Abstract

BACKGROUND Immune thrombocytopenia is an autoimmune disease characterised by decreased platelet count. In recent years, novel therapeutic regimens have been investigated in randomised controlled trials (RCTs). We aimed to compare the efficacy and safety of different treatments in newly diagnosed adult primary immune thrombocytopenia. METHODS We did a systematic review and network meta-analysis of RCTs involving treatments for newly diagnosed primary immune thrombocytopenia. PubMed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched up to April 31, 2022. The primary outcomes were 6-month sustained response and early response. Secondary outcome was grade 3 or higher adverse events. This study is registered with PROSPERO (CRD42022296179). FINDINGS Eighteen RCTs (n = 1944) were included in this study. Pairwise meta-analysis showed that the percentage of patients achieving early response was higher in the dexamethasone-containing doublet group than in the dexamethasone group (79.7% vs 68.7%, odds ratio [OR] 1.82, 95% CI 1.10-3.02). The difference was more profound for sustained response (60.5% vs 37.4%, OR 2.57, 95% CI 1.95-3.40). Network meta-analysis showed that dexamethasone plus recombinant human thrombopoietin ranked first for early response, followed by dexamethasone plus oseltamivir or tacrolimus. Rituximab plus prednisolone achieved highest sustained response, followed by dexamethasone plus all-trans retinoic acid or rituximab. Rituximab plus dexamethasone showed 15.3% of grade 3 or higher adverse events, followed by prednis(ol)one (4.8%) and all-trans retinoic acid plus dexamethasone (4.7%). INTERPRETATION Our findings suggested that compared with monotherapy dexamethasone or prednis(ol)one, the combined regimens had better early and sustained responses. rhTPO plus dexamethasone ranked top in early response, while rituximab plus corticosteroids obtained the best sustained response, but with more adverse events. Adding oseltamivir, all-trans retinoic acid or tacrolimus to dexamethasone reached equally encouraging sustained response, without compromising safety profile. Although this network meta-analysis compared all the therapeutic regimens up to date, more head-to-head RCTs with larger sample size are warranted to make direct comparison among these strategies. FUNDING National Natural Science Foundation of China, Major Research Plan of National Natural Science Foundation of China, Shandong Provincial Natural Science Foundation and Young Taishan Scholar Foundation of Shandong Province.

Abstract

BACKGROUND Hypertensive intracerebral hemorrhage (HICH) seriously endangers the quality of life of patients and can even lead to death. Craniotomy is a common treatment method for HICH. OBJECTIVE The aim of this study was to investigate the efficacy of two different sizes of craniotomy in patients with HICH, as well as to evaluate their effects on C-reactive protein (CRP) and blood lactate levels. MATERIALS AND METHODS A total of 72 patients with HICH in the basal ganglia were operated on in our hospital from February 2017 to March 2019 and randomly divided into two groups: the small bone window (SBW) group (n = 37) and the large bone flap group (n = 35). The curative effects of the two kinds of operations were evaluated by the length of operation, the days of hospitalization, the rate of hematoma clearance, the rate of rebleeding, and the incidence of complications. Additionally, the levels of CRP and lactate were compared between the two groups. RESULTS The results showed that the average intraoperative time, hospital stay, rebleeding rate, and postoperative complications of patients in the SBW group were less than those in the large bone flap group. Moreover, the number of patients in the SBW group with good postoperative recovery, including class V and class IV, was higher than that in the large bone flap group. Minimally invasive craniotomy with SBW reduced the lactic acid and CRP levels more quickly than the large bone flap group. CONCLUSIONS An SBW was superior to a large bone flap in terms of the operative effect and lactate and CRP levels. It is concluded that an SBW has significant advantages over a large bone flap.

