Tag: nevin manimala

Clin Pharmacol Drug Dev. 2022 Jan 3. doi: 10.1002/cpdd.1064. Online ahead of print.

ABSTRACT

This study aimed to evaluate the bioequivalence of 2 amlodipine besylate tablet formulations, a generic formulation and an original formulation, and to investigate their pharmacokinetic and safety profiles. This study was designed as a randomized, open-label, single-dose, crossover, dual-period study and was divided into fasting and postprandial human bioequivalence trials. In the first trial after overnight fasting, 28 subjects were given 5-mg amlodipine besylate tablets via oral administration, and blood specimens were obtained up to 144 hours after dosing; another 28 subjects had a high-fat meal 1 hour before drug administration and proceeded the same as the fasting trial. Bioequivalence was evaluated using 90%CIs for the ratio test/reference of log area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration, log AUC from time 0 to infinity, and log peak concentration. The plasma concentrations were measured by high-performance liquid chromatography-tandem mass spectrometry. The safety was assessed throughout the study. The results show that no significant differences were observed between the pharmacokinetic profiles of the test and reference amlodipine besylate tablets in the fasting and postprandial trials. The 90%CIs of the peak concentration, AUC from time 0 to the last quantifiable concentration and AUC from time 0 to infinity of amlodipine in the 2 trials were within the commonly accepted bioequivalence criteria of 80% to 125%. Compared with the pharmacokinetic parameters of the fasting and postprandial trials, food had no significant effect on exposure of amlodipine besylate. There was no significant difference in safety statistical results between the 2 groups. The results suggest that generic and original amlodipine besylate tablets are bioequivalent with similar safety profiles.

PMID:34981666 | DOI:10.1002/cpdd.1064

CNS Neurosci Ther. 2022 Jan 3. doi: 10.1111/cns.13786. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the factors influencing enlarged perivascular space (EPVS) characteristics at the onset of acute ischemic stroke (AIS), and whether the PVS characteristics can predict later post-stroke epilepsy (PSE).

METHODS: A total of 312 patients with AIS were identified, of whom 58/312 (18.6%) developed PSE. Twenty healthy participants were included as the control group. The number of PVS in the basal ganglia (BG), centrum semiovale (CS), and midbrain (MB) was manually calculated on T₂ -weighted MRI. The scores and asymmetry index (AI) of EPVS in each region were compared among the enrolled participants. Other potential risk factors for PSE were also analyzed, including NIHSS at admission and stroke etiologies.

RESULTS: The EPVS scores were significantly higher in the bilateral BG and CS of AIS patients compared to those of the control group (both p < 0.01). No statistical differences in EPVS scores in BG, CS, and MB were obtained between the PSE group and the nonepilepsy AIS group (all p > 0.01). However, markedly different AI scores in CS were found between the PSE group and the nonepilepsy AIS group (p = 0.004). Multivariable analysis showed that high asymmetry index of EPVS (AI≥0.2) in CS was an independent predictor for PSE (OR = 3.7, 95% confidence interval 1.5-9.1, p = 0.004).

CONCLUSIONS: Asymmetric distribution of EPVS in CS may be an independent risk factor and a novel imaging biomarker for the development of PSE. Further studies to understand the mechanisms of this association and confirmation with larger patient populations are warranted.

PMID:34981639 | DOI:10.1111/cns.13786

ESC Heart Fail. 2022 Jan 3. doi: 10.1002/ehf2.13797. Online ahead of print.

ABSTRACT

AIMS: Contemporary heart failure (HF) classification based on left ventricular (LV) ejection fraction is limited for comprehensive assessment of LV function. We aimed to validate the feasibility of the contraction-relaxation coupling index (CRC) as a novel predictor for clinical outcomes in patients with acute HF.

METHODS AND RESULTS: A total of 3266 consecutive patients (median age: 74 years, 53% male) with acute HF were included. CRC was defined as the ratio of end-diastolic elastance (LV end-diastolic pressure/stroke volume) to end-systolic elastance (LV end-systolic pressure/end-systolic volume). The risk for 1 year composite endpoint of all-cause mortality or hospitalization for HF (primary outcome) was compared after group categorization using CRC tertiles (Tertile 1: CRC ≤ 0.17, Tertile 2: 0.17 < CRC ≤ 0.40, and Tertile 3: 0.40 < CRC). The median CRC was 0.3 and the median LVEF was 42%. After adjustment for clinical and echocardiographic covariates, CRC was an independent predictor for the primary outcome (hazard ratio [HR]: 1.74, 95% confidence interval [CI]: 1.47-2.07 in Tertile 3 and HR: 1.21, 95% CI: 1.02-1.44 in Tertile 2 when compared with Tertile 1; HR: 1.23, 95% CI: 1.14-1.33 per one-standard deviation increment in CRC). The risk model with CRC showed better performance in outcome discrimination than the model with LVEF (c-statistic 0.701 vs. 0.699, P for difference <0.001). Patients with higher CRC demonstrated better effectiveness of neurohormonal blockade for the primary outcome compared with those with lower CRC (HR: 0.38, 95% CI: 0.29-0.50 in Tertile 3 and HR: 0.67, 95% CI: 0.52-0.89 in Tertile 1).

