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1.
Chinese Medical Ethics ; (6): 59-61, 2024.
Article in Chinese | WPRIM | ID: wpr-1012849

ABSTRACT

The "Chinese model" of organ donation and transplantation in China has gradually been praised by the world. However, the shortage of organ is still the biggest difficulty at present, so it is urgent to improve the organ donation rate among the public and the number of individual organ donations. Through combing and analyzing some important values in Chinese traditional culture, this paper tried to help today’s organ donation find an appropriate value guidance, in order to promote the development of organ donation and transplantation in China.

2.
Acta Pharmaceutica Sinica ; (12): 867-874, 2023.
Article in Chinese | WPRIM | ID: wpr-978756

ABSTRACT

Vaccination has been proved to be the most effective strategy to prevent the Corona Virus Disease 2019 (COVID-19). The mRNA vaccine based on nano drug delivery system (NDDS) - lipid nanoparticles (LNP) has been widely used because of its high effectiveness and safety. Although there have been reports of severe allergic reactions caused by mRNA-LNP vaccines, the mechanism and components of anaphylaxis have not been completely clarified yet. This review focuses on two mRNA-LNP vaccines, BNT162b2 and mRNA-1273. After summarizing the structural characteristics, potential allergens, possible allergic reaction mechanism, and pharmacokinetics of mRNA and LNP in vivo, this article then reviews the evaluation methods for patients with allergic history, as well as the regulations of different countries and regions on people who should not be vaccinated, in order to promote more safe injection of vaccines. LNP has become a recognized highly customizable nucleic acid delivery vector, which not only shows its value in mRNA vaccines, but also has great potential in treating rare diseases, cancers and other broad fields in the future. At the moment when mRNA-LNP vaccines open a new era of nano medicine, it is expected to provide some inspiration for safety research in the process of research, development and evaluation of more nano delivery drugs, and promote more nano drugs successfully to market.

3.
International Eye Science ; (12): 1338-1342, 2023.
Article in Chinese | WPRIM | ID: wpr-978630

ABSTRACT

AIM:To evaluate the correlation between axial lengths and anterior segment parameters using swept-source optical coherence tomography(SS-OCT).METHODS:For the cross-sectional clinical study, a total of 109 adult volunteers with different degrees of myopia recruited from January 1, 2022, to March 31, 2022, at the ophthalmology clinic of the First Affiliated Hospital of Zhengzhou University were included. Participants were divided into 4 groups based on axial length(AL): group A(AL≤24.0mm), group B(24.0mm<AL≤25.0mm), group C(25.0mm<AL≤26.0mm)and group D(AL>26.0mm). Anterior segment examinations were performed using SS-OCT, including: central corneal thickness(CCT), lens thickness(LT), anterior chamber depth(ACD), anterior chamber width(ACW), angle opening distance(AOD500), angle recess area(ARA500), trabecular iris space area(TISA500), trabecular iris angle(TIA500), crystalline lens rise(CLR). The relationships between these data and AL, spherical equivalent(SE)were analyzed.RESULTS:There was no difference in the comparison of CCT among the four groups(P>0.05). There were differences in SE, LT, ACD, ACW, AOD500, ARA500, TISA500, TIA500 and CLR among the four groups(all P<0.01). SE and LT were negatively correlated with AL(r=-0.75, -0.41, all P<0.01); ACD, ACW and CLR were positively correlated with AL(r=0.58, 0.45, 0.54, all P<0.01); AOD500, ARA500, TISA500 and TIA500(temporal and nasal side)were positively correlated with AL(all P<0.01). ACD and CLR were negatively correlated with SE(r=-0.21,-0.25, all P<0.01), and LT was positively correlated with SE(r=0.21, P<0.05).CONCLUSION:As AL increases, CCT remains unchanged while the ACD and ACW increase. The position of the crystalline lens moves backward and LT decreases.

