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Assessment of the effectiveness and satisfaction of platelet-rich plasma compared with hyaluronic acid in knee osteoarthritis at minimum 7-year follow-up: A post hoc analysis of a randomized controlled trial
Wang Z, Wang R, Xiang S, Gu Y, Xu T, Jin H, Gu X, Tong P, Zhan H, Lv S
Frontiers in bioengineering and biotechnology. 2022;10:1062371
Abstract
Background: Knee osteoarthritis (KOA) can be effectively treated conservatively using platelet-rich plasma (PRP) injections into the affected joints. While the short-term therapeutic clinical benefits were well documented, the mid-term results remain undetermined. To clarify its efficacy, the mid-term clinical outcomes of intra-articular injections of either PRP or hyaluronic acid (HA) in KOA were compared. Methods: One hundred patients who complied with the inclusion criteria were randomized to undergo once a week 3 weeks, intra-articular injections of either PRP or HA. Patients were evaluated before the injection, at 3, 6, and a mean of 78.9 months of follow-up. Eighty-five patients reached the final evaluation. Data on survival, re-intervention, pain, function, imaging, and satisfaction were collected and analyzed. Results: With surgery for any reason as the endpoint, the cumulative survival rate of the PRP group was 90%, while that of the HA group was 74%. There was a significant difference between the two groups in the total re-intervention rate (56.7% vs 16.2%, p < 0.05). The comparative analyses showed significant intergroup differences in the visual analog scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (p < 0.01, p < 0.05, respectively) at the final follow-up. And base on the regression analyses, the type of treatment, age, and Kellgren-Lawrence (K-L) grade served as statistically an independent determinants of VAS (p < 0.001, p = 0.034, p < 0.001, respectively). Likewise, those variables independently determined WOMAC in our study. However, no difference was observed in the imaging evaluation, containing the K-L grade and Cartilage Lesion Score, between the two groups (p > 0.05). Besides, the satisfaction treated by the PRP was 78.6%, with a superiority compared with HA (55.8%, p < 0.05), and no complications were noted in the whole treatment process among patients who participated. Conclusion: PRP was more effective than HA in survival and re-intervention rates, VAS, and WOMAC, although there were no significant differences in the imaging evaluation between the two groups. Furthermore, patients treated with PRP were associated with higher satisfaction compared with HA.
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A multicenter, prospective, randomized clinical study to evaluate the efficacy and safety of fibrin sealant as an adjunct to sutured dural repair
Yu R, Zhu W, Kocharian R, Ilie B, Wang Z, Kang D, Zhao G, Yang H, Shu K, Liu X, et al
Chinese medical journal. 2022;135(20):2506-2508
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Efficacy, safety and bioequivalence of the human-derived B-domain-deleted recombinant factor VIII TQG202 for prophylaxis in severe haemophilia A patients
Xi Y, Jin C, Liu W, Zhou H, Wang Z, Zhou R, Lou S, Zhao X, Chen F, Cheng P, et al
Haemophilia : the official journal of the World Federation of Hemophilia. 2022
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Abstract
INTRODUCTION Current treatment of severe haemophilia A includes prophylaxis with factor VIII (FVIII) replacement. The supply of plasma-derived FVIII is short in China. PURPOSE To evaluate the efficacy and safety of a new B-domain deleted (BDD) recombinant FVIII (TQG202) produced by human-derived cells for prophylaxis in severe haemophilia A patients and compare the bioequivalence with Xyntha. METHODS This multicentre, clinical trial consisted of an open-label, randomized, two-period cross-over trial assessing single-dose pharmacokinetics (PK), and a single-arm clinical trial evaluating the efficacy and safety of 24 weeks of TQG202 prophylaxis, and repeated PK were assessed after prophylaxis phase. The single-dose was 50 IU/kg in PK assessment, and the initial dose was 30 ± 5 IU/kg for prophylaxis. The primary endpoints of prophylaxis were the annualized bleeding rate (ABR) and the incremental recovery rate of the first administration. Adverse events (AEs) were recorded. RESULTS Twenty-six participants were enrolled in the PK assessment and 81 participants in the prophylaxis phase. Mean age was 25.9 ± 10.8 years and all participants were male. The results of PK assessment showed TQG202 is bioequivalent to Xyntha. The total ABR was 2.0 (95% CI: 1.2-2.9) in prophylaxis phase. The mean incremental recovery rate of the first administration was .027 (95% CI: .026-.028) (IU/ml)/(IU/kg). AEs occurred in 42 participants, with an incidence of 51.9%. One severe AE not related to TQG202 occurred. No participants developed FVIII inhibitors. CONCLUSION TQG202 shows bioequivalence with Xyntha. The promising efficacy and tolerability in the severe haemophilia A prophylaxis support the use of TQG202in clinical practice.
