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[A multicenter, double-blind, randomized controlled clinical trial comparing ergometrine with oxytocin and oxytocin alone for prevention of postpartum hemorrhage at cesarean section]
He GL, Pan TY, Liu XX, He SY, Zhang L, Feng WS, Zhang J, He J, Xin W, Zhou YL, et al
Zhonghua fu chan ke za zhi. 2022;57(11):836-842
Abstract
Objective: To compare oxytocin combined with ergometrine with oxytocin alone in terms of primary prophylaxis for postpartum hemorrhage (PPH) at the time of cesarean section (CS). Methods: This was a multicenter double-blind randomized controlled interventional study comparing ergometrine combined with oxytocin and oxytocin alone administered at CS. From December 2018 to November 2019, a total of 298 parturients were enrolled in 16 hospitals nationwide. They were randomly divided into experimental group (ergometrine intra-myometrial injection following oxytocin intravenously; 148 cases) and control group (oxytocin intra-myometrial injection following oxytocin intravenously; 150 cases) according to 1∶1 random allocation. The following indexes were compared between the two groups: (1) main index: blood loss 2 hours (h) after delivery; (2) secondary indicators: postpartum blood loss at 6 h and 24 h, placental retention time, incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution; (3) safety indicators: nausea, vomiting, dizziness and other adverse reactions, and blood pressure at each time point of administration. Results: (1) The blood loss at 2 h after delivery in the experimental group [(402±18) ml] was less than that in the control group [(505±18) ml], and the difference was statistically significant (P<0.05). (2) The blood loss at 6 h and 24 h after delivery in the experimental group were less than those in the control group, and the differences were statistically significant (all P<0.05). There were no significant differences between the two groups in the incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution (all P>0.05). (3) Adverse reactions occurred in 2 cases (1.4%, 2/148) in the experimental group and 1 case (0.7%, 1/150) in the control group. There was no significant difference between the two groups (P>0.05). The systolic blood pressure within 2.0 h and diastolic blood pressure within 1.5 h of drug administration in the experimental group were higher than those in the control group, and the differences were statistically significant (P<0.05), but the blood pressure of the two groups were in the normal range. Conclusion: The use of ergometrine injection in CS could reduce the amount of PPH, which is safe and feasible.
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Supplementation with Iron in Pulmonary Arterial Hypertension: Two Randomized Crossover Trials
Howard Lsge, He J, Watson GMJ, Huang L, Wharton J, Luo Q, Kiely DG, Condliffe R, Pepke-Zaba J, Morrell NW, et al
Annals of the American Thoracic Society. 2021
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Abstract
RATIONALE Iron deficiency, in the absence of anaemia, is common in patients with idiopathic and heritable pulmonary arterial hypertension (PAH) and is associated with a worse clinical outcome. Oral iron absorption may be impeded by elevated circulating hepcidin levels. The safety and benefit of parenteral iron replacement in this patient population is unclear. OBJECTIVES To evaluate the safety and efficacy of parenteral iron replacement in pulmonary arterial hypertension. METHODS In two randomised, double blind, placebo-controlled 12 week crossover studies, 39 patients in Europe received a single infusion of ferric carboxymaltose (Ferinject®) 1000 mg (or 15 mg/kg if weight < 66.7Kg) or saline as placebo and 17 patients in China received iron dextran (Cosmofer®) 20 mg iron/kg body weight or saline placebo. All patients had idiopathic or heritable PAH and iron deficiency at entry as defined by: a serum ferritin < 37 µg/l or iron < 10.3 µmol/l or transferrin saturations < 16.4%. RESULTS Both iron treatments were well tolerated and improved iron status. Analysed separately and combined, there was no effect on any measure of exercise capacity (using cardiopulmonary exercise testing or 6 minute walk test) or cardio-pulmonary haemodynamics, as assessed by right heart catheterisation, cardiac magnetic resonance or plasma NT-proBNP, at 12 weeks. CONCLUSION Iron repletion by administration of a slow release iron preparation as a single infusion to PAH patients with iron deficiency without overt anaemia was well tolerated but provided no significant clinical benefit at 12 weeks. Clinical trial registered with ClinicalTrials.gov (NCT01447628).