4.
China Journal of Chinese Materia Medica ; (24): 1402-1406, 2023.
Article in Chinese | WPRIM | ID: wpr-970610

ABSTRACT

Ethnic medicine has a rich history of application. Because of the large number of ethnic groups, wide geographical distribution, and unique medical systems in China, the research on the human use experience(HUE) of ethnic medicine should combine the characteristics of ethnic medicine, be based on practical experience, and respect folk practice and tradition. The clinical positioning of ethnic medicine should consider three factors, i.e., population region, dominant diseases, and clinical demand. We should consider the development of traditional preparations that meet the needs of ethnic regions and encourage the development of new drugs that can be popularized and used nationwide for the dominant diseases of ethnic medicines. Attention should be paid to the problems such as a large number of customary articles or substitutes of ethnic medicinal materials, the phenomena of foreign bodies with the same name and different names for the same substance, the different standards of medicinal materials, and the poor processing standards. The name, processing method, source, medicinal parts, and dosage of ethnic medicinal materials or decoction pieces should be determined, and resources should be carefully evaluated to ensure the safety of medicinal resources and ecology. The preparation of ethnic medicine is mostly in the form of pills, powder, ointment, etc., with simple processing technology. The problems of low-quality stan-dards of some preparations, different prescriptions with the same name, and inconsistent processing technology should be overcome, and the process route and main process parameters should be clarified to lay the foundation for the subsequent empirical research on HUE. In the collection and analysis of the HUE data of ethnic medicine, the core guiding ideology of "patient-centered" should be established, and the experience data of patients should be collected. The problems of weak links existing in the inheritance of ethnic medicine should be solved, and flexible and diverse methods should be adopted. Meanwhile, on the premise of complying with the requirements of the principles of medical ethics, we should respect the religion, culture, and customs of ethnic areas to obtain the key HUE information of ethnic medicine. On the basis of the patient preference information and differences in regional disease epidemiology, population characteristics, and medical practice, whether the HUE conclusions of ethnic medicine can be extrapolated to patients outside the region is evaluated from the aspects of clinical benefits, risk tolerance, risk acceptance, etc. The HUE research on ethnic medicine is carried out in a clear way to guide the research and development of new ethnic medicines.


Subject(s)
Humans , Medicine, Chinese Traditional , China , Reference Standards , Technology , Drugs, Chinese Herbal/therapeutic use
5.
China Journal of Chinese Materia Medica ; (24): 4829-4833, 2023.
Article in Chinese | WPRIM | ID: wpr-1008652

ABSTRACT

Evidence-based medicine plays an important role in promoting the scientific nature of clinical decision-making. Howe-ver, there is a problem where evidence derived from clinical research may not necessarily be applicable to individual patients. Evidence-based medicine has been introduced into the field of traditional Chinese medicine(TCM) for over 20 years, and although certain achievements have been made, the overall level of clinical research evidence based on the principles of evidence-based medicine in TCM is not high. The acceptance of TCM diagnosis and treatment guidelines developed based on evidence-based medicine methods is generally low. As revealed by the analysis of the problems in the application of evidence-based medicine in the field of TCM, it is found that there is a structural contradiction between clinical randomized controlled trial(RCT) of TCM and the characteristics of TCM clinical practice. They cannot comprehensively, objectively, and truthfully reflect the clinical efficacy and safety of TCM. Conducting clinical RCTs of TCM in pursuit of "evidence" actually means giving up the advantages of TCM in clinical treatment based on syndrome differentiation, prescription changes along with syndromes, and treatment in accordance with three categories of disease cause, which leads to sacrificing some clinical effectiveness of TCM. Based on the concept of evidence-based medicine, this article proposed the construction of "clinical syndrome-based medicine" based on the optimal clinical experience, which was suitable for the characteristics of TCM clinical practice. The key to clinical syndrome-based medicine is the optimal clinical experience, and the core elements of the optimal clinical experience are regularity and reproducibility. Real-world research methods are recommended as a reference for obtaining the optimal clinical experience. Clinical syndrome-based medicine, combining the characteristics of TCM clinical practice and incorporating the concept of evidence-based medicine, is the product of integrating TCM into evidence-based medicine. It is dedicated to improving the clinical efficacy of TCM along with evidence-based medicine.


