1.Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products
Mengxia ZHAO ; Lina SUN ; Dan XU ; Wen CHAI ; Xuekong JIANG ; Zhihai MAO ; Shengliang HE
China Pharmacy 2024;35(7):783-786
In July 2023, the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products (hereinafter referred to as the Measures). This article interprets the main content of the Measures, and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter, and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time, and build a national drug standard data-sharing platform based on the basic framework of user interface layer, computing processing layer, and data storage layer. Digital drug standards will be free, and access and download services for the public will be provided.
2.Effect of AMH Levels on Embryo Quality and Clinical Outcomes of Fresh Embryo Transfer in Young Infertile Female Patients Undergoing IVF/ICSI Treatment
Jiating MAO ; Keda YU ; Juan CHAI
Journal of Medical Research 2024;53(9):147-151
Objective To investigate the impact of different levels of anti-Müllerian hormone(AMH)on embryo quality and clini-cal outcomes of fresh embryo transplantation in young infertile female patients undergoing treatment with in vitro fertilization/intracytoplas-mic sperm injection(IVF/ICSI).Methods The clinical data of 528 young infertile female patients who underwent IVF/ICSI treatment at the Center of Reproductive Medicine,Jinhua People's Hospital from January 2020 to December 2021 were retrospectively analyzed,and they were divided into three groups based on serum AMH levels:low AMH group(n=93),medium AMH group(n=273)and high AMH group(n=162).Baseline information,laboratory indicators,and clinical outcomes of the three groups were compared.Multiple linear regression analysis was used to determine the correlation between AMH and various laboratory indicators,Logistic regression analysis was adopted to correct for the impact of different baseline information on clinical outcomes in three groups.Results The results of multi-ple linear regression analysis showed that the level of AMH was an independent factor affecting the number of retrieved oocytes and normal fertilization rate,and positively correlated to the number of retrieved oocytes(β=0.630,95%CI:0.405-0.854,P<0.05),and nega-tively correlated with normal fertilization rate(β=-1.965,95%CI:-2.897-1.033,P<0.05).The results of Logistic regression a-nalysis showed that there was no significant difference in clinical outcomes among different AMH groups(P>0.05).Conclusion AMH is an independent influencing factor for predicting the number of retrieved oocytes and normal fertilization rate in young infertile female pa-tients,and AMH is a good indicator of ovarian reserve capacity,but it has no significant ability to predict clinical outcomes in fresh em-bryo transplantation.Even those with low AMH can achieve satisfactory pregnancy outcomes as long as they obtain embryos,and high AMH does not necessarily mean they can achieve better pregnancy outcomes.
3.Non-muscle myosin heavy chain 9 gene-related disorders with thrombocytopenia: report of two pedigrees and literature review.
Shu Ting MAO ; Bai LI ; Dao WANG ; Shan Shan LIU ; Shu Fang SU ; Lin Lin WEI ; Fang Yuan CHAI ; Ying LIU ; Yu Feng LIU
Chinese Journal of Pediatrics 2023;61(9):833-838
Objective: To summarize the clinical characteristics and gene variants of 2 pedigrees of non-muscle myosin heavy chain 9 related diseases (MYH9-RD) in children. Methods: The basic information, clinical features, gene variants and laboratory tests of MYH9-RD patients from 2 pedigrees confirmed in the First Affiliated Hospital of Zhengzhou University in November 2021 and July 2022 were analyzed retrospectively. "Non-muscle myosin heavy chain 9 related disease" "MYH9" and "children" were used as key words to search at Pubmed database, CNKI and Wanfang database up to February 2023. The MYH9-RD gene variant spectrum and clinical data were analyzed and summarized. Results: Proband 1 (male, 11 years old) sought medical attention due to epistaxis, the eldest sister and second sister of proband 1 only showed excessive menstrual bleeding, the skin and mucous membrane of the their mother were prone to ecchymosis after bumping, the uncle of proband 1 had kidney damage, and the maternal grandmother and maternal great-grandmother of proband 1 had a history of cataracts. There were 7 cases of phenotypic abnormalities in this pedigree. High-throughput sequencing showed that the proband 1 MYH9 gene had c.279C>G (p.N93K) missense variant, and family verification analysis showed that the variant was inherited from the mother. A total of 4 patients including proband 1 and family members were diagnosed with