1.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
2.Relationship between family resilience and mental health among military personnel:a cross lagged analysis
Kaiyuan JING ; Yanzhen YANG ; Shujuan SUN ; Yawen TAN ; Bingqing XUE ; Yijun ZHU ; Mengxue ZHAO
Journal of Army Medical University 2024;46(3):209-214
Objective To explore the causal relationship between family resilience and mental health in military personnel population.Methods A total of 204 military personnel were recruited from an army unit stationed in Western China with cluster convenience sampling.Family Resilience Scale(FRS)and Symptom Checklist 90(SCL-90)were used to survey them twice,in an interval of 4 months.Amos 26.0 was applied to construct a cross-lag model and analyze the data.Results After controlling mental symptoms from the first survey,family resilience in the first measure significantly predicted mental symptoms in the second measure(β=-0.14,P<0.05).After controlling for family resilience from the first survey,mental symptoms in the first measure significantly predicted family resilience in the second measure(β=-0.13,P<0.05).Conclusion The relationship between family resilience and mental health is mutually causal in military personnel,and one predicts the other one.Our findings highlight the key dimensions of the relationship between the two.
3.Self-neglect in elderly diabetic patients in the community:an interpretive phenomenological study
Yaping LUO ; Shujuan YU ; Miaomiao ZHU ; Hongying PAN
Chinese Journal of Nursing 2024;59(2):203-209
Objective To explore the experience and causes of self-neglect of elderly diabetic patients in community,so as to provide references for community nursing workers to identify and intervene the self-neglect behavior of elderly diabetic patients.Methods An interpretative phenomenological method was used to collect data from elderly diabetic patients registered in 3 community health service centers in Hangzhou,Zhejiang Province through semi-structured interviews.Van Manen's method was used to analyze qualitative data.Results The experience and reasons of self-neglect of elderly diabetic patients in community were summarized into 4 themes and 10 sub-themes,including neglecting personal health(low sense of self-worth,high level of self-esteem,being afraid of compromising the family),neglecting blood glucose management(weak health awareness,difficulty in blood glucose management),inadequate self-care capacity(poor financial situation,insufficient personal time,diminished mobility)and inadequate perceived support(low social support,insufficient emotional support).Conclusion The experience and reasons of self-neglect of elderly diabetic patients in community are diversified.Community health services and nursing workers should pay attention to the performance of self-neglect behavior of elderly diabetic patients and actively explore effective prevention and intervention measures.
4.Expert consensus on pediatric orthodontic therapies of malocclusions in children
Zhou CHENCHEN ; Duan PEIPEI ; He HONG ; Song JINLIN ; Hu MIN ; Liu YUEHUA ; Liu YAN ; Guo JIE ; Jin FANG ; Cao YANG ; Jiang LINGYONG ; Ye QINGSONG ; Zhu MIN ; Jiang BEIZHAN ; Ruan WENHUA ; Yuan XIAO ; Li HUANG ; Zou RUI ; Tian YULOU ; Gao LI ; Shu RUI ; Chen JIANWEI ; Liu RENKAI ; Zou SHUJUAN ; Li XIAOBING
International Journal of Oral Science 2024;16(2):186-196
Malocclusion,identified by the World Health Organization(WHO)as one of three major oral diseases,profoundly impacts the dental-maxillofacial functions,facial esthetics,and long-term development of~260 million children in China.Beyond its physical manifestations,malocclusion also significantly influences the psycho-social well-being of these children.Timely intervention in malocclusion can foster an environment conducive to dental-maxillofacial development and substantially decrease the incidence of malocclusion or reduce the severity and complexity of malocclusion in the permanent dentition,by mitigating the negative impact of abnormal environmental influences on the growth.Early orthodontic treatment encompasses accurate identification and treatment of dental and maxillofacial morphological and functional abnormalities during various stages of dental-maxillofacial development,ranging from fetal stages to the early permanent dentition phase.From an economic and societal standpoint,the urgency for effective early orthodontic treatments for malocclusions in childhood cannot be overstated,underlining its profound practical and social importance.This consensus paper discusses the characteristics and the detrimental effects of malocclusion in children,emphasizing critical need for early treatment.It elaborates on corresponding core principles and fundamental approaches in early orthodontics,proposing comprehensive guidance for preventive and interceptive orthodontic treatment,serving as a reference for clinicians engaged in early orthodontic treatment.