CONCLUSIONS: CRC provides an independent value for outcome prediction in patients with acute HF. CRC would be a sensitive indicator for prognostic risk stratification and for predicting treatment response to the neurohormonal blockade.

PMID:34981649 | DOI:10.1002/ehf2.13797

Microsc Res Tech. 2022 Jan 4. doi: 10.1002/jemt.24039. Online ahead of print.

ABSTRACT

To compare the clinical application value of positron emission tomography-computed tomography (PET-CT) and magnetic resonance imaging (MRI) in the diagnosis of cervical cancer lymph node metastasis. We searched PubMed and other databases for the studies comparing the use of PET-CT and MRI for the diagnosis of cervical cancer lymph node metastasis up to January 20, 2021. We strictly followed the inclusion and exclusion criteria to screen the literature and extract the data. Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool was used for quality evaluation of included studies, and Revman 5.3 and Stata 15.0 software were used for evaluating heterogeneity, synthesize sensitivity (SEN), specificity (SPE), positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio (DOR), and the area under the curve (AUC) and comparing the pretest and posttest probabilities. Finally, 11 studies were included for meta-analysis. The synthesized results indicated that the SEN value of PET-CT was 0.65 (0.60 ~ 0.69) and SPE was 0.93 (0.91 ~ 0.94), and the SEN value of MRI was 0.58 (0.54 ~ 0.63) and SPE was 0.91 (0.90 ~ 0.92). AUC of PET-CT was 0.824, which was significantly higher than that of MRI (AUC = 0.702; p < .05). The subgroup analysis showed that the AUC value of the study based on study design and use of blinding methods was not statistically significant (all p > .05). There was no obvious publication bias in the synthesized analysis of the diagnostic value of PET-CT and MRI (all p > .05). HIGHLIGHTS: To compare positron emission tomography-computed tomography (PET-CT) and magnetic resonance imaging (MRI) in diagnosis of cervical cancer lymph node metastasis. Synthesize sensitivity value of PET-CT was comparable with that of MRI. Area under the curve of PET-CT was significantly higher than that of MRI. There was no obvious publication bias in synthesized analysis.

PMID:34981608 | DOI:10.1002/jemt.24039

Congenit Anom (Kyoto). 2022 Jan 3. doi: 10.1111/cga.12456. Online ahead of print.

ABSTRACT

To evaluate the safety of triptan use during pregnancy in a Japanese population, we descriptively analyzed the data on pregnancy and fetal outcomes from 128 pregnant women using triptans for migraine treatment at two Japanese facilities that provided counseling on drug exposure in pregnancy between 2001 and 2017. The risks of miscarriage, low birth weight, and preterm birth were similar to those reported in the demographic statistics in Japan. The incidence proportion of malformation was also within the baseline risk range. Accumulated data suggest that exposure to triptans during pregnancy does not clearly increase the risk of negative pregnancy and fetal outcomes. This finding can help reduce anxiety in pregnant women with migraines who are taking triptans.

PMID:34981573 | DOI:10.1111/cga.12456

J Obstet Gynaecol Res. 2022 Jan 3. doi: 10.1111/jog.15142. Online ahead of print.

ABSTRACT

AIM: Frozen-thawed embryo transfer (FET) has gained popularity as an assistive reproductive technology despite its increased risk of large-for-gestational-age offspring. This study aimed to analyze the effect of FET on fetal development, particularly the growth rate and estimated fetal weight (EFW) throughout pregnancy.

METHODS: This was a single-center, retrospective study that examined 97 patients with FET conception and 477 patients with natural conception (NC) who underwent labor and delivery at our clinic between December 2015 and June 2019. Crown-rump length (CRL) in the first trimester and EFW measurements in the second and third trimesters were obtained from transabdominal ultrasound records. Birthweight was adjusted for sex, parity, and gestational age. Regression coefficients of CRL, EFW, and birthweight were compared between the FET and NC groups to examine the growth rate. Multiple regression analysis was performed to determine the relationship between birth size and baseline characteristics.

