1.Clinical validation of the safety and efficacy of sodium hyaluronate gel DX23 in the treatment of midface depression
Yan JIN ; Zhensheng HU ; Zhihua ZHANG ; Pei LIU ; Wenzhi LI
Chinese Journal of Plastic Surgery 2024;40(11):1175-1183
Objective:To investigate the efficacy and safety of injectable modified sodium hyaluronate gel DX23 in filling and treating midface depression.Methods:A prospective, randomized, multicenter, "no treatment" controlled study was conducted. Patients with midface depression who were treated from March 2019 to February 2021 at Beijing Anzhen Hospital Affiliated to Capital Medical University, Qilu Hospital of Shandong University, and Jining First People’s Hospital were enrolled. Patients were randomized using a stratified block randomization method with a random function list. The experimental group received injectable modified sodium hyaluronate gel DX23 to treat midface depression. The concentration of sodium hyaluronate in DX23 was 23 mg/ml. The syringe was inserted perpendicularly to the skin at a 90-degree angle, and the injection layers were the superficial periosteum or the subcutaneous layer. The injection volume ranged from 1 to 6 ml. The control group received no treatment. The upper boundary of the midface extended outward from the zygomatic arch to the upper margin of the helix and inward to the line connecting the outer canthus. The lower boundary was the line connecting the corner of the mouth to the earlobe. Researchers used the midface aesthetic scales (MAS) response rate at 6 months post-injection as the primary indicator to evaluate the efficacy in improving the severity of midface depression. A reduction of 1 point in the MAS score compared to pre-treatment was considered a response, i. e., effective. Secondary indicators included the MAS response rates at 6 and 12 months after the last treatment (MAS response rate=number of MAS responders/total cases × 100%), the average change in three-dimensional midface volume images, the global aesthetic improvement scale (GAIS) response rate, patient satisfaction regarding the degree of improvement in midface volume, and monitoring of adverse reactions. Data analysis was performed using SPSS 25.0, SAS 9.04, and StataIC 15.0 software. The full analysis set (FAS) and the per-protocol set (PPS) were selected for analysis. Inferential analysis used t-tests and chi-square tests, with P<0.05 considered statistically significant. Results:A total of 164 patients were enrolled. The experimental group included 134 patients (7 males and 127 females) with an average age of 43.0±9.7 years (ranging from 21.6 to 66.6 years). The control group included 30 patients (5 males and 25 females) with an average age of 39.3±11.1 years (ranging from 25.6 to 43.5 years). The experimental group received bilateral midface depression filling, with an initial use of injectable modified sodium hyaluronate gel DX23 at a volume of (4.07±1.28) ml. In the experimental group, 3 cases were lost to follow-up at 30 days, 2 cases at 60 days, and 10 cases were excluded due to protocol violations. Fifteen patients entered FAS but not PPS. Ultimately, 119 patients completed the trial. The MAS response rates in the experimental group at 6 and 12 months post-treatment were 94.96% (113/119) and 56.30% (67/119), respectively. The control group’s MAS response rate at 6 months was 3.33% (1/30). At the 6-month follow-up post-treatment, the GAIS response rates evaluated by researchers and patients in the experimental group were 97.48% (116/119) (PPS) and 97.69% (27/30) (FAS), respectively. In the control group, the GAIS response rate evaluated by researchers was 3.33% (1/30) (FAS, PPS), and the patient GAIS response rate was 0% (0/30) (FAS, PPS). There were statistically significant differences between the two groups in both researcher and patient GAIS response rates (both P<0.01). At 6 months post-injection, comparisons of midface volume changes from baseline between the experimental and control groups showed statistically significant differences [(1.65±1.40) ml (PPS) vs. (0.12±0.85) ml; (1.55±1.44) ml (FAS) vs. (0.12±0.85) ml; both P<0.001]. At the 6-month follow-up in the experimental group, 1 case was lost to follow-up. In the PPS, 81 patients were "satisfied, " 34 were "very satisfied, " and 3 were "neutral." In the control group, 29 patients were "neutral, " and 1 was "dissatisfied." A total of 128 patients in the experimental group experienced injection site reactions, including swelling, hardness, tenderness, pain, lumps (protrusions), and bruising. Over 75% of patients resolved spontaneously within 8 days. Three cases received hot compress treatment and resolved within 28 days. One case experienced swelling of the left lower eyelid 1 day after injection, which resolved after local compression for 3 months. In the control group, 1 case developed circulatory ischemia and carotid atherosclerosis 12 months after the trial began. Conclusion:Injectable modified sodium hyaluronate gel DX23 corrects midface depression through local volume augmentation and is characterized by safety and durability.
