PubMed | Shanghai JiaoTong University, Janssen Pharmaceutical, Nanjing Southeast University, Nanjing Medical University and 9 more.
Type: Clinical Trial, Phase III | Journal: Advances in therapy | Year: 2015
The objective of this study was to evaluate the efficacy and safety of decitabine in Chinese patients with myelodysplastic syndrome (MDS).Patients (18years) 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 15mg/m(2) given every 8h for three consecutive days/cycle/6weeks) or 5-day treatment (1-h intravenous infusion of 20mg/m(2) once daily on days 1-5/cycle/4weeks). 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).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 23.8months 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.Decitabine treatment was efficacious in Chinese patients with MDS with its safety profile comparable to the global studies of decitabine conducted to date.Xian-Janssen Pharmaceutical Ltd. China (a company of Johnson & Johnson).ClinicalTrials.gov identifier, NCT01751867.
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
PubMed | Beijing Friendship Hospital, Beijing Military General Hospital, Zhejiang University, Peking University and 4 more.
Type: | Journal: Arthritis research & therapy | Year: 2015
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.Patients (N=349) from the Peoples 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.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.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.ClinicalTrials.gov NCT01295580 . Registered 11 February 2011.
Guan J.-J.,Shanghai JiaoTong University |
Wang Y.,Shanghai 6th Peoples Hospital |
Zhang C.-Q.,Shanghai JiaoTong University
Yiyong Shengwu Lixue/Journal of Medical Biomechanics | Year: 2013
Bone tissues constantly receive the mechanical stimulation and maintain the dynamic balance of bone formation and resorption. Currently, the mechanism of how bone tissues sense the mechanical stimulation is still unknown. An increasing number of studies have shown that primary cilium may be the mechanical sensor of bone tissues. The primary cilium maybe transfer the extracellular mechanical signals into intracellular biochemical message through them, and the mechanical stimulation received by bone tissues can regulate bone remodeling finally. This article reviews the current researches on primary cilium, predicts the research tendency and tries to lay some foundation for the use of primary cilium to prevent and treat osteoporosis.
Huang H.-Q.,Shanghai JiaoTong University |
Fang X.-Z.,Shanghai JiaoTong University |
Shi J.,Shanghai 6th Peoples Hospital |
Hu J.,Shanghai JiaoTong University
Medical and Biological Engineering and Computing | Year: 2014
Acute myelocytic leukemia (AML) is a relapsing and deadly disease. Thus, it is important to early predict leukemia relapse. Recent studies have demonstrated strong correlations of relapse with abnormal localization of immature precursors (ALIP). However, there is no related research on automated detection of ALIP so far. To this end, we have proposed an ALIP detection method to investigate the relevance with AML relapse. Kernelized fuzzy C-means clustering is applied first to separate the foreground (with cells) and background (without cells). Image repairing is then used to wipe out noises to mark region of interest. Then, image partition is introduced to separate the overlapping cells. After that, a set of features are extracted for the classification. Thereafter, support vector machine is applied to classify precursors. At last, filtering operations are applied to obtain the binary-precursor detection results. Thirty-seven patients with AML are examined. The results show that ALIP is efficiently detected in a high sensitivity and positive predictive value by our proposed method. The investigation also demonstrates the strong correlations of AML relapse with ALIP. © 2013 International Federation for Medical and Biological Engineering.
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.
Meng Q.,Guangdong Academy of Medical science |
Zhang S.,Sun Yat Sen University |
Cheng H.,Shanghai 6th Peoples Hospital |
Chen X.,Jinan 2nd Peoples Hospital |
Jin Y.,Sun Yat Sen University
Graefe's Archive for Clinical and Experimental Ophthalmology | Year: 2010
Background: To evaluate the efficacy and safety of heavy silicone oil Oxane Hd as intraocular tamponade in the treatment of complicated retinal detachment (RD). Methods: Forty eyes of 40 patients with complicated RD were recruited for this prospective study. Inclusion criteria were proliferative vitreoretinopathy grade ≥ CP2, mainly inferior and posterior retinal breaks, or superior retinal breaks with patient's inability to posture. Oxane Hd was used as intraocular tamponade. The retinal status, the best-corrected visual acuity (BCVA) results, and any complications were observed. Results: The mean duration of Oxane Hd endotamponade was 87.9 ± 10.4 days, and the mean follow-up time after Oxane Hd removal was 438.1 ± 153.7 days. The primary anatomical success rate after Oxane Hd removal was 87.5%, and with further intervention 97.5%. The BCVA significantly improved, from mean logMAR 2.12 ± 0.60 to 1.38 ± 0.59 (P < 0.001). The postoperative complications included temporary inflammatory reaction, moderately high intraocular pressure, heavy silicone oil emulsification, lens opacity and retinal proliferative membranes. Conclusions: Without a requirement for postoperative prone position, heavy silicone oil Oxane Hd is effective and safe for the treatment of complicated RD with inferior and posterior breaks. Larger groups and a longer follow-up period will be included to further evaluate the efficacy with Oxane Hd in superior retinal breaks. © 2010 Springer-Verlag.
