Background The diagnostic value of ascitic cholesterol in the differential diagnosis of ascites is controversial. Aim To investigate the diagnostic performance of ascitic cholesterol in the differential diagnosis of ascites. Methods Consecutive patients with new-onset ascites were enrolled prospectively. The pertinent data were collected from 629 patients with all forms of ascites. Results In the training cohort, determination of the ascitic cholesterol level was a highly effective method of distinguishing non-portal hypertension (NPH) from portal hypertension (PH). At the pre-determined cut-off value of 45 mg/dL, the sensitivity of ascitic cholesterol was superior to the serum-ascites albumin gradient (SAAG) in identifying NPH-related ascites; the area under the receiver operating characteristic curve was 0.945. In the patients misdiagnosed based on SAAG classification, the diagnostic accuracy of ascitic cholesterol was 69%. The ascitic cholesterol level showed excellent performance in identifying peritoneal lesions in patients with mixed ascites. Conclusion Ascitic cholesterol is an excellent measure for detecting NPH ascites and for identifying peritoneal lesions in mixed ascites. Thus, this simple and cost-effective measure should be determined in patients with new-onset ascites (; ChiCTR-DCD-15006907).
Background Ticagrelor and prasugrel are third-generation oral P2Y(12) receptor antagonists with rapid onset and pronounced platelet inhibition. However, higher overall bleeding rates have been reported for these agents when compared with clopidogrel. Aim To compare the risk of gastrointestinal bleeding (GIB) among users of third-generation P2Y(12) inhibitors with clopidogrel. Methods We systematically searched for published randomised controlled trials of ticagrelor or prasugrel versus clopidogrel until September 2018. The primary outcome was the risk of GIB among users of third-generation P2Y(12) inhibitors when compared to clopidogrel, expressed as risk ratio (RR) and 95% confidence interval (CI). The rates of non-coronary artery bypass graft (CABG) major bleeding, life-threatening bleeding, fatal bleeding, and intracranial bleeding were analysed as secondary outcomes. Results Forty-one studies were included in the analysis of non-CABG major bleeding, of which 12 were included in the analysis of GIB including 58 678 patients. Third-generation P2Y(12) inhibitors were associated with higher risk of GIB as compared with clopidogrel (RR 1.28, 95% CI 1.13-1.46). The findings were consistent for upper (RR 1.32, 95% CI 1.05-1.67) and unspecified GIB (RR 1.25, 95% CI 1.01-1.53), but not lower GIB (RR 1.25, 95% CI 0.95-1.65). Subgroup analysis showed higher GIB risk in prasugrel studies (RR 1.40, 95% CI 1.10-1.77) than in ticagrelor studies (RR 1.15, 95% CI 0.94-1.39). Third-generation P2Y(12) inhibitors also increased the risk of non-CABG major bleeding (RR 1.18, 95% CI 1.08-1.28). Conclusion Third-generation P2Y(12) inhibitors were associated with increased risk of GIB and non-CABG major bleeding when compared with clopidogrel.
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Background Data on tenofovir disoproxil fumarate (TDF) therapy for preventing vertical transmission of hepatitis B virus (HBV) in the real-world setting are limited. Aim To investigate TDF for preventing vertical transmission of HBV in real-world practice. Methods Hepatitis B e-antigen (HBeAg)-positive mothers with HBV-DNA >6 log(10) IU/mL to receive TDF between gestational weeks 24-33 and delivery were prospectively enrolled and followed until post-partum week 28. All infants received immunoprophylaxis. Primary endpoints were safety of TDF use and mother-to-child transmission rates. Secondary outcomes were maternal HBV-DNA level suppression (<200 000 IU/mL) at delivery and HBeAg and hepatitis B surface antigen (HBsAg) serologic changes during the study. Results Among 147 mothers enrolled, 143 started TDF and 143/144 infants completed the study. At delivery, 93.7% (134/143) of the mothers achieved HBV-DNA<200 000 IU/L. On-treatment, alanine aminotransferase (ALT) flares were observed in 8.4% (12/143) of mothers. After TDF cessation, ALT increased in 7.7% (11/143) of the mothers and 2.8% (4/143) achieved HBeAg negativity, but none had HBsAg loss. At birth, HBsAg was detected in 13.9% (20/144) of newborns and none at post-partum week 28. Vertical transmission rates among infants were 0.7% (1/144, intention-to-treat) and 0% (per-protocol). No infants had birth defects. No serious adverse effects were reported in either mothers or infants. Breastfeeding did not increase the HBV infection rate among infants although mothers had viral rebound after TDF cessation. Conclusions TDF for highly viraemic mothers was well tolerated and reduced vertical transmission of HBV in a real-world setting. There were no safety concerns during the postpartum 28-week follow-up. Registry number: Chinese Clinical Trial Registration No. ChiCTR-OIC-17010869
Background The Barcelona Clinic Liver Cancer (BCLC) staging system is the most widely used staging system for hepatocellular carcinoma (HCC). However, the classifications of early (BCLC-A) and intermediate (BCLC-B) stage HCC remain controversial. Aim To refine the staging of BCLC-A and -B. Methods A total of 986 patients with HCC undergoing liver resection from two institutions formed the training cohort, and 694 from another institution were the validation cohort. Time-dependent receiver operating characteristic (ROC) curve analysis was performed to evaluate the performance of tumour size in predicting overall survival (OS), and determined the optimised cut-off. Discriminatory performance was evaluated using Harrell's concordance index (C-index). Results Patients with multiple tumours exceeding Milan criteria but within up-to-seven criteria had similar OS and disease-free survival (DFS) to those with multiple tumours meeting Milan criteria, and were assigned to the modified BCLC-A stage. The area under the ROC curve of tumour size for predicting OS was 0.778, and the diameter of 7 cm was the optimal cut-off to identify patients with single tumours who had higher OS than BCLC-B stage patients. Due to the similar OS, patients with single HCCs >7 cm were assigned to the modified BCLC-B stage. The C-indexes of the modified BCLC classification for OS and DFS were higher compared to the original version. The findings were supported by the validation cohort. Conclusions The modified staging of BCLC-A and -B, based on single tumour >7 cm and multiple tumours beyond up-to-seven criteria, could be more accurate to predict the prognosis of HCC patients. Liver resection could benefit patients with resectable multifocal HCCs beyond the Milan criteria.
