COVID-19 vaccination is essential. However, no study has reported adverse events (AEs) after ChAdOx1 nCoV-19 vaccination in patients with end-stage renal disease (ESRD) on hemodialysis (HD). This ...study investigated the AEs within 30-days after the first dose of ChAdOx1 nCoV19 (Oxford-AstraZeneca) in ESRD patients on HD. A total of 270 ESRD patients on HD were enrolled in this study. To determine the significance of vascular access thrombosis (VAT) post vaccination, we performed a self-controlled case study (SCCS) analysis. Of these patients, 38.5% had local AEs; local pain (29.6%), tenderness (28.9%), and induration (15.6%) were the most common. Further, 62.2% had systemic AEs; fatigue (41.1%), feverishness (20%), and lethargy (19.9%) were the most common. In addition, post-vaccination thirst affected 18.9% of the participants with female predominance. Younger age, female sex, and diabetes mellitus were risk factors for AEs. Five patients had severe AEs, including fever (n = 1), herpes zoster (HZ) reactivation (n = 1), and acute VAT (n = 3). However, the SCCS analysis revealed no association between vaccination and VAT; the incidence rate ratio (IRR)-person ratio was 0.56 (95% CI 0.13-2.33) and 0.78 (95% CI 0.20-2.93) IRR-event ratio 0.78 (95% CI 0.15-4.10) and 1.00 (95% CI 0.20-4.93) in the 0-3 months and 3-6 months period prior to vaccination, respectively. Though some ESRD patients on HD had local and systemic AEs after first-dose vaccination, the clinical significance of these symptoms was minor. Our study confirmed the safety profile of ChAdOx1 nCoV-19 in HD patients and presented a new viewpoint on vaccine-related AEs. The SCCS analysis did not find an elevated risk of VAT at 1 month following vaccination. Apart from VAT, other vaccine-related AEs, irrespective of local or systemic symptoms, had minor clinical significance on safety issues. Nonetheless, further coordinated, multi-center, or registry-based studies are needed to establish the causality.
This study investigated the effect of melatonin on clinical outcomes in patients with coronavirus disease 2019 (COVID‐19). We searched PubMed, the Web of Science, the Cochrane Library, Ovid MEDLINE, ...and Clinicaltrials.gov for randomized controlled trials (RCTs) published before September 11, 2021. Only RCTs that compared the clinical efficacy of melatonin with a placebo in the treatment of patients with COVID‐19 were included. The primary outcome measure was the clinical recovery rate. We included three RCTs in this meta‐analysis. Melatonin 3 mg three times daily was administered in one RCT, and 3 or 6 mg daily before bedtime in the other two trials. Treatment duration was 14 days in two RCTs and 7 days in one trial. The clinical recovery rates were 94.2% (81/86) and 82.4% (70/85) in the melatonin and control groups, respectively. Overall, patients receiving melatonin had a higher clinical recovery rate than did the controls (odds ratio OR: 3.67; 95% CI: 1.21−11.12; I2 = 0%, p = 0.02). The risk of intensive care unit admission was numerically lower in the melatonin group than in the control group (8.3% 6/72 vs. 17.6% 12/68, OR: 0.45; 95% CI: 0.16−1.25; I2 = 0%, p = 0.13), and the risk of mortality was numerically lower in the melatonin group than in the control group (1.4% 1/72 vs. 4.4% 3/68, OR: 0.32; 95% CI: 0.03−3.18; I2 = 0%, p = 0.33). In conclusion, melatonin may help improve the clinical outcomes of patients with COVID‐19.
Highlight
This study investigated the effect of melatonin on clinical outcomes in patients with coronavirus disease 2019.
Patients receiving melatonin had a higher clinical recovery rate than did the controls (odds ratio: 3.67; 95% CI: 1.21−11.12; I2 = 0%, p = 0.02).
The risk of intensive care unit admission was only insignificantly lower in the melatonin group than in the control group.
The risk of mortality was insignificantly lower in the melatonin group than in the control group.
