Therapeutics and Clinical Risk Management最新文献

Pelvic inflammatory disease (PID) is a common reproductive health disorder among women of reproductive age. The treatment of PID has slowly evolved, reflecting changing antibiotic susceptibility and advancements in therapeutics and research; however, it has been largely unchanged over the last several decades. The most recent treatment recommendations consider the severity of infection, clinical presentation, and the polymicrobial nature of the disease. In addition, the role of novel organisms like Mycoplasma genitalium in PID is of emerging significance. PID treatment guidance offers oral and parenteral treatment options based on the patient's clinical status; however, deviations from the published guidelines are a general concern. Point of care (POC) testing for precision care, provision of adherence support, optimizing self-management and prevention strategies, and other alternative or synergistic approaches that maximize treatment outcomes will be instrumental for addressing the current challenges in PID diagnosis and management.

Introduction: Psoriasis is a chronic, immune-mediated skin condition with significant detriments to physical/mental health. While systemic therapies are available for the treatment of moderate-to-severe psoriasis, patients can experience therapeutic failure, loss of efficacy, or medical contraindications that require other therapeutic options.

Objective: With the recent approval of deucravacitinib, a first-in-class TYK2 small molecule inhibitor administered orally for psoriasis patients, we reviewed data from randomized controlled trials (RCTs) to synthesize its clinical utility. To our knowledge, this is the first systematic review and meta-analysis of deucravacitinib comparing its clinical efficacy to placebo in psoriasis.

Methods: A literature search was conducted in PubMed (MEDLINE), Embase, and the Cochrane Central Register of Controlled Trials to identify RCTs studying deucravacitinib in human patients with moderate-to-severe psoriasis.

Results: One placebo-controlled Phase II RCT and two placebo-controlled/active-comparator Phase III RCTs were included for review. Patients (N=1953) treated with deucravacitinib 6 mg daily showed marked improvement in disease severity (Psoriasis Area and Severity Index (PASI), static Physician Global Assessment (sPGA) and quality-of-life outcomes compared to patients administered comparator (apremilast) and placebo. Clinical improvement given deucravacitinib was noted for scalp psoriasis but not fingernail psoriasis. Meta-analysis (deucravacitinib, n=888; placebo, n=466) comparing rates of clearance (sPGA 0/1) demonstrated superior efficacy of deucravacitinib compared to placebo (odds ratio, 12.87; 95% confidence interval, 8.97-18.48; χ²=4.08, I²=51%). Deucravacitinib was well-tolerated, with similar rate of occurrence and type of adverse events reported among patients treated with placebo or apremilast at Week 12-16. No cardiovascular events, serious infections, or lab abnormalities were noted.

Conclusion: Deucravacitinib possesses good efficacy, with no report of safety concerns associated with prior JAK inhibitors used for psoriasis. Meta-analysis demonstrated deucravacitinib's superiority compared to placebo, indicating its promising clinical utility. Further studies are needed to observe long-term safety and efficacy, and to compare deucravacitinib to existing treatments.

Background: The visualization of the glottis may be inadequate in morbidly obese patients when a standard Macintosh blade laryngoscope (MCL) is used. The Vie Scope^® (VS) is a novel type laryngoscope consisting of a straight, enclosed, illuminated tube that offers intubation via a bougie using the paraglossal technique. In this prospective, nonrandomized comparative study, we tested the research hypothesis that the VS may improve visualization of the glottic larynx in comparison to the MCL.

Materials and methods: After obtaining institutional ethics committee approval, 60 morbidly obese patients (BMI >40 kg/m²) undergoing elective non-head and neck surgery were included in the study. After induction of general anesthesia (GA), the glottic visualization was performed using the two laryngoscopes in succession, first MCL size 3 or 4 followed by the VS and was assessed using the modified Cormack-Lehane scale. Tracheal intubation was performed using the VS The first pass intubation success and the total success rate was recorded only for the VS Intubation time was not measured because of the paired study design.

Results and discussion: Mean demographic data included: age 41.9±8.2 years, height 171.2±10.2 cm, weight 129.9±21.6 kg, BMI 44.95±3.85 kg/m². Using MCL, Cormack-Lehane grade 1 was observed in 36 (60%) cases; grade 2 in 7/60 (11.6%); grade 3 in 13/60 (21.7%); and grade 4 in 4/60 (6.7%). Poor laryngeal views represented by grades 3 and 4 were observed in 28.4% of patients with the MCL. Grades obtained with the VS were all grade 1 (100%). The first attempt intubation success was in 58/60 (96.7%) with the VS. No complications were observed.

Conclusion: The Vie Scope^® laryngoscope, using the paraglossal technique of tracheal intubation, significantly improves visualization of the vocal cords in morbidly obese patients compared to the standard Macintosh laryngoscope.

