4.Bendamustine combined with pomalidomide and dexamethasone in relapsed multiple myeloma with extramedullary disease: a multicenter study.
Hong Ying WU ; Xia ZHOU ; Xiao Xia CHU ; Xiu Zhi DENG ; Cheng Lu YUAN ; Xue Hong RAN ; Guo Qiang LIU ; Chuan Bo FAN ; Hong Yuan HAO ; Yu Ping ZHONG
Chinese Journal of Hematology 2023;44(8):667-671
		                        		
		                        			
		                        			Objective: To evaluate the efficacy and safety of bendamustine combined with pomalidomide and dexamethasone (BPD regimen) in the treatment of relapsed multiple myeloma (MM) with extramedullary disease. Methods: This open, single-arm, multicenter prospective cohort study included 30 relapsed MM patients with extramedullary disease diagnosed in seven hospitals including Qingdao Municipal Hospital. The patients were treated with BPD regimen from February 2021 to November 2022. This study analyzed the efficacy and adverse reactions of the BPD regimen. Results: The median age of the 30 patients was 62 (47-72) years, of which 18 (60% ) had first-time recurrence. The overall response rate (ORR) of the 18 patients with first-time recurrence was 100%, of which three (16.7% ) achieved complete remission, 10 (55.5% ) achieved very good partial remission (VGPR), and five (27.8% ) achieved partial remission (PR). The ORR of 12 patients with recurrence after second-line or above treatment was 50%, including zero patients with ≥VGPR and six patients (50% ) with PR. Three cases (25% ) had stable disease, and three cases (25% ) had disease progression. The one-year progression free survival rate of all patients was 65.2% (95% CI 37.2% -83.1% ), and the 1-year overall survival rate was 90.0% (95% CI 76.2% -95.4% ). The common grade 3-4 hematology adverse reactions included two cases (6.7% ) of neutropenia and one case (3.3% ) of thrombocytopenia. The overall adverse reactions are controllable. Conclusions: The BPD regimen has good efficacy and tolerance in relapsed MM patients with extramedullary disease.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Multiple Myeloma/drug therapy*
		                        			;
		                        		
		                        			Bendamustine Hydrochloride/therapeutic use*
		                        			;
		                        		
		                        			Prospective Studies
		                        			;
		                        		
		                        			Dexamethasone/therapeutic use*
		                        			;
		                        		
		                        			Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
		                        			
		                        		
		                        	
5.Preliminary application of a novel distraction reductor in the surgical treatment of unstable distal radius fractures with metaphyseal volar comminution
Shengli XIA ; Meiqi QIAO ; Ziyuan MA ; Feng GAO ; Bin WANG ; Shaojun WANG ; Zeyi SUN ; Xiaoxiao ZHOU ; Cunguo YI ; Ribao SU ; Xiaoguang JIN ; Xiuhui WANG ; Xuhan CHEN
Chinese Journal of Orthopaedic Trauma 2023;25(8):663-669
		                        		
		                        			
		                        			Objective:To evaluate a novel distraction reductor in the surgical treatment of unstable distal radius fractures with metaphyseal volar comminution.Methods:From January 2019 to December 2020, 27 patients with unstable distal radius fracture complicated with metaphyseal volar comminution were treated at Department of Orthopaedics, Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences. They were 6 males and 21 females, with an age of (69.4±9.4) years. All fractures were unilateral and closed, involving the right side in 17 cases and the left side in 10 cases. All patients were treated by internal fixation with an anatomical locking plate through the volar approach and the novel distraction reductor was used to reduce the fracture ends. Regular imaging examinations were performed to evaluate the reduction, maintenance and union of fractures after surgery. One year after operation, the curative efficacy was assessed by evaluation of the range of wrist motion, Disabilities of the Arm, Shoulder and Hand (DASH) score, Gartland-Werley score and Bartra radiology score.Results:All the operations went on successfully with a duration of (92.3±8.9) min. All the incisions healed primarily. The follow-up time was (15.9±2.9) months. The radial height, palmar tilt, ulnar inclination and articular surface step-off immediately after operation [(11.23±1.51) mm, 12.10°±3.44°, 20.54°±3.44°, and (0.95±0.42) mm] were not significantly lost compared with those one year after operation [(11.22±1.55) mm, 12.07°±3.44°, 20.51°±3.33°, and (0.93±0.40) mm] (all P>0.05). One year after operation, the range of wrist motion was good with dorsiflexion of 59.7°±5.5°, palm flexion of 63.0°±9.1°, pronation of 66.5°±5.5°, supination of 61.2°±5.6°, radial deviation of 22.7°±4.8°, and ulnar deviation of 30.3°±6.1°; DASH score was 13.5±5.5; Bartra radiology score was 88.6±6.5, giving an excellent and good rate of 88.9% (24/27);Gartland-Werley score was 2.7±2.1, giving an excellent and good rate of 92.6% (25/27). Follow-ups observed no poor fracture healing, internal fixation failure, tendon or nerve injury or traumatic arthritis. Conclusion:In the surgical treatment of unstable distal radius fractures with metaphyseal volar comminution, the novel distraction reductor can lead to ideal reduction of displaced fractures and effectively correct the shortening caused by volar cortex comminution to achieve satisfactory functional effects in clinic.
		                        		