2.Software-aided efficient identification of the components of compound formulae and their metabolites in rats by UHPLC/IM-QTOF-MS and an in-house high-definition MS2 library:Sishen formula as a case
Hong LILI ; Wang WEI ; Wang SHIYU ; Hu WANDI ; Sha YUYANG ; Xu XIAOYAN ; Wang XIAOYING ; Li KEFENG ; Wang HONGDA ; Gao XIUMEI ; Guo DE-AN ; Yang WENZHI
Journal of Pharmaceutical Analysis 2024;14(10):1484-1495
Identifying the compound formulae-related xenobiotics in bio-samples is full of challenges.Conventional strategies always exhibit the insufficiencies in overall coverage,analytical efficiency,and degree of automation,and the results highly rely on the personal knowledge and experience.The goal of this work was to establish a software-aided approach,by integrating ultra-high performance liquid chromatography/ion-mobility quadrupole time-of-flight mass spectrometry(UHPLC/IM-QTOF-MS)and in-house high-definition MS2 library,to enhance the identification of prototypes and metabolites of the compound formulae in vivo,taking Sishen formula(SSF)as a template.Seven different MS2 acquisition methods were compared,which demonstrated the potency of a hybrid scan approach(namely high-definition data-independent/data-dependent acquisition(HDDIDDA))in the identification precision,MS1 coverage,and MS2 spectra quality.The HDDIDDA data for 55 reference compounds,four component drugs,and SSF,together with the rat bio-samples(e.g.,plasma,urine,feces,liver,and kidney),were acquired.Based on the UNIFI? platform(Waters),the efficient data processing workflows were estab-lished by combining mass defect filtering(MDF)-induced classification,diagnostic product ions(DPIs),and neutral loss filtering(NLF)-dominated structural confirmation.The high-definition MS2 spectral li-braries,dubbed in vitro-SSF and in vivo-SSF,were elaborated,enabling the efficient and automatic identification of SSF-associated xenobiotics in diverse rat bio-samples.Consequently,118 prototypes and 206 metabolites of SSF were identified,with the identification rate reaching 80.51%and 79.61%,respectively.The metabolic pathways mainly involved the oxidation,reduction,hydrolysis,sulfation,methylation,demethylation,acetylation,glucuronidation,and the combined reactions.Conclusively,the proposed strategy can drive the identification of compound formulae-related xenobiotics in vivo in an intelligent manner.
