He X.,Ningbo 6th Hospital |
Ye P.,Ningbo 6th Hospital |
Hu Y.,Ningbo 6th Hospital |
Huang L.,Ningbo 6th Hospital |
And 4 more authors.
Archives of Orthopaedic and Trauma Surgery | Year: 2013
Objectives: To present a case series of patients with posterior bicondylar tibial plateau fractures treated by direct exposure and buttress plate fixation through posterior inverted L-shaped approach. Methods: Between August 2007 and July 2010, eight middle aged patients were identified to have posterior bicondylar tibial plateau fractures. All the eight patients underwent direct fracture exposure, reduction under visualization, and buttress plate fixation through posterior inverted L-shaped approach. Results: All the cases were followed for an average of 28.1 months (24-36 months). All the cases had satisfactory reduction except one case, which had a 3-mm stepoff postoperatively. None of the complications such as infection, necrosis of the skin incision or the loosening and breakage of the internal fixator occurred. The average radiographic bony union time and full weightbearing time were 11.5 weeks (10-14 weeks), and 13.8 weeks (11-17 weeks) respectively. The average range of motion of the affected knee was from 3.6 to 127.8 at 1 year after the operation. Conclusions: The posterior inverted L-shaped approach would not involve osteotomy, tendotomy or division of muscles, while allowing satisfied visualization of the entire posterior aspect of tibial plateau and appropriate placement of hardware. This approach is a safe and effective way for the treatment of posterior bicondylar tibial plateau fractures. © 2012 Springer-Verlag Berlin Heidelberg. Source
Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: A multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz
Zhang H.,Peking University |
Zhang K.,Peking University |
Zhang X.,Shanghai 6th Peoples Hospital |
Zhu Z.,Shanghai 9th Peoples Hospital |
And 8 more authors.
Arthritis Research and Therapy | Year: 2015
Introduction: Intra-articular injection of hyaluronic acid (HA) is often used as therapy for knee osteoarthritis because it is less expensive and less aggressive than total knee replacement. Therefore, it is important to document whether HA is safe and efficacious. We tested whether single and multiple injection viscosupplementation with HA is associated with clinically meaningful pain relief in a new randomized clinical trial (RCT). Our objective was to compare safety and efficacy of intra-articular HA in two formulations: one 3.0 ml injection of Durolane versus five 2.5 ml injections of Artz for the treatment of knee osteoarthritis pain. Methods: Patients (N = 349) from the People's Republic of China were randomized to treatment (Durolane = 175, Artz = 174). The Durolane group received a 3.0 ml injection at week 0 (baseline), with sham skin punctures at weeks 1, 2, 3, and 4. The Artz group received one 2.5 ml injection at each of the same time points. The primary assessment tool was the Likert-type Western Ontario and McMaster University (WOMAC) pain scale at weeks 0, 6, 10, 14, 18, and 26. Secondary assessments were WOMAC physical function, knee stiffness, and global self-assessment, at identical time points. Statistically-controlled analyses were non-inferiority of Durolane over 18, then over 26 weeks, with a priori non-inferiority defined as 8% of the relevant scale. Acetaminophen was permitted as rescue analgesia and all adverse events (AEs) were recorded. Results: Overall study retention was excellent; 332 patients (95.1%) completed 18 weeks and 319 (91.4%) completed 26 weeks, with no significant retention difference between treatment arms. All variables met non-inferiority criteria over 18 and 26 weeks. Efficacy response in both arms was >90%. Treatment-related AEs were 9.8% (17/174) for Artz and 13.1% (23/175) for Durolane. Conclusions: A single injection of Durolane is non-inferior to 5 injections of Artz over 18 and 26 weeks for pain, physical function, global self-assessment, and knee stiffness. Both treatments were efficacious, safe, and well tolerated. Trial registration: ClinicalTrials.gov NCT01295580. Registered 11 February 2011. © Zhang et al.; licensee BioMed Central. Source
Wu D.,Soochow University of China |
Du X.,Guangdong General Hospital |
Jin J.,Zhejiang University |
Xiao Z.,Institute of Hematology and Blood Diseases Hospital |
And 13 more authors.
