Efficacy and safety of chloroquine and hydroxychloroquine for the treatment of COVID19 infection: An umbrella review

Introduction: Among all therapeutic approaches for COVID-19, most controversies have been raised about the efficacy and safety hydroxychloroquine (HCQ) and chloroquine. We conducted an umbrella review to assess any potential benefits of hydroxychloroquine and chloroquine in treating COVID-19.Methods: We searched the Cochrane Database of Systematic Reviews, PubMed and covid-evidence.org from December 2019 until July 2022. Time to viral clearance, need for mechanical ventilation and mortality were assessed as main efficacy outcomes. The analysis was performed using R package version 4.1.2.Result : Hydroxychloroquine had no benefit in decreasing time to viral clearance at days 7 (RR 0.81; 95% CI 0.63, 1.03) and 14 (RR 1.00; 95% CI 0.90, 1.139). Chloroquine has no statistically significant effect in decreasing the time of viral negativity at days 7 (RR 1.20; 95%CI 0.64, 2.25) and 14 (RR 1.08; 95%CI 0.85, 1.36). There is no difference in the need for mechanical ventilation among hydroxychloroquine plus azithromycin versus standard of care groups. Hydroxychloroquine marginally increased the mortality rate compared to placebo but not statistically significant (RR 1.09; P-value 0.05). Adding azithromycin to hydroxychloroquine had no statistically significant effect of decreasing mortality (RR 0.52; 95%CI 0.13, 2.07). Treatments with hydroxychloroquine increased the risk of adverse effects (RR 2.71; 95%CI 1.66, 4.43; p-value <0.0001). Adding azithromycin to hydroxychloroquine increased the adverse events (RR 1.74; 95% CI 1.27, 2.38). Conclusion: Though access to antivirals is an important challenge in developing countries, the decision to sus-pend hydroxychloroquine and chloroquine in treating COVID-19 appears right

Application Status and Evaluation of Combination Vaccines / 中国生物工程杂志

A combination vaccine which consists of ≥2 immunogens is intended to provide protection against two or more diseases or against multiple serotypes of a single disease. The use of combination vaccines decrease the number of vaccine injections in the regular immunization schedules. However,the development of combination vaccines is more complicated than monovalent vaccines,preservatives and adjuvants used with one component may alter the potency of other components. Physical,chemical,and biological interactions between the components of combination vaccines must be considered to avoid detrimental effects on safety or efficacy. Therefore combination vaccines present unique challenges for product evaluation. This paper presents a review of research application status,the evaluation of effectiveness and safety,as well as development prospects on combination vaccines.

Open Clinical Trial to Assess the Efficacy and Safety of Quetiapine in Patients of Schizophrenia / 대한정신약물학회지

OBJECTIVE: The efficacy, tolerability and safety of quetiapine in schizophrenia patients diagnosed by the diagnostic criteria of schizophrenia of the Diagnostic Statistical Manual 4th edition was studied in psychiatric department of 4 hospital in Korea. METHODS: Sixty-four patients (male 31, female 33;age 34.2+/-10.4 years; illness duration 8.1+/-8.3 years) who showed acute exacerbation, partial response, or intolerable adverse event to previous antipsychotic drugs were recruited. Doses of quetiapine were adjusted to maximize efficacy and minimize adverse events. Efficacy was assessed by the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression (CGI) scale. Tolerability and safety were assessed by reports of adverse events, clinically significant abnormal laboratory values and changes from the baseline to week 8 in the Abnormal Involuntary Movement Scale (AIMS) and Simpson-Angus total score as index of extrapyramidal symptoms (EPS). RESULTS: Fiftythree patients completed the 8 weeks trial. The clinical symptoms indexed by BPRS were significantly improved (baseline score=37.9+/-13.0, score at the end=24.3+/-13.6;F=41.5, d.f.=2.4, p=0.000). The CGI score of severity of illness was also significantly reduced (baseline score=4.7+/-1.1, score at the end= 3.6+/-1.2;F=27.6, d.f.=2.2, p=0.000). The frequencies of the worsening of AIMS and Simpson-Angus scores at the end of study were 7.5% and 4.2%, respectively. The most common adverse events of at least moderate intensity were EPS (9.3%), constipation (6.3%), and sedation (4.7%). CONCLUSION: The results of this study suggest that quetiapine is effective, may have a favorable EPS, and has overall safe tolerability in the patients with schizophrenia, and schizophreniform disorder.

Open Clinical Trial to Assess the Efficacy and Safety of Quetiapine in Patients of Schizophrenia / 대한정신약물학회지

OBJECTIVE: The efficacy, tolerability and safety of quetiapine in schizophrenia patients diagnosed by the diagnostic criteria of schizophrenia of the Diagnostic Statistical Manual 4th edition was studied in psychiatric department of 4 hospital in Korea. METHODS: Sixty-four patients (male 31, female 33;age 34.2+/-10.4 years; illness duration 8.1+/-8.3 years) who showed acute exacerbation, partial response, or intolerable adverse event to previous antipsychotic drugs were recruited. Doses of quetiapine were adjusted to maximize efficacy and minimize adverse events. Efficacy was assessed by the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression (CGI) scale. Tolerability and safety were assessed by reports of adverse events, clinically significant abnormal laboratory values and changes from the baseline to week 8 in the Abnormal Involuntary Movement Scale (AIMS) and Simpson-Angus total score as index of extrapyramidal symptoms (EPS). RESULTS: Fiftythree patients completed the 8 weeks trial. The clinical symptoms indexed by BPRS were significantly improved (baseline score=37.9+/-13.0, score at the end=24.3+/-13.6;F=41.5, d.f.=2.4, p=0.000). The CGI score of severity of illness was also significantly reduced (baseline score=4.7+/-1.1, score at the end= 3.6+/-1.2;F=27.6, d.f.=2.2, p=0.000). The frequencies of the worsening of AIMS and Simpson-Angus scores at the end of study were 7.5% and 4.2%, respectively. The most common adverse events of at least moderate intensity were EPS (9.3%), constipation (6.3%), and sedation (4.7%). CONCLUSION: The results of this study suggest that quetiapine is effective, may have a favorable EPS, and has overall safe tolerability in the patients with schizophrenia, and schizophreniform disorder.

The Clinical study for Efficacy and Safety of Amezinium methylsulfate

BACKGROUND: Amezinium methylsulfate(Risumic) is the useful drug in the treatment of essential hypotension. This drug elevate blood pressure by stimulating sympathetic nervous system and improve symptoms related hypotension. This study was designed to evaluate efficacy and safety of Risumic for patients with essential hypotension. METHODS: This study was performed in patients with systolic blood pressure less than 100mmHg from June, 1999 to December, 1999. Risumic blood pressure response, improvement of symptom and side effect were examined in a double-blind, placebo-controlled, crossover trial. RESULTS: Total of 54 patients participated in this study and only 55.6% of them were finished and the rest of them(44.4%) was stopped. 6 patients of this patients were stopped because of side effects. But there was no difference in side effects in Risumic and placebo periods. In diastolic BP, Risumic group is 5mmHg higher than placebo group. And then there was significant difference in statistics. CONCLUSIONS: In essential hypotensive patients, Risumic is elevater DBP than SBP, side effects frequency was no significance difference in Risumic and placebo group.