparison were the number of patients remaining on initial therapy (infliximab or adalimumab) at 52 weeks and the number of patients in clinical remission at 52 weeks (Simple Clinical Colitis Activity [SCCAI] score ≤ 3).

Results

Seventy-eight infliximab and 63 adalimumab patients were analysed. At 52 weeks, 83% of infliximab patients and 59% of adalimumab patients remained on therapy (P = 0.001). At 52 weeks, 62% of the infliximab group were in clinical remission compared to 32% of the adalimumab group (P = 0.0004). Primary non-response was reported in 24% of adalimumab patients and 5% of infliximab patients (P = 0.001). There were no significant differences in colectomy rates or hospital admission for acute flares at 52 weeks.

Conclusions

Our real-world results affirm the findings of network meta-analyses of clinical trials, suggesting that infliximab is superior to adalimumab in the maintenance of remission in UC up to 52 weeks.

背景抗肿瘤坏死因子治疗是一种治疗中重度活动性溃疡性结肠炎(UC)的有效方法。最近对对照试验数据的网络荟萃分析表明,静脉注射药物(英夫利昔单抗)优于皮下注射药物(阿达木单抗)。我们进行了一项回顾性多中心队列研究,以确定这两种药物的比较有效性。方法从五家英国医院的治疗数据库中确定的UC患者,如果他们已经完成诱导并正在接受维持治疗,则将其纳入其中。接受英夫利昔单抗作为急性重症UC“抢救”治疗的患者被排除在外。比较的主要终点是52周时仍在接受初始治疗(英夫利昔单抗或阿达木单抗)的患者人数和52周时临床缓解的患者人数(单纯临床结肠炎活性[ScAI]评分≤3)。结果对78例英夫利昔单抗和63例阿达木单抗患者进行了分析。52周时,83%的英夫利昔单抗患者和59%的阿达木单抗患者仍在接受治疗(P=0.001),与阿达木单抗组的32%相比,英夫利昔单抗组62%的患者处于临床缓解期(P=0.0004)。据报道,24%的阿达木单抗患者和5%的英夫利单抗患者出现原发性无反应(P=0.001)。52岁时,结肠切除率或急性发作入院率没有显著差异周。结论我们的真实世界结果证实了临床试验的网络荟萃分析结果,表明英夫利昔单抗在维持UC缓解长达52周方面优于阿达木单抗。
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引用次数: 1
A ‘real‐world’ retrospective multi‐centre cohort study comparing infliximab and adalimumab for the maintenance of remission in ulcerative colitis 一项“真实世界”回顾性多中心队列研究比较英夫利昔单抗和阿达木单抗维持溃疡性结肠炎缓解的疗效
Pub Date : 2021-06-02 DOI: 10.1002/ygh2.467
V. Kronsten, M. Colwill, S. Nayeemuddin, J. Limdi, C. Selinger, G. Scott, L. Al‐Hillawi, S. Salehi, P. Blaker, G. Chung-Faye, A. Kent, P. Dubois, B. Hayee
Anti‐tumour necrosis factor therapy is an established treatment for moderate‐to‐severely active ulcerative colitis (UC). Recent network meta‐analyses of controlled trial data have indicated a superiority of intravenous drugs (infliximab) over subcutaneous (adalimumab). We conducted a retrospective multi‐centre cohort study to determine the comparative effectiveness of these two drugs.
抗肿瘤坏死因子治疗是治疗中度至重度活动性溃疡性结肠炎(UC)的常用方法。最近对对照试验数据的网络meta分析表明静脉注射药物(英夫利昔单抗)优于皮下注射药物(阿达木单抗)。我们进行了一项回顾性多中心队列研究,以确定这两种药物的比较有效性。
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引用次数: 1
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GastroHep
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