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Efficacy of Eltrombopag with Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone on Severe Aplastic Anaemia: A Systematic Review and Meta-analysis
Zhang S, Wang Q, Cui K, Cheng B, Fan J, Hu S
Clinical drug investigation. 2023
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Abstract
BACKGROUND AND OBJECTIVE Severe aplastic anaemia (SAA) is a syndrome of bone marrow failure caused by T cell-mediated destruction of haematopoietic stem cells and progenitor cells. Whether patients with SAA should be treated with eltrombopag (EPAG) and immunosuppressive therapy (IST) or IST alone remains debatable. Therefore, we conducted this meta-analysis to compare the efficacy of eltrombopag + IST with that of IST alone in patients with SAA and to assess the difference in the efficacy of eltrombopag in adults and children. METHODS We performed this meta-analysis by retrieving studies that met the inclusion and exclusion criteria from PubMed, EMBASE, and the Cochrane Library up to 1 January 2023. We used a random-effects model to calculate odds ratios (ORs) with 95% confidence intervals (CIs) for primary and secondary outcomes. I(2) statistics were used to evaluate the heterogeneity of the included studies. RESULTS Six studies involving a total of 699 patients were included. In terms of the primary outcomes, our pooled results indicated that patients treated with EPAG + IST had a higher 6-month overall response rate (OR = 2.25; 95% CI, 1.60-3.16; p < 0.00001), a higher 6-month complete response rate (OR = 2.61; 95% CI, 1.82-3.74; p < 0.00001), and a lower 6-month nonresponse rate (OR = 0.32; 95% CI, 0.19-0.52; p < 0.00001). However, there was no significant difference in the rate of 6-month partial response (OR = 0.94; 95% CI, 0.49-1.81; p = 0.85). CONCLUSION This meta-analysis indicated that patients treated with additional eltrombopag for IST may have a higher rate of haematological response.
PICO Summary
Population
Children and adults with severe aplastic anaemia (6 studies, n= 699).
Intervention
Eltrombopag (EPAG) and immunosuppressive therapy (IST), (n= 364).
Comparison
IST alone (n= 335).
Outcome
Patients treated with EPAG + IST had a higher 6-month overall response rate (odds ratio (OR), 2.25; 95% confidence interval (CI), [1.60, 3.16]), a higher 6-month complete response rate (OR, 2.61; 95% CI [1.82, 3.74]), and a lower 6-month non-response rate (OR, 0.32; 95% CI [0.19, 0.52]). There was no significant difference in the rate of 6-month partial response (OR, 0.94; 95% CI [0.49, 1.81]).
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The efficacy and safety of tranexamic acid in high tibial osteotomy: a systematic review and meta-analysis
Ma J, Lu H, Chen X, Wang D, Wang Q
Journal of orthopaedic surgery and research. 2021;16(1):373
Abstract
OBJECTIVE The present meta-analysis was conducted to evaluate the efficacy and safety of the application of tranexamic acid (TXA) in patients undergoing high tibial osteotomy (HTO). METHODS PubMed (MEDLINE), EMBASE, and Cochrane Library were systematically searched for relevant literature from inception until 1 February 2021. A combined searching strategy of subject words and random words was adopted. After testing for potential publication bias and/or heterogeneity, we aggregated variables by using the random-effect model. The primary comparison outcome measures were total blood loss, hemoglobin decrease, drain output, wound complications, thrombotic events, and blood transfusion rate of the TXA group versus control. The meta-analysis was performed using the RevMan 5.3 software. RESULTS A total of 5 studies were included involving 532 patients. The results showed that there were significant differences in the two groups concerning total blood loss (95% confidence interval [CI] - 332.74 to - 146.46, P < 0.00001), hemoglobin decrease on postoperative day (POD) 1, 2, and 5 (POD 1 95% CI - 1.34 to - 0.63, P < 0.00001; POD 2 95% CI - 1.07 to - 0.68, P < 0.00001; POD 5 95% CI - 1.46 to - 0.84, P < 0.00001), drain output (POD total 95% CI - 195.86 to - 69.41, P < 0.00001) and wound complications (RR = 0.34, 95% CI 0.12 to 0.97, P = 0.04). Nonsignificant differences were found in the incidence of thromboembolic events (RR = 0.46, 95% CI 0.09 to 2.41, P = 0.36) and blood transfusion rate (RR = 0.25, 95% CI 0.03 to 2.27, P = 0.22). CONCLUSIONS This meta-analysis of the available evidence demonstrated that TXA could reduce total blood loss, hemoglobin decrease, drain output, and wound complications without increasing the incidence of thromboembolic events in patients undergoing HTO. But there is no obvious evidence that TXA could reduce blood transfusion rates. Further studies, including more large-scale and well-designed randomized controlled trials, are warranted to assess the efficacy and safety issues of routine TXA use in HTO patients.
