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  • Guo H
  • Liu C
  • Kang L
  • Liu Y
Hematology. 2024 Dec;29(1):2335419 doi: 10.1080/16078454.2024.2335419.
OBJECTIVE:

This article conducts a systematic review of eltrombopag combined with immunosuppressive therapy for the treatment of aplastic anemia (AA), to demonstrate the effectiveness and safety of eltrombopag.

METHODS:

PubMed, Cochrane Library, Embase, OVID, Web of Science, China National Knowledge Infrastructure, and Wanfang databases were searched. Studies that met the inclusion criteria were collected, ranging from the establishment of the database to August 2023. Two reviewers performed meta-analyses using the Cochrane systematic review method and RevMan 5.3 software.

RESULTS:

This meta-analysis enrolled 5 studies with a total of 542 AA patients, including 274 in the experimental group and 268 in the control group. Meta-analyses were performed for efficacy and adverse reactions. The endpoint of effects included 6-month complete response (CR), 6-month partial response (PR), and 6-month overall response (OR). Eltrombopag combined with immunotherapy showed significant improvements in 6-month CR (OR: 2.20; 95% CI;1.54-3.12; P < 0.0001) and 6-month OR (OR = 3.66, 95% CI 2.39-5.61, P < 0.001)compared to immunosuppressive therapy for AA patients. In terms of safety, eltrombopag combined with immunosuppressive therapy showed significantly increased pigment deposition and abnormal liver function compared to immunosuppressive therapy alone.

CONCLUSION:

Compared to immunosuppressive therapy alone, eltrombopag combined with immunosuppressive therapy showed significant improvements in 6-month CR and 6-month OR. However, it also resulted in increased pigment deposition and abnormal liver function in terms of safety.

  • Wu L
  • Su F
  • Luo P
  • Dong Q
  • Ma M
  • et al.
Platelets. 2024 Dec;35(1):2292612 doi: 10.1080/09537104.2023.2292612.
BACKGROUND:

Platelet-rich plasma (PRP) is a therapeutic approach that is gaining attention for its potential in the treatment of poor ovarian response. This meta-analysis aimed to systematically review and analyze clinical studies to evaluate the impact of PRP on poor responders undergoing ovarian stimulation for IVF.

METHODS:

A comprehensive search was conducted in electronic databases, including PubMed, Embase, Scopus, Web of Science, and the Cochrane Library to identify relevant studies published in English. The pooled data, such as pregnancy outcome, number of MII oocytes, number of transferable embryos, and ovarian reserve markers were analyzed using R version 4.2.3.

RESULTS:

A total of 10 trials were enrolled in the present meta-analysis. Following PRP treatment, live birth rate was found to be 16.6% (95% CI 8.8%-26.1%), while clinical pregnancy rate was observed to be 25.4% (95% CI 13.1%-39.9%). PRP pretreatment resulted in a higher number of MII oocytes (MD 1.073, 95% CI 0.720 to 1.427), a higher number of embryos (MD 0.946, 95% CI 0.569 to 1.323), a higher antral follicle count (MD 1.117; 95% CI 0.689 to 1.544), and the change of hormone levels.

CONCLUSIONS:

Among the studies evaluated in this review, PRP showed promising results in poor responder. Further research is required to clarify the potential role of PRP in female reproductive health.

Editor's Choice
  • Brown AN
  • Yendluri A
  • Lawrence KW
  • Cordero JK
  • Moucha CS
  • et al.
J Am Acad Orthop Surg. 2024 Jun 1;32(11):508-515 doi: 10.5435/JAAOS-D-23-00503.
POPULATION:

Patients undergoing orthopaedic surgery (108 randomised controlled trials).

INTERVENTION:

Tranexamic acid (TXA).

COMPARISON:

Placebo/control; other antifibrinolytic/clotting agents; TXA with a different dose or route of administration.

OUTCOME:

A total of 192 outcomes were reported across the 108 included studies. The median fragility index (FI) of the 192 outcomes was 4 (IQR= 2, 5) with an associated fragility quotient (FQ) of 0.03 (IQR= 0.019, 0.050). 45 outcomes were reported as statistically significant with a median FI of 1 (IQR= 1, 5) and associated FQ of 0.02 (IQR= 0.011, 0.034). 147 outcomes were reported as nonsignificant with a median reverse fragility index of 4 (IQR= 3, 5) and associated FQ of 0.04 (IQR= 0.023, 0.051). The adult reconstruction, trauma, and spine subspecialties had a median FI of 4. Sports had a median FI of 3. Shoulder and elbow and foot and ankle had median FIs of 6.

