AIM To compare the effectiveness and safety of vonoprazan-based therapy with proton pump inhibitor(PPI)-based therapies to treat Helicobacter pylori(H. pylori).METHODS We retrospectively analysed data from first-line(...AIM To compare the effectiveness and safety of vonoprazan-based therapy with proton pump inhibitor(PPI)-based therapies to treat Helicobacter pylori(H. pylori).METHODS We retrospectively analysed data from first-line(vonoprazan or PPI with 200 mg clarithromycin and 750 mg amoxicillin twice daily for 7 d)(n = 1353) and second-line(vonoprazan or PPI with 250 mg metronidazole and 750 mg amoxicillin twice daily for 7 d)(n = 261) eradication treatments for H. pylori- positive patients with associated gastrointestinal diseases from April 2014 to December 2015 at Hattori Clinic, Japan. The primary endpoint was the eradication rate, which was assessed with a full analysis set. The secondary endpoints were adverse events and related factors.RESULTS After the first-line treatments, the eradication rates for vonoprazan, esomeprazol, rabeprazole, and lansoprazole were 87.9%(95%CI: 84.9%-90.5%), 71.6%(95%CI: 67.5%-75.5%), 62.9%(95%CI: 52.0%-72.9%), and 57.3%(95%CI: 50.4%-64.1%), respectively. The vonoprazan eradication rate was significantly higher than that of the PPIs(P < 0.01). Interestingly, smoking did not affect the H. pylori eradication rate in the vonoprazan group(P = 0.34), whereas it decreased the rates in the PPI groups(P = 0.013). The incidence of adverse events in the vonop-razan group was not different from the PPI group(P = 0.054), although the vonoprazan group exhibited a wider range of adverse events. Vonoprazan-based triple therapy was highly effective as a second-line treatment, with an eradication rate similar to that of PPI-based therapy.CONCLUSION Vonoprazan might be superior to PPIs in first-line H. pylori therapy, particularly for smokers. However, caution is required due to possible adverse events.展开更多
Oral nucleoside/nucleotide analogues(NAs) are currently the backbone of chronic hepatitis B(CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of pat...Oral nucleoside/nucleotide analogues(NAs) are currently the backbone of chronic hepatitis B(CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of patients have been treated with NAs. Safety data has accumulated over the years. The aim of this article is to review and update the adverse effects of oral NAs. NAs can cause class adverse effects(i.e., myopathy, neuropathy, lactic acidosis) and dissimilar adverse effects. All NAs carry a "Black Box" warning because of the potential risk for mitochondrial dysfunction. However, these adverse effects are rarely reported. The majority of cases are associated with lamivudine and telbivudine. Adefovir can lead to dose- and time-dependent nephrotoxicity, even at low doses. Tenofovir has significant renal and bone toxicity in patients with human immunodeficiency virus(HIV) infection. However, bone and renal toxicity in patients with CHB are not as prominent as in HIV infection. Entecavir and lamivudine are not generally associated with renal adverse events. Entecavir has been claimed to increase the risk of lactic acidosis in decompensated liver disease and high Model for End-Stage Liver Disease scores. However, current studies reported that entecavir could be safely used in decompensated cirrhosis. An increase in fetal adverse events has not been reported with lamivudine, telbivudine and tenofovir use in pregnant women, while there is no adequate data regarding entecavir and adefovir. Further long-term experience is required to highlight the adverse effects of NAs, especially in special patient populations, including pregnant women, elderly and patients with renal impairment.展开更多
AIM To evaluate the therapeutic effects of ursodeoxycholic acid(UDCA) on autoimmune hepatitis(AIH).METHODS A total 136 patients who were diagnosed with AIH were included in our study. All of the patients underwent a l...AIM To evaluate the therapeutic effects of ursodeoxycholic acid(UDCA) on autoimmune hepatitis(AIH).METHODS A total 136 patients who were diagnosed with AIH were included in our study. All of the patients underwent a liver biopsy, and had at least a probable diagnosis on the basis of either the revised scoring system or the simplified scores. Initial treatment included UDCA monotherapy(Group U, n = 48) and prednisolone(PSL) monotherapy(Group P, n = 88). Group U was further classified into two subgroups according to the effect of UDCA: Patients who had achieved remission induction with UDCA monotherapy and showed no sign of relapse(Subgroup U1, n = 34) and patients who additionally received PSL during follow-up(Subgroup U2, n = 14). We