Subject(s)
Humans , Reproducibility of Results , Medicine, Chinese Traditional , Treatment Outcome , Evidence-Based Medicine , Syndrome , Drugs, Chinese Herbal/therapeutic use
6.
China Journal of Chinese Materia Medica ; (24): 4825-4828, 2023.
Article in Chinese | WPRIM | ID: wpr-1008651

ABSTRACT

The human use experience of traditional Chinese medicine(TCM) is of great significance for the development of new traditional Chinese medicine. In 2023, the National Medical Products Administration(NMPA) issued the Special Regulations on Registration Management of Traditional Chinese Medicine, which explicitly encouraged the conduct of high-quality human use experience research on TCM clinical practice to obtain sufficient evidence for registration support. It also required that human use experience research should comply with relevant requirements and undergo registration verification. The quality of human use experience research on TCM directly determines the reliability of the evidence. This article discussed the quality requirements for human use experience research on TCM from the perspectives of basic requirements, organizational management, key pharmaceutical information, scientific research, risk management, ethical compliance, and study implementation and proposed differential treatment in quality requirements and registration verification focus based on different research purposes, stages, and types of studies. While ensuring the authenticity of data, retrospective studies should pay particular attention to the integrity of the data, and prospective studies should focus on the normativity of the data, which may affect the research conclusions. Human use experience research, as part of drug registration materials, falls within the scope of relevant regulatory oversight. Researchers should have a strong awareness of regulations to avoid serious quality issues. The standardized conduct of human use experience research on TCM requires joint efforts from regulatory authorities, applicants, research institutions, and researchers to establish a research quality management system based on the clinical characteristics of TCM.


Subject(s)
Humans , Medicine, Chinese Traditional , Prospective Studies , Reproducibility of Results , Retrospective Studies , Pharmaceutical Preparations , Drugs, Chinese Herbal/therapeutic use
7.
Acta Academiae Medicinae Sinicae ; (6): 276-285, 2022.
Article in Chinese | WPRIM | ID: wpr-927876

ABSTRACT

Objective To investigate the relationship between the expression of glutathione peroxidase(GPX)genes and the clinical prognosis in glioma patients,and to construct and evaluate the model for predicting the prognosis of glioma. Methods The clinical information and GPX expression of 663 patients,including 153 patients of glioblastoma(GBM)and 510 patients of low-grade glioma(LGG),were obtained from The Cancer Genome Atlas(TCGA)database.The relationship between GPX expression and patient survival was analyzed.The key GPX affecting the prognosis of glioma was screened out by single- and multi-factor Cox's proportional-hazards regression models and validated by least absolute shrinkage and selection operator(Lasso)regression.Finally,we constructed the model for predicting the prognosis of glioma with the screening results and then used concordance index and calibration curve respectively to evaluate the discrimination and calibration of model. Results Compared with those in the control group,the expression levels of GPX1,GPX3,GPX4,GPX7,and GPX8 were up-regulated in glioma patients(all P<0.001).Moreover,the expression levels of other GPX except GPX3 were higher in GBM patients than in LGG patients(all P<0.001).The Kaplan-Meier curves showed that the progression-free survival of GBM with high expression of GPX1(P=0.013)and GPX4(P=0.040),as well as the overall survival,disease-specific survival,and progression-free survival of LGG with high expression of GPX1,GPX7,and GPX8,was shortened(all P<0.001).GPX7 and GPX8 were screened out as the key factors affecting the prognosis of LGG.The results were further used to construct a nomogram model,which suggested GPX7 was the most important variable.The concordance index of the model was 0.843(95%CI=0.809-0.853),and the calibration curve showed that the predicted and actual results had good consistency. Conclusion GPX7 is an independent risk factor affecting the prognosis of LGG,and the nomogram model constructed with it can be used to predict the survival rate of LGG.


