1.Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines: A Scoping Analysis
Yajing LI ; Miaomiao LI ; Le ZHANG ; Wenya WANG ; Hui ZHAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):227-238
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines (CPMs), aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs (Angong Niuhuang Wan, Jufang Zhibao Wan, Suhexiang Wan, Pien Tze Huang, Niuhuang Qingxin Wan, Qinggong Shoutao Wan, Compound Realgar Natural Indigo Tablets, Xihuang Wan, Dingkun Wan, Babao Wan, and Guilingji Capsules) were selected. A total of 365 related studies were included in this review, comprising 331 clinical studies (of which 291 were randomized controlled trials), 30 systematic reviews and Meta-analyses, 3 expert consensus, and 1 rapid health technology assessment. Among the 11 CPMs, 2(Angong Niuhuang Wan and Jufang Zhibao Wan) had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus (frequency of 7), Bovisc Alculus (7), and Borneol (5). The dosage forms included pills, capsules, oral liquid, tablets, and lozenges. The diseases treated by these CPMs mainly included malignant tumors, cerebrovascular diseases, gynecological diseases, and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases, and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred, of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies, incomplete information on medicine package, and non-standard clinical research designs remain to be addressed in the future.
2.Analysis of Specific Chromatogram of Classical Formula Qianghuo Shengshi Tang Reference Samples
Wenya GAO ; He XU ; Mingli LI ; Haiyu ZHAO ; Yanyan ZHOU ; Hongjie WANG ; Jian YANG ; Xiaolu WEI ; Zhikun FAN ; Nan SI ; Baolin BIAN
Chinese Journal of Modern Applied Pharmacy 2024;41(10):1350-1356
OBJECTIVE
To establish the specific chromatogram of Qianghuo Shengshi Tang(QHSS) reference sample, clarify the key quality attributes of QHSS, providing reference for the quality evaluation of QHSS reference sample.
METHODS
The SilGreen C18 column(4.6 mm×250 mm, 5 μm) was used. The mobile phase consisted acetonitrile and 0.2% formic acid aqueous solution. The detection wavelength was 328 nm. Established an HPLC characteristic spectrum analysis method for the reference sample of QHSS. A variety of chromatographic columns and different instruments were applied to investigate the adaptability of the system. HPLC-LTQ-Orbitrap MS was used to identify the specific peaks of the QHSS reference samples in positive ion mode.
RESULTS
There were 14 peaks in the specific chromatogram, which belonged to Notopterygii Rhizoma Et Radix, Angelicae Pubescentis Radix, Ligustici Rhizoma Et Radix, Chuanxiong Rhizome, Viticis Fructus, respectively. Ferulic acid(peak 3) was reference peak. A total of 22 compounds were identified by mass spectrometry, including coumarin and flavonoids.
CONCLUSION
The established specific chromatogram method of QHSS is simple, stable and reproducible. The material basis of QHSS reference sample is basically determined, providing a reference for the development and quality control of QHSS.
3.Development of a grading diagnostic model for schistosomiasis-induced liver fibrosis based on radiomics and clinical laboratory indicators
Zhaoyu GUO ; Juping SHAO ; Xiaoqing ZOU ; Qinping ZHAO ; Peijun QIAN ; Wenya WANG ; Lulu HUANG ; Jingbo XUE ; Jing XU ; Kun YANG ; Xiaonong ZHOU ; Shizhu LI
Chinese Journal of Schistosomiasis Control 2024;36(3):251-258
Objective To investigate the feasibility of developing a grading diagnostic model for schistosomiasis-induced liver fibrosis based on B-mode ultrasonographic images and clinical laboratory indicators. Methods Ultrasound images and clinical laboratory testing data were captured from schistosomiasis patients admitted to the Second People’s Hospital of Duchang County, Jiangxi Province from 2018 to 2022. Patients with grade I schistosomiasis-induced liver fibrosis were enrolled in Group 1, and patients with grade II and III schistosomiasis-induced liver fibrosis were enrolled in Group 2. The machine learning binary classification tasks were created based on patients’radiomics and clinical laboratory data from 2018 to 2021 as the training set, and patients’radiomics and clinical laboratory data in 2022 as the validation set. The features of ultrasonographic images were labeled with the ITK-SNAP software, and the features of ultrasonographic images were extracted using the Python 3.7 package and PyRadiomics toolkit. The difference in the features of ultrasonographic images was compared between groups with t test or Mann-Whitney U test, and the key imaging features were selected with the least absolute shrinkage and selection operator (LASSO) regression algorithm. Four machine learning models were created using the Scikit-learn repository, including the support vector machine (SVM), random forest (RF), linear regression (LR) and extreme gradient boosting (XGBoost). The optimal machine learning model was screened with the receiver operating characteristic curve (ROC), and features with the greatest contributions to the differentiation features of ultrasound images in machine learning models with the SHapley Additive exPlanations (SHAP) method. Results The ultrasonographic imaging data and clinical laboratory testing data from 491 schistosomiasis patients from 2019 to 2022 were included in the study, and a total of 851 radiomics features and 54 clinical laboratory indicators were captured. Following statistical tests (t = −5.98 to 4.80, U = 6 550 to 20 994, all P values < 0.05) and screening of key features with LASSO regression, 44 features or indicators were included for the subsequent modeling. The areas under ROC curve (AUCs) were 0.763 and 0.611 for the training and validation sets of the SVM model based on clinical laboratory indicators, 0.951 and 0.892 for the training and validation sets of the SVM model based on radiomics, and 0.960 and 0.913 for the training and validation sets of the multimodal SVM model. The 10 greatest contributing features or indicators in machine learning models included 2 clinical laboratory indicators and 8 radiomics features. Conclusions The multimodal machine learning models created based on ultrasound-based radiomics and clinical laboratory indicators are feasible for intelligent identification of schistosomiasis-induced liver fibrosis, and are effective to improve the classification effect of one-class data models.
