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1.
Safety and efficacy of double plasma molecular adsorption system with sequential low-volume plasma exchange in intermediate-stage hepatitis B virus-related acute-on-chronic liver failure
Xu W, Zhu S, Yang L, Li Z, Wu L, Zhang Y, Chen J, Deng Z, Luo Q, Peng L
Journal of medical virology. 2023
Abstract
BACKGROUND Current evidence suggests that the mortality rate of intermediate-stage hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) remains high. We aimed to investigate the safety and efficacy of double plasma molecular adsorption system (DPMAS) with sequential low-volume plasma exchange (LPE) treatment in intermediate-stage HBV-related ACLF. METHODS This prospective study recruited intermediate-stage HBV-related ACLF patients and was registered on ClinicalTrials.gov (NCT04597164). Eligible patients were randomly divided into a trial group and a control group. Patients in both groups received comprehensive medical treatment. Patients in the trial group further received DPMAS with sequential LPE. Data were recorded from baseline to week 12. RESULTS 50 patients with intermediate-stage HBV-related ACLF were included in this study. The incidence of bleeding events and allergic reactions in the trial group was 12% and 4%, respectively, with no other treatment-related adverse events. The levels of TBIL and PT-INR, and MELD scores after each session of DPMAS with sequential LPE were significantly lower than those before treatment (all p<0.05). The 12-week cumulative liver transplantation-free survival rates in the trial and control groups were 52% and 24%, respectively (p=0.041). The 12-week cumulative overall survival rates in the trial and control groups were 64% and 36%, respectively (p=0.048). The Kaplan-Meier survival analysis revealed significant differences in liver transplantation-free survival (p=0.047) and overall survival (p=0.038) between the trial and control groups. COX regression analysis indicated that BUN (p=0.038), DPMAS with sequential LPE (p=0.048) and COSSH-ACLF II score (p<0.001) were significant risk factors for mortality. CONCLUSION DPMAS with sequential LPE treatment is safe and effective for patients with intermediate-stage HBV-related ACLF. This article is protected by copyright. All rights reserved.
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2.
The therapeutic window of intravenous immunoglobulin (IVIG) and its correlation with clinical outcomes in Kawasaki disease: a systematic review and meta-analysis
Li Z, Cai J, Lu J, Wang M, Yang C, Zeng Z, Tang Q, Li J, Tang W, Luo H, et al
Italian journal of pediatrics. 2023;49(1):45
Abstract
BACKGROUND The optimal therapeutic window to start intravenous immunoglobulin (IVIG) for Kawasaki disease (KD) is highly debatable. We aimed to summarize the existing literature to evaluate the therapeutic window of IVIG treatment and its correlation with clinical outcomes in KD patients. METHODS We searched the databases from inception to August 26, 2022, without language restrictions. The primary outcomes were initial IVIG resistance and coronary artery lesions (CALs) in acute phase. Secondary outcome was CALs during 1-2 months of follow-up. RESULTS 27 studies involving 41,139 patients were included in this study. Very low-quality evidence showed that the earlier IVIG treatment within 4 days had a higher IVIG-resistance rate (RR, 1.80; 95% CI, 1.50-2.15; P < .00001; I(2) = 75%) than the late treatment. Very low-quality evidence showed that IVIG treatment for more than 7 days was associated with a higher risk of CALs in acute phase(RR, 0.57; 95% CI, 0.40-0.80; P = .001; I(2) = 76%). There was a lower risk of CALs during 1-2 months follow-up for those who started IVIG administration within 10 days from the onset. CONCLUSIONS Overall, IVIG treatment within 7 days of illness seems to be the optimal therapeutic window of IVIG. IVIG treatment within 7 days is found to be effective for reducing the risk of coronary artery lesions and cardiac sequelae in KD patients. The early IVIG treatment within 4 days should be vigilant for the IVIG resistance although large multi-center randomized trials with well design are needed.
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3.
