Therapeutics and Clinical Risk Management最新文献

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: The optimal red blood cell transfusion strategy for children remains unclear. We developed an individualized red blood cell transfusion strategy for children and tested the hypothesis that transfusion guided by this strategy could reduce blood exposure, without increasing perioperative complications in children.

Methods: In this randomized controlled clinical trial, 99 children undergoing noncardiac surgeries who had blood loss of more than 20% total blood volume were randomly assigned to an individualized-strategy group using Pediatric Perioperative-Transfusion-Trigger Score or a control group. The amount of transfused red blood cell was counted, and patients were followed up for postoperative complications within 30 days.

Results: Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group (p < 0.05). During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs 1.33±1.20 Red-Blood-Cell units per patient, p = 0.02). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs 18%, p = 0.160). No significant difference was found in the other outcomes.

Conclusion: This trial proved that red blood cell transfusion guided by the individualized strategy reduced perioperative blood exposure in children, without increasing the incidence of severe complications. This conclusion needs to be reaffirmed by larger-scale, multicenter clinical trials.

Objective: Accurate preoperative localization of abnormal parathyroid glands is crucial for successful surgical management of secondary hyperparathyroidism (SHPT). This study was conducted to compare the effectiveness of preoperative MRI, 4D-CT, and ultrasonography (US) in localizing parathyroid lesions in patients with SHPT.

Methods: We performed a retrospective review of prospectively collected data from a tertiary-care hospital and identified 52 patients who received preoperative MRI and/or 4D-CT and/or US and/or ^99mTc-MIBI and subsequently underwent surgery for SHPT between May 2013 and March 2020. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of each imaging modality to accurately detect enlarged parathyroid glands were determined using histopathology as the criterion standard with confirmation using the postoperative biochemical response.

Results: A total of 198 lesions were identified intraoperatively among the 52 patients included in this investigation. MRI outperformed 4D-CT and US in terms of sensitivity (P < 0.01), specificity (P = 0.455), PPV (P = 0.753), and NPV (P = 0.185). The sensitivity and specificity for MRI, 4D-CT, and US were 90.91%, 88.95%, and 66.23% and 58.33%, 63.64%, and 50.00%, respectively. The PPV of combined MRI and 4D-CT (96.52%) was the highest among the combined 2 modalities. The smallest diameter of the parathyroid gland precisely localized by MRI was 8×3 mm, 5×5 mm by 4D-CT, and 5×3 mm by US.

Conclusion: MRI has superior diagnostic performance compared with other modalities as a first-line imaging study for patients undergoing renal hyperparathyroidism, especially for ectopic or small parathyroid lesions. We suggest performing US first for diagnosis and then MRI to make a precise localization, and MRI proved to be very helpful in achieving a high success rate in the surgical treatment of renal hyperparathyroidism in our own experience.

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.

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.

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.

Purpose: Perioperative anaphylaxis (POA) is an acute severe systemic hypersensitivity reaction characterized by life-threatening respiratory and circulatory collapse. In our previous study, we reported the epidemiology of suspected POA in China. In the present study, we aimed to elucidate the management and outcomes of these cases and further verify the risk factors for near-fatal and fatal outcomes.

Patients and methods: This was a retrospective study of 447 cases of suspected life-threatening POA encountered at 112 tertiary hospitals in mainland China between September 2018 and August 2019. Patient characteristics, symptoms, duration of hypotension, treatments, and clinical outcomes were documented. Bivariate logistic regression was used to identify risk factors for near-fatal and fatal outcomes.

Results: Most cases of suspected POA (89.9%) were recognized and treated within 5 min. Epinephrine was administered as the initial treatment in 232 (51.9%) cases. Corticosteroids (26.6%), other vasoactive drugs (18.3%), and bronchodilators (1.6%) were also administered as the initial treatment instead of epinephrine. The initial dosage of epinephrine (median, 35 µg) was insufficient according to the anaphylaxis guidelines. On multivariable analysis, age ≥65 years (odds ratio [OR] 7.48; 95% confidence interval [CI]: 1.33-41.87, P=0.022), ASA physical status IV (OR 17.68; 95% CI: 4.53-68.94; P<0.001), and hypotension duration ≥15 min (OR 3.63; 95% CI: 1.11-11.87; P=0.033) were risk factors for fatal and near-fatal outcomes.

Conclusion: Most cases in this study were managed in a timely manner, but the epinephrine application should be optimized according to the guidelines. Age ≥65 years, ASA physical status IV, and long-term hypotension were risk factors for near-fatal and fatal outcomes.