Comparison of early versus late addition of granulocyte and monocyte adsorption for incomplete remission induction in ulcerative colitis.

Background and aim: Ulcerative colitis (UC) is characterized by repeated relapse and remission. Because no fundamental therapeutic strategy has been established, the treatment goal is generally to maintain the remission phase for a long period after rapid remission induction. Granulocyte and monocyte adsorption (GMA) for UC is reportedly quite safe because it does not affect immunosuppression. Moreover, it is useful in combination with other remission induction therapy. The aim of this study was to evaluate the difference in efficacy by the timing of the addition of GMA with corticosteroids, calcineurin inhibitors, and anti-cytokine therapy for active UC. Methods: The study included 59 patients. Patients who started GMA of 5-11 days were in the early GMA combination group. Patients who started GMA 12 days or more were in the late GMA combination group. The primary endpoint was difference in the effect of additional GMA according to the timing of the intervention. The secondary endpoint was difference in the time to remission induction between the two groups. Results: Of the 32 early GMA group patients, 24 achieved remission induction. Of the 27 late group patients, 18 achieved remission induction. No significant difference in induction rates was found (P = 0.481). The early group had shorter mean time to remission induction (P < 0.001). Conclusions: In conclusion, results suggest that early addition of GMA might lead to earlier remission in patients who have had an inadequate response to remission induction therapy with corticosteroids, calcineurin inhibitors, and anti-cytokine therapy.

Effect of the COVID-19 pandemic on Vogt-Koyanagi-Harada disease.

To determine the disease prevalence rate and clinical characteristics of Vogt-Koyanagi-Harada (VKH) disease among new patients before and after the declaration of a state of emergency (April 7, 2020) in Japan. New patients and patients with newly diagnosed VKH disease were categorized into "Before" and "After" groups based on the initial visit. The prevalence rate, sex ratio, and age of patients newly diagnosed with VKH were compared between the groups. Best-corrected visual acuity (BCVA) and recurrence rates were compared among 59 patients observed for > 12 months after receiving pulse steroid therapy. For reference, we also examined the prevalence rate of patients newly diagnosed with acute angle closure (AAC) in the Before and After groups. The prevalence rates of VKH disease among newly diagnosed patients (P < 0.05) or patients with AAC (P < 0.001) were significantly higher in the After group. No significant differences in sex ratio or age of VKH disease were observed in both groups. BCVA and recurrence rates showed no significant differences. The COVID-19 pandemic increased the prevalence of VKH disease among new patients compared with that of AAC. However, the clinical features of VKH disease were unlikely affected by the COVID-19 pandemic.

Clinical significance of a basophil activation test for Japanese beekeepers naturally sensitized to honey bee venom.

BACKGROUND: The basophil activation test (BAT) has high sensitivity and specificity for diagnosing Hymenoptera venom allergy and is useful for predicting the clinical sensitivity of bee venom-allergic patients after venom immunotherapy. Patients sensitized to Hymenoptera venom are at risk for systemic reactions (SRs) to subsequent stings. Therefore, a tool that can predict the occurrence of SRs and the severity of Hymenoptera stings is needed. OBJECTIVE: We performed BATs on Japanese beekeepers naturally sensitized to honey bee venom (HBV) and analyzed the positive threshold concentration for the occurrence of SRs following honey bee stings (HBS). METHODS: Sixty-one beekeepers were interviewed and blood samples were taken. Data including history of HBS and the occurrence and severity of SRs to HBS were recorded. Blood samples were exposed to HBV-specific IgE antibodies (sIgE) and BAT was performed. Participants with HBV-sIgE ≥ class 1 were considered sensitized to HBV. The positive threshold for BAT scored as 0.0001, 0.001, 0.01, 0.1, and 1 µg/ml was classified as classes 5, 4, 3, 2, and 1, respectively. Samples negative at 1 µg/ml were classified as class 0. RESULTS: About 40% of beekeepers with a positive BAT threshold ≤ 0.1 µg/ml had SRs after HBS. The mean score of the BAT positivity threshold for beekeepers who developed SRs was significantly lower than that for beekeepers with no history of SRs (2.6 ± 0.8 vs 1.4 ± 1.1, P < 0.01). CONCLUSION: Analysis of the positive threshold of BAT in Japanese beekeepers naturally sensitized to HBV may be a useful tool for predicting the occurrence of SRs.