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Early-TIPS Versus Current Standard Therapy for Acute Variceal Bleeding in Cirrhosis Patients: A Systemic Review With Meta-analysis
Li S, Zhang C, Lin LL, Wang Q, Zuo HX, Zhan AL, Luo J, Niu YM, Zhong GQ
Front Pharmacol. 2020;11:603
Abstract
Background: The survival of early placement (within 72h after admission) of transjugular intrahepatic portosystemic shunts (early-TIPS) in patients with cirrhosis and acute variceal bleeding (AVB) is controversial. Objectives: We performed a systemic review and meta-analysis to assess whether early-TIPS could improve survival in patients with cirrhosis and acute variceal bleeding. Methods: A systematic search of the literature was conducted in PubMed, EMBASE, and Cochrane Library published before 25 June 2019 for eligible studies that compared early-TIPS with a combination of endoscopic variceal ligation (EVL) and pharmacotherapy in the therapeutic effect in AVB patients. Results: A total of five studies with 1,754 participants were enrolled. The early-TIPS demonstrated a significant improvement in prevention of treatment failure (OR=0.11,95%CI=0.05-0.23), 6-weeks mortality (OR=0.24,95%CI=0.13-0.46), rebleeding within 6 weeks (OR=0.21,95%CI=0.12-0.36), rebleeding within 1 year (OR=0.16,95%CI=0.07-0.36), new or worsening ascites (OR=0.33,95%CI=0.21-0.53), except in encephalopathy (OR=1.29,95%CI=0.996-1.67). For 1-year mortality, a significant prior effect was also observed in early-TIPS (OR=0.64,95%CI=0.46-0.90), and the beneficial effect in Child-Pugh C patients (OR=0.35,95%CI=0.18-0.68) was equal to Child-Pugh B patients (OR=0.34,95%CI=0.25-0.58). No difference in liver transplantation and mortality caused by liver failure was observed. Conclusions: Early covered-TIPS could be recommended for the management of AVB patients in cirrhosis demonstrating a significant improvement in treatment failure, both short- and long-term mortality, rebleeding risk, and new or worsening ascites compared to standard therapy, especially for high-risk AVB patients. It will also apply to patients with Child-Pugh A until solutions to prevent hepatic encephalopathy in future research are found.
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Use of urinary balloon catheter to prevent postoperative bleeding after ultrasound-guided vacuum-assisted breast biopsy
Lian ZQ, Yu HY, Zhang AQ, Xie SM, Wang Q
The breast journal. 2019
Abstract
Postoperative bleeding is the most frequent serious complications after vacuum-assisted breast biopsy (VABB). The aim of this study was to evaluate the clinical effect of using urinary balloon catheter to prevent postoperative bleeding after ultrasound-guided VABB. From May 2016 to June 2018, 324 patients who underwent ultrasound-guided VABB were randomized into the study group and control group. In the study group, an urinary balloon catheter was inserted into the excision cavity to prevent bleeding and hematoma. In the control group, compression with thorax pressure bandage was used for hemostasis. Postoperative subcutaneous ecchymosis and hematoma were recorded and compared between the two groups. The rates of postoperative ecchymosis and hematoma in the study group were significantly lower than that in the control group (5.6% vs 13.0%, P < .05; 8.0% vs 20.4%, P < .05). Among patients with lesions ≤1.5 cm, the rates of postoperative ecchymosis and hematoma were 2.9% and 4.3% in the study group, 6.5% and 11.7% in the control group, but there was no statistically significant difference between the two groups (P > .05). Among patients with lesions >1.5 cm, the rates of postoperative ecchymosis and hematoma in the study group were significantly lower than that in the control group (7.6% vs 18.8%, P < .05; 10.9% vs 28.2%, P < .05). Hemostasis with balloon urinary catheter is a safe and effective method to prevent postoperative bleeding after VABB.
