1.Intelligent transformation of pharmaceutical quality control laboratories: challenges and future trends
Li-ling HUANG ; Yu-qiong KONG ; Heng-yuan MA
Acta Pharmaceutica Sinica 2024;59(10):2723-2729
Drug testing involves many analytical instruments and test items, sample pretreatment is tedious, the industry's intelligence level remains low, making drug testing a labour-intensive job. However, in the era of Industry 4.0 intelligent manufacturing, intelligent transformation of the quality control (QC) laboratory has become the focus of industry. At the same time, driven by consistency evaluation of the quality and efficacy of generic drugs and the centralized procurement policies, pharmaceutical companies have intensified their competition, further stimulating the intrinsic demand for laboratory intelligence. Based on the current state and future trends of the pharmaceutical industry, this review discusses the development of a digital and automated QC laboratory. It points out the necessity of transitioning from the traditional centralized laboratory model to an intelligent, distributed quality control model to accommodate continuous manufacturing processes. At the same time, it also analyses the potential challenges in the implementation process and coping strategies, in order to provide relevant practitioners with ideas for building intelligent QC laboratories.
2.Causes and global, regional, and national burdens of traumatic brain injury from 1990 to 2019
Xiao-Fei HUANG ; Shuai-Feng MA ; Xu-Heng JIANG ; Ren-Jie SONG ; Mo LI ; Ji ZHANG ; Tian-Jing SUN ; Quan HU ; Wen-Rui WANG ; An-Yong YU ; He LI
Chinese Journal of Traumatology 2024;27(6):311-322
Purpose::Traumatic brain injury (TBI), currently a major global public health problem, imposes a significant economic burden on society and families. We aimed to quantify and predict the incidence and severity of TBI by analyzing its incidence, prevalence, and years lived with disability (YLDs). The epidemiological changes in TBI from 1990 to 2019 were described and updated to provide a reference for developing prevention, treatment, and incidence-reducing measures for TBI.Methods::A secondary analysis was performed on the incidence, prevalence, and YLDs of TBI by sex, age group, and region ( n =21,204 countries and territories) between 1990 and 2019 using the Global Burden of Diseases, Injuries, and Risk Factors Study 2019. Proportions in the age-standardized incidence rate due to underlying causes of TBI and proportions of minor and moderate or severe TBI were also reported. Results::In 2019, there were 27.16 million (95% uncertainty intervals ( UI): 23.36 -31.42) new cases of TBI worldwide, with age-standardized incidence and prevalence rates of 346 per 100,000 population (95% UI: 298 -401) and 599 per 100,000 population (95% UI: 573 -627), respectively. From 1990 to 2019, there were no significant trends in global age-standardized incidence (estimated annual percentage changes: -0.11%, 95% UI: -0.18% --0.04%) or prevalence (estimated annual percentage changes: 0.01%, 95% UI: -0.04% -0.06%). TBI caused 7.08 million (95% UI: 5.00 -9.59) YLDs in 2019, with age-standardized rates of 86.5 per 100,000 population (95% UI: 61.1 -117.2). In 2019, the countries with higher incidence rates were mainly distributed in Central Europe, Eastern Europe, and Australia. The 2019 global age-standardized incidence rate was higher in males than in females. The 2019 global incidence of moderate and severe TBI was 182.7 per 100,000 population, accounting for 52.8% of all TBI, with falls and road traffic injuries being the main causes in most regions. Conclusions::The incidence of moderate and severe TBI was slightly higher in 2019, and TBI still accounts for a significant portion of the global injury burden. The likelihood of moderate to severe TBI and the trend of major injury under each injury cause from 1990 to 2019 and the characteristics of injury mechanisms in each age group are presented, providing a basis for further research on injury causes in each age group and the future establishment of corresponding policies and protective measures.
