Abstract

PURPOSE Leukocyte- and platelet-rich fibrin (L-PRF) and advanced-platelet-rich fibrin (A-PRF) that are derivatives of PRF (platelet-rich fibrin) accelerate wound healing and reduce postoperative sequelae after tooth extraction. This network meta-analysis aimed to investigate the effectiveness of L-PRF and A-PRF in mandibular third molar extraction and provide suggestions for alleviating postoperative symptoms and signs. METHODS A comprehensive search of the literature was conducted in PubMed, Embase, Web of Science, and SinoMed databases up to Oct 9, 2020. Three types of randomized controlled trials were included to investigate the effects of PRF derivatives after extracting mandibular third molars: A-PRF and L-PRF groups; A-PRF and control groups; L-PRF and control groups. Their relative effectiveness and ranking were assessed using network meta-analysis and the surface under the cumulative ranking curve (SUCRA) with STATA 16.0 and Revman 5.3, respectively. RESULTS Ten randomized controlled trials were included, with 307 mandibular third molar extraction patients involved. The results showed that A-PRF had the best effect among the 3 groups in improving postoperative pain on the third (SUCRA = 98.2%) and seventh (SUCRA = 88.4%) days; L-PRF promoted soft tissue healing (MD=-0.90, 95% CI [-1.40, -0.40], P = .0004) on the seventh day compared with the control. However, other comparisons showed no significant differences (P > .05). CONCLUSION The limited results confirmed that PRF derivatives only reduced some postoperative symptoms and did not prevent them all. Application of A-PRF after third molar extraction reduced postoperative pain, and L-PRF improved the degree of soft tissue healing.

Abstract

Objective: To study the efficacy and patient comfort of absorbable hemostatic powder after endoscopic sinus surgery (ESS). Methods: A total of 21 (17 males, 4 females) patients with an average age of 42(ranging from 18 to 65) underwent bilateral ESS for chronic rhinosinusitis(CRS) in Beijing Tongren Hospital, Capital Medical University between October 2015 and July 2019 were enrolled to compare the effect of absorbable hemostasis powder with Nasopore using an intrapatient control design. A randomized controlled trial was conducted in the left and right nasal cavities of the same patient. If hemostatic powder was applied in the experiment nasal cavity, the Nasopore was applied in the control nasal cavity. The mean preoperative sinus computed tomography (CT) score was 6.25. All patients competed for symptom diaries using a visual analog scale (VAS, score out of 10) at baseline, through 1, 7, 14 and 30 days. Outcomes including bleeding, facial pain, nasal obstruction, nasal discharges using VAS were recorded separately for both sides. Postoperative endoscopic scores were also investigated. SPSS 22 and Graphpad prism 8.0 statistical softwares were used for the analysis. Paired t-test or nonparametric test was used between the test side and the control side. The difference was statistically significant (P<0.05). Results: The bleeding score and total nasal symptom VAS scores at postoperative days (POD) 1, 7, 14 and 30 were not significantly different(t=1.341, 0.552, 0.631, 0.158, all P>0.05;t=0.944, 1.471, 1.612, 2.251, all P>0.05). There was no significant difference between absorbable hemostasis powder and Nasopore side on POD 1, 7, 14 and 30 in terms of each nasal symptom VAS scores(all P>0.05). On POD 1, 7 and 14, the packing material degeneration scores of the absorbable hemostasis powder side were significantly lower than those of the Nasopore side [(1.33±0.21)vs(2.00±0.00),(0.38±0.18) vs (1.95±0.22), 0 vs (1.80±0.13), all P<0.01]. There were significant differences between absorbable hemostasis powder and Nasopore side on POD 1, 7, 14 and 30 in terms of endoscopic scores (edema, crusting, discharges, scar, polyps and material degeneration, t=3.07, 7.00, 6.41, 2.69, all P<0.05). Conclusions: The absorbable hemostasis powder and Nasopore has similar postoperative hemostasis effect. The absorbable hemostasis powder is rapidly cleared and without negative effects on mucosal wound healing 14 days postoperatively.

