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Gastrointestinal adverse effects associated with the use of intravenous oliceridine compared with intravenous hydromorphone or fentanyl in acute pain management utilizing adjusted indirect treatment comparison methods

J Comp Eff Res. 2024 Mar 18:e230041. doi: 10.57264/cer-2023-0041. Online ahead of print.

ABSTRACT

Background: In the absence of head-to-head comparative data from randomized controlled trials, indirect treatment comparisons (ITCs) may be used to compare the relative effects of treatments versus a common comparator (either placebo or active treatment). For acute pain management, the effects of oliceridine have been compared in clinical trials to morphine but not to fentanyl or hydromorphone. Aim: To assess the comparative safety (specifically differences in the incidence of nausea, vomiting and opioid-induced respiratory depression [OIRD]) between oliceridine and relevant comparators (fentanyl and hydromorphone) through ITC analysis. Methods: A systematic literature review identified randomized clinical trials with oliceridine versus morphine and morphine versus fentanyl or hydromorphone. The ITC utilized the common active comparator, morphine, for the analysis. Results: A total of six randomized controlled trials (oliceridine – 2; hydromorphone – 3; fentanyl – 1) were identified for data to be used in the ITC analyses. The oliceridine data were reported in two studies (plastic surgery and orthopedic surgery) and were also reported in a pooled analysis. The ITC focused on nausea and vomiting due to limited data for OIRD. When oliceridine was compared with hydromorphone in the ITC analysis, oliceridine significantly reduced the incidence of nausea and/or vomiting requiring antiemetics compared with hydromorphone (both orthopedic surgery and pooled data), while results in plastic surgery were not statistically significant. When oliceridine was compared with hydromorphone utilizing data from Hong, the ITC only showed a trend toward reduced risk of nausea and vomiting with oliceridine that was not statistically significant across all three comparisons (orthopedic surgery, plastic surgery and combined). An ITC comparing oliceridine with a study of fentanyl utilizing the oliceridine orthopedic surgery data and combined orthopedic and plastic surgery data showed a trend toward reduced risk that was not statistically significant. Conclusion: In ITC analyses, oliceridine significantly reduced the incidence of nausea and/or vomiting or the need for antiemetics in orthopedic surgery compared with hydromorphone and a non-significant trend toward reduced risk versus fentanyl.

PMID:38497192 | DOI:10.57264/cer-2023-0041

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Effect of Resection and Surgical Experience on Survival in Patients with Craniopharyngiomas: Endoscopic Transsphenoidal Surgery in Series of 31 Cases

Turk Neurosurg. 2024;34(2):331-342. doi: 10.5137/1019-5149.JTN.46067-23.1.

ABSTRACT

AIM: To share the surgical outcomes of 31 patients who underwent endoscopic endonasal transsphenoidal surgery (EETS) at a single center.

MATERIAL AND METHODS: This retrospective analysis of 31 craniopharyngioma cases (2013-2022) with a minimum 6-month follow-up included demographic data, preoperative findings, postoperative resection volumes, recurrence rates, pathological diagnoses, and complications.

RESULTS: Herein, 34 EETS surgeries were performed on 31 patients (12 males, 19 females). The presenting symptoms included visual loss (58%), hypopituitarism (54.8%), and diabetes insipidus (25.8%). Gross total resection was achieved in 87% of the patients, with 64.5% total and 22.5% near-total resection. Total resection prevented recurrences, contrasting with 75% recurrence in the subtotal resection patients (p=0.000). The primary patients showed 73.1% total resection, while only 20% of the recurrent patients achieved it (p=0.049). When comparing the first 16 cases with the last 15 cases in terms of surgical experience, the rates of resection (p=0.040) and recurrence-free survival (p=0.020) in the last 15 cases were statistically significant. Patients with preoperative visual loss demonstrated 94.4% improvement or stability postoperatively. Postoperative complications included hypopituitarism (71.4%), permanent diabetes insipidus (60.8%), worsening vision (6.5%), cerebrospinal fluid leakage (9.7%), meningitis (6.5%), and a 3.2% perioperative mortality rate.

CONCLUSION: This study underscores the role of surgical resection in craniopharyngiomas, emphasizing the impact of surgical experience on recurrence-free survival. Primary surgery, with minimal complications and maximal resection, is crucial in managing recurrence challenges. Endoscopic endonasal transsphenoidal surgery, particularly in experienced centers, offers advantages such as panoramic vision and access to the third ventricle base, facilitating total and near-total resection and extending recurrence-free survival.