3.Association between Residential Greenness and Cardiometabolic Risk Factors among Adults in Rural Xinjiang Uygur Autonomous Region,China:A Cross-Sectional Study
Jian LEYAO ; Yang BO ; Ma RULIN ; Guo SHUXIA ; He JIA ; Li YU ; Ding YUSONG ; Rui DONGSHENG ; Mao YIDAN ; He XIN ; Sun XUEYING ; Liao SHENGYU ; Guo HENG
Biomedical and Environmental Sciences 2024;37(10):1184-1194
Objective This study aimed to explore the relationships between residential greenness and cardiometabolic risk factors among rural adults in Xinjiang Uygur Autonomous Region(Xinjiang)and thus provide a theoretical basis and data support for improving the health of residents in this region. Methods We recruited 9,723 adult rural residents from the 51st Regiment of the Third Division of the Xinjiang Production and Construction Corps in September 2016.The normalized difference vegetation index(NDVI)was used to estimate residential greenness.The generalized linear mixed model(GLMM)was used to examine the association between residential greenness and cardiometabolic risk factors. Results Higher residential greenness was associated with lower cardiometabolic risk factor prevalence.After adjustments were made for age,sex,education,and marital status,for each interquartile range(IQR)increase of NDVI500-m,the risk of hypertension was reduced by 10.3%(OR=0.897,95%CI=0.836-0.962),the risk of obesity by 20.5%(OR=0.795,95%CI=0.695-0.910),the risk of type 2 diabetes by 15.1%(OR=0.849,95%CI=0.740-0.974),and the risk of dyslipidemia by 10.5%(OR=0.895,95%CI=0.825-0.971).Risk factor aggregation was reduced by 20.4%(OR=0.796,95%CI=0.716-0.885)for the same.Stratified analysis showed that NDVI500-m was associated more strongly with hypertension,dyslipidemia,and risk factor aggregation among male participants.The association of NDVI500-m with type 2 diabetes was stronger among participants with a higher education level.PM10 and physical activity mediated 1.9%-9.2%of the associations between NDVI500-m and obesity,dyslipidemia,and risk factor aggregation. Conclusion Higher residential greenness has a protective effect against cardiometabolic risk factors among rural residents in Xinjiang.Increasing the area of green space around residences is an effective measure to reduce the burden of cardiometabolic-related diseases among rural residents in Xinjiang.
4.Incidence and influencing factors of non-alcoholic fatty liver disease among rural Uyghur ethnic group residents in Xinjiang Production and Construction Corps
Caiyin LI ; Shuxia GUO ; Yu LI ; Heng GUO ; Rulin MA ; Xianghui ZHANG ; Xinping WANG ; Yunhua HU ; Keerman MULATIBIEKE ; Shipeng GAO ; Jia HE
Chinese Journal of Epidemiology 2024;45(8):1149-1157
Objective:To investigate the incidence characteristics and influencing factors of non-alcoholic fatty liver disease (NAFLD) in rural Uyghur ethnic group residents in Xinjiang Production and Construction Corps and to provide scientific evidence for early identification and prevention of NAFLD for residents.Methods:A total of 10 158 participants were included from the Xinjiang Uygur ethnic group population cohort. A prospective cohort study and Cox proportional hazards regression model analysis were used to explore the influencing factors and clustering of NAFLD, and the dose-response relationship between related biochemical indicators and the risk of NAFLD was studied using a restricted cubic spline.Results:The cumulative incidence rate of NAFLD was 6.9%, and the incidence density of NAFLD was 12.06/1 000 person-years. The incidence density of NAFLD in females was higher than in males (14.72/1 000 person-years vs. 9.17/1 000 person-years, P<0.001). The incidence density of NAFLD gradually increased with age in the total population, both men and women (all P<0.001). In the general population, an education level of junior high school or above was a protective factor for NAFLD, while older age, divorce, widowhood, overweight, obesity, hypertension, increased glomerular filtration rate, decreased HDL-C, increased LDL-C, and increased ALT were risk factors for NAFLD. Estimated glomerular filtration rate (eGFR), HDL-C, LDL-C, and ALT were non-linearly correlated with the incidence of NAFLD, and there was a significant dose-response relationship between them. Only 19.1% of residents had no NAFLD risk factors; over 80.9% had ≥1 NAFLD risk factors. The risk of NAFLD increased with the number of risk factors. Conclusions:The incidence of NAFLD in rural Uygur ethnic group residents in Xinjiang Production and Construction Corps was relatively low, but most residents had one or more risk factors for NAFLD. Prevention and control of NAFLD in this population cannot be ignored. In addition, people of older age, divorced or widowed, low education level, overweight or obese, hypertension, and abnormal eGFR, HDL-C, LDL-C, and ALT were the high-risk groups of NAFLD that need to be paid attention to in this population.