Abstract

BACKGROUND Nafamostat mesilate (NM), a broad-spectrum and potent serine protease inhibitor, can be used as an anticoagulant during extracorporeal circulation, as well as a promising drug effective against coronavirus disease 2019 (COVID-19). We conducted a systematic meta-analysis to evaluate the safety and efficacy of NM administration in critically ill patients who underwent blood purification therapy (BPT). METHODS The Cochrane Library, Web of Science and PubMed were comprehensively searched from inception to August 20, 2021, for potential studies. RESULTS Four randomized controlled trials (RCTs) and seven observational studies with 2723 patients met the inclusion criteria. The meta-analysis demonstrated that conventional therapy (CT) significantly increased hospital mortality compared with NM administration (RR = 1.25, p = 0.0007). In subgroup analyses, the in-hospital mortality of the NM group was significantly lower than that of the anticoagulant-free (NA) group (RR = 1.31, p = 0.002). The CT interventions markedly elevated the risk ratio of bleeding complications by 45% (RR = 1.45, p = 0.010) compared with NM interventions. In another subgroup analysis, NM used exhibited a significantly lower risk of bleeding complications than those of the low-molecular-weight heparin (LMWH) used (RR = 4.58, p = 0.020). The filter lifespan was decreased significantly (MD = -10.59, p < 0.0001) in the NA groups compared with the NM groups. Due to the poor quality of the included RCTs, these results should be interpreted with caution. CONCLUSION Given the better survival outcomes, lower risk of bleeding, NM anticoagulation seems to be a safe and efficient approach for BPT patients and could yield a favorable filter lifespan. More multi-center RCTs with large samples are required for further validation of this study.

Abstract

BACKGROUND The latest basic studies and clinical evidence have confirmed the safety and efficacy of intraoperative autologous blood cell transfusion in cardiac surgery and orthopaedics. However, in caesarean section, there are still concerns about the contamination of amniotic fluid and foetal components, and consequently the application of intraoperative autologous blood cell transfusion is not universal. Therefore, this study aimed to evaluate the clinical value of intraoperative autologous blood cell transfusion in obstetric surgery. METHODS A prospective, randomized, controlled, feasibility study was performed in women undergoing caesarean section. One hundred sixteen participants were randomly assigned at a 1:1 ratio into either the intraoperative cell salvage group or the control group. Allogeneic blood cells were transfused into patients with haemoglobin concentrations < 80 g/dL in both the intraoperative cell salvage group and the control group. RESULTS No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc. However, compared with the control group, patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay. CONCLUSION The results of this study suggest that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. TRIAL REGISTRATION All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (2016-XJS-003-01) as well as the 1964 Helsinki Declaration and its later amendments or other comparable ethical standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on September 28, 2015.

Abstract

The ongoing outbreak of Coronavirus Disease 2019 (COVID-19) is hitting the world hard, but the relationship between coagulation disorders and COVID-19 is still not clear. This study aimed to explore whether early coagulation tests can predict risk stratification and prognosis. PubMed, Web of Science, Cochrane Library, and Scopus were searched electronically for relevant research studies published up to March 24, 2020, producing 24 articles for the final inclusion. The pooled standard mean difference (SMD) of coagulation parameters at admission were calculated to determine severe and composite endpoint conditions (ICU or death) in COVID-19 patients. Meta-analyses revealed that platelet count was not statistically related to disease severity and composite endpoint; elevated D-dimer correlated positively with disease severity (SMD 0.787 (0.277-1.298), P= 0.003, I(2)= 96.7%) but had no significant statistical relationship with composite endpoints. Similarly, patients with prolonged prothrombin time (PT) had an increased risk of ICU and increased risk of death (SMD 1.338 (0.551-2.125), P = 0.001, I(2) = 92.7%). Besides, increased fibrin degradation products (FDP) and decreased antithrombin might also mean the disease is worsening. Therefore, early coagulation tests followed by dynamic monitoring is useful for recognizing coagulation disorders accompanied by COVID-19 and guiding timely therapy to improve prognosis.