PMID:38497187 | DOI:10.5137/1019-5149.JTN.46067-23.1

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Effects of Focal Cerebellar Injury on Fracture Healing and Oxidative Stress in Rat Model: An Experimental Animal Study

Turk Neurosurg. 2024;34(2):314-324. doi: 10.5137/1019-5149.JTN.44200-23.2.

ABSTRACT

AIM: To examine the effect of cerebellar damage on the process of fracture healing.

MATERIAL AND METHODS: A total of forty-two male rats were selected at random and subsequently allocated into three distinct groups. The experimentals were divided into two subgroups within each group, with the intention of sacrificing them during the third and sixth weeks. Group 1 had isolated femoral fracture, Group 2 had femoral fracture after craniotomy, and Group 3 had femoral fracture accompanying cerebellar injury after craniotomy. Left femoral fractures in rats in all groups were treated using an intramedullary Kirschner wire. Radiological, histological, and biochemical evaluations were conducted at 3 and 6 weeks to assess the processes of fracture healing. To determine the effects of fracture healing and cerebellar injury on oxidant-antioxidant systems, catalase (CAT), malondialdehyde, superoxide dismutase (SOD), and glutathione peroxidase (GPx) activities were measured.

RESULTS: Between the time frame of 3 to 6 weeks, Group 3 had higher radiography scores, alkaline phosphatase levels, callus/ diaphyse ratio, callus improvement, and bone mineral density in comparison to the other groups. The activity of SOD was found to be statistically negligible in all groups, suggesting that SOD does not have a substantial impact on fracture healing in cerebellar injury. However, notable increases in the activity of GPx and CAT enzymes were observed, showing their considerable involvement in the process of fracture healing.

CONCLUSION: Cerebellar injury reduces the oxidative stress in the fracture area and contributes positively to fracture healing by means of radiologically, biochemically and histopathologically.

PMID:38497185 | DOI:10.5137/1019-5149.JTN.44200-23.2

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The Effects of Regulating Increased Blood Glucose Levels on Plasma Endothelin-1 Levels After Severe Head Trauma in Rats

Turk Neurosurg. 2024;34(2):263-267. doi: 10.5137/1019-5149.JTN.43318-23.2.

ABSTRACT

AIM: To examine the effects of regulating increased blood glucose levels on plasma ET-1 levels after severe head trauma in rats.

MATERIAL AND METHODS: Traumatic diffuse brain injury-induced rats were followed for 7 days and were randomly divided into two groups of 36 rats. Pre- and posttraumatic blood glucose and ET-1 levels were measured in group 1 (control). Posttraumatic blood glucose levels were maintained at normal levels using insulin and both blood glucose and ET-1 levels were measured at 2, 6, 12, 24, and 48 h and 7 days posttrauma in group 2. The study excluded animals that died and had skull fractures.

RESULTS: Posttraumatic plasma ET-1 levels (n=36) were significantly higher than baseline values in group 1 (p < 0.05). ET-1 levels in group 2 at the 7-day follow-up after trauma were significantly higher than baseline values (n=36) (p < 0.05). However, the increased ET-1 levels were statistically significantly lower in group 2 than in group 1 (p < 0.05).

CONCLUSION: The increased ET-1 levels were significantly prevented by keeping blood glucose levels within normal limits with insulin after severe head trauma. Thus, secondary injury to cerebral blood flow can be prevented by reducing the occurrence of vasospasm that starts in the early posttraumatic period or by stimulating the release of nitric oxide. Therefore, further studies on the role of ET-1 and insulin in developing secondary injuries after severe head trauma would be beneficial.

PMID:38497179 | DOI:10.5137/1019-5149.JTN.43318-23.2

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Is The Modular Dynamic System as Effective as Classical Dynamic Systems in Long Segment Dynamic Thoracolumbar Stabilization?

Turk Neurosurg. 2024;34(2):256-262. doi: 10.5137/1019-5149.JTN.42746-22.2.

ABSTRACT

AIM: To evaluate the outcomes of dynamic stabilization in the multilevel degenerative spondylotic spine, and to compare the two dynamic systems (Dynesys® and Orthrus®) to reveal the increasing role of dynamic systems in the management of the degenerative spine.

MATERIAL AND METHODS: A total of 74 patients who received dynamic stabilization for degenerative pathologies were retrospectively analyzed. Demographic details: preoperative data including neurological status, pain scores, and radiology; and intraoperative data including blood loss, duration of surgery, complications, and postoperative data including the neurologic status, duration of hospital stay, and pain scores were examined.