Advances in Therapy | Year: 2015
Introduction: The objective of this study was to evaluate the efficacy and safety of decitabine in Chinese patients with myelodysplastic syndrome (MDS). Methods: Patients (≥18 years) who had a de novo or secondary MDS diagnosis according to French–American–British classification and an International Prognostic Scoring System score ≥0.5 were enrolled and randomized (1:1) to one of two decitabine regimens: 3-day treatment (3-h intravenous infusion of 15 mg/m2 given every 8 h for three consecutive days/cycle/6 weeks) or 5-day treatment (1-h intravenous infusion of 20 mg/m2 once daily on days 1–5/cycle/4 weeks). After a minimum of 30 patients were assigned to 3-day schedule, the remaining were assigned to the 5-day schedule. The primary efficacy endpoint was the overall response rate (ORR). Secondary outcome measures included hematologic improvement (HI), cytogenetic response rate, the time to acute myeloid leukemia (AML) progression, and overall survival (OS). Results: In total, 132 of 135 enrolled patients (3-day treatment, n = 36; 5-day treatment, n = 99) discontinued treatment (major reasons included patient withdrawal/lack of efficacy, n = 48; adverse events, n = 23; and disease progression, n = 22). During the study, 35 of 132 (26.5%) patients from the intent-to-treat (ITT) group achieved significant (P < 0.001) ORR [3-day group (n = 10, 29.4%), P = 0.003; 5-day group (n = 25, 25.5%), P < 0.001]. The HI rate was similar between the 3-day (47.1%) and 5-day groups (48.0%). Cytogenetic response was achieved in 20 of the 30 (66.7%) patients who had a baseline cytogenetic abnormality. Fifty-three (40.2%) AML transformations or deaths occurred and the median AML-free survival time was 23.8 months for all patients from the ITT set; 24-month OS rate was 48.9%. Adverse events of myelosuppression-related disorders (85.6%) and infections (43.2%) were commonly reported. Conclusion: Decitabine treatment was efficacious in Chinese patients with MDS with its safety profile comparable to the global studies of decitabine conducted to date. Funding: Xian-Janssen Pharmaceutical Ltd. China (a company of Johnson & Johnson). Trial registration: ClinicalTrials.gov identifier, NCT01751867. © 2015, The Author(s). Source
Han X.-X.,Qingdao University |
Zhang M.,Weifang Peoples Hospital |
Ma A.-G.,Qingdao University |
Ge S.,Shanghai 6th Peoples Hospital |
And 3 more authors.
British Journal of Nutrition | Year: 2011
The objective of the present study was to investigate age-related differences in erythrocyte membrane fluidity (EMF) and changes in antioxidant capacity following supplementation. A total of seventy-four children were randomly divided into two groups: group A1 was the placebo-controlled group and group A2 was supplemented daily with 600 μg retinol, 1•0 mg β-carotene, 100 mg tocopherol, 300 mg ascorbic acid and 200 μg Se. A total of ninety young people were randomly divided into B1 and B2 groups, and ninety-one elderly subjects were divided into C1 and C2 groups. Groups B1 and C1 were placebo-controlled groups, and groups B2 and C2 were daily supplemented with 900 μg retinol, 1•5 mg β-carotene, 200 mg tocopherol, 500 mg ascorbic acid and 400 μg Se. Results showed that plasma malondialdehyde (MDA) was 5•35 μmol/l in children, which was lower than in young and elderly people. The MDA levels of the young and elderly individuals in the treated groups were significantly lower compared with the control groups, but the supplementation did not alter MDA levels in children. At baseline, there was a lower value of polarisation (p) and microviscosity (σ) in children, indicating a higher EMF, than in both the young and elderly subjects. After the 2-month trial, the p and σ values of young and elderly subjects in the treated groups decreased significantly in comparison with the placebo groups, indicating an increase in EMF. In conclusion, there was a background of higher MDA levels and lower EMF in young and elderly people than in children, which could be improved by antioxidant supplementation. © 2011 The Authors. Source
Cai W.,University of Rochester |
Zhao B.,Shanghai 6th Peoples Hospital |
Conover D.,Enterprise Corp |
Liu J.,University of Rochester |
And 2 more authors.
Medical Physics | Year: 2012
Purpose: This research is designed to develop and evaluate a flat-panel detector-based dynamic cone beam CT system for dynamic angiography imaging, which is able to provide both dynamic functional information and dynamic anatomic information from one multirevolution cone beam CT scan. Methods: A dynamic cone beam CT scan acquired projections over four revolutions within a time window of 40 s after contrast agent injection through a femoral vein to cover the entire wash-in and wash-out phases. A dynamic cone beam CT reconstruction algorithm was utilized and a novel recovery method was developed to correct the time-enhancement curve of contrast flow. From the same data set, both projection-based subtraction and reconstruction-based subtraction approaches were utilized and compared to remove the background tissues and visualize the 3D vascular structure to provide the dynamic anatomic information. Results: Through computer simulations, the new recovery algorithm for dynamic time-enhancement curves was optimized and showed excellent accuracy to recover the actual contrast flow. Canine model experiments also indicated that the recovered time-enhancement curves from dynamic cone beam CT imaging agreed well with that of an IV-digital subtraction angiography (DSA) study. The dynamic vascular structures reconstructed using both projection-based subtraction and reconstruction-based subtraction were almost identical as the differences between them were comparable to the background noise level. At the enhancement peak, all the major carotid and cerebral arteries and the Circle of Willis could be clearly observed. Conclusions: The proposed dynamic cone beam CT approach can accurately recover the actual contrast flow, and dynamic anatomic imaging can be obtained with high isotropic 3D resolution. This approach is promising for diagnosis and treatment planning of vascular diseases and strokes. © 2012 American Association of Physicists in Medicine. Source