3.Clinical validation of the safety and efficacy of sodium hyaluronate gel DX23 in the treatment of midface depression
Yan JIN ; Zhensheng HU ; Zhihua ZHANG ; Pei LIU ; Wenzhi LI
Chinese Journal of Plastic Surgery 2024;40(11):1175-1183
Objective:To investigate the efficacy and safety of injectable modified sodium hyaluronate gel DX23 in filling and treating midface depression.Methods:A prospective, randomized, multicenter, "no treatment" controlled study was conducted. Patients with midface depression who were treated from March 2019 to February 2021 at Beijing Anzhen Hospital Affiliated to Capital Medical University, Qilu Hospital of Shandong University, and Jining First People’s Hospital were enrolled. Patients were randomized using a stratified block randomization method with a random function list. The experimental group received injectable modified sodium hyaluronate gel DX23 to treat midface depression. The concentration of sodium hyaluronate in DX23 was 23 mg/ml. The syringe was inserted perpendicularly to the skin at a 90-degree angle, and the injection layers were the superficial periosteum or the subcutaneous layer. The injection volume ranged from 1 to 6 ml. The control group received no treatment. The upper boundary of the midface extended outward from the zygomatic arch to the upper margin of the helix and inward to the line connecting the outer canthus. The lower boundary was the line connecting the corner of the mouth to the earlobe. Researchers used the midface aesthetic scales (MAS) response rate at 6 months post-injection as the primary indicator to evaluate the efficacy in improving the severity of midface depression. A reduction of 1 point in the MAS score compared to pre-treatment was considered a response, i. e., effective. Secondary indicators included the MAS response rates at 6 and 12 months after the last treatment (MAS response rate=number of MAS responders/total cases × 100%), the average change in three-dimensional midface volume images, the global aesthetic improvement scale (GAIS) response rate, patient satisfaction regarding the degree of improvement in midface volume, and monitoring of adverse reactions. Data analysis was performed using SPSS 25.0, SAS 9.04, and StataIC 15.0 software. The full analysis set (FAS) and the per-protocol set (PPS) were selected for analysis. Inferential analysis used t-tests and chi-square tests, with P<0.05 considered statistically significant. Results:A total of 164 patients were enrolled. The experimental group included 134 patients (7 males and 127 females) with an average age of 43.0±9.7 years (ranging from 21.6 to 66.6 years). The control group included 30 patients (5 males and 25 females) with an average age of 39.3±11.1 years (ranging from 25.6 to 43.5 years). The experimental group received bilateral midface depression filling, with an initial use of injectable modified sodium hyaluronate gel DX23 at a volume of (4.07±1.28) ml. In the experimental group, 3 cases were lost to follow-up at 30 days, 2 cases at 60 days, and 10 cases were excluded due to protocol violations. Fifteen patients entered FAS but not PPS. Ultimately, 119 patients completed the trial. The MAS response rates in the experimental group at 6 and 12 months post-treatment were 94.96% (113/119) and 56.30% (67/119), respectively. The control group’s MAS response rate at 6 months was 3.33% (1/30). At the 6-month follow-up post-treatment, the GAIS response rates evaluated by researchers and patients in the experimental group were 97.48% (116/119) (PPS) and 97.69% (27/30) (FAS), respectively. In the control group, the GAIS response rate evaluated by researchers was 3.33% (1/30) (FAS, PPS), and the patient GAIS response rate was 0% (0/30) (FAS, PPS). There were statistically significant differences between the two groups in both researcher and patient GAIS response rates (both P<0.01). At 6 months post-injection, comparisons of midface volume changes from baseline between the experimental and control groups showed statistically significant differences [(1.65±1.40) ml (PPS) vs. (0.12±0.85) ml; (1.55±1.44) ml (FAS) vs. (0.12±0.85) ml; both P<0.001]. At the 6-month follow-up in the experimental group, 1 case was lost to follow-up. In the PPS, 81 patients were "satisfied, " 34 were "very satisfied, " and 3 were "neutral." In the control group, 29 patients were "neutral, " and 1 was "dissatisfied." A total of 128 patients in the experimental group experienced injection site reactions, including swelling, hardness, tenderness, pain, lumps (protrusions), and bruising. Over 75% of patients resolved spontaneously within 8 days. Three cases received hot compress treatment and resolved within 28 days. One case experienced swelling of the left lower eyelid 1 day after injection, which resolved after local compression for 3 months. In the control group, 1 case developed circulatory ischemia and carotid atherosclerosis 12 months after the trial began. Conclusion:Injectable modified sodium hyaluronate gel DX23 corrects midface depression through local volume augmentation and is characterized by safety and durability.
