1.Excavation and evaluation of tocilizumab and infliximab for adverse drug event signals among children
Yue TAN ; Ning-Ning GE ; Jing PENG ; Wen-Shuang QIU ; Xin ZHANG ; Lan-Fang LI
The Chinese Journal of Clinical Pharmacology 2024;40(5):732-736
Objective To analyze the risk of adverse drug events in pediatric clinical applications of tocilizumab versus inflixima.Methods Adverse event(AE)reporting data for tocilizumab versus infliximab in the U.S.Food and Drug Administration Adverse Event Reporting System database for the pediatric population from Q1 2013 to Q1 2023 were collected.AE risk signal mining was performed using the reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method.AEs were also classified and statistically analyzed according to the preferred system organ classification and preferred terminology(PT)of the International Dictionary of Medical Terminology.Results Data were extracted and cleaned to include 1 052 AE reports with 198 positive PT signals for tocilizumab as the suspected drug and 9 1 39 AE reports with 387 positive PT signals for infliximab as the suspected drug.The analyses suggested that the stronger positive risk signals for both drugs were focused on gastrointestinal disorders,infectious and invasive diseases,laboratory tests,musculoskeletal and connective tissue disorders,and blood,vascular,and lymphatic disorders.The risk signals for infliximab were focused on gastrointestinal disorders,infections,and infectious diseases,while the risk signals for tocilizumab were focused on the musculoskeletal muscle system.Conclusion Clinical use of both drugs in children has multi-system effects,tocilizumab may have effects on growth and development,and infliximab has effects on the gastrointestinal tract in children.
2.Iodine Nutrition,Thyroid-stimulating Hormone,and Related Factors of Postpartum Women from three Different Areas in China:A Cross-sectional Survey
Yun Xiao SHAN ; Yan ZOU ; Chun Li HUANG ; Shan JIANG ; Wen Wei ZHOU ; Lan Qiu QIN ; Qing Chang LIU ; Yan Xiao LUO ; Xi Jia LU ; Qian De MAO ; Min LI ; Yu Zhen YANG ; Chen Li YANG
Biomedical and Environmental Sciences 2024;37(3):254-265
Objective Studies on the relationship between iodine,vitamin A(VA),and vitamin D(VD)and thyroid function are limited.This study aimed to analyze iodine and thyroid-stimulating hormone(TSH)status and their possible relationships with VA,VD,and other factors in postpartum women. Methods A total of 1,311 mothers(896 lactating and 415 non-lactating)from Hebei,Zhejiang,and Guangxi provinces were included in this study.The urinary iodine concentration(UIC),TSH,VA,and VD were measured. Results The median UIC of total and lactating participants were 142.00 μg/L and 139.95 μg/L,respectively.The median TSH,VA,and VD levels in all the participants were 1.89 mIU/L,0.44 μg/mL,and 24.04 ng/mL,respectively.No differences in the UIC were found between lactating and non-lactating mothers.UIC and TSH levels were significantly different among the three provinces.The rural UIC was higher than the urban UIC.Obese mothers had a higher UIC and a higher prevalence of excessive TSH.Higher UICs and TSHs levels were observed in both the VD deficiency and insufficiency groups than in the VD-sufficient group.After adjustment,no linear correlation was observed between UIC and VA/VD.No interaction was found between vitamins A/D and UIC on TSH levels. Conclusion The mothers in the present study had no iodine deficiency.Region,area type,BMI,and VD may be related to the iodine status or TSH levels.
