Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis and Acute Exacerbation of Chronic Bronchitis: A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Acute bronchitis and acute exacerbations of chronic bronchitis (AECB) have cough and sputum as the main symptoms with a high prevalence and substantial economic burden. Although the demand for bronchitis treatment increases due to causes, such as air pollution, the appropriateness of antibiotic prescriptions and the effects of current symptomatic treatments for bronchitis are unclear. GHX02, which is a combined formulation containing four herbs, and has been clinically used for bronchitis in South Korea. We conducted a phase II, randomized, double-blind, and placebo-controlled, multicenter trial to evaluate its efficacy and safety. Patients with acute bronchitis or AECB were recruited and randomized to receive high-dose GHX02 (1920 mg/day), standard-dose GHX02 (960 mg/day), or placebo for 7 days. The primary outcome measure was the change in Bronchitis Severity Score (BSS) from baseline to Day 7. The secondary outcomes were the frequency of coughing fits, Questionnaire of Clinical Symptoms of Cough and Sputum (QCSCS), Leicester Cough Questionnaire (LCQ), Integrative Medicine Outcome Scale (IMOS), and Integrative Medicine Patient Satisfaction Scale (IMPSS). A total of 117 patients were randomized to parallel groups (38 in the high-dose GHX02, 41 in the standard-dose GHX02 group, and 38 in the placebo group). The mean differences in BSS from baseline to Day 7 in the treatment groups (4.2 ± 2.0 and 4.5 ± 1.8 in the high-dose GHX02 and standard-dose GHX02 groups, respectively) were higher than the placebo group (3.8 ± 2.1), p = 0.028. The mean differences in the frequency of coughing fits from baseline to Day 7 and IMPSS were better in the GHX02 treatment group than in the placebo group (standard-dose GHX02 group vs placebo group, p = 0.036). The QCSCS, LCQ, IMOS, and GHX02 of the treatment groups also showed more improvement than the placebo group, but there were no statistically significant differences between the groups. There were no severe adverse effects during the trial. This study supports that GHX02 is effective and safe for patients with bronchitis and provides the basis for progression to a phase III study.Clinical Trial Registration: [https://cris.nih.go.kr] WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003665].

Introducing antimicrobial stewardship to the outpatient clinics of a suburban academic health system

Objective: To establish an antimicrobial stewardship program in the outpatient setting. Design: Prescribers of antimicrobials were asked to complete a survey regarding antimicrobial stewardship. We also monitored their compliance with appropriate prescribing practices, which were shared in monthly quality improvement reports. Setting: The study was performed at Loyola University Health System, an academic teaching healthcare system in a metropolitan suburban environment. Participants: Prescribers of antimicrobials across 19 primary care and 3 immediate- and urgent-care clinics. Methods: The voluntary survey was developed using SurveyMonkeyand was distributed via e-mail. Data were collected anonymously. Rates of compliance with appropriate prescribing practices were abstracted from electronic health records and assessed by 3 metrics: (1) avoidance of antibiotics in adult acute bronchitis and appropriate antibiotic treatment in (2) patients tested for pharyngitis and (3) children with upper respiratory tract infections. Results: Prescribers were highly knowledgeable about what constitutes appropriate prescribing; verified compliance rates were highly concordant with self-reported rates. Nearly all prescribers were concerned about resistance, but fewer than half believed antibiotics were overprescribed in their office. Among respondents, 74% reported intense pressure from patients to prescribe antimicrobials inappropriately. Immediate- and urgent-care prescribers had higher rates of compliance than primary-care prescribers, and the latter group responded well to monthly reports and online educational resources. Conclusions: Intense pressure from patients to prescribe antimicrobials when they are not indicated leads to overprescribing, an effect compounded by the importance of patient satisfaction scores. Compliance reporting improved the number of appropriate antibiotics prescribed in the primary care setting.