5.Risk factors for parastomal hernias:a systematic review and meta-analysis
Kai-Lei WANG ; Li-Na MA ; Guang-Bo BU ; Guang-Dong ZHANG ; Hui FAN ; Fei YU ; Heng-Rui DU ; Gang MA
Chinese Journal of Current Advances in General Surgery 2024;27(6):463-470
Objective:To evaluate the risk factors for the formation of parastomal Hernias(PSH)using meta-analysis,and to provide a theoretical basis for the prevention and treatment of PSH.Methods:Case control or Cohort study of PSH risk factors were collected by searching PubMed,CNKI,Wanfang data and other databases.Extract relevant data and perform meta-analysis using RevMan 5.3.Results:The results included a total of 16 studies,with a total sample size of 2411 cases,including 670 in the PSH group and 1741 in the non PSH group.The results showed that advanced age,female gender,BMI≥25,hypertension,COPD/chronic cough,diabetes,and postoperative Hypoproteinemia could increase the risk of PSH(P<0.05);Smoking,previous ab-dominal surgery history,preoperative radiotherapy/chemotherapy etc.,were not significantly asso-ciated with the occurrence of PSH(P>0.05).Conclusion:The current evidence shows that ad-vanced age,female gender,BMI≥25,hypertension,COPD/chronic cough,diabetes,postoperative Hypoproteinemia are risk factors for PSH,and extraperitoneal stoma can reduce the occurrence of PSH.
6.Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome (version 2024)
Junyu WANG ; Hai JIN ; Danfeng ZHANG ; Rutong YU ; Mingkun YU ; Yijie MA ; Yue MA ; Ning WANG ; Chunhong WANG ; Chunhui WANG ; Qing WANG ; Xinyu WANG ; Xinjun WANG ; Hengli TIAN ; Xinhua TIAN ; Yijun BAO ; Hua FENG ; Wa DA ; Liquan LYU ; Haijun REN ; Jinfang LIU ; Guodong LIU ; Chunhui LIU ; Junwen GUAN ; Rongcai JIANG ; Yiming LI ; Lihong LI ; Zhenxing LI ; Jinglian LI ; Jun YANG ; Chaohua YANG ; Xiao BU ; Xuehai WU ; Li BIE ; Binghui QIU ; Yongming ZHANG ; Qingjiu ZHANG ; Bo ZHANG ; Xiangtong ZHANG ; Rongbin CHEN ; Chao LIN ; Hu JIN ; Weiming ZHENG ; Mingliang ZHAO ; Liang ZHAO ; Rong HU ; Jixin DUAN ; Jiemin YAO ; Hechun XIA ; Ye GU ; Tao QIAN ; Suokai QIAN ; Tao XU ; Guoyi GAO ; Xiaoping TANG ; Qibing HUANG ; Rong FU ; Jun KANG ; Guobiao LIANG ; Kaiwei HAN ; Zhenmin HAN ; Shuo HAN ; Jun PU ; Lijun HENG ; Junji WEI ; Lijun HOU
Chinese Journal of Trauma 2024;40(5):385-396
Traumatic supraorbital fissure syndrome (TSOFS) is a symptom complex caused by nerve entrapment in the supraorbital fissure after skull base trauma. If the compressed cranial nerve in the supraorbital fissure is not decompressed surgically, ptosis, diplopia and eye movement disorder may exist for a long time and seriously affect the patients′ quality of life. Since its overall incidence is not high, it is not familiarized with the majority of neurosurgeons and some TSOFS may be complicated with skull base vascular injury. If the supraorbital fissure surgery is performed without treatment of vascular injury, it may cause massive hemorrhage, and disability and even life-threatening in severe cases. At present, there is no consensus or guideline on the diagnosis and treatment of TSOFS that can be referred to both domestically and internationally. To improve the understanding of TSOFS among clinical physicians and establish standardized diagnosis and treatment plans, the Skull Base Trauma Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association, Neurotrauma Group of the Neurosurgery