INTRODUCTION:

Randomized controlled trials (RCTs) represent the highest level of evidence in orthopaedic surgery literature, although the robustness of statistical findings in these trials may be unreliable. We used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of outcomes reported in RCTs that assess the use of tranexamic acid (TXA) across orthopaedic subspecialties.

METHODS:

PubMed, EMBASE, and MEDLINE were queried for RCTs (2010-present) reporting dichotomous outcomes with study groups stratified by TXA administration. The FI and rFI were defined as the number of outcome event reversals needed to alter the significance level of significant and nonsignificant outcomes, respectively. FQ was determined by dividing the FI or rFI by sample size. Subgroup analyses were conducted based on orthopaedic subspecialty.

RESULTS:

Six hundred five RCTs were screened with 108 studies included for analysis comprising 192 total outcomes. The median FI of the 192 outcomes was 4 (IQR 2 to 5) with an associated FQ of 0.03 (IQR 0.019 to 0.050). 45 outcomes were reported as statistically significant with a median FI of 1 (IQR 1 to 5) and associated FQ of 0.02 (IQR 0.011 to 0.034). 147 outcomes were reported as nonsignificant with a median rFI of 4 (IQR 3 to 5) and associated FQ of 0.04 (IQR 0.023 to 0.051). The adult reconstruction, trauma, and spine subspecialties had a median FI of 4. Sports had a median FI of 3. Shoulder and elbow and foot and ankle had median FIs of 6.

DISCUSSION:

Statistical outcomes reported in RCTs on the use of TXA in orthopaedic surgery are fragile. Reversal of a few outcomes is sufficient to alter statistical significance. We recommend reporting FI, rFI, and FQ metrics to aid in interpreting the outcomes reported in comparative trials.

Editor's Choice
  • Liu CW
  • Anih J
  • Lebedeva V
  • Gungor A
  • Wang C
  • et al.
J Clin Anesth. 2024 Jun;94:111417 doi: 10.1016/j.jclinane.2024.111417.
POPULATION:

Patients undergoing non-obstetric surgery (300 trials, n= 53,085).

INTERVENTION:

Intravenous tranexamic acid.

COMPARISON:

Placebo or usual care without tranexamic acid.

OUTCOME:

From all the included studies, 45,958 participants (86.6%) were enrolled in 228 trials (76.0%) that explicitly excluded patients with kidney disease. Definitions of kidney diseased used for exclusion varied widely. Most were non-specific and some corresponded to mild disease. Only 5 trials adjusted dosing for kidney function. Meta-analysis of two large trials found tranexamic acid unlikely to substantially increase or decrease the occurrence of thrombotic events in patients with estimated glomerular filtration rate <60 mL/min/1.73m(2) (RR 0.95; 95% CI [0.83, 1.07]) or ≥ 60 mL/min/1.73m(2) (RR 1.00; 95% CI [0.91, 1.11], but both trials excluded patients with severe kidney disease. No analysis could be performed regarding seizure risk. One large trial in non-cardiac surgery reported similar reduction in bleeding across subgroups of kidney function but excluded patients with creatinine clearance <30 mL/min.

STUDY OBJECTIVE:

To assess how kidney disease is handled in randomized trials evaluating the safety and efficacy of perioperative tranexamic acid, and to evaluate its effects across levels of kidney function.

DESIGN:

Systematic review and meta-analysis of randomized controlled trials.

SETTING:

We screened studies from a previous comprehensive systematic review, and updated its search of PubMed, Embase, and Cochrane CENTRAL to July 31, 2023.

PATIENTS:

Patients undergoing non-obstetric surgery.

INTERVENTIONS:

Intravenous tranexamic acid compared to placebo or usual care without tranexamic acid.

MEASUREMENT:

We summarized the handling of kidney disease in eligibility criteria, dose adjustments for kidney function, and effects of tranexamic acid on thrombotic events, seizures, and bleeding by subgroups of kidney function.

