Notes

[CT Image-based Surgery Help Method pertaining to Still left Atrial Appendage Occlusion].
Amoxicillin/clavulanate is a widely used oral formulation of penicillin combined with a β-lactamase inhibitor. When using amoxicillin/clavulanate in the elderly, the risk of adverse drug reaction may be greater. This study aimed to evaluate the pharmacokinetics (PKs) and safety of multiple-dose amoxicillin/clavulanate administration in healthy elderly subjects and to compare the observed PK profiles with those in healthy younger adults. An open-label, one-sequence, multiple administration study was conducted in 16 healthy elderly subjects.

Subjects orally received amoxicillin and clavulanate 750/187.5 twice daily for 9 days. For PK analysis, serial blood samples were collected up to 12 hours after the last administration of amoxicillin/clavulanate. The demographic and PK data of this study were compared to those of healthy young adults from a separate study with a similar design. Safety assessments including clinical laboratory tests, physical examination, vital signs, and adverse event (AE) monitoring were performed throughout the study.

All AEs were mild, and no serious AEs were reported in this study. The systemic exposure of amoxicillin and clavulanate was ~ 90% and 60% higher, respectively, in the elderly subjects than in the younger subjects. However, the time required to reach maximum concentration at steady state and the elimination half-life were similar in the two age groups.

Although multiple administration of amoxicillin/clavulanate 750/187.5 mg was safe and well-tolerated, the systemic exposure of amoxicillin and clavulanate was higher in elderly subjects than in younger subjects.
Although multiple administration of amoxicillin/clavulanate 750/187.5 mg was safe and well-tolerated, the systemic exposure of amoxicillin and clavulanate was higher in elderly subjects than in younger subjects.
Currently, the novel coronavirus pneumonia is rampaging around the world, 13.2-21.3% of patients with COVID-19 infection developed severe or critical illness. Treatment of these critically ill patients is becoming one of the major challenges we are facing. Frequently, more than 10 types of drugs are used simultaneously in the treatment of these critically ill patients, and the combination of many different drugs may easily lead to drug interactions and adverse reactions. Therefore, clinical pharmacist should participate in the optimization of drug treatment programs.

A case of a critically ill COVID-19 patient with respiratory failure and diabetes mellitus is used as an example of an analysis of the treatment plan, utilization of combined medications, and the delivery of pharmaceutical care.

There were some drug use unreasonable phenomena, including the extended continuation of arbidol treatment, the use of broad-spectrum antibacterial drugs, the use of drugs with unproven anti-coronavirus effects.

Clinical pharmacists should participate in the optimization of drug treatment programs and provide pharmaceutical care for critically ill COVID-19 patients; this can promote the rational use of drugs.
Clinical pharmacists should participate in the optimization of drug treatment programs and provide pharmaceutical care for critically ill COVID-19 patients; this can promote the rational use of drugs.
Evolocumab, a human monoclonal antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9), markedly reduces low-density lipoprotein cholesterol (LDL-C). Here we characterize the pharmacokinetics, pharmacodynamics, safety, and tolerability of evolocumab manufactured at a new site administered in healthy Chinese subjects.

This phase 1 study of a single subcutaneous 140-mg dose of evolocumab was conducted in healthy subjects of Chinese descent residing in Hong Kong. Subjects were followed through day 85.

20 subjects (all men) were enrolled. Mean (SD) age was 26.6 (8.5) years; baseline LDL-C was 2.4 (0.7) mmol/L. Mean (SD) evolocumab maximum serum concentration (C
) was 14.1 (5.0) μg/mL; area under the serum drug concentration-time curve from time 0 to time of last quantifiable concentration (AUC
) was 178 (80) day×μg/mL; AUC from time 0 to infinity (AUC
) was 187 (80) day×μg/mL; terminal half-life was 5.95 (1.76) days; median time to reach C
(t
) was 4.0 days. Maximum LDL-C decrease (-57.5%) was observed on day 15 and recovered to baseline by day 57. The most common adverse events (AEs) were nasal congestion (20%), oropharyngeal pain (15%), sneezing (15%), cough (10%), upper respiratory tract infection (10%), and diarrhea (10%). Most AEs were isolated incidences of mild severity, with no serious or treatment-related events. No anti-evolocumab antibodies were detected.

A single 140-mg dose of evolocumab manufactured at the new site and administered in healthy Chinese subjects was associated with typical antibody pharmacokinetics, rapid and reversible decreases in LDL-C, and no new safety events.
A single 140-mg dose of evolocumab manufactured at the new site and administered in healthy Chinese subjects was associated with typical antibody pharmacokinetics, rapid and reversible decreases in LDL-C, and no new safety events.
Potential advantages of bemiparin compared to enoxaparin are a longer half-life, once-a-day dosage, and possibly a better safety profile due to the more selective antagonistic action toward Xa coagulation factor. We evaluated the efficacy and safety of bemiparin compared with enoxaparin as prophylaxis or treatment of venous thromboembolic disease.