Effect of intrauterine infusion of platelet-rich plasma for women with recurrent implantation failure: a systematic review and meta-analysis
Deng H, Wang S, Li Z, Xiao L, Ma L
Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology. 2022;:1-8
Abstract
This study evaluated the effect of intrauterine perfusion of autologous platelet-rich plasma (PRP) on pregnancy outcomes in women with recurrent implantation failure (RIF). Key biomedical databases were searched to identify relevant clinical trials and observational studies. Outcomes included clinical pregnancy rate, chemical pregnancy rate, implantation rate, live birth rate, and abortion rate. Data was extracted from ten studies (six randomised controlled trials, four cohort studies) involving 1555 patients. Pregnancy outcomes were improved in women treated with PRP compared to controls: clinical pregnancy rate (RR = 1.96, 95% CI [1.67, 2.31], p < 0.00001, I(2) = 46%), chemical pregnancy rate (RR = 1.79, 95% CI [1.54, 2.08], p < 0.00001, I(2) = 29%), implantation rate (RR = 1.90, CI [1.50, 2.41], p < 0.00001, I(2) = 0%), live birth rate (RR = 2.83, CI [1.45, 5.52], p = 0.0007, I(2) = 83%), abortion rate (RR = 0.40, 95% CI [0.18, 0.90], p = 0.03, I(2) = 59%). These data imply PRP has potential to improve pregnancy outcomes in women with RIF, suggesting a promising role in assisted reproductive technology.IMPACT STATEMENTWhat is already known on this subject? Platelet-rich plasma (PRP) is an autologous blood product that contains platelets, various growth factors, and cytokines at concentrations above the normal baseline level. Recent studies have shown that intrauterine infusion of autologous PRP can improve pregnancy outcomes in infertile women.What do the results of this study add? This systematic review and meta-analysis of data from ten studies (n = 1555; 775 cases and 780 controls) investigated the effect of intrauterine perfusion of autologous PRP on pregnancy outcomes in women with recurrent implantation failure (RIF). Findings suggest that pregnancy outcomes, including clinical pregnancy rate, chemical pregnancy rate, implantation rate, live birth rate and abortion rate were improved in women treated with PRP compared to controls.What are the implications of these findings for clinical practice and/or further research? RIF remains a challenge for researchers, clinicians, and patients. Our study identified PRP as a potential intervention in assisted reproduction. As an autologous blood preparation, PRP eliminates the risk of an immune response and transmission of disease. PRP is low cost and effective and may represent a new approach to the treatment of patients with RIF.
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4.
Platelet-rich plasma use in meniscus repair treatment: a systematic review and meta-analysis of clinical studies
Li Z, Weng X
Journal of orthopaedic surgery and research. 2022;17(1):446
Abstract
BACKGROUND There is conflicting clinical evidence whether platelet-rich plasma (PRP) therapies could translate to an increased meniscus healing rate and improved functional outcomes. The objective of this systematic review and meta-analysis was to compare the failure rate and patient-reported functional outcomes in meniscus repair augmented with and without PRP. METHODS We comprehensively searched the PubMed, Web of Science, Medline, Embase, and Cochrane Library databases to identify studies that compared the clinical efficacy of meniscus repair performed with PRP versus without PRP. The primary outcome was the meniscus repair failure rate, while the secondary outcomes were knee-specific patient-reported outcomes, including the International Knee Documentation Committee (IKDC) score, Lysholm knee scale, visual analog scale, Tegner activity level score, Western Ontario and McMaster Universities Osteoarthritis Index score, Single Assessment Numeric Evaluation score, and Knee injury and Osteoarthritis Outcome Score. Furthermore, subgroup analyses were performed by stratifying the studies according to the PRP preparation technique to investigate the potential sources of heterogeneity among studies. RESULTS Our meta-analysis included nine studies (two RCTs and seven non-RCTs) with 1164 participants. The failure rate in the PRP group was significantly lower than that in the non-PRP group [odds ratio: 0.64, 95% confidence interval (CI) (0.42, 0.96), P = 0.03]. Furthermore, the PRP group was associated with a statistically significant improvement in the visual analog scale for pain [Mean difference (MD): - 0.76, 95% CI (- 1.32, - 0.21), P = 0.007] and Knee injury and Osteoarthritis Outcome Score-symptom [MD: 8.02, 95% CI (2.99, 13.05), P = 0.002] compared with the non-PRP group. However, neither the IKDC score nor the Lysholm knee scale showed any differences between the two groups. In addition, the results of subgroup analyses favored PRP over platelet-rich fibrin matrix (PRFM) regarding the IKDC score. CONCLUSIONS Although meniscus repairs augmented with PRP led to significantly lower failure rates and better postoperative pain control compared with those of the non-PRP group, there is insufficient RCT evidence to support PRP augmentation of meniscus repair improving functional outcomes. Moreover, PRP could be recommended in meniscus repair augmentation compared with PRFM. PRFM was shown to have no benefit in improving functional outcomes.
