Tag: pubmed

Chin J Integr Med. 2022 Oct 27. doi: 10.1007/s11655-022-3688-3. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of Guanxin Danshen Dripping Pills (GXDS) in the treatment of depression or anxiety in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI).

METHODS: From September 2017 to June 2019, 200 CHD patients after PCI with depression and anxiety were included and randomly divided into GXDS (100 cases) and placebo control groups (100 cases) by block randomization and a random number table. Patients in the GXDS and control groups were given GXDS and placebo, respectively, 0.4 g each time, 3 times daily for 12 weeks. The primary outcomes were scores of Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Scale (GAD-7) and the Seattle Angina Pectoris Scale (SAQ). The secondary outcomes included 12 Health Survey Summary Form (SF-12) scores and the first onset time and incidence of major adverse cardiovascular events (MACEs). Other indices including blood pressure, blood lipids, microcirculation and inflammatory-related indices, etc. were monitored at baseline, week 4, and week 12.

RESULTS: In the full analysis set (200 cases), after treatment, the PHQ-9 and GAD-7 scores in the GXDS group were considerably lower than those in the control group (P<0.05). Compared with the baseline, the total PHQ-9 scores of the experimental and control groups decreased by 3.97 and 1.18, respectively. The corrected mean difference between the two groups was -2.78 (95% CI: -3.47, -2.10; P<0.001). The total GAD-7 score in the GXDS group decreased by 3.48% compared with the baseline level, while that of the placebo group decreased by 1.13%. The corrected mean difference between the two groups was -2.35 (95% CI: -2.95, -1.76; P<0.001). The degree of improvement in SAQ score, SF-12 score, endothelin and high-sensitive C-reactive protein levels in the GXDS group were substantially superior than those in the placebo group, and the differences between the two groups were statistically significant (P<0.05). Similar results were obtained in the per protocol population analysis of 177 patients. Three cases of MACES were reported in this study (1 in the GXDS group and 2 in the placebo group), and no serious adverse events occurred.

CONCLUSIONS: GXDS can significantly alleviate depression and anxiety, relieve symptoms of angina, and improve quality of life in patients with CHD after PCI. (Registration No. ChiCTR1800014291).

PMID:36301456 | DOI:10.1007/s11655-022-3688-3

Chin J Integr Med. 2022 Oct 27. doi: 10.1007/s11655-022-3685-6. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of Jianpi Jieyu Decoction (JJD) for treating patients with mild-to-moderate depression of Xin (Heart)-Pi (Spleen) deficiency (XPD) syndrome.

METHODS: In this multi-center, randomized, controlled study, 140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019. They were randomly divided into JJD group and paroxetine group by using a random number table, with 70 cases in each group. The patients in the JJD group were given JJD one dose per day (twice daily at morning and evening, 100 mL each time), and the patients in the paroxetine group were given paroxetine (10 mg/d in week 1; 20 mg/d in weeks 2-6), both orally administration for a total of 6 weeks. The primary outcome was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 6 from baseline. The secondary outcomes included the Hamilton Anxiety Scale (HAMA) score, Traditional Chinese Medicine Symptom Scale (TCMSS), and Clinlcal Global Impression (CGI) scores at the 2nd, 4th, and 6th weekends of treatment, HAMD-17 response (defined as a reduction in score of >50%) and HAMD-17 remission (defined as a score of ⩽7) at the end of the 6th week of treatment. Adverse events (AEs) were also recorded.

RESULTS: From baseline to week 6, the HAMD-17 scores decreased 10.2 ± 4.0 and 9.1 ± 4.9 points in the JJD and paroxetine groups, respectively (P=0.689). The HAMD-17 response occurred in 60% of patients in the JJD group and in 50% of those in the paroxetine group (P=0.292); HAMD-17 remission occurred in 45.7% and 30% of patients, respectively (P=0.128). The differences of CGI scores at the 6th week were not statistically significant (P>0.05). There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week (P=0.001 and P=0.014). The HAMA scores declined 8.1 ± 3.0 and 6.9 ± 4.3 points from baseline to week 6 in the JJD and paroxetine groups, respectively (P=0.905 between groups). At 4th week of treatment, there was a significant difference in HAMA between the two groups (P=0.037). TCMSS decreased 11.4 ± 5.1, and 10.1 ± 6.8 points in the JJD and paroxetine groups, respectively (P=0.080 between groups). At the 6th week, the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group (7.14% vs. 22.86%, P<0.05).

