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Autologous Platelet-Rich Gel for the Treatment of Diabetic Sinus Tract Wounds: A Clinical Study
Xie J, Fang Y, Zhao Y, Cao D, Lv Y
The Journal of surgical research. 2019
Abstract
BACKGROUND The aim of this study was to evaluate the efficacy of autologous platelet-rich gel (APG) in the treatment of deep sinus tract wounds from diabetic ulcers. METHODS Forty-eight patients with diabetic ulcers were randomly classified into two groups: an APG treatment group (25 patients) and a conventional wound dressing control group (23 patients). The sinus tract closure times, ulcer healing rates, hospitalization times, and hospitalization expenses of the two groups were compared. RESULTS There were no significant differences in the basic data and wound conditions between the two groups. The cure (healed wound) rates were 96% and 87% for the APG group and control group, respectively. During the first 4 wk, the sinus tract closure rate for the APG group was significantly higher than that for the control group. However, there was no significant difference in the sinus tract healing between the two groups at the end of the 8th wk. For the APG group and the control group, the average hospital stays were 19.36 +/- 7.239 d and 48.13 +/- 11.721 d, respectively, and the total hospitalization expenses were 2.48 +/- 0.45 ten thousand yuan and 5.63 +/- 1.35 ten thousand yuan (P < 0.05), respectively. These differences were statistically significant. CONCLUSIONS When compared with conventional wound dressings, APG can accelerate the healing of deep sinus tract wounds associated with diabetic ulcers.
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2.
Eltrombopag versus romiplostim in treatment of children with persistent or chronic immune thrombocytopenia: a systematic review incorporating an indirect-comparison meta-analysis
Zhang J, Liang Y, Ai Y, Li X, Xie J, Li Y, Zheng W, He R.
Scientific Reports. 2018;8((1)):576.
Abstract
In absence of direct comparison, we conducted an indirect-comparison meta-analysis to evaluate the efficacy and safety of thrombopoietin-receptor agonists(TPO-RAs) in treatment of pediatric persistent or chronic immune thrombocytopenia(ITP). PubMed, Embase, Cochrane Library, Clinical Trials.gov, China National Knowledge Infrastructure, and Chinese Biomedical Literature Database were searched from their earliest records to May 2017. Randomized controlled trials comparing the TPO-RAs with placebo in pediatric ITP were included. Outcomes included overall response rate(primary), durable response, overall or clinically significant bleeding, the proportion of patients receiving rescue medication, and safety. Five randomized placebo-controlled studies(N = 261) were analyzed. The overall response[Risk Ratio(RR) 0.57, 95% confidence interval(CI) 0.21-1.56], the incidence of adverse events (RR 0.96, 95%CI 0.66-1.39), durable response(RR 2.48, 95%CI 0.31-19.97), and the proportion of patients receiving rescue treatment(RR 0.73, 95%CI 0.20-2.73) were similar between eltrombopag and romiplostim group. Nevertheless, eltrombopag might have lower risk of overall bleeding(RR 0.43, 95%CI 0.23-0.80) and clinically significant bleeding(RR 0.33, 95%CI 0.12-0.89) than romiplostim. This meta-analysis suggests that eltrombopag might be similar to romiplostim in efficacy and safety, but seems to reduce the risk of bleeding compared to romiplostim. Furthermore, cost of the treatment, comorbidity of patients and drug compliance should also be considered in clinical decision making.
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3.
Eltrombopag versus romiplostim in treatment of adult patients with immune thrombocytopenia: A systematic review incorporating an indirect-comparison meta-analysis
Zhang J, Liang Y, Ai Y, Li X, Xie J, Li Y, Zheng W, He R
Plos One. 2018;13((6)):e0198504.
Abstract
PURPOSE In absence of direct comparison randomized controlled trials (RCTs), indirect comparison was conducted to evaluate the efficacy and safety of thrombopoietin-receptor agonists (TPO-RAs) in treatment of adult immune thrombocytopenia (ITP). METHODS We searched PubMed, Embase and Cochrane Library, Clinical Trials.gov, China National Knowledge Infrastructure, and Chinese Biomedical Literature Database from their earliest records to May 2017. RCTs comparing the TPO-RAs with placebo in adult ITP were included. Primary outcomes were the overall response rate. Secondary outcomes included safety, durable response, overall or clinically significant bleeding, and the proportion of patients receiving rescue medication. RESULTS Nine randomized placebo-controlled trials (786 participants) were included in this systematic review. Overall response [Risk Ratio(RR) = 0.59, 95%Confidence Interval(CI): 0.24-1.45], the incidence of adverse events (RR = 0.98, 95%CI: 0.79-1.21), durable response (RR = 0.47, 95%CI: 0.08-2.81), the incidence of overall bleeding (RR = 1.15, 95%CI: 0.52-2.57) and clinically significant bleeding (RR = 1.09, 95%CI: 0.37-3.24), and the proportion of patients receiving rescue treatment (RR = 0.95, 95%CI: 0.47-1.90) were similar between eltrombopag and romiplostim. CONCLUSIONS Eltrombopag and romiplostim might be equivalent in efficacy and safety for adult ITP, however, physicians should still take into account drug cost and comorbidities of the specific patient while making decisions on the treatment of ITP with TPO-RAs. REGISTRATION PROSPERO International Prospective Register of Systematic Review (PROSPERO 2017: CRD42017068661).
