Comparative efficacy of platelet-rich plasma applied in myringoplasty: A systematic review and meta-analysis
PloS one. 2021;16(1):e0245968
BACKGROUND Tympanic membrane (TM) perforation is quite common in the clinical setting. Chronic TM perforations require surgical treatments such as myringoplasty. Currently, platelet-rich plasma (PRP) is a novel, effective substance that is increasingly utilized for TM perforation repair. This study aims to evaluate the effectiveness of PRP in the application of TM perforation repair. METHODS A systematic search was conducted to screen the Medline, Embase, Cochrane, Scopus and Web of Science databases up to July 2020. Studies were identified in accordance with the selection criteria by two coauthors independently. Data regarding the healing and hearing outcomes were pooled and analyzed via Review Manager version 5.3 and STATA version 12.0 software. Odds ratio (OR) was utilized to compare the closure rate. Furthermore, the results of hearing improvements and incidence of complications were also compared to evaluate the effectiveness of PRP. RESULTS A total of eight studies with 455 participants were eligible according to the selection criteria. Compared to conventional surgery, the OR of closure was 2.70 (95% CI: 1.27 to 5.76, P = 0.01, I2 = 0%) in randomized controlled trial (RCT) subgroup and 6.18 (95% CI: 2.22 to 17.25, P = 0.0005, I2 = 0) in non-RCT subgroup. The overall OR of closure was 3.69 (95% CI: 2.02 to 6.74, P<0.0001, I2 = 0%), suggesting a significant effect on the healing of TM perforation. Between preoperative and postoperative hearing results, there is no statistical difference between the PRP and the control groups. Additionally, the use of PRP resulted in a lower incidence of complication than the use of conventional approaches. CONCLUSION The application of PRP during the TM surgeries can enhance the closure rate, provide similar hearing improvements and decrease the incidence of postoperative complications. Given these advantages, PRP can be considered an effective treatment for TM regeneration.
A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia
Journal of hematology & oncology. 2021;14(1):37
BACKGROUND Hetrombopag, a novel thrombopoietin receptor agonist, has been found in phase I studies to increase platelet counts and reduce bleeding risks in adults with immune thrombocytopenia (ITP). This phase III study aimed to evaluate the efficacy and safety of hetrombopag in ITP patients. METHODS Patients who had not responded to or had relapsed after previous treatment were treated with an initial dosage of once-daily 2.5 or 5 mg hetrombopag (defined as the HETROM-2.5 or HETROM-5 group) or with matching placebo in a randomized, double-blind, 10-week treatment period. Patients who received placebo and completed 10 weeks of treatment switched to receive eltrombopag, and patients treated with hetrombopag in the double-blind period continued hetrombopag during the following open-label 14-week treatment. The primary endpoint was the proportion of responders (defined as those achieving a platelet count of ≥ 50 × 10(9)/L) after 8 weeks of treatment. RESULTS The primary endpoint was achieved by significantly more patients in the HETROM-2.5 (58.9%; odds ratio [OR] 25.97, 95% confidence interval [CI] 9.83-68.63; p < 0.0001) and HETROM-5 (64.3%; OR 32.81, 95% CI 12.39-86.87; p < 0.0001) group than in the Placebo group (5.9%). Hetrombopag was also superior to placebo in achieving a platelet response and in reducing the bleeding risk and use of rescue therapy throughout 8 weeks of treatment. The durable platelet response to hetrombopag was maintained throughout 24 weeks. The most common adverse events were upper respiratory tract infection (42.2%), urinary tract infection (17.1%), immune thrombocytopenic purpura (17.1%) and hematuria (15%) with 24-week hetrombopag treatment. CONCLUSIONS In ITP patients, hetrombopag is efficacious and well tolerated with a manageable safety profile. Trial registration Clinical trials.gov NCT03222843 , registered July 19, 2017, retrospectively registered.
Early coagulation tests predict risk stratification and prognosis of COVID-19
The ongoing outbreak of Coronavirus Disease 2019 (COVID-19) is hitting the world hard, but the relationship between coagulation disorders and COVID-19 is still not clear. This study aimed to explore whether early coagulation tests can predict risk stratification and prognosis. PubMed, Web of Science, Cochrane Library, and Scopus were searched electronically for relevant research studies published up to March 24, 2020, producing 24 articles for the final inclusion. The pooled standard mean difference (SMD) of coagulation parameters at admission were calculated to determine severe and composite endpoint conditions (ICU or death) in COVID-19 patients. Meta-analyses revealed that platelet count was not statistically related to disease severity and composite endpoint; elevated D-dimer correlated positively with disease severity (SMD 0.787 (0.277-1.298), P= 0.003, I(2)= 96.7%) but had no significant statistical relationship with composite endpoints. Similarly, patients with prolonged prothrombin time (PT) had an increased risk of ICU and increased risk of death (SMD 1.338 (0.551-2.125), P = 0.001, I(2) = 92.7%). Besides, increased fibrin degradation products (FDP) and decreased antithrombin might also mean the disease is worsening. Therefore, early coagulation tests followed by dynamic monitoring is useful for recognizing coagulation disorders accompanied by COVID-19 and guiding timely therapy to improve prognosis.
Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19
ImportanceConvalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed ObjectiveTo evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19 Design, Setting, and ParticipantsOpen-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020 The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation) The trial was terminated early after 103 of a planned 200 patients were enrolled InterventionConvalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity Main Outcomes and MeasuresPrimary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]) Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours ResultsOf 103 patients who were randomized (median age, 70 years;60 [58 3%] male), 101 (98 1%) completed the trial Clinical improvement occurred within 28 days in 51 9% (27/52) of the convalescent plasma group vs 43 1% (22/51) in the control group (difference, 8 8% [95% CI, −10 4% to 28 0%];hazard ratio [HR], 1 40 [95% CI, 0 79-2 49];P = 26) Among those with severe disease, the primary outcome occurred in 91 3% (21/23) of the convalescent plasma group vs 68 2% (15/22) of the control group (HR, 2 15 [95% CI, 1 07-4 32];P = 03);among those with life-threatening disease the primary outcome occurred in 20 7% (6/29) of the convalescent plasma group vs 24 1% (7/29) of the control group (HR, 0 88 [95% CI, 0 30-2 63];P = 83) (Pfor interaction = 17) There was no significant difference in 28-day mortality (15 7% vs 24 0%;OR, 0 65 [95% CI, 0 29-1 46];P = 30) or time from randomization to discharge (51 0% vs 36 0% discharged by day 28;HR, 1 61 [95% CI, 0 88-2 93];P = 12) Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87 2% of the convalescent plasma group vs 37 5% of the control group (OR, 11 39 [95% CI, 3 91-33 18];P < 001) Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care Conclusion and RelevanceAmong patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference Trial RegistrationChinese Clinical Trial Registry:ChiCTR2000029757
Efficacy and safety of tranexamic acid in total hip replacement: A PRISMA-compliant meta-analysis of 25 randomized controlled trials
BACKGROUND Hip osteoarthritis is one of the most prevalent musculoskeletal degenerative diseases in elderly. Total hip arthroplasty (THA) is the most effective surgical treatment for end stage hip osteoarthritis. Tranexamic acid (TA) is a potent drug to reduce surgical blood loss in surgery, therefore, as a potential drug for application in THA. OBJECTIVES To identify the combined efficacy of TA administration in THA. A meta-analysis including 25 randomized controlled trials was conducted for generating synthesized effects. METHODS This meta-analysis followed the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines for reporting systematic reviews and meta-analysis. A total of 25 Randomized controlled trials (RCTs) were included for meta-analysis. RESULTS The pooled results illustrated that total blood loss, intraoperative blood loss, postoperative blood loss, hemoglobin drop, transfusion rate, and average hospital stay were significantly lower than controls (standardized mean difference or odds ratio (OR) (95%CI): -0.87, (-1.13,-0.61), -0.68, (-0.96,-0.39), -1.41, (-2.24,-0.59), -1.11, (-1.63,-0.58), 0.28, (0.20,-0.38), -0.17, (-0.49,0.14), P < .05, respectively). Moreover, TA acts efficiently without increasing risk of thromboembolic events with OR = 1.14, 95%CI = 0.50-2.62, P = .75. Subgroup analysis indicated no statistically significant differences between a higher dose of topical TA (≥2 g or 15 mg/kg) or a lower dose (<2 g or 15 mg/kg). CONCLUSION The findings indicated that TA is clinically effective and safe in patients receiving total hip arthroplasty.
Intravenous immunoglobulin treatment for repeated IVF/ICSI failure and unexplained infertility: a systematic review and a meta-analysis
American Journal of Reproductive Immunology. 2013;70((6):):434-47.
Intravenous immunoglobulin (IVIG) has been introduced empirically into IVF/ICSI programs with the hopes of improving in vitro fertilization (IVF) success. However, the effects of IVIG have been inconsistent. We investigated the effects of IVIG on hard outcomes, including implantation rate, clinical pregnancy rate, live birth rate, miscarriage rate, and live birth rate per embryo transferred. The PubMed, EMBASE, and CNKI databases were searched up to June of 2013 and 10 studies were included. Case-controlled studies comparing IVIG with placebo in IVF/ICSI women and/or unexplained infertility were included. Using fixed and random effects models, the pooled risk ratios (RR) with 95% confidence intervals (CIs) were calculated. The use of IVIG was significantly associated with a higher implantation rate and RR was 2.708 (95%CI: 1.302-5.629) compared with the placebo. The clinical pregnancy rate and the live birth rate were significantly increased in patients randomized to IVIG; RR was 1.475 (95%CI: 1.191-1.825) for the clinical pregnancy rate and RR was 1.616 (95%CI: 1.243-2.101) for the live birth rate. Moreover, the miscarriage rate was significantly less in patients randomized to IVIG (0.352, 95%CI: 0.168-0.738), but the live birthrate per embryo transferred was not (2.893; 95%CI: 0.810-10.331) less. Our results strongly support that IVIG is a useful treatment option for women undergoing repeated IVF failure. 2013 John Wiley & Sons Ltd.