Infusion Rate Research Articles

3D printed titanium banana interbody cages versus titanium-coated PEEK bullet cages for TLIF.

Lumbar degenerative spinal disease is a common, major cause of pain and disability. Titanium and polyetheretherketone (PEEK) are popular materials for interbody implants although evidence is mixed on which material is superior in terms of fusion and subsidence. The purpose of this study was to evaluate the clinical outcome of 3D printed titanium (3DPT) cages in patients undergoing TLIFs, as well as complication profiles based on widely used outcome metrics and reoperation events. A retrospective review was conducted for patients receiving 1- or 2-level TLIF at an academic medical center between January 2018 and May 2022. Patients were divided into two cohorts according to the material of interbody cage(s), either 3DPT banana or titanium-coated PEEK bullet. Radiographs, patient-reported outcome measures (PROMs), and complications were analyzed and compared. All included patients had radiographic and clinical follow-up of at least one year. 200 patients with 277 interbody cage-implanted levels were included. Patients received either 3DPT (n = 140) or PEEK (n = 60) interbody cages with 202 and 75 instrumented vertebral levels per cohort, respectively. At one year, the 3DPT cohort demonstrated a higher fusion rate of 93.3 % compared to the PEEK cohort's fusion rate of 73.2 % (p < 0.0001). Subsidence rates were 6.0 % and 25.0 % for the 3DPT and PEEK groups, respectively (p < 0.0001). While 3DPT and PEEK interbody cages demonstrated few adverse events at short- and long-term follow-up, 3DPT exhibited a higher rate of fusion and lower rate of subsidence at one year.

A prospective evaluation of cellular bone matrix for posterolateral lumbar fusion.

Autograft bone is the gold standard graft used in posterolateral lumbar intertransverse fusion (PLF) but can be limited by supply and donor site morbidity. Cadaveric cellular allografts represent an alternative source of graft material that avoids these limitations. To assess the safety and efficacy of ViviGenRCellular Bone Matrix in comparison to autograft bone in PLF. We performed a prospective study of 20 subjects who underwent PLF including 55 segmental levels. Each patient received ViviGen over the decorticated posterolateral gutter on one side an autograft bone on the other side. Fusion grading was assigned by a blinded independent neuroradiologist using a CT-based modified Lenke radiographic classification at 12 months. There was a nonsignificant increase in surgical levels showing grade A fusion for ViviGen as compared to autograft bone (62 % vs. 44 %, p = 0.056). There was a nonsignificant decrease for Vivigen compared to autograft bone in grade B (16.4 % vs 25.5 %, p = 0.241) and fusion failure (21.8 % vs 30.9 %, p = 0.279). 69 % of subjects had significant improvement in back pain numeric rating and Oswestry scores. 73 % of patients had improvement in their leg pain scores. There were no significant changes in lumbar lordosis (p = 0.611) or mean segmental lordosis (p = 0.417). At 12 months, 35 % of all levels had a > 2-degree change on flexion versus extension views while 21 % of all levels had a > 3-degree change. ViviGen cellular bone matrix demonstrates its theoretical bone-generative properties by showing non-inferiority relative to autograft with regards to fusion rates and similarity regarding patient reported outcome measures. Cellular bone matrix agents may represent a safe and noninferior alternative to autograft bone while circumventing potential drawbacks of the latter.

Biomechanical analysis of a newly designed and 3D printed plate-locking interbody cage: an observational study of finite element analysis

