1.Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection.
Xuelin LI ; Jinfa TANG ; Fei MENG ; Chunxiao LI ; Yanming XIE
China Journal of Chinese Materia Medica 2011;36(20):2786-2788
OBJECTIVETo study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection.
METHODSet down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis.
RESULTStudy the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions.
CONCLUSIONThe central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.
Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Injections ; Product Surveillance, Postmarketing ; methods
2.Study on 10 409 cases of post-marketing safety Danhong injection centralized monitoring of hospital.
Xuelin LI ; Jinfa TANG ; Fei MENG ; Chunxiao LI ; Yanming XIE
China Journal of Chinese Materia Medica 2011;36(20):2783-2785
OBJECTIVETo study Danhong injection adverse reactions (ADR) incidence, nature and clinical performance, provide the basis for the clinical safety of drugs.
METHODMulti-center, a large sample of hospitals focused on monitoring method.
RESULTDanhong injection ADR for the rapid onset and ease the quick recovery, the rate was 0. 682% , the newly discovered ADR constipation, sweating, tinnitus, irritability, joint disease, erythema, venous pain, phlebitis, local numbness, pain, weakness, gastrointestinal ulcer bleeding, vasospasm, cyanosis.
CONCLUSIONDanhong injection adverse reactions are type A adverse reactions occasionally, centralized monitoring of hospital medicine injection method is to carry out post-marketing safety re-evaluation of appropriate methods.
Drug-Related Side Effects and Adverse Reactions ; epidemiology ; Drugs, Chinese Herbal ; adverse effects ; Hospitals ; Humans ; Injections ; Product Surveillance, Postmarketing ; methods
3.Comparison of diagnostic accuracy of digital breast tomosynthesis, digital mammography, and ultrasonography for the non-calcified ductal carcinoma in situ of the breast
Xiaohui SU ; Qing LIN ; Chunxiao CUI ; Jie FEI ; Lili LI ; Jinzhu MA
Chinese Journal of Radiology 2018;52(1):15-19
Objective To compare the diagnostic value of digital breast tomosynthesis (DBT), digital mammography(DM),and ultrasonography(US)for the non-calcified ductal carcinoma in situ(DCIS) of the breast.Methods To retrospectively analyze the imaging and clinical data of ductal carcinoma in situ which was confirmed by surgical pathology and displayed as non-calcified lesions in mammography in 110 patients.DBT,DM and US were performed in all the 110 cases.The breast imaging report and data system (BI-RADS)classification and breast density classification were evaluated using the 5th edition of BI-RADS. In our study, BI-RADS 4B, 4C, and 5 were regarded to be in agreement with the pathologic findings, BI-RADS 1,2,3,and 4A were considered to be negative.BI-RADS c and d were classified as dense breasts, BI-RADS a and b were classified as fatty breasts.The imaging findings of the non-calcified ductal carcinoma in situ were evaluated.The differences in the detection rate and the diagnostic accuracy among the DBT,DM and US in all cases and in different breast density were compared using χ2 test. Results The detection rates of DBT,DM,and US for non-calcified DCIS in all cases were 84.5%(93/110),70.9%(78/110),95.5% (105/110).Pairwise comparisons among the three techniques showed statistically significant difference(P<0.05). The diagnostic accuracy of DBT, DM, and US were 70.0% (77/110), 44.5% (49/110), and 69.1% (76/110),respectively.The diagnostic accuracy of DBT and US were significantly higher than that of DM(P<0.01). Of the 110 patients, 89 patients were classified as dense breasts and non-dense breasts in the remaining 21 patients.The detection rates of DBT,DM,and US for non-calcified DCIS in dense breasts were 82.0%(73/89),65.2%(58/89),and 96.6%(86/89).Pairwise comparisons among the three techniques showed statistically significant difference(P<0.01).The diagnostic accuracy of DBT,DM,and US for non-calcified DCIS in dense breast were 65.2% (58/89), 38.2% (34/89) and 66.3% (59/89), respectively.The diagnostic accuracy of DBT and US were significantly higher than that of DM in dense breast(P<0.01).The detection rate and diagnostic accuracy for DBT,DM,and US in non-dense breasts were not statistically different(P>0.05).By DBT and DM,most cases of non-calcified DCIS presented as a mass lesion with an irregular shape, indistinct margin,and isodense composition.Conclusion US is more advantageous to the detection of the non-calcified DCIS and the non-calcified DCIS in the dense breast.