3.Comparison of Wild and Cultivated Codonopsis pilosula Based onTraditional Quality Evaluation
Xiaoyan LAN ; Chunfang TIAN ; Zhilai ZHAN ; Li ZHOU ; Xiang LI ; Zidong QIU ; Tiegui NAN ; Qili YUAN ; Xiaoliang LIN ; Congkui TIAN ; Meilan CHEN ; Liping KANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):156-164
ObjectiveTo conduct a systematic comparative study on wild and cultivated Codonopsis pilosula(CP) from three aspects, including characters, microscopy, and contents of primary and secondary metabolites. MethodWild and cultivated CP samples were collected, their characters were measured using vernier caliper, tape measure and balance, the paraffin sections were stained with safranin-fixed green dyeing, and their microstructure were observed under the optical microscope. The content of alcohol-soluble extracts in wild and cultivated CP was determined according to the method for determination of extract under CP in the 2020 edition of Chinese Pharmacopoeia, the starch content was determined by anthrone colorimetry, the content of total polysaccharides was determined by kit method, Fiber analyzer was used to determine the content of fiber components, and ultra performance liquid chromatography(UPLC) was used to determine the content of monosaccharides, disaccharides and some secondary metabolites. Multivariate statistical analysis methods such as principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were employed to screen key differential components between wild and cultivated CP on the basis of variable importance in the projection(VIP) value>1 and P<0.05. ResultIn terms of morphological characteristics, the "lion's head-like" shape, longitudinal wrinkles, and circumferential wrinkles below the root cap of wild CP were more pronounced in wild CP compared to the cultivated ones. Regarding transverse sectional features, wild CP had more fissures on the outer side of the cortex and a larger duramen. Under microscopic examination, wild CP had more stone cells, a larger proportion of xylem, and the presence of cork cells arranged in rings in the xylem, while cultivated CP has a larger proportion of phloem, smaller vessel diameters, and a more loosely arranged vascular system. In terms of primary metabolites, the contents of 45% ethanol-soluble extract and total polysaccharides in cultivated CP were significantly higher than those in the wild ones(P<0.05), the contents of lignin, hemicellulose, cellulose, fructose and glucose in wild CP were significantly higher than those in the cultivated ones(P<0.05), while sucrose content in the cultivated CP was significantly higher than that in the wild ones(P<0.05). Concerning secondary metabolites, the contents of tryptophan and tangshenoside Ⅰ in cultivated CP were significantly higher than those in the wild ones(P<0.05), whereas the contents of lobetyolinin, lobetyol and atractylenolide Ⅲ in wild CP were significantly higher than those in the cultivated ones(P<0.05). ConclusionThere are significant differences between wild and cultivated CP in terms of morphological characteristics, microscopic features and chemical composition. Glucose, fructose, sucrose, tangshenoside Ⅰ, tryptophan and cellulose components are the key differential components between wild and cultivated CP. Wild CP contains more polyacetylenes and fructose, whereas cultivated CP has higher levels of tangshenoside Ⅰ and sucrose, with noticeably lower cellulose content. These distinctions may be related to their growth conditions, growth years and cultivation techniques. Based on the results of this study, it is recommended to increase polyacetylenes and the content ratio of fructose to sucrose as an indicators to characterize different production methods of CP, in order to guide the high-quality production of CP.
4.Comparison of Wild and Cultivated Paeoniae Radix Rubra Based on Traditional Quality Evaluation
Chunfang TIAN ; Qiannan HU ; Zhilai ZHAN ; Xiaoyan LAN ; Xiang LI ; Li ZHOU ; Tiegui NAN ; Zidong QIU ; Liping KANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):165-174
ObjectiveTo compare wild and cultivated Paeoniae Radix Rubra(PRR) in three aspects, including character, microscope, determination of primary and secondary metabolites. MethodSeventeen batches of wild and nine batches of cultivated PRR were collected,their character data were measured by vernier caliper and scales, and their paraffin sections were made by safranin-fixed green dyeing for the observation of microscopic features. The content of ethanol-soluble extracts and total tannin from wild and cultivated PRR was determined by the method of general principle 2201 and 2202 in the 2020 edition of Chinese Pharmacopoeia, the content of polysaccharides was determined by phenol-sulfuric acid method. Anthrone colorimetry was used to determine the content of starch, and Van Soest method of washing fiber was used to determine the content of fiber. The contents of fructose, glucose and sucrose in wild and cultivated PRR were determined by ultra-high performance liquid chromatography evaporative light scattering detection(UPLC-ELSD), and the secondary metabolites(gallic acid, methyl gallate, catechin, oxypaeoniflorin, albiflorin, paeoniflorin, ellagic acid, 1,3,4,6-tetragalloylglucose, galloylpaeoniflorin, 1,2,3,4,6-O-pentagalloylglucose, naringenin, benzoylpaeoniflorin and benzoylalbiflorin) were determined by UPLC. Principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to analyze the data of wild and cultivated PRR, the contribution of different factors to the difference was determined according to the variable importance in the projection(VIP) value>1 and P<0.05. ResultIn term of characters, wild PRR showed the traditional characteristic of Zaopi Fencha, its outer skin was loose and easy to fall off, its surface had longitudinal furrow and wrinkle, but the outer skin of cultivated PRR was not easy to fall off, and its surface was relatively smooth. The radial texture of xylem of wild PRR cross-section was more obvious, showing radial striations, vacuoles and more cracks, while the radial texture of xylem of cultivated PRR cross-section was not obvious, dense and some had cracks. Microscopically, the number of radial vessels arranged in the xylem of wild PRR was more than that of cultivated PRR, the number of calcium oxalate clusters in the phloem and xylem of wild PRR was more than that of cultivated PRR, while the number of starch grains was significantly higher in cultivated PRR. In terms of the content of primary chemical constituents, the contents of polysaccharides and starch of cultivated PRR were significantly higher than those of wild PRR(P<0.05), while the contents of cellulose, lignin, fructose and glucose of wild PRR were significantly higher than those of cultivated PRR(P<0.05). The results of determination of 13 secondary metabolites showed that the contents of paeoniflorin, methyl gallate, catechin and oxypaeoniflorin in wild PRR were significantly higher than those in cultivated PRR(P<0.05), while the contents of albiflorin, gallic acid, ellagic acid, naringenin, benzoylpaeoniflorin and benzoylalbiflorin were significantly lower than those of cultivated PRR(P<0.05). A total of 10 variables contributing to the differentiation between wild and cultivated PRR were screened, including albiflorin, cellulose, benzoylpaeoniflorin, oxypaeoniflorin, naringenin, ellagic acid, starch, lignin, paeoniflorin and total tannins. ConclusionThere are significant differences between wild and cultivated PRR in characters, microscopic characteristics, contents of primary and secondary metabolites. It is suggested that the content ratio of paeoniflorin and albiflorin, the contents of oxypaeoniflorin and cellulose can be used as indicators to characterize production methods of PRR so as to improve the quality standard of PRR. This study can provide reference for the improvement of quality standard of PRR and the guidance of high quality production of PRR.