4.Status quo of nursing practice and organizational management for reperfusion therapy in ischemic stroke in Beijing
Shanshan ZHANG ; Wenya CAO ; Hong CHANG ; Jie ZHAO ; Qingfeng MA ; Ting YANG ; Gaoting MA ; Mengrao LIU ; Suai LI
Chinese Journal of Modern Nursing 2024;30(27):3744-3749
Objective:To investigate the status of nursing practice and organizational management for reperfusion therapy in ischemic stroke across medical institutions in Beijing.Methods:In June 2023, a survey was conducted among nursing managers from 62 medical institutions under the jurisdiction of the Beijing Stroke Treatment Quality Control and Improvement Center. The survey aimed to assess the current nursing practices and organizational management for reperfusion therapy in ischemic stroke.Results:Among the 62 medical institutions, 16.13% (10/62) had dedicated reperfusion therapy nurses for stroke, and 87.10% (54/62) had established specific nursing protocols and procedures for stroke reperfusion therapy within their departments. However, 27.42% (17/62) of these institutions based the development and updates of their protocols on experiential summaries rather than standardized guidelines. In terms of nursing practice, there was room for improvement in emergency identification and triage of suspected stroke patients, assistance with intravenous thrombolysis, patient condition monitoring, early rehabilitation, and related health education. Regarding nursing quality control, significant differences were observed between institutions that regularly conducted quality control of stroke reperfusion therapy nursing and those that organized regular training sessions for nurses in this area ( P<0.05) . Conclusions:While nursing practices and quality for stroke reperfusion therapy in Beijing are progressing, there are disparities in regional development. There is a high demand for specialized stroke nursing and targeted technical training.
5.Construction and preliminary evaluation of Stroke Nursing Specialist theoretical training curriculum system
Hong CHANG ; Jie ZHAO ; Kaiting FANG ; Siying TIAN ; Wenya CAO
Chinese Journal of Practical Nursing 2023;39(5):355-362
Objective:Based on the core competence of stroke certified registered nurses, this study construct the theoretical raining curriculum system for stroke certified registered nurses and made a preliminary evaluation.Methods:Using Delphi expert consultation method and based on literature research, the first draft of training course for stroke certified registered nurses was formed. In the form of Email, 14 experts in the field of stroke care who met the selection criteria were sent a questionnaire, and two rounds of consultation were conducted. The theoretical raining curriculum system for the training of stroke specialist nurses was constructed; the purpose sampling method was used to evaluate the application effect of the stroke specialist nursing theoretical training curriculum system through the theoretical performance and satisfaction evaluation of 127 trainees who participated in the first phase of the stroke specialist nursing theoretical training curriculum.Results:The recovery rate and effective rate of the two rounds of expert consultation questionnaire were 14/14, the authority coefficient of the second round of expert consultation was 0.94, and the expert Kandall coordination coefficients of the first, second and third-level indexes were 0.356, 0.216, 0.207 respectively ( P<0.05). The training curriculum of stroke specialist nurses finally formed included 5 primary indicators (Professional practice concept, general nursing knowledge, stroke diagnosis and treatment, acute stroke nursing management, secondary prevention of cerebrovascular disease), 21 secondary indicators and 63 tertiary indicators. The Analytic hierarchy process was used to determine the weight coefficients of all levels of indicators, and the consistency Ratio <0.1. Based on the curriculum system as the content framework, theoretical courses were set up to train stroke specialist nurses. 109 trainees completed the post-training assessment. Before training, the qualified rate of theoretical performance of stroke certified registered nurses was 77.95% (99/127), and after training, the qualified rate of theoretical performance of stroke certified registered nurses was 100% (109/109). The difference was statistically significant ( χ 2=27.60, P<0.01). The excellent rate of theoretical performance of stroke certified registered nurses before training was 35.43% (45/127), and 100% (109/109) after training, the difference was statistically significant ( χ 2=24.17, P<0.01).The average score of the trainees′ satisfaction was (38.90±2.55) points. Conclusions:The theoretical raining curriculum system for stroke certified registered nurses setting constructed in this study standardizes the training system of stroke nurses to a certain extent, and provides a basis for the construction of homogeneous training courses in China in the future.