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4.
Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review
Li Y, Zhang J, Liang Y, Ai Y, Xie J, Zheng W
Expert Opinion on Pharmacotherapy. 2017;18((15):):1543-1551
Abstract
OBJECTIVE We conducted a systematic review to assess the efficacy and safety of Thrombopoietin-receptor agonists(TPOras) for pediatric immune thrombocytopenia(ITP). METHODS We searched PubMed, Embase and Cochrane Library from their earliest records to January 2017. Randomized controlled trials(RCTs) evaluating the efficacy and safety of TPOras in children were included. Primary outcomes were durable response and clinically significant bleeding. Secondary outcomes were overall response, overall bleeding events, the proportion of patients receiving rescue medication and adverse events(AEs). RESULTS Five randomized RCTs(261participants) were included in this systematic review. Compared with placebo group, the proportion of patients achieving durable platelet response was significantly higher in Eltrombopag(92 participants, P=0.0004) or Romiplostim(62 participants, P=0.002) group, so was the overall response in Eltrombopag[RR=2.64, 95%CI(1.58, 4.44)] or Romiplostim[RR=5.05, 95%CI(2.21, 11.53)] group. Both clinically significant bleeding(159 participants, P=0.04) and total bleeding(183 participants, P=0.01) in Eltrombopag group were significantly less frequent than those in placebo group, while no significant difference between Romiplostim and placebo group. The proportion of patients receiving rescue medication, the incidence of overall AEs and serious AEs between TPO-receptor agonists and placebo group were not significantly different. CONCLUSION TPOras might improve both durable and overall platelet response in pediatric ITP, compared with placebo.
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5.
Matching-adjusted indirect comparisons of efficacy of BAY 81-8973 vs two recombinant factor VIII for the prophylactic treatment of severe hemophilia A
Pocoski J, Li N, Ayyagari R, Church N, Maas Enriquez M, Xiang Q, Kelkar S, Du EX, Wu EQ, Xie J
Journal of Blood Medicine. 7:129-37, 2016.. 2016;7:129-37
Abstract
BACKGROUND No head-to-head trials comparing recombinant factor VIII (rFVIII) products currently exist. This was a matching-adjusted indirect comparison (MAIC) study of efficacy of BAY 81-8973 with antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM) and turoctocog alfa for the prophylaxis of severe hemophilia A. METHODS A systematic literature review was conducted to identify trials of rAHF-PFM and turoctocog alfa. Comparisons were conducted using BAY 81-8973 individual patient data (IPD) from LEOPOLD trials and published data from rAHF-PFM and turoctocog alfa trials. Differences in outcome reporting were reconciled using transformation of BAY 81-8973 IPD. Patients in pooled LEOPOLD trials were weighted to match baseline characteristics for rAHF-PFM or turoctocog alfa trials using MAICs. After matching, annualized bleed rates (ABRs) were compared using weighted t-tests. RESULTS Two rAHF-PFM trials and one turoctocog alfa trial were identified. In these trials, rFVIIIs were dosed thrice weekly or every other day; in LEOPOLD trials, BAY 81-8973 was dosed twice- or thrice weekly. Three MAICs were conducted because the two rAHF-PFM trials calculated ABRs differently, matching for age, race, and weight (turoctocog alfa only). BAY 81-8973 had similar ABR of all bleeds vs rAHF-PFM (two trials: 4.8 vs 6.3, 1.9 vs 1.8 [square root transform]) and lower ABR of spontaneous bleeds and trauma bleeds (2.6 vs 4.1, 2.1 vs 4.7; both P<0.05). BAY 81-8973 showed lower ABR of all bleeds and spontaneous bleeds vs turoctocog alfa (4.3 vs 6.5, 2.8 vs 4.3; both P<0.05) and similar ABR of trauma bleeds (1.5 vs 1.6). In subgroup analysis, twice-weekly BAY 81-8973 had similar ABRs of all bleeds, spontaneous bleeds, and trauma bleeds compared to rAHF-PFM and turoctocog alfa. CONCLUSION This indirect comparison found that prophylaxis with BAY 81-8973, even including the lower frequency of two times a week and lower factor VIII consumption, has efficacy comparable to rAHF-PFM and turoctocog alfa, which were dosed thrice weekly or every other day. The use of IPD enabled adjustments for differences in calculation of ABRs and population characteristics between trials.
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Patterns of prior treatment and bleeds among patients with severe hemophilia a: impact on frequency of dosing with Bay 81-8973 in the Leopold I trial
Church N, Ayyagari R, Pocoski J, Sajeev G, Kelkar SS, Du EX, Mass-Enriquez M, Xie J
Blood. 2015;126((23)): Abstract No. 1103.