5.A multicenter retrospective cohort study on the attributable risk of patients with Acinetobacter baumannii sterile body fluid infection
Lei HE ; Dao-Bin JIANG ; Ding LIU ; Xiao-Fang ZHENG ; He-Yu QIU ; Shu-Mei WU ; Xiao-Ying WU ; Jin-Lan CUI ; Shou-Jia XIE ; Qin XIA ; Li HE ; Xi-Zhao LIU ; Chang-Hui SHU ; Rong-Qin LI ; Hong-Ying TAO ; Ze-Fen CHEN
Chinese Journal of Infection Control 2024;23(1):42-48
Objective To investigate the attributable risk(AR)of Acinetobacter baumannii(AB)infection in criti-cally ill patients.Methods A multicenter retrospective cohort study was conducted among adult patients in inten-sive care unit(ICU).Patients with AB isolated from sterile body fluid and confirmed with AB infection in each cen-ter were selected as the infected group.According to the matching criteria that patients should be from the same pe-riod,in the same ICU,as well as with similar APACHE Ⅱ score(±5 points)and primary diagnosis,patients who did not infect with AB were selected as the non-infected group in a 1:2 ratio.The AR was calculated.Results The in-hospital mortality of patients with AB infection in sterile body fluid was 33.3%,and that of non-infected group was 23.1%,with no statistically significant difference between the two groups(P=0.069).The AR was 10.2%(95%CI:-2.3%-22.8%).There is no statistically significant difference in mortality between non-infected pa-tients and infected patients from whose blood,cerebrospinal fluid and other specimen sources AB were isolated(P>0.05).After infected with AB,critically ill patients with the major diagnosis of pulmonary infection had the high-est AR.There was no statistically significant difference in mortality between patients in the infected and non-infec-ted groups(P>0.05),or between other diagnostic classifications.Conclusion The prognosis of AB infection in critically ill patients is highly overestimated,but active healthcare-associated infection control for AB in the ICU should still be carried out.
6.The role of comprehensive intervention measures in improving the patho-gen detection rate of hospitalized patients before antimicrobial therapy
Yue-Li LI ; Jin-Lan CUI ; Lan-Juan MEI ; Qiu-Chun LIU ; Ju-Fang TIAN
Chinese Journal of Infection Control 2024;23(3):370-376
Objective To understand the pathogen detection of hospitalized patients before antimicrobial therapy in a hospital through implementation of comprehensive intervention measures,and provide reference basis for the de-velopment of targeted measures.Methods Hospitalized patients who received therapeutic antimicrobial agents in this hospital were selected as the research subjects.Patients who were hospitalized from January to May 2022 were selected as the pre-intervention group,comprehensive intervention measures were taken from June to October 2022,and those who were hospitalized from November 2022 to March 2023 were selected as the post-intervention group.The pathogen detection rate before antimicrobial therapy,sterile specimen detection rate,antimicrobial use rate,de-tection rate of key multidrug-resistant organisms of patients before and after the intervention were analyzed.Results Compared to before intervention,the proportion of pathogen detection rate before antimicrobial therapy(62.09%vs 74.04%),detection rate of healthcare-associated infection diagnosis-related pathogens(62.82%vs 92.73%),and sterile specimen detection rate(35.17%vs 41.06%)of hospitalized patients after intervention all increased signifi-cantly,with statistically significant differences(all P<0.05).After intervention,pathogen detection rate before the combination use of key antimicrobial agents was not statistically different from before intervention(93.33%vs 90.48%,P>0.05),while antimicrobial use rate was lower than before intervention(39.93%vs 44.95%,P<0.05).There was no statistically significant difference in the detection rate of key multidrug-resistant organisms be-fore and after intervention(all P>0.05).Conclusion Adopting scientific and rational intervention measures can improve the pathogen detection rate,provide a reference basis for the rational use of antimicrobial agents.There was no significant improvement in the pathogen detection rate before the combination use of key antimicrobial agents and the detection rate of key multidrug-resistant organisms,indicating that relevant measures still need to be further optimized.