Abstract

OBJECTIVES To evaluate the efficacy of Traditional Chinese Medicine, specifically Jianpi Bushen (JPBS) therapy, for treatment of patients with chronic kidney disease (CKD) anemia. METHODS Randomized controlled trials of JPBS therapy for CKD anemia were searched and selected from seven electronic databases. The Cochrane collaboration tool was used to conduct methodological quality assessment. RevMan v5.3 software was utilized to perform data analysis. RESULTS In total, 12 randomized controlled trials with 799 patients met the meta-analysis criteria. The aggregated results indicated that JPBS therapy is beneficial for CKD anemia by improving the clinical efficacy rate [risk ratio (RR) = 1.23, 95% confidence interval (CI): (1.14, 1.33), P < 0.00001] and hemoglobin (Hb) [weighted mean difference (WMD) = 9.55, 95% CI: (7.97, 11.14), P < 0.00001], serum ferritin (SF) [WMD = 6.22, 95% CI: (2.65, 9.79), P = 0.0006], red blood cell (RBC) [WMD = 0.31, 95% CI: (0.24, 0.38), P < 0.00001], hematocrit (HCT) [WMD = 2.95, 95% CI: (2.36, 3.54), P < 0.00001], serum creatinine (SCr) [WMD = 64.57, 95% CI: (33.51, 95.64), P < 0.0001], and blood urea nitrogen (BUN) levels [WMD = 3.76, 95% CI: (2.21, 5.31), P <0.00001]. Furthermore, evidence suggests that JPBS therapy is safe and does not increase adverse reactions compared with western medicine (WM) alone. CONCLUSION This study found that JPBS therapy has a positive effect on the treatment of CKD anemia. However, more well-designed, double-blind, large-scale randomized controlled trials are needed to assess the efficacy of JPBS therapy in the treatment of CKD anemic patients.

Abstract

ImportanceConvalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed ObjectiveTo evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19 Design, Setting, and ParticipantsOpen-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020 The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation) The trial was terminated early after 103 of a planned 200 patients were enrolled InterventionConvalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity Main Outcomes and MeasuresPrimary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]) Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours ResultsOf 103 patients who were randomized (median age, 70 years;60 [58 3%] male), 101 (98 1%) completed the trial Clinical improvement occurred within 28 days in 51 9% (27/52) of the convalescent plasma group vs 43 1% (22/51) in the control group (difference, 8 8% [95% CI, −10 4% to 28 0%];hazard ratio [HR], 1 40 [95% CI, 0 79-2 49];P =  26) Among those with severe disease, the primary outcome occurred in 91 3% (21/23) of the convalescent plasma group vs 68 2% (15/22) of the control group (HR, 2 15 [95% CI, 1 07-4 32];P =  03);among those with life-threatening disease the primary outcome occurred in 20 7% (6/29) of the convalescent plasma group vs 24 1% (7/29) of the control group (HR, 0 88 [95% CI, 0 30-2 63];P =  83) (Pfor interaction =  17) There was no significant difference in 28-day mortality (15 7% vs 24 0%;OR, 0 65 [95% CI, 0 29-1 46];P =  30) or time from randomization to discharge (51 0% vs 36 0% discharged by day 28;HR, 1 61 [95% CI, 0 88-2 93];P =  12) Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87 2% of the convalescent plasma group vs 37 5% of the control group (OR, 11 39 [95% CI, 3 91-33 18];P <  001) Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care Conclusion and RelevanceAmong patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference Trial RegistrationChinese Clinical Trial Registry:ChiCTR2000029757

Abstract

BACKGROUND A tourniquet is a device commonly used to control massive hemorrhage during knee replacement surgery. However, the question remains whether the use of tourniquets affects the permeability of the bone cement around the knee prosthesis. Moreover, the long-term effects and stability of the knee prosthesis are still debatable. The aim of this study was to examine whether the use of a tourniquet increases the thickness of the cement mantle and affects the postoperative blood loss and pain during primary total knee arthroplasty (TKA) using meta-analysis. METHODS We searched the Cochrane Central Library, MEDLINE, Embase, PubMed, CNKI, and Wang Fang databases for randomized controlled trials (RCTs) on primary TKA, from inception to November 2019. All RCTs in primary TKA with and without a tourniquet were included. The meta-analysis was conducted using RevMan 5.2 software. RESULTS A total of eight RCTs (677 knees) were analyzed. We found no significant difference in the age and sex of the patients. The results showed that the application of tourniquet affects the thickness of the bone cement around the tibial prosthesis (WMD = 0.16, 95%CI = 0.11 to 0.21, p < 0.00001). However, in our study, there was no significant difference in postoperative blood loss between the two groups was observed (WMD = 12.07, 95%CI = - 78.63 to 102.77, p = 0.79). The use of an intraoperative tourniquet can increase the intensity of postoperative pain (WMD = 1.34, 95%, CI = 0.32 to 2.36, p = 0.01). CONCLUSIONS Tourniquet application increases the thickness of the bone cement around the prosthesis and may thus increase the stability and durability of the prosthesis after TKA. The application of an intraoperative tourniquet can increase the intensity of postoperative pain.