Background: To investigate all-cause and cause-specific mortality in Taiwanese patients with type 1 diabetes.Methods: A cohort of 17,203 patients with type 1 diabetes were identified from Taiwan’s ...National Health Insurance claims in the period of 1998–2014. Person-years were accumulated for each individual from date of type 1 diabetes registration to date of death or the last day of 2014. Age, sex, and calendar year standardized mortality ratios (SMRs) were calculated with reference to the general population.Results: In up to 17 years of follow-up, 4,916 patients died from 182,523 person-years. Diabetes (30.15%), cancer (20.48%), circulatory diseases (13.14%), and renal diseases (11.45%) were the leading underlying causes of death. Mortality rate (26.93 per 1,000 person-years) from type 1 diabetes in Taiwan was high, the cause of death with the highest mortality rate was diabetes (8.12 per 1,000 person-years), followed by cancer (5.52 per 1,000 person-years), and circulatory diseases (3.54 per 1,000 person-years). The all-cause SMR was significantly elevated at 4.16 (95% confidence interval, 4.04–4.28), with a greater all-cause SMR noted in females than in males (4.62 vs 3.79). The cause-specific SMR was highly elevated for diabetes (SMR, 16.45), followed by renal disease (SMR, 14.48), chronic hepatitis and liver cirrhosis (SMR, 4.91) and infection (SMR, 4.59). All-cause SMRs were also significantly increased for all ages, with the greatest figure noted for 15–24 years (SMR, 8.46).Conclusions: Type 1 diabetes in both genders and all ages was associated with significantly elevated SMRs for all-cause and mostly for diabetes per se and renal disease.
Background: We aimed to investigate associations between exposure to various trajectories of severe hypoglycemic events and risk of dementia in patients with type 2 diabetes.Methods: In 2002–2003, ...677,618 patients in Taiwan were newly diagnosed as having type 2 diabetes. Among them, 35,720 (5.3%) experienced severe hypoglycemic events during the 3-year baseline period following diagnosis. All patients were followed from the first day after baseline period to the date of dementia diagnosis, death, or the end of 2011. A group-based trajectory model was used to classify individuals with severe hypoglycemic events during the baseline period. Cox proportional hazard models with the competing risk method were used to relate dementia risk to various severe hypoglycemia trajectories.Results: After a median follow-up 6.70 and 6.10 years for patients with and without severe hypoglycemia at baseline, respectively, 1,952 (5.5%) individuals with severe hypoglycemia and 23,492 (3.7%) without developed dementia during follow-up, for incidence rates of 109.80 and 61.88 per 10,000 person-years, respectively. Four groups of severe hypoglycemia trajectory were identified with a proportion of 18.06%, 33.19%, 43.25%, and 5.50%, respectively, for Groups 1 to 4. Groups 3 (early manifestation but with later decrease) and 4 (early and sustained manifestation) were associated with a significantly increased risk of dementia diagnosis, with a covariate-adjusted subdistribution hazard ratio of 1.22 (95% confidence interval, 1.14–1.31) and 1.25 (95% confidence interval, 1.02–1.54), respectively.Conclusion: Our analysis highlighted that early manifestation of severe hypoglycemic events may contribute more than does late manifestation to the risk of dementia among individuals newly diagnosed as having type 2 diabetes.
Dementia increases the risk of death in older patients hospitalized for acute illnesses. However, the effect of dementia on the risks of developing acute organ dysfunction and severe sepsis as well ...as on the risk of hospital mortality in hospitalized older patients remains unknown, especially when treatments for these life-threatening situations are considered.
In this population-based cohort study, we analyzed 41,672 older (≥ 65 years) patients, including 3,487 (8.4%) with dementia, from the first-time admission claim data between 2005 and 2007 for a nationally representative sample of one million beneficiaries enrolled in the Taiwan National Health Insurance Research Database. Outcomes included acute organ dysfunction, severe sepsis, and hospital mortality. The effect of dementia on outcomes was assessed using multivariable logistic regression.
Dementia was associated with a 32% higher risk of acute organ dysfunction (adjusted odds ratio aOR 1.32, 95% confidence interval CI 1.19-1.46), a 50% higher risk of severe sepsis (aOR 1.50, 95% CI 1.32-1.69) and a 28% higher risk of hospital mortality (aOR 1.28, 95% CI 1.10-1.48) after controlling age, sex, surgical condition, comorbidity, principal diagnosis, infection status, hospital level, and length of hospital stay. However, the significant adverse effect of dementia on hospital mortality disappeared when life-support treatments, including vasopressor use, hemodialysis, mechanical ventilation, and intensive care, were also controlled.