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Efficacy and Safety of Chinese Herbal Medicine for Primary Intracerebral Hemorrhage: A Systematic Review of Randomized Controlled Trials
Wang HL, Zeng H, Xu MB, Zhou XL, Rong PQ, Jin TY, Wang Q, Zheng GQ
Frontiers in pharmacology. 2019;10:1139
Abstract
Background: Primary intracerebral hemorrhage (ICH) is the most harmful subtype of stroke, but there have yet been no specific proven therapies. Chinese herbal medicine (CHM) has been used for ICH for more than a thousand years; however, currently it is still lacking of available evidence. The objective of this study is to assess the current available evidence of CHM for acute ICH according to randomized controlled trials. Methods: Eight databases were searched from the year of their respective inception to November 2017. Only the studies that assessed at least four domains with "yes" according to the Cochrane risk of bias tool were selected for analysis. All the data were analyzed by using Review Manager 5.3 software. P < 0.05 was considered to be statistically significant. Results: Forty-five studies with 4,517 individuals were identified. CHM paratherapy can improve dependency, neurological function deficit, volume of hematoma, clinical effective rate, and volume of perihematomal edema compared with CHM alone or placebo (all P < 0.05). By contrast, it was not significant for improving the mortality rate of ICH patients (P > 0.05). In addition, adverse events were reported in 16 studies, whereas 29 studies did not mention it. The frequency of adverse events was 70/972 in the trial group and 48/944 in the control group. Conclusion: The present study provided supportive evidence of CHM for improving dependency of ICH and showed generally safety; however, there is still lack of evidence for improving mortality rate, and it opens for further study.
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Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial
Lv Y, Yang Z, Liu L, Li K, He C, Wang Z, Bai W, Guo W, Yu T, Yuan X, et al
The lancet. Gastroenterology & hepatology. 2019
Abstract
BACKGROUND The survival benefit of early placement of transjugular intrahepatic portosystemic shunts (TIPS) in patients with cirrhosis and acute variceal bleeding is controversial. We aimed to assess whether early TIPS improves survival in patients with advanced cirrhosis and acute variceal bleeding. METHODS We did an investigator-initiated, open-label, randomised controlled trial at an academic hospital in China. Consecutive patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomly assigned (2:1) to receive either early TIPS (done within 72 h after initial endoscopy [early TIPS group]) or standard treatment (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation for the prevention of rebleeding, with TIPS as rescue therapy when needed [control group]). Randomisation was done by web-based randomisation system using a Pocock and Simon's minimisation method with Child-Pugh class (B vs C) and presence or absence of active bleeding as adjustment factors. The primary outcome was transplantation-free survival, analysed in the intention-to-treat population, excluding individuals subsequently found to be ineligible for enrolment. This study is registered with ClinicalTrials.gov, number NCT01370161, and is completed. FINDINGS From June 26, 2011, to Sept 30, 2017, 373 patients were screened and 132 patients were randomly assigned to the early TIPS group (n=86) or to the control group (n=46). After exclusion of three individuals subsequently found to be ineligible for enrolment (two patients in the early TIPS group with non-cirrhotic portal hypertension or hepatocellular carcinoma, and one patient in the control group due to non-cirrhotic portal hypertension), 84 patients in the early TIPS group and 45 patients in the control group were included in the intention-to-treat population. 15 (18%) patients in the early TIPS group and 15 (33%) in the control group died; two (2%) patients in the early TIPS group and one (2%) in the control group underwent liver transplantation. Transplantation-free survival was higher in the early TIPS group than in the control group (hazard ratio 0.50, 95% CI 0.25-0.98; p=0.04). Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0.02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0.046). There were no significant differences between the two groups in the incidence of hepatic hydrothorax (two [2%] of 84 patients in the early TIPS group vs one [2%] of 45 in the control group; p=0.96), spontaneous bacterial peritonitis (one [1%] vs three [7%]; p=0.12), hepatic encephalopathy (29 [35%] vs 16 [36%]; p=1.00), hepatorenal syndrome (four [5%] vs six [13%]; p=0.10), and hepatocellular carcinoma (four [5%] vs one [2%]; p=0.68). There was no significant difference in the number of patients who experienced other serious adverse events (ten [12%] vs 11 [24%]; p=0.07) or non-serious adverse events (21 [25%] vs 19 [42%]; p=0.05) between groups. INTERPRETATION Early TIPS with covered stents improved transplantation-free survival in selected patients with advanced cirrhosis and acute variceal bleeding and should therefore be preferred to the current standard of care. FUNDING National Natural Science Foundation of China, National Key Technology R&D Program, Optimized Overall Project of Shaanxi Province, Boost Program of Xijing Hospital.