4.Clinical characteristics and treatment strategies of 128 cases of injury due to winter snow sports in parts of Qingdao
Fei MENG ; Fengxiang ZHANG ; Chunxiao ZHAO ; Chengyu LYU ; Haining ZHANG ; Lixin LI
Chinese Journal of Orthopaedic Trauma 2023;25(12):1037-1042
Objective:To analyze the clinical characteristics and management strategies of the patients who were injured in winter snow sports in parts of Qingdao in order to provide useful information for "300 million people participating in ice and snow sports" .Methods:A retrospective study was conducted to analyze the data of 128 patients who had been admitted to Department of Orthopaedics, Qingdao Central Hospital for skiing injuries from November 2019 to March 2021. The gender, type, location and cause of injury, and treatment method of the patients were statistically analyzed.Results:Of the 128 patients, 72 were males and 56 females with an age of (32.0±12.1) years. Single injury accounted for 97.66% (125/128) while multiple injuries 2.34% (3/128). 46 injuries (35.11%, 46/131) due to single board skiing occurred in 44 patients (34.38%, 44/128); 85 injuries (64.89%, 85/131) due to double board skiing occurred in 84 cases (65.62%, 84/128). As for injury types, there were 44 cases (34.38%, 44/128) of soft tissue injury and 84 fractures (65.62%, 84/128). The top 3 injured locations were the lower leg (24.43%, 32/131), the peri-wrist part (18.32%, 24/131), and the peri-knee part (15.27%, 20/131). The most vulnerable location was, respectively, the wrist joint (26.09%, 12/46) in single board skiing and the calf (31.76%, 27/85) in double board skiing. The top three causes of injury were accidental fall (39.06%, 50/128), being struck by someone or emergency evacuation (14.84%, 19/128), and mismatched equipment models (12.50%, 16/128). The proportion of skiing beginners was as high as 76.56% (98/128). Surgical treatment was performed in 49 cases (38.28%, 49/128), and conservative treatment in 79 cases (61.72%, 79/128).Conclusions:The clinical characteristics of the patients who were injured in winter snow sports in parts of Qingdao are high proportions of skiing beginners, falls and fractures. Special attention needs to be paid to wrist protection in single board skiing and checking the ski disengagement device before double board skiing. Most patients may need only conservative treatment because although a number of patients required surgical treatment, severe multiple injuries were rare.
5.Thoughts and exploration on course construction of critical care medical
Jing FAN ; Mu ZHANG ; Shihui LIN ; Jing WU ; Aiping ZHANG ; Chunxiao LIU ; Fei YUAN ; Fang XU
Chinese Journal of Medical Education Research 2018;17(5):488-492
At present,there are still many problems in critical care medicine education and teaching,such as imperfect theoretical system,inconsistent teaching materials,uneven teaching staff,lack of practice opportunities and places.The development of intensive care medical teaching should be combined with "organ-system-centered" teaching reform,strengthen the construction of the theoretical system,drive the development of teaching staff,build high-quality practice bases,promote the curriculum to be more specialized,optimized and standardized,so as to promote the development of the subject.
6.Digital breast tomosynthesis for diagnosing non-calcified masses in dense breasts
Tiantian BIAN ; Zengjie WU ; Qing LIN ; Chunxiao CUI ; Lili LI ; Xiaohui SU ; Jie FEI ; Feifei MENG ; Congcong WANG
Chinese Journal of Medical Imaging Technology 2018;34(4):553-557
Objective To analyze the clinical value of digital breast tomosynthesis (DBT) compared with digital mammography (DM) and ultrasound for diagnosing non-calcified masses in dense breasts.Methods Images taken with DBT,DM and ultrasound of 1144 patients with non-calcified masses in dense breasts were retrospectively analyzed using breast imaging reporting and data system (BI-RADS).Taking histopathologic results as golden standards,the detection rate and diagnostic accuracy,sensitivity,specificity,false negative and BI-RADS category were evaluated and compared statistically.Results The detection rate of DBT,DM and ultrasound for non-calcified massed in dense breasts was 86.62% (991/1 144),77.80% (890/1 144) and 99.65% (1 140/1 144),respectively (P<0.05),while the diagnostic accuracy was 83.92% (960/1 144),75.00% (858/1 144) and 94.67% (1 083/1 144),respectively (P<0.01).The sensitivity of DBT,DM and ultrasound was 89.39% (312/349),79.93% (231/289) and 92.70% (432/466),the specificity was 81.51% (648/795),73.33% (627/855) and 96.02% (651/678),while the false negative rate was 10.60%(37/349),20.07% (58/289) and 7.30% (34/466),respectively.No significant difference was found for benign lesions among three examination methods (P=0.75),while there was significant difference for malignant lesions among three examination methods (P<0.01),and the differences of ultrasonography with DM and DBT,DBT and DM in the for BI-RADS category of malignant lesions were statistically significant (all P<0.016 7).Conclusion For suspected masses in dense breasts,DBT shows significant advantage than DM,while DBT has the similar advantage compared with ultrasound for the detection and diagnosis of non-calcified masses in dense breasts.