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5.
Prospective, randomized, controlled, noninferiority clinical trial to evaluate the safety and efficacy of absorbable macroporous polysaccharide composites as adjunct to hemostasis during open surgery
Li H, Li Z, He X, Zhang F, OuYang Z, Wu G, Liu P, Yang S, Dong L, Zhen M, et al
Journal of cardiac surgery. 2022
Abstract
BACKGROUND To address intraoperative bleeding in cardiac surgery, reducing blood transfusion requirements, is mandatory to achieve effective hemostasis. Hemostatic agents may limit localized persistent bleeding. The introduction of carboxymethyl-chitosan component into the hemostatic agent and the application of the radiation crosslinking technique maintain its capacity for achieving intraoperative hemostasis, thus increasing the clinical utility. METHODS A prospective, noninferiority and randomized controlled clinical trial to compare the safety and efficacy of absorbable macroporous polysaccharide composites (AMPC, treatment group) with compound microporous polysaccharide hemostatic powder (CMPHP, control group) (2:1 ratio) as adjuncts to hemostasis in open surgery. The main indication was used for hemostasis in various traumatic hemorrhage areas, including cardiothoracic, vascular, and general surgery. The primary endpoint was success rate of hemostasis within 300 s (at a 10% noninferiority margin). The secondary endpoint was hemostasis time. Both endpoints were assessed in the modified intention-to-treat (MITT) population. Safety parameters were assessed. This study is fully compliant with the CONSORT statement. RESULTS Randomized patients in AMPC and CMPHP groups were 168 and 84, respectively. In MITT population, the success rates of hemostasis within 300 s were 98.8% (163 of 165) in AMPC and 94.0% (78 of 83) in CMPHP (treatment difference 4.8% [95% CI -0.57% to 10.20%]). AMPC was thus noninferior to CMPHP. Hemostasis time (median [interquartile range]) with AMPC (87 [52.5, 180] s) was better than CMPHP (110 [54.5, 181] s). Changes in laboratory parameters over time and shifts to abnormal values were typical of surgeries and similar between two groups. No noticeable adverse effects associated with AMPC or CMPHP were observed. CONCLUSIONS AMPC is well tolerated as topical hemostatic agent, noninferior to commercial CMPHP, and exhibits excellent safety. This study provides a novel hemostatic agent which appears to offer significant clinical advantage in various hemorrhage areas.
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6.
Platelet-Rich Plasma Combined With Autologous Grafting in the Treatment of Long Bone Delayed Union or Non-union: A Meta-Analysis
An W, Ye P, Zhu T, Li Z, Sun J
Frontiers in surgery. 2021;8:621559
Abstract
Background: Platelet-rich plasma (PRP) has been suggested as an emerging treatment for bone defects. However, whether PRP could enhance the therapeutic efficacy of autologous bone grafting for long bone delayed union or non-union remains unknown. A meta-analysis of randomized and non-randomized controlled trials (RCT and NRCT) was performed to summarize current evidence. Methods: Relevant RCTs and NRCTs comparing the influences of autologous bone grafting on healing of long bone delayed union or non-union with and without PRP were obtained by searching PubMed, Embase, Cochrane's Library, China National Knowledge Infrastructure, and WanFang databases from inception to September 10, 2020. A random-effect model was applied to pool the results with the incorporation of the potential heterogeneity. Subgroup analysis according to study design was also performed. Results: Six RCTs and two NRCTs with 420 patients were included. Compared to patients allocated to autologous bone grafting alone, those allocated to combined treatment with PRP and autologous bone grafting were not associated with higher rates of radiographic bone healing [risk ratio (RR): 1.06, 95% confidence interval (CI): 0.99-1.13, P = 0.09; I (2) = 24%] or excellent/good posttreatment limb function (RR: 1.14, 95% CI: 0.95-1.37, P = 0.37; I (2) = 0%) but was associated with a shorter healing time (mean difference: -1.35 months, 95% CI: -1.86 to -0.84, P < 0.001; I (2) = 58%). Subgroup analysis according to study design showed similar results for the above outcomes (P-values for subgroup difference all >0.10). Conclusions: Combined treatment with PRP and autologous bone grafting may be effective to accelerate the healing of long bone delayed union or non-union compared to autologous bone grafting alone.