Subject(s)
Humans , Brain Neoplasms , Glioblastoma , Glioma/diagnosis , Glutathione Peroxidase/metabolism , Peroxidases , Prognosis , Proportional Hazards Models
8.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 7-14, 2021.
Article in Chinese | WPRIM | ID: wpr-905921

ABSTRACT

Objective:To control the quality of the reference sample of Wenjingtang by establishing the specific chromatograms. Method:On the basis of analyzing 15 batches of Wenjingtang freeze-dried powder samples, a high performance liquid chromatography (HPLC) specific chromatogram analysis method of Wenjingtang was established. The system adaptability was investigated and the retention time, relative retention value and deviation caused by different chromatographic columns and instruments were calculated by using the same brand of chromatographic columns, four different brands of chromatographic columns and instruments from three different manufacturers. The precision, repeatability and stability of this method was further completed. The possible chemical components of the freeze-dried powders were speculated and identified by ultra-performance liquid chromatography-quadrupole-time-of-flight mass spectrometry (UPLC-Q-TOF-MS<italic><sup>n</sup></italic>). Chromatographic separation was performed on ACQUITY UPLC BEH C<sub>18</sub> column (2.1 mm×100 mm, 1.7 μm) with acetonitrile (A)-0.1% formic acid aqueous solution (B) as mobile phase for gradient elution (0-2.8 min, 10%A; 2.8-8.0 min, 10%-18%A; 8.0-12.2 min, 18%-25%A; 12.2-15.3 min, 25%-40%A; 15.3-17.4 min, 40%A; 17.4-20.5 min, 40%-90%A), and column temperature was set at 30 ℃ with flow rate of 0.4 mL·min<sup>-1</sup>. Mass spectrometry was performed on electrospray ionization, data were collected under positive and negative ion modes, and the detection range was <italic>m</italic>/<italic>z</italic> 50-1 600. Result:Ten characteristic peaks were selected as the distinguishing features in this specific chromatograms, and eight of them were identified by comparing with the reference standards, including paeoniflorin (peak 1), liquiritin apioside (peak 2), liquiritin (peak 3), ferulic acid (peak 4), iquiritigenin (peak 6), cinnamaldehyde (peak 8), paeonol (peak 9)and glycyrrhizic acid (peak 10). By mass spectrometry analysis, 30 compounds were identified, and the source of medicinal materials were assigned. It mainly contained triterpenoid saponins and flavonoids from Glycyrrhizae Radix et Rhizoma, ginsenosides from Ginseng Radix et Rhizoma, monoterpenoid glycosides and tannins from Paeoniae Radix Alba, steroids in Achyranthis Bidentatae Radix, phenolic acids in Angelicae Sinensis Radix. Conclusion:The established characteristic chromatographic analysis method of Wenjingtang is simple, stable and repeatable. The chemical composition of the freeze-dried powder of Wenjingtang is basically defined by mass spectrometry identification and source attribution, which can provide reference for the development and quality control of Wenjingtang in the future.

9.
China Journal of Chinese Materia Medica ; (24): 5987-5991, 2021.
Article in Chinese | WPRIM | ID: wpr-921721

ABSTRACT

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.


Subject(s)
Humans , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Prescriptions , Reproducibility of Results , Research
10.
China Journal of Chinese Materia Medica ; (24): 5005-5014, 2021.
Article in Chinese | WPRIM | ID: wpr-921638