compared the clinical and histological findings between each groups, and investigated factorscontributing to the response to UDCA monotherapy.RESULTS In Group U, 34 patients(71%) achieved and maintained remission over 49(range: 8-90) mo(Subgroup U1) and 14 patients(29%) additionally received PSL(Subgroup U2) during follow-up. Two patients in Subgroup U2 achieved remission induction once but additionally required PSL administration because of relapse(15 and 35 mo after the start of treatment). The remaining 12 patients in Subgroup U2 failed to achieve remission induction during follow-up, and PSL was added during 7(range: 2-18) mo. Compared with Subgroup U2, Subgroup U1 had significantly lower alanine aminotransferase(ALT) levels at onset(124 IU/L vs 262 IU/L, P = 0.023) and a significantly higher proportion of patients with mild inflammation(A1) on histological examination(70.6% vs 35.7%, P = 0.025). When multivariate analysis was performed to identify factors contributing to the response to UDCA monotherapy, only a serum ALT level of 200 IU/L or lower was found to be associated with a significant difference(P = 0.013).CONCLUSION To prevent adverse events related to corticosteroids, UDCA monotherapy for AIH needs to be considered in patients with a serum ALT level of 200 IU/L or lower.展开更多
AIM To evaluate the efficacy of a newly developed dilator for endoscopic ultrasound(EUS)-guided drainage(ES Dilator).METHODS Fourteen consecutive patients who had undergone EUSguided choledochoduodenostomy(EUS-CDS) wi...AIM To evaluate the efficacy of a newly developed dilator for endoscopic ultrasound(EUS)-guided drainage(ES Dilator).METHODS Fourteen consecutive patients who had undergone EUSguided choledochoduodenostomy(EUS-CDS) with the ES Dilator were identified from a prospectively maintained database and enrolled in the study group.Fourteen other patients who had undergone EUS-CDS without the dilator just prior to its introduction were analyzed as the control group.A historical cohort study was carried out comparing the two groups.The main outcome measurement was the procedure time.The technical success rate and early AE rate were also compared between the two groups.RESULTS There were no significant differences in age,sex and etiology of biliary obstruction.The utilization rate of a plastic stent was higher in the control group(36% vs 0%).The technical success rate was 100% in both groups.The mean procedure time was significantly shorter in the study group than in the control group(27 ± 7 min vs 44 ± 26 min,P = 0.026).Additionally,there were no patients who required more than 40 min for the procedure in the study group.Early adverse events occurred in 29%(4/14) of the control group whereas none in the study group.The adverse events in all 4 patients was bile peritonitis,including pan-peritonitis in one patient.All patientsrecovered with conservative treatment by medication.CONCLUSION The newly developed dilator was found to be useful for shortening procedure time and would prevent adverse events related to bile leakage in EUS-CDS.展开更多
Gastroesophageal reflux is a common phenomenon in infants,but the differentiation between gastro-esophageal reflux and gastroesophageal reflux disease can be difficult.Symptoms are non-specific and there is increasing...Gastroesophageal reflux is a common phenomenon in infants,but the differentiation between gastro-esophageal reflux and gastroesophageal reflux disease can be difficult.Symptoms are non-specific and there is increasing evidence that the majority of symptoms may not be acid-related.Despite this,gastric acid inhibitors such as proton pump inhibitors are widely and increasingly used,often without objective evidence or investigations to guide treatment.Several studies have shown that these medications are ineffective at treating symptoms associated with reflux in the absence of endoscopically proven oesophagitis.With a lack of evidence for efficacy,attention is now being turned to the potential risks of gastric acid suppression.Previously assumed safety of these medications is being challenged with evidence of potential side effects including GI and respiratory infections,bacterial overgrowth,adverse bone health,food allergy and drug interactions.展开更多