4.Development of microsatellite markers and analysis of genetic characteristics of laboratory Apodemus peninsulae population
Qing ZHANG ; Xiwen ZHANG ; Song HE ; Bao YUAN ; Jian CHEN ; Wenzhi REN ; Fushi QUAN ; Jinping HU ; Yu DING
Acta Laboratorium Animalis Scientia Sinica 2024;32(4):468-476
Objective Polymorphic microsatellite markers developed for Apodemus peninsulae can enrich its genetic data and lay a foundation for genetic quality control and gene mapping.Methods Microsatellite loci were screened based on the genome sequence of Apodemus peninsulae,and microsatellite primers were identified.The genetic diversity of the population was analyzed by multiplex PCR.Results Thirty microsatellite markers were successfully developed and evaluated using 60 samples of Apodemus peninsulae.A total of 152 alleles were detected,with an average of 5.067 alleles per locus.The average observed heterozygosity was 0.592.The average Shannon index was 1.265.The average polymorphism information content was 0.598.Conclusions Based on the microsatellite loci developed in this study,the genetic diversity of Apodemus peninsulae can be effectively analyzed,laying a foundation for establishing genetic quality standards and detection method.
5.A retrospective study on the prevalence and risk factors of neurogenic lower urinary tract dysfunction for acute ischemic stroke in China: A case-control study
Fengming HAO ; Shuxian LI ; Lanlan YU ; Yingjie HU ; Ling CHEN ; Wenzhi CAI
Investigative and Clinical Urology 2024;65(4):368-377
Purpose:
This study identified risk factors for neurogenic lower urinary tract dysfunction (NLUTD) in patients with acute ischemic stroke (AIS) through multidimensional analysis of the medical records of patients, aiming to reduce the incidence of NLUTD, improve prognosis, and facilitate rehabilitation.
Materials and Methods:
In this case-control study, patients with AIS were recruited from two tertiary general hospitals in Shenzhen, China, from March 2021 to October 2023. Patients were divided into NLUTD and non-NLUTD groups based on the presence and absence of NLUTD, respectively. Comparative analysis was performed using the Mann–Whitney U and chi-square tests, with significant variables being included in logistic regression analysis.
Results:
Of the 652 participants enrolled in this study, 119 participants (18.3%) developed NLUTD. Bivariate analysis showed that 39 of 54 screened factors exhibited a significant correlation (p<0.05) with the incidence of NLUTD after AIS. Significant variables identified through logistic regression analysis included Glasgow coma scale (GCS) and National Institutes of Health Stroke Scale (NIHSS) scores, anemia, aphasia, pneumonia, brainstem involvement, multiple lesions, urine clarity (CLA), random venous blood glucose (GLU) and hemoglobin (HGB) levels, and white blood cell (WBC) count.
Conclusions
A total of 11 risk factors for NLUTD were identified in this study. This finding provides valuable guidance for reducing the incidence of NLUTD after AIS and improving the quality of life of patients.
6.Standard for monitoring and evaluation of two-dimensional- and three-dimensional-transesophageal echocardiography during transcatheter tricuspid valve replacement
Cuizhen PAN ; Wei LI ; Daxin ZHOU ; Yuan ZHANG ; Wenzhi PAN ; Shasha CHEN ; Jing SHI ; Haiyan CHEN ; Dehong KONG ; Yu LIU ; Zhenyi GE ; Chunqiang HU ; Kefang GUO ; Xianhong SHU ; Junbo GE
Chinese Journal of Ultrasonography 2023;32(5):449-454
Transcatheter tricuspid valve intervention is the new frontier of interventional cardiology. The LuX-Valve is a radial force-independent orthotopic tricuspid valve replacement device developed in China. The LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system is changed from the trans-atrial to the transjugular approach, which further reduces trauma and pulmonary complications compared with the first generation LuX-Valve. The first-in-human study has been completed at Zhongshan Hospital, Fudan University and an exploratory multicentre clinical study is underway. Echocardiography plays an important role in pre-TTVR screening, intraoperative guidance and postoperative evaluation and follow-up, especially two-dimensional transoesophageal echocardiography (2D-TEE) and three-dimensional transoesophageal echocardiography (3D-TEE). However, there is a lack of appropriate intraoperative guidance and assessment protocols. In this study, we briefly described the protocols and imaging considerations for intraoperative 2D-TEE and 3D-TEE to ensure the successful implantation of TTVR.