ABSTRACT

Based on the textual research on literature, the key information of Wenjing Decoction were tested and identified, and 15 batches of lyophilized powder samples of Wenjing Decoction were prepared. The specific components, including paeoniflorin, glycyrrhizin, ginsenosides(Rg_1, Re and Rb_1), glycyrrhizic acid, and paeonol, were used as indexes to establish the HPLC method for quantitative evaluation, and the content ranges and transfer rates of these components were determined. The results showed that the contents of paeoniflorin, glycyrrhizin, ginsenosides Rg_1 + Re, ginsenoside Rb_1, glycyrrhizic acid, and paeonol in the 15 batches of samples were 0.62%-0.86%, 0.25%-0.76%, 0.14%-0.30%, 0.07%-0.21%, 0.63%-1.16%, and 0.09%-0.25%, respectively, and their transfer rates from the decoction pieces to the reference materials were 14.99%-19.42%, 28.11%-40.93%, 25.92%-61.88%, 25.03%-64.06%, 23.43%-35.53%, and 5.34%-10.44%, respectively. The consistency of the transfer rates between batches indicated that the preparation process was stable. It is suggested that the contents of paeoniflorin, glycyrrhizin, ginsenosides Rg_1 + Re, ginsenoside Rb_1, glycyrrhizic acid, and paeonol in Wenjing Decoction should not be less than 0.52%, 0.35%, 0.15%, 0.10%, 0.63%, and 0.12%, respectively. In this study, we determined the contents and analyzed the quantity transfer process of the index components in Wenjing Decoction, which can provide a basis for the follow-up development of Wenjing Decoction and the quality control of related preparations.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Glycyrrhizic Acid , Powders , Quality Control
11.
International Eye Science ; (12): 1675-1679, 2021.
Article in English | WPRIM | ID: wpr-886702

ABSTRACT

@#AIM: To investigate the refractive outcomes and changes of corneal astigmatism and higher-order aberrations(HOAs)after Toric implantable Collamer lens implantation(Toric ICL).<p>METHODS: Prospective nonrandomized clinical trial studies. This study included 102 eyes of 57 patients underwent Toric ICL for myopic astigmatism correction. Uncorrected visual acuity(UCVA), manifest refraction, best spectacle-corrected visual acuity(BSCVA), manifest refractive cylinder, the corneal astigmatism and HOAs were measured preoperatively and up to 6mo after surgery. The vectors were measured using corneal topography, the Pentacam HR system and Wavefront analyzer.<p>RESULTS:Postoperative, the percentage of eyes had a spherical equivalent refraction within -1.00 D were 93.80%. The percentage of eyes within -0.50 D of emmetropia were 85.30%. The percentage of eyes which postoperative UCVA ≥20/25 was 66.30% and the percentage of eyes which postoperative UCVA ≥20/20 was 65.50%. The corneal astigmatism and aberrations preoperatively showed no statistical significance compared with postoperative. The total eyes aberrations and coma resulted in slight changes and had no statistically significant.<p>CONCLUSION:The corneal incision of Toric ICL implantation caused no changes in astigmatism and higher-order wavefront aberrations of cornea.

12.
China Journal of Chinese Materia Medica ; (24): 260-266, 2021.
Article in Chinese | WPRIM | ID: wpr-878969

ABSTRACT

Dabie Mountain in Anhui province is a genuine producing area of Poria cocos, commonly known as Anling. Jinzhai county in Anhui province is a traditional producing area of P. cocos, and it is also a key county for poverty alleviation in Dabie Mountains. Poverty alleviation of traditional Chinese medicine producing area is an important measure to implement the major strategic deployment of the central government. The planting of P. cocos is helpful to promote the development of traditional Chinese medicine industry in Dabie Mountains and help poverty alleviation. P. cocos is a saprophytic fungus with special demands on soil and ecological environment, and its planting appears a scattered and irregular distribution. Traditional investigation methods are time-consuming and laborious, and the results are greatly influenced by subjective factors. In order to obtain the suitable planting area of P. cocos in Jinzhai county, according to the field survey, the research team has explored the regional, biological characteristics and cultivation methods of P. cocos in the county, and obtained the altitude distribution area suitable for the growth of P. cocos. Then, the MaxEnt niche model was used to analyze the relationship between ecological factors and distribution areas, and the potential distribution zoning of P. cocos in Jinzhai county was studied. Combined with the characteristics of P. cocos planting pattern, taking ZY-3 remote sensing image as the data source, the maximum likelihood method was used to extract the area that could be used for P. cocos cultivation in Jinzhai county, and the reason why artificial planting P. cocos was mainly distributed in the west of Jinzhai county was analyzed. The suitable regional classification of P. cocos in Jinzhai county was obtained by superposition of suitable altitude distribution area, MaxEnt analysis and area extracted from remote sensing image, which provided data support for the planting planning of P. cocos in Jinzhai county.