Comparison of BMI changes in Japanese adults receiving face-to-face versus online counseling for specific health guidance: a noninferiority prospective observational study.

OBJECTIVES: This study aimed to evaluate the noninferiority of online counseling over face-to-face counseling for specific health guidance (SHG). METHODS: This prospective observational study was conducted using specific health checkup (SHC) and SHG data of individuals with health insurance in Japan. We analyzed data from 1431 participants who met the inclusion criteria, including those who underwent online or face-to-face counseling between April 1, 2020 and March 31, 2021, and received an SHC in the following year but no earlier than 90 days after their first counseling session. Assessed variables comprised demographics, counseling methods, and SHC results, including baseline questionnaire findings and body mass index (BMI) at follow-up. We performed inverse probability of treatment weighting (IPTW) using propensity scores, with changes in BMI as the objective variable and the counseling method as the explanatory variable. We set the noninferiority margin to 0.175, based on a previous study. RESULTS: The online and face-to-face counseling groups comprised 455 (31.8%) and 976 (68.2%) participants, respectively. The number of men and mean age were 214 (47.0%) and 49.9 years (SD: 6.9 years), respectively, in the online counseling group, and 491 (50.3%) and 51.1 years (SD: 7.6 years), respectively, in the face-to-face counseling group. IPTW using propensity scores revealed a regression coefficient of -0.014 (95% CI: -0.157 to 0.129) for the online group compared with the face-to-face group (P = .847). The CI was within the noninferiority margin. CONCLUSIONS: The effects of online counseling on BMI are likely noninferior to those of face-to-face counseling.

Associations between the burdens of comorbid sleep problems, central sensitization, and headache-related disability in patients with migraine.

Objective: Sleep disturbances are common in migraine patients and affect quality of life. Central sensitization (CS) is likely to play a role in the increased severity and chronicity of migraine. We hypothesized that the number of comorbid sleep problems would affect headache-related disability through the effects of central sensitization (CS). Methods: We performed a cross-sectional study including 215 consecutive patients with migraine. Insomnia was defined as a Pittsburgh Sleep Quality Index (PSQI) global score greater than 5. Probable REM sleep behavior disorder (pRBD) was defined as an RBD screening score of 5 or greater. Excessive daytime sleepiness (EDS) was defined as an Epworth Sleepiness Scale score of 10 or higher. Suspected sleep apnea (SA) was defined as patients with snoring or sleep apnea witnessed 3 or more nights a week. CS was assessed by the Central Sensitization Inventory (CSI). Results: Restless legs syndrome, insomnia, EDS, SA and pRBD were observed in 25.6%, 71.6%, 34.4%, 10.2%, and 21.4%, respectively, of the patients. At least one sleep problem was present in 87.0% of the patients. According to the results of the multinomial logistic regression analysis with no sleep problems as a reference, after we corrected for adjustment factors, the Migraine Disability Assessment (MIDAS) score significantly increased when three or more comorbid sleep problems were present. According to our mediation analysis, an increased number of sleep problems had a direct effect on the MIDAS score after we adjusted for other variables, and the CSI score was indirectly involved in this association. Conclusion: The present study showed an association between migraine-related disability and the burden of multiple sleep problems, which was partially mediated by CS.

Real-world effectiveness of erenumab in Japanese patients with migraine.

