Keigai-rengyo-to as post-exposure prophylaxis for severe acute respiratory syndrome coronavirus 2 infection.

BACKGROUND: Effective prevention against COVID-19 is urgently required to control vaccine breakthrough infection. Laboratory and clinical data suggested that Keigai-rengyo-to (KRT) performs biological activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We investigated whether KRT could prevent SARS-CoV-2 in medical personnel exposed to patients with COVID-19. METHODS: We conducted an open-label controlled clinical trial of medical personnel after COVID-19 vaccination at our hospital (ClinicalTrials.gov: UMIN000048389). Participants were close contacts recently exposed (<72 h) to patients with COVID-19. We provided the participants with KRT (7.5 g/day for 5 days) or no drug as a control. The primary endpoint was nicking endonuclease amplification reaction or polymerase chain reaction confirming incident SARS-CoV-2 infection. Safety was assessed in all treated participants. RESULTS: Between January and September 2022, 38 close contacts were assigned: 20 to the KRT group and 18 to the control group. During 2 weeks of follow-up, 10/38 (26%) participants had new-onset COVID-19. The incidence of COVID-19 was significantly lower in the KRT group (2/20; 10%) than in the control group (8/18; 44%), with a medium effect size (p < 0.05; phi coefficient = -0.391; total absolute risk reduction: 34.4% points). The number needed to treat to prevent the occurrence of a COVID-19 case was 2.9. The overall relative risk was 0.23 (95% confidence interval: 0.06-0.78). No serious safety problems were detected. CONCLUSION: Post-exposure prophylaxis with KRT can prevent the onset of COVID-19 in close contacts after vaccination. More randomized clinical trials with larger samples are required to better evaluate KRT as a post-exposure prophylaxis of SARS-CoV-2.

A predictive model to estimate fever after receipt of the second dose of Pfizer-BioNTech coronavirus disease 2019 vaccine: An observational cohort study.

Background and Aims: Fever after coronavirus disease 2019 (COVID-19) vaccination is generally a mild and benign event, but can cause excessive anxiety in younger adults. This study aimed to find key factors that include allergic diseases or physique that determine fever after vaccination. Methods: We conducted an observational cohort study in our hospital to assess post-COVID-19 vaccination fever from April to June 2021. A total of 153 medical personnel aged 22-86 years of age were involved in the study to receive two doses, intramuscularly 21 days apart, of the Pfizer-BioNTech COVID-19 vaccine (30 µg per dose). Vaccination records were taken more than 72 h after vaccination. Clinical and laboratory variables (age, sex, allergy history, weight, height, serum hemoglobin concentration, and these derivatives) were examined by multivariable logistic regression analysis using the peak axillary temperature in the 4-day period after the second vaccination as a dependent variable. Results: No serious safety problems were detected. The incidence of a postsecond vaccination fever of 37.3°C or above was 29.4%. Logistic regression analysis found age, history of perennial allergic rhinitis, body surface area, body weight, percent overweight, and serum hemoglobin concentration as independent predictors of postvaccination fever. The characteristics of this individual were incorporated into the numerical model of human thermoregulation. The evaluation of this model had a sensitivity of 66.1% and a specificity of 90.7% in the detection of postvaccination fever. The multiple coefficient of determination (R 2) was 0.410. Conclusion: The COVID-19 vaccine induced higher rates of fever during the 4-day period after the second vaccination. Younger age, part of the allergy history, small and light body, and concentrated blood were associated with postvaccination fever.

Predictive factors for hyperglycaemic progression in patients with schizophrenia or bipolar disorder.