7.Stress analysis of trabecular hip prosthesis stem implantation
Bo LI ; Li-Lan GAO ; Ya CHEN ; Shu-Hong LIU ; Ya-Hui HU ; Lin-Wei LYU ; Jin-Duo YE ; Chun-Qiu ZHANG
Chinese Medical Equipment Journal 2024;45(3):29-35
Objective To analyze the stresses in implanted titanium solid and bone trabecular prosthesis hip replacements.Methods A femur model was built inversely based on Mimics software,and optimized using Geomagic software,and then materialized by SolidWorks software.The osteotomized femur was assembled with the metal femoral stem to form a model,and then the model was imported into ABAQUS for finite element calculation.The upper femur was divided into four regions in different states of integration:medial proximal point(small trochanter region),lateral proximal region(large trochanter region),proximal point of the femoral stem(region around the mid-portion of the styloid process)and distal region(around the end of the styloid process and distal portion).Calculations were carried out over the femoral stresses before and after implantation of titanium solid and trabecular prostheses under gait and stair-climbing loads and the interfacial stresses when the region was unintegrated.The type of deformation at the bone interface was analyzed by means of a stress ellipsoid.Results At the small trochanter region,the stress shielding rates of the trabecular prosthesis under gait and stair climbing loads were reduced by 20.5%and 14.7%compared to the titanium solid prosthesis,respectively.In case of different integration states of the titanium solid prosthesis,the interface tensile stresses under the gait and stair climbing loads were up to 10.842 MPa and 12.900 MPa,and the shear stresses reached 7.050 MPa and 6.805 MPa,respectively;in case of different integration states of the trabecular prosthesis,the interface tensile stresses under the gait and stair climbing loads were up to 3.858 MPa and 4.389 MPa,and the shear stresses reached 4.156 MPa and 3.854 MPa,respectively.Under the 2 different loads,the inboard shear stress ellipsoid of the interface opened toward the sides and the bone interface showed tensile deformation;the outboard shear stress ellipsoid of the interface opened up and down and had compressive deformation.Conclusion After total hip arthroplasty,the overall performance of the trabecular prosthesis is better than that of the titanium solid prosthesis.The unintegrated edges of the prosthesis-bone interface are susceptible to stress concentrations and distortion which may result in occurrence of failures.[Chinese Medical Equipment Journal,2024,45(3):29-35]
8.Vaccination against coronavirus disease 2019 in patients with pulmonary hypertension: A national prospective cohort study
Xiaohan WU ; Jingyi LI ; Jieling MA ; Qianqian LIU ; Lan WANG ; Yongjian ZHU ; Yue CUI ; Anyi WANG ; Cenjin WEN ; Luhong QIU ; Yinjian YANG ; Dan LU ; Xiqi XU ; Xijie ZHU ; Chunyan CHENG ; Duolao WANG ; Zhicheng JING
Chinese Medical Journal 2024;137(6):669-675
Background::Coronavirus disease 2019 (COVID-19) has potential risks for both clinically worsening pulmonary hypertension (PH) and increasing mortality. However, the data regarding the protective role of vaccination in this population are still lacking. This study aimed to assess the safety of approved vaccination for patients with PH.Methods::In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) were enrolled from October 2021 to April 2022. The primary outcome was the composite of PH-related major adverse events. We used an inverse probability weighting (IPW) approach to control for possible confounding factors in the baseline characteristics of patients.Results::In total, 706 patients with PH participated in this study (mean age, 40.3 years; mean duration after diagnosis of PH, 8.2 years). All patients received standardized treatment for PH in accordance with guidelines for the diagnosis and treatment of PH in China. Among them, 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. None of the participants were infected with COVID-19 during our study period. Overall, 398 patients received inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine, whereas 30 received recombinant protein subunit vaccine. After adjusting for baseline covariates using the IPW approach, the odds of any adverse events due to PH in the vaccinated group did not statistically significantly increase (27/428 [6.3%] vs. 24/278 [8.6%], odds ratio = 0.72, P = 0.302). Approximately half of the vaccinated patients reported at least one post-vaccination side effects, most of which were mild, including pain at the injection site (159/428, 37.1%), fever (11/428, 2.6%), and fatigue (26/428, 6.1%). Conclusions::COVID-19 vaccination did not significantly augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.