6.Epidemiological characteristics of childhood infectious diseases in a single center in Beijing City from 2007 to 2021
Wenya FENG ; Yunhua YAO ; Chengsong ZHAO ; Yuchuan LI ; Huan LIU ; Yi TIAN ; Gang LIU
Chinese Journal of Infectious Diseases 2023;41(7):447-453
Objective:To analyze the epidemiological characteristics of childhood infectious diseases in a single center in Beijing City from 2007 to 2021, and to provide scientific basis for the management of infectious diseases in hospitals.Methods:The clinical data of outpatients or inpatients aged<18 years old with infectious diseases recorded in the Nationwide Health Information-based Disease Control and Prevention Information System of Beijing Children′s Hospital, Capital Medical University from January 1, 2007 to December 31, 2021 were collected. Descriptive epidemiological methods were used to analyze the types of infectious diseases, population distribution, time distribution characteristics, as well as the etiological characteristics of major infectious diseases.Results:There were 219 260 cases reported, accounting for 5.73‰(219 260/38 295 800) of the total number of hospital cases, with two peaks of 25 469 and 22 928 cases in 2010 and 2019, respectively. The main category of infectious diseases was class C, accounting for 77.51%(169 947/219 260). According to the classification of transmission routes, fecal-oral transmission infectious diseases were the most common, with 144 712 cases (66.00%), followed by air and droplet transmission infectious diseases with 73 946 cases (33.73%), showing an increasing trend by year. The top five diseases in terms of incidence were hand, foot and mouth disease (114 864 cases), influenza (28 703 cases), varicella (22 190 cases), other infectious diarrheal diseases (21 040 cases) and scarlet fever (11 500 cases). Among the 219 260 children, there were 131 546 males and 87 714 females, with a male-to-female ratio of 1.5 to 1. Children aged≤6 years old comprised the majority, with a total of 189 593 cases (86.47%). The peak period of infectious diseases reporting was from May to July. Hand, foot and mouth disease was mainly caused by Coxsackie virus A16(35.02%(1 258/3 592)), while Coxsackie virus A6 had been increasing rapidly since 2017. The main pathogen of influenza was influenza A virus (62.18%(7 400/11 900)), while other infectious diarrhea was mainly caused by rotavirus (87.55%(4 283/4 892)).Conclusions:There is an intermittent outbreak in the incidence of childhood infectious diseases, and air and droplet transmission infectious diseases have shown an upward trend in recent years. Hand, foot and mouth disease, influenza, varicella, other infectious diarrheal diseases and scarlet fever are the main infectious diseases affecting children. Different diseases have the characteristics of age and onset season. The prevention and control of infectious diseases should be updated gradually according to the epidemic trend. Proper protection should be taken during peak seasons and for key populations.