Abstract

BACKGROUND This meta-analysis focuses on the controversial efficacy and safety of platelet-rich plasma (PRP) as compared with hyaluronic acid (HA) in the clinical treatment of knee osteoarthritis. We have attempted to provide an evidence-based medicine protocol for the conservative treatment of knee osteoarthritis. In addition, we included the latest relevant literature in this meta-analysis, and a staging study was conducted to compare the therapeutic effects of PRP and HA for knee osteoarthritis over different time periods. METHODS An online computer search with "platelet-rich plasma" and "knee osteoarthritis" as search terms was conducted in the PubMed, EMBASE, and Cochrane Library databases. We conducted a quality assessment of the retrieved literature and extracted the following indicators: visual analog scale (VAS) score, subjective International Knee Documentation Committee (IKDC) score, Western Ontario and McMaster Universities (WOMAC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), and adverse events. RevMan5.3 software was used to determine the effect sizes, and indicators were compared across studies at three different time points from the administration of treatment. RESULTS A total of 14 randomized controlled trials (RCTs) involving 1350 patients were included. Long-term VAS, IKDC, WOMAC-Pain, WOMAC-Stiffness, WOMAC-Physical Function, and WOMAC-Total scores at each time point were higher in the PRP group than in the HA group. There were no significant differences in the remaining indicators between the two groups. CONCLUSION Compared with HA, PRP offers obvious advantages in the conservative treatment of knee osteoarthritis. Treatment with PRP can reduce long-term pain and improve knee joint function with no additional risks. Therefore, PRP can be widely used for the conservative treatment of knee osteoarthritis.

Abstract

BACKGROUND Arthroscopic repair of rotator cuff tears, although commonly performed, carries the risk of retears. Therefore, bioremediation techniques such as platelet-rich plasma injections have been used as adjuvant therapies. The clinical efficacy of platelet-rich plasma in the arthroscopic repair of full-thickness rotator cuff injury is controversial. We performed a meta-analysis to evaluate the clinical effectiveness and safety of platelet-rich plasma and provide evidence-based medical recommendations for selecting the proper clinical treatment plan for full-thickness rotator cuff injuries. METHODS A search for the terms "platelet-rich plasma" and "rotator cuff" was performed in the PubMed, EMBASE, and Cochrane Library databases using a computer. After conducting quality evaluations and data extraction, RevMan 5.3 software was used to combine the effect sizes, and the GRADEpro Guideline Development Tool was used to rate the level of evidence from aspects of functional score, pain score and retear rate. RESULTS Eight randomized controlled trials involving 566 patients were included. The long-term retear rate(RR = 0.96, 95% CI [0.52, 1.78], P = .89), Constant score(RR = 0.96, 95% CI [0.52, 1.78], P = .89), and Visual Analog Scale score for pain (SMD = -0.28, 95% CI [-0.60, 0.04], P = .08), as well as both the long-term and short-term Disabilities of the Arm, Shoulder, and Hand scores(SMD = -0.13, 95% CI [-0.44, 0.18], P = .41;SMD = -0.02, 95% CI [-0.40, 0.36], P = .93), were not significantly different between the platelet-rich plasma and control groups. However, the short-term retear rate(RR = 0.29, 95% CI [0.13, 0.65], P = .003) and Visual Analog Scale score (SMD = -0.41, 95% CI [-0.62, -0.19], P = .0002) were significantly lower, while the short-term Constant score(SMD = 0.37, 95% CI [0.19, 0.55], P < .0001) and short-term and long-term University of California at Los Angeles activity scores (SMD = 0.38, 95% CI [0.16, 0.60], P = .0008;SMD = 0.85, 95% CI [0.48, 1.22], P < .00001) were significantly higher, in the platelet-rich plasma group than in the control group. CONCLUSION Platelet-rich plasma injection can effectively improve the short-term outcomes following arthroscopic repair of full-thickness rotator cuff tears, thus reducing the rate of retears, alleviating pain, and improving patients' shoulder function. Specifically, the clinical outcomes are better with the use of platelet-rich plasma in single-row fixation than in other fixation techniques. Therefore, platelet-rich plasma injection can be recommended as an adjuvant therapy in single-row repair for improved short-term results.