MYH9-RD. The proband 2 (female, 1 year old) sought medical attention duo to fever and cough, and the father's physical examination revealed thrombocytopenia. There were 2 cases of phenotypic abnormalities in this pedigree. High-throughput sequencing showed that there was a c.4270G>A (p.D1424N) missense variant in the proband 2 MYH9 gene, and family verification analysis showed that the variant was inherited from the father. A total of 2 patients including proband 2 and his father were diagnosed with MYH9-RD. A total of 99 articles were retrieved, including 32 domestic literatures and 67 foreign literatures. The MYH9-RD cases totaled 149 pedigrees and 197 sporadic patients, including 2 pedigrees in our study. There were 101 cases with complete clinical data, including 62 sporadic cases and 39 pedigrees. There were 56 males and 45 females, with an average age of 6.9 years old. The main clinical manifestations were thrombocytopenia, skin ecchymosis, and epistaxis. Most patients didn't receive special treatment after diagnosis. Six English literatures related to MYH9-RD caused by c.279C>G mutation in MYH9 gene were retrieved. Italy reported the highest number of cases (3 cases). Twelve literatures related to MYH9-RD caused by c.4270G>A mutation in MYH9 gene were retrieved. China reported the highest number of cases (9 cases). Conclusions: The clinical manifestations of patients in the MYH9-RD pedigrees varied greatly. MYH9 gene c.279C>G and c.4270G>A mutations are the cause of MYH9-RD.
Infant
;
Humans
;
Female
;
Male
;
Child
;
Myosin Heavy Chains/genetics*
;
Ecchymosis
;
Epistaxis
;
Pedigree
;
Retrospective Studies
;
Muscular Diseases
;
Thrombocytopenia
;
Cytoskeletal Proteins
4.Diagnosis model of the white matter injury of premature infants based on ultrasonography radiomics
Ting ZHU ; Wei JIANG ; Shuang ZHANG ; Dan CHAI ; Jiaoyu MAO ; Zhen LEI ; Yuya WEI
Chinese Journal of Ultrasonography 2023;32(4):324-331
Objective:To investigate the value of the ultrasonography in the diagnosis of the white matter injury of premature infants based on gray-scale ultrasonography radiomics.Methods:A total of 256 premature infants in Huazhong University of Science and Technology Union Shenzhen Hospital and Shenzhen Hospital of Southern Medical University from August 2018 to April 2022 were analyzed retrospectively. The computer-generated random numbers were assigned to the training set and the verification set according to 6∶4 ratio. On the basis of standardized collection of craniocerebral ultrasound images, the radiomics features were extracted from imaging by Pyradiomics 3.0.1 software package, the Mann-Whitney U test and the least absolute shrinkage and selection operator (LASSO) and stepwise regression were used to select the optimal features. Then the Logistic regression was used to build radiomics model. According to MRI, ROC curve was utilized to evaluate the performance of the model. The craniocerebral ultrasound images in the validation set were independently diagnosed by a senior physician and a junior physician, and then the above two physicians diagnosed again with the help of the radiomics, and the diagnostic abilities of this model were compared with those of the junior and senior physicians with and without radiomics assist. Results:A total of 5 optimal features were selected to develop radiomics model. The sensitivity, specificity, accuracy and the area under the ROC curve (AUC) in the training and validation sets were 0.861, 0.775, 0.799, 0.818; 0.929, 0.824, 0.853, 0.876, respectively. The sensitivity, specificity, accuracy and AUC in the senior sonographer, the junior sonographer, and both of them with radiomics assist for the dagnosis in the validation set were 0.929, 0.892, 0.902, 0.910; 0.714, 0.743, 0.735, 0.729; 0.929, 0.919, 0.922, 0.924; 0.857, 0.824, 0.833, 0.841, respectively. Performance of radiomics model reached the level of the senior sonographer (AUC: 0.876 vs 0.910, P=0.284), which was significantly better than the performance of the junior sonographer(AUC: 0.876 vs 0.729, P=0.001). Performance of the junior sonographer with radiomics assist was significantly better than the performance of the junior sonographer(AUC: 0.841 vs 0.729, P=0.003). Performance of the senior sonographer with radiomics assist was comparable to that of the senior sonographer(AUC: 0.924 vs 0.910, P=0.156). Conclusions:The ultrasound diagnosis method based on radiomics technology shows good diagnostic performance for the white matter injury of premature infants. It is helpful to improve the diagnostic ability of junior sonographer. It is expected to assist the sonographers in diagnosis and provide objective, consistent and accurate results for clinical practice.