MAIN RESULTS:

We evaluated 300 trials with 53,085 participants; 45,958 participants (86.6%) were enrolled in 228 trials (76.0%) that explicitly excluded patients with kidney disease. Definitions of kidney diseased used for exclusion varied widely. Most were non-specific and some corresponded to mild disease. Only 5 trials adjusted dosing for kidney function. Meta-analysis of two large trials found tranexamic acid unlikely to substantially increase or decrease the occurrence of thrombotic events in patients with eGFR <60 mL/min/1.73m2 (RR, 0.95; 95% CI: 0.83 to 1.07) or ≥ 60 mL/min/1.73m2 (RR, 1.00; 95% CI, 0.91 to 1.11; P for subgroup difference = 0.47), but both trials excluded patients with severe kidney disease. No analysis could be performed regarding seizure risk. One large trial in noncardiac surgery reported similar reduction in bleeding across subgroups of kidney function but excluded patients with creatinine clearance <30 mL/min.

CONCLUSIONS:

The large evidence base supporting perioperative tranexamic acid suffers from broad and unjustified exclusion of patients with kidney disease. Typical perioperative dosing of tranexamic acid is likely safe and effective in patients with creatinine clearance >30 mL/min, but effects in more severe kidney disease are unknown.

  • Cui Y
  • Mai Y
  • Liu X
  • Mu H
Eur J Oral Sci. 2024 Jun;132(3):e12978 doi: 10.1111/eos.12978.

This study aimed to compare clinical benefits of autologous platelet concentrate with other periodontal regenerative approaches in intrabony defects. An electronic and hand search of studies up to December 2022 was conducted. Randomized controlled trials with at least 6 months of follow-up were identified to compare autologous platelet concentrates with enamel matrix derivative, bone graft, guided tissue regeneration, and open-flap debridement. All approaches involved papilla preservation flap surgery. The outcomes included probing depth reduction, clinical attachment level gain, linear bone fill, and safety. A network meta-analysis and meta-regression were performed. Fifty-seven studies were included in five network meta-analyses. Autologous platelets concentrate and its adjunct treatments achieved significantly greater clinical and radiographic parameters than did open-flap debridement, and had comparable or better performance than other regenerative treatments. Platelet-rich fibrin showed superiority over platelet-rich plasma in probing depth reduction at 6-month follow-up. Minimal pain and improved wound healing were observed in the treatments with autologous platelet concentrate. Meta-regression showed that deeper baseline intrabony defects resulted in larger probing depth reductions, while smoking impaired the effectiveness of regenerative surgeries. Minimal invasive flap designs led to less effect of regenerative materials. Autologous platelet concentrate is a promising biomaterial in periodontal regeneration due to its convenience, safety, and biocompatibility characteristics.

  • Herber A
  • Covarrubias O
  • Daher M
  • Tung WS
  • Gianakos AL
Foot Ankle Surg. 2024 Jun;30(4):285-293 doi: 10.1016/j.fas.2024.02.004.
INTRODUCTION:

Plantar fasciitis (PF) is the most common cause of heel pain in adults. There are numerous non-operative treatments available including platelet rich plasma (PRP) injections. PPR has demonstrated effectiveness for a range of musculoskeletal conditions including plantar fasciitis.

PURPOSE/OBJECTIVE:

To compare the effectiveness of PRP to other conservative treatment options for the management of PF.

METHODS:

A systematic search of PubMed and Google Scholar was performed for randomized control trials (RCT) comparing PRP to other treatment modalities. Studies met inclusion criteria if mean and standard deviations for visual analog scale (VAS) pain scores, plantar fascia thickness (PFT), Foot Function Index (FFI), or American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score were reported. Mean differences (MD) were used to compare VAS pain, PFT, FFI, and AOFAS between PRP and other treatments.

