Abstract

OBJECTIVE To investigate the clinical effect of platelet-rich fibrin (PRF) combined with guided bone regeneration (GBR) in the reconstruction of peri-implantitis bone defect. METHODS This prospective study included 80 patients with peri-implantitis who underwent implant restoration in the Department of Stomatology in our hospital. The eligible patients were randomly divided into control group and observation group, with 40 cases in each group. Patients in the control group were treated with flap curettage combined with GBR, while those in the observation group received a mixture of PRF and bone powder implanted with GBR and covered with PRF biofilm. The differences of pain 24 hours after surgery, bleeding at 7 days after surgery, and the degree of bone defect between the two groups at 60 days after surgery were compared. At 60 days and 120 days after surgery, separately, the regenerated bone density of patients in the two groups was measured, analyzed and compared. The degree of regenerated bone defect in transverse and longitudinal directions after 60 days was compared between the two reconstruction procedures. RESULTS The pain at 24 hours after surgery and the bleeding at 7 days after surgery in the observation group were milder than those in the control group (P<0.001). There was significant difference in the degrees of bone defect at 60 days after surgery (P<0.05). Compared with the control group, the regenerated bone density of the observation group was significantly higher both at 60 days and 120 days after surgery (P<0.001). CONCLUSION The combination of PRF and GBR technology has an obvious effect in repairing bone defects in patients with peri-implantitis, and can reduce the pain of patients during the repair process.

Abstract

BACKGROUND To evaluate the efficacy and safety of recombinant human serum albumin /granulocyte colony-stimulating factor (rHSA/G-CSF) in breast cancer following receipt of cytotoxic agents. METHODS The phase 1b trial assessed the pharmacokinetics, pharmacodynamics, and safety of dose-escalation, ranging from rHSA/G-CSF 1800 μg, 2100 μg, and 2400 μg. Randomized controlled phase 2b trial was further conducted to ensure the comparative efficacy and safety of rHSA/G-CSF 2400 μg and rhG-CSF 5 μg/kg. In multicenter, randomized, open-label, parallel, phase 2 study, participants treated with anthracycline-containing chemotherapy were assigned in a ratio 1:1:1 to receive double delivery of rHSA/G-CSF 1200 μg, 1500 μg, and continuous rhG-CSF 5 μg/kg. RESULTS Between December 16, 2014, to July 23, 2018, a total of 320 patients were enrolled, including 25 individuals in phase 1b trial, 80 patients in phase 2b trial, and 215 participants in phase 2 study. The mean duration of agranulocytosis during the first chemotherapeutic intermission was observed as 1.14 ± 1.35 days in rHSA/G-CSF 1500 μg, which was comparable with that of 1.07 ± 0.97 days obtained in rhG-CSF control (P = 0.71). Safety profiles were assessed to be acceptable ranging from rHSA/G-CSF 1800 μg to 2400 μg, while the double delivery of HSA/G-CSF 2400 μg failed to meet the noninferiority in comparison with rhG-CSF. CONCLUSION The prospective randomized controlled trials demonstrated that rHSA/G-CSF was efficacious and well-tolerated with an approachable frequency and expense of application for prophylactic management of agranulocytosis. The double delivery of rHSA/G-CSF 1500 μg in comparisons with paralleling G-CSF preparations is warranted in the phase 3 trial. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT02465801 (11/17/2014), NCT03246009 (08/08/2017), NCT03251768 (08/07/2017).