Inborn errors of thymic stromal cell development and function which are associated with congenital athymia result in life-threatening immunodeficiency with susceptibility to infections and autoimmunity. Athymic patients can be treated by thymus transplantation using cultured donor thymus tissue. Outcomes in patients treated at Duke University Medical Center and Great Ormond Street Hospital (GOSH) over the past three decades have shown that sufficient T-cell immunity can be recovered to clear and prevent infections, but post-treatment autoimmune manifestations are relatively common. Whilst thymus transplantation offers the chance of long-term survival, significant challenges remain to optimise the outcomes for the patients. In this review, we will discuss unmet needs and offer practical guidance based on the experience of the European Thymus Transplantation programme at GOSH. Newborn screening (NBS) for severe combined immunodeficiency (SCID) and routine use of next-generation sequencing (NGS) platforms have improved early recognition of congenital athymia and increasing numbers of patients are being referred for thymus transplantation. Nevertheless, there remain delays in diagnosis, in particular when the cause is genetically undefined, and treatment accessibility needs to be improved. The majority of athymic patients have syndromic features with acute and chronic complex health issues, requiring life-long multidisciplinary and multicentre collaboration to optimise their medical and social care. Comprehensive follow up after thymus transplantation including monitoring of immunological results, management of co-morbidities and patient and family quality-of-life experience, is vital to understanding long-term outcomes for this rare cohort of patients. Alongside translational research into improving strategies for thymus replacement therapy, patient-focused clinical research will facilitate the design of strategies to improve the overall care for athymic patients.

Purpose: Preseptal and pretarsal botulinum toxin injections are approved for treatment of hemifacial spasm and blepharospasm. However, the long-term data is limited. We compared the efficacy, safety, and costs between preseptal and pretarsal injection in hemifacial spasm and blepharospasm.

Patients and methods: The data were retrieved between 2011 and 2021. Consecutive hemifacial spasm and blepharospasm botulinum toxin patients were categorized as preseptal or pretarsal. Study outcomes were the difference in pre-and post-treatment modified Jankovic scale, self-reporting scales, time-related treatment, safety, and cost.

Results: Of 152 botulinum toxin-injected patients, 117 (77.0%) patients had hemifacial spasm and 35 (33.0%) patients had blepharospasm. Analysis included data pertinent to 1665 injections in hemifacial spasm (920 preseptal and 745 pretarsal) and 527 injections in blepharospasm (210 preseptal and 317 pretarsal). The difference between pre-and post-treatment modified Jankovic scale was lower in the preseptal group than in the pretarsal group in both hemifacial spasm and blepharospasm (1.5±0.8 vs 1.8±0.6, P-value <0.001 and 1.8±0.8 vs 3.1±0.9, P-value <0.001). There was no difference in duration of maximum response in hemifacial spasm between groups, while the blepharospasm with preseptal had a longer duration than blepharospasm with pretarsal. The preseptal injection was associated with more adverse events overall than the pretarsal (9.4% vs 5.2%, P-value <0.001). The total dose and cost per session in the preseptal group is lower for onabotulinum toxin but higher for abobotulinum toxin.

Conclusion: Pretarsal injections reduced symptom severity with fewer side effects. Further studies on the pharmacoeconomics of both techniques are required.

Articular cartilage repair is a sophisticated process that has is being recently investigated. There are several different approaches that are currently reported to promote cartilage repair, like cell-based therapies, biologics, and physical therapy. Cell-based therapies involve the using stem cells or chondrocytes, which make up cartilage, to promote the growth of new cartilage. Biologics, like growth factors, are also being applied to enhance cartilage repair. Physical therapy, like exercise and weight-bearing activities, can also be used to promote cartilage repair by inducing new cartilage growth and improving joint function. Additionally, surgical options like osteochondral autograft, autologous chondrocyte implantation, microfracture, and others are also reported for cartilage regeneration. In the current literature review, we aim to provide an up-to-date discussion about these approaches and discuss the current research status.

Pompe disease (PD) is a neuromuscular disorder caused by a deficiency of acid alpha-glucosidase (GAA) - a lysosomal enzyme responsible for hydrolyzing glycogen. GAA deficiency leads to accumulation of glycogen in lysosomes, causing cellular disruption. The severity of PD is directly related to the extent of GAA deficiency - if no or minimal GAA is produced, symptoms are severe and manifest in infancy, known as infantile onset PD (IOPD). If left untreated, infants with IOPD experience muscle hypotonia and cardio-respiratory failure leading to significant morbidity and mortality in the first year of life. In contrast, late-onset PD (LOPD) patients have more GAA activity and present later in life, but also have significant respiratory function decline. Despite FDA-approved enzyme replacement therapy, respiratory insufficiency remains a major cause of morbidity and mortality, emphasizing the importance of early detection and management of respiratory complications. These complications include impaired cough and airway clearance, respiratory muscle weakness, sleep-related breathing issues, and pulmonary infections. This review aims to provide an overview of the respiratory pathology, monitoring, and management of PD patients. In addition, we discuss the impact of novel approaches and therapies on respiratory function in PD.

