Efficacy and safety of garenoxacin tablets on clinically diagnosed atypical pneumonia: Postmarketing surveillance in Japan

We performed a postmarketing surveillance study to determine the efficacy and safety of the oral quinolone antibacterial agent garenoxacin (Geninax R Tablets 200 mg) against atypical pneumonia. Between October 2009 and July 2011, patients with community-acquired pneumonia visited 26 facilities in Japan; we collected survey forms from 105 of these patients who were suspected of having atypical pneumonia based on the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults. We examined the safety in 105 patients and the efficacy in 71 patients. 1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients) and 92.3% (12/13 patients), respectively. The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain). 2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively. In conclusion, garenoxacin showed an efficacy rate of greater than 90% for suspected atypical pneumonia and confirmed atypical pneumonia. Garenoxacin is considered to be useful in daily practice

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016)

Background and purposeThe Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016), a Japanese-specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 and published in the Journal of JSICM, [2017; Volume 24 (supplement 2)] https://doi.org/10.3918/jsicm.24S0001 and Journal of Japanese Association for Acute Medicine [2017; Volume 28, (supplement 1)] http://onlinelibrary.wiley.com/doi/10.1002/jja2.2017.28.issue-S1/issuetoc.This abridged English edition of the J-SSCG 2016 was produced with permission from the Japanese Association of Acute Medicine and the Japanese Society for Intensive Care Medicine.MethodsMembers of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ) and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two-thirds (> 66.6%) majority vote of each of the 19 committee members.ResultsA total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J-SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation, and its supporting evidence were also added to each recommendation statement. We conducted meta-analyses for 29 CQs. Thirty-seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for five CQs.ConclusionsBased on the evidence gathered, we were able to formulate Japanese-specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non-specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals

Association between regional critical care capacity and the incidence of invasive mechanical ventilation for coronavirus disease 2019: a population-based cohort study

Abstract Background Coronavirus disease 2019 (COVID-19) has exposed critical care supply shortages worldwide. This study aimed to investigate the association between regional critical care capacity and the incidence of invasive mechanical ventilation following novel COVID-19 during the pandemic in Japan, a country with a limited intensive care unit (ICU) bed capacity of a median of 5.1 ICU beds per 100,000 individuals. Methods This population-based cohort study used data from the CRoss Icu Searchable Information System database and publicly available databases provided by the Japanese government and Japanese Society of Intensive Care Medicine. We identified patients recently diagnosed with COVID-19, those who received invasive mechanical ventilation, and those who received extracorporeal membrane oxygenation (ECMO) between February 2020 and March 2023. We analyzed the association between regional critical care capacity (ICU beds, high-dependency care unit (HDU) beds, resource-rich ICU beds, and intensivists) and the incidence of invasive mechanical ventilation, ECMO, and risk-adjusted mortality across 47 Japanese prefectures. Results Among the approximately 127 million individuals residing in Japan, 33,189,809 were recently diagnosed with COVID-19, with 12,203 and 1,426 COVID-19 patients on invasive mechanical ventilation and ECMO, respectively, during the study period. Prefecture-level linear regression analysis revealed that the addition of ICU beds, resource-rich ICU beds, and intensivists per 100,000 individuals increased the incidence of IMV by 5.37 (95% confidence interval, 1.99–8.76), 7.27 (1.61–12.9), and 13.12 (3.48–22.76), respectively. However, the number of HDU beds per 100,000 individuals was not statistically significantly associated with the incidence of invasive mechanical ventilation. None of the four indicators of regional critical care capacity was statistically significantly associated with the incidence of ECMO and risk-adjusted mortality. Conclusions The results of prefecture-level analyses demonstrate that increased numbers of ICU beds, resource-rich ICU beds, and intensivists are associated with the incidence of invasive mechanical ventilation among patients recently diagnosed with COVID-19 during the pandemic. These findings have important implications for healthcare policymakers, aiding in efficiently allocating critical care resources during crises, particularly in regions with limited ICU bed capacities. Registry and the registration no. of the study/trial The approval date of the registry was August 20, 2020, and the registration no. of the study was lUMIN000041450

Multisystem inflammatory syndrome in adults with COVID‐19 requiring mechanical ventilation: A retrospective cohort study