RESULTS:

Twenty-one RCTs which altogether included 1356 patients were included in the meta-analysis. PRP demonstrated significantly greater improvements in VAS pain scores compared to extracorporeal shock wave therapy (ESWT) (SMD: 0.86; CI: [0.30, 1.41]; p = 0.002), corticosteroid injections (CSI) (SMD: 1.08; CI: [0.05, 2.11]; p = 0.04), and placebo (SMD: 3.42; CI: [2.53, 4.31]; p < 0.00001). In terms of FFI, no significant differences existed among PRP, ESWT, CSI, dextrose prolotherapy (DPT), and meridian trigger points (MTP) in enhancing foot functionality. However, PRP demonstrated a marked advantage over phonophoresis, showing a substantial improvement in FFI scores (SMD: 3.07, 95% CI: 2.34-3.81). PRP did not demonstrate superiority over ESWT, CSI, or MTP for improving PFT, but it was notably more effective than phonophoresis (SMD: 3.18, 95% CI: 2.43-3.94). PRP demonstrated significantly greater improvements in AOFAS scores over CSI (SMD: 3.31, CI: [1.35, 5.27], p = 0.0009) and placebo (SMD: 3.75; CI: [2.81, 4.70]; p < 0.00001).

CONCLUSION:

PRP is more effective than CSI, ESWT, and placebo in reducing VAS and more effective than CSI and placebo in improving AOFAS. PRP did not demonstrate a consistent advantage across all outcome measures, such as PFT and FFI. These findings underscore the complexity of PF treatment and call for a more standardized approach to PRP preparation and outcome measurement.

LEVEL OF EVIDENCE:

Level I Meta-Analysis.

  • Zhang S
  • Ouyang M
  • Liu L
Chronic Illn. 2024 Jun;20(2):221-232 doi: 10.1177/17423953231180453.
BACKGROUND:

Hemodialysis patients are common to have renal anemia in the nephrology practice. For the renal anemia, the high-dose iron from the intravenous route is an important treatment option. We can understand the treatment effects and cardiovascular events of high-dose intravenous iron reviewing the randomized clinical trials.

METHODS:

We compared the high-dose and low-dose iron treatments to find if the high-dose intravenous iron can influence the hematological parameters more significantly than the low-dose iron. The cardiovascular events were also analyzed for the high-dose iron treatment. Six studies with a total of 2422 renal anemia patients under hemodialysis were enrolled. We focused the outcomes of hemoglobin, transferrin saturation percentage, ferritin, erythropoietin dose, and cardiovascular events.

RESULTS:

The high-dose intravenous iron might be associated with a greater number of ferritin, transferrin saturation percentage, and hemoglobin. In addition, the erythropoietin dose was less needed to maintain the ideal hemoglobin range in the high-dose intravenous iron group.

CONCLUSIONS:

In current meta-analysis, the high-dose intravenous iron might show the superior effects on the ferritin, transferrin saturation percentage, and hemoglobin levels and needed dose of erythropoietin when compared to low-dose iron treatment.

  • Stephanos M
  • Stewart CMB
  • Mahmood A
  • Brown C
  • Hajibandeh S
  • et al.
Ann Hepatobiliary Pancreat Surg. 2024 May 31;28(2):115-124 doi: 10.14701/ahbps.23-137.

To compare the outcomes of low central venous pressure (CVP) to standard CVP during laparoscopic liver resection. The study design was a systematic review following the PRISMA statement standards. The available literature was searched to identify all studies comparing low CVP with standard CVP in patients undergoing laparoscopic liver resection. The outcomes included intraoperative blood loss (primary outcome), need for blood transfusion, mean arterial pressure, operative time, Pringle time, and total complications. Random- effects modelling was applied for analyses. Type I and type II errors were assessed by trial sequential analysis (TSA). A total of 8 studies including 682 patients were included (low CVP group, 342; standard CVP group, 340). Low CVP reduced intraoperative blood loss during laparoscopic liver resection (mean difference [MD], -193.49 mL; 95% confidence interval [CI], -339.86 to -47.12; p = 0.01). However, low CVP did not have any effect on blood transfusion requirement (odds ratio [OR], 0.54; 95% CI, 0.28-1.03; p = 0.06), mean arterial pressure (MD, -1.55 mm Hg; 95% CI, -3.85-0.75; p = 0.19), Pringle time (MD, -0.99 minutes; 95% CI, -5.82-3.84; p = 0.69), operative time (MD, -16.38 minutes; 95% CI, -36.68-3.39; p = 0.11), or total complications (OR, 1.92; 95% CI, 0.97-3.80; p = 0.06). TSA suggested that the meta-analysis for the primary outcome was not subject to type I or II errors. Low CVP may reduce intraoperative blood loss during laparoscopic liver resection (moderate certainty); however, this may not translate into shorter operative time, shorter Pringle time, or less need for blood transfusion. Randomized controlled trials with larger sample sizes will provide more robust evidence.