CONCLUSION: Compared with paroxetine, JJD was associated with a significantly lower incidence of AEs in patients with mild-to-moderate depression of XPD syndrome, with no difference in efficacy at 6 weeks. (Trial registration No. ChiCTR2000040922).

PMID:36301455 | DOI:10.1007/s11655-022-3685-6

J Ultrasound. 2022 Oct 27. doi: 10.1007/s40477-022-00728-6. Online ahead of print.

ABSTRACT

PURPOSE: Respiratory distress syndrome (RDS), also known as hyaline membrane disease, is the most common clinical syndrome encountered among preterm infants, and the complications of the disease account for substantial mortality. Diagnosis of RDS is based on the clinical status of patients in correlation with laboratory parameters and chest X-ray. Lung ultrasound despite its wide use still is not incorporated into diagnostic algorithms. The aim of the study was to evaluate the diagnostic ability of lung ultrasound in diagnosing respiratory distress syndrome as well as in the monitoring of the response to treatment. A secondary aim was to propose a modified ultrasound grading scale.

METHODS: The prospective study included 150 neonates with clinical and radiographic signs of neonatal respiratory distress syndrome within the first 24 h of life, with different gestational age (≤ 35 weeks). Lung ultrasound was performed by two radiologists and correlated with a chest X-ray. Two gradation scales (ultrasound and X-ray) were compared and each scale was correlated with the patient’s clinical data.

RESULTS: In comparison between ultrasound findings and X-ray results showed a statistically significant difference in a favor of ultrasound. Based on the presence of subpleural consolidations, further differentiation of ultrasound profiles were made into subgroups and new ultrasound classification have been proposed.

CONCLUSION: Our study showed that lung ultrasound enables the diagnosing of respiratory distress syndrome in premature neonates and also shows a significant correlation with chest X-ray, which is considered as a radiological method of choice for the diagnosis of RDS.

PMID:36301438 | DOI:10.1007/s40477-022-00728-6

Pharmacoeconomics. 2022 Oct 27. doi: 10.1007/s40273-022-01209-8. Online ahead of print.

ABSTRACT

Fenfluramine, tradename Fintepla^®, was appraised within the National Institute for Health and Care Excellence (NICE) single technology appraisal (STA) process as Technology Appraisal 808. Within the STA process, the company (Zogenix International) provided NICE with a written submission and a mathematical health economic model, summarising the company’s estimates of the clinical effectiveness and cost-effectiveness of fenfluramine for patients with Dravet syndrome (DS). This company submission (CS) was reviewed by an evidence review group (ERG) independent of NICE. The ERG, Kleijnen Systematic Reviews in collaboration with Maastricht University Medical Centre, produced an ERG report. This paper presents a summary of the ERG report and the development of the NICE guidance. The CS included a systematic review of the evidence for fenfluramine. From this review the company identified and presented evidence from two randomised trials (Study 1 and Study 1504), an open-label extension study (Study 1503) and ‘real world evidence’ from a prospective and retrospective study. Both randomised trials were conducted in patients up to 18 years of age with DS, whose seizures were incompletely controlled with previous anti-epileptic drugs. A Bayesian network meta-analysis was performed to compare fenfluramine with cannabidiol plus clobazam. There was no evidence of a difference between any doses of fenfluramine and cannabidiol in the mean convulsive seizure frequency (CSF) rate during treatment. However, fenfluramine increased the number of patients achieving ≥ 50% reduction in CSF frequency from baseline compared to cannabidiol. The company used an individual-patient state-transition model (R version 3.5.2) to model cost-effectiveness of fenfluramine. The CSF and convulsive seizure-free days were estimated using patient-level data from the placebo arm of the fenfluramine registration studies. Subsequently, a treatment effect of either fenfluramine or cannabidiol was applied. Utility values for the economic model were obtained by mapping Pediatric Quality of Life Inventory data from the registration studies to EuroQol-5D-3L Youth (EQ-5D-Y-3L). The company included caregiver utilities in their base-case, as the severe needs of patients with DS have a major impact on parents and caregivers. There were several key issues. First, the company included caregiver utilities in the model in a way that when patients in the economic model died, the corresponding caregiver utility was also set to zero. Second, the model was built in R statistical software, resulting in transparency issues. Third, the company assumed the same percentage reduction for convulsive seizure days as was estimated for CSF. Fourth, during the final appraisal committee meeting, influential changes were made to the model that were not in line with the ERG’s preferences (but were accepted by the appraisal committee). The company’s revised and final incremental cost effectiveness ratio (ICER) in line with committee preferences resulted in fenfluramine dominating cannabidiol. Fenfluramine was recommended as an add-on to other antiepileptic medicines for treating seizures associated with DS in people aged 2 years and older in the National Health Service (NHS).