Anterior cervical interbody fusion (ACDF) has become a classic surgical procedure for the treatment of cervical degenerative diseases, and various interbody cages are widely used in this procedure. We used 3D printing technology to produce a new type of plate-locking cage, anticipating to achieve high fusion rate with the high biomechanical stability. This study is to compare the biomechanical characteristics between a newly designed interbody cage and a conventional Zero-profile cage during ACDF using finite element analysis. The CT images of a 35-year-old healthy male were extracted and saved in DICOM format. Mimics Research 19.0, Geomagic Wrap 2017, NX12. 0, Abaqus 6.14 were used to construct the finite element models, then, titanium plate, titanium screw, cages, and the residual parts of both groups were assembled with reference to the surgical approach of ACDF (C4/5), following the successful establishment of both surgical models, a total of six boundary and loading conditions were tested, including flexion, extension, left and right bending, and left and right axial torsion. It is found that the plate stress peak of the new cage group decreased 73.78 MPa, 70.00%; 77.17 MPa, 70.67%; 59.77 MPa, 64.97%; 49.94 MPa, 58.28%; 44.55 MPa, 68.38%; 46.14 MPa, 68.00% in flexion, extension, left bending, right bending, left axial torsion and right axial torsion, respectively. There were no obvious increases of C5 upper endoplate stress peak between these two surgical models (< 50%), except 11.68 MPa, 153.08%; 6.55 MPa, 51.45%; in flexion and extension. The 3D-printed porous plate-locking cage was shown to be biomechanically stable compared to the conventional Zero-profile cage, and it is worth noticing that the stress on the plate of the new cage is less than that on screw of the conventional cage, which indicates that the risk of fracture, loosening, and prolapse of the new cage is less likely to occur.

Anterior Lumbar Interbody Fusion (ALIF) Versus Full-Endoscopic/Percutaneous TLIF With a Large-Footprint Interbody Cage: A Comparative Observational Study.

Exploratory prospective observational case-control study. Aim of this study was to compare clinical and radiologic outcome, as well as peri-operative complications, of anterior lumbar interbody fusion (ALIF) and full-endoscopic/percutaneous trans-Kambin transforaminal lumbar interbody fusion (pTLIF) with a large-footprint interbody cage. Patients that underwent elective ALIF and pTLIF with a large-footprint interbody cage were prospectively evaluated. Clinical follow-up was measured pre- and post-operatively with Visual Analogic Scale and Oswestry Disability Index scores. Radiologic outcome was assessed with a computed tomography scan and standing films at 12months. 44 patients underwent ALIF and 43 pTLIF surgery (total 87 cases). Clinical pre- and post-operative scores were comparable between both groups with 33.4months mean follow-up. Median surgical time was significantly lower for pTLIF (28minutes) compared to ALIF (72minutes). Radiologic outcome was favorable for ALIF with a significantly higher increase in segmental lordosis compared to pTLIF. Fusion rates did not significantly differ between both groups. ALIF showed significantly less cage subsidence than pTLIF. Complications included 9 (21%) cases with transitory post-operative radiculitis for ALIF and 12 (28%) for pTLIF; post-operative partial muscle weakness 3(6%) cases for ALIF and 4 (9%) for pTLIF. Two (4%) cases required revision surgery for pTLIF. ALIF and trans-Kambin pTLIF obtained comparable clinical outcome and fusion rates, while segmental lordosis restoration was favorable for ALIF. pTLIF required less surgery time and presented less intra-operative complications, while ALIF reported lower rates of post-operative subsidence, revision surgery and complications during follow-up.

High Modified 5 Factor Frailty Index is Associated With Worse PROMs and Decreased Return to Activities After 1 or 2 Level MI-TLIF.

Retrospective cohort study. Frailty is defined as a state of minimal "physiologic reserve." The modified 5 factor frailty index (mFI-5) is a recently proposed metric for assessing frailty and has been previously studied as a predictor of morbidity and mortality. However, its utility in predicting postoperative patient reported outcomes (PROMs) and return to activities remains understudied. This is a retrospective cohort study of patients undergoing 1 or 2 level minimally invasive transforaminal lumbar interbody fusion queried from a prospectively maintained multi-surgeon registry. Comorbidities including hypertension, congestive heart failure, diabetes, chronic obstructive pulmonary disease, and functional status were utilized to calculate the mFI-5. Patients were separated into 3 cohorts, "non-frail," "moderately frail" or "severely frail" based on their mFI-5. Patient outcomes were compared between the cohorts. 392 patients were included of which 227 patients were non-frail, 134 were moderately frail, and 31 were severely frail. Frail patients had longer operative time (P = 0.002), greater estimated blood loss (P = 0.038). Despite similar preoperative PROMs, at a longer term follow up, frail patients also had worse PROM scores for ODI (P = 0.009), VAS-back (P = 0.028), and VAS-leg (P = 0.004). Frail patients had worse preoperative (P = 0.017) and postoperative (P < 0.001) SF-12 PCS. At 1-year, frail patients had lower rates of fusion (P = 0.002). Frail patients also demonstrated lower rates of returning to work (P = 0.018), returning to driving (P = 0.027), and discontinuation of narcotics (P = 0.004). Frail patients as measured by the mFI-5 index demonstrated worse postoperative outcomes following 1 or 2 level MI-TLIF. Careful patient selection and preoperative optimization may be especially important in frail patients.

