1.Herbal Textual Research on Bletillae Rhizoma in Famous Classical Formulas
Dan ZHAO ; Tao ZHOU ; Chaolei LUO ; Dewei GAN ; Lingling LIU ; Chuanzhi KANG ; Zhikun WU ; Xu LI ; Yan FU ; Guoqiong CAO ; Yongping ZHANG ; Chenghong XIAO ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):77-88
In order to provide basic information for the utilization and development of famous classical formulas containing Bletillae Rhizoma, this article systematically analyzes the historical evolution of the name, origin, harvesting and processing of Bletillae Rhizoma by reviewing the ancient materia medica, prescription books, medical books and modern literature. The research results showed that Baiji(白及) was the main name, some scholars took Baiji(白芨) as its main name, and there were many other names such as Baiji(白给), Baigen(白根), Baiji(白苙). The mainstream source of Bletillae Rhizoma was the tubers of Bletilla striata, and drying, large, white, solid, root-free and skin removed completely were the good quality standards. With the promotion of wild to cultivated medicinal materials, there were certain differences between their traits, and the quality evaluation indexes should be adjusted accordingly. The origin of records in the past dynasties was widely distributed, with Guizhou and Sichuan having high production and good quality in modern times. The harvesting period is mostly in spring and autumn, and harvested in autumn was better. The processing and processing technology is relatively simple, and it was used fresh or powdered in past dynasties, while it is mainly sliced for raw use in modern times. Based on the results, it is suggested that the tubers of Bletilla striata of Orchidaceae should be used in the famous classical formulas, and it should be uniformly written as Baiji(白及). And if the original formula indicates the requirement of processing, it should be operated according to the requirement, if the requirement of processing is not indicated, it can be used in raw form as medicine.
2.Progress in methodological research on bridging the efficacy-effectiveness gap of clinical interventions (1): to improve the validity of real-world evidence
Zuoxiang LIU ; Zilin LONG ; Zhirong YANG ; Shuyuan SHI ; Xinran XU ; Houyu ZHAO ; Zuyao YANG ; Zhu FU ; Haibo SONG ; Tengfei LIN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(2):286-293
Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.
3.Progress in methodological research on bridging the efficacy-effectiveness gap of clinical interventions(2): to improve the extrapolation of efficacy
Zuoxiang LIU ; Zilin LONG ; Zhirong YANG ; Shuyuan SHI ; Xinran XU ; Houyu ZHAO ; Zuyao YANG ; Zhu FU ; Haibo SONG ; Tengfei LIN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(4):579-584
Objective:Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:A total of 12 articles were included. Three methods in the included literature focused on: ①improving the design of traditional RCT to increase population representation; ②combining RCT Data with real-world data (RWD) for analysis;③calibrating RCT results according to real-world patient characteristics.Conclusions:Improving the design of RCT to enhance the population representation can improve the extrapolation of the results of RCT. Combining RCT data with RWD can give full play to the advantages of data from different sources; the results of the RCT were calibrated against real-world population characteristics so that the effects of interventions in real-world patient populations can be predicted.
4.EIT-based study of lung ventilation and perfusion regional distribution and ventilation/perfusion matching in different body positions
Ti-Xin HAN ; Yi-Fan LIU ; Meng DAI ; Pu WANG ; Jian-An YE ; Zhi-Bo ZHAO ; Zhan-Qi ZHAO ; Feng FU
Chinese Medical Equipment Journal 2024;45(5):1-7
Objective To compare regional pulmonary ventilation and perfusion and ventilation/perfusion(V/Q)matching in different body positions using electrical impedance tomography(EIT).Methods Ten healthy experimental pigs were selected to collect their EIT lung ventilation and perfusion data in supine,prone,left lateral and right lateral positions.The EIT data underwent analysis and image reconstruction using MATLAB R2022b and EIDORS v3.9.The effective regions with ventilation and perfusion were determined and the V/Q matching regions were computed with the maximum pixel value 20%as the threshold.Comparisons were carried out over the V/Q matching indexes including V/Q match%,dead space%and shunt%and ventilation and perfusion distribution in regions of interest(ROIs)including ROI1,ROI2,ROI3 and ROI4 in different body positions.Results The differences in V/Q match%,dead space%and shunt%of the experimental animals in varied positions were not statistically significant(P>0.05).The regional distribution of pulmonary ventilation and perfusion changed in different positions,and the regional distributions differed in ROIl,ROI2 and ROI3 for ventilation(P<0.05)and in ROI1 and ROI2 for perfusion(P<0.05).The ventilation and perfusion regions were distributed consistently with the gravity-dependent areas in supine and prone positions whereas conversely in the right and left lateral positions.Conclusion The V/Q matching indexes of one subject have high test consistency in different body positions;gravity-dependent areas varied with the changes of the body positions,which affected the distribution of pulmonary ventilation and perfusion regions;EIT can be used for measuring the changed pulmonary ventilation and perfusion due to different positions and determining the influences of position changes on pulmonary ventilation and perfusion and V/Q matching.[Chinese Medical Equipment Journal,2024,45(5):1-7]