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Superior blood-saving effect and postoperative recovery of comprehensive blood-saving strategy in infants undergoing open heart surgery under cardiopulmonary bypass
Wu T, Liu J, Wang Q, Li P, Shi G
Medicine. 2018;97((27)):e11248.
Abstract
BACKGROUND Optimization of blood-saving strategies during open heart surgery in infants is still required. This study aimed to study a comprehensive blood-saving strategy during cardiopulmonary bypass (CPB) on postoperative recovery in low-weight infants undergoing open heart surgery. METHODS This was a prospective study of 86 consecutive infants (weighing <5 kg) with acyanotic congenital heart disease treated at the Tianjin Chest Hospital between March and December 2016, and randomized to the control (traditional routine CPB) and comprehensive blood-saving strategy groups. The primary endpoints were blood saving and clinical prognosis. The secondary endpoints were safety and laboratory indicators, prior to CPB (T1), after 30 minutes of CPB (T2), after modified ultrafiltration (T3), and postoperative 12 (T4), 24 (T5), 48 (T6), and 72 h (T7). RESULTS The total priming volume and banked red blood cells in the comprehensive strategy group were significantly lower than in the control group (P = .009 and P = .04, respectively). In the comprehensive strategy group, immediately after CPB, the amount of salvaged red blood cells exceeded the priming red blood cells by 40 +/- 11 mL. Postoperatively, the comprehensive strategy group showed a significant decrease in the inotrope score (P = .03), ventilation time (P = .03), intensive care unit stay (P = .04), and hospital stay (P = .03) in comparison with the control group. CONCLUSION The comprehensive blood-saving strategies for CPB were associated with less blood use and favorable postoperative recovery in low-weight infants with congenital heart disease undergoing open heart surgery.
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Tranexamic acid versus aminocaproic acid for blood management after total knee and total hip arthroplasty: a systematic review and meta-analysis
Liu Q, Geng P, Shi, Wang Q, Wang P
International Journal of Surgery (London, England). 2018;54((Pt A):):105-112
Abstract
OBJECTIVE To compare the efficacy and safety of tranexamic acid and aminocaproic acid for reducing blood loss and transfusion requirements after total knee and total hip arthroplasty. METHODS We conduct electronic searches of Medline (1966-2017.11), PubMed (1966-2017.11), Embase (1980-2017.11), ScienceDirect (1985-2017.11) and the Cochrane Library (1900-2017.11). The primary outcomes, including total blood loss, hemoglobin decline and transfusion requirements. Secondary outcomes include length of hospital stay and postoperative complications such as the incidence of deep vein thrombosis and pulmonary embolism. Each outcome is combined and calculated using the statistical software STATA 12.0. Fixed/random effect model is adopted based on the heterogeneity tested by I(2) statistic. RESULTS A total of 1,714 patients are analyzed across three randomized controlled trials (RCTs) and one non-RCT. The present meta-analysis reveals that TXA is associated with a significantly reduction of total blood loss and postoperative hemoglobin drop compared with EACA. No significant differences are identified in terms of transfusion rates, length of hospital stay, and the incidence of postoperative complications. CONCLUSION Although total blood loss and postoperative hemoglobin drop are significant greater in EACA groups, there is no significant difference between TXA and EACA groups in terms of transfusion rates. Based on the current evidence available, higher quality RCTs are still required for further research.
