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The efficacy and safety of tranexamic acid in lumbar surgery: A meta-analysis of randomized-controlled trials
Xiao K, Zhuo X, Peng X, Wu Z, Li B
Joint diseases and related surgery. 2022;33(1):57-85
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Abstract
OBJECTIVES This meta-analysis aims to assess tranexamic acid (TXA) effectiveness and safety in lumbar surgery. PATIENTS AND METHODS Renewals of randomized-controlled trials (RCTs) were conducted utilizing databases of medical literature such as PubMed, China Science and Technology Journal Database, Cochrane Library, China National Knowledge Infrastructure (CNKI), and EMBASE to compare principal and safety endpoints. The risk ratio (RR), standard mean difference (SMD), and 95% confidence intervals (CIs) were calculated. For the evaluation of the quality of the included studies, the Cochrane risk of bias criteria were utilized by two authors. RESULTS In total, 49 articles were enrolled that included 4,822 patients. Of the patients, 2,653 were administered TXA and 2,169 were in the control group. The findings indicated that TXA was capable of significantly lowering postoperative blood loss (PBL), transfusion rate, transfusion volume, total blood loss (TBL), intraoperative blood loss (IBL), and drainage compared to the control group. Besides, hemoglobin (Hb) and hematocrit (Hct) values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis (DVT). Subgroup analysis was administrated according to the administration method of TXA and the operation type and intravenous and topical TXA were combined in the meta-analysis. CONCLUSION This meta-analysis showed that TXA had the potential to significantly lower PBL, transfusion rate, transfusion volume, TBL, IBL, and drainage compared to the control group. Besides, Hb and Hct values were higher in the TXA group compared to the control group. Its hemostatic potential after lumbar spine surgery is trustworthy. It is still controversial in safety endpoints that TXA can significantly reduce D-dimer compared to the control group, without no significant variations in DVT in both the TXA and control groups.
PICO Summary
Population
Patients undergoing lumbar surgery (49 studies, n= 4,822).
Intervention
Tranexamic acid (TXA), (n= 2,653).
Comparison
Normal saline (n= 2,169).
Outcome
TXA significantly lowered postoperative blood loss, transfusion rate, transfusion volume, total blood loss, intraoperative blood loss, and drainage compared to the control group. Haemoglobin and haematocrit values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis.
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Can intraoperative suturing reduce the incidence of posttonsillectomy hemorrhage? A systematic review and meta-analysis
Li B, Wang M, Wang Y, Zhou L
Laryngoscope investigative otolaryngology. 2022;7(4):1206-1216
Abstract
OBJECTIVE This study was to compare tonsillectomy with intraoperative suturing (TIS) and tonsillectomy without intraoperative suturing (TsIS) in preventing postoperative tonsillectomy hemorrhage (PTH). METHODS The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was followed. Articles compare TIS and TsIS in preventing PTH were included. The quality of eligible studies was assessed with the Newcastle-Ottawa Scale (NOS) by two independent investigators. Random effect models were used to determine odds ratio (OR) with 95% CIs. RESULTS A total of 15 studies were analyzed. The pooled results showed the PTH rate was lower in the TIS group (OR = 0.64; 95% CI, 0.47-0.88). The TIS group had a lower primary and secondary PTH rate than the TsIS group with OR values of 0.44 (95% CI, 0.30-0.64) and 0.70 (95% CI, 0.54-0.90), respectively. However, suturing did not show an advantage in reducing the risk of returning to the operation room for hemostasis (OR = 0.57; 95% CI, 0.13-2.47). Adults might benefit from the intraoperative suturing procedure (OR = 0.31; 95% CI, 0.16-0.60). Patients with more than three stitches on each side had a lower PTH rate (OR: 0.44; 95% CI, 0.32-0.60). Suturing the tonsillar fossa and pillars simultaneously could reduce the PTH rate (OR = 0.47; 95% CI, 0.34-0.64). CONCLUSIONS Intraoperative suturing is a good strategy for preventing PTH. More multicenter randomized controlled studies should be conducted to demonstrate the efficacy of this procedure. LEVEL OF EVIDENCE 5.
