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.Exploration of the Disease Mechanism and Treatment of Colorectal Cancer Based on the "One Qi Circulation"
Zhiying WANG ; Ling XU ; Jialin YAO ; Jiajun SONG ; Yun LI ; Shujuan FU ; Yabin GONG ; Yi ZHONG
Journal of Traditional Chinese Medicine 2024;65(10):1068-1071
Based on the theory of "one qi circulation" founded by HUANG Yuanyu, the core disease mechanism of colorectal cancer is the innate spleen deficiency and stomach qi failing to bear downward, which leads to the turbidity assemble in large intestine, forming the carcinoma toxin, and ultimately transforms into colorectal cancer. The treatment should base on recovering the circulation of qi, Huangya Decoction (黄芽汤) as the basic formula, the circulation of qi ascending and descending as the base, adjusting ascending and descending together with Xiaqi Decoction (下气汤), and differentiating the syndrome on yin-yang excess-deficiency; for spleen-kidney yang deficiency syndrome, treated with Tianhun Decoction (天魂汤) to supplement liver, kidney and assist yang; for liver-kidney yin deficiency syndrome, treated wtih Dipo Decoction (地魄汤) to supplement lung, kidney, and assist yang. They jointly prompt one qi circulation to provide the thoughts for the treatment of colorectal cancer by traditional Chinese medicine.
3.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.
4.Research on the application of non-contact physiological and psychological detection in the analysis of long-term simulated weightlessness effects
Shuai DING ; Zi XU ; Qian RONG ; Shujuan LIU ; Zihao LIU ; Yuan WU ; Yao YU ; Zhili LI ; Cheng SONG ; Lina QU ; Hao WANG ; Yinghui LI
Space Medicine & Medical Engineering 2024;35(2):78-83,98
Objective Explore a non-contact physiological and psychological detection model based on facial video in simulations of weightlessness effects,research new methods for non-contact heart rate and negative mood state detection in long-term simulations of weightlessness effect analysis.Methods Construct a non-contact physiological and psychological data collection system for fusion analysis of visible light and thermal infrared videos.Collect physiological and psychological data of volunteers in the"Earth Star-Ⅱ"90-day head-down bed rest experiment.A non-contact heart rate detection model based on GCN facial multi-region feature fusion and a non-contact negative mood state detection model considering data reliability were constructed,and the effectiveness of the models were validated with finger clip heart rate and POMS-SF scale as labels.Results The experimental results show that the average difference in the Bland-Altman plot of the non-contact heart rate detection model is-1.26 bpm,and 96.3%of value error detection data falls within the 95%confidence interval,indicating a high consistency between the model detected heart rate and the finger clip heart rate.The non-contact negative mood state detection model achieves an accuracy of>0.85 for detecting tension,depression,anger,and fatigue.Features such as heart rate,AU06,eye gaze,and head pose were observed to be important to mood state detection.Conclusion Non-contact physiological and psychological detection methods not only can be utilized for long-term physiological analysis in simulations of weightlessness effects,but also provide a novel technical approach for on-orbit astronauts health assurance during long-term space flight in the future.
5.The value of early VA-ECMO support in the perioperative period of emergency percutaneous coronary intervention
Haijia YU ; Jingchao LI ; Huihui SONG ; Luqian CUI ; Shujuan DONG ; Yingjie CHU ; Lijie QIN
Chinese Journal of Emergency Medicine 2024;33(7):946-954
Objective:To investigate the effect of different timing of arterial -venous extracorporeal membrane oxygenation (VA-ECMO) on the prognosis of patients with acute myocardial infarction complicated with cardiogenic shock (AMICS).Methods:This study was a prospective cohort study. AMICS patients received VA-ECMO support primary percutaneous coronary intervention in Henan Provincial People's Hospital from May 2017 to July 2023 were divided into early VA-ECMO group and late VA-ECMO group. 64 AMICS patients who met the indications for VA-ECMO implantation, but did not revive VA-ECMO were included as control group. Demographic characteristics, coronary interventional (PCI) information and complications after VA-ECMO implantation were collected. The primary end points was 1-year survival, minor end point were in-hospital and perioperative death. Multivariate Logistic and Cox regression models were used to evaluate the effect of timing of VA-ECMO on prognosis of AMICS patients. Kaplan-Meier survival curve was used to analyze the 1-year survival outcome of the 3 groups.Results:A total of 143 AMICS patients were included, and materials of 136 patients entered in the final analysis, including 42 in the early VA-ECMO group, 34 in the late VA-ECMO group, and 60 in the non-VA-ECMO group. Compared with the late VA-ECMO group, the early VA-ECMO group had a higher ratio of PPCI after VA-ECMO, a longer D-to-B time, a shorter VA-ECMO support time, a higher success rate of VA-ECMO withdrawal, and a lower complication rate (all P<0.05). Compared with the early VA-ECMO group, the perioperative, in-hospital and 1-year mortality were significantly higher in Non-ECMO support (all P<0.05). There was no difference in perioperative and in-hospital mortality between the early VA-ECMO group and the late VA-ECMO group, but the 1-year mortality in the late VA-ECMO group was significantly higher ( P<0.05). Perioperative, in-hospital and 1-year mortality rates were lower in the late VA-ECMO group than in the no-VA-ECMO group, but the differences were not statistically significant. Multivariate Logistic and Cox regression analysis showed that after adjusting interference factors, early VA-ECMO was still a protective factor for in-hospital ( OR=0.244, P=0.015) and one year ( HR=0.308, P=0.001)mortality. Kaplan-Merier survival curve showed that compared with the late VA-ECMO group and the group without VA-ECMO, the early VA-ECMO group had the highest 1-year survival rate. Conclusion:Patients with AMICS may benefit more from early VA-ECMO than from late VA-ECMO support for PPCI.