Lower Respiratory Tract Infections in Primary Care, Review Article

Any infectious illness of the upper or lower respiratory tract is classified as a respiratory tract infection (RTI). Acute bronchitis, bronchiolitis, pneumonia, and tracheitis are examples of lower respiratory tract infections (LRTIs). The most prevalent cause of death from lower respiratory infections is pneumococcal pneumonia. Pneumonia is a major cause of death globally. new advances in pneumonia diagnosis and treatment have been made, identification of new pathogens as well as the development of newer therapeutic agents like fluoroquinolones, macrolides, streptogramins, oxazolidinones, and –actam antibiotics. Despite these advancements, respiratory tract infections continue to be a challenge in both the diagnostic and therapeutic domains. Because detecting and treating pneumonia may be difficult, a number of professional organizations have created treatment recommendations. In this review we’ll be looking at LRTIs and pneumonia epidemiology, etiology, diagnosis and treatment.

Myocarditis in the Presence of Respiratory Syncytial Virus (RSV) Infection: A Case Study

Background/Objective: Respiratory syncytial virus (RSV) causes acute respiratory infections in children and adults. RSV has many non-specific symptoms such as cough and dyspnea. RSV is associated with high mortality in children, the elderly, and immunocompromised individuals. Although rare, RSV has been reported to cause extrapulmonary complications such as arrhythmias and myocarditis. This case focuses on a patient infected with RSV who presents with acute sustained monomorphic ventricular tachycardia (SMVT). Case Overview: An 83 year-old patient with a history of type 2 diabetes mellitus, hypertension, persistent atrial fibrillation, and asthma presented to the emergency department with concerns of cough, malaise, and a syncopal episode. Upon admission, the patient tested positive for RSV and was diagnosed with acute bronchitis exacerbated by history of asthma. The patient soon developed SMVT with heart rates as high as 235 beats per minute. After consultation with an electrophysiologist, the VT was attributed to myocarditis as a result of the RSV infection. Oral amiodarone was prescribed, and the patient was discharged two weeks later. In a follow-up visit, no SMVT was reported, and the dosage of amiodarone was decreased. Discussion: With the onset of the SARS-CoV2 pandemic in early 2020, myocarditis associated with viral infection has been of interest in recent literature. Many cases of cardiovascular complications have been reported in patients infected with SARS-CoV2. Consequently, it is important to discuss cases of other respiratory viruses also presenting with arrhythmia and myocarditis. In the current case, a patient with RSV developed new onset VT. VT can be life-threatening and can cause further cardiovascular complications. Conclusion: RSV can cause new onset cardiovascular complications, albeit rare. It is important for clinicians to be aware of such complications especially in cases in which patients have preexisting cardiovascular conditions. Patients infected with RSV should be closely monitored for new onset complications.

Diagnostics of an acute bronchitis and community-acquired pneumonia and tactics of antibacterial therapy using amoxicillin