Association between intraoperative fluid management and postoperative outcomes in living kidney donors: a retrospective cohort study

Optimal fluid strategy for laparoscopic donor nephrectomy (LDN) remains unclear. LDN has been a domain for liberal fluid management to ensure graft perfusion, but this can result in adverse outcomes due to fluid overload. We compared postoperative outcome of living kidney donors according to the intraoperative fluid management. Five hundred and five LDNs performed over a six-year period at a tertiary hospital were analyzed. Donors were divided into tertiles according to intraoperative crystalloid infusion rate (ml/kg/hr), and associations between the tertile and outcomes were investigated with inverse probability of treatment weighting with entropy balancing. Primary outcome was maximal rise of serum creatinine (sCr). Secondary outcomes were sCr rise meeting Acute Kidney Injury (AKI) criteria, time to reach minimal sCr, and length of hospital stay. The following covariates were used: age, sex, body weight, height, diabetes mellitus, hypertension, preoperative estimated glomerular filtration rate, operation duration, surgeon, nephrectomy side, and estimated blood loss. Median intraoperative crystalloid infusion rate was 3.5, 4.6, and 6.0 ml/kg/hr in the first, second, and third tertile, respectively (group 1, 2, and 3). Maximal rise of sCr did not differ between groups (P = 0.274). Twofold increase in sCr (equivalent to stage 2 AKI) during the first week and prolonged hospitalization were most frequent in group 1 [7.8 vs. 1.1 vs. 1.5%, P = 0.004; 7.9 vs. 3.1 vs. 0.7%, P = 0.003]. Time to reach minimal sCr was longest in group 1. No differences were found in recipient early renal function. Hypovolemia is associated with poor postoperative outcomes after LDN. Efforts to find the optimal fluid management should be continued.

The incidence of inflow and drain pain and associated risk factors for patients on peritoneal dialysis

BackgroundThe high prevalence and prolonged duration of inflow pain and drain pain experienced by peritoneal dialysis (PD) patients following PD catheter implantation impact their quality of life. However, there is limited data on the frequency and predisposing factors of these pains in the Chinese population undergoing peritoneal dialysis.MethodsThis study encompassed individuals who underwent peritoneal dialysis catheter implantation at our institution from September 1, 2023, to March 31, 2024. Patients’ experiences of inflow pain and drain pain were evaluated using a questionnaire survey and the visual analog scale (VAS), with pain status followed up via telephone for 3 months post-surgery.ResultsA total of 141 patients were included in this study. Inflow pain occurred at rates of 56.0%, 20.9%, 16.9%, and 17.3% at 1-week, 1-month, 2-month, and 3-month postoperatively, respectively, while drain pain rates were 51.8%, 24.3%, 22.3%, and 19.5% for the same period. Slowing down the infusion rate of dialysate (57.0%) or stopping its drainage (60.3%) proved effective in reducing pain. Logistic regression analysis revealed that age (OR = 0.96, P = 0.02), gender (OR = 0.37, P = 0.03), and the method of PD catheter implantation (OR = 2.37, P = 0.04) were independent factors associated with inflow or drain pain within 1-week postoperatively.ConclusionThe occurrence of inflow pain and drain pain following peritoneal dialysis catheter implantation is notable. Age, gender, and the method of catheter implantation were identified as independent factors influencing the incidence of inflow or drain pain within the first postoperative week.

First-in-Human Phase 1 study of a CD16A bispecific innate cell engager, AFM24, targeting EGFR-expressing solid tumors.