Abstract

Objective: Intraoperative bleeding during endoscopic sinus surgery (ESS) for high-grade rhinosinusitis can be serious and can further obscure the surgical field. This study was designed to evaluate the effect of tranexamic acid (TXA) on the surgical visualization of ESS for high-grade rhinosinusitis. Methods: In total, 60 patients with high-grade chronic rhinosinusitis (Lund-Mackay score 12 or greater) treated by ESS were randomized into two groups: the control group (Group C) or the TXA group (Group T). Each group included 30 patients. Patients in Group T received intravenous TXA, and those in Group C received normal saline. The Boezaart grading scale (BS) score was assessed as the primary outcome. Total blood loss (TBL), whole blood coagulation, and fibrinolysis were assessed by Sonoclot analysis, and complications were recorded and compared between the groups. Result: A significant difference was found in the BS score between Group T and Group C [2.02 (1.88-2.05) vs. 2.27 (2.13-2.41), P = 0.011]. Increases in platelet function (PF) and fibrin degradation time (FDT) were assessed during the operation and showed significant differences between Group T and Group C (P = 0.040 for PF; P = 0.010 for FDT). No difference in complications was found between the two groups. Conclusion: A 15 mg/kg bolus of intravenous TXA before surgery can improve the surgical visualization of ESS for high-grade chronic rhinosinusitis without causing significant adverse effects. Intravenous TXA may be beneficial in ESS for high-grade chronic rhinosinusitis. Clinical Trial Registration: https://www.chictr.org.cn/edit.aspx?pid=121653&htm=4.

Abstract

BACKGROUND Maternal hypotension is the most frequent complication of spinal anesthesia for cesarean delivery, and intravenous fluid preloading is a preventive measure. We aimed to assess the efficacy of colloids versus crystalloids for preloading to reduce the incidence of spinal anesthesia-induced hypotension and vasopressor requirement in healthy parturients during elective cesarean delivery. METHODS We searched the Cochrane Library, MEDLINE and EMBASE to identify all studies published to June, 2019, through OVID and PubMed. We included randomized controlled trials, comparing colloid preloading with crystalloid preloading in women having spinal anesthesia for cesarean delivery. Primary outcomes were the incidence of hypotension and vasopressor requirement. Secondary outcomes included nausea and/or vomiting, neonatal Apgar score, neonatal umbilical blood pH. We used standardized mean differences for expressing continuous outcomes and risk ratios for dichotomous outcomes. Random-effect model was performed to estimate the pooled risk ratios and standardized mean differences. RESULTS Thirty-three randomized controlled trials contributed data for this meta-analysis. Fewer women experienced hypotension in the colloid group compared with the crystalloid group (risk ratio: 0.72, 95% confidence interval: 0.63-0.82; 2566 women, 32 studies; P < .00001). The total ephedrine dose required was significantly lower with colloid preloading (standardized mean difference: -0.37, 95% CI: -0.64 to -0.09; 1472 women, 19 studies; P = .009). Colloid preloading was also associated with fewer phenylephrine requirement compared with crystalloid preloading (standardized mean difference: -0.54, 95% CI: -0.82 to -0.25; 169 women; P = .0002). The incidence of nausea and/or vomiting was significantly reduced with colloid preloading (risk ratio: 0.72, 95% CI: 0.55-0.95; 1601 women, 20 studies; P = .02). However, the incidence of 1-minute Apgar score < 7, umbilical artery pH < 7.2 and umbilical vein pH < 7.2 were not statistically different between groups. CONCLUSIONS Colloid preloading is superior to crystalloid preloading in reducing the incidence of hypotension induced by spinal anesthesia and vasopressor requirement in the healthy parturients undergoing elective cesarean delivery.The PROSPERO registration number: CRD42018096402.

Abstract

Refractory wounds present a complex and serious clinical dilemma in plastic and reconstructive surgery. However, there are currently no standard guidelines for the treatment of refractory wounds. Artificial dermis (AD) has achieved some satisfactory results, but also has some limitations. Autologous platelet-rich plasma (PRP), as a cell-therapy material, was a valuable and safe treatment dressing for chronic non-healing wounds. This study aimed to evaluate the efficacies of artificial dermis (AD) with and without autologous platelet-rich plasma (PRP) in patients with refractory wounds. Sixteen patients with refractory wounds were randomly allocated to autologous PRP therapy combined with artificial dermis (PRP + AD [N = 8]) or an artificial dermis program only (AD [N = 8]). We compared the efficacies of the two methods in terms of times to wound healing, infection control, and AD vascularization, as well as hospitalization days and eventual clinical outcomes.13 patients achieved complete healing, including seven (87.5%) in the PRP + AD group and six (75.0%) in the AD group (P > .05). The times to wound healing, infection control, and AD vascularization, and hospitalization time after transfer were significantly shorter in the PRP + AD group compared with the AD group (P < .05). In conclusion, the combination of AD and PRP promoted refractory wound healing and shortened waiting times compared with simple dermal grafts.

