Current medical research and opinion
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Regulations for new drug approvals require stringent safety testing and efficacy trial programs. The approval process for generic drugs, however, is significantly streamlined. Bioavailability data can substitute for new rounds of efficacy trials, thereby both decreasing time to approval and reducing the costs required for new studies. ⋯ Long-acting, inert delivery vehicles for the drug have become available for the same indications. Safety and bioavailability profiles of the long-acting products are the same or improved over the parent product. A review of the long-acting drugs provides compelling evidence to recommend that generic drug-controlled release products may be eligible for alternative regulatory programs.
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Coronavirus disease 2019 (COVID-19) has now brought major challenges to public health and the economy globally since December 2019, which requires effective treatment and prevention strategies to adapt to the impact of the pandemic. We, therefore, explored the prognostic factors for patients with COVID-19 and the contribution of immunomodulatory therapy on COVID-19 outcome. ⋯ For in-hospital patients with COVID-19 of all severity levels, a high risk for fatal outcome was observed in those treated with glucocorticoids, immunoglobulin, thymosin, and ammonium glycyrrhizinate. The results of this study do not support immunomodulatory therapy in patients admitted to the hospital with COVID-19. Further prospective studies are essential to clarify our findings, especially for non-critically ill patients.
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Clinical observations demonstrated that COVID-19 related pneumonia is often accompanied by hematological and coagulation abnormalities including lymphopenia, thrombocytopenia, and prolonged prothrombin time. The evaluation of laboratory findings including coagulation and inflammation parameters may represent a promising approach for early determination of COVID-19 severity. ⋯ We suggest that CRP and PT levels present on admission in COVID-19 patients may be used as early prognostic markers of severe pneumonia requiring transfer to ICU.
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Six prospective real-world studies of antihypertensive treatment with valsartan-centric regimens were pooled to: (1) examine the effectiveness of ∼90 days of second- or later-line valsartan treatment in hypertensive patients with known comorbidities; and (2) identify physician- and patient-related determinants associated with systolic (SBP) and diastolic blood pressure (DBP) outcomes in these patients. ⋯ Valsartan-centric regimens have significant BP lowering benefits in this pooled sample of patients with known comorbidities. Many observed determinants of BP outcomes are modifiable or manageable.
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Spontaneous reporting of adverse drug reactions (ADRs) to pharmacovigilance centers is a common and inexpensive method of ADR detection. Although China requires patients to report ADRs directly, the reporting rate is extremely low. We assessed public knowledge, attitudes, and practice (KAP) regarding pharmacovigilance in Shaanxi Province, China. ⋯ The public has poor awareness about, but a positive attitude toward, pharmacovigilance. Unclear feedback pathways and lack of understanding about the seriousness of ADRs were the main reasons patients did not report ADRs, and respondents had difficulty with parts of the reporting form. The government should publicize the importance of ADR monitoring and develop more suitable forms and measures for patients to report ADR.