We searched PubMed, Embase, Cochrane Library, Clinical Trials.gov, Google academics, and Conference Abstracts (2014-2019) of the American Society of Hematology and the Spanish Society of Hematology and Hemotherapy. Randomized trials that included bemiparin and enoxaparin were included as treatment arms. The outcomes evaluated were the incidence of venous thromboembolic disease and the proportion of adverse events in each group. Two independent researchers selected, evaluated, and extracted the data in duplicate. Four studies with a total of 5,473 patients were included.

Most patients were included in prevention studies (N=5,161). Bemiparin proved the non-inferiority in terms of efficacy with respect to enoxaparin (relative risk 0.76; 95% confidence interval (95% CI) 0.56-1.01; p=0.06) (heterogeneity I
=34%). Anisomycin We recorded 222 adverse events in 2,742 patients treated with bemiparin and 288 adverse events in 2,731 patients treated with enoxaparin (8.1 vs. 10.5 adverse events per 100 patients, respectively; p=0.003). However, the meta-analysis for safety showed a significant heterogeneity making not possible to pool the result across the trials.

Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated.
Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated.
To evaluate the pharmacokinetics, pharmacodynamics, and tolerability of JY09, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, in healthy subjects.

Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received subcutaneous JY09 or placebo according to a randomized, double-blind, placebo-controlled, single-center, dose-escalating phase I trial design. Blood samples were collected over a 42-day period, and JY09 in plasma was determined by an electrochemical luminescence method. For the pharmacodynamic evaluation, oral glucose tolerance tests (OGTTs) were conducted predose and on day 5 after the target dose, during which plasma glucose, insulin, C-peptide, and glucagon concentrations were analyzed. Tolerability was assessed using physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity.

In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC
and C
from 0.7to6.0 mg JY09. The half-life of JY09 was ~9.3 days, and the peak concentration was reached at ~60-72 hours. Following the OGTT, an increase in C-peptide concentration was observed after exposure to JY09 at the dose of 6.0mg compared to the placebo group. JY09 was well tolerated in healthy Chinese subjects following a single dose of up to 6.0mg. No symptomatic hypoglycemia was reported, and the most commonly observed adverse event was suppressed appetite, and its incidence was dose-dependent. Four subjects (13%) developed anti-JY09 antibodies.

JY09 has a long half-life of ~9.3 days, with an acceptable safety profile.
JY09 has a long half-life of ~ 9.3 days, with an acceptable safety profile.
Memantine is currently the only drug that acts on the glutamate energy system to treat Alzheimer's disease. link2 A generic memantine tablet was developed to offer an alternative to the marketed tablet formulation. The purpose of this study was to assess the bioequivalence of two different memantine formulations among healthy male Chinese subjects under fasting and fed conditions.

We carried out single-center, randomized, single-dose, open-label, two-period, cross-over studies which including 20 healthy male Chinese subjects under fasting and fed conditions, respectively. Plasma samples were collected prior to and up to 240hours after dosing. Key pharmacokinetic parameters including area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC
), area from time zero to infinite (AUC
), and C
were used for bioequivalence assessment.

Under fasting condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 106.5 - 114.0% for C
, 99.4 - 107.9% for AUC
, and 100.0 - 109.6% for AUC
. Under fed condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 94.8 - 104.3% for C
, 98.2 - 110.5% for AUC
, and 99.2 - 113.0% for AUC
.

The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).
The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. link3 That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).
The aim of the study was to evaluate the efficacy and safety of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis, and a meta-analysis was performed using randomized controlled trials (RCTs).

We searched studies published on PubMed, Cochrane Central Register of Controlled Trials, and Embase to collect RCTs comparing etelcalcetide with placebo for the treatment of SHPT. Unpublished studies and information were also searched in ClinicalTrials.

Five RCTs involving 1,268 participants were eligible for inclusion in this meta-analysis. Compared with placebo, etelcalcetide contributed to more participants who achieved ≥30% reduction in parathyroid hormone (PTH) (relative risk (RR) 8.64; 95% CI, 6.66 to 11.19; p < 0.00001) and a PTH level of ≤300 pg/mL (RR 11.80; 95% CI, 8.15 to 17.08; p < 0.00001) as well as an increase in the incidence of hypocalcemia (RR 18.76; 95% CI, 4.55 to 77.26, p < 0.0001), nausea (RR 1.79; 95% CI, 1.19 to 2.70; p = 0.006), or vomiting (RR 1.
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