AIM To evaluate the safety and efficacy of surgical left atrial appendage occlusion(s-LAAO) during concomitant cardiac surgery.METHODS We performed a comprehensive literature search through May 31 st 2018 for all elig...AIM To evaluate the safety and efficacy of surgical left atrial appendage occlusion(s-LAAO) during concomitant cardiac surgery.METHODS We performed a comprehensive literature search through May 31 st 2018 for all eligible studies comparing s-LAAO vs no occlusion in patients undergoing cardiac surgery. Clinical outcomes during follow-up included: embolic events, stroke, all-cause mortality, atrial fibrillation(AF), reoperation for bleeding and postoperative complications. We further stratified the analysis based on propensity matched studies and AF predominance.RESULTS Twelve studies(n = 40107) met the inclusion criteria.s-LAAO was associated with lower risk of embolic events(OR: 0.63, 95%CI: 0.53-0.76; P < 0.001) and stroke(OR: 0.68, 95%CI: 0.57-0.82; P < 0.0001).Stratified analysis demonstrated this association was more prominent in the AF predominant strata. There was no significant difference in the incidence risk of allcause mortality, AF, and reoperation for bleeding and postoperative complications.CONCLUSION Concomitant s-LAAO during cardiac surgery was associated with lower risk of follow-up thromboembolic events and stroke, especially in those with AF without significant increase in adverse events. Further randomized trials to evaluate long-term benefits of s-LAAO are warranted.展开更多
AIM To evaluate new therapies for hepatitis C virus(HCV), data about real-world outcomes are needed.METHODS Outcomes of 223 patients with genotype 1 HCV who started telaprevir-or boceprevir-based triple therapy(May 20...AIM To evaluate new therapies for hepatitis C virus(HCV), data about real-world outcomes are needed.METHODS Outcomes of 223 patients with genotype 1 HCV who started telaprevir-or boceprevir-based triple therapy(May 2011-March 2012) at the Mount Sinai Medical Center were analyzed. Human immunodeficiency viruspositive patients and patients who received a liver transplant were excluded. Factors associated with sustained virological response(SVR24) and relapse were analyzed by univariable and multivariable logistic regression as well as classification and regression trees. Fast virological response(FVR) was defined as undetectable HCV RNA at week-4(telaprevir) or week-8(boceprevir). RESULTS The median age was 57 years, 18% were black, 44% had advanced fibrosis/cirrhosis(FIB-4 ≥ 3.25). Only 42%(94/223) of patients achieved SVR24 on an intention-totreat basis. In a model that included platelets, SVR24 was associated with white race [odds ratio(OR) = 5.92, 95% confidence interval(CI): 2.34-14.96], HCV sub-genotype 1b(OR = 2.81, 95%CI: 1.45-5.44), platelet count(OR = 1.10, per x 104 cells/μL, 95%CI: 1.05-1.16), and IL28 B CC genotype(OR = 3.54, 95%CI: 1.19-10.53). Platelet counts > 135 x 103/μL were the strongest predictor of SVR by classification and regression tree. Relapse occurred in 25%(27/104) of patients with an end-oftreatment response and was associated with non-FVR(OR = 4.77, 95%CI: 1.68-13.56), HCV sub-genotype 1a(OR = 5.20; 95%CI: 1.40-18.97), and FIB-4 ≥ 3.25(OR = 2.77; 95%CI: 1.07-7.22). CONCLUSION The SVR rate was 42% with telaprevir-or boceprevirbased triple therapy in real-world practice. Low platelets and advanced fibrosis were associated with treatment failure and relapse.展开更多
文摘AIM To compare the effectiveness and safety of vonoprazan-based therapy with proton pump inhibitor(PPI)-based therapies to treat Helicobacter pylori(H. pylori).METHODS We retrospectively analysed data from first-line(vonoprazan or PPI with 200 mg clarithromycin and 750 mg amoxicillin twice daily for 7 d)(n = 1353) and second-line(vonoprazan or PPI with 250 mg metronidazole and 750 mg amoxicillin twice daily for 7 d)(n = 261) eradication treatments for H. pylori- positive patients with associated gastrointestinal diseases from April 2014 to December 2015 at Hattori Clinic, Japan. The primary endpoint was the eradication rate, which was assessed with a full analysis set. The secondary endpoints were adverse events and related factors.RESULTS After the first-line treatments, the eradication rates for vonoprazan, esomeprazol, rabeprazole, and lansoprazole were 87.9%(95%CI: 84.9%-90.5%), 71.6%(95%CI: 67.5%-75.5%), 62.9%(95%CI: 52.0%-72.9%), and 57.3%(95%CI: 50.4%-64.1%), respectively. The vonoprazan eradication rate was significantly higher than that of the PPIs(P < 0.01). Interestingly, smoking did not affect the H. pylori eradication rate in the vonoprazan group(P = 0.34), whereas it decreased the rates in the PPI groups(P = 0.013). The incidence of adverse events in the vonop-razan group was not different from the PPI group(P = 0.054), although the vonoprazan group exhibited a wider range of adverse events. Vonoprazan-based triple therapy was highly effective as a second-line treatment, with an eradication rate similar to that of PPI-based therapy.CONCLUSION Vonoprazan might be superior to PPIs in first-line H. pylori therapy, particularly for smokers. However, caution is required due to possible adverse events.