RESULTS: Patients in both groups showed statistically significant improvements in their Visual Analog Scale and Oswestry Disability Index scores. Significant corrections of thoracic kyphosis (T2-T12), the sagittal vertical axis, and T10-L2 thoracolumbar kyphosis were obtained in our cohort (p < 0.05). A total of 4 patients received revision surgery due to screw loosening. Patients were discharged after 3-4 days and mobilized on the first postoperative day.

CONCLUSION: We did not experience any serious issues in terms of stabilization in the cases in which we employed both systems. Our patients’ clinical results were satisfactory in both systems. Existing systems can be used safely even in long-segment stabilization surgeries.

PMID:38497178 | DOI:10.5137/1019-5149.JTN.42746-22.2

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Evaluation of Percutaneous Unilateral Kyphoplasty Results in Osteoporotic Vertebral Compression Fractures Using Individual 3D Printed Guide Template Support

Turk Neurosurg. 2024;34(2):250-255. doi: 10.5137/1019-5149.JTN.43052-22.2.

ABSTRACT

AIM: To compare the clinical and radiological outcomes of unilateral percutaneous kyphoplasty (PKP) surgeries performed using 3D printing technology in patients with osteoporotic compression fractures to conventional unilateral PKP surgeries.

MATERIAL AND METHODS: Patients with acute painful single-level osteoporotic vertebral compression fracture (OVCF) who need surgical treatment were divided into two groups: group A (patients who had 3D template-guided PKP) and group B (patients who conventional PKP). To compare the two surgical procedures, Total Absorbed Radiation Dose (TARD), pre- and postoperative visual analog scale (VAS) scores, and Total Surgery Time (TST) were calculated and compared between groups in both surgical groups.

RESULTS: A total of 44 patients with single-level OVCF who were experiencing acute pain were successfully operated on, with 22 patients in each group. TARD (2.6 ± 0.4 mGy vs. 6.1 ± 1.9 mGy, p < 0.05) and TST (12.4 ± 2.6 min vs. 20.2 ± 3.2 min, p < 0.05) differed significantly different between groups A and B. There was no statistically significant difference between the patient groups in preoperative and postoperative VAS values (p > 0.05). Cement leakage was lower in group A (3/22, 13.6%) than in group B (6/22, 27.3%) (p > 0.05). There were no neurological complications or infections in either group.

CONCLUSION: When compared to the conventional procedure, the unilateral percutaneous kyphoplasty method was supported by a 3D printing guide template. By reducing operative time and radiation exposure, tt has resulted in a more effective surgical procedure for patients and a safer surgical procedure for surgeons and anaesthesiologists.

PMID:38497177 | DOI:10.5137/1019-5149.JTN.43052-22.2

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Degree of awareness and practices on urinary tract infections: A study of Sri Lankan school teachers selected from a chronic kidney disease high-prevalent setting

Urologia. 2024 Mar 18:3915603241237563. doi: 10.1177/03915603241237563. Online ahead of print.

ABSTRACT

OBJECTIVE: As key stakeholders in educational settings, teachers’ awareness on Urinary Tract Infections (UTI) will ultimately enhance its management in schools and community. This study aimed to assess the level of knowledge, attitudes, and practices (KAP) on UTIs among teachers in Sri Lanka.

MATERIALS AND METHODS: Conveniently selected 373 school teachers were assessed using a pre-tested questionnaire. Each of the individual was scored and categorized as either satisfactory or poor. Descriptive statistics and chi-square tests were performed to describe the outcomes.

RESULTS: Around 80% of respondents demonstrated awareness regarding the microbial origin of UTIs, while 42% possessed knowledge of women’s increased susceptibility to UTIs. Over 90% of participants had favorable attitudes toward drinking adequate amounts of water, personal hygiene, and consulting doctors for UTI symptoms. Each inquiry demonstrated significant disparities between individuals with satisfactory and poor attitudes (p = 0.000), with over 95% adhered to effective hygiene practices as a preventive measure against UTIs. The demographics of the participants did not show any significance over the KAP results of the study (p < 0.05).

CONCLUSIONS: The study revealed satisfactory levels of awareness and favorable attitudes among respondents on UTIs. However, there is a further need for increased awareness, specifically regarding the risk factors associated with UTIs.