7.Establishment of Specific Chromatogram and Thin-layer Identification Method for Kaixinsan
Wenya GAO ; Min FENG ; Chang GAO ; Haiyu ZHAO ; Yanyan ZHOU ; Hongjie WANG ; Ruipeng YU ; Yipeng ZHAO ; Lili ZHANG ; Yanqing GAO ; Yanhong XIAO ; Cuina CHENG ; Xiaolu WEI ; Nan SI ; Baolin BIAN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(13):37-44
ObjectiveTo establish the specific chromatogram and thin layer chromatography(TLC) identification method of Kaixinsan(KXS) samples, in order to clarify the key quality attributes and provide reference for the quality evaluation of KXS. MethodHigh performance liquid chromatography(HPLC) specific chromatogram of KXS was developed with YMC Hydrosphere C18 column(4.6 mm×250 mm, 5 μm), the mobile phase was acetonitrile(A)-0.2% formic acid aqueous solution(B) for gradient elution(0-15 min, 2%-20%A; 15-25 min, 20%-25%A; 25-30 min, 25%-30%A; 30-45 min, 30%-31%A; 45-50 min, 31%-44%A; 50-65 min, 44%-45%A; 65-73 min, 45%-75%A; 73-95 min, 75%-100%A; 95-105 min, 100%A; 105-105.1 min, 100%-2%A; 105.1-120 min, 2%A), the detection wavelength was 320 nm. Ultra high performance liquid chromatography-linear ion trap-electrostatic field orbitrap mass spectrometry(UHPLC-LTQ-Orbitrap MS) was used to identify the chemical components of KXS with electrospray ionization(ESI), negative ion mode and scanning range of m/z 50-2 000. TLC identification methods for Poria and Ginseng Radix et Rhizoma in KXS were established. ResultThere were 11 common peaks in the specific chromatogram of KXS, attributed to Polygalae Radix, Poria and Acori Tatarinowii Rhizoma. Taking peak 9(α-asarone) as the reference peak, the relative standard deviations of the retention times of 15 batches of KXS samples were<0.2%. A total of 34 compounds were identified by UHPLC-LTQ-Orbitrap MS, including terpenoids, phenylpropanoids, oligosaccharides and ketones. The established TLC had good separation and was rapid, reliable, simple, feasible, suitable for the identification of Poria and Ginseng Radix et Rhizoma in KXS. ConclusionThe specific chromatogram and TLC of KXS are stable and reproducible. The material basis of KXS is basically clarified by MS, which can provide a reference for the development and quality control of KXS.
8.Ethics considerations on brain-computer interface technology.
Zhe ZHANG ; Xu ZHAO ; Yixin MA ; Peng DING ; Wenya NAN ; Anmin GONG ; Yunfa FU
Journal of Biomedical Engineering 2023;40(2):358-364
The development and potential application of brain-computer interface (BCI) technology is closely related to the human brain, so that the ethical regulation of BCI has become an important issue attracting the consideration of society. Existing literatures have discussed the ethical norms of BCI technology from the perspectives of non-BCI developers and scientific ethics, while few discussions have been launched from the perspective of BCI developers. Therefore, there is a great need to study and discuss the ethical norms of BCI technology from the perspective of BCI developers. In this paper, we present the user-centered and non-harmful BCI technology ethics, and then discuss and look forward on them. This paper argues that human beings can cope with the ethical issues arising from BCI technology, and as BCI technology develops, its ethical norms will be improved continuously. It is expected that this paper can provide thoughts and references for the formulation of ethical norms related to BCI technology.
Humans
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Brain-Computer Interfaces
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Technology
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Brain
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User-Computer Interface
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Electroencephalography
9.Establishment of Specific Chromatogram and TLC Identification for Qingxin Lianziyin
Wenya GAO ; Xiujing MA ; Chang GAO ; Haiyu ZHAO ; Yanyan ZHOU ; Hongjie WANG ; Ruipeng YU ; Yipeng ZHAO ; Cuie YAN ; Lifang GAO ; Nan SI ; Baolin BIAN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(11):34-42