Abstract

OBJECTIVES Safe blood transfusion plays an important role in the prevention of transfusion-transmissible infections, and hepatitis C virus (HCV) infection is one of the major problems associated with this procedure. This meta-analysis aimed to determine the prevalence of HCV infection in Chinese blood donors. STUDY DESIGN The study design of this study is a meta-analysis. METHODS Eligible studies were retrieved from PubMed, Embase, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang literature databases from 2010 to 2020. The effect measure was presented as HCV prevalence with a 95% confidence interval (CI). Q test was used to assess the heterogeneity, and the I(2) statistics was determined to decide whether a random effects model or a fixed effects model should be used as the pooling method. Subgroup analyses were also conducted. RESULTS A total of 62 eligible studies, including 9,007,220 HCV blood donors, were analysed. Of the total blood donors, 35,017 were infected with HCV. The pooled HCV prevalence was 0.415% (95% CI: 0.371-0.458). The subgroup analysis revealed that the prevalence of positivity to anti-HCV antibodies was significantly different in each year (P < 0.05). However, no significant difference was observed in HCV prevalence in terms of sex. Moreover, the prevalence of positivity to anti-HCV was remarkably higher in first-time blood donors than in repeat blood donors (P < 0.05), and the rate of HCV infection among university students was significantly lower than that among soldiers (P < 0.05). CONCLUSIONS The rate of HCV infection showed a downward trend from 2010 to 2014, increased in 2015-2016, and finally decreased in 2017-2018. Thus, the prevalence of HCV infection has decreased in Chinese blood donors after comprehensive prevention and treatment.

Abstract

AIMS: To assess the efficacy and safety of iron supplementation for perioperative anemia in geriatric patients with hip fracture. METHODS A systematic search was conducted for studies published using PubMed, EMBASE and Cochrane Library Databases that compared iron supplementation with placebo in patients undergoing hip fracture surgery. The outcomes were blood transfusion rate and volume, length of stay, infection and mortality (last follow-up). Sub-group and sensitivity analyses were performed in cases of substantial heterogeneity. RESULTS The meta-analysis (6 studies: 1201 patients) indicated that iron supplements were not associated with reducing blood transfusion rate (OR 0.92, 95% CI 0.60-1.41; P = 0.69), but high heterogeneity (I(2) = 61%) was detected and a significant association was found in sensitivity analysis of four studies (n = 637; OR 0.68, 95% CI 0.49-0.95; P = 0.02). A significant reduction was detected in transfusion volume (two studies: n = 234; MD - 0.45 units/patient, 95% CI - 0.74 to - 0.16; P = 0.002), hospital stay (five studies: n = 998; MD - 1.42, 95% CI - 2.18 to - 0.67; P = 0.0002) and caused no increased risk of mortality (five studies: n = 937; OR 0.94, 95% CI 0.65-1.36; P = 0.76) and infection (four studies: n = 701; OR 0.58, 95% CI 0.38-0.90; P = 0.01). Sub-group analyses of four studies showed that the preoperative intravenous use of iron at 200-300 mg (two studies) may be the beneficial option for hip fractures patients. CONCLUSIONS Iron supplementation, especially preoperative intravenous use of 200-300 mg iron, is safe and associated with reducing transfusion requirement and hospital stay. Unfortunately, data were too limited to draw a definite conclusion. Further evaluation is required before recommending iron supplementation for older patients with hip fracture surgeries.

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.