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Efficacy and safety of autologous platelet-rich fibrin for the treatment of infertility with intrauterine adhesions
Wang Z, Yang M, Mao L, Wang X, Wang S, Cui G, Hou Z, Yang M, Cui L, Bai W
The journal of obstetrics and gynaecology research. 2021
Abstract
AIM: To evaluate the efficacy and safety of autologous platelet-rich fibrin (PRF) for the treatment of infertility with intrauterine adhesions. METHODS Forty patients who suffered from infertility with intrauterine adhesions (IUAs) were enrolled in this prospective trial from October 2018 to December 2019. They were randomly divided into a PRF group and a control group. Both groups underwent transcervical resection of adhesions (TCRA) during the follicular phase. PRF group: PRF prepared from autologous venous blood was placed in the uterine cavity after TCRA and after the first menstrual re-fluid; control group: no PRF insertion. After the second menstrual re-fluid, both groups underwent hysteroscopy to reevaluate adhesion severity. Pregnancy rate, intrauterine adhesion score, menstrual volume and duration, and endometrial thickness were assessed and adverse events were recorded. RESULTS (1) PRF group pregnancy rate was significantly higher than the control group (55.0% vs. 20.0%). Mean follow-up time was (17.63 ± 2.33) months. All patients fell pregnant naturally. Four (PRF) and one (control) patients delivered live births without placental complications. (2) Intrauterine adhesion scores decreased compared with treatment-before. (3) In the pictorial blood loss assessment chart, score and menstrual duration during the 3rd menstrual cycle showed significant improvements for both groups. (4) Endometrial thickness also showed an increasing trend, and subendometrial bloodflow improved. (5) No treatment-related serious adverse events were noted. CONCLUSION Placing PRF into the uterine cavity of infertility patients with IUAs following TCRA is a safe and effective therapeutic method.
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Clinical efficacy of comprehensive nursing in patients with cerebral hemorrhagic hemiplegia
Wang Z, Pan J, Wang L, Chen P
American journal of translational research. 2021;13(5):5526-5532
Abstract
OBJECTIVE To explore the clinical efficacy of comprehensive rehabilitation nursing (CRN) intervention in patients with cerebral hemorrhagic hemiplegia (CHH). METHODS A total of 102 patients with CHH admitted to our hospital were selected for the prospective study. The patients were randomly divided into the control group (n=51) and the observation group (n=51) according to the random number table method. Routine nursing was performed in the control group, while CRN was conducted in the observation group. Fugl-Meyer motor function assessment scale, activity of daily living scale (Barthel index), self-rating anxiety scale (SAS), complications and muscle strength improvement (Brunnstrom assessment) were compared between the two groups. RESULTS Compared with those before nursing, Fugl-Meyer score, Barthel index and SAS score in the two groups after nursing were significantly improved (P<0.01). Fugl-Meyer score and Barthel index of the observation group were significantly higher than those of the control group after nursing, while SAS score showed the opposite change (P<0.001). The incidence of complications in the control group was 49.02%, and that in the observation group was 29.41% (P<0.05). The rate of muscle strength improvement in the observation group was 80.39% after nursing, which was significantly higher than that in the control group (60.78%; P<0.05). CONCLUSION CRN intervention has a positive clinical efficacy in patients with CHH. It can enhance motor ability, improve the ability of daily life, amend psychological mood and reduce the incidence of complications.
