Current Medical Research and Opinion最新文献

There is an increasing demand for effective treatments for depression, particularly for individuals grappling with treatment-resistant depression. Over recent years, a surge of interest has focused on exploring the safety and efficacy of psilocybin as a potential treatment for depression. However, preliminary findings from phase 2 studies have been inconclusive, prompting critical examination of issues such as maintaining blinding and the role of adjunctive psychotherapy. The maintenance of double-blinding and the role of adjunctive psychotherapy introduce biases that complicate the attainment of conclusive results in clinical research. Examining historical data reveals a recurrent pattern linked to the use of psychoactive substances, which starts with an excess of optimism and ends with general addictive behaviors and a heightened risk of serious public health problems. Considering these findings, a cautious and measured approach is imperative, given that the efficacy and safety of psilocybin treatment have yet to be unequivocally established. The potential for excessive optimism among researchers is a notable concern, as unwarranted enthusiasm may inadvertently facilitate the widespread adoption of this treatment without sufficient empirical support. In navigating the complexities of depression treatment, it is necessary to strike a balance between innovation and prudence to ensure evidence-based advancement of therapeutic approaches.

Background: Low back pain (LBP) is a debilitating phenomenon that significantly impacts quality-of-life (QoL). The PainDETECT questionnaire (PD-Q) is a screening tool aimed at distinguishing nociceptive pain (NoP) and neuropathic pain (NeP) classifications. Associations between these classifications and patient-reported outcome measures (PROMs) and sociodemographic parameters are yet to be established.

Objective: The study aimed to determine the relationship between NeP as assessed by the PD-Q and pain, disability, QoL, and sociodemographic factors.

Methods: A retrospective analysis of an ongoing prospectively collected database was conducted involving 512 patients aged >18 years who presented to a tertiary spine clinic for LBP having completed the PainDETECT questionnaire, Oswestry Disability Index (ODI), EuroQol Five-Dimensional (EQ-5D) questionnaire, or answered questions regarding sociodemographic status.

Results: The NeP group had a higher mean numerical rating scale (NRS) score (7.96$\pm$1.54 vs. 5.76$\pm$2.27, p <.001) and lower age (55$\pm$15.6 vs. 59$\pm$17.8, p <.05) compared to the NoP group. When confounded for NRS, analysis of covariance demonstrated an 89.5% higher total ODI score (p <.001) and 50.5% lower EQ-5D utility score (p <.001) in the NeP compared to NoP group. Smokers and individuals with a no partner marital status were 2.373 (OR = 2.373, 95% CI = 1.319-4.266, p <.01) and 2.384 times (OR = 2.384, 95% CI = 1.390-4.092, p <.01) more likely to have NeP compared to NoP, respectively. Patients with NeP were also of lower income class compared to patients with NoP (Z = -2.45, p <.05).

Conclusion: NeP was associated with higher levels of disability and lower QoL. Smokers, individuals with a no partner marital status, and individuals with a lower income class were more likely to suffer NeP rather than NoP. These findings have illuminated a crucial notion: in patients with elevated NRS, the detrimental impact of NeP on patient wellbeing underscores the fundamental need to represent pain on a nociceptive-neuropathic continuum, permitting more accurate differentiation of pain components.

Background: Post-COVID-19 condition (PCC), also known as "long COVID," is characterized by persistent symptoms, negatively affecting the well-being of individuals with PCC. Anhedonia (i.e. reduced capacity for pleasure) and compromised psychosocial functioning are notable symptoms in those with PCC. We aimed to provide insights to understand the effects of anhedonia and impaired psychosocial functioning of individuals with PCC.

Methods: This post-hoc analysis used data from an 8-week, double-blind, randomized, placebo-controlled trial which evaluated vortioxetine for cognitive deficits in individuals with PCC (Clinicaltrials.gov Identifier: NCT05047952). A total of 147 eligible participants were randomly assigned to receive vortioxetine or matching placebo over eight weeks of double-blind treatment. Our study investigated the relationship between anhedonia, assessed by the Snaith-Hamilton Pleasure Scale (SHAPS), and psychosocial functioning, measured with the Post-COVID Functional Status (PCFS) scale. The analysis was conducted using a generalized linear model, with adjustments for relevant covariates such as age, sex, education, suspected versus confirmed COVID diagnosis, MDD diagnosis, and alcohol consumption.

Results: Of the 147 participants, 143 participants had available baseline data for analysis. We observed that baseline PCFS score was statistically significantly positively correlated to baseline SHAPS score (β = 0.070, p = 0.045, 95% CI).

Discussions: Our analysis revealed a significant relationship between measures of anhedonia and psychosocial functioning in adults with PCC. Strategies that aim to improve patient-reported outcomes with PCC need to prioritize the prevention and treatment of hedonic disturbances in patients experiencing PCC.

