Post-marketing safety concerns with nirmatrelvir: A disproportionality analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System.

AIMS: Nirmatrelvir is an antiviral drug with a novel mechanism of action, targeting the 3-CL protease, and is used in the treatment of COVID-19. However, the potential side effects have not yet been fully studied. The aim of this study was to identify potential safety signals of nirmatrelvir by analysing post-marketing safety data based on the largest publicly available worldwide pharmacovigilance database. METHODS: We analysed nirmatrelvir adverse events to identify and characterize relevant safety signals based on the FDA Adverse Event Reporting System database in 2022. The case/non-case approach was used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for adverse events (AEs) that numbered 4 or more. RESULTS: A total of 26 846 cases were included. Disease recurrence (ROR [95% CI] = 413.2 [395.6-431.59]), dysgeusia (ROR [95% CI] = 110.84 [106.04-115.85]), anosmia (ROR [95% CI] = 15.21 [12.76-18.11]), ageusia (ROR [95% CI] = 9.80 [8.50-11.3]) and urticaria (ROR [95% CI] = 1.91 [1.69-2.17]) were the main safety signals. In addition, abdominal pain upper and skin toxicity were two specific safety signals of nirmatrelvir. In the pregnant population, there was a significant increased ROR for life-threatening conditions (ROR [95% CI] = 8.00 [1.77-36.20]). CONCLUSIONS: Our study identified that the main and specific safety signals of nirmatrelvir were disease recurrence, dysgeusia, abdominal pain upper and skin toxicity. Clinicians and pharmacists should be vigilant of these AEs, although differentiating between COVID-19 symptoms and AEs can be challenging. Notably, a potential safety concern of nirmatrelvir should be a warning based on a small number of events in the pregnant population. However, the available data are insufficient, and further continued pharmacovigilance and surveillance is needed to fully understand this issue.

The influence of professional identity, job satisfaction, burnout on turnover intention among village public health service providers in China in the context of COVID-19: A cross-sectional study

Background In China, COVID-19 has undoubtedly posed a huge challenge to the capacity of rural public health services. Village public health service providers are responsible for reporting and dealing with infectious diseases and public health emergencies. However, the turnover of village public health service providers is gravely threatening the stability of rural primary health system step by step. This study systematically evaluated the effects of professional identity, job satisfaction, burnout on turnover intention of village public health service providers, and further measured the mediating effect of job satisfaction and burnout between professional identity and turnover intention. Methods From May to June 2019, 1,244 village public health service providers in Shandong Province were selected as the research objects. Sociodemographic characteristics, professional identity, job satisfaction, burnout and turnover intention were quantitated by self-completed questionnaire and measured by Likert 5–7 scale. Person correlation analysis, One-way ANOVA, and Structural Equation Modeling (SEM) were used for statistical analysis and mediating effect evaluation. Results Five hundred and sixty-four (45.3%) village public health providers had high turnover intension. Professional identity had a direct positive effect on job satisfaction (β = 0.146, p < 0.001), job satisfaction had a direct negative effect on burnout (β = 0.263, p < 0.001), and turnover intension (β = −0.453, p < 0.001), while burnout had a direct positive effect on turnover intension (β = 0.242, p < 0.001). Between professional identity and turnover intention, job satisfaction 95%CI: (−0.289)–(−0.11) had significant mediating effects. Job satisfaction 95%CI: (−0.216)–(−0.077) also had significant mediating effects between professional identity and burnout, and burnout had significant mediating effects between job satisfaction and turnover intension, 95%CI: (−0.116)–(−0.052). These results strongly confirm that professional identity, job satisfaction, and burnout are early and powerful predicators of turnover intention. Conclusion According to the results, medical administration and management departments should pay attention to improve the professional attraction of public health services by improving the public's understanding of the profession, reducing work intensity, timely granting of subsidy funds, improving old-age security, ensuring the income level, increasing the new force and so on, so as to reduce turnover intension and ensure the health equity of village residents.