PMID:36301414 | DOI:10.1007/s40273-022-01209-8

Obes Surg. 2022 Oct 27. doi: 10.1007/s11695-022-06328-x. Online ahead of print.

ABSTRACT

PURPOSE : Intestinal remodeling and adaptation of the alimentary limb after Roux-en-Y gastric bypass (RYGB) play an important role in the pathophysiological events that lead to type 2 diabetes mellitus (T2DM) improvement. Intestinal absorptive loop hypertrophy and growth following surgery have been related to GLP-2 secretion by ileal L-cells. The secretion of peptide tyrosine-tyrosine (PYY) enterohormone after a meal has been proposed as a trigger for ileal secretion of GLP-1. Our aim is to determine the role of PYY as a GLP-2 secretion modulator as an adaptation result in the alimentary limb after RYGB.

METHOD: We used a non-obese euglycemic rodent model. Circulating glucose, insulin, PYY, and GLP-2 were measured in the experimental and control groups. We used four groups: fasting control, Sham-operated, RYGB-operated (RYGB), and RYGB-operated and treated with BIIE0246 (RYGB + BII). BIIE0246 is a NPY2 receptor antagonist in L-cells. Intestinal glucose transporters and GLP-1 and PYY gut expression and hypertrophy were analyzed after 12 weeks of surgery.

RESULTS: RYGB increased PYY3-36 plasma levels in rats with or without BII treatment. A high-insulin response was observed in the RYGB group but not in the control or RYGB + BII groups. BIIE0246 treatment limited plasma GLP-2 levels. In the alimentary intestinal limb, hypertrophy and SGLT1 and GLUT1 expression appeared to be reduced after RYGB compared to controls.

CONCLUSION: The postprandial ileal PYY secretion is enhanced after RYGB. This increase mediates GLP-2 release through its binding to the Y2 receptor on L-cells. This mechanism plays a role in alimentary limb hypertrophy after surgery.

PMID:36301409 | DOI:10.1007/s11695-022-06328-x

Prev Sci. 2022 Oct 27. doi: 10.1007/s11121-022-01449-2. Online ahead of print.