Objective: Use of tele-technology for monitoring symptoms, functional parameters, and quality-of-life of people with asthma is essential. Delivering this information among patients is mandated for a better outcome and made possible via patient education (PE). This review aims to summarize the types of telerehabilitation modalities, dosage, and outcome measures used to assess the effectiveness of PE among people with asthma.

Methods: We adopted a scoping review methodology. Thematic analysis was used to synthesize the data. The Preferred Reporting System for Meta-Analysis for Scoping Reviews (PRISMA-ScR) was followed during the review process.

Results: PubMed, Embase, and Scopus were searched, with 34 studies meeting inclusion criteria. Results are presented in three themes: telerehabilitation platforms used to deliver PE among patients with asthma; content, duration, and frequency of the PE administered; and patient-reported outcome measures used to evaluate the effectiveness of PE.

Conclusion: This scoping study detailed the types of telerehabilitation modalities, dosage, and outcome measures used to assess the effectiveness of PE in people with asthma. This review will be especially beneficial to those considering where additional research or implementation of telerehabilitation for asthma patients is required. The studies emphasized the involvement of several healthcare experts, emphasizing the significance of a multidisciplinary approach to efficient PE delivery and possible improvements in asthma management through telerehabilitation. Although a range of telerehabilitation platforms were generally accepted, hybrid models that integrate online and in-person sessions could further enhance patient satisfaction and quality-of-life. Comprehensive economic analyses are also required, and solving technology issues is essential to maximizing the efficacy of these initiatives.

Objective: MSB11022 is a biosimilar of adalimumab that has been shown comparable bioequivalence, safety, tolerability, and immunogenicity profiles to the reference adalimumab in healthy volunteers or in patients with psoriasis or rheumatoid arthritis (RA). This is the first study conducted under clinical practice conditions evaluating the switch from reference adalimumab to MSB11022 in patients with RA.

Methods: Retrospective and multicenter study with data from the medical records of patients with RA who switched from reference adalimumab or another biosimilar to MSB11022 and maintained this treatment for at least 6 months. Information registered comes from baseline visit, the moment of the switch, and the follow-up visits.

Results: Data from 86 patients were evaluated (median age 63.5 years, 75.6% female, 44.2% had erosive RA). Only 3.5% of the patients received biologic therapy prior to adalimumab. At baseline, median DAS28-CRP was 1.77 (80.2% in remission and 96.5% with low disease activity) and median CDAI was 4.00 (44.2% in remission and 90.7% with low disease activity). After a median follow-up of 8 months, median DAS28-CRP was 1.87 (86.0% in remission and 94.2% with low disease activity) and median CDAI was 4.00 (38.5% in remission and 95.3% with low disease activity). Only three patients experienced pain, swelling, and stinging at the injection site or a locally extensive hematoma in the area of administration.

Conclusions: Adalimumab biosimilar MSB11022 maintained the efficacy benefits provided by previous adalimumab treatments with a safety profile in line with that already described for other biosimilars.

Background: We aimed to summarize survival data from RCTs in patients with GO adenocarcinoma; estimate and explain worst-, typical-, and best-case-scenarios of survival time; and determine if simple multiples of median overall survival (mOS) could estimate these percentiles.

Methods: We systematically searched RCTs of systemic therapies for GO adenocarcinoma published 2000-2022. The following key percentiles were extracted from overall survival curves: 90th (worst-case), 75th (lower-typical), 25th (upper-typical), and 10th (best-case). We tested if these percentiles could be estimated by simple multiples of mOS: 0.25 of the median for the 90^th percentile, 0.5 for the 75^th, 2 for the 25^th, and 3 for the 10^th.

Results: We identified 44 trials (22,447 participants). For first line chemotherapy and immunotherapy combined (CI) trials (n = 3) worst-to-best case survival time ranged from 4 months to not reached, compared to 3-30 months for other trials (n = 27) and 1-23 months for subsequent lines (n = 14). Simple multiples of mOS accurately estimated the following survival percentiles: 90^th (n = 3/3 trials), 75^th (n = 3/3), and 25^th (n = 2/3) in first line CI trials. In other first line trials, the mOS accurately estimated the 90^th survival percentile in n = 22/27 trials, 75^th percentile in n = 26/27, 25^th percentile in 27/27 trials, and 10^th percentile in 22/27 trials. Simple multiples of the mOS accurately predicted the 90^th, 75^th, 25^th, and 10^th survival percentiles in the majority of trials of second and subsequent lines apart from chemotherapy and immunotherapy only trials.

Conclusion: We provide realistic, evidence-based prognostic information as scenarios for survival time which can inform clinical decision-making. Simple multiples of the mOS accurately estimated the percentiles for most groups.

Background: The current gold standard of scoliosis correction procedures is still posterior spinal fusion, an extensively studied procedure. anterior vertebral body tethering is a newer surgical technique for the correction of scoliotic curves. Consequently, best practices have yet to be determined.