RESULTS: The growth rate was higher in the first trimester in the FET group than in the NC group (difference: 0.19 mm/day, p = 0.018). CRL, EFW, and adjusted birthweight were higher in the FET group than in the NC group throughout pregnancy. The factors associated with the development of larger offspring through FET than through NC were advanced maternal age, primiparity, cesarean section delivery, and high birthweight.

CONCLUSIONS: Throughout pregnancy, FET resulted in a larger offspring than in NC, with accelerated growth observed only during the first trimester. Thus, FET highly affects early fetal development.

PMID:34981599 | DOI:10.1111/jog.15142

Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2022 Jan;36(1):41-44;50. doi: 10.13201/j.issn.2096-7993.2022.01.009.

ABSTRACT

Objective:To understand the sensitization characteristics of humulus pollen in patients with allergic rhinitis or allergic asthma in Beijing, and to explore the proportion of the population allergic to humulus pollen. Methods:Selected 8380 patients who were diagnosed with allergic rhinitis, allergic asthma, and allergic rhinitis combined with asthma in outpatient clinic from January 2017 to December 2019. SPT test was performed with humulus allergen reagent to compare the sensitization distribution of humulus pollen by age and disease, and analyze the sensitization characteristics of humulus pollen. Results:The total positive rate of humulus pollen SPT reached 49.59%.The positive rate of humulus pollen SPT was the highest in the age group of 10 to 14 years old, reaching 71.98%, compared with other age groups, there was a statistical difference （P<0.01）; and the positive rate of SPT in patients under 10 years of age gradually increased with age, and the positive rate of SPT in patients over 50 years of age gradually decreased with age. Humulus pollen SPT positive patients ++++ and above accounted for 41.43%, which was significantly different from other groups （P<0.01）. Single humulus was less allergenic, accounting for about 23.87%. Most of them were combined with multiple pollen allergies （76.13%）, and often combined with chenopodiaceae pollen sensitization （92.81%）. Conclusion:The SPT positive rate of humulus pollen in patients with allergic rhinitis or asthma in Beijing area is nearly 50%. The positive rate of SPT is the highest among patients aged 10-14, and most of them show strong positive reactions. It is suggested that humulus pollen is the main allergen of allergic rhinitis and asthma, and the sensitization of humulus pollen tends to be multiple allergens.

PMID:34979618 | DOI:10.13201/j.issn.2096-7993.2022.01.009

Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2022 Jan;36(1):24-26. doi: 10.13201/j.issn.2096-7993.2022.01.005.

ABSTRACT

Objective:To evaluate the Eustachian tube function of children with simple adenoid hypertrophy and adenoid hypertrophy with secretory otitis media（OME） by using the A/N value of lateral radiograph of nasopharyngeal X-ray and EDQ-7 scale scores. Methods:Sixty cases of children with adenoid hypertrophy admitted from February 2019 to August 2021 were all underwent nasopharyngeal X-ray lateral radiographs to determine the adenoid/nasopharyngeal cavity ratio（A/N ratio） and then determine the size of adenoids. The Eustachian tube function ETDQ-7 survey was used to evaluate the patient’s self-evaluation of the severity of the disease and ear symptoms, and the degree of influence were scored. Subsequently, the correlation between adenoid hypertrophy with OME and ETDQ-7 scores was statistically analyzed by using the Spearman rank correlation statistical method. Results:In adenoid hypertrophy with OME group, the ETDQ-7 scores of A/N≤0.60, A/N 0.61-0.70 and A/N≥0.71 were 4.15±1.75, 14.55±6.67 and 23.95±6.63, respectively. The higher the grade of adenoid hypertrophy, the higher the ETDQ-7 scores. In adenoid hypertrophy with OME group, the degree of adenoid hypertrophy was positively correlated with the ETDQ-7 scores（P<0.05）. Conclusion:Adenoid hypertrophy is also one of the potential factors causing OME in children.

PMID:34979614 | DOI:10.13201/j.issn.2096-7993.2022.01.005

Infect Chemother. 2021 Dec;53(4):767-775. doi: 10.3947/ic.2021.0125.

ABSTRACT

BACKGROUND: Neutralizing antibody cocktail therapy, REGN-COV2, is promising in preventing a severe form of coronavirus disease 2019 (COVID-19), but its effectiveness in Japan has not been fully investigated.