The Impact of Covid-19 On Maternal Delivery Experiences and Breastfeeding Practices in China: A Cross-Sectional Study (preprint)

Background: The COVID-2019 pandemic has placed extensive pressure on health systems and posed a severe public health challenge worldwide. Lockdown measures implemented in many countries have delayed virus spread. However, a considerable number of people have faced unprecedented pressure, especially the pregnant and breast-feeding women, because face-to‐face professional support has been reduced during the lockdown in many countries. Objectives To compare the delivery and infant feeding experiences of women who delivered before (BL) versus during (DL) the Covid-19 pandemic in Beijing, China. Methods Women aged ≥ 18 years with an infant ≤ 18 months of age completed an anonymous survey. Information/links were shared online and via local clinics in Beijing. Logistic regression was performed to assess predictors of breastfeeding during the first 6-months. Results 2233 women provided data; BL 1241 (55.6%), DL 992 (44.4%). The 6-month mostly breastfeeding (MBF, mainly breastfeeding with few non-formula fluids added) rate was significantly higher in the DL mothers (71.6%), compared to the BL mothers (60.6%). MBF was predicted by delivery during the lockdown period (OR1.42, 95% confidence interval 1.06, 1.90), younger maternal age, discussing infant feeding in a feeding support group, and getting support from friends or relatives. Moreover, relative to those little affected by COVID, those who were much affected were less likely to MBF. Conclusion The COVID-19 pandemic and lockdown measures influenced mothers’ planned birth location and breastfeeding intention. However, breastfeeding practice was maintained during the pandemic. The reported breastfeeding rates were high and our results highlight the importance of feeding support as well as potential beneficial effects of increased mother-infant contact during the lockdown period which is relevant even under normal circumstances.

An especial transition phase of hospitals: the adaptation of hospital operations to the development of COVID-19 and policy adjustments.

The ongoing pandemic coronavirus disease 19 (COVID-19) remains a significant issue for global health, economics, and society. In order to balance epidemic control and economic recovery, many countries have successively announced the gradual relaxation of some lockdown restrictions. Hospitals and medical staff constitute the backbone in this war against COVID-19. In response to this serious situation, many hospitals went into emergency and impaired healthcare access to patients with conditions other than COVID-19. Therefore, gradually promoting hospital operations and functions back to the new normal is important, especially when this outbreak has been effectively controlled. In this study, we introduce existing and potential problems that could seriously affect people's health. Additionally, we propose that an especial transition phase between the emergency and regular modes of hospitals can be well adapted to the current situation.

Chinese Patent Medicines in the Treatment of Coronavirus Disease 2019 (COVID-19) in China.

BACKGROUND: Coronavirus Disease 2019 (COVID-19) is an emerging and rapidly evolving disease, with no recommended effective anti-coronavirus drug treatment. Traditional Chinese Patent Medicines (CPMs) have, however, been widely used to treat COVID-19 in China, and a number of clinical practice results have shown them to have a significant role in its treatment. Consequently, numerous guidelines and expert consensus have recommended the use of CPMs to treat COVID-19. AIM OF THE STUDY: The objectives of this review are to provide up-to-date information on the pharmacology and clinical research on CPMs in the treatment of COVID-19, discuss the research findings, and to better guide clinical application and scientific research on CPMs in the treatment of COVID-19. METHODS: The frequencies of CPM recommendations by guidelines and expert consensus for treatment of COVID-19 in China were ranked. This report identifies the top 10 CPMs, which include Huoxiang Zhengqi capsule (HXZQC), Lianhua Qingwen capsule (LHQWC), Jinhua Qinggan granule (JHQGG), Shufeng Jiedu capsule (SFJDC), Tanreqing injection (TRQI), Xiyanping injection (XYPI), Xuebijing injection (XBJI), Shenfu injection (SFI), Shengmai injection (SMI), and Angong Niuhuang pill (AGNHP). Relevant studies from 2000 to 2020 on these top 10 CPMs, covering usage, dosage, mechanism, curative effect, and precautions, were collected from pharmacopoeia, reports, and theses via library and digital databases (including PubMed, CNKI, Google Scholar, Web of Science, and Elsevier). RESULTS: The properties of the top 10 CPMs included antiviral, antibacterial, anti-inflammatory, antipyretic and analgesic, anti-acute lung injury, anti-shock, immune regulation, and enhancement of pulmonary function. In addition, clinical research results and Chinese treatment data showed that the CPMs had good therapeutic efficacy in the treatment of COVID-19, and adverse reactions were minimal. CONCLUSIONS: Knowledge of the characteristics of the top 10 CPMs and precautions that should be taken may help clinicians to rationally improve therapeutic efficacy, and promote the role of Chinese Medicine in the control of the COVID-19 global epidemic.