Objective:To analyze and evaluate the safety and efficacy of a Chinese domestically manufactured Heart Con-type implantable third-generation magnetic and hydrodynamic levitation left ventricular assist device(LVAD) for the treatment of end-stage heart failure(ESHF), by reporting the results of eleven-center clinical trial on 50 cases.Methods:This study was a multicenter clinical trial, designed by means of prospective, multicenter and single-group target value. 50 subjects with ESHF were competitively enrolled and treated with HeartCon as the LVAD in eleven centers. The primary efficacy measure was survival, defined as either the subjects experiencing the transition to heart transplantation(HT) or myocardial recovery assisted by the device within 90 days, or as successfully assisted by the LVAD for full 90 days after implantation. The target survival rate was 60%, other observations included implantation success rate, mortality, pump failure needing replacement or emergency heart transplantation.Results:All enrolled 50 patients received LVAD implantation successfully, 46 survived with the pump for 90 days, 1 patient transitioned to heart transplantation, and 3 patients experienced pump thrombosis, within which 2 patients underwent pump replacement and continued to live with the pump for 90 days, and the other one received emergency heart transplantation. There were no dropout subjects. The survival rate at full 90 days after HeartCon implantation was 100%. The survival rates with pump in the full set analysis and the protocol set analysis were 96.00% and 95.92% respectively, which were higher than the target value of 60%. The differences were both statistically significant( P<0.05). Conclusion:The results of the multicenter clinical trial with the largest sample size in China using domestically manufactured third-generation LVAD has demonstrated that, HeartCon is a safe and effective LVAD to treat ESHF patients.

Objective To investigate the influence of internal and external sphincter loss synergy on stress distributions and urine flow rates of lower urinary tract organs and tissues. Methods Based on collodion slice, the geometric model of the lower urinary tract was reconstructed, and finite element model of the lower urinary tract with muscle active force was established. Through fluid structure coupling simulation, the changes of tissue stress and urine flow rate were simulated under four conditions: normal contraction of internal and external sphincter, total loss of muscle active force and single loss of muscle active force for internal and external sphincters at the end of urination. Results The urethral stress changes in normal contraction of internal and external sphincter muscles were the same as the clinically measured urethral pressure changes. Compared with normal contraction, when the internal sphincter lost its muscle active force alone, stress of the internal sphincter and the urethra of the prostate was reduced by 33.6% and 13.8%, and flow rate of urine in this position was also reduced. When the external sphincter lost its muscle active force alone, the urethral stress of the external sphincter and external urethra was reduced by 59.5% and 24.03%, respectively. When the internal and external sphincter lost muscle active force, stress of the internal sphincter, the prostate, the external sphincter and the external urethra were reduced by 38.77%, 18.6%, 63.58%, 29.74%, respectively, and flow velocity in the corresponding position was also reduced. Conclusions Internal and external sphincter loss synergy resulted in the difference of tissue stress and urine flow rate. The results can provide the theoretical basis for surgical treatment of urinary incontinence caused by sphincter.

Nanoparticles are considered to be a powerful approach for the delivery of poorly water-soluble drugs. One of the main challenges is developing an appropriate method for preparation of drug nanoparticles. As a simple, rapid and scalable method, the flash nanoprecipitation (FNP) has been widely used to fabricate these drug nanoparticles, including pure drug nanocrystals, polymeric micelles, polymeric nanoparticles, solid lipid nanoparticles, and polyelectrolyte complexes. This review introduces the application of FNP to produce poorly water-soluble drug nanoparticles by controllable mixing devices, such as confined impinging jets mixer (CIJM), multi-inlet vortex mixer (MIVM) and many other microfluidic mixer systems. The formation mechanisms and processes of drug nanoparticles by FNP are described in detail. Then, the controlling of supersaturation level and mixing rate during the FNP process to tailor the ultrafine drug nanoparticles as well as the influence of drugs, solvent, anti-solvent, stabilizers and temperature on the fabrication are discussed. The ultrafine and uniform nanoparticles of poorly water-soluble drug nanoparticles prepared by CIJM, MIVM and microfluidic mixer systems are reviewed briefly. We believe that the application of microfluidic mixing devices in laboratory with continuous process control and good reproducibility will be benefit for industrial formulation scale-up.