Background: The COVID-19 pandemic continues, and this condition has caused many cases in various countries around the world, resulting in more than 6 million deaths worldwide. Herbal medicines can act as immunomodulators, anti-inflammatories, antioxidants, antimicrobials, and others depending on the type and content of the herbs used. Previous studies have shown that several types of herbs, such as Echinacea purpurea, Curcumin or Turmeric, Nigella sativa, and Zingiber officinale, have proven their effectiveness as herbal plants for COVID-19.

Methods: We conducted a comprehensive literature search through five databases, namely, PubMed, Scopus, Embase, Wiley, and ProQuest to assess the efficacy of phytopharmaceuticals until July 12, 2022. We used the Cochrane RoB 2.0 for the quality assessment of the study.

Results: Phytopharmaceuticals significantly improved patients' recovery rate (OR = 3.54; p < 0.00001) and reduced deaths (OR = 0.24; p < 0.0001) compared to the control group. Phytopharmaceuticals also performed as a protective factor for COVID-19 clinical symptoms, such as dyspnea (OR = 0.42; p < 0.05) and myalgia (OR = 0.31; p = 0.02) compared to the control group. However, there is no statistically significant effect on cough (OR = 0.76; p = 0.61) and fever (OR = 0.60; p < 0.20). The results were not affected by patients' covariates [hypertension, diabetes mellitus, and cardiovascular diseases (meta-regression p > 0.05)].

Conclusion: Herbal medicine has the potential as an adjuvant therapy in the management of COVID-19.

Purpose: Myocardial injury after non-cardiac surgery is closely related to major adverse cardiac and cerebrovascular event and is difficult to identify. This study aims to investigate how to predict the myocardial injury of thoracic surgery and whether intraoperative variables contribute to the prediction of myocardial injury.

Methods: The prospective study included adult patients with high cardiovascular risk who underwent elective thoracic surgery from May 2022 to October 2022. Multivariate logistic regression was used to establish a model with baseline variables and a model with baseline and intraoperative variables. We compare the predictive performance of two models for postoperative myocardial injury.

Results: In general, 31.5% (94 of 298) occurred myocardial injury. Age ≥65 years old, obesity, smoking, preoperative hsTnT, and one-lung ventilation time were independent predictors of myocardial injury. Compared with baseline model, the intraoperative variables improved model fit, modestly improved the reclassification (continuous net reclassification improvement 0.409, 95% CI, 0.169 to 0.648, P<0.001, improved integrated discrimination 0.036, 95% CI, 0.011 to 0.062, P<0.01) of myocardial injury cases, and achieved higher net benefit in decision curve analysis.

Conclusion: The risk stratification and anesthesia management of high-risk patients are essential. The addition of intraoperative variables to the baseline predictive model improved the performance of the overall model of myocardial injury and helped anesthesiologists screen out the patients at the greatest risk for myocardial injury and adjust anesthesia strategies.

Objective: This study aims to compare 1-month's efficacy and safety of single-session ethanol ablation and radiofrequency ablation for treating both purely cystic nodules and predominantly cystic thyroid nodules.

Materials and methods: This short-term retrospective study was approved by the Ethics Committee of the Institutional Review Board of Danang Family hospital, and written informed consent for procedures was obtained for all patients. Thirty-nine patients who presented with cystic thyroid nodules and met inclusion criteria were extracted from the computerized medical records. The internal fluid of cystic thyroid nodules was aspirated as much as possible. Ethanol ablation was performed using 18-gauge needles with 99.5% ethanol, and RFA used a cooled-electrode RFA system and 18-gauge internally cooled electrodes via the trans-isthmic approach, moving-shot technique. Nodule volume, therapeutic success rate, the largest diameter, thyroid function tests, and complications were evaluated and compared before and after treatment in each group.

Results: Among 39 patients, 17 patients were undergone EA (mean age of 47.35 years; the proportion of female of 76.5%; purely thyroid cyst percentage of 41.4%) and 22 patients were undergone RFA (mean age of 46.63 years; the proportion of female of 86.4%; purely thyroid cyst percentage of 54.5%). Both treatment techniques showed a significant reduction of the largest diameter and nodule volume (p<0.05) without complications. RFA reduced nodule volume and the largest nodule size greater than EA treatment at 1-month post-ablation (p<0.05). In addition, the therapeutic success rate in the RFA group was higher than in the EA group.

Conclusion: Both RFA and EA treatment with single-session confirm the efficacy and safety for cystic thyroid nodules at 1-month follow-up, RFA reduced greater in nodule volume and the largest nodule size than the EA treatment. Thus, the therapeutic success rate in the RFA group was higher than in the EA group.