Background Faecal microbiota transplantation (FMT) is effective for Clostridium difficile infections (CDI) refractory to standard treatment and is being studied in other diseases. Aim To evaluate donor characteristics, procedures and clinical outcomes of FMT. Methods We systematically reviewed FMT studies published up to 29 August 2018 using MEDLINE (R) and EMBASE and identified clinical studies with FMT donor information. We reported data on donor characteristics, screening criteria, administration, clinical outcomes and adverse events. Results Among 5267 reports, 239 full-text articles were screened and 168 articles were included. FMT was performed commonly for CDI (n = 108) and inflammatory bowel disease (IBD) (n = 31). We reported characteristics of 1513 donors [58% male; mean age, 34.3 years; mean body mass index, 21.6]. Donors in Asia were younger than the West (mean age 30.7 vs 32.9, P = 0.00075). Less than 50% of studies screened donors for transmittable pathogens. Final cure rate for CDI was 95.6% (95% confidence interval [CI], 93.9%-97.1%) and final remission rates for ulcerative colitis (UC) and Crohn's disease (CD) were 39.6% (95% CI, 25.4%-54.6%) and 47.5% (95% CI, 29.4%-65.8%), respectively. Cure rates in CDI and final remission rates for CD and UC were comparable across all routes of FMT administration. Overall adverse event incidence was <1%, mostly GI-related. Adverse event rates did not differ significantly between routes of FMT administration or indication. Conclusions In a systematic review assessing donor characteristics and FMT efficacy, we observed heterogeneity in donor selection, application and outcomes of FMT. These data can facilitate standardisation of FMT protocols for various diseases.
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Background Owing to the importance of early treatment, simple and reliable methods for monitoring inflammatory bowel disease (IBD) are needed. Aims To determine whether circulating microRNAs are reliable biomarkers for IBD monitoring. Methods Serum levels of 17 candidate microRNAs were measured by quantitative real-time polymerase chain reaction in a discovery cohort (n = 120). Differentially expressed serum microRNAs were further investigated in an independent training cohort (n = 341). Correlations between relative microRNA levels and disease activity were evaluated. A disease control group was included to investigate the specificity of microRNA. Logistical regression was used to construct a microRNA classifier to identify endoscopic activity. Its predictive value was explored in the validation cohort (n = 66) using the area under the receiver operating characteristic curve (AUC). Results Serum microRNA146b-5p (miR-146b-5p) expression was 2.87- and 2.72-fold higher in patients with Crohn's disease and ulcerative colitis, respectively, than in healthy controls. Serum miR-146b-5p was significantly correlated with disease activity and was more specific than C-reactive protein (CRP). A classifier was built for Crohn's disease, ie P [Endoscopically active] = 11+e2.937-0.737(miR-146b-5p)-0.008PLT, with a greater AUC of 0.869 [0.764-0.940] than that for CRP (0.680 [0.554-0.790]) (P = 0.0043). Conclusions MiR-146b-5p may better reflect mucosal inflammation in IBD than CRP. The Crohn's disease classifier developed in this study may be valuable for identifying endoscopic activity in patients with Crohn's disease.
Background Neuromodulators are considered potential therapeutic options for refractory gastro-oesophageal reflux-induced chronic cough. Aim To compare the efficacy of gabapentin and baclofen in patients with suspected refractory gastro-oesophageal reflux-induced chronic cough. Methods Two hundred and thirty-four patients with suspected refractory gastro-oesophageal reflux-induced chronic cough, who failed an 8-week course of omeprazole and domperidone, were recruited into the open-labelled study and randomly assigned to receive either gabapentin (maximum daily dose of 900 mg) or baclofen (maximum daily dose of 60 mg) for 8 weeks as add-on therapy to the previous treatment. The primary end point was the successful rate of cough resolution; and the secondary end-points included cough sensitivity to capsaicin and gastro-oesophageal reflux disease questionnaire score and reported side effects. Results One hundred and eleven patients in the gabapentin group and 106 in the baclofen group completed the study. The overall success rate for cough resolution was comparable (57.3% vs 53.0%, chi(2) = 0.357, P = 0.550) between the two groups. In parallel, cough sensitivity to capsaicin and gastro-oesophageal reflux disease questionnaire score decreased after treatment with either gabapentin or baclofen. However, gabapentin was associated with less frequent somnolence (20.5% vs 35.0%, chi(2) = 6.156, P = 0.013) and dizziness (11.1% vs 23.9%, chi(2) = 6.654, P = 0.010) than baclofen. Conclusions Gabapentin and baclofen have similar therapeutic efficacy for suspected refractory gastro-oesophageal reflux-induced chronic cough. However, gabapentin may be preferable because of fewer side effects. Trial Register: ; No.: ChiCTR-ONC-13003066.
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