Therapeutics and Clinical Risk Management最新文献

Purpose: To compare and analyze the therapeutic effects of endoscopy-assisted laparoscopic surgery (EALS) and laparoscopic surgery (LS) in the treatment of gastric duplication cysts (GDCs).

Patients and methods: We reviewed the clinical data of children with GDCs who underwent surgical treatment at Hubei Maternal and Child Health Hospital, Yijishan Hospital of Wannan Medical College, and Qingdao Women and Children's Medical Center from September 2014 to November 2022.

Results: The study comprised 29 children with GDCs, including 14 in the EALS group and 15 in the LS group. There was no significant difference between the two groups in terms of age, sex, weight, and cyst size characteristics. There was a significant difference between the two groups in terms of average surgical time (P>0.05), which was 1.100 ± 0.833 hours in the EALS group and 1.933 ± 0.159 hours in the LS group. There was a significant difference between the two groups (P<0.05) in average intraoperative blood loss, which was 7.93 ± 3.81 milliliters in the EALS group and 11.80 ± 2.72 milliliters in the LS group. There was a significant difference between the two groups (P<0.05) in average postoperative fasting time, which was 73.79 ± 8.36 hours in the EALS group and 114.1 ± 9.24 hours in the LS group. There was a significant difference between the two groups (P<0.05) in average postoperative hospital stay, which was 10.21 ± 4.25 days in the EALS group and 14.47 ± 4.36 days in the LS group.

Conclusion: EALS technology can not only shorten surgical time, accurately locate GDCs, reduce injuries, and decrease the probability of complications but also achieve treatment goals safely and reliably.

Background: Fluid resuscitation is routinely needed for critically ill patients. However, the optimal choice between crystalloids and normal saline is in heat debate.

Objective: To conduct a meta-analysis comparing normal saline and balanced crystalloids in the treatment of critically ill patients with composite mortality as the primary outcome.

Methods: PubMed, Embase, Medline, Web of Science, and Cochrane Library were searched from inception up to March 2022. Studies of critically ill adult patients assigned to receive normal saline or balanced crystalloids were included. We conducted a meta-analysis using an inverse variance, random-effects model in addition to trial sequential analysis (TSA). The primary outcome was composite mortality. Subgroup analyses were also conducted.

Results: Eighteen full-text studies (n=36,224) were included. Balanced crystalloids were associated with lower mortality compared with normal saline (risk ratio [RR]=0.96; 95% confidential interval [CI] 0.93, 1; p=0.03; I²=0) and lower incidence of acute kidney injury/acute renal failure (RR =0.93; 95% CI = 0.87, 0.99; p=0.03). No significant difference was observed in other outcomes. In the sepsis patients, the balanced crystalloid showed a lower composite mortality rate compared with normal saline (RR =0.91; 95% CI = 0.85, 0.99; p=0.02). TSA analysis demonstrated that, with 80% power, the effect of balanced crystalloid is not larger than a 10% relative decrease in composite mortality compared with normal saline.

Conclusion and relevance: This study demonstrated that balanced crystalloids could be an optimal choice over normal saline in critically ill patients to a reduced composite mortality rate. In patients with sepsis, the difference is especially significant. Nonetheless, the optimal resuscitation fluid option between saline and balanced crystalloid solutions should be investigated further with more evidence.

Objective: To retrospectively evaluate the efficacy and security of Willis covered stent (WCS) deployment for complex vascular diseases of the internal carotid (ICA) and vertebral (VA) arteries.

Methods: Retrospective analysis was performed on complex vascular disease patients (n=36) treated with WCSs at our center between March 2017 and December 2022, with a 3-36-months follow-up surveillance and digital subtraction angiography (DSA) examination.

