Comparative efficacy of 19 drug therapies for patients with idiopathic thrombocytopenic purpura: a multiple-treatments network meta-analysis
Zhou H, Fan J, He J, Hu S
Annals of hematology. 2022
Immune thrombocytopenia (ITP) is the most common clinical bleeding disorder with a high mortality rate and poor long-term survival quality in severe patients. There is controversy on how to choose the appropriate treatment. We systematically reviewed 19 randomized controlled trials (including 2615 participants) from January 1, 2015, to April 20, 2021. These investigations compared multiple drugs or their combinations in the therapeutic dose range for the treatment of ITP. The primary endpoint was based on the proportion of patients who responded to these therapies. The efficacy of eltrombopag plus rituximab, avatrombopag, dexamethasone plus anti-HP, and dexamethasone plus rhTPO was significantly higher than placebo (OR: 46.66, 29.44, 2.66, 1.86) or dexamethasone alone (OR: 46.22, 29.01, 2.22, 1.40). Placebo, oral immunosuppressants, and dexamethasone plus oseltamivir were less effective than the other ITP therapies tested. Eltrombopag plus rituximab may be the best choice when starting treatment for ITP.
People with idiopathic thrombocytopenia purpura (ITP) enrolled in clinical trials, and identified by systematic review (n= 2,615, 19 RCTs).
Interventions for ITP: romiplostim, eltrombopag, rituximab, prednisolone, IVIG, efgartimod, dexamethasone or avatrombopag.
Placebo, dexamethasone, danazol or other drug interventions.
The efficacy of eltrombopag plus rituximab, avatrombopag, dexamethasone plus anti-HP, and dexamethasone plus rhTPO was significantly higher than placebo (odds ratio [OR]: 46.66, 29.44, 2.66, 1.86) or dexamethasone alone (OR: 46.22, 29.01, 2.22, 1.40). Placebo, oral immunosuppressants, and dexamethasone plus oseltamivir were less effective than the other ITP therapies tested.
Effectiveness of "Stop the Bleed" Courses: A Systematic Review and Meta-analysis
Tang X, Nie Y, Wu S, DiNenna MA, He J
Journal of surgical education. 2022
OBJECTIVE Our object was to comprehensively analyze the existing body of evidence to evaluate the Stop the Bleed (STB) course effectiveness and satisfaction and find the direction of improvement for the future. STUDY DESIGN A literature search with the term "Stop the Bleed" in the electronic databases PubMed, Web of Science, EMBASE, Cochrane Library was performed, retrieving records from January 1, 2013 to April 13, 2022 based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. In addition, all selected papers' references were examined for qualified studies that were missed during the first search. Original publications were included that reported on (1) clinical studies of the STB course implementation; and (2) studies comparing students' hemostasis ability and attitude (comfort, confidence, and willingness) before and after the STB course. The literature search and data extraction were done independently by 2 writers. To establish consensus, disagreements will be handled with the help of a third reviewer. For data synthesis, the most inclusive data from studies with repeated data were abstracted. Changes in hemostasis questionnaire scoring and operation evaluation after the STB course were the main outcomes. RESULTS This systematic review and meta-analysis includes 36 trials with a total of 11,561 trainees. Thirty-one of them were undertaken in the USA, while the other 5, accounting for 13.9%, were conducted in other regions. Among various evaluation methods, 3 trials with 927 trainees indicated that scores of correct uses of tourniquet significantly increased after the STB course (mean difference of post versus pre groups, 44.28; 95% CI 41.24-47.32; p < 0.001). Significant difference was also observed in the willingness to apply a hemostatic dressing in a real-world situation (risk ratio for post versus pre groups, 1.28; 95% CI 1.08-1.52; p = 0.004) (7 studies and 2360 participants). The results indicate that hemostasis knowledge and skills after the STB course had improved, but statistics indicated that STB courses implemented in the USA were more effective than other regions. CONCLUSIONS AND RELEVANCE Meta-analysis showed that comparison before and after the STB course were significantly different. However, the outcome measures in each study were different and could not, therefore, be compiled in all cases. The effectiveness and worth of implementation of STB in different countries should be continuously evaluated in the future.
Efficacy and safety of nafamostat mesilate anticoagulation in blood purification treatment of critically ill patients: a systematic review and meta-analysis
Lin Y, Shao Y, Liu Y, Yang R, Liao S, Yang S, Xu M, He J
Renal failure. 2022;44(1):1263-1279
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.
[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
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.
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
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.
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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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).
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
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.
Effect of early restrictive fluid resuscitation on inflammatory and immune factors in patients with severe pelvic fracture
Jiang LM, He J, Xi XY, Huang CM
Chinese journal of traumatology = Zhonghua chuang shang za zhi. 2019
PURPOSE To study the effect of early restrictive fluid resuscitation (EFR) on inflammatory and immune factors in patients with severe pelvic fracture (SPF). METHODS A total of 174 SPF patients in the Department of Orthopaedics, the First Affiliated Hospital of Chengdu Medical College from July 2015 to June 2018 were involved in this study and divided into EFR group (n = 87) and control group (n = 87) using the random number table method. Conventional fluid resuscitation (CFR) was performed in control group, and EFR was performed in EFR group. The incidences of acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS) during rescue, successful rescue rate, blood transfusion volume, fluid input, and resuscitation time were compared between the two groups. The parameters including prothrombin time (PT), hematocrit (HCT), platelet (PLT) and blood lactate (BL) at the 4th hour after fluid resuscitation were recorded. The levels of inflammatory factors (TNF-alpha, IL-6, CRP) and immune factors (CD3(+), CD4(+), CD8(+), CD4+/CD8+) were compared between the two groups before treatment and 7 days after treatment. The revised acute physiologic and chronic health evaluation system and the sequential organ failure assessment scores were adopted for evaluation before treatment and 7 days after treatment. RESULTS The incidences of ARDS and MODS during rescue in EFR group were significantly lower than those in control group, and the successful rescue rate in EFR group was significantly higher than that in control group (p = 0.015, 0.010). The blood transfusion volume, fluid input, resuscitation time in EFR group were significantly lower than those in control group (p = 0.016, 0.002, 0.001). At the 4th hour after fluid resuscitation, PT and BL in EFR group were significantly lower than those in control group, while HCT and PLT in EFR group were significantly higher than those in control group (p = 0.021, 0.003, 0.016, 0.021). On day 7 after treatment, TNF-alpha, IL-6, CRP and CD8(+) in EFR group were significantly lower than those in control group (p = 0.003, 0.004, 0.007, 0.007), while CD3(+), CD4(+) and CD4+/CD8+ in EFR group were significantly higher than those in control group (p = 0.004, 0.000, 0.003). On day 7 after treatment, the revised acute physiologic and chronic health evaluation (APACHE) system and the sequential organ failure assessment (SOFA) scores in EFR group were significantly lower than those in control group (p = 0.000, 0.001). CONCLUSION EFR can effectively eliminate inflammatory factors, improve immune function, maintain the stability of blood components, reduce the incidences of ARDS and MODS, and elevate the successful rescue rate in patients with SPF.
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.
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.
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
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.