Therapeutics and Clinical Risk Management最新文献

Objective: To identify risk factors for postoperative sore throat (POST) after general anesthesia in oral and maxillOfacial surgery.

Material and methods: This study is a retrospective cohort design study. We enrolled patients with oral and maxillofacial surgery who underwent endotracheal intubation under general anesthesia in the Stomatology Hospital, Zhejiang University School Of Medicine between April 2020 and April 2021. They were divided into the POST group and the without POST group. The distribution Of various characteristics in the two groups was firstly analyzed. Then, logistic regression analysis was performed to explore the independent predictors for POST occurrence. Following this, logistic regression and random forest models were constructed and their performance was evaluated to predict POST occurrence.

Results: A total of 891 participants were enrolled in the study. Female gender and cough during extubation were significantly associated with increased POST occurrence in multivariate analysis (all P <0.05). Stratified logistic regression analysis results showed that the female gender was an independent predictor for POST occurrence in the 4≤age≤14 and 1460 group after adjusting American Society of Anesthesiologists status and throat and lung disease (all P <0.05). The logistic regression model had a similar effect to the random forest model in predicting POST occurrence. Interestingly, the female gender had a higher important weight compared to the cough during extubation.

Conclusion: This research reveals female gender and cough during extubation as potential risk factors for POST occurrence, which may provide guidance for the effective prevention of POST in oral and maxillofacial surgery.

Purpose: Tacrolimus is recommended by KDIGO Clinical Practice Guidelines as an initial therapy for the treatment of membranous nephropathy (MN). However, little is known about the factors that influence response and recurrence of the disease after tacrolimus therapy, and there are limited data regarding the duration of tacrolimus treatment. Here, we present a real-world retrospective cohort study of 182 MN patients treated with tacrolimus, aiming to assess the efficacy and safety of tacrolimus in the treatment of MN.

Patients and methods: The clinical data of 182 patients with MN treated with tacrolimus and followed up for at least one year were analyzed retrospectively for the efficacy and safety of tacrolimus.

Results: The mean follow-up period was 27.3 (19.3-41.6) months. A total of 154 patients (84.6%) achieved complete or partial remission, and 28 patients (15.4%) did not. Multivariate Cox regression analysis showed that male and higher baseline BMI were independently associated with lower, while higher serum albumin was associated with higher probability of remission. Among the responders, 56 patients (36.4%) relapsed. After adjustments for age and sex, Cox regression analysis revealed that the longer period of full-dose tacrolimus was administered, the lower the incidence of relapse. However, high levels of serum creatinine and proteinuria at the onset of tacrolimus discontinuation were risk factors for relapse. During the treatment of tacrolimus, a decline in renal function (≥50% increase in serum creatinine after the onset of tacrolimus treatment) was the most common adverse reaction, observed in 20 (11.0%) patients, followed by elevated blood glucose and infection, but the latter two occurred mostly during treatment with tacrolimus plus corticosteroids.

Conclusion: Tacrolimus is effective in the treatment of MN, but the relapse rate is high. Clinical studies with larger sample sizes are needed to further explore the use of tacrolimus in the treatment of membranous nephropathy.

Objective: The effect of labor analgesia on gastric emptying rate will affect the management of fasting during the perinatal period. To evaluate gastric emptying after labor analgesia using the gastric antrum ultrasound examination.

Methods: From September 2022 to January 2023, a prospective controlled observational study was conducted. The Study group (epidural analgesia group) and Observation group (pharmacological and non-pharmacological interventions group) were successively enrolled and grouped using the random envelope method. However, labor analgesia was supplied according to maternal women's wishes, and intention-to-treat (ITT) and per-protocol (PP) analyses were performed to establish its effect on stomach emptying. The gastric emptying rate during the first stage of labor was considered to be the primary outcome.

Results: From September 2022 to January 2023, 120 persons were studied, 90 in the Study group and 30 in the Observation group. 33 people's analgesic selection was discordant with the grouped one. ITT analysis showed that the Study group's cross-sectional area (CSA) fell from baseline (624.19 ± 92.70 mm²) to 334.64 ± 46.32 mm² after 1 hour and to 217.26 ± 29.90 mm² after 2 hours. In the Observation group, the CSA similarly dropped from 620.10 ± 100.73 mm² to 331.30 ± 51.19 mm² and 214.70 ± 28.73 mm², p<0.001. CSA was not significantly different between groups, p>0.05. The PP analysis also indicated no significant changes in the CSA between the two groups at 3 time-points, p>0.05. At the first hour, the Study and Observation group had stomach emptying speeds of 300.05 ± 103.74 mm²/h and 259.50 ± 125.25 mm²/h, respectively, which were greater than those at the second hour (115.75 ± 43.51 mm²/h vs 124.36 ± 58.98 mm²/h), p<0.001.