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Hypertension management in elderly with severe intracerebral hemorrhage
Zhao J, Yuan F, Fu F, Liu Y, Xue C, Wang K, Yuan X, Li D, Liu Q, Zhang W, et al
Annals of clinical and translational neurology. 2021;8(10):2059–2069
Abstract
OBJECTIVE To explore the effect of individualized blood pressure (BP)-lowering treatment on the outcomes of elderly patients with severe intracerebral hemorrhage (ICH). METHODS We performed an exploratory analysis of Controlling Hypertension After Severe Cerebrovascular Event (CHASE) trial, which was a multicenter, randomized, controlled clinical trial. Patients with severe ischemic or hemorrhagic stroke (defined as GCS ≤ 12 or NIHSS ≥ 11) were randomized into individualized versus standard BP-lowering treatment in CHASE trial. In this exploratory analysis, patients with severe ICH were included. The primary outcome was the percentage of patients with 90-day functional independence defined as modified Rankin Scale (mRS) ≤2. RESULTS We included 242 patients with severe ICH in the present analysis, consisting of 142 patients aged <65 years and 100 patients aged ≥65 years. There were significant differences between patients aged ≥65 years and <65 years in the proportion of functional independence (47.9% vs. 15.0%, P < 0.001) and good outcome (73.9% vs. 50.0%, P < 0.001) at day 90. In patients aged ≥65 years, the adjusted individualized BP-lowering treatment had an unequivocal effect on the functional independence at day 90 (21.6% vs. 8.2%, odds ratio [OR]: 4.309, 95% confidence interval [CI]: 1.040-17.859, P = 0.044) and improved the neurological deficits at discharge (∆ NIHSS ≥ 4: 64.7% vs. 34.7%, OR: 4.300, 95% CI: 1.599-11.563, P = 0.004). INTERPRETATION Compared with the younger counterparts, the elderly patients (≥65 years) with acute severe ICH might benefit more from individualized BP-lowering treatment.
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Treatment of maternal anemia by using oral iron drugs combined with diet therapy
Wenting J, Junjuan C, Pingli L, Baoe J, He J, Xiuqin Z
Pakistan journal of pharmaceutical sciences. 2020;33(5(Special)):2417-2422
Abstract
Iron deficiency anemia is a common nutritional deficiency disease in women during pregnancy, mainly due to the increased iron requirements of pregnant women and fetuses, resulting in a lack of iron elements necessary for the production of red blood cells, resulting in a decrease in the number of red blood cells and the symptoms of anemia; Causes chronic fetal hypoxia and affects the normal development of some important organs of the fetus. This article explores the clinical value of oral iron drugs combined with diet therapy for maternal anemia. Observed the changes of hemoglobin (Hb), red blood cell count (RBC), average hemoglobin concentration (McHc), serum iron (SI), transferrin saturation (TS) and other indicators of pregnant women before and after treatment and the differences in pregnancy outcomes. Compared with before treatment, the maternal Hb, RBC, McHc, SI, TS and other indicators increased to a certain extent after treatment. Among them, the increase of each indicator in the experimental group is significantly larger than that in the control group. Differences between groups are considered to be meaningful after statistical analysis. (P<0.05). Oral iron drugs combined with diet therapy can effectively improve the symptoms of anemia and have a positive impact on pregnancy outcomes.
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A systematic review of tranexamic acid usage in patients undergoing femoral fracture surgery
Zhang P, Bai J, He J, Liang Y, Chen P, Wang J
Clinical Interventions in Aging. 2018;13:1579-1591.