文摘Oral nucleoside/nucleotide analogues(NAs) are currently the backbone of chronic hepatitis B(CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of patients have been treated with NAs. Safety data has accumulated over the years. The aim of this article is to review and update the adverse effects of oral NAs. NAs can cause class adverse effects(i.e., myopathy, neuropathy, lactic acidosis) and dissimilar adverse effects. All NAs carry a "Black Box" warning because of the potential risk for mitochondrial dysfunction. However, these adverse effects are rarely reported. The majority of cases are associated with lamivudine and telbivudine. Adefovir can lead to dose- and time-dependent nephrotoxicity, even at low doses. Tenofovir has significant renal and bone toxicity in patients with human immunodeficiency virus(HIV) infection. However, bone and renal toxicity in patients with CHB are not as prominent as in HIV infection. Entecavir and lamivudine are not generally associated with renal adverse events. Entecavir has been claimed to increase the risk of lactic acidosis in decompensated liver disease and high Model for End-Stage Liver Disease scores. However, current studies reported that entecavir could be safely used in decompensated cirrhosis. An increase in fetal adverse events has not been reported with lamivudine, telbivudine and tenofovir use in pregnant women, while there is no adequate data regarding entecavir and adefovir. Further long-term experience is required to highlight the adverse effects of NAs, especially in special patient populations, including pregnant women, elderly and patients with renal impairment.
文摘AIM To evaluate the therapeutic effects of ursodeoxycholic acid(UDCA) on autoimmune hepatitis(AIH).METHODS A total 136 patients who were diagnosed with AIH were included in our study. All of the patients underwent a liver biopsy, and had at least a probable diagnosis on the basis of either the revised scoring system or the simplified scores. Initial treatment included UDCA monotherapy(Group U, n = 48) and prednisolone(PSL) monotherapy(Group P, n = 88). Group U was further classified into two subgroups according to the effect of UDCA: Patients who had achieved remission induction with UDCA monotherapy and showed no sign of relapse(Subgroup U1, n = 34) and patients who additionally received PSL during follow-up(Subgroup U2, n = 14). We compared the clinical and histological findings between each groups, and investigated factorscontributing to the response to UDCA monotherapy.RESULTS In Group U, 34 patients(71%) achieved and maintained remission over 49(range: 8-90) mo(Subgroup U1) and 14 patients(29%) additionally received PSL(Subgroup U2) during follow-up. Two patients in Subgroup U2 achieved remission induction once but additionally required PSL administration because of relapse(15 and 35 mo after the start of treatment). The remaining 12 patients in Subgroup U2 failed to achieve remission induction during follow-up, and PSL was added during 7(range: 2-18) mo. Compared with Subgroup U2, Subgroup U1 had significantly lower alanine aminotransferase(ALT) levels at onset(124 IU/L vs 262 IU/L, P = 0.023) and a significantly higher proportion of patients with mild inflammation(A1) on histological examination(70.6% vs 35.7%, P = 0.025). When multivariate analysis was performed to identify factors contributing to the response to UDCA monotherapy, only a serum ALT level of 200 IU/L or lower was found to be associated with a significant difference(P = 0.013).CONCLUSION To prevent adverse events related to corticosteroids, UDCA monotherapy for AIH needs to be considered in patients with a serum ALT level of 200 IU/L or lower.
文摘AIM To evaluate the efficacy of a newly developed dilator for endoscopic ultrasound(EUS)-guided drainage(ES Dilator).METHODS Fourteen consecutive patients who had undergone EUSguided choledochoduodenostomy(EUS-CDS) with the ES Dilator were identified from a prospectively maintained database and enrolled in the study group.Fourteen other patients who had undergone EUS-CDS without the dilator just prior to its introduction were analyzed as the control group.A historical cohort study was carried out comparing the two groups.The main outcome measurement was the procedure time.The technical success rate and early AE rate were also compared between the two groups.RESULTS There were no significant differences in age,sex and etiology of biliary obstruction.The utilization rate of a plastic stent was higher in the control group(36% vs 0%).The technical success rate was 100% in both groups.The mean procedure time was significantly shorter in the study group than in the control group(27 ± 7 min vs 44 ± 26 min,P = 0.026).Additionally,there were no patients who required more than 40 min for the procedure in the study group.Early adverse events occurred in 29%(4/14) of the control group whereas none in the study group.The adverse events in all 4 patients was bile peritonitis,including pan-peritonitis in one patient.All patientsrecovered with conservative treatment by medication.CONCLUSION The newly developed dilator was found to be useful for shortening procedure time and would prevent adverse events related to bile leakage in EUS-CDS.