		                        		
		                        		
		                        	
6.Clinical characteristics and risk factors for prolonged recovery after one-stage arterial switch operation for patients with transposition of the great arteries
Zhongyuan LU ; Xu WANG ; Shoujun LI ; Jun YAN ; Min ZENG ; Shengli LI ; Xia LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(01):43-47
		                        		
		                        			
		                        			Objective    To summarize the early clinical features and perioperative management strategies for patients with transposition of the great arteries (TGA) after one-stage arterial switch operation (ASO), and investigate the risk factors for prolonged recovery in ICU, with a focus on the age structure and deformity complexity. Methods    The clinical data of 231 consecutive TGA patients who underwent one-stage ASO were retrospectively analyzed. There were 165 males and 66 females, aged from 3 d to 10 years. The patients were sequenced by the length of ICU stay. The time at the 75th percentile was defined as the critical value for grouping. Patients with an ICU stay time over this point were allocated to a prolonged recovery group (n=54), while the rest were allocated to a normal recovery group (n=177). The perioperative clinical data were compared between the two groups, and the risk factors for prolonged recovery were evaluated. Results    About half (49.6%) of the patients received late operation. The mean ICU stay time was 23.9±15.6 d in the prolonged recovery group, and 4.9±2.3 d in the normal recovery group. Complication of aortic arch lesion, delayed chest closure and postoperative pulmonary infection were independent risk factors for prolonged recovery after ASO in ICU. However, late operation had no significant effect on the overall recovery. Conclusion    With strict surgery indications and excellent postoperative management, most patients can have satisfactory early-stage outcomes, but are confronted with  increased complications, which is associated with prolonged recovery. Complication of aortic arch lesion, delayed chest closure and postoperative pulmonary infection are independent factors for delayed recovery of ASO.
		                        		
		                        		
		                        		
		                        	
7.The first outbreak of dengue fever and molecular tracing in Puyang, 2019
Guofeng XU ; Qingjie ZHANG ; Yuhua ZHANG ; Xiaofei MENG ; Guangkang LI ; Yonghao GUO ; Weimin XIE ; Shengli XIA
Chinese Journal of Preventive Medicine 2021;55(8):978-982
		                        		
		                        			
		                        			Objective:This study retrospectively analyzed an outbreak of dengue fever in Puyang of Henan province in 2019, in order to find the sources of infection.Methods:Dengue virus IgM/IgG and NS1 antigen were tested by colloidal gold method. E gene was amplified by PCR. MegaX was used for sequences alignment to construct evolutionary distance trees.Results:After clinical and laboratory confirmation, there were 81 cases of dengue fever, 17 of which were imported case who were local farmers and worked in Combadia and Thailand, and 64 of which were indigenous cases. The E gene alignment results showed that the pathogen of this epidemic was Vietnamese 1 and highly homologous with the Vietnamese strain. After the local outbreak, dengue virus E gene developed a nucleotide site mutation which can be steadily transmission.Conclusion:The dengue fever outbreak in Puyang was a local outbreak caused by dengue virus type 1, which was associated with imported cases. Gene sequencing showed that the imported pathogen had a relatively stable and transmissible nucleotide mutation after the local epidemic.
		                        		