  • Phillips A
  • Bradley C
  • Cash J
  • Sangiovanni R
  • Wingerson C
Am J Health Syst Pharm. 2024 May 24;81(11):e274-e282 doi: 10.1093/ajhp/zxae009.
PURPOSE:

The purpose of this review is to evaluate current literature on the treatment of factor Xa inhibitor-associated bleeds with 4-factor prothrombin complex concentrate (4F-PCC), with a focus on the effect of low versus high dosing of 4F-PCC on hemostatic efficacy and safety outcomes.

SUMMARY:

A search of PubMed and EBSCOhost was performed to identify studies evaluating patients with a factor Xa inhibitor-bleed treated with 4F-PCC at either low or high doses. Studies of patients receiving alternative reversal agents such as fresh frozen plasma and andexanet alfa or where no comparator group was evaluated were excluded from the analysis. To assess the effect of these 4F-PCC dosing strategies, the primary outcome of interest was hemostatic efficacy. Four studies meeting inclusion criteria were included in this review. In each of the included studies, similar rates of hemostatic efficacy, hospital mortality, and venous thromboembolism were observed in the low- and high-dose cohorts.

CONCLUSION:

These results suggest low- and high-dose 4F-PCC may confer similar clinical effectiveness and safety; however, these findings should be evaluated and confirmed with future prospective studies.

  • Yu Q
  • Funaki B
  • Ahmed O
Br J Radiol. 2024 May 7;97(1157):920-932 doi: 10.1093/bjr/tqae037.
BACKGROUND:

Transarterial embolization (TAE) for acute lower gastrointestinal bleeding (LGIB) can be technically challenging due to the compromise between achieving haemostasis and causing tissue ischaemia. The goal of the present study is to determine its technical success, rebleeding, and post-embolization ischaemia rates through meta-analysis of published literature in the last twenty years.

METHODS:

PubMed, Embase, and Cochrane Library databases were queried. Technical success, rebleeding, and ischaemia rates were extracted. Baseline characteristics such as author, publication year, region, study design, embolization material, percentage of superselective embolization were retrieved. Subgroup analysis was performed based on publication time and embolization agent.

RESULTS:

A total of 66 studies including 2121 patients who underwent embolization for acute LGIB were included. Endoscopic management was attempted in 34.5%. The pooled overall technical success, rebleeding, post-embolization ischaemia rates were 97.0%, 20.7%, and 7.5%, respectively. Studies published after 2010 showed higher technical success rates (97.8% vs 95.2%), lower rebleeding rates (18.6% vs 23.4%), and lower ischaemia rates (7.3% vs 9.7%). Compared to microcoils, NBCA was associated with a lower rebleeding rate (9.3% vs 20.8%) at the expense of a higher post-embolization ischaemia rate (9.7% vs 4.0%). Coagulopathy (P = .034), inotropic use (P = .040), and malignancy (P = .002) were predictors of post-embolization rebleeding. Haemorrhagic shock (P < .001), inotropic use (P = .026), malignancy (P < .001), coagulopathy (P = .002), blood transfusion (P < .001), and enteritis (P = .023) were predictors of mortality. Empiric embolization achieved a similarly durable haemostasis rate compared to targeted embolization (23.6% vs 21.1%) but a higher risk of post-embolization ischaemia (14.3% vs 4.7%).

CONCLUSION:

For LGIB, TAE has a favourable technical success rate and low risk of post-embolization ischaemia. Its safety and efficacy profile has increased over the last decade. Compared to microcoils, NBCA seemed to offer a more durable haemostasis rate at the expense of higher ischaemia risk. Due to the heterogeneity of currently available evidence, future prospective and comparative studies are warranted.

ADVANCES IN KNOWLEDGE:

(1) Acute LGIB embolization demonstrate a high technical success rate with acceptable rate of rebleeding and symptomatic ischaemia rates. Most ischaemic stigmata discovered during routine post-embolization colonoscopy were minor. (2) Although NBCA seemed to offer a more durable haemostasis rate, it was also associated with a higher risk of ischaemia compared to microcoils. (3) Coagulopathy, malignant aetiology, and inotropic use were predictors of rebleeding and mortality. (4) Routine post-embolization endoscopy to assess for ischaemia is not indicated.