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Effectiveness of shengxuexiaoban capsules combined with glucocorticoid therapy for immune thrombocytopenia: A meta-analysis
Ding MY, Li B, Yang M, Zhai WS, Song CD, Zhang J, Zhang QY, Li PF, Liu LY
PloS one. 2022;17(9):e0275122
Abstract
OBJECTIVE To evaluate the effectiveness of the Shengxuexiaoban Capsules combined with glucocorticoid therapy for immune thrombocytopenia (ITP). METHODS We collected randomized controlled trials (RCTs) using shengxuexiaoban capsules in combination with glucocorticoid to treat ITP by searching major Chinese and English electronic databases. The outcome indicators were the effective rate, recurrence rate, the number of platelets in the blood, recovery time of platelets, and adverse reactions. We used STATA 16.0 and RevMan 5.3 for meta-analysis and GRADE pro. for evidence quality evaluation. RESULTS A total of 27 RCTs were included in the meta-analysis, and the results showed a significant difference (all p<0.05) in the effective rate, recurrence rate, the number of platelets, and the recovery time of platelets (≥ 100×109) between ITP patients in the control group (who received glucocorticoid therapy alone) and test group (who received glucocorticoid therapy combined with the Shengxuexiaoban Capsules). And that Shengxuexiaoban capsules combined with glucocorticoid therapy were safe. The funnel plot and Egger's test results indicated no obvious publication bias. The GRADE evidence rating showed an intermediate quality of evidence rating for recurrence rate and overall effectiveness. CONCLUSION Glucocorticoid therapy combined with the Shengxuexiaoban Capsules showed more effectiveness in the treatment of ITP. It can improve the effective rate, reduce the recurrence rate, increase the number of platelets and shorten the recovery time of platelets, and has a good safety profile.
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A randomized controlled trial to compare the efficacy of regenerated and non-regenerated oxidized cellulose gauze for the secondary treatment of local bleeding in patients undergoing hepatic resection
Zhang C, Fu D, Wang F, Zhong X, Yang L, Wu G, Li B, Zhang J
Annals of surgical treatment and research. 2021;100(4):193-199
Abstract
PURPOSE Oxidized cellulose is available in many forms, but manufactured using either a regenerated or non-regenerated process. In this study, we evaluated the effects of 2 different hemostatic agents for the treatment of local bleeding in patients undergoing hepatic resection. METHODS This was a monocentric, parallel-group, randomized, and controlled clinical trial to compare oxidized regenerated cellulose gauze (ORCG) with oxidized non-regenerated cellulose gauze (ONRCG) in patients undergoing hepatectomy. The primary endpoint was the time to hemostasis at the target bleeding site. The secondary endpoints were the postoperative drainage volume on the first 2 days after surgery and the hospital stay. RESULTS There was no significant difference between the ORCG and ONRCG groups in time to hemostasis from column analysis (238.8 ± 121.6 seconds vs. 193.7 ± 85.3 seconds, P = 0.068), and there were no differences in the rates of hemostatic success between the 2 groups at 120 seconds (18.4% vs. 24.3%; odds ratio [OR], 0.703; 95% confidence interval [CI], 0.231-2.136) and 300 seconds (71.1% vs. 89.2%; OR, 0.298; 95% CI, 0.085-1.041). However, the ONRCG group was superior to the ORCG group in hemostasis according to the survival analysis (log-rank test, P = 0.044). Moreover, there were also no significant differences between the 2 groups in postoperative drainage volume on the first 2 days (P = 0.436, P = 0.381) and hospital stay (P = 0.537, P = 0.200). CONCLUSION ONRCG was not inferior to ORCG as a hemostatic agent in patients undergoing liver resection.