Abstract

IMPORTANCE Excessive bleeding and transfusion increase morbidity and mortality in patients receiving coronary artery bypass grafting (CABG), especially in those exposed to antiplatelet agents. OBJECTIVE To evaluate the influence and interaction of clopidogrel bisulfate and tranexamic acid on bleeding and transfusion outcomes. DESIGN A multicenter randomized and blinded trial. SETTING Seven medical centers across China. PARTICIPANTS Patients eligible for randomization were 1173 men and women aged 18 to 85 years undergoing primary and isolated on-pump CABG; 570 adults were randomized and 552 were analyzed. Patients were recruited and stratified into 3 levels according to preoperative clopidogrel exposure (clopidogrel ingestion <=7 days, clopidogrel discontinuation >7 days, and nonexposure). INTERVENTION Patients were randomized to receive tranexamic acid (10-mg/kg-1 bolus and 10-mg/kg-1/h-1 maintenance dose) or placebo. MAIN OUTCOME MEASURE The primary outcomes included blood loss, major bleeding, and red blood cell (RBC) transfusion volume and exposure. RESULTS As compared with controls, clopidogrel increased blood loss (mean difference [MD], 270 mL; 95% CI, 135 to 404 mL), major bleeding (risk difference [RD], 18.5; 95% CI, 7.85 to 29.2), volume of RBCs transfused (MD, 2.97 U; 95% CI, 1.51 to 4.43 U), and RBC transfusion exposure (RD, 17.9; 95% CI, 8.51 to 27.2). As compared with placebo, tranexamic acid reduced blood loss (MD, -278 mL; 95% CI, -380 mL to -176 mL), major bleeding (RD, -19.5; 95% CI, -27.7 to -11.4), volume of RBCs transfused (MD, -2.58 U; 95% CI -3.61 U to -1.55 U), and RBC transfusion exposure (RD, -18.9; 95% CI, -26.4 to -11.4). Subgroup analysis demonstrated a significantly enhanced effect of tranexamic acid especially in patients with impaired platelet function. CONCLUSIONS AND RELEVANCE Preoperative clopidogrel exposure increased bleeding and transfusion requirements in patients receiving on-pump CABG. Tranexamic acid reduced this risk and provided extra protection selectively in the patients with persistent clopidogrel exposure within 7 days before surgery. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01060163.

Abstract

To investigate whether platelet-rich plasma (PRP) when used with allograft bone improves the management outcome of displaced intra-articular calcaneal fractures. Over a 7-year period, all displaced type III calcaneal fractures admitted in our department (276 fractures in 254 patients) were randomly divided into three groups according to the plan of management: autograft alone (n = 101), allograft combined with PRP (n = 85), or allograft alone (n = 90). Radiographic imaging and three-dimensional computed tomography were used to assess the thalamic portion, Bohler's angle, the crucial angle of Gissane, and the height, width and length of the calcaneum. The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hind-foot scoring system was used to evaluate the hind foot function at 12, 24, and 72 months postsurgery. At 12 months no significant difference existed in outcome amongst the treatment groups (p > 0.05). However, at 24 and 72 months the results of the autograft, and the allograft combined with PRP, were similar and both were significantly better than that of the allograft alone (p < 0.05). PRP augmented the favorable outcome of allografts in the management of displaced calcaneal fractures, and matched that of autograft used alone. The findings of this study thus support the clinical use of PRP in conjunction with allograft in the treatment of displaced intra-articular calcaneal fractures. Copyright 2012 Orthopaedic Research Society.

Abstract

OBJECTIVE This study evaluates the anti-inflammatory activity of full-dose and pump-prime-only(low-dose) aprotinin by means of comparing tumor necrosis factor alpha(TNF-alpha) levels of both groups after CPB. METHODS Twenty-nine adults with rheumatic heart disease were randomized into three groups: (1) full-dose aprotinin-treated group(Group A, n = 10); (2) pump-prime-only aprotinin-treated group(Group B, n = 10), and (3) control group(Group C, n = 9). Plasma concentrations of TNF-alpha were measured by enzyme-linked immunosorbent assay technique at baseline(before operation), and at 2, 24 hours after CPB termination. RESULTS A significant(P < 0.05) increase of TNF-alpha occurred in all three groups at 2 and 24 hours after CPB termination when compared with the same group at baseline. In Group A, TNF-alpha level was significantly lower than that in group C(P < 0.05) at 24 hours after CPB, but not in group B(P > 0.05). CONCLUSIONS Both CPB and operative stimulus induce the increase of cytokine TNF-alpha after CPB. Full-dose aprotinin has the anti-inflammatory effect by means of reducing TNF-alpha level after CPB. Low-dose aprotinin dose not reduce TNF-alpha level. So it no significant anti-inflammatory effect.