BACKGROUND: Patients with schizophrenia or bipolar disorder have a high risk of developing type 2 diabetes. AIMS: To identify predictive factors for hyperglycaemic progression in individuals with schizophrenia or bipolar disorder and to determine whether hyperglycaemic progression rates differ among antipsychotics in regular clinical practice. METHOD: We recruited 1166 patients who initially had normal or prediabetic glucose levels for a nationwide, multisite, l-year prospective cohort study to determine predictive factors for hyperglycaemic progression. We also examined whether hyperglycaemic progression varied among patients receiving monotherapy with the six most frequently used antipsychotics. RESULTS: High baseline serum triglycerides and coexisting hypertension significantly predicted hyperglycaemic progression. The six most frequently used antipsychotics did not significantly differ in their associated hyperglycaemic progression rates over the 1-year observation period. CONCLUSIONS: Clinicians should carefully evaluate baseline serum triglycerides and coexisting hypertension and perform strict longitudinal monitoring irrespective of the antipsychotic used. DECLARATION OF INTEREST: The authors report no financial or other relationship that is relevant to the subject of this article. Relevant financial activities outside the submitted work are as follows. I.K. has received honoraria from Astellas, Chugai Pharmaceutical, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai, Eli Lilly, Janssen Pharmaceutical, Kyowa Hakko Kirin, Meiji Seika Pharma, MSD, Nippon Chemiphar, Novartis Pharma, Ono Pharmaceutical, Otsuka Pharmaceutical, Pfizer, Tanabe Mitsubishi Pharma, Shionogi and Yoshitomiyakuhin; has received research/grant support from AbbVie GK, Asahi Kasei Pharma, Astellas, Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai, Eli Lilly, GlaxoSmithKline, Kyowa Hakko Kirin, Meiji Seika Pharma, MSD, Novartis Pharma, Ono Pharmaceutical, Otsuka Pharmaceutical, Pfizer, Takeda Pharmaceutical, Tanabe Mitsubishi Pharma, Shionogi and Yoshitomiyakuhin; and is a member of the advisory boards of Dainippon Sumitomo Pharma and Tanabe Mitsubishi Pharma. Y.T. has received speaker's honoraria from Dainippon-Sumitomo Pharma, Otsuka, Meiji-Seika Pharma, Janssen Pharmaceutical, Daiichi-Sankyo Company, UCB Japan and Ono Pharmaceutical. K.U. has received honoraria from Dainippon Sumitomo Pharma, Eisai, Eli Lilly, Janssen Pharmaceutical, Kyowa Hakko Kirin, Meiji Seika Pharma, MSD, Takeda Pharmaceutical, Hisamitsu Pharmaceutical, Otsuka Pharmaceutical, Pfizer, Tanabe Mitsubishi Pharma, Shionogi and Yoshitomiyakuhin. B.Y. has received speaker's honoraria from Otsuka Pharmaceutical and Janssen Pharmaceutical. J. I. has received honoraria from Dainippon Sumitomo Pharma, Eli Lilly, Janssen Pharmaceutical, Meiji Seika Pharma, MSD, Novartis Pharma, Otsuka Pharmaceutical and Mochida Pharma.

[An experimental weekly visit of the ward at Higashi Yamato Hospital--a holistic cooperation].

The city of Higashi Yamato is located in the northern part of Tama, Suburbs of Tokyo, and the population of Higashi Yamato is approximately 80,000. The Higashi Yamato visiting nursing station was opened in April 1998. As of April 2006, we have over 100 patients, and the aggregate visiting nursing services have provided more than 600 cases. Our station's uniqueness is that forty percent of the patients have malignant neurological disorders and are terminal stage patients, and that they are all covered by medical care insurance. We also provide nursing services to patients who are expected to be dying peacefully at home averaging 4 patients per month. Higashi Yamato Hospital, attached to the visiting nursing station, is an acute phase hospital and has 274 beds. The average hospital stay for our patients was 13 days in 2005. We promote an early discharge from the hospital for patients who have a high need of medical and nursing care and for the patients who are at the terminal stage. However, there were many cases where visiting nursing care services were provided because of a local care manager's request rather than a visiting nursing care need for patients who will be discharged soon from the hospital and for those expecting to have the service. In reality, we have observed a family being felt that his or her patient was pushed out from the hospital, a family who has no confidence in taking a nursing task at home, and a family who could not cope with the patient's changing condition. Therefore, we wanted resolve these observed problems urgently to create close cooperation with the hospital in order to provide continued nursing care after a patient is discharged from the hospital and to have home medical care safely. As a result, we planned a visit to the ward on a weekly basis starting on February 2006. We report here because we had a good result.

Schwannoma of the nasal septum removed with endoscopic surgery.

A 50-year-old woman presented with a 30-year history of nasal obstruction. She had been treated for paranasal sinusitis at other hospitals and she was referred to our hospital for further examination. Flexible endoscopy revealed a mass in the posterior aspect of the right nasal cavity to the posterior aspect of the left nasal cavity around the posterior edge of the nasal septum.

Sertraline treatment of patients with major depressive disorder who failed initial treatment with paroxetine or fluvoxamine.

This study was undertaken to examine the long-term effectiveness and safety of switching to sertraline from other selective serotonin reuptake inhibitors (SSRIs) in the treatment of non-remitted or treatment-intolerant major depressive disorder. The study included 25 patients with major depressive disorder according to DSM-IV-TR criteria. None had achieved remission with paroxetine or fluvoxamine, but each had been used in an adequate dose for an adequate time period or had been intolerant of these SSRIs. Most patients (n=22, 88%) were non-remitters. Switching was accomplished by gradual cross-titration and tapering. We conducted assessments at baseline and at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. Outcomes were assessed using the Quick Inventory of Depressive Symptomatology-Self-Report, Japanese version (QIDS-SRJ) score (primary outcome), the 17-item Hamilton Depression Rating Scale (HDRS), and the Clinical Global Impressions (CGI) scale. Mean QIDS-SRJ and HDRS scores improved significantly from baseline to week 8 and week 24. At the respective endpoints of weeks 8 and 24, remitters on QIDS-SRJ (≤5) were 2 of 25 (8%) and 4 of 25 (16%). At weeks 8 and 24, 11 of 25 (44%) were responders on QIDS-SRJ (≥50% reduction). Five patients (20%) terminated early, before week 8, because of side effects and/or lack of efficacy. These preliminary data suggest that the switching strategy from paroxetine or fluvoxamine to sertraline might be effective and well-tolerated in patients with non-remitted or treatment-intolerant major depressive disorder.