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The pharmacodynamic effect of terlipressin versus high-dose octreotide in reducing hepatic venous pressure gradient: a randomized controlled trial
Li B, Chen J, Zhang CQ, Wang GC, Hu JH, Luo JJ, Zhang W, Wei YC, Zeng XQ, Chen SY
Annals of translational medicine. 2021;9(9):793
Abstract
BACKGROUND Vasoactive drugs can reduce portal venous pressure and control variceal bleeding. However, few studies have explored the hemodynamic effects of terlipressin and high-dose octreotide in such patients. Our purpose was to evaluate the hemodynamic changes and safety of using terlipressin and high-dose octreotide in patients with decompensated liver cirrhosis. METHODS A multi-center randomized controlled trial was conducted. Cirrhotic patients with a history of variceal bleeding were included. Terlipressin or high-dose octreotide was administered during the procedure of measuring hepatic venous pressure gradient (HVPG). Hemodynamic parameters and symptoms were recorded. RESULTS A total of 88 patients were included. HVPG was significantly reduced at 10, 20, and 30 min after drug administration in the terlipressin group (16.3±6.4 vs. 14.7±5.9, 14.0±6.1, and 13.8±6.1, respectively, P<0.001) and the high-dose octreotide group (17.4±6.6 vs. 15.1±5.8, 15.3±6.2, and 16.1±6.0, respectively P<0.01). Decreased heart rate and increased mean arterial pressure were more often observed in the terlipressin group. The overall response rates were not significantly different between the groups (52.8% vs. 44.8%, P=0.524). The terlipressin group had significantly higher response rates at 30 min compared to the high-dose octreotide group in those with alcoholic liver cirrhosis [6/6 (100%) vs. 0/4 (0%), P=0.005]. The incidence of adverse drug events was rare and similar in the two groups. CONCLUSIONS Both terlipressin and high-dose octreotide were effective and safe for reducing HVPG. The pharmacodynamic effect of terlipressin persisted longer. The terlipressin group had higher response rates in those with alcoholic cirrhosis (trial number: NCT02119884).
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Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage
Song J, Wang Y, Xu F, Sun H, Zhang X, Xia L, Zhang S, Li K, Peng X, Li B, et al
CNS drugs. 2021
Abstract
BACKGROUND Intraventricular hemorrhage (IVH) is a common complication in preterm infants that has poor outcomes, especially in severe cases, and there are currently no widely accepted effective treatments. Erythropoietin has been shown to be neuroprotective in neonatal brain injury. OBJECTIVE The objective of this study was to evaluate the protective effect of repeated low-dose recombinant human erythropoietin (rhEPO) in preterm infants with IVH. METHODS This was a single-blinded prospective randomized controlled trial. Preterm infants ≤ 32 weeks gestational age who were diagnosed with IVH within 72 h after birth were randomized to receive rhEPO 500 IU/kg or placebo (equivalent volume of saline) every other day for 2 weeks. The primary outcome was death or neurological disability assessed at 18 months of corrected age. RESULTS A total of 316 eligible infants were included in the study, with 157 in the rhEPO group and 159 in the placebo group. Although no significant differences in mortality (p = 0.176) or incidence of neurological disability (p = 0.055) separately at 18 months of corrected age were seen between the rhEPO and placebo groups, significantly fewer infants had poor outcomes (death and neurological disability) in the rhEPO group: 14.9 vs. 26.4%; odds ratio (OR) 0.398; 95% confidence interval (CI) 0.199-0.796; p = 0.009. In addition, the incidence of Mental Development Index scores of < 70 was lower in the rhEPO group than in the placebo group: 7.2 vs. 15.3%; OR 0.326; 95% CI 0.122-0.875; p = 0.026. CONCLUSIONS Treatment with repeated low-dose rhEPO improved outcomes in preterm infants with IVH. TRIAL REGISTRATION The study was retrospectively registered on ClinicalTrials.gov on 16 April 2019 (NCT03914690).
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Terlipressin Versus Norepinephrine for Septic Shock: A Systematic Review and Meta-Analysis
Huang P, Guo Y, Li B, Liu Q
Frontiers in pharmacology. 2019;10:1492
Abstract
Purpose: The meta-analysis aims to evaluate the efficacy and safety of terlipressin compared with norepinephrine for septic shock. Materials and Methods: The relevant studies from MEDLINE, Cochrane Library, Embase were searched by two independent investigators. A variety of keywords were used to search the studies. Stata software (version 11.0, Stata Corp LP, College Station, TX, USA) was used for statistical analysis. Results: A total of six studies were identified and incorporated into the meta-analysis. The results showed that there was no difference for 28-day mortality (RR = 0.99, 95% CI = [0.85,1.15], P = 0.849), AE (RR = 2.54, 95% CI = [0.58,11.08], P = 0.214), and MAP (SMD = -0.10, 95% CI = [-0.35,0.14], P = 0.405), OI, urinary output, Scr, total bilirubin, ALT, and AST between TP group and NE group. While TP could decrease HR at 24 and 48 h compared with NE. Conclusions: Current results suggest that terlipressin showed no added survival benefit for septic shock when compared with norepinephrine, while terlipressin could decrease heart rate in the late phase of septic shock compared with norepinephrine without further liver and kidney injury. Systematic Review Registration: PROSPERO (ID: CRD42019128743). Available online at: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42019128743.