Methods: A single-institution, retrospective, review of all patients diagnosed with adolescent idiopathic scoliosis who underwent two row anterior vertebral body tethering between June 2020 and April 2022 was performed.

Results: Over the study period, 95 patients met inclusion: 79 females (83.2%) and 16 males (16.8%), age 14.4 ± 2.5 years, with a body mass index of 20.0 ± 2.9, and an average of 8.4 ± 2.1 levels treated. 28 (29.5%) procedures were for double curves and 67 (70.5%) for single curves. After tethering, a chest tube was positioned in each corrected side. A total of 123 chest tubes were analyzed, including 67 single curves and 28 double curves. The average chest tube duration was 2.5 ± 1.1 days and the average length of stay was 5.0 ± 2.0 days. The average chest tube output eight hours prior to removal was 61.1 ± 45.6 mL. There was no significant difference in average length of stay for patients who underwent correction of a single curve versus a double curve nor was there a difference in average length of stay or chest tube duration for revisions compared to primary procedures. For the entire cohort, the 30-day emergency department visit rate was 7.4% (n = 7) and the readmission rate was 4.2% (n = 4).

Conclusions: This early review of a 2-year two row vertebral body tethering postoperative experience provides a report of a safe and effective approach to chest tube management at a single academic center.

Objective: To describe the clinical burden and healthcare resource utilization associated with managing transfusion-dependent β-thalassemia (TDT) in France.

Methods: We used the French National Health Data System (système national des données de santé) to identify eligible patients from January 1, 2012, to March 1, 2019. Inclusion criteria were a diagnosis of β-thalassemia, ≥8 red blood cell (RBC) transfusion episodes per year in ≥2 consecutive years following the diagnosis, and ≥1 year of follow-up data. Patients were excluded if medical records showed evidence of sickle cell disease, α-thalassemia, hereditary persistence of fetal hemoglobin, or hematopoietic stem cell transplant. Clinical complications, mortality, treatment use, and healthcare resource utilization were evaluated.

Results: Overall, 331 eligible patients with TDT were identified. Mean age was 26.1 (standard deviation [SD]: 18.0) years, and 50.5% were male. Common clinical complications were endocrine (26.0%), hepatobiliary (22.7%), and cardiopulmonary (18.7%). Fifteen (4.5%) patients died during follow-up, with a mortality rate of 1.16 deaths per 100 person-years (mean age of death: 52.5 years [SD: 22]). Patients had a mean of 13.5 (SD: 5.2) RBC transfusion episodes and 11.2 (SD: 5.3) iron chelation therapy treatments per year. Healthcare resource utilization was substantial, with a mean of 14.8 inpatient hospitalizations (including 13.8 mean inpatient day cases) and 16.9 outpatient prescriptions per patient per year.

Conclusions: Patients with TDT in France experience significant clinical complications, elevated mortality, and substantial healthcare resource utilization driven by frequent RBC transfusion episodes and inpatient hospitalizations. These results reinforce the need for disease-modifying therapies for this patient population.

Objective: To evaluate the overall survival (OS) of patients with chronic lymphocytic leukemia (CLL) receiving either ibrutinib monotherapy as a first-line (1L) treatment or chemotherapy/chemoimmunotherapy-based (CT/CIT) regimens in 1L followed by ibrutinib in the second line (1L CT/CIT-2L ibrutinib) after disease progression by emulating a randomized trial comparing both treatment sequences.

Methods: Patient-level data from the RESONATE-2 trial (NCT01722487) and real-world PHEDRA databases were analyzed. Three scenarios were considered using the following data sources: (1) RESONATE-2, (2) combined RESONATE-2/PHEDRA, (3) combined RESONATE-2/PHEDRA for 1L ibrutinib and PHEDRA for 1L CT/CIT-2L ibrutinib. Propensity score-based weights and inverse probability of censoring weighting were used to adjust for baseline (Scenarios 2 and 3) and time-dependent confounding (all scenarios), and to address potential biases. A weighted Cox proportional hazards model was used to estimate the OS hazard ratio (HR) and 95% confidence interval (CI) for 1L ibrutinib versus 1L CT/CIT-2L ibrutinib.

Results: Results from Scenario 1 showed a significantly lower risk of death with 1L ibrutinib compared with 1L chlorambucil followed by 2L ibrutinib (HR 0.35 [95% CI 0.20-0.62]). Results from Scenarios 2 and 3 demonstrated a reduced risk of death with 1L ibrutinib compared with 1L CT/CIT-2L ibrutinib (HR 0.35 [0.21-0.61] and 0.64 [0.39-1.04], respectively).

Conclusion: The analyses consistently showed a reduced risk of death when ibrutinib was used as a 1L treatment in CLL compared with delaying its use until 2L after CT/CIT regimens, which suggests that initiating ibrutinib in 1L is advantageous for improving survival outcomes.