Abstract

PURPOSE Tranexamic acid (TXA) has been widely used in hip and knee arthroplasty to reduce perioperative blood loss and blood transfusion, but the dosage and efficacy of TXA in posterior lumbar spinal surgery are not fully clear. The aim of this study was to investigate the efficacy and safety of TXA and to determine whether 2 doses of TXA could reduce the blood loss in primary single-segment or double-segment posterior lumbar fusion surgery. MATERIALS AND METHODS A total of 150 patients with lumbar degenerative disease undergoing posterior lumbar interbody fusion surgery between October 2017 and February 2019 were randomized to 3 groups. Group A was treated with 0.9% normal saline solution without TXA, group B was treated with a 15 mg/kg loading dose intravenous infusion 30 minutes before surgery, and group C was treated with a 15 mg/kg loading dose intravenous infusion 30 minutes before surgery; then, the same dose was administered again 3 hours later. The assessed outcomes were the operation time, the total blood loss, the hidden blood loss, postoperative drainage, blood transfusions, incidence of venous thromboembolism, and incision infection. RESULTS The total blood loss, the hidden blood loss, and postoperative drainage were the lowest in group C. The amount of intraoperative blood loss was similar among the 3 groups. The hemoglobin and hematocrit values of the third postoperative day were the highest in group C. No significant differences in the incidence of complications and adverse events from TXA use were observed among the 3 groups. The use of TXA, the operation time, and the number of fusion segments were identified as risk factors related to total blood loss. CONCLUSION Two doses of TXA significantly reduced the total blood loss, the hidden blood loss and postoperative drainage, and decreased hemoglobin and hematocrit drop in patients undergoing posterior lumbar fusion without increasing the risk of complications.

Abstract

Objective: To investigate the effectiveness of the reconstruction of posterior cruciate ligament (PCL) with platelet rich plasma (PRP) and 3-strand peroneal longus tendons under arthroscope. Methods: Between June 2014 and December 2017, 58 patients with PCL rupture were randomly divided into two groups: the trial group (PRP assisted reconstruction of 3-strand peroneal longus tendons) and the control group (4-strand hamstring tendon reconstruction alone), 29 cases in each group. There was no significant difference in gender, age, injury side, Kellgren-Lawrence grade, time from injury to operation, and preoperative American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, International Knee Documentation Committee (IKDC) score, Lysholm score between the two groups (P>0.05). Before operation, at 3 months and 12 months after operation, the IKDC score and Lysholm score of the two groups were recorded to evaluate the knee joint function, AOFAS ankle-hindfoot score was used to evaluate ankle function; KT-2000 examination (knee flexion of 90 degrees , 30 lbs) was used to evaluate the difference of bilateral knee joint posterior relaxation at 12 months after operation, and MRI was used to evaluate ligament reconstruction; CT was used to evaluate the bone tunnel expansion of femur and tibia at 3 months and 12 months after operation. Results: The operation was completed successfully in both groups, there was no complication in the donor tendon area. All the incisions healed by first intention. All the patients were followed up for more than 1 year. The follow-up time of the trial group was 13-17 months, with an average of 15.0 months; that of the control group was 15-20 months, with an average of 15.4 months. At 3 and 12 months after operation, there was no significant difference in AOFAS ankle-hindfoot score when compared with preoperative score and between the two groups ( P>0.05). At 3 and 12 months after operation, the IKDC score and Lysholm score of the two groups were significantly improved, and further improvement was found at 12 months when compared with at 3 months ( P<0.05); the scores in the trial group were significantly better than those of the control group ( P<0.05). At 12 months after operation, the difference of the posterior relaxation of the bilateral knees in the trial group was less than 5 mm in 27 cases, 6-10 mm in 2 cases; in the control group was less than 5 mm in 20 cases, 6-10 mm in 6 cases, and >10 mm in 3 cases; the difference between the two groups was not significant ( Z=0.606, P=0.544). At 12 months after operation, MRI of knee joint showed that all patients had good PCL graft. The MRI score of the trial group was better than that of the control group ( t=2.425, P=0.019). CT examination at 3 and 12 months after operation showed that the bone tunnel expansion of femur and tibia in the trial group were significantly better than those in the control group ( P<0.05). Conclusion: PRP combined with 3-stand peroneal longus tendons can significantly improve the function and stability of knee joint, effectively promote graft remodeling, and promote tendon bone healing, reduce the expansion of bone tunnel. The effectiveness is satisfactory.