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7.
Tourniquet use in primary total knee arthroplasty is associated with a hypercoagulable status: a prospective thromboelastography trial
Huang CR, Pan S, Li Z, Ruan RX, Jin WY, Zhang XC, Pang Y, Guo KJ, Zheng X
International orthopaedics. 2021
Abstract
STUDY DESIGN Prospective study. PURPOSE The main purpose of this study was to investigate whether the use of a tourniquet changes the blood coagulation state following primary total knee arthroplasty (TKA) by means of conventional coagulation tests and thromboelastography (TEG) analyses. METHODS A total of 154 patients who underwent primary unilateral TKA from January 2018 to October 2020 were enrolled. Seventy-nine patients were randomized into a tourniquet group, and 75 were randomized into a no-tourniquet group. Demographic data, surgical time, intra-operative blood loss, transfusion rate, and wound complications were collected. Complete blood count, conventional coagulation tests, and TEG were performed the day before surgery, one day after surgery, three days after surgery, and seven days after surgery. Lower extremity Doppler ultrasound was performed the day before surgery and seven days after surgery. RESULTS The baseline characteristics of the patients were similar between the two groups. Hidden blood loss, transfusion rate, and wound complications were similar between the two groups, but the intra-operative blood loss of the tourniquet group was lower than that of the no-tourniquet group. The calculated total blood loss of the tourniquet group was higher than that of the no-tourniquet group. In terms of conventional coagulation tests and TEG, the tourniquet group had higher values of fibrin degradation products, D-dimer, maximum amplitude, and coagulation index (p < 0.001). The incidence of deep vein thrombosis (DVT) in the tourniquet group was higher than that in the no-tourniquet group (21.5% compared with 8%; p = 0.019). CONCLUSION The application of a tourniquet during TKA significantly increases the amount of calculated total blood loss and does not decrease the post-operative transfusion rate. Using a tourniquet in routine TKA exacerbates the early post-operative hypercoagulable status together with a higher incidence of below-knee asymptomatic DVT observed via conventional coagulation tests, TEG, and ultrasonic Doppler.
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8.
Tranexamic Acid versus Epsilon-Aminocaproic Acid in Total Knee Arthroplasty: A Meta-Analysis
Li Z, Sun X, Li W, Zhang M
Journal of healthcare engineering. 2021;2021:1758066
Abstract
OBJECTIVE At present, the effect of tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA) on total knee arthroplasty (TKA) remains controversial. Therefore, the aim of this meta-analysis is to compare the differences between the effects of TXA and EACA in TKA. METHODS We used electronic databases, including PubMed, Embase, MEDLINE, Ovid, ScienceDirect, Cochran Library, Google Scholar, clinical trial, and Chinese related databases, for literature search to find any effect of TXA and EACA in TKA. The differences between groups were compared by odds ratio (OR), weighted mean difference (WMD), and 95% confidence interval (CI). A total of four studies, including 3 randomized controlled trials (RCT) and 1 cohort study, were involved in this meta-analysis, involving 1836 participants. Among these participants, 816 belonged to the TXA group and 1020 belonged to the EACA group. RESULTS Meta-analysis indicated no difference in surgery time (WMD = 0.01, 95% CI -0.35 to 0.36), total amount of blood loss (WMD = 0.14, 95% CI -0.09 to 0.37), transfusion rate (OR = 0.74, 95% CI 0.20 to 2.78), transfusion units per patient (SMD = -0.15, 95% CI -0.54 to 0.25), complications (OR = 0.75, 95% CI 0.37 to 1.55), and length of stay (SMD = -0.01, 95% CI -0.11 to 0.08). CONCLUSIONS Our results suggest that the effect of TXA is not superior to EACA in TKA. However, this conclusion still needs to be further confirmed by multicenter and large-sample clinical trials.