Results: The WCSs were successfully deployed in all the patients. The 36 included lesions were carotid-cavernous sinus fistulas (CCFs; n=10) (27.8%), complex saccular aneurysms (n=10) (27.8%), traumatic pseudoaneurysms (n=7) (19.4%), blood blister-like aneurysms (BBAs; n=5) (13.9%), and iatrogenic carotid or vertebral artery ruptures (n=4) (11.1%). The WCS was released at the communicating segment (n=2) (5.6%), the ophthalmic segment (n=3) (8.3%), the clinoid and cavernous segment (n=28) (77.8%), the petrous segment (n=2) (5.6%) of ICA and the V3 segment (n=1) (2.8%) of VA. Postoperative DSA showed complete lesion occlusion in 26 patients (72.2%) who were immediately treated with WCSs, and endoleaks occurred in 3 patients (8.3%) (endoleaks resolved postadjustment in 7 patients (19.4%)). In patients (n=3) (8.3%) treated with double stents at the break of the ICA, the endoleak remained in 1 CCF patient (2.8%) during the 3-month follow-up, and the residual shunt disappeared after the second stent system was placed 3 months later. No aneurysm, bleeding or infarct recurrence reported, and only 1 patient (2.8%) had mild asymptomatic in-stent stenosis. Deaths and procedural complications did not occur during follow-up.

Conclusion: Treatment with a WCS for intracranial complex vascular diseases resulted in satisfactory clinical outcomes and appeared effective and safe. Controlled, multicenter, large sample sizes and longer follow-up periods studies are necessary.

Objective: In this study, we aim to examine the effects of osteotomy under varying posterior slope angles on knee joint function recovery following knee arthroplasty.

Methods: We conducted a retrospective analysis from September 2015 to September 2018 on 240 patients who underwent knee arthroplasty three years previously. The study participants were categorized based on changes in the angle of the posterior slope before and after surgery: Group 1, > 5°; Group 2, 3°-5°; Group 3, 0°-3°; Group 4, -3°-0°; Group 5, < -3°. All participants were affected with knee osteoarthritis. The Knee Society Clinical Rating System (KSS) knee function score, Western Ontario and McMaster Universities Arthritis Index (WOMAC) knee function score, Visual Analogue Scale (VAS) pain score, and postoperative complications were measured 3 years after surgery.

Results: The level of pain experienced by the patients decreased significantly than before, with pain scores ranging from 1.0-3.0, and there was a statistical difference between groups (H = 93.400, P < 0.001). The KSS score increased, with group 5 having the lowest median score of 78.0 and group 2 having the highest median score of 97.0, and there was a statistical difference between groups (H = 164.460, P < 0.001). The WOMAC score was reduced, with the median score being 24.0, 11.0, 14.0, 20.0, and 26.0, in the five groups, respectively. Group 5 had the highest score, while Group 2 had the lowest score, and there was a statistically significant difference between groups (H = 164.223, P < 0.001). No symptoms such as periprosthetic femoral fracture, prosthetic loosening, or pad wear were detected in patients postoperatively.

Conclusion: Osteotomy at various posterior slope angles in total knee arthroplasty impacts postoperative knee function rehabilitation. An excessive increase or decrease in angle can have an impact on the postoperative recovery of knee function.

Background: Rheumatic mitral stenosis(RMS) may leads to left ventricular remodeling (LVR), which can persist even after valve surgery. Identifying markers for early structure and function in patients with rheumatic heart disease who are at risk for adverse LVR after surgery can help determine the optimal timing of intervention. This study aimed to investigate whether preoperative parameters of global left ventricular long-axis strain (LVGLS) and mechanical discretization (MD) could predict postoperative adverse LVR.

Methods: A total of 109 adult patients with RMS and 50 healthy controls were enrolled in this study. Baseline clinical features, conventional echocardiography results, LVGLS, and MD were compared between the two groups. Pre- and post-surgery echocardiography measurements were collected, and adverse LVR was defined as a>15% increase in left ventricular end-diastolic volume or >10% decrease in left ventricular ejection fraction. Binary regression analysis was used to determine independent predictors of poor left ventricular remodeling.

Results: The variables associated with adverse LVR in this study were LVGLS (P<0.001, odds ratio: 1.996, 95% CI: 1.394-2.856) and MD (P=0.011, odds ratio: 1.031, 95% CI: 1.007-1.055). The poorly reconstructed group had lower absolute values of LVGLS and higher MD than the healthy control group and the non-poorly reconstructed group. A LVGLS cutoff of -15.0% was the best predictor for patients with poorly reconstructed LVR (sensitivity: 75.7%; specificity: 100.0%; AUC: 0.93), and a MD cutoff of 63.8ms was the best predictor (sensitivity: 63.8%; specificity: 98.6%; AUC: 0.88).