5.Ginsenoside Rc:A potential intervention agent for metabolic syndrome
Zhengjie LU ; Tongyun MAO ; Kaiqi CHEN ; Longxin CHAI ; Yongguo DAI ; Kexin LIU
Journal of Pharmaceutical Analysis 2023;13(12):1375-1387
Ginsenoside Rc,a dammarane-type tetracyclic triterpenoid saponin primarily derived from Panax ginseng,has garnered significant attention due to its diverse pharmacological properties.This review outlined the sources,putative biosynthetic pathways,extraction,and quantification techniques,as well as the pharmacokinetic properties of ginsenoside Rc.Furthermore,this study explored the pharmaco-logical effects of ginsenoside Rc against metabolic syndrome(MetS)across various phenotypes including obesity,diabetes,atherosclerosis,non-alcoholic fatty liver disease,and osteoarthritis.It also highlighted the impact of ginsenoside Rc on multiple associated signaling molecules.In conclusion,the anti-MetS effect of ginsenoside Rc is characterized by its influence on multiple organs,multiple targets,and multiple ways.Although clinical investigations regarding the effects of ginsenoside Rc on MetS are limited,its proven safety and tolerability suggest its potential as an effective treatment option.
6.Chinese expert consensus on the technical standard of direct anterior hip arthroplasty for elderly femoral neck fracture (version 2023)
Zhonghua XU ; Lun TAO ; Zaiyang LIU ; Yang LI ; Jie LI ; Jun ZHANG ; Xia ZHANG ; Min WANG ; Changqing LI ; Guangxing CHEN ; Liu YANG ; Dawei ZHANG ; Xiaorui CAO ; Guoqiang ZHANG ; Pingyue LI ; Nirong BAO ; Chuan LI ; Shenghu ZHOU ; Zhengqi CHANG ; Bo WU ; Wenwei QIAN ; Weiguo WANG ; Ming LYU ; Hao TANG ; Hu LI ; Chuan HE ; Yunsu CHEN ; Huiwu LI ; Ning HU ; Mao NIE ; Feng XIE ; Zhidong CAO ; Pengde KANG ; Yan SI ; Chen ZHU ; Weihua XU ; Xianzhe LIU ; Xinzhan MAO ; Jie XIE ; Xiaogang ZHANG ; Boyong XU ; Pei YANG ; Wei WANG ; Xiaofeng LI ; Eryou FENG ; Zhen ZHANG ; Baoyi LIU ; Jianbing MA ; Hui LI ; Yuanchen MA ; Li SUN ; Zhifeng ZHANG ; Shuo GENG ; Guanbao LI ; Yuji WANG ; Erhu LI ; Zongke ZHOU ; Wei HUANG ; Yixin ZHOU ; Li CAO ; Wei CHAI ; Yan XIONG ; Yuan ZHANG
Chinese Journal of Trauma 2023;39(11):961-973
Femoral neck fracture (FNF) in the elderly patients is currently a major health challenge worldwide, with excessive consumption of medical resources, high incidence of complications as well as suboptimal outcome and prognosis. Hip joint arthroplasty (HJA) has been the mainstream treatment for FNF in the elderly, but the conventional surgical approaches and techniques are still confronted with a series of bottlenecks such as dislocation, limp and limb length discrepancy. In recent years, direct anterior approach (DAA) for HJA (DAA-HJA) has been a major new choice in the field of joint replacement, which achieves improved clinical effectiveness of HJA in the treatment of elderly FNF, due to the fact that DAA approach involves the neuromuscular interface and accords with the idea of soft tissue retention and enhanced recovery after surgery. However, there is still a lack of unified understanding of standard technique and procedure of DAA-HJA in the treatment of elderly FNF. Therefore, relevant experts from the Hip Joint Group of Chinese Orthopedics Association of Chinese Medical Association, Youth Arthrology Group of Orthopedic Committee of PLA, Orthopedic Committee of Chongqing Medical Association, Branch of Orthopedic Surgeons of Chongqing Medical Doctor Association and Sport Medicine Committee of Chongqing Medical Association were organized to formulate the " Chinese expert consensus on the technical standard of direct anterior hip arthroplasty for elderly femoral neck fracture ( version 2023)" based on evidence-based medicine. This consensus mainly proposed 13 recommendations covering indications, surgical plans, prosthesis selections, surgical techniques and processes, and postoperative management of DAA-HJA in elderly patients with FNF, aiming to promote standardized, systematic and patient-specific diagnosis and treatment to improve the functional prognosis of the patients.