7.Comparative analysis of blood components distribution in 24 domestic prefecture-level blood stations
Cheng PENG ; Guanlin HU ; Li LI ; Zhenxing WANG ; Jinghan ZHANG ; Yugen CHENG ; Liping HUANG ; Qiuhong MUO ; Yang LIU ; Wenzhi WANG ; Haining WANG ; Hao LI ; Youhua SHEN ; Xiaojuan YANG ; Guoqian YANG ; Ling WU ; Feng YAN ; Ning LI ; Jing LIU ; Lin BAO ; Mengshang ZHANG ; Jing CUI ; Zhujun FU ; Helong GUO ; Shutao PANG
Chinese Journal of Blood Transfusion 2022;35(9):942-946
【Objective】 To understand the current situation of blood components distribution in domestic prefecture-level blood stations through analyzing the components distribution data of 24 prefecture-level blood stations in China. 【Methods】 The data of components distribution of 24 blood stations from 2017 to 2020 as well as the data of blood deployment of 24 blood stations from 2019 to 2020 were collected and analyzed. 【Results】 From 2017 to 2020, positive annual growth in red blood cells, plasma and cryoprecipitate was observed in 22, 19 and 15 out of the 24 blood stations, and the annual growth median rate of above three components was 5.24%, 3.80% and 3.25%, respectively. Among the 24 prefecture-level blood stations, 23 carried out the preparation of cryoprecipitate. 【Conclusion】 The distribution of red blood cells, cryoprecipitate and plasma in prefecture-level blood stations is increasing year by year. However, there is a overstock of plasma, and most blood stations need blood employment.
8. Analysis of prescribing of antiplatelet drug in patients with coronary heart disease in department of geriatrics
Xiya LU ; Yuxing LI ; Wenzhi LI ; Yuanyuan PENG ; Yi HU ; Li WAN ; Bilian CHEN ; Xiya LU ; Yuxing LI ; Wenzhi LI ; Yi HU ; Li WAN
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(11):1285-1291
AlM: To analyze the prescribing of different antiplatelet drugs and clinical conditions of patients with coronary heart disease in department of Geriatrics. METHODS: This study was a single center and cross-sectional study. Patients with coronary heart disease were recruited when hospitalized in the department of Geriatrics department, Xiangya Hospital, Central South University between December 2021 and June 2022. We investigated and analyzed the clinical conditions of patients including the prescribing of the antiplatelet drugs. RESULTS: A total of 347 coronary heart disease patients with a mean age of (65.2 ± 10.1) years were included. The antiplatelet drug clopidogrel was the most commonly prescribed. Among the different dual antiplatelet therapy (DAPT), aspirin combined with clopidogrel was the most widely used. With the increasing of the numbers of target coronary lesions, the prescribing rate of clopidogrel increased significantly (P < 0.05). In three groups with different degrees of target coronary lesions, the prescribing rate of aspirin was higher than that of indobufene (P < 0.05). Compared with patients taking aspirin, the patients taking indobufene were older with a higher blood creatinine level, a higher proportion of chronic gastropathy and the higher level of platelet aggregation rates (P < 0.05). CONCLUSlON: Clopidogrel is the most commonly prescribed antiplatelet drugs in patients with coronary heart disease. Aspirin combined with clopidogrel is the most widely used in DAPT. Compared with aspirin, indobufene is more commonly used in elderly patients with the chronic gastritis and a higher serum creatinine level.