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9.
Synergistic effects of intravenous and intra-articular tranexamic acid on reducing hemoglobin loss in revision total knee arthroplasty: a prospective, randomized, controlled study
Yuan X, Wang J, Wang Q, Zhang X
Transfusion. 2018;58((4):):982-988
Abstract
BACKGROUND Tranexamic acid decreases blood loss in primary total knee arthroplasty, and no related prospective randomized clinical trials have been conducted to evaluate the effectiveness and safety of tranexamic acid in revision total knee arthroplasty. Thus, we conducted this work to evaluate the synergistic effects of intravenous plus intra-articular tranexamic acid on reducing hemoglobin loss compared with intra-articular tranexamic acid alone in revision total knee arthroplasty. STUDY DESIGN AND METHODS This prospective, controlled study randomized 96 patients undergoing revision total knee arthroplasty into two groups: an intravenous plus intra-articular tranexamic acid group (48 patients who received 20 mg/kg intravenous tranexamic acid and 3.0 g intra-articular tranexamic acid); and an intra-articular tranexamic acid alone group (48 patients who received the same intravenous volume of normal saline and 3.0 g intra-articular tranexamic acid). The primary outcome was hemoglobin loss. Secondary outcomes included the volume of drain output, the percentage of patients who received transfusions, the number of units transfused, and thromboembolic events. RESULTS The baseline data, preoperative hemoglobin, and tourniquet time were similar in both groups. There was significantly less hemoglobin loss in the intravenous plus intra-articular tranexamic acid group compared with the intra-articular tranexamic acid alone group (2.7 +/- 0.6 g/dL and 3.7 +/- 0.7 g/dL; p < 0.001). Compared with the intra-articular tranexamic acid alone group, the intravenous plus intra-articular tranexamic acid group also had significantly less drain output, fewer patients who received transfusions, and fewer units transfused (all p < 0.05). There were no significant differences in thromboembolic events in the two groups during the 3-month follow-up. CONCLUSION Compared with intra-articular tranexamic acid alone, combined intravenous plus intra-articular tranexamic acid significantly reduced hemoglobin loss and the need for transfusion without an apparent increase in thromboembolic events in patients who underwent revision total knee arthroplasty.
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10.
Comparison of 3 routes of administration of tranexamic acid on primary unilateral total knee arthroplasty: a prospective, randomized, controlled study
Yuan X, Li B, Wang Q, Zhang X
The Journal of Arthroplasty. 2017;32((9):):2738-2743
Abstract
BACKGROUND The mode of administration for tranexamic acid (TXA) to significantly reduce the decrease in hemoglobin (Hb), number of transfusions, relevant costs, and side effects in patients undergoing primary unilateral total knee arthroplasty (TKA) has not been resolved. METHODS A total of 560 patients undergoing primary unilateral TKA were randomized into 4 groups: intravenous group (140 patients receiving 2 doses of 20 mg/kg intravenous TXA), topical group (140 patients administered 3.0 g topical TXA), oral group (140 patients given 2 doses of 20 mg/kg oral TXA), and a control group (140 patients not given TXA). The primary outcomes included postoperative 48-hour Hb loss and drainage volume, number of transfusions, transfusion and TXA costs, and thromboembolic complications. Secondary outcomes were postoperative inpatient time and wound healing 3 weeks after TKA. RESULTS Baseline data among the 4 groups were similar. The 48-hour Hb loss and drainage volume in the intravenous, topical, and oral groups were significantly less (P < .05) than those in the control group, and the latter had significantly more transfusions and transfusion costs than the other 3 groups (P < .05). The TXA cost was lowest in the oral group compared with that in the topical and intravenous groups (P < .05). No differences in thromboembolic complications, postoperative inpatient time, or wound healing were observed among the groups. However, wound dehiscence and continuous wound discharge occurred in the topical group. CONCLUSION All the 3 modes of TXA administration significantly reduced postoperative Hb loss, the number of transfusions, and transfusion costs compared with those in the control group. No pulmonary embolism or infection was observed. Oral TXA is recommended because it provided a similar clinical benefit and resulted in the lowest TXA cost compared with the other 2 modes of TXA administration.