ABSTRACT

Suicide is the fourth leading cause of death among adolescents, globally. Though post-primary, school-based suicide prevention (PSSP) has the potential to be a key strategy for preventing adolescent suicidal thoughts and behaviours (STBs), there are persisting challenges to translating PSSP research to practice. Intervention and contextual factors relevant to PSSP are likely key to both PSSP effectiveness and implementation. As such, this systematic review aimed to summarise the effectiveness of PSSP for adolescent STBs and highlight important intervention and contextual factors with respect to PSSP. PsycINFO, Medline, Education Source, ERIC, Web of Science, and the Cochrane Central Register of Controlled Trials were searched to identify randomised and non-randomised studies evaluating the effectiveness of interventions located in post-primary, school-based settings targeting adolescent STBs. PSSP effectiveness and intervention and contextual factors were synthesised narratively. Twenty-eight studies were retained, containing nearly 47,000 participants. Twelve out of twenty-nine trials comparing intervention and independent control comparators reported statistically significant reductions in STBs postintervention, and 5/7 trials comparing preintervention and postintervention scores demonstrated significant reductions in STBs over time. Reporting and analysis of intervention and contextual factors were lacking across studies, but PSSP effectiveness and intervention acceptability varied across type of school. Although school personnel commonly delivered PSSP interventions, their input and perspectives on PSSP interventions were lacking. Notably, adolescents had little involvement in designing, inputting on, delivering and sharing their perspectives on PSSP interventions. Twenty out of twenty-eight studies were rated as moderate/high risk of bias, with non-randomised trials demonstrating greater risks of bias and trial effectiveness, in comparison to cluster randomised trials. Future research should prioritise complete reporting and analysis of intervention and contextual factors with respect to PSSP, involving key stakeholders (including adolescents and school personnel) in PSSP, and investigating key stakeholders’ perspectives on PSSP. Given the inverse associations between both study quality and study design with PSSP effectiveness, particular consideration to study quality and design in PSSP research is needed. Future practice should consider PSSP interventions with universal components and PSSP which supports and involves key stakeholders in engaging with PSSP.

PMID:36301381 | DOI:10.1007/s11121-022-01449-2

Wien Klin Wochenschr. 2022 Oct 27. doi: 10.1007/s00508-022-02098-9. Online ahead of print.

ABSTRACT

BACKGROUND: Remdesivir is the only antiviral agent approved for the treatment of hospitalized coronavirus disease 2019 (COVID-19) patients requiring supplemental oxygen. Studies show conflicting results regarding its effect on mortality.

METHODS: In this single center observational study, we included adult hospitalized COVID-19 patients. Patients who were treated with remdesivir were compared to controls. Remdesivir was administered for 5 days. To adjust for any imbalances in our cohort, a propensity score matched analysis was performed. The aim of our study was to analyze the effect of remdesivir on in-hospital mortality and length of stay (LOS).

RESULTS: After propensity score matching, 350 patients (175 remdesivir, 175 controls) were included in our analysis. Overall, in-hospital mortality was not significantly different between groups remdesivir 5.7% [10/175] vs. control 8.6% [15/175], hazard ratio 0.50, 95% confidence interval (CI) 0.22-1.12, p = 0.091. Subgroup analysis showed a significant reduction of in-hospital mortality in patients who were treated with remdesivir ≤ 7 days of symptom onset remdesivir 4.2% [5/121] vs. control 10.4% [13/125], hazard ratio 0.26, 95% CI 0.09 to 0.75, p = 0.012 and in female patients remdesivir 2.9% [2/69] vs. control 12.2% [9/74], hazard ratio 0.18 95%CI 0.04 to 0.85, p = 0.03. Patients in the remdesivir group had a significantly longer LOS (11 days vs. 9 days, p = 0.046).

CONCLUSION: Remdesivir did not reduce in-hospital mortality in our whole propensity score matched cohort, but subgroup analysis showed a significant mortality reduction in female patients and in patients treated within ≤ 7 days of symptom onset. Remdesivir may reduce mortality in patients who are treated in the early stages of illness.

PMID:36301355 | DOI:10.1007/s00508-022-02098-9

Environ Monit Assess. 2022 Oct 27;195(1):39. doi: 10.1007/s10661-022-10642-3.