Conclusion: Epidural analgesia, pharmacological, and non-pharmacological labor analgesia had little effect on gastric emptying, and gastric antrum ultrasonography can be utilized to monitor maternal gastric volume changes.

Background: Antibody-mediated rejection (AMR) is emerging as the main cause of graft loss after kidney transplantation. Our previous study revealed the gut microbiota alternation associated with AMR in kidney transplant recipients, which was predicted to affect the metabolism-related pathways.

Methods: To further investigate the shifts in intestinal metabolic profile among kidney transplantation recipients with AMR, fecal samples from kidney transplant recipients and patients with end-stage renal disease (ESRD) were subjected to untargeted LC-MS-based metabolomics.

Results: A total of 86 individuals were enrolled in this study, including 30 kidney transplantation recipients with AMR, 35 kidney transplant recipients with stable renal function (KT-SRF), and 21 participants with ESRD. Fecal metabolome in patients with ESRD and kidney transplantation recipients with KT-SRF were parallelly detected as controls. Our results demonstrated that intestinal metabolic profile of patients with AMR differed significantly from those with ESRD. A total of 172 and 25 differential metabolites were identified in the KT-AMR group, when compared with the ESRD group and the KT-SRF group, respectively, and 14 were common to the pairwise comparisons, some of which had good discriminative ability for AMR. KEGG pathway enrichment analysis demonstrated that the different metabolites between the KT-AMR and ESRD groups or between KT-AMR and KT-SRF groups were significantly enriched in 33 or 36 signaling pathways, respectively.

Conclusion: From the metabolic point of view, our findings may provide key clues for developing effective diagnostic biomarkers and therapeutic targets for AMR after kidney transplantation.

Objective: This study aimed to compare the anatomical and functional outcomes of the modified McIndoe vaginoplasty for Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome using swine small intestinal submucosa (SIS) graft or homologous skin grafts.

Methods: A total of 115 patients with MRKHs who underwent neovaginoplasty between January 2012 and December 2021 were included in the study. Among them, 84 patients received vaginal reconstruction with SIS graft, whereas 31 neovaginoplasty underwent a skin graft procedure. The length and width of the neovagina were measured, and sexual satisfaction was evaluated using the Female Sexual Function Index (FSFI). The operation details, cost, and complications were also assessed.

Results: The SIS graft group had a significantly shorter mean operation time (61.13±7.17min) and less bleeding during the operation (38.57±9.46mL) compared to the skin graft group (92.1±9.47min and 55.81±8.28mL, respectively). The mean length and width of the neovagina in the SIS group were comparable to the skin graft group at 6 months follow-up (7.73±0.57 cm versus 7.6±0.62cm, P=0.32). The SIS group had a higher total FSFI index than the skin graft group (27.44±1.58 versus 25.33±2.16, P=0.001).

Conclusion: The modified McIndoe neovaginoplasty using SIS graft is a safe and effective alternative to homologous skin grafts. It results in comparable anatomical outcomes and superior sexual and functional outcomes. Overall, these results suggest that the modified McIndoe neovaginoplasty using SIS graft is preferred for MRKH patients who require vaginal reconstruction.

From a surgical point of view, the development of preoperative oncological treatment has had a profound effect on the surgical treatment trends of cancer as well as on the outcomes of cancer patients. Consequently, these changes have challenged formerly entrenched oncological surgical principles. In our short report, we aimed to summarize the main shifts regarding the surgical principles of cancer treatment due to the development of preoperative oncological therapy in recent years. As a result of successful preoperative treatment, surgeons may perform less radical surgeries, the required free resection margin has been narrowed down to a few millimeters in dimension and preoperative treatment is justified in both definitely resectable tumors and in oligometastatic tumors as well. For prognosis assessment, the post-preoperative oncological treatment stage is now considered decisive, rather than the pretreatment stage as previously thought. Other changes include the introduction of the watch and wait strategy and the reverse order of treatment of the primary tumor and metastasis. Observing the continuously improving outcomes of cancer patients and the developments in oncological treatment modalities, a further expansion of the indication of preoperative treatments is to be expected.

Hereditary angioedema (HAE) is a condition characterized by episodes of cutaneous and submucosal edema. Angioedema of the extremities and abdominal attacks are the most common manifestations of the disease. It can also affect the upper airways with the potential of becoming life-threatening. The two most common causes of HAE are a deficiency of C1 inhibitor (classified as type 1 HAE) or a dysfunction of C1 inhibitor (type 2 HAE). A malfunction or deficiency of C1 inhibitor leads to an overactivated plasma kallikrein (an inflammatory vasoactive peptide), that increases bradykinin, mediating the angioedema episodes in patients with HAE. To minimize the difficulties of this pathology and to improve patients' quality of life, prevention of this condition is essential. Berotralstat is a unique option for oral administration for routine prophylaxis. This drug acts by binding to kallikrein and reducing its plasma activity, lowering bradykinin levels. Open-label studies have demonstrated the effectiveness of a single daily dose of berotralstat 150 mg in preventing HAE attacks. This review aims to examine studies performed to elucidate the efficacy, safety, and tolerability of berotralstat.