Наиболее частыми формами инфекций нижних дыхательных путей в практике врача являются острый бронхит и внебольничная пневмония. Врачу приходится принимать решение о тактике ведения таких пациентов с учетом клинической картины и результатов обследования. Внебольничная пневмония является распространенным и потенциально угрожающим жизни заболеванием органов дыхания. Острота проблемы состоит в том, что в периоды эпидемий гриппа или других респираторных вирусных инфекций, когда активируется Streptococcus рneumoniae, отмечается рост заболеваемости внебольничной пневмонией. Однако последние годы показали, что этиология пневмонии значительно расширилась и среди причин внебольничной пневмонии важное место помимо бактерий стали занимать пневмотропные вирусы (новый коронавирус SARS-CoV-2, MERS, вирусы гриппа А, в т. ч. пандемичесий H1N1, птичьего гриппа, бокавирусы, метапневмовирусы и др.). Ассоциация бактерий и вирусов утяжеляет течение болезни. В мире пневмонией ежегодно болеют 5-8 человек на 1 тыс. взрослого населения, в Европе – 2-15. В России случаи внебольничной пневмонии у взрослых превышают 1,5 млн в год. В 2020 г. в России зарегистрирован значительный рост заболеваемости по внебольничной пневмонии – в 3,6 раза (1856,18 на 100 тыс. населения), в том числе по вирусной пневмонии – в 109 раз (783,08 на 100 тыс. населения), что обусловлено распространением нового коронавируса SARS-CoV-2. Рассмотрены подходы к диагностике и медикаментозной терапии бронхита и внебольничной пневмонии. Оценена клиническая эффективность лечения, включающего прием амоксициллина, результаты позволяют рекомендовать амоксициллин для использования в амбулаторной практике. The most frequent forms of lower respiratory tract infections in practice of the doctor are the acute bronchitis and community-acquired pneumonia. The doctor should make the decision on tactics of maintaining such patients taking into account a clinical picture and results of inspection. Community-acquired pneumonia is a common and potentially life-threatening respiratory disease. The severity of the problem is that during periods of influenza epidemics or other respiratory viral infections, when Streptococcus pneumoniae is activated, there is an increase in the incidence of community-acquired pneumonia. However, recent years have shown that the etiology of pneumonia has expanded significantly, and among the causes of community-acquired pneumonia, in addition to bacteria, pneumotropic viruses began to occupy an important place (new coronavirus SARS-CoV-2, MERS, influenza A viruses, including pandemic H1N1, avian influenza, bocaviruses, metapneumoviruses, etc.). The association of bacteria and viruses makes the disease worse. In the world, 5-8 people per 1,000 adults suffer from pneumonia annually, in Europe – 2-15. In Russia, cases of community-acquired pneumonia in adults exceed 1,5 million per year. In 2020, Russia registered a significant increase in the incidence of community-acquired pneumonia – 3,6 times (1856,18 per 100 thousand population), including viral pneumonia – 109 times (783,08 per 100 thousand population) due to the spread of the new coronavirus SARS-CoV-2. Approaches to diagnostics and medicamentous therapy of bronchitis and community-acquired pneumonia are considered. Clinical performance of the treatment including intake of amoxicillin is estimated, results allow to recommend amoxicillin for use in out-patient practice.

Implementation of Veterans Affairs Primary Care Antimicrobial Stewardship Interventions For Asymptomatic Bacteriuria And Acute Respiratory Infections

Background Outpatient antimicrobial prescribing is an important target for antimicrobial stewardship (AMS) interventions to decrease antimicrobial resistance. The objective of this study was to design, implement, and evaluate the impact of AMS interventions focused on asymptomatic bacteriuria (ASB) and acute respiratory infections (ARIs) in the primary care setting. Methods This stepped-wedge trial evaluated the impact of multifaceted educational interventions to providers on adult patients presenting to primary care clinics for ARIs and ASB. The primary outcome was percentage of overall antibiotic prescriptions as a composite of prescriptions for ASB, acute bronchitis, upper respiratory infection not otherwise specified, uncomplicated sinusitis, and uncomplicated pharyngitis. Secondary outcomes were the individual components of the primary outcome; a composite safety endpoint of related hospital, emergency department, or primary care visits within 4 weeks; antibiotic selection appropriateness; and patient satisfaction surveys. Results A total of 887 patients were included (405 preintervention and 482 postintervention). After controlling for type I error using Bonferroni correction, the primary outcome was not significantly different between groups (56% vs 49%). There was a statistically significant decrease in prescriptions for acute bronchitis (20.99% vs 12.66%; P = .0003). Appropriateness of antibiotic prescriptions for uncomplicated sinusitis (odds ratio [OR], 4.96 [95% confidence interval {CI}, 1.79–13.75]; P = .0021) and pharyngitis (OR, 5.36 [95% CI, 1.93–14.90]; P = .0013) was improved in the postintervention vs the preintervention group. The composite safety outcome and patient satisfaction surveys did not differ between groups. Conclusions Multifaceted educational interventions targeting providers can improve antibiotic prescribing for indications rarely requiring antimicrobials without increasing re-visits or patient satisfaction surveys.