ABSTRACT

Groundwater contamination becomes an alarming threat to the provision of ecosystem services and natural resources. A very high level of groundwater contamination has been observed in the northeastern states particularly in North Tripura district. Therefore, the present study considered the region as a case study to evaluate the hydrogeochemical facies, heavy metal pollution and irrigation indices, and their impact on human health. For the investigation, we have collected a total of 35 groundwater samples from North Tripura district. Hydrogeochemical facies through Piper plot reflect Ca²⁺-Mg²⁺-HCO₃^– and Na⁺-HCO₃^– as dominant water types. Gibbs plot identifies the dominance of rock-water interaction process in groundwater hydrochemistry. Geochemical plots indicate the dominance of silicate weathering, ion exchange and carbonate dissolution processes in groundwater mineralisation. The order of trace metal contaminations follows Fe > As > Zn > Mn > Cu > Pb. Results of heavy metal indices suggest above 80% samples are at high risk due to high Fe contamination. The risk of the heavy metal indices is associated with rising elevation in southern part of North Tripura. Findings of health risk assessment study imply that children face much carcinogenic and non-carcinogenic risks than adults because of unsafe levels of Fe and As. Multivariate statistical tools are applied to unravel interrelationships among all ions and trace metals as well as probable hydrogeochemical processes in groundwater. Results of Wilcox and USSL plots suggest 77% samples meet irrigation suitability criteria. Besides, the analysis suggests a better insight to identify hydrogeochemical processes controlling groundwater chemistry and the suitability of groundwater for irrigation and drinking purposes. The study also suggests treatment and sustainable management of groundwater resources is compulsory to reduce trace metal contaminations before public use.

PMID:36301348 | DOI:10.1007/s10661-022-10642-3

Arch Gynecol Obstet. 2022 Oct 27. doi: 10.1007/s00404-022-06778-9. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to evaluate the postoperative course after different methods of hysterectomy for benign diseases with special emphasis on time to recovery and patient-centred aspects such as postoperative quality of life and satisfaction.

METHODS: A collective of 242 women who had undergone vaginal hysterectomy (VH), laparoscopic supracervical hysterectomy (LASH) or total laparoscopic hysterectomy (TLH) for various benign conditions was studied in this retrospective investigation. Patients completed a standardised questionnaire addressing quality of life, recovery and sick leave as well as general questions on their postoperative course after hysterectomy.

RESULTS: A total of 242 cases were analysed (82 VH, 92 LASH and 68 TLH). The data demonstrate significant differences in regard to age between groups. The present study shows shorter hospitalisation with laparoscopy, with LASH patients returning to work at least one week earlier on average. There were no relevant differences in the overall postoperative course during the index hospital stay. In the long run, laparoscopic patients were not more satisfied with their choice than VH patients.

CONCLUSION: No significant long-term differences could be observed in terms of quality of life and overall postoperative satisfaction between VH and LH groups. In regard to socioeconomic aspects, laparoscopic approaches were associated with shorter hospitalisation and LASH patients returning to work at least one week earlier on average. Contrary to these data on objective recovery; however, a laparoscopic approach did not lead to patient-perceived, i.e. subjective improvement of time to full recovery.

PMID:36301347 | DOI:10.1007/s00404-022-06778-9

J Womens Health (Larchmt). 2022 Oct 25. doi: 10.1089/jwh.2022.0065. Online ahead of print.

ABSTRACT

Background: The U.S. Preventive Services Task Force recommends biennial screening mammography for average-risk women aged 50-74 years. We aim to generate county-level prevalence estimates for mammography use to examine disparities among counties. Materials and Methods: We used data from the 2018 Behavioral Risk Factor Surveillance System (BRFSS) (n = 111,902 women) and linked them to county-level data from the American Community Survey. We defined two outcomes: mammography within the past 2 years (current); and mammography 5 or more years ago or never (rarely or never). We poststratified the data with U.S. Census estimated county population counts, ran Monte Carlo simulations, and generated county-level estimates. We aggregated estimates to state and national levels. We validated internal consistency between our model-based and BRFSS state estimates using Spearman and Pearson correlation coefficients. Results: Nationally, more than three in four women [78.7% (95% confidence interval {CI}: 78.2%-79.2%)] were current with mammography, although with large variations among counties. Also, nationally, about one in nine women [11% (95% CI: 10.8%-11.3%)] rarely or never had a mammogram. County estimates for being current ranged from 60.4% in New Mexico to 86.9% in Hawaii. Rarely or never having a mammogram ranged from 6% in Connecticut to 23.0% in Alaska, and on average, almost one in eight women in all the counties. Internal consistency correlation coefficient tests were ≥0.94. Conclusions: Our analyses identified marked county variations in mammography use across the country among women aged 50-74 years. We generated estimates for all counties, which may be helpful for targeted outreach to increase mammography uptake.

PMID:36301186 | DOI:10.1089/jwh.2022.0065