5.Different types of programmed cell death in periodontitis
Shasha ZHU ; Weidong TIAN ; Shujuan GUO
STOMATOLOGY 2024;44(8):624-629
Periodontitis is a chronic inflammatory and destructive disease in which plaque acts as an initiator.Recruitment of host im-mune cells and production of multiple inflammatory mediators leads to periodontal tissue damage.Programmed cell death(PCD)is a self-destructive process that is actively initiated by cells under specific conditions and can be mainly categorized into apoptosis,necrop-tosis,autophagy,pyroptosis,ferroptosis,cuproptosis,etc.Different types of programmed cell death have their own distinctive roles in periodontitis.In this review,we summarizes the characteristics of different types of PCD and their role in the progression of periodonti-tis,in order to provide new research ideas on the pathogenic mechanism of periodontitis and more references for the precise treatment of periodontitis.
6.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
7.Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
Huiqiang HUANG ; Zhiming LI ; Lihong LIU ; Liang HUANG ; Jie JIN ; Hongyan TONG ; Hui ZHOU ; Zengjun LI ; Zhenqian HUANG ; Wenbin QIAN ; Kaiyang DING ; Quande LIN ; Ming HOU ; Yunhong HUANG ; Jingbo WANG ; Pengcheng HE ; Xiuhua SUN ; Xiaobo WANG ; Zunmin ZHU ; Yao LIU ; Jinhai REN ; Huijing WU ; Liling ZHANG ; Hao ZHANG ; Liangquan GENG ; Jian GE ; Ou BAI ; Liping SU ; Guangxun GAO ; Xin LI ; Yanli YANG ; Yijian CHEN ; Aichun LIU ; Xin WANG ; Yi WANG ; Liqun ZOU ; Xiaobing HUANG ; Dongping HUANG ; Shujuan WEN ; Donglu ZHAO ; Jun MA
Journal of Leukemia & Lymphoma 2023;32(8):457-464
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
8.Value and influencing factors of preoperative MRI evaluation for previous cesarean scar defect associated abnormal uterine bleeding in patients undergoing laparoscopic surgery
Qi ZHANG ; Changwei LIN ; Jiaoyang WU ; Dabao XU ; Shujuan ZHU ; Bin JIANG
Journal of Central South University(Medical Sciences) 2023;48(9):1316-1324
Objective:As the cesarean section rate increases year by year,the treatment of previous cesarean scar defects(PCSD)poses a significant challenge.This study aims to evaluate the clinical value of preoperative magnetic resonance imaging(MRI)technology and analyze relevant influencing factors for patients with abnormal uterine bleeding(AUB)associated with cesarean scar defects who underwent laparoscopic surgery.Methods:A retrospective cohort analysis was performed on women who underwent laparoscopic surgery for PCSD-related AUB at the Department of Gynecology,the Third Xiangya Hospital of Central South University from 2018 to 2022.A total of 57 patients who underwent laparoscopic surgery for the treatment of AUB associated with PCSD were divided into 2 groups based on their postoperative clinical cure status:The clinically-cured group(n=28,49.1%)and the non-clinically-cured group(n=29,50.9%).After a postoperative follow-up period of 3 months for all participants,logistic regression analysis was conducted to explore the correlation between the clinical cure rate of AUB associated with cesarean scar defects treated by laparoscopic surgery and various factors.These factors included patient age,clinical symptoms,obstetric history,history of cesarean section,basic clinical information,preoperative MRI parameters,and postoperative menstrual conditions.Results:There were no significant differences in many aspects,including the patient's age at the time of previous cesarean section,number of pregnancy,time since the previous cesarean section,the uterus position assessed by preoperative T2 signal MRI,defect length,defect width,residual muscle layer thickness,adjacent uterine muscle layer thickness,and distance from the defect to the external cervical os between the 2 groups(all P>0.05).However,the time of onset of AUB symptoms(P=0.036,OR=1.019,95%CI 1.002 to 1.038)and the depth of the defect on the preoperative MRI(P=0.010,OR=5.793,95%CI 1.635 to 25.210)were identified as risk factors affecting the clinical cure rate.Conclusion:The time of onset of AUB symptoms and the depth of the defect on preoperative MRI are risk factors that influence the clinical cure rate of laparoscopic surgery for the treatment of AUB associated with PCSD,which could be helpful for evaluating the prognosis of disease.