Quantifying the Gap between Expected and Actual Rates of Antibiotic Prescribing in British Columbia, Canada

Despite decades of stewardship efforts to combat antimicrobial resistance and quantify changes in use, the quality of antibiotic use in British Columbia (BC) remains unknown. As the overuse and misuse of antibiotics drives antibiotic resistance, it is imperative to expand surveillance efforts to examine the quality of antibiotic prescriptions. In late 2019, Canadian expected rates of antibiotic prescribing were developed for common infections. These rates were utilized to quantify the gap between the observed rates of prescribing and Canadian expected rates for antibiotic use for the province of BC. The prescribing data were extracted and matched to physician billing systems using anonymized patient identifiers from January 1, 2000 to December 31, 2018. Outpatient prescribing was further subdivided into community and emergency department settings and stratified by the following age groups: <2 years, 2–18 years, and ≥19 years. The proportions of physician visits that received antibiotic prescription were compared against the Canadian expected rates to quantify the unnecessary use for 18 common indications. Respiratory tract infections (RTI), including acute bronchitis, acute sinusitis, and acute pharyngitis, reported significant levels of overprescribing. Across all ages and health care settings, prescribing for RTI indications occurred at rates 2–8 times higher than the expected rates recommended by a group of expert Canadian physicians. Understanding the magnitude of unnecessary prescribing is a first step in delineating the provincial prescribing quality. The quantification of antibiotic overuse offers concrete targets for provincial stewardship efforts to reduce unnecessary prescribing by an average of 30% across both outpatient and emergency care settings.

MEDICAL AND SOCIAL MONITORING OF INCIDENCE RATE OF ACUTE BRONCHITIS AND PNEUMONIA IN CHILDERN (BASED ON DATA FROM MICROBIOLOGICAL LABORATORY OF THE CITY OF HLUKHIV, SUMY REGION)

The article emphasizes on medical and social monitoring of the incidence of acute bronchitis and pneumonia in children and elucidates the peculiarities of the course of these diseases during the Covid-19 pandemic. It has been established that the main cause of acute respiratory viral infection (ARVI), including pneumonia and bronchitis, and other respiratory diseases, is an impairment of the mechanisms of specific and non-specific protection. In terms of prevalence, bronchitis and pneumonia occupy the first place among broncho-pulmonary diseases in children. Recurrent bronchitis occurs in children of different ages, but most often in the childhood period from 4 to 7 years. The highest number of hospitalized children with acute bronchitis and pneumonia was observed in the city of Hlukhiv and the Hlukhiv district, Sumy region, in 2019; the number of boys significantly exceeded the number of girls. The main cause for the decrease in the incidence and pathogenicity of SARS-CoV-2 infection in children is still remaining unclear. Although this decrease in incidence was attributed to reduced exposure and risk factors during the initial phase of a pandemic, it is now understood that biological factors that interfere with the pathogenesis of infection and the immune response may play a protective role in children compared to the more aggressive clinical manifestations seen in adults. The data obtained demonstrate the patients with acute bronchitis have different numbers of erythrocyte sedimentation rate (ESR). Some patients, 43 out of 64, have normal ESR values, within 4-12 mm / h (p <0.05). With an exacerbation of the process, an increase in ESR is noted in the range of 12-14 mm / h in 21 patients. We have found out acute pneumonia in children is associated with complex changes in blood parameters, and, in particularly, with neutrophilic leukocytosis, increased hemoglobin up to 170 ± 1.4 g / l, an accelerated ESR, a significant increase in platelets. The positive effect of physiotherapy exercises and massage can also improve the parameters of the peripheral blood in the children. Thus, these supportive measures maintain the general mechanisms of homeostasis.