The efficacy and safety of tranexamic acid in lumbar surgery: A meta-analysis of randomized-controlled trials
Joint diseases and related surgery. 2022;33(1):57-85
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.
Patients undergoing lumbar surgery (49 studies, n= 4,822).
Tranexamic acid (TXA), (n= 2,653).
Normal saline (n= 2,169).
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.
Effectiveness of shengxuexiaoban capsules combined with glucocorticoid therapy for immune thrombocytopenia: A meta-analysis
PloS one. 2022;17(9):e0275122
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.
Can intraoperative suturing reduce the incidence of posttonsillectomy hemorrhage? A systematic review and meta-analysis
Laryngoscope investigative otolaryngology. 2022;7(4):1206-1216
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.
Measurement of postpartum blood loss using a new two-set liquid collection bag for vaginal delivery: A prospective, randomized, case control study
BACKGROUND Postpartum hemorrhage (PPH) is a major obstetric complication, and the real-time measurement of blood loss is important in the management and treatment of PPH. We designed a new two-set liquid collection bag (TSLCB) for measuring postpartum blood loss in vaginal delivery. The aim of this study was to evaluate the effectiveness of the TSLCB in separating the blood from the amniotic fluid during vaginal delivery and in determining the accuracy of the measured postpartum blood loss. METHODS A prospective, randomized, case control study was conducted in the Women's Hospital, Zhejiang University School of Medicine, from March 2018 to April 2018. Sixty single pregnant women with spontaneous labor at 37-41 weeks without maternal complications were randomly divided into the experimental and control groups. The TSLCB was used to evaluate separately the amount of blood and amniotic fluid. For the control group, visual estimation and traditional plastic blood-collecting consumables were used to estimate the amount of postpartum blood loss. The measured blood loss between the two groups was compared, and the association of the measured blood loss with various clinical lab indices and vital signs was investigated. RESULTS The TSLCB (the experimental group) improved the detection of the measured blood loss compared with visual estimation and the traditional method (the control group) (P < .05). In the experimental group, correlation analysis showed that the measured blood loss at delivery and within 24 h of delivery was significantly associated with the decreased hemoglobin level, red blood cell count, and hematocrit level of patients (r = -0.574, -0.455, -0.437; r = 0.-595, -0.368, -0.374; P < .05). In the control group, only the measured blood loss within 24 h of delivery was associated with the decreased hemoglobin level (r = -0.395, P < .05). No blood transfusion and plasma expanders were required in the treatment of PPH for both groups. CONCLUSIONS The TSLCB can be used to accurately measure the postpartum blood loss in vaginal delivery by medical personnel.
Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage
CNS drugs. 2021
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).
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
Annals of surgical treatment and research. 2021;100(4):193-199
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.
The pharmacodynamic effect of terlipressin versus high-dose octreotide in reducing hepatic venous pressure gradient: a randomized controlled trial
Annals of translational medicine. 2021;9(9):793
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).
Outcomes of platelet-rich plasma for plantar fasciopathy: a best-evidence synthesis
Journal of orthopaedic surgery and research. 2020;15(1):432
BACKGROUND Plantar fasciopathy (PF) is a very common disease, affecting about 1/10 people in their lifetime. Platelet-rich plasma (PRP) had been demonstrated to be useful in achieving helpful effects for plantar fasciopathy. The purpose of this study was to compare the pain and functional outcomes between PRP and corticosteroid (CS) or placebo for plantar fasciopathy through meta-analysis and provide the best evidence. METHODS Literature was searched systematically to explore related studies that were published in Cochrane Library, PubMed, Embase, Medline, SpringerLink, OVID, and ClinicalTrials.gov . Articles regarding comparative research about the outcomes of PRP therapy and CS or placebo injection were selected. Data of pain and functional outcomes was extracted and imported into Reviewer Manager 5.3 to analyze. RESULTS Thirteen RCTs were included and analyzed. Analysis results showed significant superiority of PRP in outcome scores when compared with CS (VAS: MD = - 0.85, P < 0.0001, I(2) = 85%; AOFAS MD = 10.05, P < 0.0001, I(2) = 85%), whereas there is no statistical difference in well-designed double-blind trials (VAS: MD = 0.15, P = 0.72, I(2) = 1%; AOFAS MD = 2.71, P = 0.17, I(2) = 0%). In the comparison of the PRP and the placebo, the pooled mean difference was - 3.76 (P < 0.0001, 95% CI = - 4.34 to - 3.18). CONCLUSIONS No superiority of PRP had been found in well-designed double-blind studies, whereas it is implied that the outcomes of PRP are better than placebo based on available evidence.
Convalescent plasma in the treatment of severe covid-19: A systematic review and meta-analysis
Iranian Journal of Public Health. 2020;49(11):2022-2031
Background: COVID-19 is a public health emergency of international concern Its incidence rates and mortality are very high;however, so far, an effective drug treatment remains unknown Based on the role of convalescent plasma therapy in previously identified viral pneumonias, patients with severe COVID-19 have been given this therapy This systematic review and meta-analysis aimed to summarize the clinical evidence regarding the efficacy and safety of convalescent plasma therapy in the treatment of severe COVID-19 Methods: PubMed, Embase, Ovid, China Knowledge Network, China Biomedical, VIP Chinese Sci-tech Journal, Wanfang Database, and the International Clinical Trials Registry Platform were searched up to 21 June 2020, to identify clinical studies and registered trials on the use of convalescent plasma in the treatment of critically ill patients with COVID-19 Stata 13 0 was used to perform Meta-analysis All records were screened as per the protocol eligibility criteria Results: Nineteen clinical reports regarding convalescent plasma in the treatment of severe COVID-19 were included Through systematic analysis, convalescent plasma was found to yield some efficacy on severe COVID-19 and had almost no obvious adverse reactions Conclusion: Convalescent plasma therapy seems to yield some efficacy among patients with severe COVID-19 and almost no obvious adverse reactions were found However, at present, the clinical evidence is insufficient, and there is an urgent need for support from high-quality clinical trial data © 2020, Iranian Journal of Public Health All rights reserved
Terlipressin Versus Norepinephrine for Septic Shock: A Systematic Review and Meta-Analysis
Frontiers in pharmacology. 2019;10:1492
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.