Innate immune cell-based therapies have shown promising antitumor activity against solid and hematologic malignancies. AFM24, a bispecific innate cell engager, binds CD16A on natural killer (NK) cells/macrophages and EGFR on tumor cells, redirecting antitumor activity towards tumors. The safety and tolerability of AFM24 was evaluated in this Phase 1/2a dose escalation/dose expansion study in patients with recurrent or persistent, advanced solid tumors known to express EGFR. The main objective in Phase 1 was to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). The primary endpoint was the incidence of dose-limiting toxicities (DLTs) during the observation period. Secondary endpoints included the incidence of treatment emergent adverse events and pharmacokinetics. In the dose escalation phase, 35 patients received AFM24 weekly across seven dose cohorts (14-720 mg). One patient experienced a DLT of Grade 3 infusion-related reaction (IRR). IRRs were mainly reported after the first infusion; these were manageable with premedication and a gradual increase in infusion rate. Pharmacokinetics were dose-proportional and CD16A receptor occupancy on NK cells approached saturation between 320-480 mg. Paired tumor biopsies demonstrated activation of innate and adaptive immune responses within the tumor. Best objective response was stable disease in 10/35 patients; four had stable disease for 4.3-7.1 months. AFM24 was well tolerated with 480 mg established as the RP2D. AFM24 could be a novel therapy for patients with EGFR-expressing solid tumors with suitable tolerability and appropriate pharmacokinetic properties for further development in combination with other immuno-oncology therapeutics.

Atomic Insights into pH-Dependent and Water Permeation of mRNA-Lipid Nanoparticles.

The exposure of mRNA to water is likely to contribute to the instability of RNA vaccines upon storage under nonfrozen conditions. Using atomistic molecular dynamics (MD) simulations, we investigated the pH-dependent structural transition and water penetration behavior of mRNA-lipid nanoparticles (LNPs) with the compositions of Moderna and Pfizer vaccines against COVID-19 in an aqueous solution. It was revealed that the ionizable lipid (IL) membranes of LNPs were extremely sensitive to pH, and the increased acidity could cause a rapid membrane collapse and hydration swelling of LNP, confirming the high releasing efficiency of both LNP vaccines. The free energy profiles of water penetration showed that the conical structure of IL played a key role in obstructing water from entering the inner core of LNPs: the molecular geometry with more tail chains, lower linearity, and looser packing structure resulted in higher water permeability, leading to lower stability in nonfrozen liquid environment. On the other hand, the geometry of IL also dominated the fusion behavior of LNP with endosomal membrane during the endosomal escape. Thus, for LNP-based vaccines with both high release efficiency and high stability, a suitable molecular structure of ILs should be selected to seek a balance between the packing tightness and fusion rate of membranes.

Plasma transfusions in neonatal intensive care units: a prospective observational study

ObjectiveDespite lack of evidence supporting efficacy, prophylactic fresh frozen plasma and Octaplas transfusions may be administered to very preterm infants to reduce bleeding risk. International variation in plasma transfusion practices...

Impact of pedicle screw accuracy on clinical outcomes after 1- or 2-level minimally invasive transforaminal lumbar interbody fusion.

When creating minimally invasive spine fusion constructs, accurate pedicle screw fixation is essential for biomechanical strength and avoiding complications arising from delicate surrounding structures. As research continues to analyze how to improve accuracy, long-term patient outcomes based on screw accuracy remain understudied. The objective of this study was to analyze long-term patient outcomes based on screw accuracy. This is a retrospective cohort study of patients who underwent 1- or 2-level minimally invasive transforaminal lumbar interbody fusion and were queried from a prospectively maintained multisurgeon registry. Pedicle screws were assessed for accuracy and graded as poor, acceptable, or good. Patient demographic characteristics and outcomes including complications, patient-reported outcome measures (PROMs), return to activities, and fusion rates were compared between the cohorts. A total of 665 pedicle screws in 153 patients were evaluated and included in the final analysis. Of these, 20 (13.1%) patients had poor screws, 63 (41.2%) had acceptable screws, and 70 (45.7%) had good screws. All groups showed similar and significant improvements in all PROMs, although the poor screw group experienced delayed improvement in physical function. A majority of patients in all groups returned to working and driving and discontinued narcotics at similar rates. However, the poor screw group displayed significantly slower return to activities. There were no significant differences in intraoperative or postoperative complications, although the poor screw group experienced significantly lower fusion rates. Patients with poorly accurate pedicle screws experienced delayed return to activities and decreased fusion rates with similar long-term PROMs. Surgeons should continue to focus on placing accurate pedicle screws, and research should continue to analyze ways to ensure accurate screw placement.