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Clinical Application of Microsurgery Using the Cerebellar Medulla Fissure Approach in Severe Ventricular Hemorrhage with Casting of the Fourth Ventricle and Its Influence on Neurological Recovery
Gao F, Wang H, Wang Z
Evidence-based complementary and alternative medicine : eCAM. 2021;2021:3699233
Abstract
OBJECTIVE To investigate the clinical application of microsurgery using the cerebellar medulla fissure approach in severe ventricular hemorrhage with casting of the fourth ventricle and its effect on neurological recovery. METHODS A total of 80 patients with severe intraventricular hemorrhage accompanied by casting and dilation of the fourth ventricle who were admitted to the neurosurgery department between July 2019 and December 2020 were randomly divided into an observation group and a control group, with 40 patients in each group. The drainage tube extubation time and length of hospital stay of the two groups were compared. The 3-day hematoma clearance of the two groups was observed. Postoperative consciousness was evaluated by GCS, and the patients' recovery was evaluated by GOS at three months. The activities of daily living (ADL) scores of the two groups were compared to evaluate patients' postoperative self-care ability. The incidence of postoperative complications in the two groups was collected. Independent risk factors for poor prognosis were analyzed by logistics regression. RESULTS The postoperative hospitalization time and the drainage tube extubation time in the observation group were significantly lower than those in the control group. The ratio of hematoma clearance ≥90% in the observation group was significantly higher than that of the control group. Postoperative GCS scores and GOS scores in the observation group were significantly higher than those of the control group. The rate of postoperative complications in the observation group was significantly lower than that of the control group. The rate of good ADL grading in the observation group was significantly higher than that in the control group. Age and surgical method were independent risk factors for poor prognosis. CONCLUSION Microsurgery using the cerebellar medulla fissure approach can effectively improve the condition of severe ventricular hemorrhage with casting of the fourth ventricle and promote the recovery of patients' neurological function.
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Efficacy of human immunoglobulin injection and effects on serum inflammatory cytokines in neonates with acute lung injury
Wang S, Tang Z, Zheng X, Deng J, Wang Z
Experimental and therapeutic medicine. 2021;22(3):931
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Abstract
The present study aimed to explore the efficacy of intravenous immunoglobulin (IVIG) injection in neonates with acute lung injury (ALI) and assess its effects on serum inflammatory cytokine levels. The research subjects were 140 neonates with ALI who were evenly distributed into a control group (COG) and a study group (STG). The COG patients were treated routinely, whereas patients in the STG were administered IVIG in addition to the standard treatment received by the COG. The arterial partial pressure of oxygen (PaO(2)), PaO(2)/fraction of inspired oxygen (FIO(2)), mechanical ventilation time and hospitalization time were compared between the two groups. ELISA was used to determine the levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in the patients before treatment and at 12, 24 and 36 h after treatment. The Kaplan-Meier method was used to analyze the survival of the patients, including their survival for 30 days after treatment. The patients were divided into high and low cytokine expression groups based on their mean expression levels of serum IL-6 and TNF-α before treatment. After treatment, PaO(2) and PaO(2)/FiO2 were significantly higher and mechanical ventilation and hospitalization time were reduced in the STG in comparison with the COG (all P<0.001). At 12, 24 and 36 h after treatment, serum IL-6 and TNF-α levels in the STG were lower than those in the COG (both P<0.05). The 30-day survival rate after treatment was not significantly different between the two groups (P>0.05). The 30-day survival rate in the high IL-6 and high TNF-α expression COG was lower than that in the low IL-6 and low TNF-α expression COG (both P<0.05). The results of the present study indicate that IVIG may improve pulmonary gas exchange, shorten the course of disease and reduce the inflammatory response in neonates with ALI.
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Methylprednisolone Pulse Therapy or Additional IVIG for Patients with IVIG-Resistant Kawasaki Disease
Wang Z, Chen F, Wang Y, Li W, Xie X, Liu P, Zhang X, Zhang L, Huang P
Journal of immunology research. 2020;2020:4175821
Abstract
There have been no robust data from clinical trials to guide the clinician in the choice of therapeutic agents for the child with intravenous immunoglobulin (IVIG) resistance. The treatment regimen for IVIG-resistant patients varies between institutions, and the best option has not yet been established. Therefore, in this trial, a total of 955 patients with Kawasaki disease (KD) were selected and were initially treated with IVIG (2 g/kg), of whom 80 (8.38%) assessed as IVIG resistant were randomly divided into two groups: Group A received the second IVIG treatment (n = 40), and Group B received methylprednisolone pulse therapy (MPT, n = 40). The whole fever time, duration of fever after retreatment, hospital days, medical costs, readmission rate, and laboratory examination difference (△) were calculated. Coronary artery lesion (CAL) outcomes were followed up over two years. Patients in the MPT group had shorter fever after retreatment and lower medical costs; more rapid declines in C-reactive protein (CRP), neutrophils (N%), and platelet (PLT) levels; and more rapid rise in sodium. However, they also probably had a higher incidence of treatment failure and CALs than the additional IVIG treatment group in the long-term follow-up. Caution is still required in the use of MPT to treat IVIG-resistant KD.