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Final results of a randomized study comparing two dosing regimens of epoetin alfa in patients with chemotherapy-induced anemia: 80,000 U every two weeks vs 40,000 U weekly
Henry DH, Kamin M, Wilhelm F, Williams D, Xie J, Woodman RC
Journal of Clinical Oncology. 2006;24((18_suppl)):8624.
Abstract
8624 Background: Epoetin alfa is typically administered weekly (QW) for the treatment of chemotherapy (CT)-induced anemia. Less frequent dosing can be more convenient for patients (pts) and healthcare providers. This is the first study to examine extended interval initial dosing with epoetin alfa 80,000 U every two weeks (Q2W) vs the standard 40,000 U QW regimen. METHODS This randomized, open-label, 13-week study enrolled pts with non-myeloid malignancies with baseline (BL) hemoglobin (Hb) < 11 g/dL and CT planned for > 12 weeks. Pts were assigned (1:1) to receive epoetin alfa 40,000 U QW or 80,000 U Q2W subcutaneously. Drug was held for Hb > 13 g/dL and dose was reduced for Hb > 12 g/dL or rate of rise > 1 g/dL in any 2-week period. For inadequate Hb response, 80,000 U Q2W pts were switched to 40,000 U QW and 40,000 U QW patients were increased to 60,000 U QW. The primary analysis was a comparison of the mean Hb change from BL to end of study (EOS). RESULTS 298 pts received > 1 dose of drug (153 Q2W, 145 QW). BL characteristics were comparable between groups: 66% female, overall mean age 62 yrs, and BL Hb 10.0 g/dL. Most common tumor types were breast (25%), NSCLC (15%) and colorectal (14%). Efficacy was analyzed in 295 pts (151 Q2W, 144 QW) who had > 1 post-BL Hb value. The mean Hb change from BL to EOS for Q2W was 1.27 +/- 1.48 g/dL compared to 1.28 +/- 1.60 g/dL for QW [difference 0, 1-sided 95% CI -0.25,-]. In the per protocol population, the difference in mean Hb change was similar. Mean Hb values over time were also similar between groups. Kaplan-Meier estimates of post-28 day transfusion rates were 11.2% in Q2W vs. 12.0% in QW. Fewer Q2W pts compared to QW pts required dose holds (21% vs 42%) or dose reductions (41% vs 59%). 13% of Q2W pts were switched to QW dosing and 37% of QW pts required a dose increase. The incidences of clinically relevant TVEs and deaths were similar in the Q2W vs QW groups (7.8% vs 7.6% and 6.5% vs 6.2%, respectively). CONCLUSIONS Pts treated with epoetin alfa 80,000 U Q2W demonstrated similar Hb increases, transfusion rates, and safety outcomes compared to pts treated with 40,000 U QW. Epoetin alfa 80,000 U every other week is an effective regimen that may provide a more convenient dosing option for pts with CT-induced anemia. [Table: see text].
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8.
Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia
Henry DH, Gordan LN, Charu V, Wilhelm FE, Williams D, Xie J, Woodman RC
Current Medical Research and Opinion. 2006;22((7):):1403-13.
Abstract
OBJECTIVE This randomized, open-label, multicenter study compared the efficacy and safety of epoetin alfa (EPO) 80 000 U every 2 weeks (Q2W) to the FDA-approved regimen of 40 000 U weekly (QW) in patients with chemotherapy-induced anemia. RESEARCH DESIGN AND METHODS A total of 310 patients with nonmyeloid malignancy and baseline hemoglobin (Hb) RESULTS Analysis of the primary endpoint revealed that the mean change in Hb from baseline to study end was comparable between the Q2W and QW groups in the per-protocol population (1. 6 g/dL vs 1. 8 g/dL, respectively; treatment difference, -0. 2 g/dL; one-sided 95% confidence interval [-0. 56, -]); similar results were observed in the mITT population. Among patients on study at Day 29, 9. 6% (13/135) and 11. 1% (14/126) of patients in the Q2W and QW groups, respectively, received a transfusion between Day 29 and the end of the study (p = 0. 709). Dose withholds (21% vs 42%, p < 0. 001) and dose reductions (41% vs 59%, p = 0. 003) were less common for Q2W than QW. Safety profiles were similar between groups; clinically relevant thrombotic vascular events occurred in 8% of patients in each group. The open-label dosing and the patient attrition rate did not appear to influence overall study results. CONCLUSIONS Extended dosing (80 000 U Q2W) and once-weekly dosing (40 000 U QW) of EPO provided comparable safety and efficacy for chemotherapy-induced anemia.
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Randomized, open-label study of epoetin alfa 40,000 U once weekly versus 80,000 U every two weeks in anemic patients with cancer receiving chemotherapy
Henry DH, Xie J, Woodman RC
Blood. 2005;106((11):): Abstract No. 3772.