7.Effects of optimum time of ambulation on comfort and safety of atrial fibrillation patients after radiofrequency ablation
Yi ZHUANG ; Aoshuang ZHU ; Yiming MAO ; Liyu CHAI ; Jingyi WANG ; Shujie WANG ; Jingjing XIE ; Benling LI ; Yun ZOU ; Mei ZHENG ; Yuan JI ; Liangfeng ZHANG ; Ling SUN ; Jia GUO ; Jie LUO ; Yajing XU
Chinese Journal of Practical Nursing 2022;38(32):2481-2486
Objective:To explore the optimum time of ambulation of atrial fibrillation patients after radiofrequency ablation, to provide basis for patients' early postoperative rehabilitation.Methods:By convenient sampling method, a total of 120 patients with atrial fibrillation after radiofrequency ablation were collected at Yanghu Branch and City Branch of Changzhou Second People's Hospital from January 2020 to May 2021. They were divided into the early group, middle group and late group according to the random number table method, each group were 40 cases. All patients received routine postoperative intervention, the time of ambulation were 4, 6 and 12 h after operation in the early group, middle group and late group, respectively. The complication rate within 24 h after operation was compared among the three groups, and the comfort level of the three groups at 24, 48 and 72 h after operation was evaluated with Comfort Status Scale (GCQ).Results:Finally, 111 patients were included, including 37 in the early group, 38 in the middle group and 36 in the late group. There was no significant difference in the incidence of bleeding or hematoma, urinary retention, lumbago within 24 h after operation among the three groups ( P>0.05). The incidence of postural hypotension within 24 h after operation in the early group was 2.7% (1/37), which was lower than 21.1% (7/38) and 25.0% (9/36) in the middle and late groups, with a statistically significant difference ( χ2=4.86, 7.67, both P<0.05). At 48 and 72 h after operation, the scores of physiological dimension, psychological dimension and the total score of GCQ in the early group were (20.68 ± 3.07), (22.54 ± 3.35), (81.68 ± 6.11) and (22.54 ± 3.73), (24.38 ± 2.49), (84.92 ± 6.37), higher than those in the middle group (19.16 ± 2.19), (21.32 ± 2.27), (78.24 ± 5.58), (20.93 ± 2.85), (22.32 ± 2.04), (81.66 ± 6.56), and those in the late group (18.44 ± 1.50) (21.31 ± 1.99), (78.06 ± 4.32), (20.89 ± 2.25), (21.58 ± 1.86), (80.28 ± 6.44), the differences were statistically significant ( t values were 2.19-4.15, all P<0.05). Conclusions:Ambulation at 4 h after operation does not increase peripheral vascular complications, but can reduce the incidence of postural hypotension and improve the comfort of patients with atrial fibrillation after radiofrequency ablation.
8.Evaluation of taste changes of Scutellariae Radix before and after wine-frying based on electronic ongue technology and its application in identification of Scutellariae Radix pieces.