Background: Real-world evidence of erenumab effectiveness in migraine patients in Asia with various comorbidities and multiple previous medication failures is still limited. Methods: A 6-month single-center cohort study of 45 patients with episodic or chronic migraine (CM) treated with erenumab was conducted. In the cohort, 60.0% were switching from other calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs), and 66.7% had ≥4 prophylaxis failures. The change in monthly migraine days (MMDs) from baseline and percentages of responders after treatment were calculated. Weekly migraine days (WMDs) were obtained at baseline and at months 1, 2 and 3 and were compared between weeks 2 and 4. Results: In total, 36%, 47%, and 63% of patients had a ≥30% response at 1, 3, and 6 months, respectively. The cumulative percentage of patients achieving a ≥30% response over 6 months was 85%. Early responders (average ≥ 30% response at 1-3 months) accounted for 37.8%, 55.6%, and 25.9% of the total, CGRP mAb-naïve, and CGRP mAb-switching groups, respectively. Late responders (average < 30% response at 1-3 months and average ≥ 30% response at 4-6 months) accounted for 46.4%, 37.5%, and 58.8% of nonearly responders in the total, CGRP mAb-naïve, and CGRP mAb-switching groups, respectively. Mild adverse reactions were observed in 5 patients (11.1%). Wearing-off, defined as an increase in the number of WMDs ≥2 between week 2 and week 4, was observed in 2.4-12.5% at months 1-3. Conclusion: Erenumab was effective in migraine patients. At least 4-6 months may be preferable for efficacy evaluation in patients switching to erenumab from other CGRP mAbs.

The COVID-19 pandemic affects pregnancy complications and delivery outcomes in Japan: a large-scale nationwide population-based longitudinal study.

The impact of the coronavirus disease 2019 (COVID-19) pandemic on pregnancy outcomes in Japan at the national level is unclear. This study aimed to assess the impact of the pandemic on pregnancy complications and delivery outcomes in Japan using nationwide population-based longitudinal data. Secondary data from the Japan Society of Obstetrics and Gynecology from 2016 to 2020 were analyzed. Obstetric information, pregnancy complications, and delivery information of pregnant women over 22 weeks of gestation were compared before and during the pandemic. The trends of hypertensive disorder of pregnancy, fetal growth restriction, and APGAR < 7 increased, whereas those of preterm birth and low birth weight decreased during the COVID-19 pandemic. Pregnancy complications and delivery outcomes have worsened during the COVID-19 pandemic in Japan. Social changes caused by unprecedented situations may have massively influenced pregnancy in several ways. Our findings suggest that even in mild lockdowns like those in Japan, the introduction of social fear during the pandemic might negatively impact pregnancy outcomes.

Association between neuromuscular blocking agent use and outcomes among out-of-hospital cardiac arrest patients treated with extracorporeal cardiopulmonary resuscitation and target temperature management: A secondary analysis of the SAVE-J II study.

Background: Neuromuscular blocking agents are used to control shivering in cardiac arrest patients treated with target temperature management. However, their effect on outcomes in patients treated with extracorporeal cardiopulmonary resuscitation is unclear. Methods: This study was a secondary analysis of the SAVE-J II study, a retrospective multicenter study of 2175 out-of-hospital cardiac arrest patients treated with extracorporeal cardiopulmonary resuscitation in Japan. We classified patients into those who received neuromuscular blocking agents and those who did not and compared in-hospital mortality and incidence rates of favorable neurological outcome and in-hospital pneumonia between the groups using multivariable regression models and stabilized inverse probability weighting with propensity scores. Results: Six hundred sixty patients from the SAVE-J II registry were analyzed. Neuromuscular blocking agents were used in 451 patients (68.3%). After adjusting for potential confounders, neuromuscular blocking agents use was not significantly associated with in-hospital mortality (aHR 0.88; 95% CI, 0.67-1.14), favorable neurological outcome (aOR 0.85; 95% CI, 0.60-1.11), or pneumonia (aOR 1.52; 95% CI, 0.85-2.71). The results for in-hospital mortality (aHR 0.89; 95% CI, 0.64-1.25), favorable neurological outcome (aOR 0.94; 95% CI, 0.59-1.48) and pneumonia (aOR 1.59; 95% CI, 0.74-3.41) were similar after weighting was performed. Conclusions: Although data on the rationale for using neuromuscular blocking agents were unavailable, their use was not significantly associated with outcomes in out-of-hospital cardiac arrest patients treated with extracorporeal cardiopulmonary resuscitation and targeted temperature management. Neuromuscular blocking agents should be used based on individual clinical indications.