9.Expert consensus on difficulty assessment of endodontic therapy
Huang DINGMING ; Wang XIAOYAN ; Liang JINGPING ; Ling JUNQI ; Bian ZHUAN ; Yu QING ; Hou BENXIANG ; Chen XINMEI ; Li JIYAO ; Ye LING ; Cheng LEI ; Xu XIN ; Hu TAO ; Wu HONGKUN ; Guo BIN ; Su QIN ; Chen ZHI ; Qiu LIHONG ; Chen WENXIA ; Wei XI ; Huang ZHENGWEI ; Yu JINHUA ; Lin ZHENGMEI ; Zhang QI ; Yang DEQIN ; Zhao JIN ; Pan SHUANG ; Yang JIAN ; Wu JIAYUAN ; Pan YIHUAI ; Xie XIAOLI ; Deng SHULI ; Huang XIAOJING ; Zhang LAN ; Yue LIN ; Zhou XUEDONG
International Journal of Oral Science 2024;16(1):15-25
Endodontic diseases are a kind of chronic infectious oral disease.Common endodontic treatment concepts are based on the removal of inflamed or necrotic pulp tissue and the replacement by gutta-percha.However,it is very essential for endodontic treatment to debride the root canal system and prevent the root canal system from bacterial reinfection after root canal therapy(RCT).Recent research,encompassing bacterial etiology and advanced imaging techniques,contributes to our understanding of the root canal system's anatomy intricacies and the technique sensitivity of RCT.Success in RCT hinges on factors like patients,infection severity,root canal anatomy,and treatment techniques.Therefore,improving disease management is a key issue to combat endodontic diseases and cure periapical lesions.The clinical difficulty assessment system of RCT is established based on patient conditions,tooth conditions,root canal configuration,and root canal needing retreatment,and emphasizes pre-treatment risk assessment for optimal outcomes.The findings suggest that the presence of risk factors may correlate with the challenge of achieving the high standard required for RCT.These insights contribute not only to improve education but also aid practitioners in treatment planning and referral decision-making within the field of endodontics.
10.Application effect of disinfection-oriented bundle management mode on en-vironmental cleaning and disinfection quality management of intensive care unit
Xiao SONG ; Qiu-Lan CHEN ; Li-Ping FU
Chinese Journal of Infection Control 2024;23(6):742-749
Objective To explore the application effect of disinfection-oriented bundle management mode of envi-ronmental cleaning and disinfection quality management of intensive care unit(ICU).Methods The bundle mana-gement mode was used to intervene the cleaning and disinfection of ICU environment.January-December 2022 and January-December 2023 were classified as pre-and post-intervention periods respectively.The awareness rate of dis-infection knowledge,monitoring results of environmental hygiene,detection of MDRO and healthcare-associated in-fection(HAI)of patients before and after intervention were compared.Results The awareness rates of disinfection knowledge and the clearance rate of fluorescent labeling on frequently-touched environmental surface increased from 68.58%and 78.45%(pre-intervention)to 88.45%and 96.44%(post-intervention),respectively,both with sta-tistical significance(both P<0.05).The qualification rates of bacterial culture from frequently-touched environ-mental surface and hands of healthcare workers(HCWs)increased from 70.63%and 87.90%(pre-intervention)to 88.36%and 94.15%(post-intervention),respectively,both with statistical significance(both P<0.05).The de-tection rates of methicillin-resistant Staphylococcus aureus(MRSA)and carbapenem-resistant Acinetobacter bau-mannii(CRAB)from frequently-touched environmental surface were 0.49%and 1.46%(pre-intervention),as well as 0 and 0.27%(post-intervention),respectively,both with statistical significance(both P<0.05).The inci-dences of HAI(4.97%)and CRAB HAI(0.77%)post-intervention were lower than pre-intervention(7.46%and 1.62%,respectively),differences were both statistically significant(both P<0.05).Conclusion Intervention in environmental cleaning and disinfection of ICU with bundle management mode can effectively improve the effect of cleaning and disinfection in ICU,enhance cleaners'awareness on disinfection prevention and control,decrease the detection rates of MRSA and CRAB,reduce the risk of HAI,and ensure medical safety.

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