ObjectiveTo establish the specific chromatogram and thin layer chromatography(TLC) of Qingxin Lianziyin(QXLZY) benchmark samples, in order to clarify the key quality attributes and provide a reference for the quality evaluation of QXLZY. MethodHigh performance liquid chromatography(HPLC) specific chromatogram of QXLZY benchmark samples was developed by using a YMC Hydrosphere C18 column(4.6 mm×250 mm, 5 μm) with the mobile phase of acetonitrile(A)-0.2% formic acid aqueous solution(B) for gradient elution(0-10 min, 5%-20%A; 10-20 min, 20%A; 20-25 min, 20%-24%A; 25-40 min, 24%-30%A; 40-55 min, 30%-50%A; 55-65 min, 50%-100%A; 65-75 min, 100%A; 75-75.1 min, 100%-5%A; 75.1-90 min, 5%A), and the detection wavelength was 360 nm. Ultra-high performance liquid chromatography-linear ion trap/orbitrap mass spectrometry(UHPLC-LTQ-Orbitrap MS) with electrospray ionization(ESI) was used to identify the components of QXLZY benchmark samples by accurate relative molecular weight and multilevel MS fragment ion information, the detection conditions were positive and negative ion modes and data dependency scanning mode. TLC identification methods for Ophiopogonis Radix, Lycii Cortex, Nelumbinis Semen, Poria, Astragali Radix and Ginseng Radix et Rhizoma in QXLZY were established. ResultA total of 15 characteristic peaks were identified from Glycyrrhizae Radix et Rhizoma, Plantaginis Semen and Scutellariae Radix, and the relative standard deviations of the retention times of 15 characteristic peaks in 15 batches of QXLZY benchmark samples were≤3% with peak 8(baicalin) as the reference peak. A total of 100 compounds, including flavonoids, organic acids, saponins, amino acids and others, were identified in the benchmark samples by UHPLC-LTQ-Orbitrap MS. The established TLC had good separation and was suitable for the identification of Ophiopogonis Radix, Lycii Cortex, Nelumbinis Semen, Poria, Astragali Radix and Ginseng Radix et Rhizoma in QXLZY. ConclusionThe material basis of QXLZY benchmark samples is basically determined by MS designation and source attribution. The established specific chromatogram and TLC of QXLZY are simple, stable and reproducible, which can provide a reference for the development and quality control of QXLZY.
10.TiRobot combined with three-dimensional imaging to assist minimally invasive treatment of pelvic fractures
Yongbiao WANG ; Xiaoreng FENG ; Yiyi YAO ; Jinbiao LIN ; Jinfa ZHENG ; Lianxiong GUAN ; Yupeng LI ; Zhaopei LUO ; Wenya ZHAO
Chinese Journal of Orthopaedic Trauma 2022;24(10):856-861
Objective:To explore the efficacy and safety of TiRobot combined with three-dimensional imaging in the minimally invasive surgery for pelvic fractures.Methods:A retrospective analysis was conducted of the 40 patients with pelvic fracture who had been treated by fixation with S1 and S2 sacroiliac screws at Department of Orthopaedics and Traumatology, Yangjiang People's Hospital from January 2019 to May 2021. They were divided into 2 groups according to their treatment methods. In the TiRobot group of 20 cases subjected to percutaneous sacroiliac screw fixation assisted by TiRobot combined with three-dimensional imaging, there were 13 males and 7 females with an age of (38.2 ± 8.8) years. In the manual group of 20 cases subjected to fixation with manual placement of sacroiliac screws under conventional C-arm fluoroscopy, there were 11 males and 9 females with an age of (37.3 ± 9.2) years. The 2 groups were compared in terms of fluoroscopy time for screw placement, guide needle adjustment, operation time, intraoperative blood loss, visual analogue scale (VAS) 72 hours after operation, postoperative hospital stay, time to ambulation, excellent to good rate of screw placement, complication rate, fracture union time, Majeed score at 6 months after operation, and excellent to good rate of functional evaluation.Results:There was no significant difference between the 2 groups in their preoperative general data, showing they were comparable ( P > 0.05). In the TiRobot group, fluoroscopy time for screw placement [(8.2 ± 2.9) s], guide needle adjustment [(0.4 ± 0.2) times], operation time [(67.4 ± 5.5) min], and intraoperative blood loss [(36.5 ± 8.0) mL] were significantly less than those in the manual group [(40.4 ± 4.5) s, (8.6 ± 0.7) times, (78.4 ± 7.2) min, and (41.6 ± 7.8) mL], postoperative VAS [3.0 (4.0, 5.0) points] was significantly lower than that in the manual group [4.0 (5.0, 6.0) points], the excellent to good rate of screw placement (100%, 40/40) was significantly higher than that in the manual group (85.0%, 34/40), and the complication rate (5.0%,1/20) was significantly lower than that in the manual group (35.0%, 7/20) (all P < 0.05). There was no significant difference between the 2 groups in postoperative hospital stay, time to ambulation, fracture union time, Majeed score, or excellent to good rate of functional evaluation ( P > 0.05). Conclusion:In the minimally invasive surgery for pelvic fractures, TiRobot combined with three-dimensional imaging leads to positive outcomes, because it can reduce operation time and radiation exposure, improve accuracy of screw placement, and increase safety.


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