Real-world experience with monthly and quarterly dosing of fremanezumab for the treatment of patients with migraine in Japan.

Background: The effectiveness of fremanezumab in treating migraine has been demonstrated in randomized controlled trials. However, real-world study results are still limited. Methods: We conducted a single-center, observational study that included patients with episodic migraine (EM) and chronic migraine (CM) who received fremanezumab monthly or quarterly over 6-month periods. The primary outcome of this study was to evaluate changes in monthly migraine days (MMD) and responder achievement after treatment with fremanezumab. The secondary aim was to characterize the predictors of responder at 6 months. We also evaluated the effectiveness of fremanezumab in the patients who switched from other calcitonin gene-related peptide (CGRP) monoclonal antibodies, and compared the effectiveness of fremanezumab between the monthly and quarterly dosing groups. One hundred twenty-seven patients with migraine (age, 45.2 ± 12.6 years; 96 women) who received at least one dose of fremanezumab with ≥3 months of follow-up were included. The number of MMD was assessed by headache diary. Results: The changes in MMD from baseline at 1, 3, and 6 months were -6.1 ± 4.7, -7.7 ± 4.4, and - 8.5 ± 4.5 days in the total cohort, respectively (p < 0.001). The ≥50%, ≥ 75 and 100% responder rates at 6 months were 67.6, 22.5, and 5.4% in the total cohort, 90.4, 36.5, and 9.6% in the EM group, and 52.2, 14.9, and 1.5% in the CM group, respectively. Fremanezumab was also effective in 35 patients who switched from other CGRP monoclonal antibodies. Quarterly and monthly fremanezumab doses were equally effective in MMD reduction in the EM and CM groups. In the CM group, 65.1% experienced remission to EM after 6 months. Adverse reactions were mild and occurred in 9.5% of total patients. An at least ≥50% reduction in MMD from months 1 to 3 better predicted a ≥ 50% reduction in MMD at 6 months with 90.5% sensitivity and 80.6% specificity (p < 0.001). Conclusion: In our real-world study, quarterly and monthly fremanezumab dosing showed both favorable effectiveness and tolerability in patients with migraine.

Could efficacy at 1 week after galcanezumab administration for patients with migraine predict responders at 3 months? A real world study.

BACKGROUND: In real-world studies, it is unclear whether galcanezumab has a significant effect in the first week after administration. METHODS: We retrospectively assessed 55 high-frequency episodic migraine (HFEM) and chronic migraine patients who received three galcanezumab doses. Mean changes in the numbers of weekly migraine days (WMDs) during month 1 and migraine days per month (MMDs) after 1-3 months of treatment were obtained. Clinical factors related to a ≥ 50% response rate (RR) at month 3 were analyzed. The prediction of ≥ 50% responders at month 3 using different weekly RRs at week 1 (W1) was evaluated. The RR at W1 was calculated with the following formula: RR (%) = 100 - [(WMDs at W1/baseline WMD) × 100]. RESULTS: The number of MMDs significantly improved from baseline to 1, 2 and 3 months. The ≥ 50% RR was 50.9% at 3 months. The number of WMDs decreased significantly from baseline to week 1 (- 1.6 ± 1.7 days), week 2 (- 1.2 ± 1.6 days), week 3 (- 1.0 ± 1.3 days), and week 4 (- 1.1 ± 1.6 days) during month 1. The RR at W1 was largest (44.6 ± 42.2%). The ≥ 30%, ≥ 50% and ≥ 75% RRs at W1 were significantly predictive of a ≥ 50% RR at 3 months. Logistic regression analysis predicting a ≥ 50% RR at month 3 showed that the RR at W1 was the sole contributing factor. CONCLUSION: In our study, galcanezumab showed a significant effect in the first week after administration, and the RR at W1 could predict the RR at 3 months.

Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan.

BACKGROUND: Real-world data on the effectiveness of calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) in migraine patients are needed. METHODS: We performed a single-center, real-world study with an observation period of up to 12 months (mean 7.5 ± 3.4 months) after CGRP mAb administration. A total of 228 Japanese patients with episodic or chronic migraine (age, 45.9 ± 13.2 years; 184F; 45 erenumab; 60 galcanezumab; 123 fremanezumab) who were treated with CGRP mAbs for at least three months were ultimately included in this study. RESULTS: In the total cohort, after CGRP mAb treatment, mean monthly migraine days decreased by 7.2 ± 4.8, 8.3 ± 4.7, and 9.5 ± 5.0 at three, six and 12 months, respectively. The ≥50% monthly migraine day reduction rates at three, six and 12 months were 48.2%, 61.0% and 73.7%, respectively. In the logistic regression analysis, the presence of osmophobia and fewer baseline monthly migraine days contributed to ≥50% responders at three, six and 12 months. The ≥50% responders at three or six months were useful in predicting ≥50% responders at 12 months. In subgroups of patients with difficult-to-treat migraine (those with medication overuse headache or psychiatric comorbidities) and previous CGRP mAb users, monthly migraine days were substantially reduced over 12 months. There was no difference in monthly migraine day reduction over 12 months among three different CGRP mAbs. Adverse reactions were observed in 28 (12.3%) patients, with injection site reactions being the most common (n = 22) though generally mild in severity. CONCLUSION: This real-world study confirmed the efficacy and safety of three different CGRP mAbs for prophylactic treatment of patients with migraine.

The Factors Influencing Pregnant Women's Selection of Media Sources to Obtain Information on COVID-19 in Japan in 2021.

Pregnant women presumably gather information about the coronavirus disease 2019 (COVID-19) from various sources. However, it is difficult for pregnant women who are not medical professionals to source the appropriate information because of the infodemic related to the COVID-19 pandemic. Therefore, the objective of our study was to investigate how pregnant women gathered information about COVID-19 and COVID-19 vaccination. To address this issue, we conducted an online questionnaire survey between 5 October and 22 November 2021, which was approved by the Ethics Committee of Nihon University School of Medicine. We received 4962 responses after excluding 1179 insufficient answers. Our study found that age, occupation, and infection-risk anxiety influenced the selection of media for obtaining information. Pregnant women who were older, medical professionals, public servants, or educators tended to rely on specialized medical websites, whereas housewives tended to use mass media, social media, and sources with uncertain scientific evidence. Additionally, the number of weeks of gestation and the method of conception (natural or assisted reproductive conception) affected the selection of media. The accessibility of COVID-19 information for pregnant women was determined by their social background and pregnancy status. We need to continue making efforts to ensure that appropriate information is readily available to pregnant women and their families.

Comparison of Three Diagnostic Definitions of Metabolic Syndrome and Estimation of Its Prevalence in Mongolia.

We sought to estimate the prevalence of metabolic syndrome (MS) in the urban population of Mongolia and suggest a preferred definition. This cross-sectional study comprised 2076 representative samples, which were randomly selected to provide blood samples. MS was defined by the National Cholesterol Education Program's Adults Treatment Panel III (NCEP ATP III), the International Diabetes Federation (IDF), and the Joint Interim Statement (JIS). The Cohen's kappa coefficient (κ) was analyzed to determine the agreement between the individual MS components using the three definitions. The prevalence of MS in the 2076 samples was 19.4% by NCEP ATP III, 23.6% by IDF, and 25.4% by JIS criteria. For men, moderate agreement was found between the NCEP ATP III and waist circumference (WC) (κ = 0.42), and between the JIS and fasting blood glucose (FBG) (κ = 0.44) and triglycerides (TG) (κ = 0.46). For women, moderate agreement was found between the NCEP ATP III and high-density lipoprotein cholesterol (HDL-C) (κ = 0.43), and between the JIS and HDL-C (κ = 0.43). MS is highly prevalent in the Mongolian urban population. The JIS definition is recommended as the provisional definition.