Abstract

OBJECTIVE To evaluate efficacy of platelet-rich plasma (PRP) injection in carpal tunnel syndrome (CTS), we conducted this meta-analysis, as well as proposed a protocol for its application in curative processes. METHODS All randomized controlled trials (RCTs) of PRP for the management of mild or moderate CTS were included in this study. Database search was conducted from study inception to July 2020, including PubMed, Embase, Web of Science, and Cochrane Library. We used visual analogue scores (VAS) and the Boston Carpal Tunnel Questionnaire (BCTQ) as evaluation tools for primary outcomes. Second outcomes comprised cross-sectional area (ΔCSA) and electrophysiological indexes including distal motor latency (DML), sensory peak latency (SPL), motor nerve conduction velocity (MNCV), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP). The pooled data were analyzed using RevMan 5.3. Subgroup and sensitivity analyses were conducted with the evidence of heterogeneity. Egger' test was used to investigate publication bias. RESULTS 9 RCTs were finally screened out with 434 patients included. Control groups comprised corticosteroid injection in 5 trials, saline injection in 1 trial, and splint in 3 trials. At the 1st month after follow-up, only ΔCSA between the PRP group and the control group showed significant difference (P < 0.05). In the 3rd month, there were statistically significant differences in VAS, BCTQ, SPL, SNCV, and ΔCSA between two groups (P < 0.05), while no statistically significant differences were found in the remaining outcomes. In the 6th month, there were statistically significant differences at BCTQ (P < 0.05) in primary outcomes and ΔCSA (P < 0.05) in secondary outcomes between two groups. As to adverse events in PRP injection, only one study reported increased pain sensation within 48 h after injections. CONCLUSION This systematic review and meta-analysis demonstrates that the PRP could be effective for mild to moderate CTS and superior to traditional conservative treatments in improving pain and function and reducing the swelling of the median nerve for a mid-long-term effect. To some extent, the electrophysiological indexes also improved after PRP injection compared with others conservative treatments.

Abstract

Background: Avatrombopag is a novel oral, nonpeptide thrombopoietin receptor agonist (TPO-RA). A few studies have shown that avatrombopag is effective against thrombocytopenia. However, no systematic review has been conducted on the efficacy and safety of avatrombopag. Therefore, the aim of this study was to comprehensively assess the efficacy and safety of avatrombopag patients with thrombocytopenia. Methods: Databases including Medline, PubMed, Embase, the Cochrane Library and ClinicalTrials.gov were searched for randomized controlled trials that compared avatrombopag with placebo in patients with thrombocytopenia. The deadline was March 2019. Results: In total, 743 patients were analyzed in five clinical trials. Patients treated with avatrombopag achieved higher platelet response (OR: 17.71, 95% CI [11.01 to 28.48], p < 0.00001) than with placebo. Avatrombopag produced an absolute increment in platelet count (WMD: 31.13%, 95% CI [22.27 to 39.99], p < 0.00001) unlike the placebo. In addition, the incidence of serious adverse events (RR: 1.18, 95% CI [0.72 to 1.93], p = 0.51) and deaths (RR: 0.93, 95% CI [0.19 to 4.45], p = 0.93) in patients treated with avatrombopag was not significantly different from that in patients treated with placebo. The incidence of adverse events in patients treated with avatrombopag was slightly higher than that in patients treated with placebo (RR: 1.25, 95% CI [1.05 to 1.49], p = 0. 01) after one trial with high heterogeneity was removed. Conclusions: This meta-analysis showed that avatrombopag was an effective treatment for thrombocytopenia, but there is sufficient evidence to indicate that adverse events may occur.