6.Clinical and cardiac MR characteristics of heart involvement in patients with Fabry disease
Yangfei XU ; Kai YANG ; Xiaofeng LIU ; Xiuyu CHEN ; Yanyan SONG ; Yihui WANG ; Yucong ZHENG ; Shiqin YU ; Shujuan YANG ; Jiaxin WANG ; Zhixiang DONG ; Minjie LU ; Shihua ZHAO
Chinese Journal of Radiology 2022;56(2):168-174
Objective:To investigate the clinical and cardiac magnetic resonance (CMR) characteristics of heart involvement in patients with Fabry disease (AFD).Methods:From January 2018 to March 2021, eight AFD patients [3 males and 5 females, mean age (50±11) years old, range 26-60 years old] confirmed by genetic testing or pathology in Fuwai Hospital were retrospectively included in this study. At the same time, sixteen patients with hypertrophic cardiomyopathy (HCM) [6 males and 10 females, mean age (46±15) years old] and 16 healthy individuals [6 males and 10 females, mean age (51±11) years old] were included as controls. The clinical baseline data and CMR data of the patients were collected and analyzed. The CMR data were analyzed using the software CVI42, with the corresponding parameters automatically generated. One-way ANOVA or Kruskal-Wallis test was used to compare the differences in the parameters among the three groups. Independent-samples t test, Fisher precise test or Mann-Whitney U test were used for the comparison between each two groups. Results:Statistically significant difference was found in renal insufficiency between the HCM group and the AFD group; No other significant difference was found in other clinical factors and ECG results (all P>0.05). CMR results showed that in the AFD group, there were 5 cases with symmetric or roughly symmetric hypertrophy, and 3 with asymmetric hypertrophy. The late gadolinium enhancement (LGE) showed myocardial enhancement in 5 patients, mainly presenting as multiple intermural enhancement, and partially as local subendocardial enhancement. In the HCM group, fourteen cases suffered mainly asymmetric ventricular septal thickening, with or without thickening of other parts of left ventricular wall; and 2 cases had thickening of middle and distal part of the left ventricle. The LGE showed myocardial enhancement in 14 patients, which manifested as focal or patchy enhancement in hypertrophic myocardium, including focal enhancement in the right ventricular insertion of ventricular septum (more common) and subendocardial enhancement in the middle and far segments of left ventricle. Statistically significant difference was found in the differences between the left atrial anterior posterior diameter, the maximum wall thickness of left ventricular, the left ventricular myocardial mass index (LVMI) and the native T 1 value among the three groups (all P<0.001). However, there was no statistically significant difference in the left atrial anterior posterior diameter and the maximum wall thickness of left ventricular between AFD group and HCM group ( P>0.05). The LVMI in AFD group was higher than that in healthy group and HCM group (all P<0.05). Significant difference was found in the native T 1 value among the three groups, with the native T 1 value of the AFD group [(1 177.4±46.0) ms] was significantly lower than that of the healthy group [(1 244.5±34.3) ms] and the HCM group [(1 278.8±41.6) ms], with ( F=13.10, P<0.001). Conclusions:The clinical characteristics of AFD and HCM are quite similar. When AFD is suspected, CMR imaging should be the first choice for imaging examination. Especially, T 1 mapping imaging can provide important information for the diagnosis of AFD.