Natural History of Small Gastric Subepithelial Lesions Less than 20 mm: A Multicenter Retrospective Observational Study (NUTSHELL20 Study).

BACKGROUND AND AIM: Small gastric subepithelial lesions (SELs) are sometimes encountered in daily esophagogastroduodenoscopy (EGD) practice, but whether once-annual or twice-annual endoscopy can provide sufficient follow-up remains unclear. Because follow-up based on small-SEL characteristics is important, this study clarified the natural history of gastric SELs less than 20 mm. METHODS: This retrospective multicenter observation study conducted at 24 Japanese hospitals during April 2000 to March 2020 examined small gastric SELs of ≤20 mm diameter. The primary outcome was the rate of size increase of those SELs detected using EGD, with growth times assessed irrespective of SEL pathological diagnoses. RESULTS: We examined 824 cases with tumors of 1-5 mm diameter in 298 (36.2%) cases, 6-10 mm in 344 (41.7%) cases, 11-15 mm in 112 (13.6%) cases, and 16-20 mm in 70 (8.50%) cases. An increase of small gastric SELs was observed in 70/824 patients (8.5%). The SELs larger than 6 mm increased, even after 10 years. No-change and increasing groups had no significantly different malignant findings at diagnosis. In cases of gastrointestinal stromal tumors (GISTs), internal cystic change in endoscopic ultrasound (EUS) is a risk factor for an increased tumor size. The predictive tumor growth cutoff size at initial diagnosis was 13.5 mm. CONCLUSIONS: Small gastric SELs less than 20 mm have an approximately 8.5% chance of increase. Predictive markers for GIST growth are tumor size ≥13.5 mm and internal cystic change in EUS.

Usefulness of Adding Maspin Staining to p53 Staining for EUS-FNA Specimens of Pancreatic Ductal Adenocarcinoma.

Background: Endoscopic ultrasound-guided puncture aspiration biopsy (EUS-FNA) of pancreatic ductal adenocarcinoma (PDAC) is highly diagnostic, but it is difficult to distinguish from benign disease. Our objective was to determine the usefulness of maspin staining, in addition to conventional p53 staining, in the diagnosis of PDAC by EUS-FNA. Methods: Of the patients who underwent EUS-FNA and were diagnosed with PDAC, we retrospectively identified 90 cases in which both maspin and p53 staining were performed. In addition, we identified 28 cases of benign pancreatic disease diagnosed using EUS-FNA and these were selected as a control group. For analysis of EUS-FNA specimens, Cohen's Kappa (κ) coefficient and the prevalence and bias adjusted Kappa statistic (PABAK) were applied to assess the significance of sensitivity and specificity, comparing p53, maspin, p53+maspin. Results: The sensitivity and specificity of p53 staining were 48.9% and 100%. The κ coefficient was 0.31 (95%CI 0.18−0.44) (p < 0.01) and the PABAK coefficient was 0.22 (95%CI 0.03−0.40). The results for maspin staining were 88.9% and 92.9%. The κ coefficient was 0.72 (95%CI 0.54−0.90) (p < 0.01) and the PABAK coefficient was 0.78 (95%CI 0.64−0.88). The results for the combination of maspin and p53 staining were 94.4% and 92.2%. The κ coefficient was 0.82 (95%CI 0.64−1.00) (p < 0.01) and the PABAK coefficient was 0.86 (95%CI 0.74−0.94). Conclusion: Adding maspin staining to p53 staining showed high sensitivity and specificity. Our results demonstrated the usefulness of their combined use that might contribute to the improvement of tissue diagnostic performance of PDAC by EUS-FNA.