Conclusion: Speckle tracking echocardiography has potential value for predicting the progression of adverse LVR and for identifying non-responders among patients with RMS undergoing surgery.

Objective: COVID-19, coinciding with the opioid epidemic in the United States, has had significant impacts on health-care utilization. While mixed, early analyses signaled a potential resurgence in opioid use following the pandemic. The primary study objective was to assess the association of the COVID-19 pandemic with opioid utilization among Health First Colorado (Colorado's Medicaid Program) members and a non-Medicaid managed care cohort who did not have a diagnosis of cancer or sickle cell disease.

Patients and methods: Using an interrupted time series and segmented regression analysis, this population-level study assessed the association of the COVID-19 pandemic on prescribed utilization of long- and short-acting opioid analgesics among Health First Colorado members and a random sample of non-Medicaid managed care members. Pharmacy claims data for both cohorts were assessed between October 1, 2018, and September 30, 2021, with April 2020 identified as the interruption of interest. We evaluated the following monthly opioid use measures separately for short-acting and long-acting opioids: number of members filling an opioid, total fills, and total days supplied.

Results: Short- and long-acting opioid utilization was significantly decreasing among Health First Colorado members in the 18 months prior to the start of COVID-19. After the onset of the pandemic, utilization stabilized and slopes were not significantly different from zero. Among the non-Medicaid managed care cohort, short- and long-acting opioid utilization significantly decreased in the 18 months leading up to the onset of the pandemic. After the onset of the pandemic, utilization of long-acting opioids stabilized, while utilization of short-acting opioids significantly increased.

Conclusion: While we observed an increase in opioid utilization measures post-pandemic in the non-Medicaid managed care cohort, a similar increase was not observed in Health First Colorado members suggesting that thoughtful opioid policies put in place pre-pandemic may have been effective at controlling potential inappropriate opioid utilization.

Purpose: This study aims to systematically review the hepatic safety of febuxostat and allopurinol in adult gout patients.

Methods: We searched for information using the following databases: PubMed, Cochrane Library, and Scopus. The inclusion criteria were to review all randomized controlled trials (RCT) that compared allopurinol and febuxostat for adult gout patients that had an assessment of liver function outcomes. Non-English studies on case reports, case series, reviews, and abstracts only were excluded. We extracted information from the studies to answer the research question, ie, study design, publication year, population, sample size, patient characterization, duration, Jadad score, and liver function outcomes.

Results: We screened 512 publications from the databases and identified 11 studies that met the inclusion criteria. Ten out of 11 included studies were double-blind RCTs. In the majority of the included studies, no statistically significant differences were observed in terms of hepatic safety data between febuxostat and allopurinol. However, in studies where allopurinol titration was used, it posed a challenge to maintain blinding. Notably, consistent adverse events related to liver function findings were observed across all reviewed RCTs. These abnormal liver function test results sometimes led to study withdrawal based on the investigators' assessment. Nevertheless, the investigators classified most liver function test elevations as mild to moderate in severity.

Conclusion: Our analysis concluded that adult gout patients enrolled in the included RCTs exhibited similar hepatic safety profiles for both febuxostat and allopurinol treatment. Liver function abnormalities were identified in all RCTs included in this systematic review. Consequently, it is important for the product labeling information of both allopurinol and febuxostat to present and describe the current safety data to guide healthcare practitioners when prescribing these medications to patients. Pharmacovigilance and post-marketing pharmacoepidemiology data are essential in establishing the comprehensive safety profile.

Aim: Subtrochanteric shortening osteotomy (SSO) is often applied during total hip arthroplasty (THA) in high hip dislocations. The aim of the present paper was to evaluate the results of fixation by autogenous cortical plate technique on sites of SSO in THA for patients with Crowe type IV developmental dysplasia of the hip (DDH).

Methods: We conducted a historical prospective cohort study and reviewed 67 patients (82 THAs) with SSO performed between March 2016 and May 2020. Thirty-nine patients (48 hips) obtained stability by intramedullary pressure provided by the S-ROM modular prostheses and with or without prophylactic binding by stainless-steel wire after osteotomy and before stem implantation (group A). Twenty-eight patients (34 hips) were fixed with autogenous cortical plate technique and stainless-steel wire or cables (group B). Time of operations, complications, radiographic results and clinical scores were compared.