Abstract
Background: Patients undergoing femoral fracture surgery frequently require blood transfusion. Tranexamic acid (TXA) has been widely used to decrease transfusion rate in joint replacement surgery. Therefore, we conducted a systematic review to evaluate the efficacy and safety of TXA usage in femoral fracture surgery. Materials and methods: Studies involving TXA usage in femoral fracture surgery were searched through four electronic databases. The end points included total blood loss, postoperative hemoglobin decline, transfusion rate, thromboembolic events, 90-day mortality, and operative time. The present study was performed following Cochrane Reviewers' Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and was carried out by using Stata 14.0 software. Results: Eleven studies concerning intravenous (IV) application of TXA and three studies concerning topical administration of TXA were included. Twelve studies were randomized controlled trials (RCTs), and one was a retrospective cohort study. Regarding IV TXA, our paper indicated that the IV TXA group had less total blood loss (weighted mean difference [WMD] = -319.282, P = 0.000), lower postoperative hemoglobin decline (WMD = -1.14, P = 0.000) and lower transfusion rate (risk difference [RD] = -0.172, P = 0.000). No significant differences were found in thromboembolic events (RD = 0.008, P = 0.507), 90-day mortality (RD = 0.009, P = 0.732) and operative time (WMD = -2.227, P = 0.103). Regarding topical TXA, no significant differences were found in the transfusion rate (RD = -0.098, P = 0.129), postoperative hemoglobin decline (WMD = -1.137, P = 0.231), thromboembolic events (RD = -0.017, P = 0.660) and operative time (WMD = -4.842, P = 0.136). Conclusion: Our meta-analysis demonstrated that both IV and topical application of TXA reduced transfusion rate in femoral fracture surgery. However, still further studies are needed to identify the optimal route of administration, TXA dosage and timing. In addition, high-quality RCTs with a large sample size are required to figure out the safety of TXA application, especially in the elderly, before its wide recommendation.
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The efficacy of tranexamic acid in reducing blood loss in total shoulder arthroplasty: a meta-analysis
He J, Wang XE, Yuan GH, Zhang LH
Medicine. 2017;96((37)):e7880.
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Abstract
BACKGROUND The purpose of this meta-analysis is to compare the efficacy of tranexamic acid (TXA) versus placebo after a total shoulder arthroplasty (TSA). METHODS In April 2017, a systematic computer-based search was conducted in the databases of PubMed, Embase, Web of Science, Cochrane Library, and Google. Studies comparing TXA versus placebo in reducing blood loss after TSA were included. The endpoints were the need for transfusion, blood loss in drainage, hemoglobin drop, and total blood loss. Stata 12.0 software was used for the meta-analysis. RESULTS Six studies involving a total of 637 patients met the inclusion criteria. The meta-analysis revealed that, compared with control groups, treatment with TXA could decrease the need for transfusion (P < .00001), blood loss in drainage (P = .000), hemoglobin drop (P = .001), and total blood loss (P = .000). CONCLUSION TXA can decrease the need for transfusion as well as total blood loss in TSA patients. There was a negative correlation between the TXA dose and the need for transfusion and blood loss in drainage. Because the administration route and the dose of TXA were different, more studies are needed in order to identify the optimal dose and route.
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Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis
Zhang P, Liang Y, Chen P, Fang Y, He J, Wang J
Bmc Musculoskeletal Disorders. 2017;18((1)):90.
Abstract
BACKGROUND The use of intravenous (IV) or topical tranexamic acid (TXA) in total hip arthroplasty has been proven to be effective and safe in total hip arthroplasty. However, which of these two administration routes is better has not been determined. The combined administration of TXA has been used in total knee arthroplasty with satisfactory results. We hypothesized that combined application of TXA may be the most effective way without increased rate of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolisms (PE) in patients subjected to primary total hip replacement (THA). A meta-analysis was conducted to compare the efficacy and safety of the combined use of tranexamic acid (TXA) relative to topical or intravenous (IV) use alone for treatment of primary THA. The outcomes included total blood loss, postoperative hemoglobin decline, transfusion rates, and the incidence rates of deep vein thrombosis (DVT) and pulmonary embolisms (PE). METHODS We searched electronic databases including PubMed, EMBASE, the Cochrane Library, Web of Science, the Chinese Biomedical Literature database, the CNKI database, and Wanfang Data until September 2016. The references of the included articles were also checked for additional potentially relevant studies. There were no language restrictions for the search. The data of the included studies were analyzed using RevMan 5.3 software. RESULTS Seven studies met the inclusion criteria, encompassing a total of 1762 patients. Our meta-analysis demonstrated that total blood loss, postoperative hemoglobin decline, and transfusion rates were significantly lower for patients that received the combined treatment compared to patients that received either topical or intravenous administration of TXA. No statistical differences were found in the incidence of deep venous thrombosis (DVT) or pulmonary embolism (PE). CONCLUSION The group that received the combined treatment had lower total blood loss, postoperative hemoglobin decline, and transfusion rates without an increased rate of thrombotic events (DVT or PE). The topical or intravenous use of TXA in primary THA is generally considered to be safe and effective. This meta-analysis demonstrated that combined TXA application may be superior to topical or intravenous application of TXA alone. However, larger, high-quality randomized control trials are required for greater confidence in this finding.