MATERIALS AND METHODS: To evaluate the effectiveness of REGN-COV2, clinical data of 20 patients with COVID-19 who received REGN-COV2 was compared with the control by matching age and sex. The primary outcome was the time from the onset to defervescence, the duration of hospitalization, and oxygen requirement. A sensitivity analysis using Bayesian analysis was also conducted.

RESULTS: The time to defervescence was significantly shorter in the treatment group (5.25 vs. 7.95 days, P = 0.02), and so was the duration of hospitalization (7.115 vs. 11.45, P = 0.0009). However, the oxygen therapy requirement did not differ between the two groups (15% vs. 35%, P = 0.27). For Bayesian analysis, the median posterior probability of the time to defervescence since the symptom onset on the REGN-COV2 group was 5.28 days [95% credible interval (CrI): 4.28 – 6.31 days], compared with the control of 7.99 days (95% CrI: 6.81 – 9.24 days). The posterior probability of the duration of the hospitalization on the REGN-COV2 group was 7.17 days (95% CrI: 5.99 – 8.24 days), compared with the control of 11.54 days (95% CrI: 10.28 – 13.14 days). The posterior probability of the oxygen requirement on the REGN-COV2 group was 18% (95% CrI: 3 – 33%), compared with the control of 36% (95% CrI: 16 – 54%).

CONCLUSION: REGN-COV2 may be effective in early defervescence and shorter hospitalization. Its effectiveness for preventing a severe form of infection needs to be evaluated by further studies.

PMID:34979607 | DOI:10.3947/ic.2021.0125

Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2022 Jan;36(1):8-13. doi: 10.13201/j.issn.2096-7993.2022.01.002.

ABSTRACT

Objective:The purpose of this study was to compare the olfactory function examination results of patients with post-viral olfactory dysfunction（PVOD） in different prognostic groups and analyze prognostic factors, especially the influence of olfactory bulb volume（OBV） on prognosis, so as to provide objective basis for clinical diagnosis and treatment. Methods:After approval by the hospital ethics committee, the patients with PVOD admitted to Beijing Anzhen Hospital’s outpatient department from January 2019 to December 2019 were followed up for at least 1 year. These patients completed the Sniffin’ Sticks test and MRI examination of the olfactory pathway before treatment. According to the results of the Sniffin’ Sticks test after 1 year follow-up（threshold-discrimination-identification（TDI） score of the patients was increased at least 6 points）, the patients were divided into two groups as the improvement group and the non-improvement group. The prognostic factors of PVOD patients were preliminarily determined by comparing the differences of various factors and the results of olfactory function examination between the two groups. Results:In this study, 47 patients with PVOD were included, with the smell improvement rate was 53.2%. Compared with the improvement group, the patients in the non-improvement group had longer duration, poorer initial olfactory function, higher olfactory threshold, and poorer olfactory discrimination and recognition ability（All P<0.01）. There was no statistical difference in terms of gender, age, allergic rhinitis and smoking between the two groups（All P>0.05）.The OBV of the non-improvement group was （59.48±23.92） mm³, which was significantly lower than that in the improvement group（[92.77±14.35]mm³, P<0.001）. Multiple logistic regression analysis showed that prognostic factors included course of disease（OR 0.677, 95%CI 0.461-0.993, P=0.046）, initial T value（OR 263.806, 95%CI 1.028-67 675.884, P=0.049） and OBV（OR 1.160, 95%CI 1.002-1.343, P=0.047）. The area under the receiver operating characteristic curve（ROC curve） of OBV was 0.888（0.797-0.979, P<0.001）. The correct diagnostic index of OBV≥78.50 mm³was used to determine the prognosis of olfactory function, with a specificity of 0.818 and a sensitivity of 0.840. The ROC curve analysis showed that the area under the ROC curve of duration was 0.822（0.703-0.940, P<0.001）. The correct diagnostic index of the duration ≤6 months was used to determine the prognosis of olfactory function, with a specificity of 0.727 and a sensitivity of 0.800. The area of T score was 0.793（0.662-0.924, P=0.001）. T score ≥1.25 was used as the correct diagnostic index to determine the prognosis of olfactory function. The specificity and sensitivity were 0.818 and 0.680, respectively. Conclusion:The prognosis of olfactory function in PVOD patients is related to the course of disease, the degree of olfactory loss and OBV. Those with no improvement in olfactory function have a longer disease course, aggravated olfactory damage and reduced OBV than those with improved olfactory function. The factors of Duration ≤6 months, T value ≥1.25 and OBV≥78.50 mm³suggested better prognosis, and the results of objective olfactory examination have greater value in evaluating the prognosis of olfactory function.

PMID:34979611 | DOI:10.13201/j.issn.2096-7993.2022.01.002