In hospitalized older patients, the presence of dementia increased the risks of acute organ dysfunction, severe sepsis and hospital mortality. However, after intervention using life-support treatments, dementia only exhibited a minor role on short-term mortality.
Alpha-lipoic acid, epalrestat, and mecobalamin are widely used as monotherapies for diabetic peripheral neuropathy. However, whether a triple-combination therapy with these three drugs is superior to ...monotherapy or dual therapy remains debatable.
Nine randomized controlled trials were identified through a search on electronic databases such as PubMed, Web of Science, and Cochrane Library. The trial participants (N = 1153) were divided into the experimental group who received the triple-combination therapy and the control group who received conventional or dual therapy with the aforementioned drugs.
Therapeutic outcomes were better in the experimental group than in the control group (odds ratio: 3.74; 95 % confidence interval: 2.57–5.45; I2 = 0 %; p < 0.00001). No statistic difference was noted in adverse effects. Compared with the control group, the experimental group exhibited significant improvements in median motor nerve conduction velocity (MNCV), sensory nerve conduction velocity (SNCV), peroneal MNCV, peroneal SNCV, and vibration perception thresholds (VPT) in the left and right lower limbs. In the control group, a subgroup analysis by treatment strategy revealed similar improvements in total efficacy, MNCV, and SNCV.
For diabetic peripheral neuropathy, the triple-combination therapy may be more effective than monotherapy or dual therapy.
•DPN is the most common complication of DM.•ALA + MC + epalrestat might be an effective and safety treatment procedure.
Objective
To assess the trend in prevalence and socioeconomic correlates of diabetes in pregnancy (DIP) in Taiwan from 2007 to 2014.
Methods
In all, 1 606 344 pregnancies, including 199 383 DIP (1693 ...with pre‐pregnancy type 1 diabetes T1DM, 17 171 with pre‐pregnancy type 2 diabetes T2DM, and 180 519 with gestational diabetes mellitus GDM) were investigated. Logistic regression models were performed to identify the covariates significantly associating with DIP.
Results
Over the study period, the prevalence of pre‐pregnancy T2DM increased by 568.44%; the prevalence of T1DM and GDM also increased but with a smaller magnitude. However, only the prevalence of pre‐pregnancy T2DM showed an increase after socioeconomic variables were considered. Compared with immigrant mothers, native‐born mothers had a significantly higher adjusted odds ratio of DIP, particularly pre‐pregnancy T1DM (3.33, 95% confidence interval 1.57–7.05). Additionally, indigenous mothers and those from rural areas had a higher prevalence of pre‐pregnancy T2DM but lower prevalence of GDM. Lower maternal education and income were associated with higher prevalence of pre‐pregnancy T1DM but lower prevalence of pre‐pregnancy T2DM and GDM.
Conclusion
Socioeconomic variables largely accounted for the increased secular trend in pre‐pregnancy T1DM and GDM, but the prevalence of pre‐pregnancy T2DM still doubled, which was independent of socioeconomic covariates.
Synopsis
Diabetes in pregnancy, particularly pre‐pregnancy type 2 diabetes, has been increasing in Taiwan, and it shows obvious socioeconomic inequality and urban–rural disparity.
Albuminuria is a well-known predictor of chronic kidney disease in patients with type 2 diabetes mellitus (DM). However, proteinuria is associated with chronic complications in patients without ...albuminuria. In this retrospective cohort study, we explored whether non-albumin proteinuria is associated with all-cause mortality and compared the effects of non-albumin proteinuria on all-cause mortality between patients with and without albuminuria. We retrospectively collected data from patients with type 2 DM for whom we had obtained measurements of both urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR) from the same spot urine specimen. Urinary non-albumin protein-creatinine ratio (UNAPCR) was defined as UPCR-UACR. Of the 1809 enrolled subjects, 695 (38.4%) patients died over a median follow-up of 6.4 years. The cohort was separated into four subgroups according to UACR (30 mg/g) and UNAPCR (120 mg/g) to examine whether these indices are associated with all-cause mortality. Compared with the low UACR and low UNAPCR subgroup as the reference group, multivariable Cox regression analyses indicated no significant difference in mortality in the high UACR and low UNAPCR subgroup (hazard ratio HR 1.189, 95% confidence interval CI 0.889-1.589, P = 0.243), but mortality risks were significantly higher in the low UACR and high UNAPCR subgroup (HR 2.204, 95% CI 1.448-3.356, P < 0.001) and in the high UACR with high UNAPCR subgroup (HR 1.796, 95% CI 1.451-2.221, P < 0.001). In the multivariable Cox regression model with inclusion of both UACR and UNAPCR, UNAPCR ≥ 120 mg/g was significantly associated with an increased mortality risk (HR 1.655, 95% CI 1.324-2.070, P < 0.001), but UACR ≥ 30 mg/g was not significantly associated with mortality risk (HR 1.046, 95% CI 0.820-1.334, P = 0.717). In conclusion, UNAPCR is an independent predictor of all-cause mortality in patients with type 2 DM.