PMID:38497160 | DOI:10.1177/03915603241237563

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Efficacy of intravenous high-dose methotrexate in preventing relapse to the central nervous system in R-CHOP(-like)-treated, high-risk, diffuse large B-cell lymphoma patients and its effect on mortality: a systematic review and meta-analysis

Haematologica. 2024 Mar 14. doi: 10.3324/haematol.2023.284281. Online ahead of print.

ABSTRACT

CNS relapse in patients with diffuse large B-cell lymphoma (DLBCL) carries a dismal prognosis with most clinical guidelines recommending CNS prophylaxis to patients deemed at high risk for CNS relapse. However, results from observational studies investigating the effect of CNS prophylaxis have yielded conflicting results.

OBJECTIVES: To evaluate: 1) whether addition of prophylactic intravenous HD-MTX reduces the risk of CNS relapse in high-risk DLBCL patients treated with R-CHOP or similar and 2) whether HD-MTX prophylaxis confers an overall survival benefit, irrespective of CNS relapse.

METHODS: A systematic search of MEDLINE/PubMed and EMBASE on DLBCL patients at high risk of CNS relapse treated with R-CHOP or similar receiving HD-MTX as intervention and a comparator arm receiving no prophylaxis and/or IT prophylaxis. Risk of Bias was estimated using the ROBINS-I tool and the quality of the evidence by the GRADE approach. Finally, a meta-analysis based on the systematic review was conducted.

RESULTS: A total of 1812 studies were screened. No RCT’s were identified. Seven observational studies comprising 1661 patients met inclusion criteria. We found a statistically non-significant relative risk of 0.54 [0.27-1.07, 95% CI] of CNS relapse for patients receiving HD-MTX vs. controls. The meta-analysis investigating mortality demonstrated a relative risk of death of 0.70 [0.44-1.11, 95% CI] for HD-MTX treated vs. controls. The overall risk of bias was adjudged as “serious” and the quality of the evidence was rated as low.

CONCLUSION: Our data indicate that HD-MTX does not prevent, or at best, only slightly reduces the risk of CNS relapse and confers no survival benefit.

PMID:38497149 | DOI:10.3324/haematol.2023.284281

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Neoadjuvant PD-1 Plus Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Technol Cancer Res Treat. 2024 Jan-Dec;23:15330338241231610. doi: 10.1177/15330338241231610.

ABSTRACT

BACKGROUND: Clinical studies have shown that programmed cell death-1 (PD-1) inhibitors can activate T cells and inhibit cancer growth. Therefore, the use of a PD-1 inhibitor plus chemotherapy as neoadjuvant chemotherapy for locally advanced esophageal cancer is worth further exploration.

METHODS: Patients with locally advanced esophageal squamous cell carcinoma were enrolled in this study to receive two cycles of a preoperative combination of toripalimab, paclitaxel, and cisplatin. Efficacy was evaluated after two treatment cycles. The patients’ postoperative pathological staging was analyzed and compared. Surgery was performed within 42 days of the start date of the last chemotherapy cycle.

RESULTS: Neoadjuvant immunochemotherapy achieved a high pathologic complete response (pCR) rate (29.0%), major pathological response rate (41.9%), and objective response rate (80.6%) and demonstrated statistically significant downstaging after neoadjuvant therapy (P < .05) with manageable treatment-related adverse effects. No significant association was found between PD-L1 level and pCR (P = .365). In addition, R0 resection was achieved in all 31 (100%) patients during surgery. For all the included patients, the one-year progression-free survival rate was 87.1% (95% CI: 75.3%-98.9%), the one-year overall survival (OS) rate was 96.8% (95% CI: 79.8%-95.9%), and the two-year OS rate was 83.9% (95% CI: 71.6%-92.2%).

CONCLUSIONS: Our findings indicate that this combination may be a potential neoadjuvant therapy regimen in this setting.

PMID:38497137 | DOI:10.1177/15330338241231610

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Clinical utility of point-of-care glucose testing in the assessment of gestational diabetes: Prospective cohort study

BJOG. 2024 Mar 18. doi: 10.1111/1471-0528.17811. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the clinical utility of point-of-care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT).

DESIGN: Prospective cohort study.

SETTING: Antenatal clinics at King’s College Hospital.

POPULATION: Women screened for GDM between March and June 2020.

METHODS: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse-It 5.40.2.

MAIN OUTCOME MEASURES: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method.

RESULTS: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%-99%) and 97% (93%-98%) at fasting and 97% (91%-99%) and 79% (71%-84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%.

CONCLUSIONS: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h.

PMID:38497098 | DOI:10.1111/1471-0528.17811