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Timing of tourniquet release in total knee arthroplasty: a meta-analysis
Zhang P, Liang Y, He J, Fang Y, Chen P, Wang J
Medicine. 2017;96((17)):e6786.
Abstract
BACKGROUND For total knee arthroplasty (TKA), the tourniquet is routinely employed for better visualization, less blood loss, and easier cementation. However, the time to release tourniquet remains controversial. Therefore, we performed current meta-analysis to assess whether releasing tourniquet before wound closure is more effective in reducing blood loss than releasing tourniquet after wound closure in TKA without an increased risk of complications. METHODS To conduct this meta-analysis, we searched Medline, Embase, Web of science, and the Cochrane library up to November 2016, for randomized controlled trials comparing tourniquet releasing before and after wound closure in TKA. A meta-analysis was performed following the guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. Methodological quality of the trials was assessed using the Cochrane risk assessment scale. The data of the included studies were analyzed using Stata 12.0. RESULTS Sixteen trials involving 1010 patients were identified in current meta-analysis. Our meta-analysis demonstrated that there were no significant differences in the 2 groups in terms of calculated blood loss (weighted mean difference [WMD] = 160.65, 95% confidence interval [CI]: -0.2 to 321.49, P = .05), postoperative blood loss (WMD = -45.41, 95% CI: -120.11 to 29.29, P = .233),postoperative hemoglobin decline (WMD = 0.16, 95% CI: -2.5 to 2.82, P = .905), transfusion volume (WMD = 79.19, 95% CI: -5.05 to 163.44, P = .065),transfusion rates (relative risk [RR] = 1.19, 95% CI: 0.95-1.50, P = .134), major complications (RR = 0.51, 95% CI: 0.15-1.73, P = .278), and deep vein thrombosis (RR = 0.44, 95% CI: 0.14-1.37, P = .157).Compared with the group of releasing tourniquet after wound closure, the group of releasing tourniquet before wound closure had a higher volume of total blood loss (WMD = 130.96, 95% CI: 58.83-203.09, P = .000) and a longer operation time (WMD = 6.56, 95% CI: 3.12-10.01, P = .000). However, releasing tourniquet before wound closure could reduce minor complications (RR = 0.53, 95% CI: 0.34-0.82, P = .004). CONCLUSIONS On the basis of current meta-analysis, the method of releasing tourniquet before wound closure could increase total blood loss and operation time; nevertheless, the risk of complications decreased. Thus, if patients are in severe anemia condition, the tourniquet perhaps should be released after wound closure to decrease blood loss. In contrary, releasing tourniquet before wound closure to decrease the risk of complications would be a better choice.
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Efficacy and safety of intravenous tranexamic acid administration in patients undergoing hip fracture surgery for hemostasis: a meta-analysis
Zhang P, He J, Fang Y, Chen P, Liang Y, Wang J
Medicine. 2017;96((21)):e6940.