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High-dose dexamethasone plus recombinant human thrombopoietin versus high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial
Yu Y, Wang M, Hou Y, Qin P, Zeng Q, Yu W, Guo X, Wang J, Wang X, Liu G, et al
American journal of hematology. 2020
Abstract
We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO) versus HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs. 66.7%, P < 0.001) and complete response (CR, 75.0% vs. 42.7%, P < 0.001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs. 36.5%, P = 0.02; sustained CR: 46.0% vs. 32.3%, P = 0.043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044. This article is protected by copyright. All rights reserved.
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[Effectiveness and mechanism of pure platelet-rich plasma on osteochondral injury of talus]
Wei F, Wang Z
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. 2019;33(5):555-562
Abstract
Objective: To explore the effectiveness and mechanism of pure platelet-rich plasma (P-PRP) on osteochondral injury of talus. Methods: Thirty-six patients with osteochondral injury of talus selected between January 2014 and October 2017 according to criteria were randomly divided into control group (group A), leukocyte PRP (L-PRP) group (group B), and P-PRP group (group C), with 12 cases in each group. There was no significant difference in gender, age, disease duration, and Hepple classification among the three groups ( P>0.05). Patients in the groups B and C were injected with 2.5 mL L-PRP or P-PRP at the bone graft site, respectively. Patients in the group A were not injected with any drugs. The American Orthopaedic Foot and Ankle Society (AOFAS) score and visual analogue scale (VAS) score were used to evaluate the effectiveness before operation and at 3, 6, and 12 months after operation. Study on the therapeutic mechanism of P-PRP: MC3T3-E1 cells were randomly divided into control group (group A), L-PRP group (group B), and P-PRP group (group C). Groups B and C were cultured with culture medium containing 5% L-PRP or P-PRP respectively. Group A was cultured with PBS of the same content. MTT assay was used to detect cell proliferation; ELISA was used to detect the content of matrix metalloprotein 9 (MMP-9) protein in supernatant; alkaline phosphatase (ALP) activity was measured; and real-time fluorescence quantitative PCR (qRT-PCR) was used to detect the expression of osteopontin (OPN), collagen type , and MMP-9 in cells. Western blot was used to detect the expression of MMP-9 in supernatant and phosphoinositide 3-kinase (PI3K), phosphorylated protein kinase B (pAKT), and phosphorylated c-Jun (p-c-Jun) in cells. Results: All patients were followed up 13-25 months, with an average of 18 months. No complication such as wound infection and internal fixation failure occurred. MRI showed that the degree of injury was similar between the three groups before operation, and patients in the three groups all recovered at 6 months after operation. Moreover, group C was superior to groups A and B. Compared with preoperation, AOFAS scores and VAS scores in the three groups were all significantly improved at each time point after operation ( P<0.05). AOFAS score of group C was significantly higher than that of groups A and B at 3, 6, and 12 months after operation ( P<0.05); there was no significant difference in VAS score between the three groups ( P>0.05). Study on the therapeutic mechanism of P-PRP: The absorbance ( A) value, ALP activity, the relative mRNA expression of OPN and collagen type in group C were significantly higher than those in groups A and B ( P<0.05), and those in group B were significantly higher than those in group A ( P<0.05). The relative expression of MMP-9 protein and mRNA and the content of MMP-9 protein detected by ELISA in group B were significantly higher than those in groups A and C, while those in group C were significantly lower than those in group A ( P<0.05). Western blot detection showed that the relative expression of PI3K, pAKT, and p-c-Jun protein in group B was significantly higher than those in groups A and C ( P<0.05), but there was no significant difference between groups A and C ( P>0.05). Conclusion: P-PRP is superior to L-PRP for osteochondral injury of talus, which may be related to the inhibition of PI3K/AKT/AP-1 signaling pathway in the osteoblast, thereby reducing the secretion of MMP-9.