Abstract Aim Multisystem inflammatory syndrome in adults (MIS‐A) is a hyperinflammatory multisystem condition associated with coronavirus disease (COVID‐19). Critically ill COVID‐19 patients may develop multiorgan damage and elevated inflammatory responses, thus making it difficult to differentiate between progression to organ damage due to COVID‐19 itself or MIS‐A. This study aimed to explore the characteristics and complications of MIS‐A in critical COVID‐19 patients. Methods The Japan Extracorporeal Membrane Oxygenation (ECMO) Network and ICU Collaboration Network developed a web‐based database system called the CRoss Intensive Care Unit Searchable Information System (CRISIS) to monitor critical COVID‐19 patients throughout Japan. We retrospectively identified patients with MIS‐A among critical COVID‐19 patients enrolled from March 2020 to December 2021, using CRISIS. Our MIS‐A definition required patients to be at least 18 years of age, have laboratory evidence of inflammation, severe dysfunction of at least two extrapulmonary organ systems, and no plausible alternative diagnoses. Results Of the 1052 patients, 26 (2.5%) were diagnosed with MIS‐A. The MIS‐A patients had a higher likelihood of using ECMO (13% vs. 46%, p < 0.001) and lower overall survival (77% vs. 42%, p < 0.001) than non‐MIS‐A patients. More than 80% of the MIS‐A cases occurred 3 weeks after the COVID‐19 onset. Conclusion Multisystem inflammatory syndrome in adults can occur in 2.5% of critically ill COVID‐19 patients, and the mortality rate is high. Multisystem inflammatory syndrome in adults may be considered when there is a re‐elevation of the unexplained inflammatory response and severe dysfunction of at least two extrapulmonary organ systems several weeks after the onset of COVID‐19

Additional file 1 of Trends in survival during the pandemic in patients with critical COVID-19 receiving mechanical ventilation with or without ECMO: analysis of the Japanese national registry data

Additional file 1: Table 1. Activities of the Japan ECMO networ

Additional file 4 of Trends in survival during the pandemic in patients with critical COVID-19 receiving mechanical ventilation with or without ECMO: analysis of the Japanese national registry data

Additional file 4: Fig. S3. ROC curve analysis for predicting poor outcome in patients with severe COVID-19 receiving mechanical ventilation. (A) ROC curve for age, (B) for body mass index, (C) for the number of ventilator days, and (D) for the number of mechanical ventilations experienced at an institution for patients with severe COVID-19. ROC, receiver operating characteristic curve; COVID-19, coronavirus disease 201

Additional file 2 of Trends in survival during the pandemic in patients with critical COVID-19 receiving mechanical ventilation with or without ECMO: analysis of the Japanese national registry data

Additional file 2: Fig. S1. Serial changes in the number of patients with severe COVID-19 receiving mechanical ventilation and ECMO, and the serial proportion of patients who had ECMO added to mechanical ventilation. There have been five outbreaks of COVID-19 in Japan to date, and the number of patients receiving mechanical ventilation increased continuously. However, the proportion of patients changed from mechanical ventilation to ECMO decreased continuously. The gray bars indicate the numbers of patients receiving mechanical ventilation, the black bars indicate the numbers of patients receiving ECMO, and the white circles indicate the proportions of patients who were changed from mechanical ventilation to ECMO. COVID-19, coronavirus disease 2019; ECMO, extracorporeal membrane oxygenatio

Additional file 3 of Trends in survival during the pandemic in patients with critical COVID-19 receiving mechanical ventilation with or without ECMO: analysis of the Japanese national registry data

Additional file 3: Fig. S2. Serial changes in the survival rates of patients with severe COVID-19 receiving mechanical ventilation (A) and ECMO (B). (A) The number of patients receiving mechanical ventilation increased with each outbreak from the first to the fifth outbreaks; however, the survival rate improved continuously. The gray bars indicate the numbers of survivors, the black bars indicate the numbers of deaths, and the white circles indicate the survival rates. (B) The survival rate remained nearly unchanged throughout the five outbreaks, except for a slight decrease during the third outbreak. The survival rate divided by the average number of patients per month (busyness-adjusted survival index) improved continuously. The gray bars indicate the numbers of survivors, the black bars indicate the numbers of deaths, the white circles indicate the survival rates, and the white diamonds indicate the busyness-adjusted survival index values. COVID-19, coronavirus disease 2019; ECMO, extracorporeal membrane oxygenatio

Additional file 5 of Trends in survival during the pandemic in patients with critical COVID-19 receiving mechanical ventilation with or without ECMO: analysis of the Japanese national registry data

Additional file 5: Fig. S4. ROC curve analysis for predicting poor outcome in patients with critical COVID-19 receiving ECMO. (A) ROC curve for age, (B) body mass index, (C) number of ventilator days before starting ECMO, (D) number of ECMO experiences at an institution for patients with critical COVID-19, and (E) number of ECMO days. ROC, receiver operating characteristic curve; COVID-19, coronavirus disease 2019; ECMO, extracorporeal membrane oxygenatio