Objective To access the influence factors of diagnostic delay of endometriosis. Methods We designed a questionnaire of diagnostic delay of endometriosis. From February 2014 to February 2016,400 patients who had dysmenorrhea and diagnosed with endometriosis by surgery in Peking University Third Hospital were surveyed retrospectively. Time and risk factors of diagnostic delay were analyzed.Results The diagnostic delay of 400 patients was 13.0 years(0.2-43.0 years),78.5%(314/400) patients thought pain was a normal phenomenon and didn′ t see the doctor. Patients who suffered dysmenorrhea at menarche experienced longer diagnostic delay than those who had dysmenorrhea after menarche(18.0 vs 4.5 years;Z=191.800,P<0.01).Patients who suffered aggravating dysmenorrhea experienced shorter delay time than those who suffered stable or relieving dysmenorrhea(11.0 vs 12.5 vs 18.0 years;Z=8.270, P<0.05), with the difference statistically significant, single factor analysis shows. Severe dysmenorrhea, deep infiltration endometriosis(DIE), family history of dysmenorrhea or endometriosis, previous surgical history of endometriosis,high stage,with infertility,adenomyoma or other symptoms,could help to shorten diagnostic delay with no significant difference(P>0.05). By multiple logistic regression analysis,the results shown that whether have dysmenorrhea at menarche and clinical diagnosis time were the independent factors affecting delayed diagnosis(P<0.01).Conclusions Diagnostic delay of endometriosis is common and the mean delay time is 13.0 years mainly due to the unawareness of dysmenorrhea. Dysmenorrhea at menarche,clinical diagnosis time and dysmenorrhea intensity are the factors affecting time of diagnostic delay.

Objective: To analysis the biomechanical and biocompatible properties of calcium phosphate cement (CPC) enhanced by chitosan short nanofibers(CSNF) and Arg-Gly-Asp (RGD). Methods: Chitosan nanofibers were prepared by electrospinning, and cut into short fibers by high speed dispersion. CPC with calcium phosphorus ratio of 1.5:1 was prepared by Biocement D method. The composition and structure of CPC, CSNF, RGD modified CSNF (CSNF-RGD), CSNF enhanced CPC (CPC-CSNF), RGD modified CPC-CSNF (CPC-CSNF-RGD) were observed by infrared spectrum, X-ray diffraction (XRD) and scan electron microscopy (SEM). The mechanical properties were measured by universal mechanical testing instrument. The adhesion and proliferation of MC3T3 cells were assessed using immunofluorescence staining and MTT method. Results: The distribution of CSNF in the scaffold was homogeneous, and the porous structure between the nanofibers was observed by SEM. The infrared spectrum showed the characteristic peaks at 1633 nm and 1585 nm, indicating that RGD was successfully grafted on chitosan nanofibers. The XRD pattern showed that the bone cement had a certain curability. The stain-stress test showed that break strengths were (17.74±0.54) MPa for CPC-CSNF and (16.67±0.56) MPa for CPCP-CSNF-RGD, both were higher than that of CPC(all P<0.05). The immunofluorescence staining and MTT results indicated that MC3T3 cells grew better on CPC-CSNF-RGD after 240 min of culture(all P<0.05). Conclusion: CSNF-RGD can improve the biomechanical property and biocompatibility of CPC, indicating its potential application in bone tissue repair.
3T3 Cells ; Animals ; Biocompatible Materials ; Bone Cements ; chemistry ; metabolism ; pharmacology ; Calcium Phosphates ; metabolism ; Cell Proliferation ; drug effects ; Chitosan ; chemistry ; pharmacology ; Mice ; Nanofibers ; chemistry ; Oligopeptides ; chemistry