Association between the interval of worksite dental check-ups and dental and medical expenditures: a single-site, 12-year follow-up study in Japan.

OBJECTIVES: The purpose of this study was to identify the effective intervals of worksite dental check-ups to reduce cumulative dental expenditures (CDEs) and cumulative medical expenditures (CMEs), based on 12 years of follow-up dental check-ups. SETTING, DESIGN AND PARTICIPANTS: A longitudinal study was conducted between 2002 and 2014 fiscal years. A total of 2691 full-time employees (2099 males and 592 females) aged 20-59 years in a manufacturing company in Japan were recruited. PRIMARY AND SECONDARY OUTCOME MEASURES: Based on the follow-up of 12-year dental check-ups, the interval of dental check-ups visits was classified into the following categories: 'Once per year' as the regular group, 'At least once per 2 years' as the subregular group and others as the irregular group. CDEs and CMEs per capita were examined by the three groups of dental check-ups interval after adjustment for sex, age, occupation and total CMEs at baseline. For sensitivity analysis, decayed teeth, missing teeth and Community Periodontal Index were added as adjustment factors. RESULTS: Compared with the irregular group, the pooled CDEs (including dental check-ups fee) per capita in the subregular group (OR 0.91, 95% CI 0.85 to 0.98) and regular group (OR 0.87, 95% CI 0.81 to 0.93) were significantly lower overall. The younger adults in the subregular group and younger-aged and middle-aged adults in the regular group had significantly lower CDEs. Sensitivity analysis confirmed these findings. CONCLUSIONS: Our findings suggest that regular and subregular worksite dental check-ups were related to reduction of CDEs. It is important to promote a yearly interval between dental check-ups.

Impact of health literacy on anxiety and depressive symptoms in pregnant women in Japan during the COVID-19 pandemic.

To investigate the relationships between communicative and critical health literacy (CCHL) and anxiety and depressive symptoms (ADs) in pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. A cross-sectional study was conducted and 5466 pregnant women responded in Japan in September 2020. A Kessler 6 scale (K6) score ≥ 10, an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 13, and four CCHL groups were analyzed using a logistic regression model and trend test. The proportions of pregnant women with a K6 score ≥ 10 and EPDS score ≥ 13 were 13.5 and 15.4%, respectively. In comparisons with the low CCHL group, the adjusted odds ratio (95% CI) for anxiety symptoms was 0.770 (0.604-0.982) in the high CCHL group, while those for depressive symptoms were 0.777 (0.639-0.946), 0.665 (0.537-0.824), and 0.666 (0.529-0.838) in the lower, higher, and high CCHL groups (all p < 0.05), respectively, after adjustments for potential confounding factors, such as age, weeks of gestation, complications, history, number of children, marital status, education, employment, and income. Higher CCHL was associated with significantly lower adjusted odds ratios for anxiety (p for trend = 0.019) and depressive symptoms (p for trend < 0.001). These results suggest a relationship between CCHL and ADs in pregnant women during the COVID-19 pandemic.

Making Hematochezia of Unknown Origin Known: A Retrospective Analysis.