Abstract

Background: Severe bleeding and massive transfusion of blood products may be associated with increased morbidity and mortality of cardiac surgery. A transfusion algorithm incorporating thromboelastography (TEG) or rotational thromboelastometry (ROTEM) can help to determine the appropriate time and target for the use of hemostatic blood products, which may thus reduce the quantity of blood loss as well as blood products transfused. Methods: We conducted meta-analysis and trial sequential analysis to evaluate the effects of TEG or ROTEM-guided transfusion algorithms vs. standard treatments for patients undergoing cardiac surgery with cardiac pulmonary bypass. Results: Nineteen studies with a total of 15,320 participants, including 13 randomized controlled trials (RCTs), were included. All-cause mortality was not reduced either in overall studies or in RCTs. Blood loss volume was reduced by 132 mL in overall studies [mean difference (MD): -132.46, 95% CI: -207.49, -57.43; I(2) =53%, P<0.01], and by 103 mL in RCTs (MD: -103.50, 95% CI: -156.52, -50.48; I(2) =0%, P<0.01). The relative risks (RRs) in RCTs were 0.89 (95% CI: 0.80-0.98; I(2) =0%, P=0.02) for red blood cells transfusion, 0.59 (95% CI: 0.42-0.82; I(2) =55%, P<0.01) for fresh frozen plasma transfusion, and 0.81 (95% CI: 0.74-0.90; I(2) =0%, P<0.01) for platelet transfusion, respectively. Trial sequential analysis of continuous data on blood loss and dichotomous outcomes on transfusion of blood products suggested the benefits of a TEG/ROTEM-guided algorithm. Conclusions: TEG or ROTEM-guided transfusion strategies may reduce blood loss volume and the transfusion rates in adult patients undergoing cardiac surgery.

Abstract

INTRODUCTION The purpose of this study was to investigate the benefits of three different post-operative limb positions in primary total knee arthroplasty (TKA). METHODS The trial was a single-surgeon, randomized, controlled trial, and 135 patients following primary TKA were randomized into three groups: group A (45 patients who were treated with the hip fixed at 50 degrees and knee flexed at 90 degrees for 6 hours post-operatively), group B (45 patients who were treated with the hip elevated at 30 degrees and knee flexed at 45 degrees for 6 hours post-operatively), and group C (45 patients in whom the affected knee was fully extended after surgery). Tranexamic acid was used in all patients. RESULTS The total blood loss and hidden blood loss in group A (921 +/- 209 mL, 597 +/- 213 mL) were significantly less than in groups B (1125 +/- 222 mL, 784 +/- 229 mL) and C (1326 +/- 291 mL, 915 +/- 301 mL) and less in group B compared with group C. The drain volume in groups A (158 +/- 35 mL) and B (174 +/- 45 mL) was significantly lower than in group C (249 +/- 31 mL). The maximum haemoglobin drop in group A (3.1 +/- 0.5 g/dL) was statistically significantly less than in groups B (3.6 +/- 0.7 g/dL) and C (4.3 +/- 0.4 g/dL). The range of motion (ROM) in groups A (102 +/- 3 degrees , 105 +/- 2 degrees ) and B (100 +/- 3 degrees , 104 +/- 2 degrees ) was significantly better than in group C (98 +/- 3 degrees , 102 +/- 2 degrees ) at the time of discharge and one month after surgery; it was also significantly less for group A (104.9 +/- 2.1%, 108.0 +/- 2.4%) compared with groups B (106.7 +/- 3.1%, 108.3 +/- 2.7%) and C (108.4 +/- 3.2%, 110.6 +/- 3.0%) with post-operative knee swelling. No differences in transfusion requirements and complications were observed among the three groups. CONCLUSIONS The affected knee flexion position was superior to the use of a fully extended position for blood management, but it only contributed to better early functional recovery up to three months post-operatively in TKA. In addition, by fixing the affected knee at a high flexion position of 90 degrees , patients could achieve less blood loss, lower knee swelling, and better early results for ROM and patient satisfaction than the other two groups.

Abstract

PURPOSE The aim of this study was to demonstrate the association between tranexamic acid (TXA)-combined application and knee flexion in the first 24 hour post-operatively that could reduce total blood loss and transfusion need in patients undergoing total knee arthroplasty (TKA), without sacrificing safety. METHODS Ninety TKA patients were divided into three groups randomly: the flexion group: the knee was in 90 degrees flexion position for the first 12 hour post-surgery and kept at 60 degrees for the next 12 hour, combined with 1 g TXA topical and 1 g TXA intravenous application. The extension group: the knee was in fully extension position post-operatively, combined with topical and intravenous TXA application. The controlled group: the knee was in fully extension position post-operatively combined with single intravenous TXA application. The primary outcomes included blood loss variables and transfusion values. The secondary outcomes included post-operative hospital stay, knee flexion degree, complication rate, and hospital charge. RESULTS The total blood loss and transfusion needs in the flexion group were significantly reduced in comparison with that in the extension group and controlled group. The post-operative knee flexion motion was significant higher in the flexion group than the other two groups. There was no difference among the three groups with regard to the rates of complications. CONCLUSIONS Keeping the knee in flexion position combined with topical and intravenous TXA application in patients undergoing primary unilateral TKA significantly reduced post-operative bleeding and the transfusion rate compared with what was found after treatment with extension knee position or single intravenous TXA application. LEVEL OF EVIDENCE Therapeutic Level I.