1.
Efficacy of concentrated growth factor combined with grafting materials vs. grafting materials alone for the treatment of periodontal intrabony defects: a systematic review and meta-analysis
Yao M, Hu J, Jiang L, Guo R, Wang X
Annals of translational medicine. 2023;11(4):184
Abstract
BACKGROUND Concentrated growth factor (CGF) is a novel biomaterial that can effectively promote tissue growth, but it is uncertain whether adding CGF can product additional effects in the periodontal tissue growth. The purpose of this meta-analysis was to assess the efficacy of CGF combined with grafting materials versus grafting materials alone for the treatment of periodontal intrabony defects. METHODS The PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), China Biology Medicine Disc (CBM), Wanfang, and VIP databases were searched from inception date to June 2022. The inclusion criteria were: (I) randomized controlled trials (RCTs) comparing CGF combined with grafting materials with the single use of grafting materials for the treatment of periodontal intrabony defects, (II) studies providing outcomes of probing depth (PD) and clinical attachment loss (CAL). The literature searches and screening, data extraction, and quality assessment were performed by two reviewers, respectively. The Cochrane bias risk assessment tool was used to assess the quality of the literature. Meta-analysis was performed using Stata 15.0. RESULTS A total of 8 randomized controlled trials (RCTs) were obtained, including 150 intrabony defect sites in the combination groups and 153 sites in the control groups. Meta-analysis showed that the combination groups was more effective than the control groups in PD [weighted mean difference (WMD) =-0.73, 95% confidence interval (CI): -0.94, -0.51, P=0.005], CAL (WMD =-0.56, 95% CI: -0.94, -0.19, P=0.003), and bone filling (BF) (WMD =-0.43, 95% CI: -0.65, -0.21, P=0.001), but the difference was not statistically significant between two groups in the change of gingival recession (REC) (WMD =-0.15, 95% CI: -0.44, 0.14, P=0.312). One study presented a high risk of bias due to lost follow-up, and the rest were unclear risk of bias. CONCLUSIONS For the treatment of periodontal intrabony defects, our meta-analysis showed that CGF combined with grafting materials was more effective than the use of grafting materials alone. However, the findings should be interpreted with caution due to the average quality of RCTs.
2.
A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia
Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, et al
Journal of hematology & oncology. 2021;14(1):37
Abstract
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.
3.
rhTPO combined with chemotherapy and G-CSF for autologous peripheral blood stem cells in patients with refractory/relapsed non-Hodgkin's lymphoma
Zhu J, Hao SG, Hu J, Zhuang JL, Wang C, Bai HT
Cancer management and research. 2019;11:8371-8377
Abstract
Objective: The mobilization and collection of sufficient autologous peripheral blood stem cells (APBSCs) are important for the fast and sustained reconstruction of hematopoietic function after autologous transplantation. This study aims to evaluate the mobilization effect and safety of thrombopoietin (TPO) combined with chemotherapy + G-CSF for APBSCs in patients with refractory/relapsed non-Hodgkin's lymphoma. Methods: A total of 78 patients were included in the present study. After receiving mobilization chemotherapy, all patients were randomly divided into two groups: TPO group (n=40), patients were given subcutaneous injection of rhTPO + G-CSF, and control group (n=38), patients were given subcutaneous injection of G-CSF. The primary endpoint was the total number of obtained CD34+ cells. The secondary endpoints were the mononuclear cell count, the proportion of target and minimum mobilization, the engraftment time of neutrophils and platelets after APBSCT, the number of platelet and red blood cell infusions, the incidence of infectious fever and fever duration, and TPO-related side effects in patients. Results: TPO participation significantly increased the total CD34+ cell count. A higher proportion of patients in the TPO group achieved the minimum and target CD34+ cells, when compared to the control group. TPO-related adverse events were not observed in either of these groups. In addition, there were no significant differences in engraftment time, the number of platelet and red blood cell transfusions, the incidence of infectious fever, and fever duration between these two groups. Conclusion: TPO combined with chemotherapy + G-CSF can safely and effectively enhance the mobilization effect for APBSCs in patients with refractory/relapsed non-Hodgkin's lymphoma.
4.
Clinical study of Shengxuening tablet combined with rHuEPO for the treatment of renal anemia of maintenance hemodialysis patients
Cheng X, Yu G, Hu J, Xu X, Luo F, Shen P, Zhang G, Yang N
Experimental and Therapeutic Medicine. 2016;12((1)):157-160.
Abstract
The aim of the present study was to investigate the clinical effects of Shengxuening tablet (silkworm excrement) combined with recombinant human erythropoietin (rHuEPO) for the treatment of renal anemia of maintenance hemodialysis (MHD) patients. Seventy-two MHD patients with renal anemia were included in the study and randomly divided into the control (n=34) and observation (n=38) groups. Patients in the control group were treated by hypodermic injection of 100-150 U/(kg.w) rHuEPO and patients in the observation group were treated by rHuEPO + 1.0 g t.i.d. p.o. Shengxuening tablet. The two groups were assisted by conventional treatments including iron, folic acid, vitamin B12 and L-carnitine. After 3 and 6 months, improvement of anemia was compared. After 3 months, the hemoglobin, hematocrit, serum ferritin and transferrin saturation levels of the observation group were significantly higher than those of the control group (p<0.05). In addition, C-reactive protein and superoxide dismutase levels of the observation group were significantly lower than those of the control group (p<0.05). After 6 months, indices of the observation group were ameliorated while the improvement of control group was not obvious, and indices of the observation group were significantly higher than those of the control group (p<0.05). Consumption of rHuEPO in the observation group was significantly less than that of the control group, and the total effective rate was significantly higher than that of the control group (p<0.05). In conclusion, Shengxuening tablet combined with rHuEPO was safe and effective for the treatment of renal anemia of MHD patients.