9.Downregulation of Micall2a Gene Expression Inhibited Vascular Development in Zebrafish
Jinxian YANG ; Shujuan WANG ; Jinyun ZHAI ; Shunxing ZHU
Laboratory Animal and Comparative Medicine 2023;43(3):282-287
Objective To explore the expression pattern of Micall2a gene during the early development of zebrafish embryos and the effect of this gene on zebrafish vascular development.MethodsWhole embryo in situ hybridization was used to detect Micall2a expression levels at different stages of early embryo development of Tg (fli:GFP) transgenic (labeled with green fluorescent protein) and wild type zebrafish (AB). Micall2a gene expression was downregulated by microinjection of a morpholine antisense oligonucleotide, and real-time fluorescent quantitative PCR was used to detect mRNA expression of the gene at different developmental stages of zebrafish embryos. Laser confocal microscopy was used to observe and analyze vascular phenotypic changes in zebrafish after the downregulation of Micall2a. ResultsMicall2a was expressed in the brain, heart, and vascular system of zebrafish embryos at the 24th, 36th, and 48th hours post fertilization. The mRNA level of Micall2a increased after microinjection of morpholine antisense oligonucleotides, inhibiting vascular development in zebrafish embryos, resulting in internode angiogenesis defects in zebrafish. ConclusionDownregulation of Micall2a expression inhibits the development of blood vessels in zebrafish.
10.Optimization, reliability and validity test of Manchester needs tool for injured children
Yanan ZHU ; Chenchen HOU ; Zhimei LIU ; Shujuan WANG ; Fujuan CHEN ; Lanling WEI ; Huihui XU
Chinese Journal of Trauma 2023;39(10):933-939
Objective:To optimize the Manchester needs tool for injured children (MANTIC) scale , and evaluate its reliability and validity among injured children. Methods:The MANTIC scale was optimized through Delphi expert consultation and pre-tests. From March 2023 to June 2023 , a total of 317 injured children admitted in 7 level A tertiary hospitals in Zhejiang and Shandong provinces and their families were surveyed with general data, optimized MANTIC scale, and EuroQol 5-dimension health questionnaire for youth (EQ-5D-Y). Item analysis was conducted on the data of the 317 patients collected with optimized MANTIC scale through the test for homogeneity and value-based decision-making method and the content validity test of the scale was evaluated with item-level content validity index (I-CVI) and scale-level content validity index (S-CVI). It was evaluated with KMO test values and Bartlett′s test of sphericity to determine whether the scale was suitable for exploratory factors. The number of common factors was determined based on the K1 criterion and scree plot to further obtain the structural validity of the scale of the item load value. The correlation validity of the scale was evaluated with the correlation coefficient of the optimized MANTIC scale and EQ-5D-Y. The reliability of the scale was tested with Cronbach alpha coefficient and Guttman split-half reliability coefficient. Results:A total of 332 questionnaires were distributed, among which 317 valid ones were collected, with a response rate of 95.6%. The test of homogeneity in the item analysis showed that the correlation coefficient between each item and the total score of the scale was 0.40-0.80. The results of the value-based decision-making method showed that the critical ratio of high-and low-scored groups was 6.08-28.01. The quality of all the items met the retention requirements so that the reliability and validity tests could be continued. Validity test found that I-CVI was 0.83-1.00, consistent S-CVI was 0.83, and mean S-CVI was 0.95. In structural validity analysis, the KMO value was 0.96, and the Chi-square value of Bartlett′s test of sphericity was 10755.76 ( P<0.01). A total of 9 common factors were extracted with the K1 criterion (eigen value>1), and the scree plot indicated 9 common factors with a cumulative variance contribution rate of 73.46%. Factor extraction and rotation showed that the load value of each item of the scale ranged from 0.589 to 0.874. The correlation coefficient of the optimized MANTIC scale and EQ-5D-Y was r= 0.55 ( P<0.01).Reliability test showed that the Cronbach alpha coefficient of the total scale and all dimensions was 0.96 and 0.77-0.98, and the Guttman split-half reliability coefficient was 0.76 and 0.73-0.98. Conclusion:The optimized MANTIC scale can attain good reliability, validity, consistency and stability, and can reflect the concept to be expressed and the content to be evaluated, indicating that it can be used to evaluate the injury rehabilitation needs of injured children and their families throughout the entire treatment process.

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