Background: Acute coronary syndrome (ACS) patients need intense therapy and diagnostic evaluation for improved treatment. In Ethiopia, where patient deaths and hospital stays are rising, the ACS treatment is thought to be not very effective.

Methods: A retrospective cross-sectional study was conducted at St. Paul Hospital. The data were collected from patients medical records using a structured data abstraction checklist from 2018 to 2020. The data was entered, analyzed, and interpreted using SPSS version 24 software.

Results: Of 157 ACS patients, 69 (43.9%) had a STEMI diagnosis. Age was 63.69 years on average (SD: 8.23). The typical amount of time between the onsets of ACS symptoms to hospital presentation was 79.3 hours (3.3 days). For 104 (66.2%) patients, hypertension was the main risk factor for the development of ACS. Killip class III and IV patients made up about 3.8% of the ACS patients at St. Paul hospital. An EF of less than 40% was present in 36.3% of patients. Loading doses of aspirin (90.4%), anticoagulants (14%), beta-blockers (82.8%), statins (86%), clopidogrel (7.6%), and nitrates (2.5%) are among the medications taken inside hospitals. Of 157 ACS patients, 6 (3.8%) patients with medical records examined died while receiving treatment in the hospital, while 151 (96.2%) patients were discharged alive.

Conclusion: STEMI was the most common diagnosis for ACS patients at St. Paul Hospital. The two main hospital events for these patients were CHF and cardiogenic shock.

Background: Association between dependence on oxygen therapy (OT) and natural disease progression in people with cystic fibrosis (pwCF) has not been estimated yet. The aim of this study is to understand the prognosis for pwCF on OT, evaluating how the transition probabilities from being alive without lung transplantation (LTx) to LTx and to death, and from being alive after LTx to death change in pwCF with and without OT.

Methods: We used 2008-2017 data from the 35-country European CF Society Patient Registry. A multi-state model was fitted to assess the effects of individual risk factors on transition probabilities.

Results: We considered 48,343 pwCF aged from 6 to 50 years. OT (HR 5.78, 95% CI: 5.32-6.29) and abnormal FEV₁ (HR 6.41, 95% CI: 5.28-7.79) were strongly associated with the probability of having LTx; chronic infection with Burkholderia cepacia complex (HR 3.19, 95% CI: 2.78-3.67), abnormal FEV₁ (HR 5.00, 95% CI: 4.11-6.08) and the need for OT (HR 4.32, 95% CI: 3.93-4.76) showed the greatest association with the probability of dying without LTx. Once pwCF received LTx, OT (HR 1.75, 95% CI: 1.41-2.16) and abnormal FEV₁ (HR 1.63, 95% CI: 1.18-2.25) were the main factors associated with the probability of dying. An association of gross national income with the probability of receiving LTx and with the probability of dying without LTx was also found.

Conclusion: Oxygen therapy is associated with poor survival in pwCF with and without LTx; harmonization of CF care throughout European countries and minimization of the onset of pulmonary gas exchange abnormalities using all available means remains of paramount importance.

Dystrophic epidermolysis bullosa (DEB) is one of the major types of EB, a rare hereditary group of trauma-induced blistering skin disorders. DEB is caused by inherited pathogenic variants in the COL7A1 gene, which encodes type VII collagen, the major component of anchoring fibrils which maintain adhesion between the outer epidermis and underlying dermis. DEB can be subclassified into dominant (DDEB) and recessive (RDEB) forms. Generally, DDEB has a milder phenotype, while RDEB patients often have more extensive blistering, chronic inflammation, skin fibrosis, and a propensity for squamous cell carcinoma development, collectively impacting on daily activities and life expectancy. At present, best practice treatments are mostly supportive, and thus there is a considerable burden of disease with unmet therapeutic need. Over the last 20 years, considerable translational research efforts have focused on either trying to cure DEB by direct correction of the COL7A1 gene pathology, or by modifying secondary inflammation to lessen phenotypic severity and improve patient symptoms such as poor wound healing, itch, and pain. In this review, we provide an overview and update on various therapeutic innovations for DEB, including gene therapy, cell-based therapy, protein therapy, and disease-modifying and symptomatic control agents. We outline the progress and challenges for each treatment modality and identify likely prospects for future clinical impact.