5.The application of nurse-performed point-of-care ultrasound in the management of abdominal distension in patients with enteral nutrition in ICU
Xiumei NI ; Shaohua HU ; Jiangying HAN ; Hong FU ; Yuehong CAI ; Lican ZHAO ; Jihai WANG ; Xuemei ZHAN
Chinese Journal of Nursing 2024;59(17):2123-2129
Objective To explore the application of nurse-performed point-of-care ultrasound in abdominal distension of ICU patients with enteral nutrition.Methods Purposive sampling method was used to select 108 patients with enteral nutrition abdominal distension admitted to the ICU of a tertiary A general hospital in Hefei City from January to December 2022,and they were divided into an experimental group and a control group according to random number table method.The experimental group used bedside ultrasound to evaluate the stomach,intestine and abdominal cavity of patients with abdominal distension,and implemented targeted treatment measures according to the evaluation results.The control group was given corresponding treatment measures according to the abdominal sight,touch,tapping,listening and traditional syringe withdrawal method.Intra-abdominal pressure,abdominal circumference,feeding compliance rate and feeding interruption rate,ICU stay time and mechanical ventilation time were compared at the 1st,3rd and 5th day.Results 11 cases dropped out of the study due to transfer,automatic discharge,death,etc.,and 97 cases were included 51 cases in the experimental group and 46 cases in the control group.Repeated measurement ANOVA showed that intra-abdominal pressure and abdominal circumference time in the 2 groups had interaction with each other(F=41.724,P<0.001;F=17.762,P<0.001).Generalised estimating equations showed that there was only a between-group effect for the rates of feeding compliance and feeding disruption in 2 groups(Wald y2=18.033,P<0.001;Wald x2=6.567,P<0.001).Simple effect analysis showed that on the 3rd and 5th day after intervention.The experimental group had lower abdominal depression and the feeding interruption rate was lower than the control group(P<0.05).On the 5th day after interven-tion,the abdominal circumference of the experimental group was lower than that of the control group,the feeding compliance rate was higher than that of control group(P<0.05).After intervention,in the experimental group,the mechanical ventilation time was shorter than that of the control group(P<0.05).There was no significant difference in ICU stay time between the 2 groups(P=0.095).Conclusion The application of nurse-performed point-of-care ultrasound in the management of abdominal distension in patients with enteral nutrition in ICU is feasible and scientific,which is helpful for the management of patients with enteral nutrition abdominal distension in ICU,reducing internal abdominal pressure,shortening mechanical ventilation time,and avoiding the occurrence of feeding intolerance.
6.Prediction method for weaning outcomes based on machine learning and electrical impedance tomography
Pu WANG ; Zhan-Qi ZHAO ; Meng DAI ; Yi-Fan LIU ; Jian-An YE ; Xiang TIAN ; Ti-Xin HAN ; Feng FU
Chinese Medical Equipment Journal 2023;44(10):1-6
Objective To propose a method for predicting weaning outcomes based on machine learning and electrical impedance tomography(EIT).Methods Firstly,EIT image features were extracted from a total of 84 samples from 30 patients,and the important features screened with the extreme gradient boosting(XGBoost)algorithm were used as inputs to the model.Secondly,the prediction model was built with six machine learning methods,namely random forest(RF),support vector machines(SVM),XGBoost,gradient boosting decision tree(GBDT),logistic regression(LR)and decision tree(tree).Then the prediction model had its prediction performance evaluated by AUC,accuracy,sensitivity and specificity under imbalanced dataset,over-sampling balanced dataset and random under-sampling balanced dataset.Results In terms of AUC,accuracy and specificity,the model under the over-sampling balanced dataset and the random under-sampling balanced dataset behaved better than that under the imbalanced dataset(P<0.05);in terms of sensitivity,the difference in model performance between the over-sampling balanced dataset and the imbalanced dataset was not statistically significant(P>0.05),and the model performance under the random under-sampling balanced dataset decreased when compared with that under the imbalanced dataset(P<0.05).There were no significant differences between the model performance under the over-sampling balanced dataset and that under the random under-sampling balanced dataset(P>0.05).The model based on XGBoost behaved the best under the over-sampling balanced dataset,with an AUC of 0.769,an accuracy of 0.808,a sensitivity of 0.938 and a specificity of 0.600.Conclusion The method based on machine learning and EIT predicts weaning outcomes of patients with prolonged mechanical ventilation,and thus can be used for auxiliary decision support for clinicians to determine the appropriate timing of weaning.[Chinese Medical Equipment Journal,2023,44(10):1-6]
7.Progress in research of economic evaluation of COVID-19 vaccination strategies.