INTRODUCTION: Hematochezia is observed frequently in daily practice. However, natural hemostasis often prevents identification of the bleeding source during observations. This study was conducted to clarify risk factors related to rebleeding in hematochezia patients without an identified cause of bleeding. METHODS: We analyzed patients who were admitted to Dokkyo Medical University Hospital during April 1, 2009, through March 31, 2015, with the chief complaint of hematochezia. Main outcome measures included the rebleeding rate and the period until rebleeding in hematochezia patients without an identified bleeding source. RESULTS: We selected 159 patients for analyses. Rebleeding was observed in 46 (28.9%) of 159 patients. The median period until first rebleeding was 166 days (2-3,046 days). Univariate analysis indicated that risk factors for rebleeding were male gender (p = 0.029), higher age (p = 0.023), antithrombotic medicines (p = 0.047), lower hemoglobin on admission (p = 0.024), and the presence of diverticula (p = 0.002). Multivariate analysis indicated the presence of diverticula (p = 0.023) and male gender (p = 0.043) as rebleeding risk factors. DISCUSSION/CONCLUSION: In patients with hematochezia of unknown origin, risk factors for rebleeding indicated in this study, especially the presence of diverticula and male gender, should be given particular attention by physicians.

Effect of Novel Stratified Lipid Risk by "LDL-Window" and Flow-Mediated Dilation on the Prognosis of Coronary Artery Disease Using the FMD-J Study A Data.

BACKGROUND: Elevated levels of triglyceride (TG) and non-high-density lipoprotein cholesterol (non-HDL-C) are regarded as a residual lipid risk in low-density lipoprotein cholesterol (LDL-C)-lowering therapy. This study investigated the association between lipid risk stratified by TG and non-HDL-C and the prognosis of patients with coronary artery disease (CAD), and the association between stratified lipid risk and flow-mediated dilatation (FMD) index.Methods and Results: The 624 CAD patients enrolled in flow-mediated dilation (FMD)-J study A were divided into 4 groups: low-risk group (n=413) with TG <150 mg/dL and non-HDL-C <170 mg/dL; hyper-TG group (n=180) with TG ≥150 mg/dL and non-HDL-C <170 mg/dL; hyper-non-HDL group (n=12) with TG <150 mg/dL and non-HDL-C ≥170 mg/dL; and high-risk group (n=19) with TG ≥150 mg/dL and non-HDL-C ≥170 mg/dL. Comparison of the groups showed the cumulative incidence of a 3-point major adverse cardiovascular event (MACE) was different and highest in the high-risk group in all the patients (P=0.009), and in patients with a FMD index ≥7.0% (P=0.021), but not in those with a FMD index <7.0%. Multivariable regression analysis showed that high lipid risk (P=0.019) and FMD <7.0% (P=0.040) were independently correlated with the incidence of a 3-point MACE. CONCLUSIONS: Novel stratification of lipid risk, simply using TG and non-HDL-C levels, combined with FMD measurement, is useful for predicting cardiovascular outcomes in patients with CAD.

The vaccination status and adverse effects of COVID-19 vaccine among pregnant women in Japan in 2021.

To investigate the vaccination status and adverse reactions to the COVID-19 vaccine among pregnant women in Japan, we conducted an online questionnaire survey from October 5 to November 22, 2021. The number of participants in the online survey was 6576. Of the participants, 4840 (73.6%) were vaccinated twice, and 557 (8.5%) were vaccinated once. A total of 1179 (17.9%) responders had never been vaccinated against COVID-19. The most frequent adverse reaction was local pain at the injection site. The incidence of local adverse reactions was almost identical after the first and the second vaccinations, while systemic reactions, such as fever and fatigue/malaise, and adverse reactions outside the vaccination site such as headache and arthralgia, were more frequent after the second vaccination than after the first vaccination. Regarding the obstetrical complications, uterine tension and/or contraction was observed in 1.65% of the pregnant women after the first vaccination and in 2.98% after the second vaccination, and uterine pain appeared in 1.06% of the pregnant women after the second vaccination. However, serious symptoms, such as hemorrhage, decreased fetal movement, edema, increased blood pressure, and amniorrhexis, were seen in less than 1% of vaccinated women after both the first and second vaccinations. This study clarified the characteristics of vaccination, adverse reactions, and obstetrical symptoms in pregnant women in Japan who had the COVID-19 vaccine up to the second dose. As a booster vaccination is currently underway, further study is needed to improve the management of pregnant women during the current pandemic.