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Efficacy and safety of Danggui Buxue Decoction in combination with western medicine treatment of anemia for renal anemia: a systematic review and meta-analysis
Zhao MM, Zhang Y, Li LS, Yu ZK, Li B
Annals of Translational Medicine. 2017;5((6)):136.
Abstract
BACKGROUND To evaluate the efficacy and safety of Danggui Buxue Decoction for renal anemia when combined with western medicine treatment of anemia. METHODS Electronic searching Medline, Embase, Web of Science, Cochrane Library, Chinese BioMedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), WanFang data, Chinese Sci-tech periodical full-text database (VIP). Randomized controlled trials reported results of efficacy and safety of Danggui Buxue Decoction in combination with western medicine treatment of anemia for renal anemia. The "risk of bias assessment tool (Version 5.1.0)" of Cochrane Handbook was applied to assess the quality of included trials and RevMan 5.3 software was used for data analysis. RESULTS A total of 111 studies was retrieved, seven studies including 460 cases were included, the methodological quality of included trials was poor. The result of meta-analysis demonstrated that there was no difference in hemoglobin (Hb) [weighted mean differences (WMD) =-8.75, 95% confidence interval (CI): (-18.64, 1.13), P=0.08], whereas the subgroup analysis showed the difference was significant when the ratio of Radix Astragali to Radix Angelicae Sinensis was 5:1 [WMD =-16.27, 95% CI: (-28.73, -3.80), P=0.01], increase of Hb was more effective in experimental group than control group and the difference was not significant when the ratio of Radix Astragali to Radix Angelicae Sinensis was 5 not equal1 [WMD =-0.57, 95% CI: (-4.52, 3.39), P=0.78]. There were significant differences in red blood cell (RBC) [WMD =-0.49, 95% CI: (-0.69, -0.28), P<0.00001], hematocrit (HCT) [WMD =-1.92, 95% CI: (-3.15, -0.69), P=0.002] and clinical efficacy [odd ratio (OR) =0.30, 95% CI: (0.13, 0.69), P=0.004] between Danggui Buxue Decoction combination group and control group, the experimental group was better than control group. There was no adverse event reported in the experimental group. CONCLUSIONS Danggui Buxue Decoction in combination with conventional western medicine (CWM) for renal anemia might be superior to CWM alone and there was no adverse event in the experimental group, it might be more effective when the ratio of Radix Astragali to Radix Angelicae Sinensis was 5:1. However, the quality of included studies was not high, and less attention was paid to the safety, high quality randomized controlled trials are needed to further confirm the findings.
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9.
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.
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10.
Efficacy and safety of iron supplementation for the elderly patients undergoing hip or knee surgery: a meta-analysis of randomized controlled trials
Yang Y, Li H, Li B, Wang Y, Jiang S, Jiang L
Journal of Surgical Research. 2011;171((2):):e201-7.
Abstract
BACKGROUND Anemia is a frequent co-morbidity in the elderly patients undergoing hip or knee surgery and is often associated with poor clinical outcomes. Mild to moderate anemia is often treated with intravenous or oral iron supplementation. However, the efficacy and safety of iron supplementation in treating anemia for the elderly patients undergoing hip or knee surgery remains controversial. METHODS Only prospective, randomized studies that compared iron supplementation with no iron supplementation in the elderly patients undergoing hip or knee surgery were included. Six studies met the inclusion criteria: the target population consisted of patients undergoing hip or knee surgery treated with iron supplementation; the study was a published randomized trial. Each outcome measure tested was assessed for heterogeneity. If significant heterogeneity was present for more than 75%, data from the studies were not combined. If there was no significant heterogeneity (less than 40%), a weighted mean difference (WMD) or combined relative risk was calculated using a fixed effects model, while a random effects model was applied when heterogeneity was within 40% to 75%. RESULTS Our meta-analysis demonstrated the increase of hemoglobin level in patients undergoing hip or knee surgery with iron supplementation. However, no significant difference on the length of hospital stay, morbidity, 1-mo mortality, the infection rate, the rate and volume of allogeneic blood transfusions, and the adverse drug effects was found between the patients with iron treatment and those without. CONCLUSION Our meta-analysis suggested that iron supplementation was safe and effective in treating anemia for the elderly patients undergoing hip or knee surgery. Copyright Copyright 2011 Elsevier Inc. All rights reserved.