Results: One intraoperative fracture and a dislocation occurred, while component loosening, ectopic ossification and osteolysis were not observed. Group B had a higher union rate at the 4th month than group A (P = 0.015) while there were no significant differences of union rates at the 8th (P = 0.811) and the 12th month (P = 0.722) and of the average healing time (P = 0.181). No significant differences were found in hip function scores (HHS and WOMAC Osteoarthritis Index) between two groups.

Conclusion: Fixation with autogenous cortical plate from the cylinder of femoral bone contributes to early bone union of osteotomy ends in Crowe type IV DDH patients compared to those who do not apply the technique. Besides of application of autogenous cortical strut grafts, relevant measures are as well recommended to prevent nonunion after SSO.

Purpose: This study aimed to determine the effect of hard candies on gastric content volume and pH in patients undergoing elective esophagogastroduodenoscopy and colonoscopy. Additionally, the study evaluated the difficulty of the procedure, complications, and satisfaction levels of the endoscopist and patient.

Patients and methods: A randomized controlled study equally recruited 108 outpatients to candy and control groups. The patients in the candy group could consume sugar-free candies within 2 hours before anesthesia, while the controls remained fasted. The endoscopic procedure began under topical pharyngeal anesthesia and intravenous sedation. A blinded endoscopist suctioned the gastric volume through an endoscope. A blinded anesthesia provider tested the gastric pH with a pH meter. The primary outcome variables were gastric volume and pH. The secondary outcome variables were complications, the difficulty of the procedure, and endoscopist and patient satisfaction.

Results: The characteristics of both patient groups were comparable. The mean gastric volume of the candy group (0.43 [0.27-0.67] mL/kg) was not significantly different from that of the control group (0.32 [0.19-0.55] mL/kg). The gastric pH of both groups was similar: 1.40 (1.10-1.70) for the candy group and 1.40 (1.20-1.90) for the control group. The procedure-difficulty score of the candy group was higher than that of the control group. The satisfaction scores rated by the endoscopist and the patients in both groups were comparable. In addition, most endoscopists and patients in the candy and control groups reported being "very satisfied". No complications were observed in either group.

Conclusion: Hard candies did not affect gastric volume or pH. Elective gastrointestinal endoscopic procedures in adult patients who preoperatively consume candies could proceed to prevent delays and disruption of workflows.

Objective: Metformin-associated lactic acidosis (MaLA) occurs rarely and is thus difficult to study. We analysed 4241 individual case safety reports of lactic acidosis (LA) that implicated metformin as a suspected drug reported to the pharmacovigilance database of Merck KGaA, Darmstadt, Germany. The primary objective was to review reports for quality and completeness of data to support diagnoses of MaLA. We also explored the correlations between reported biomarkers, and associations between biomarkers and outcomes.

Research design and methods: Records were analysed for completeness in supporting diagnoses of LA or metformin-associated LA (MaLA), against commonly used diagnostic criteria. Correlations between indices of exposure to metformin and biomarkers of LA and mortality were investigated.

Results: Missing data was common, especially for plasma metformin. Clinical/biomarker evidence supported a diagnosis of LA in only 33% of cases (LA subpopulation) and of MaLA in only 9% (MaLA subpopulation). The metformin plasma level correlated weakly with plasma lactate (positive) and pH (negative). About one-fifth (21.9%) of cases reported a fatal outcome. Metformin exposure (plasma level or dose) was not associated with increased mortality risk (there was a suggestion of decreased risk at higher levels of exposure to metformin). Plasma lactate was the only variable associated with increased risk of mortality. Examination of concomitant risk factors for MaLA identified renal dysfunction (including of iatrogenic origin) as a potential driver of mortality in this population.

Conclusion: Despite the high frequency of missing data, this is the largest analysis of cases of MaLA supported by measurements of circulating metformin, and lactate, and pH, to date. Plasma lactate, and not metformin dose or plasma level, appeared to be the main driver of mortality in the setting of LA or MaLA. Further research with more complete case reports is required.