		                        		
		                        		
		                        	
8.The first outbreak of dengue fever and molecular tracing in Puyang, 2019
Guofeng XU ; Qingjie ZHANG ; Yuhua ZHANG ; Xiaofei MENG ; Guangkang LI ; Yonghao GUO ; Weimin XIE ; Shengli XIA
Chinese Journal of Preventive Medicine 2021;55(8):978-982
		                        		
		                        			
		                        			Objective:This study retrospectively analyzed an outbreak of dengue fever in Puyang of Henan province in 2019, in order to find the sources of infection.Methods:Dengue virus IgM/IgG and NS1 antigen were tested by colloidal gold method. E gene was amplified by PCR. MegaX was used for sequences alignment to construct evolutionary distance trees.Results:After clinical and laboratory confirmation, there were 81 cases of dengue fever, 17 of which were imported case who were local farmers and worked in Combadia and Thailand, and 64 of which were indigenous cases. The E gene alignment results showed that the pathogen of this epidemic was Vietnamese 1 and highly homologous with the Vietnamese strain. After the local outbreak, dengue virus E gene developed a nucleotide site mutation which can be steadily transmission.Conclusion:The dengue fever outbreak in Puyang was a local outbreak caused by dengue virus type 1, which was associated with imported cases. Gene sequencing showed that the imported pathogen had a relatively stable and transmissible nucleotide mutation after the local epidemic.
		                        		
		                        		
		                        		
		                        	
9.A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants
Zhiqiang XIE ; Dongyang ZHAO ; Haitao HUANG ; Jinbo GOU ; Wei ZHANG ; Yongli YANG ; Lili HUANG ; Yanxia WANG ; Xue WANG ; Lifeng XU ; Tao ZHU ; Shengli XIA
Chinese Journal of Preventive Medicine 2020;54(9):947-952
		                        		
		                        			
		                        			The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants. From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348). The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (<0.001). ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.
		                        		
		                        		
		                        		
		                        			Antibodies, Bacterial
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Infant
		                        			;
		                        		
		                        			Meningococcal Vaccines
		                        			;
		                        		
		                        			adverse effects
		                        			;
		                        		
		                        			immunology
		                        			;
		                        		
		                        			Vaccines, Conjugate
		                        			
		                        		
		                        	
10.Safety and immunogenicity of a split-virion quadrivalent influenza vaccine
LIU Shuzhen ; MENG Li ; XI Peipei ; ZHANG Yongchao ; FAN Bei ; LI Changgui ; XIA Shengli ; PAN Ruowen
Journal of Preventive Medicine 2020;32(11):1091-1095
		                        		
		                        			Objective :
		                        			 To evaluate the safety and immunogenicity of a split-virion quadrivalent influenza vaccine.
		                        		
		                        			Methods :
		                        			The healthy people aged three years or over in Wuyang County and Xiping County of Henan Province were divided into the experimental group, control group 1 and control group 2, and were vaccinated with split-virion quadrivalent influenza vaccines, split-virion trivalent influenza vaccines (without B/Victoria) and a split-virion trivalent influenza vaccines (without B/Yamagata) , respectively. The hemagglutination inhibition (HI) antibodies were detected before and after immunization. The incidence rate of adverse events following immunization (AEFI) , HI antibody positive conversion rate, the protection rate of HI antibodies and the growth of geometric mean titer (GMT) were calculated and compared with the standard of Food and Drug Administration (FDA).
		                        		
		                        			Results:
		                        			Totally 2 924 people were recruited, with 975 in the experimental group, 974 in the control group 1 and 975 in control group 2. The incidence rate of AEFI in the experimental group was 11.7%, higher than 7.9% in control group 1 and 8.8% in control group 2 (P < 0.05) during 30 minutes and 8 days after inoculation. The positive conversion rates of HI antibodies of H1N1, H3N2, By and Bv in the experimental group were 78.5%, 53.3%, 78.3% and 62.9%, respectively. The rate differences of the positive conversion rates of HI antibodies of By between the experimental group and control group 2, and of Bv between the experimental group and control group 1 were 42.1% (95%CI: 38.0%-46.2%) and 33.2% (95%CI: 28.9%-37.5%) , with both lower limits of 95%CI more than -0.10. The GMT increase of HI antibodies was more than 2.5 times in the three groups. The protective rates of HI antibodies of H1N1, H3N2, By and Bv in the experimental group were 87.7%, 98.7%, 93.6% and 77.2%, respectively. The protective rates of HI antibodies of By in control group 2 and Bv in control group 1 were 71.1% and 51.0%, both lower than those in the experimental group (P < 0.05).
		                        		
		                        			Conclusions 
		                        			After the inoculation of the quadrivalent influenza vaccine, the positive conversion rates (>40%) , protection rates (>70%) and GMT increase (>2.5 times) of HI antibodies of H1N1, H3N2, By and Bv all meet the quality standards of FDA. The safety and immunogenicity of the quadrivalent influenza vaccine are not inferior to those of the trivalent influenza vaccine.
		                        		
		                        		
		                        		
		                        	
            

Result Analysis
Print
Save
E-mail