Abstract
BACKGROUND Patients undergoing hip fracture surgery frequently require blood transfusion. Tranexamic acid (TXA) has been widely used to decrease blood loss and transfusion rates in joint replacement surgery. Therefore, we conducted a meta-analysis to evaluate efficacy and safety of intravenous TXA administration in patients suffering from hip fractures. METHODS Electronic databases were searched before December 2016 by 2 independent reviewers, including Cochrane Library, EMBASE, PubMed, Web of Science, the Chinese Biomedical Literature database, and the China National Knowledge Infrastructure databases. Randomized controlled trials (RCTs) involving the efficacy and safety of intravenous (IV) TXA in patients who underwent hip surgery were included in our meta-analysis. The endpoints included total blood loss, hidden blood loss, postoperative hemoglobin decline, transfusion rates, the rate of thrombotic events, and operative time. Current meta-analysis was performed following the guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The pooling of data was carried out using STATA V.12.0 software. RESULT Eight RCTs were included, involving 598 participants. Current meta-analysis indicated that the IV TXA group had less total blood loss (weighted mean difference [WMD] = -277, 95%CI: -335 to -220, P = .000), less hidden blood loss (WMD = -246, 95%CI: -252 to -241, P = .000), lower postoperative hemoglobin decline (WMD = -1.36, 95% CI: -1.84 to -0.88, P = .000), and lower transfusion rates (risk difference [RD] = -0.19, 95% CI: -0.27 to -0.11, P = .000) compared to the control group. No significant differences were found regarding the rate of thrombotic events (RD = 0.02, 95% CI: = -0.01 to 0.05, P = .262) and operative time (WMD = -0.7, 95% CI: -3.3 to 1.9, P = .6). CONCLUSION It was well established that systemic administration of TXA could reduce blood loss and transfusion rates in hip fracture surgery. But the optimal regimen, dosage, and timing still need a further research. In addition, more large and high-quality randomized controlled studies are needed to focus on the safety of IV TXA application before its wide recommendation for use in hip fracture surgery.
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Intravenous versus topical tranexamic acid in primary total hip replacement: a meta-analysis
Zhang P, Liang Y, Chen P, Fang Y, He J, Wang J
Medicine. 2016;95((50)):e5573.
Abstract
BACKGROUND As the prevalence of total hip arthroplasty (THA) is increasing, it is usually associated with considerable blood loss. Tranexamic acid (TXA) has been reported to reduce perioperative blood loss in hip joint arthroplasty. But the best route of TXA administration continues to be controversial. So, we conducted a meta-analysis that integrated all data from the 7 included trials to compare the effectiveness and safety of topical and intravenous TXA administration in primary THA. The endpoints assessed in this meta-analysis include the comparisons of total blood loss, postoperative hemoglobin decline, transfusion rates, the incidence rate of deep vein thrombosis (DVT), pulmonary embolisms (PE), and wound infection. METHODS Literature searches of PubMed, EMBASE, the Cochrane Library, the Chinese Biomedical Literature database, the CNKI database, and Wan Fang Data were performed up to August 30, 2016. Randomized controlled trials (RCTs) were included in our meta-analysis if they compared the efficiency and safety of intravenous versus topical administration of TXA in patients who underwent primary THA. The endpoints included the comparisons of total blood loss, postoperative hemoglobin decline, transfusion rates, the incidence rate of DVT, PE, and wound infection. A meta-analysis was performed following the guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The pooling of data was carried out by using RevMan 5.3, Denmark. RESULTS Seven RCTs involving 964 patients met the inclusion criteria. Our meta-analysis indicated that there were no significant differences in the 2 groups in terms of total blood loss ([mean difference (MD) = -14.74, 95% confidence interval (CI): -89.21 to 59.74, P = 0.7], transfusion rates [RD = -0.02, 95% CI: -0.05 to 0.02, P = 0.39]; no significant differences were found regarding the incidence of adverse effects such as deep venous thrombosis [DVT] [RD = 0.00, 95% CI: -0.01 to 0.01, P = 1.00], PE [RD = 0.00, 95% CI: -0.01 to 0.01, P = 0.71], or wound infection [RD = -0.01, 95% CI: -0.06 to 0.04, P = 0.66]). The pooled results showed that the intravenous groups had a lower postoperative hemoglobin decline (MD = -0.47, 95% CI: -0.74 to -0.20, P = 0.0006). It was probably due to insufficient data and the varied reporting of outcomes. There was some inherent heterogeneity due to the small sample size of each primary study. CONCLUSION The topical and intravenous administrations of TXA have a similar effect on the decrease of blood loss without an increased risk of complications (DVT, PE, and wound infection). Intravenous TXA administration may have a maximum efficacy. Topical TXA administration may be preferred in patients who with high risk of thromboembolic events. However, larger, high-quality RCTs are required to explore the optimal regimen, dosage, timing still in the future in order to recommend TXA widespread use in total joint arthroplasty.