Branch of the Chinese Medical Association, Neurotrauma Group of the Traumatology Branch of the Chinese Medical Association, and Editorial Committee of Chinese Journal of Trauma organized relevant experts to formulate Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome ( version 2024) based on evidence of evidence-based medicine and clinical experience of diagnosis and treatment. This consensus puts forward 12 recommendations on the diagnosis, classification, treatment, efficacy evaluation and follow-up of TSOFS, aiming to provide references for neurosurgeons from hospitals of all levels to standardize the diagnosis and treatment of TSOFS.
7. Effect of Sea Cucumber Enzymolysis Fermentation Liquid on immunosuppressed mice based on metabonomics
Wu-Chang ZHU ; Yuan-Yuan WEI ; Hong-Mei SU ; Yu-Shen HUANG ; Si-Yun CHEN ; Zhi-Heng SU ; Jin-Bin WEI ; Ma-Lin ZHOU
Chinese Pharmacological Bulletin 2023;39(3):489-497
Aim To prepare the sea cucumber enzy¬molysis fermentation liquid (SCEFL) by enzymatic hydrolysis of protease and fermentation of probiotics and to investigate the effect of SCEFL on the immunosup-pression induced by cyclophosphamide in mice and to explore its mechanism by metabomic method. Methods The immunosuppressive model was induced by in-traperitoneal injection of cyclophosphamide. C57BL/6J mice were randomly divided into normal group, model group, Levamisole group, SCEFL groups (at low, medium and high doses). The pathological changes of spleen were observed by HE staining. The proportion of CD4
8. Effects of volatile oil from Acori graminei Rhizoma on glial fibrillary acidic protein, c-Jun N-terminal protein kinase and tumor necrosis factor-α expressions in the spinal cord dorsal horn of the inflammatory pain rats
Run-Heng ZHANG ; Cui-Zhu YANG ; Shi-Qi LI ; Shu-Han WANG ; Xin WANG ; Jing LIU ; Yu-Xin MA
Acta Anatomica Sinica 2023;54(1):23-29
Objective To investigate the influence of volatile oil from Acori graminei Rhizoma (VOA) on expressions of glial fibrillary acidic protein (GFAP), c-Jun N-terminal protein kainse (JNK) and tumour necrosis factor-α (TNF-α) in the spinal cord dorsal horn of imflammatory pain rats. Methods Totally 36 male SD rats were randomly divided into control group (control), sham-operated group (sham), complete Freund' s adjuvant group (CFA), 5 g/(kg·d) low dose VOA+CFA group (VOA-L+CFA), 10 g/(kg·d) medium dose VOA + CFA group (VOA-M+CFA) and 20 g/(kg·d) high dose VOA + CFA group (VOA-H+CFA). All animals were sacrificed immediately after continuous gavage administration for 22 days. The expressions of GFAP, JNK and TNF-α in the spinal cord dorsal horn of rats in each group were detected by immunofluorescence and Western blotting methods. Results The present results showed that the positive expressions of GFAP, JNK and TNF-α in the spinal cord dorsal horn of rats increased significantly in the CFA group, when compared to the control and sham groups (P < 0. 01). The expressions of GFAP, JNK and TNF-α in the spinal cord dorsal horn of rats with VOA treatment reduced in the dose-dependent manner, when compared to the CFA group, the positive expressions of GFAP, JNK and TNF-α reduced significantly in the dorsal horn of the spinal cord of the VOA-H+CFA group (P<0. 05, P<0. 01). Conclusion VOA reduces the expressions of GFAP, JNK and TNF-α in the spinal cord dorsal horn of rats of CFA-induced inflammatory pain.