Jing Yu ZHAO ; Pei En HAN ; Ya Qun FU ; Li YANG ; Tao REN ; Si Yan ZHAN ; Li Ming LI
Chinese Journal of Epidemiology 2022;43(4):460-465
Objective: To understand the research progresses of economic evaluation of COVID-19 vaccination strategies both at home and abroad, and provide reference for the economic evaluation of COVID-19 vaccination strategies using real word data in China. Methods: Literature retrieval was conducted for related papers published from January, 2020 to December, 2021 in Chinese and English databases, including the economic evaluation of COVID-19 vaccination, and the results of the related literatures were narratively integrated. Results: A total of 16 English literatures (including 3 reviews) were included, and it was found that the COVID-19 vaccination was cost-effective or cost-saving regardless of the vaccine types, while the cost-effectiveness in different population and under different vaccination dose strategies varied due to vaccine efficacy, vaccine price, duration of natural immunity, duration of vaccination campaign, vaccine supply, and vaccination pace. Conclusions: China lacks suitable evidences of economic evaluation of COVID-19 vaccination strategies based on real-world data in the context of long-term epidemic. Therefore, further researches of suitable strategies of booster COVID-19 vaccination are needed.
COVID-19/prevention & control*
;
COVID-19 Vaccines
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China/epidemiology*
;
Cost-Benefit Analysis
;
Humans
;
Vaccination
8.Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 1).
Shu Yuan SHI ; Zuo Xiang LIU ; Hou Yu ZHAO ; Xiao Lu NIE ; Zhu FU ; Hai Bo SONG ; Chen YAO ; Si Yan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2022;43(11):1828-1834
In recent years, researchers, pharmaceutical companies, and political makers gradually using more real-world data (RWD) to produce real-world evidence (RWE) for policy-making. A research team of Harvard University launched the RCT DUPLICATE project in 2018, aiming to replicate 30 randomized controlled trials using the medical claims database in order to explore methods for quantifying the efficacy-effectiveness gap and explain its potential sources, to enhance the credibility of the RWE. This paper reviews the background of RCT DUPLICATE Initiative, highlights the research purposes, research design and implementation process of the RCT DUPLICATE Initiative, to help domestic scholars better understand the scope and application value of RWE.
Humans
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Randomized Controlled Trials as Topic
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Cognition
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Databases, Factual
;
Research Personnel
;
Universities
9.Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 2).
Shu Yuan SHI ; Zuo Xiang LIU ; Hou Yu ZHAO ; Xiao Lu NIE ; Sheng HAN ; Zhu FU ; Hai Bo SONG ; Chen YAO ; Si Yan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2022;43(11):1835-1841
With the promotion and application of big medical data, non-interventional real-world evidence (RWE) has been used by regulators to assess the effectiveness of medical products. This paper briefly introduces the latest progress and research results of the RCT DUPLICATE Initiative launched by the research team of Harvard University in 2018 and summarizes relevant research experience based on the characteristics of China's medical service to provide inspiration and reference for domestic scholars to conduct related RWE research in the future.
Humans
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Randomized Controlled Trials as Topic
;
Cognition
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Big Data
;
Universities
10. Research progress on therapeutic strategies for improving pulmonary vascular remodeling in pulmonary hypertension
Xiang-Yun GAI ; En-Qi ZHAO ; Yan-Feng HE ; Yue-Fu ZHAO ; Jin-Yu WANG ; Feng-Run LI ; Xiang-Yun GAI ; En-Qi ZHAO ; Yan-Feng HE ; Yue-Fu ZHAO ; Jin-Yu WANG ; Feng-Run LI ; Zhan-Qiang LI
Chinese Pharmacological Bulletin 2022;38(11):1612-1616
Pulmonary hypertension(PH)is a chronic,progressive,high-mortality disease characterized by a continuous increase in pulmonary vascular pressure. All types of PH have the same characteristics,i.e.,the excessive proliferation,anti-apoptosis and inflammation of pulmonary artery endothelial cells and smooth muscle cells,which leads to progressive thickening of pulmonary small vessels,resulting in pulmonary vascular remodeling and increased pulmonary vascular resistance,ultimately leading to right ventricular hypertrophy,heart failure,and death. The drugs used to treat PH mainly include L-type calcium channel blockers,phosphodiesterase 5 inhibitors,guanosine cyclase activators,endothelin receptor antagonists,and synthetic prostacyclin and its analogues. These drugs reduce pulmonary artery pressure by relaxing pulmonary blood vessels but do not cure the patient,and their prognosis remains poor. Therefore,the development of drugs that can effectively improve or even reverse pulmonary vascular remodeling is the key to treating PH. In recent years,studies on pulmonary vascular remodeling mainly included(1)the synthesis of new small-molecule compounds;(2)the transformation of mature drugs,such as the use of drug combinations and dosage form transformation,etc.;(3)the pharmacodynamic evaluation of traditional Chinese medicines and derived compounds based on the theory of "lung distension";(4)research into monomers of traditional Chinese medicine; and(5)research into new targets.

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