7.Risk model of breast cancer prognosis based on the expression profile of long non-coding RNA
Jinsong WANG ; Chunxiao LI ; Ting WANG ; Jingyao ZHANG ; Yantong ZHOU ; Fangzhou SUN ; Mengjiao CHANG ; Fei MA ; Haijuan WANG ; Haili QIAN
Clinical Medicine of China 2020;36(3):217-222
Objective:To construct a prediction model for the prognosis of breast cancer patients with long non-coding RNA expression characteristics.Methods:To construct a long non-coding RNA(LncRNA) model for predicting the prognosis of breast cancer patients.Methods Analyzing LncRNA expression profiles and clinical characteristics of 1 081 breast cancer patients in the cancer genome atlas (TCGA) database.Performing differential expression analysis and univariate analysis on 112 paired breast cancer and normal breast tissues′ transcriptome sequencing data in the TCGA database, and screened for differentially expressed (DELncRNAs) that significantly correlated with the prognosis of BRCA (To reduce batch effects, sequencing data has been normalized using the DESeq function). One thousand eighty-one breast cancer patients were randomly divided into two groups: training set (541) and validation set (540). Performing Cox proportional hazard regression using DELncRNAs and establishing a multi-LncRNA prognosis model in the training set, followed by proportional hazards assumption test(PH assumption test). Patients were divided into high-risk and low-risk groups based on calculated risk score.Kaplan-Meier method was used for survival analysis, and 540 patients′ data were used for validation.To evaluate the prognostic value of the model in patients with squamous cell carcinoma of the lung and hepatocarcinoma in TCGA database.Gene Set Enrichment Analysis (GSEA) was used to analyze the specific mechanism of lncrna affecting the survival of patients.Results:There were 2815 differentially expressed genes screened by transcriptome sequencing, 91 of which were significantly related to the prognosis of breast cancer patients ( P<0.05). Based on the Cox regression analysis of 91 delncrna expression data from 541 breast cancer patients in training set, a Cox proportional risk regression model was constructed based on 5 LncRNA (training set AUC=0.746, validation set AUC=0.650): AC004551.1, MTOR-AS1, KCNAB1-AS2, FAM230G and LINC01283, and PH assumption test( P=0.388). K-M survival analysis showed that the survival time of high-risk group was significantly worse than that of low-risk group (median survival time: 7.049 and 12.21 years, HR 0.367, 95% CI0.228-0.597, P<0.001), and the survival time of high-risk group was significantly shorter than that of low-risk group (median survival time: 7.57 and 10.85 years, HR 0.412, 95% CI0.214-0.793, P<0.001). Similar prediction results were also obtained in other cancer species of TCGA: lung squamous cell carcinoma ( HR 0.604, 95% CI0.383-0.951, P=0.007) and liver cell carcinoma ( HR 0.551, 95% CI0.307-0.987, P=0.011). GSEA results suggested that the expression patterns of the above five LncRNA were related to the cell cycle regulation of tumor cells. Conclusion:The prognostic model constructed based on expression profile of AC004551.1, MTOR-AS1, KCNAB1-AS2, FAM230G and LINC01283 can be used to predict the prognosis of breast cancer patients, which is helpful to further guide clinical treatment.
8.Prognostic value of the 21-gene recurrence score in ER-positive, HER2-negative, node-positive breast cancer was similar in node-negative diseases: a single-center study of 800 patients.
Jiayi WU ; Weiqi GAO ; Xiaosong CHEN ; Chunxiao FEI ; Lin LIN ; Weiguo CHEN ; Ou HUANG ; Siji ZHU ; Jianrong HE ; Yafen LI ; Li ZHU ; Kunwei SHEN
Frontiers of Medicine 2021;15(4):621-628
Multi-gene assays have emerged as crucial tools for risk stratification in early-stage breast cancer. This study aimed to evaluate the prognostic significance of the 21-gene recurrence score (RS) in Chinese patients with pN0-1, estrogen receptor-positive (ER
Biomarkers, Tumor/genetics*
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Breast Neoplasms/pathology*
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Female
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Humans
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Neoplasm Recurrence, Local/pathology*
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Neoplasm Staging
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Prognosis
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Receptor, ErbB-2/genetics*
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Receptors, Estrogen
9.Impact of inhaled corticosteroid use on elderly chronic pulmonary disease patients with community acquired pneumonia.
Xiudi HAN ; Hong WANG ; Liang CHEN ; Yimin WANG ; Hui LI ; Fei ZHOU ; Xiqian XING ; Chunxiao ZHANG ; Lijun SUO ; Jinxiang WANG ; Guohua YU ; Guangqiang WANG ; Xuexin YAO ; Hongxia YU ; Lei WANG ; Meng LIU ; Chunxue XUE ; Bo LIU ; Xiaoli ZHU ; Yanli LI ; Ying XIAO ; Xiaojing CUI ; Lijuan LI ; Xuedong LIU ; Bin CAO
Chinese Medical Journal 2024;137(2):241-243