PubMed | Shanghai 6th Peoples Hospital, Associate Senior Doctor. and Executive Director.
Type: Journal Article | Journal: Obstetrical & gynecological survey | Year: 2017
Anti-mllerian hormone (AMH) is considered an important marker of ovarian reserve; however, the exact function of AMH has yet to be determined.Our purpose was to investigate factors correlated with AMH levels in Chinese women.Healthy women were divided into 2 groups: aged younger than 30 years and 30 years or older. Anti-mllerian hormone levels and biochemical indices were compared between the groups.Eighty women younger than 30 and 29 women 30 years or older were included. The mean AMH level in women younger than 30 years was 8.2 4.4 ng/mL (range, 0.1-17.2 ng/mL), and in those 30 years or older was 5.2 4.3 ng/mL (range, 0.1-13.3 ng/mL). Half of women younger than 30 years had an AMH level above a median of 8.0 ng/mL (interquartile range, 4.9-11.2 ng/mL), whereas the median in those 30 years or older was 4.6 ng/mL (interquartile range, 1.3-8.5 ng/mL). In women younger than 30 years, calcium was positively correlated (Anti-mllerian hormone levels are positively or negatively correlated with testosterone, calcium, SHBG, and triglycerides in Chinese women.
Ma J.,Shanghai 6th Peoples Hospital |
Qiao Z.,Shanghai 6th Peoples Hospital |
Xiang X.,Shanghai 6th Peoples Hospital
Carbohydrate Polymers | Year: 2011
Optimal conditions for the extraction of black fungus polysaccharides were 350 W, 5, 35 min and 90 °C, for ultrasonic power, ratio of water to sample, extraction time and extraction temperature, respectively. Gas chromatography (GC) analysis showed that black fungus polysaccharides contained glucose, xylose, mannose and ribose. Their molar percentages were 6.8%, 34.2%, 50.7% and 8.9%, respectively. FT-IR and NMR analysis showed typical chemical structure of black fungus polysaccharides. In animal experiment, high fat diet feeding for 29 days markedly reduced myocardium and blood antioxidant enzyme activities and enhanced lipid peroxidation level. Administration of black fungus polysaccharides had significantly enhanced myocardium and blood antioxidant enzyme activities and reduced lipid peroxidation level in high fat mice. Our results indicated that black fungus polysaccharides could be beneficial for protection against cardiovascular diseases and its complications. © 2011 Elsevier Ltd. All rights reserved.
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.
Jun X.,Shanghai 6th Peoples Hospital |
Chang-Qing Z.,Shanghai 6th Peoples Hospital |
Kai-Gang Z.,Shanghai 6th Peoples Hospital |
Hong-Shuai L.,Shanghai 6th Peoples Hospital |
Jia-Gen S.,Shanghai 6th Peoples Hospital
Journal of Orthopaedic Trauma | Year: 2010
Objective: To evaluate a modified free vascularized fibular grafting procedure with an anterior approach to the hip as a treatment for femoral neck nonunions. Design: Retrospective radiographic and clinical review. Setting: Level I trauma center. Patients/Participants: Twenty-six femoral neck nonunions treated between November 2000 and December 2005. Main Outcome Measurements: Harris Hip scoring system and radiographic standard evaluation for bone union. Results: The average follow-up period was 29.3 months (range, 12-63 months). The average duration of the surgery was 2.5 hours (range, 2-4 hours). Average blood loss was 300 mL (range, 200-400 mL). The neck-shaft angle was improved by 2.3° on average. Twenty-four of 26 femoral neck nonunions healed without any severe complications. Average union time was 5.3 months (range, 3-9 months). Twenty-four patients had well-functioning hips with an average Harris hip score of 87.9 as compared with the average preoperative Harris hip score of 57.8. One case developed osteonecrosis of the femoral head requiring total hip arthroplasty 2 years after the index procedure. One case developed an immediate postoperative infection. CONCLUSION: The clinical result indicates that the anterior approach modification of free vascularized fibular grafting is a valuable procedure in the treatment of femoral neck nonunions. Copyright © 2010 by Lippincott Williams & Wilkins.