文摘Gastroesophageal reflux is a common phenomenon in infants,but the differentiation between gastro-esophageal reflux and gastroesophageal reflux disease can be difficult.Symptoms are non-specific and there is increasing evidence that the majority of symptoms may not be acid-related.Despite this,gastric acid inhibitors such as proton pump inhibitors are widely and increasingly used,often without objective evidence or investigations to guide treatment.Several studies have shown that these medications are ineffective at treating symptoms associated with reflux in the absence of endoscopically proven oesophagitis.With a lack of evidence for efficacy,attention is now being turned to the potential risks of gastric acid suppression.Previously assumed safety of these medications is being challenged with evidence of potential side effects including GI and respiratory infections,bacterial overgrowth,adverse bone health,food allergy and drug interactions.
基金Supported by no external funding.Dr.Benditt is supported in part by a grant from the Dr.Earl E Bakken family in support of heart-brain research
文摘AIM To evaluate the safety and efficacy of surgical left atrial appendage occlusion(s-LAAO) during concomitant cardiac surgery.METHODS We performed a comprehensive literature search through May 31 st 2018 for all eligible studies comparing s-LAAO vs no occlusion in patients undergoing cardiac surgery. Clinical outcomes during follow-up included: embolic events, stroke, all-cause mortality, atrial fibrillation(AF), reoperation for bleeding and postoperative complications. We further stratified the analysis based on propensity matched studies and AF predominance.RESULTS Twelve studies(n = 40107) met the inclusion criteria.s-LAAO was associated with lower risk of embolic events(OR: 0.63, 95%CI: 0.53-0.76; P < 0.001) and stroke(OR: 0.68, 95%CI: 0.57-0.82; P < 0.0001).Stratified analysis demonstrated this association was more prominent in the AF predominant strata. There was no significant difference in the incidence risk of allcause mortality, AF, and reoperation for bleeding and postoperative complications.CONCLUSION Concomitant s-LAAO during cardiac surgery was associated with lower risk of follow-up thromboembolic events and stroke, especially in those with AF without significant increase in adverse events. Further randomized trials to evaluate long-term benefits of s-LAAO are warranted.
基金Supported by Janssen Scientific Affairs,LLC(partially)to Andrea D Branch to conduct the studyNational Institute of Health(NIH),Nos.DK090317 and DA031095(partially)to Andrea D Branch to conduct the study
文摘AIM To evaluate new therapies for hepatitis C virus(HCV), data about real-world outcomes are needed.METHODS Outcomes of 223 patients with genotype 1 HCV who started telaprevir-or boceprevir-based triple therapy(May 2011-March 2012) at the Mount Sinai Medical Center were analyzed. Human immunodeficiency viruspositive patients and patients who received a liver transplant were excluded. Factors associated with sustained virological response(SVR24) and relapse were analyzed by univariable and multivariable logistic regression as well as classification and regression trees. Fast virological response(FVR) was defined as undetectable HCV RNA at week-4(telaprevir) or week-8(boceprevir). RESULTS The median age was 57 years, 18% were black, 44% had advanced fibrosis/cirrhosis(FIB-4 ≥ 3.25). Only 42%(94/223) of patients achieved SVR24 on an intention-totreat basis. In a model that included platelets, SVR24 was associated with white race [odds ratio(OR) = 5.92, 95% confidence interval(CI): 2.34-14.96], HCV sub-genotype 1b(OR = 2.81, 95%CI: 1.45-5.44), platelet count(OR = 1.10, per x 104 cells/μL, 95%CI: 1.05-1.16), and IL28 B CC genotype(OR = 3.54, 95%CI: 1.19-10.53). Platelet counts > 135 x 103/μL were the strongest predictor of SVR by classification and regression tree. Relapse occurred in 25%(27/104) of patients with an end-oftreatment response and was associated with non-FVR(OR = 4.77, 95%CI: 1.68-13.56), HCV sub-genotype 1a(OR = 5.20; 95%CI: 1.40-18.97), and FIB-4 ≥ 3.25(OR = 2.77; 95%CI: 1.07-7.22). CONCLUSION The SVR rate was 42% with telaprevir-or boceprevirbased triple therapy in real-world practice. Low platelets and advanced fibrosis were associated with treatment failure and relapse.