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9.
Efficacy of autologous platelet-rich plasma gel in the treatment of refractory pressure injuries and its effect on wound healing time and patient quality of life
Liu Q, Zhang N, Li Z, He H
Clinics (Sao Paulo, Brazil). 2021;76:e2355
Abstract
OBJECTIVES To evaluate the efficacy of autologous platelet-rich plasma (PRP) gel in the treatment of refractory pressure injuries and its effect on wound healing time and quality of life of patients. METHODS A random number table method was used to group 102 patients with refractory pressure injuries into either a control group (CG) (51 cases) receiving negative pressure wound therapy (NPWT) or a study group (SG) (51 cases) receiving NPWT+PRP gel. RESULTS The total efficacy rate in the SG (92.16%) was higher than that in the CG (76.47%) (p<0.05). The SG exhibited lower visual analog scale (VAS) scores and pressure ulcer scale for healing (PUSH) scores, smaller wound sizes and depths, and shorter wound healing times than the CG after 21 days of treatment (p<0.05). After 6 months of treatment, the SG scored higher than the CG on the psychological, physiological, social functions, and daily activity domains on the World Health Organization Quality of Life (WHOQOL-BREF) scale (p<0.05). The incidence of postoperative complications in the SG (13.73%) was not significantly different from that of the CG (7.84%) (p>0.05). CONCLUSION In the treatment of refractory pressure injuries, PRP gel can accelerate wound healing, reduce wound pain, shorten the treatment cycle, regulate tissue inhibitor matrix metalloproteinase-1 (TIMP-1) and matrix metalloproteinase-9 (MMP-9) levels and the expression of specific proteins in granulation tissue, reduce the levels of the inflammatory factors interleukin-1β (IL-1β), IL-8, and tumor necrosis factor-α (TNF-α), and improve the quality of life of patients without increasing complications.
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10.
Hypertension management in elderly with severe intracerebral hemorrhage
Zhao J, Yuan F, Fu F, Liu Y, Xue C, Wang K, Yuan X, Li D, Liu Q, Zhang W, et al
Annals of clinical and translational neurology. 2021;8(10):2059–2069
Abstract
OBJECTIVE To explore the effect of individualized blood pressure (BP)-lowering treatment on the outcomes of elderly patients with severe intracerebral hemorrhage (ICH). METHODS We performed an exploratory analysis of Controlling Hypertension After Severe Cerebrovascular Event (CHASE) trial, which was a multicenter, randomized, controlled clinical trial. Patients with severe ischemic or hemorrhagic stroke (defined as GCS ≤ 12 or NIHSS ≥ 11) were randomized into individualized versus standard BP-lowering treatment in CHASE trial. In this exploratory analysis, patients with severe ICH were included. The primary outcome was the percentage of patients with 90-day functional independence defined as modified Rankin Scale (mRS) ≤2. RESULTS We included 242 patients with severe ICH in the present analysis, consisting of 142 patients aged <65 years and 100 patients aged ≥65 years. There were significant differences between patients aged ≥65 years and <65 years in the proportion of functional independence (47.9% vs. 15.0%, P < 0.001) and good outcome (73.9% vs. 50.0%, P < 0.001) at day 90. In patients aged ≥65 years, the adjusted individualized BP-lowering treatment had an unequivocal effect on the functional independence at day 90 (21.6% vs. 8.2%, odds ratio [OR]: 4.309, 95% confidence interval [CI]: 1.040-17.859, P = 0.044) and improved the neurological deficits at discharge (∆ NIHSS ≥ 4: 64.7% vs. 34.7%, OR: 4.300, 95% CI: 1.599-11.563, P = 0.004). INTERPRETATION Compared with the younger counterparts, the elderly patients (≥65 years) with acute severe ICH might benefit more from individualized BP-lowering treatment.