Background Intertwined association between infectious gastroenteritis (IGE) and inflammatory bowel disease (IBD) has not been investigated clearly. We aimed to examine the bidirectional association ...between IGE and IBD. Methods A bidirectional study using the Taiwan National Health Insurance Research Database was designed. Through a case-control design, we identified 2899 new IBD cases during 2006-2017 and matched to 28,990 non-IBD controls. We used conditional logistic regression model to estimate odds ratios (OR) of IBD for previous IGE in different exposure time-windows within 5-years before IBD diagnosis and Poisson regression model to estimate incidence rate ratio (IRR) of subsequent IGE for IBD group to non-IBD group. Results The mean age at the initial IBD diagnosis was 41 years. More IBD patients (21.49%) than controls (12.60%) had been exposed to IGE during > 6 months to 5 years before IBD diagnosis, the OR of IBD for IGE was 1.89 95% confidence interval: 1.69-2.11. Excess OR decreased as IGE exposure time before the index date increased. More IGE episodes were associated with additional increase in IBD risk (OR: 1.64, 2.19, 2.57, 3.50, and 4.57 in patients with 1, 2, 3, 4, and greater than or equal to 5 IGE episodes, respectively). The IRR of having IGE for IBD group to non-IBD group was 2.42 before IBD diagnosis and increased to 5.74 after IBD diagnosis. Conclusions These findings suggested an IGE-IBD bidirectional association. More attention is needed for physicians to develop preventive strategies and be aware of the higher risk of subsequent IGE in IBD patients. Keywords: Inflammatory bowel disease, Ulcerative colitis, Crohn's disease, Infectious gastroenteritis, Bidirectional association, Epidemiology
This meta-analysis aimed to assess the usefulness of colchicine in patients with COVID-19.
PubMed, Web of Science, Ovid MEDLINE, the Cochrane Library, Embase, and Clinicaltrials.gov were searched for ...relevant randomised controlled trials (RCTs) published between database inception and November 12, 2021. Only RCTs that compared the clinical efficacy and safety of colchicine with other alternative treatments or placebos in patients with COVID-19 were included.
Overall, 7 RCTs involving 16,024 patients were included; 7,794 patients were in the study group receiving colchicine and 8,230 were in the control group receiving placebo or standard treatment. The study and control groups had similar risk of mortality (odds ratio OR, 1.00; 95% CI, 0.91-1.09; I
2
= 0%). No significant difference was observed between the study and control groups in terms of the need for non-invasive ventilation (OR, 0.92; 95% CI, 0.83-1.03; I
2
= 0%), the need for mechanical ventilation (OR, 0.64; 95% CI, 0.32-1.32; I
2
= 58%), and length of hospital stay (mean difference, −0.42 days; 95% CI, −1.95 to 1.11; I
2
= 62%). In addition, colchicine was associated with significantly higher risks of gastrointestinal adverse events (OR, 1.81; 95% CI, 1.56-2.11; I
2
= 0%) and diarrhoea (OR, 2.12; 95% CI, 1.75-2.56; I
2
= 9%).
Colchicine does not improve clinical outcomes in patients with COVID-19, so it did not support the additional use of colchicine in the treatment of patients with COVID-19.
Key message
Colchicine could not reduce the mortality of patients with COVID-19.
No significant difference was observed between the colchicine and comparators in terms of the need for non-invasive ventilation, need for mechanical ventilation, and length of hospital stay.
Colchicine was associated with a higher risk of gastrointestinal adverse events.
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