CAR T access and outcomes in large B-cell lymphoma according to ethnicity and socioeconomic deprivation in the UK.

Data on the impact of ethnic and socioeconomic factors on Chimeric antigen receptor (CAR) T-cell therapy (access and outcomes are limited, but key to understand whether results from the registration trials are generalizable to real-world patient populations. Here, we analysed ethnicity, socioeconomic deprivation and referral patterns in a cohort of 314 large B-cell lymphoma patients approved for third-line CD19 CAR-T across three large UK CAR-T centres. Patients from deprived areas had a lower infusion rate compared to low deprivation areas (73% vs. 86%, p = 0.04). CAR-T response rates, toxicities, progression-free survival or non-relapse mortality were similar with respect to ethnicity or deprivation. We did not find evidence of referral barriers according to ethnicity, but potential regional barriers for socioeconomically deprived patients in two of three centres. Intention-to-treat overall survival was significantly inferior in patients from deprived areas (1-year OS 44.5% vs. 58% for high vs. low deprivation; p = 0.02), likely reflecting general health disparities and higher drop-out rates in this group. Our data suggest similar outcomes of CD19 CAR-T-treated patients across a socioeconomically and ethnically heterogeneous real-world population. Results demonstrate broad access to CAR-T within the UK national delivery system, but the high drop-out rate and potential regional referral barriers for deprived communities should be further investigated.

Selective Direct Vertebral Rotation Instrumentation for the Correction of Adolescent Idiopathic Scoliosis Lenke 5 Curve.

Direct vertebral rotation (DVR) effectiveness in improving scoliosis correction outcomes remains unclear and requires further investigation. This study aimed to evaluate the effectiveness of short and extended fusion techniques using en-bloc DVR in correcting adolescent idiopathic scoliosis (AIS) classified as Lenke 5 curve (5C). This retrospective study included 90 randomly selected AIS patients with Lenke 5C who underwent posterior spinal instrumentation surgery using en-bloc DVR between 2014 and 2021. Patients were divided into 2 groups: (1) extended fusion, Group A (n = 40): upper instrumented vertebra = upper-end vertebra +1 or +2 or (2) short fusion, Group B (n = 50): upper instrumented vertebra = upper-end vertebra. Radiographic parameters were compared preoperatively and at postoperative follow-ups of 6 months, 3 years, and more. The mean follow-up duration was 37.5 ± 6 months for Group A and 40.0 ± 8 months for Group B (P = 0.596). The coronal balance correction rate was comparable between the 2 groups, with no significant differences observed at the final follow-up. Significant differences were noted in the fused segment, with Group A having an average fusion rate of 6.8 ± 0 compared with 6.3 ± 0 in Group B (P = 0.001). TK and lumbar lordosis measurements at the final follow-up did not show significant differences between the groups. However, substantial differences were observed in rib hump correction, with Group A demonstrating a better correction rate than Group B at both 6 months and the last follow-up (P = 0.001 for both time points). Selective DVR spinal instrumentation effectively corrects AIS Lenke 5C. However, extended fusion demonstrates more efficient correction and greater improvement in the patient's cosmetic appearance, including better thoracic curve correction, rib hump correction, and shoulder balance, compared with short-level fusion.

Equivalence of Biosimilarity in Pharmacokinetic and Pharmacodynamic Properties of Recombinant Human Insulin Aspart.