7.Multi-enzyme isothermal rapid amplification assay for the detection of Escherichia coli O157∶H7
Shujuan WANG ; Yiling FAN ; Zhen FENG ; Bo JIANG ; Minghui SONG ; Qiongqiong LI ; Hao LIU ; Feng QIN ; Meicheng YANG
Shanghai Journal of Preventive Medicine 2022;34(6):511-518
ObjectiveA rapid enrichment and detection method for Escherichia coli O157∶H7 was developed by using multienzyme isothermal rapid amplification (MIRA) fluorescence method combined with metal organic frameworks immunomagnetic beads. MethodsUsing rfbE gene as the target, the primers, probes and reaction system were screened, and the specificity, sensitivity and practical application of this method were investigated. ResultsThe detection limit of Escherichia coli O157∶H7 was 1.18×105 CFU‧mL-1, and the detection limit of DNA concentration was 9 pg‧μL-1. The detection process was completed in 20 minutes. The test results of 47 strains (24 target strains and 23 non-target strains) were consistent with real-time PCR (RT-PCR). ConclusionA method based on metal-organic framework immunomagnetic beads enrichment combined with MIRA assay is developed in this study. The method is simple, rapid and suitable for rapid enrichment and detection of Escherichia coli O157∶H7 in food.
8.Correction to: MiR-139-5p inhibits migration and invasion of colorectal cancer by downregulating AMFR and NOTCH1.
Mingxu SONG ; Yuan YIN ; Jiwei ZHANG ; Binbin ZHANG ; Zehua BIAN ; Chao QUAN ; Leyuan ZHOU ; Yaling HU ; Qifeng WANG ; Shujuan NI ; Bojian FEI ; Weili WANG ; Xiang DU ; Dong HUA ; Zhaohui HUANG
Protein & Cell 2021;12(8):668-670
9.Role of school based symptom monitoring system in public health emergencies in Hangzhou
HUANG Chunping, WANG Bing, WANG Jing, SONG Shujuan, SUN Wei, DING Hua
Chinese Journal of School Health 2021;42(4):627-630
Objective:
To analyze the role of school based symptom monitoring system in public health emergencies in Hangzhou, to provide the basis for prevention and control strategies for public health emergencies in schools.
Methods:
Data regarding school public health emergencies in Hangzhou in 2019 were collected from the Public Health Emergencies Report Management Information System, and data regarding public health early warning in schools were collected from the Hangzhou School Symptom Monitoring System. The usage of school symptom monitoring system was analyzed by SAS 9.0 software, and the positive warning events and public health emergencies were compared and analyzed, the rate and composition ratio were compared with the χ 2 test, the number of cases was compared with the non parameter rank and the Mann Whitney test, and the trend test was conducted using Cochran Armitage test.
Results:
In 2019, the average use rate of the city s school symptom monitoring system was 54.65%, the average response rate of automatic early warning was 70.68%, and the use rate (χ 2=860.79, p<0.01) and automatic early warning response rate (χ 2=1 615.91,P<0.01) of school systems varied greatly by region. In 2019, 161 positive early warning incidents were detected through the school symptom monitoring system, 197 public health emergencies were reported through the emergency network, and fewer public health emergencies were reported in areas where more positive warning events were detected(Z=10.65,P<0.01). The proportion of disease category in positive warning events was different from that in public health emergencies in(χ 2=28.33, P<0.01). The number of cases of positive early warning events of the same disease was much lower than the number of cases of public health emergencies without warning, and the time of positive warning signals was on average 4 days ahead of the time of receiving the report of public health emergencies.
Conclusion
Smartphone based school symptom monitoring system in Hangzhou plays a sentinel role in public health emergencies prevention and control in schools.
10.Relationship of work-family conflict, work withdrawal behavior and psychological resilience of postpartum female nurses with the second-child
Weihua WU ; Yuqin CHENG ; Ju WENG ; Haohua HUANG ; Jing SONG ; Shujuan WEN
Chinese Journal of Practical Nursing 2021;37(31):2467-2472
Objective:To investigate the work-family conflict, work withdrawal behavior and psychological resilience of postpartum female nurses with the second-child, analyze the relationships between them, further analyze whether there is a mediating role of psychological resilience between work-family conflict and work withdrawal behavior.Methods:A total of 303 postpartum female nurses with the second-child were assessed with general information questionnaire, Work-Family Conflict Scale(WFC), Conner-Davidson Resilience Scale(CD-RISC) and Work Withdrawal Behavior Scale(WWBS).Results:The total score of WFC was 53.22±13.63, and the highest score in the factor of time while lowest in the factor of behavior with 18.92±5.00,16.92±6.07. The total score of WWBS was 18.79±4.26, and the score of dimension of psychological withdrawal and behavioral withdrawal was 13.99±3.53, 4.80±1.22. The total score of CD-RISC was 88.81±16.45. The total scores and scores of each dimension of WFC were positively correlated with those of WWBS( r values were 0.122-0.396, P<0.05 or 0.01). The total scores and scores of each dimension of CD-RISC were negatively correlated with those of WWBS and WFC( r values were -0.320--0.094, P<0.05 or 0.01). Structural equation modeling analysis showed that work-family conflict indirectly affected work withdrawal behavior through psychological resilience. Conclusions:Cultivating psychological resilience shows a positive effect on easing the work-family conflict and improving work withdrawal behavior for postpartum female nurses with the second-child.


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