Highlights Cilostazol is used in practice for the management of peripheral arterial disease. A generic formulation of cilostazol was compared (C max , AUC, T max ) with the brand-name product. No statistically significant differences were found in either the bioavailability or safety profiles of the two products. The generic version could increase Thai patients’ access to cilostazol.
IntroductionThis phase I study explored the immunogenicity and reactogenicity of accelerated, Q7 fractional, intradermal vaccination regimens for COVID-19.MethodsParticipants (n = 60) aged 18-60 years, naïve to SARS-CoV-2 infection or vaccination, were randomly allocated into one of four homologous or heterologous accelerated two-dose, two-injection intradermal regimens seven days apart:(1) BNT162b2-BNT162b2(n= 20),(2) ChAdOx1- BNT162b2 (n = 20), (3) CoronaVac-ChAdOx1 (n = 10), and (4) ChAdOx1-ChAdOx1 (n = 10). CoronaVac and ChAdOx1 were 20%, and BNT162b2 17%, of their standard intramuscular doses (0.1 mL and 0.05 mL per injection, respectively). Humoral immune responses were measured through IgG response towards receptor binding domains (RBD-IgG) of ancestral SARS-CoV-2 spike protein and pseudovirus neutralization tests (PVNT50). Cellular immune responses were measured using ELISpot for ancestral protein pools.ResultsImmunogenicity was highest in regimen (2), followed by (1), (4), and (3) 2 weeks after the second dose (P < 0.001 for anti-RBD-IgG and P= 0.01 for PVNT50). Each group had significantly lower anti-RBD IgG (by factors of 5.4, 3.6, 11.6, and 2.0 for regimens (1) to (4), respectively) compared to their respective standard intramuscular regimens (P < 0.001 for each). Seroconversion rates for PVNT50 against the ancestral strain were 75%, 90%, 57% and 37% for regimens (1) to (4), respectively. All participants elicited ELISpot response to S-protein after vaccination. Adverse events were reportedly mild or moderate across cohorts.DiscussionWe concluded that accelerated, fractional, heterologous or homologous intradermal vaccination regimens of BNT162b2 and ChAdOx1 were well tolerated, provided rapid immune priming against SARS-CoV-2, and may prove useful for containing future outbreaks.
Our study group consisted of 100 patients with acute stroke admitted in Stanley Medical College. The detailed history of the patients has been recorded and patients underwent a detailed clinical examination. Appropiate investigations were done. The estimated glomerular filtration rate is calculated using the MDRD and CKD-EPI equation. The study groups are stratified into 3 groups according to the renal function assessment (normal renal Function, unrecognized renal insufficiency and recognized renal insufficiency). Results: Out of the 100 patients with acute stroke included in the study, 62 have normal renal function, 31 have recognized renal insufficiency, and 7 have unrecognized renal insufficiency. Majority of the study subjects in normal renal function group were males (n=48), females in unrecognized renal insufficiency group (n=7) and males in recognized renal insufficiency group (n=24). Using single factor ANOVA test, age distribution,the mean difference of blood urea values and serum creatinine values, the mean difference of MDRD values and CKD-EPI values, the mean difference of systolic blood pressure and diastolic blood pressure ,the mean difference of hemoglobin, the mean difference of random blood sugar values were found to be statistically significant (p <0.05). Using fishers exact test,the difference in percentage of females, the difference in percentage of diabetics, the difference in percentage of subjects with dyslipidemia were found to be statistically significant (p < 0.05) In our study, modified Rankin score(MRS) was significantly higher in patients with recognized renal insufficiency compared to unrecognized renal insufficiency patients. Mortality rates are higher in patients with recognized and unrecognized renal insufficiency compared with patients with normal renal function (29%, 28.5% and 9.6% respectively, p< 0.05). Severe disability rates at discharge are also higher in patients with recognized and unrecognized renal insufficiency compared with patients with normal renal function (72.27%, 80 %, and 32.14%) respectively, p<0.05. Conclusions: 1. Unrecognized renal insufficiency is found to be a common co morbidity among patients with acute stroke in our study.2. Unrecognized renal insufficiency is significantly common among older age group and more frequently in females compared to male in our study group. 3. Mortality rate and severe disability rate are higher in patients with recognized and unrecognized renal insufficiency compared to patients with normal renal function.
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