Insulin aspart, a rapid-acting analog, achieves faster subcutaneous absorption than regular insulin. This study aimed to demonstrate equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Recombinant Human Insulin Aspart from BioGenomics Limited (as test) and Novo-Nordisk (as reference) in healthy adult males. This was a double-blind, randomized, cross-over study, assessing PK and PD parameters under fasting conditions. Participants received either 0.2U/kg of test or reference product via a subcutaneous route in the abdominal area. PK parameters included maximum serum concentration (Cmax), area under the curve [(AUC[0-t]) and (AUC [0-∞])], time to maximum serum concentration (Tmax), and half-life (t½). PD parameters included amount of glucose infused (Gtot), maximum glucose infusion rate (Rmax), time of Rmax (tRmax), late time of half-maximal glucose infusion rate (tRmax50), time of first measured glucose infusion rate (tonset), and cessation of glucose infusion/clamp (tRlast). Seventy subjects between 18 and 45years of age and body mass index between 18 and 27kg/m2 were enrolled. The 90% confidence intervals (CIs) for Cmax, AUC[0-t], AUC [0-∞] for insulin, and the 95% CIs for Gtot, Rmax for glucose were within 80%-125% as required to assess test-reference bioequivalence. No serious adverse events were observed. Both the preparations showed bioequivalence under fasting conditions with a similar safety profile.

Percutaneous hallux fusion with calcaneus bone autograft: a retrospective cohort study of clinical and radiographic outcomes.

In the case of end-stage hallux rigidus, first metatarsophalangeal (MTP) joint arthrodesis is the gold-standard and is traditionally performed via an open approach. However, complications such as nonunion have been reported to be as high as 30%. Recently, there have been reports demonstrating a percutaneous approach to be effective and safe. Forty-nine patients with end-stage hallux rigidus underwent percutaneous first MTP joint arthrodesis with calcaneus autograft performed by a single surgeon. Each patient underwent a minimum of 24 month clinical and radiographic follow up, including 3 month post operative computed tomography scans. Clinical outcomes were assessed using the Visual Analog Scale (VAS) and Foot Function Index (FFI) preoperatively and at final follow-up. Mean follow-up was 27.3 months. Bone union was observed in 46 patients (93.9%). Mean time to union was 3.1 months. Nonunion rate was 6.1%. Overall complication rate was 12.2%. Mean pre- and postoperative VAS scores were 7.5 and 0.2, respectively (P < .0001). Mean pre- and postoperative total FFI values were 56.3 and 15.7 (P < .0001), respectively. Patient satisfaction after the procedure was 93.9%. Observed union rate is comparable to the average fusion rate previously reported for open and minimally invasive procedure union rates. Mean time to union was observed to be comparable to open procedures union time. Observed overall complication rate is similar to those reported for open techniques as well. Patient reported outcomes demonstrated a significant reduction in postoperative VAS and FFI for the percutaneous metatarsophalangeal arthrodesis with calcaneus bone autograft. Patient satisfaction rates compared favorably to those reported following open surgery.

Comparison of clinical and radiological outcomes of three-column lumbar osteotomies with and without interbody cages for adult spinal deformity.