9.Astragalin Inhibits Apoptosis of Cerebral Cortex Neurons in APP/PS1 Mice
Shu-han WANG ; Cui-zhu YANG ; Run-heng ZHANG ; Jia-hong LIN ; Ya-qi YANG ; Jing LIU ; Guo-ying LI ; Yu-xin MA
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(6):983-990
ObjectiveTo investigate the effect of Astragalin (AST) on apoptosis of cerebral cortex neurons in APP/PS1 transgenic mice. MethodsEighteen six-month-old male APP/PS1 transgenic mice were randomly divided into APP/PS1 group, APP/PS1+ 40 mg/kg AST group and APP/PS1+ 20 mg/kg Donepezil (DNP) group, with six mice in each group. At the same time, six male C57BL/6 mice were selected as the normal control group. After intraperitoneal injection of AST once a day and continuous administration for one month, we used Tunel staining to detect the apoptosis of neurons in the cerebral cortex of APP/PS1 mice; immunofluorescent staining to examine the expression of apoptosis-related proteins Bax, Bcl-2, Caspase9 and Cleaved-Caspase3 in the cerebral cortex neurons of APP/PS1 mice; Western blot method to evaluate the changes of the expression of Bax, Bcl-2, Caspase9 and Caspase3. ResultsTunel staining showed that 40 mg/kg AST and 20 mg/kg DNP both reduced the apoptosis of neurons in the cerebral cortex of APP/PS1 mice, AST with more significant inhibition effect. Immunofluorescent staining revealed that 40 mg/kg AST and 20 mg/kg DNP both inhibited the expression of Bax, Caspase9, and Cleaved-Caspase3, and icreased the expression of Bcl-2 in the cerebral cortex neurons of APP/PS1 mice. Western blot results further confirmed that 40 mg/kg AST and 20 mg/kg DNP both down-regulated the expression of Bax (P < 0.05, P < 0.05), Caspase9 (P < 0.005, P < 0.05) and Caspase3 (P < 0.0001, P < 0.0001) , and up-regulated the expresstion of Bcl-2 (P < 0.05, P < 0.05) in the cerebral cortex neurons of APP/PS1 mice. ConclusionsAST can inhibit the apoptosis of cerebral cortex neurons in APP/PS1 mice.
10.Attach great importance to the significance of serum anti-müllerian hormone and androgen in the evaluation of polycystic ovary syndrome.
Chun Hua LIU ; Sai ZHANG ; Yu Xue ZHANG ; Heng Bei DONG ; Shu Yu WANG ; Yan Min MA
Chinese Journal of Preventive Medicine 2023;57(4):577-583
Polycystic ovary syndrome (PCOS) is a common endocrine disease in women of childbearing age, which seriously affects women's reproductive health. In recent years, more and more studies have found that serum anti-Müllerian hormone (AMH) has certain significance in the diagnosis and treatment evaluation of PCOS. In addition, with the improvement of detection methods, more attention has been paid to the significance of female androgens and AMH in the evaluation of PCOS. This article reviews the recent research progress of serum AMH and androgens in the evaluation of PCOS.
Female
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Humans
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Polycystic Ovary Syndrome/diagnosis*
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Androgens
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Anti-Mullerian Hormone

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