Objective To explore the efficacy and safety of Sorafenib as monotherapy to FLT3 positive acute myeloid leukemia(AML).Methods From April 2014 to December 2015,fourteen AML patients with FLT3 positive,7 males and 7 females with a median age of 42(range:14-81) years old,were enrolled in this study.Of the 14 cases,4 were de novo cases,9 refractory cases and 1 relapsed case,including 78.6％ patients with severe complications and 57.1％ patients with KPS score less than 60 [the median KPS score was 45 (20-70)].The administration of Sorafenib was 400 mg twice daily and Sorafenib was continued if tolerated.The treatment response was evaluated by MICM and the data were analyzed by paired samples t test before and after Sorafenib treatment.Results The peripheral blood WBC count [4.2 (0.9-11.8) × 109/L vs 39.6 (2.3-209.5) × 109/L,P＜0.001],the percentage of peripheral blast cell [0.07 (0-0.54) vs 0.53 (0-0.94),P＜0.001] and the percentage of bone marrow blast cell [0.266 (0.020-0.880) vs 0.604 (0.180-0.900),P=0.003] were significantly decreased after Sorafenib monotherapy compared with before.The overall response rate was 57.1％ (8/14),including 5 cases (35.7％) with complete remission(CR).Of 4 de novo cases,2 achieved CR,1 with PR,1 with NR;3 of 10 refractory and relapsed patients achieved CR and 2 cases achieved PR,5 cases NR The median duration of achieving molecular remission (FLT3-ITD negative) after Sorafenib was 46 (33-72) days,and the median progression free survival (PFS) was 53 (28-175) days.Conclusion Sorafenib shows activity in FLT3-ITD mutation positive AML patients.Sorafenib monotherapy could be used as a treatment option for elderly patients or patients with severe complications,and refractory and relapsed patients with not suitable for intensive chemotherapy.

Child ; China ; Coronavirus ; Epidemiology ; Humans

Objective To evaluate the efficacy and safety of infliximab and traditional disease modifying antirheumatic drugs (DMARDs) in the treatment of ankylosing spondylitis (AS). Methods Sixty patients with definite AS were treated with infliximab 5 mg/kg infusion at 0, 2, 6, 12 weeks and were followed up for 12 weeks. The primary endpoint was proportion of ASAS 20 responders at week 12. The secondary endpoints were the proportion of ASAS 50, the change from baseline in Bath AS functional index (BASFI).The improvement of signs and symptoms of AS and physical function were evaluated. The statistical treatments were used t-test andA2 test. Results The proportion of ASAS 20 responders at 2, 6, 12 week was 70%, 83% and 93% respectively. The proportion of ASAS50 responders at patients at 2, 6, 12 week was 13%, 37% and 57% respectively. Results for other secondary efficacy endpoints showed that infliximab could provide substantial benefits to patients with AS by reducing clinical signs and symptoms and improving range of motion, physical function and quality of life. Ten percent of the subjects reported treatment- related adverse events. The most frequently occurred were upper respiratory tract infection, followed by gastrointestinal adverse events and infusion reaction. Most treatment-related adverse events were mild to moderate in severity and disappeared after drug withdrawal. Conclusion Infliximab has been demonstrated to be effective and is well tolerated in the treatment of AS.

Objective To summerize the experiences of using random flaps to reconstruct soft tissue defects of the periorbital region.Methods Periorbital soft tissue defects in 65 patients underwent reconstruction surgery by random flaps with pedicle 1.0～2.5 cm in width.The length of the flap ranged from 1.0 cm to 3.5 cm,with the rate of length to width less than 2.5:1.Detail plans on flap and incision design were made based on the aesthetic and functional problems.Results Phenomena of blister and purplish red in the edge or the distal area of the flaps were observed in 3 cases,and were disappeared after corresponding treatment.The other flaps survived and the wound healed primarily after operation.The color and the texture of the flaps matched well to the adjacent tissues with satisfied function and aesthetic Results .Conclusion Random flap is an ideal substitute to repair periorbital soft tissue defects.

etabolic response to radiotherapy may predict the prognosis of paitents with locally advanced NPC. The prognosis is poor for patients with high FDG uptake before and after radiotherapy or SUV max-NSUV max-P .