Correcting sagittal malalignment in adult spinal deformity (ASD) is a challenging task, often requiring complex surgical interventions like pedicle subtraction osteotomies (PSOs). Different types of three-column osteotomies (3COs), including Schwab 3, Schwab 4, Schwab 4 with interbody cages, and the "sandwich" technique, aim to optimize alignment and fusion outcomes. The role of interbody cages in enhancing fusion and segmental correction remains unclear. This study aimed to compare outcomes among these 4 3CO techniques, evaluating the impact of cage use at the osteotomy site on postoperative radiographic imaging and clinical outcomes. This is a multicenter retrospective study utilizing data from a prospective multicenter database of patients undergoing complex ASD surgery. Ninety-seven patients who underwent 1 of 4 3CO techniques for thoracolumbar ASD correction with at least 2 years of follow-up were included. The sample consisted of 29 patients who underwent Schwab 3 osteotomy, 20 Schwab 4, 28 Schwab 4 with interbody cages, and 20 who underwent "sandwich" osteotomy. The Scoliosis Research Society-22 revised (SRS22r) questionnaire evaluating pain, activity, appearance, mental health, and satisfaction was used to evaluate patient reported outcomes and radiographic measures including segmental lordosis and fusion rates determined by 3 blinded reviewers were used to evaluate physiologic outcomes. This study analyzed demographic data, radiographic outcomes, patient-reported outcomes, complications, and fusion rates over a 2-year follow-up period. Fusion status was determined via serial radiographs and evaluated independently by 3 blinded reviewers. Univariate and multivariate statistical analyses were performed to assess differences among the groups and the impact of interbody cage use on outcomes. Patients undergoing "sandwich" osteotomy exhibited worse preoperative leg pain scores and lower SRS22r activity (p=.015), appearance (p=.007), and mental health domain scores (p=.0015). No differences in complications were found among groups (p>.05). Patients who underwent osteotomy with a cage were more likely to have had previous spine fusion (91.7% vs. 71.4%, p=.010). Additionally, these patients had lower preoperative SRS22r mental domain (2.9±1 vs. 3.5±1, p=.009), satisfaction (2.3±1 vs. 2.7±1.2, p=.034), and SRS22r total scores (2.3±0.6 vs. 2.6±0.6, p=.0026) but demonstrated the greatest improvement in the mental health domain (0.9±0.7 vs. 0.3±0.9, p=.002). Cage use was associated with a larger mean change in segmental lordosis at the osteotomy site (32.9±9.6 vs. 28.7±9.5, p=.038). Fusion rates were significantly higher in the cage group (79.2% vs. 55.1%, p=.0012). Regression analysis identified cage use as an independent predictor for fusion (odds ratio, 3.338; 95% confidence interval, 1.108-10.054, p=.032). Interbody cage use at the osteotomy site during 3COs for ASD correction was associated with improved fusion rates and greater segmental lordosis without increasing complication rates. Incorporating cages may provide enhanced alignment and fusion outcomes in complex ASD surgeries.

Meta-analysis of the clinical efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion versus endoscopic lumbar interbody fusion for the treatment of lumbar degenerative diseases.

To compare the efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion (UBE-LIF) and endoscopic lumbar interbody fusion (Endo-LIF) in the treatment of lumbar degenerative diseases in lumbar degenerative diseases. A thorough literature search was conducted according to the PRISMA guidelines and the PICO framework(PROSPERO 2024CRD42024592073). The databases searched included PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure(CNKI), and Wanfang Database, with a time frame of January 2020 to June 2024. Outcome metrics included operative time, rate of progress of surgical time for beginners, intraoperative bleeding, hidden blood loss(HBL), total blood loss(TBL), postoperative drainage, hospitalization time, visual analog score (VAS) for pain, Oswestry Disability Index (ODI), complications, fusion rates, and modified MacNab score excellence rates. A total of 10 papers were included, including two that were RCT trials. This study involved 710 patients, 348 in the UBE-LIF group and 362 in the Endo-LIF group. The results showed that the UBE-LIF group was superior to the Endo-LIF group in terms of operative time and rate of progress of surgical time for beginners. In contrast, the Endo-LIF group was superior to the UBE-LIF group in terms of hospitalization time, hidden blood loss, and total blood loss. There were no statistical differences between the two procedures regarding intraoperative bleeding, postoperative drainage, visual analog score for low back pain, Oswestry Disability Index, complications, fusion rates, and modified MacNab score excellence rates. Postoperative pain and safety were comparable between the two endoscopic procedures.The UBE-LIF procedure was shorter, whereas the Endo-LIF had less total blood loss and a shorter recovery time.

Optimizing Intravenous Patient-Controlled Analgesia for Cancer Pain: A Randomized Controlled Trial on Adjusted Background Infusion Rates.