9.Offline two-dimensional liquid chromatography coupled with ion mobility-quadrupole time-of-flight mass spectrometry enabling four-dimensional separation and characterization of the multicomponents from white ginseng and red ginseng
Tiantian ZUO ; Chunxia ZHANG ; Weiwei LI ; Hongda WANG ; Ying HU ; Wenzhi YANG ; Li JIA ; Xiaoyan WANG ; Xiumei GAO ; Dean GUO
Journal of Pharmaceutical Analysis 2020;10(6):597-609
Inherent complexity of plant metabolites necessitates the use of multi-dimensional information to accomplish comprehensive profiling and confirmative identification. A dimension-enhanced strategy, by offline two-dimensional liquid chromatography/ion mobility-quadrupole time-of-flight mass spec-trometry (2D-LC/IM-QTOF-MS) enabling four-dimensional separations (2D-LC, IM, and MS), is proposed. In combination with in-house database-driven automated peak annotation, this strategy was utilized to characterize ginsenosides simultaneously from white ginseng (WG) and red ginseng (RG). An offline 2D-LC system configuring an Xbridge Amide column and an HSS T3 column showed orthogonality 0.76 in the resolution of ginsenosides. Ginsenoside analysis was performed by data-independent high-definition MSE (HDMSE) in the negative ESI mode on a Vion TM IMS-QTOF hybrid high-resolution mass spectrometer, which could better resolve ginsenosides than MSE and directly give the CCS information. An in-house ginsenoside database recording 504 known ginsenosides and 58 reference compounds, was estab-lished to assist the identification of ginsenosides. Streamlined workflows, by applying UNIFI TM to auto-matedly annotate the HDMSE data, were proposed. We could separate and characterize 323 ginsenosides (including 286 from WG and 306 from RG), and 125 thereof may have not been isolated from the Panax genus. The established 2D-LC/IM-QTOF-HDMSE approach could also act as a magnifier to probe differ-entiated components between WG and RG. Compared with conventional approaches, this dimension-enhanced strategy could better resolve coeluting herbal components and more efficiently, more reli-ably identify the multicomponents, which, we believe, offers more possibilities for the systematic exposure and confirmative identification of plant metabolites.
10. Cranial measurement analysis of 3 406 infants aged 0 to 6 months in Chongqing
Wang YANG ; Jianping CHEN ; Wenzhi SHEN ; Bin HU ; Qin CHANG ; Kuilin LYU ; Qiuming PAN ; Hongxia LI ; Yuping ZHANG
International Journal of Pediatrics 2019;46(9):687-691
Objective:
The incidence and distribution of positional deformities(PD)were studied by measuring cranial types of infants aged 0-6 months of 3 hospitals in Chongqing, and the recommended values of local PD were discussed.
Methods:
Data of 3 406 infants with 0-6 months head size measurements were collected from the Second Affiliated Hospital of Army Military Medical University, Yongchuan Maternal and Child Health Care Hospital and Wanzhou Maternal and Child Health Care Hospital from September 1, 2017 to August 31, 2018, cranial vault asymmetry(CVA)and cranial index(CI)were calculated.According to different age groups, observe the distribution of cranial types, and use the current international common diagnostic criteria to understand the incidence of cranial abnormalities, and analyze the distribution of percentile values of CVA and CI in infants in Chongqing.
Results:
According to the current international standard diagnosis of PD, the incidence of simple brachycephaly was the highest(39.9%)in the overall cranial abnormalities of infants, followed by brachycephaly with plagiocephaly was the second(36.1%), simple plagiocephaly was the lowest(6.9%), and normal cranial type only accounted for 17.1%.The detection rates of plagiocephaly(36.9%)and brachycephaly(67.0%)were the lowest in the 0-2 months group, and the highest in the 3-4 months group(47.3%/83.3%), and then decreased in the 5-6 months group(46.6%/80.2%).
Conclusion
The basic values of cranial type measurement of full-term infants in chongqing were significantly different from international reports, mainly due to the large CI value.The general international diagnosis standard for positional deformities do not conform to Chinese infants.We suggest that the reference value for positional deformities in this region is as follows: CVA≥0.4 cm is abnormal, of which 0.4 cm≤CVA<0.6 cm for mild plagiocephaly, 0.6 cm≤CVA<1.0 cm for moderate plagiocephaly, CVA≥1.0 cm for severe plagiocephaly; 82%≤CI≤91% is abnormal, of which 91%≤CI<94% for mild brachycephaly; 94% ≤CI<99% for moderate brachycephaly; CI≥ 99% for severe brachycephaly.CI≤82% is scaphocephaly.

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