Chong-Chong CHAI ; Yan CAO ; Min MAO ; Jing-Yue WANG ; Na LIU ; Xin-Xin LI ; Kai ZHANG ; Dong-Ling CHEN ; Long-Yin WEI ; Yi-Hui YIN ; Fei LI
China Journal of Chinese Materia Medica 2020;45(11):2552-2559
Scutellariae Radix(Huangqin) is a well-known traditional Chinese medicine(TCM) used for the treatment of clearing heat in clinical application. It is bitter-cold by using directly, but the bitter-cold property can be relieved after wine-frying. The study of taste changes before and after wine-frying of Scutellariae Radix is of great significance in identifying Scutellariae Radix and wine-processed Scutellariae Radix and clarifying the traditional theory of wine-processing. In this experiment, 10 batches of Scutellariae Radix and wine-processed Scutellariae Radix were prepared. The contents of 5 flavonoids were determined by high performance liquid chromatography(HPLC), and principal component analysis(PCA) was performed with 5 flavonoids as variables. As a result, the contents were different in different batches of Scutellariae Radix, but Scutellariae Radix and wine-processed Scutellariae Radix could not be distinguished. Five sensory attributes(sour, salty, fresh, sweet, and bitter) were evaluated by artificial tasting, and the response values of 7 sensors(AHS, AHS, PKS, CTS, NMS, CPS, ANS, SCS) representing the taste of pieces were detected by electronic tongue. The correlation between sensory evaluation and response values of the electronic tongue were analyzed, and the results showed that the sensory evaluation of sour, salty, fresh, sweet, bitter and AHS, CTS, NMS, ANS, SCS sensors had different degrees of correlation, indicating that the electronic tongue technology can be used as an alternative to artificial taste and can serve as a means for quantifying the taste, and it can be used to evaluate the taste of TCM pieces. The taste method was used to analyze the response values of the electronic tongue, and the results showed that the bitterness of wine-processed Scutellariae Radix decreased and the salty taste increased. PCA was used to analyze taste changes before and after wine-processed Scutellariae Radix, and the results showed that taste differences between 2 pieces were divided into 2 categories. PCA loading scattering plots showed that response of saltiness and bitterness were the major factors to affect overall taste in Scutellariae Radix and wine-processed Scutellariae Radix. Based on electronic tongue response values, the Fisher discriminant model for Scutellariae Radix and wine-processed Scutellariae Radix was established, which showed that it could effectively discriminate them with a recognition rate of 100%. The experimental results showed that the electronic tongue combined with multivariate statistical analysis can be used to evaluate taste of TCM, at the same time, it could provide a fast and simple method for identifying different processed products.
Chromatography, High Pressure Liquid
;
Medicine, Chinese Traditional
;
Scutellaria baicalensis
;
Taste
;
Wine
;
analysis
9.A radiomic nomogram based on T2WI for predicting synchronous liver metastasis of rectal cancer
Zhenyu SHU ; Songhua FANG ; Yuan SHAO ; Dewang MAO ; Rui CHAI ; Yuanjun CHEN ; Xiangyang GONG
Chinese Journal of Radiology 2019;53(3):205-211
Objective To explore the clinical feasibility of predicting synchronous liver metastases based on MRI radiomics nomogram based on T2WI in rectal cancer. Methods The imaging and clinical data of 261 patients with primary rectal cancer admitted to Zhejiang People′s Hospital from April 2012 to May 2018 were retrospectively analyzed. 101 patients were accompanied by synchronous liver metastasis All cases were divided into training group (n=182) and verification group (n=79). T2WI image of each patient was selected to extract texture features by AK analysis software of GE company. A radiomics signature was constructed after reduction of dimension in training group by the least absolute shrinkage and selection operator (LASSO). Univariate logistic regression was used to select for independent clinical risk factors and multivariate logistic regression along with imaging omics tags were used to construct predictive models and nomogram. ROC was used to assess the accuracy of the nomogram in the training group and to verify them by the validation group. Finally, the clinical efficacy of each patient′s synchronized liver metastasis risk factor was calculated based on the nomogram. Results A total of 328 texture features were extracted from the T2WI. Seven most valuable features were selected after reducing the dimension by LASSO algorithm, including 3 co-occurrence matrices (GLCM) and 4 run-length matrices(RLM). Tumor staging and radiomic signatures were included in the Multifactor logistic regression to build the prediction model and nomogram. The accuracy of predicting SRLM was 0.862 and 0.844 in the training and the verification group, respectively. To evaluate the accuracy of the nomogram, radiomics signature and the tumor staging in all cases were 0.857, 0.832 and 0.663, respectively. There was no significant difference in the number of SRLM cases between the high risk group and the low risk group based on nomogram (P>0.05). Conclusion The radiomics nomogram based on T2WI can be used as a quantitative tool to predict synchronous liver metastases of rectal cancer.

Result Analysis
Print
Save
E-mail