Patient-controlled analgesia (PCA) has been considered for managing cancer pain; however, limited research has been conducted on optimizing continuous infusion rates with PCA. This study aimed to evaluate the efficacy and safety of a method that optimizes background infusion (BI) alongside PCA for titrating intravenous (IV) morphine in managing cancer-related pain. Forty-four patients with solid tumors who could not manage pain with oral or transdermal opioid analgesics were randomly assigned in a 1:1 ratio to receive IV morphine through PCA or the conventional method. In the PCA group, the BI rate was automatically adjusted on the basis of the frequency and interval of bolus button presses; contrastingly, BI rate in the conventional group was adjusted at the discretion of the medical staff. The primary outcome was the daily number of patient complaints of breakthrough pain (numeric rating scale ≥4). The PCA group reported a significant decrease in breakthrough pain complaints at 24 hours (median, 0 v 3 times/d; P = .012) and a lower proportion of nonresponders at 24 hours (21% v 55%; P = .048) compared with the conventional group. The total daily IV dose of morphine increased in the PCA group and exhibited a significant difference between two groups within 48 hours (median, 76.80 v 44.42 mg/d; P = .036). No uncontrolled opioid-related adverse effects were observed in either group. PCA, with an optimized BI rate, facilitated faster titration of IV morphine than the conventional method, achieving tolerable and rapid pain relief.

Pear-Shaped Disc as a Risk Factor for Postoperative Sclerotic Modic Changes After Transforaminal Lumbar Interbody Fusion.

Pear-shaped disc could increase the risk of intraoperative end-plate injury, which may lead to postoperative sclerotic Modic Changes (MCs). However, there are no studies on the relationship between pear-shaped disc and postoperative sclerotic MCs. Therefore, this study investigates the risk factors for postoperative sclerotic MCs following transforaminal lumbar interbody fusion (TLIF). Specifically, the study focuses on the impact of pear-shaped disc on the occurrence of postoperative sclerotic MCs and evaluates its influence on clinical outcomes. A total of 411 patients undergoing TLIF between January 2018 and January 2022 were included. Among them, 50 developed postoperative sclerotic MCs, while 361 did not. The two groups were matched based on various parameters. Clinical and radiographic evaluations, including visual analogue scale (VAS), Oswestry disability index (ODI), lumbar X-ray, CT, and MRI, were performed. Statistical analysis included independent sample t test, Pearson's chi-square test, and binary logistic regression analysis. After pairing, a total of 100 patients were included, including 50 patients in postoperative sclerotic MCs group and 50 patients in non-MCs group. There were 27 pear-shaped discs in the postoperative sclerotic MCs group, significantly higher than 7 in the non-MCs group (p < 0.001). Besides, BMI, endplate injury, and cage subsidence in the postoperative sclerotic MCs group were significantly higher than those in the non-MCs group, but the fusion rate was significantly lower than that in the non-MCs group. The postoperative and follow-up SL and surgical corrections of SL in postoperative sclerotic MCs group were significantly higher than those in non-MCs group. The independent risk factors identified for postoperative sclerotic MCs include pear-shaped disc and higher BMI. Pear-shaped disc and higher body mass index (BMI) as independent risk factors for postoperative sclerotic MCs. Patients with sclerotic MCs exhibited a lower fusion rate, increased cage subsidence, and poorer symptom improvement compared to those without MCs.

Pharmacokinetic and Pharmacodynamic Equivalence of Biosimilar and Reference Ultra-Rapid Lispro: A Comparative Clamp Study in Healthy Volunteers.

Ultra-rapid insulin lispro is an innovative insulin analogue designed to achieve rapid onset and short duration of action, aimed at optimizing glycemic control in patients with diabetes. This was a double-blind, randomized, 2-period, crossover clamp study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD), along with safety profiles, of a potential biosimilar ultra-rapid insulin lispro compared to the reference product in healthy White men. A total of 35 healthy volunteers completed hyperinsulinemic euglycemic clamp procedures across both study periods. Blood samples were collected at predefined intervals up to 8hours to assess PK parameters. Plasma glucose levels were monitored every 5minutes during the 8-hour clamps, with adjustments to the glucose infusion rate to maintain the target range. Insulin quantification in plasma was conducted using a validated enzyme-linked immunosorbent assay method. PD assessment was based on glucose infusion rate profiles during both clamps. Geometric mean ratios for maximum plasma concentration and area under the concentration-time curve from insulin administration to the last measurable concentration for the test and reference drugs fell within the bioequivalence range of 80%-125%. Furthermore, the investigational drugs demonstrated comparable PK/PD profiles of insulin lispro. Both formulations exhibited similar safety profiles primarily characterized by mild injection site reactions.