Subject(s)
Altitude , China , Medicine, Chinese Traditional , Soil , Wolfiporia
13.
China Journal of Chinese Materia Medica ; (24): 1994-1998, 2021.
Article in Chinese | WPRIM | ID: wpr-879120

ABSTRACT

Post-marketing evaluation of traditional Chinese medicine(TCM) is an important research stage in the life cycle of a drug, and the add-on-design is a common method for its post-marketing evaluation. This article introduces the basic concept of add-on-design, and points out that it is suitable for use based on the principles of medical ethics when the standard treatment should not be interrupted. The post-marketing evaluation of TCM should be carried out based on human experience and in compliance with regulations and ethics. The clinical values of TCM, such as the therapeutic effect for disease, improvement of disease symptoms, improvement in quality of life, as well as the synergism and toxicity attenuation of combined use of TCM and chemical drugs, should be fully reflected through the clinical trials designed with add-on-design. The key points of add-on-design are accurate clinical positioning, scientific estimation of sample size, and rigorous standard treatment. Standard treatment should be a recognized one, consistent and stable; appropriate and recognized efficacy indicators and targeted safety indicators should be selected; the design and operation of clinical research scheme should meet the requirements of randomization and blind method, with special emphasis on the production of qualified placebo. The add-on-design has the advantages that the rights and interests of the subjects are adequately protected. Besides, the research conclusions are easily put into clinical application. But there are also many difficulties, such as the influence of confounding bias, the "ceiling" effect of clinical efficacy, and the difficulty of interpretation of adverse events. Therefore, a rigorous research quality assu-rance system should be established, and the quality control of evaluation consistency of researchers should be emphasized to ensure strict quality control in the research process.


Subject(s)
Humans , Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Quality Control , Quality of Life
14.
China Journal of Chinese Materia Medica ; (24): 1691-1695, 2021.
Article in Chinese | WPRIM | ID: wpr-879080

ABSTRACT

The relevant laws and regulations of drug clinical trials were introduced in this paper. It is pointed out that with drug re-gulatory laws and technological advances, clinical trials have become an important link in the development of new drugs of traditional Chinese medicines(TCM). Clinical trials of new drugs of TCM must comply with the requirement of "Good Clinical Practice for Trial on Medicinal Products". In view of the particularities of clinical trials of new drugs of TCM, China has established an ethical review system for clinical research in TCM and carried out ethical review and certification of TCM research. In order to guide the development of clinical trials of new drugs of TCM, relevant departments have promulgated a series of guidelines for clinical trials of it, and established a new review system and technical requirements for clinical trials. Since 1983, the "national clinical pharmacology base" has been established. At present, there are 96 drug clinical trial institutions and 32 phase I clinical research wards in TCM hospitals, which can meet the development of clinical trials of new drugs of TCM. In the long-term practice, the technical team has continued to grow and develop, the research experience and technical strength have been significantly improved, and a large number of experts have become the backbone of clinical research in Chinese medicine. It is pointed out that we should attach importance to risk and benefit assessment, human experience, select scientific, objective and appropriate effectiveness indexes, evaluate the efficacy of TCM syndromes, and encourage the use of electronic methods in clinical research of new drugs of TCM. Based on the analysis of clinical trials of TCM in recent five years, it is pointed out that the active degree of clinical trials of new drugs of TCM is not high, the innovation ability of it is insufficient and the ability and enthusiasm of all aspects need to be improved. It is of great significance to carry out clinical trials of new traditional Chinese medicines to upgrade the TCM industry and produce high-level evidence-based medicine evidences. The high quality development of TCM can be promoted by strengthening clinical trials of new drugs of TCM.


Subject(s)
Humans , China , Drugs, Chinese Herbal , Evidence-Based Medicine , Medicine, Chinese Traditional , Syndrome
15.
China Journal of Chinese Materia Medica ; (24): 1686-1690, 2021.
Article in Chinese | WPRIM | ID: wpr-879079

ABSTRACT

This article proposes that the research and development of new Chinese medicines should be based on the clinical values of traditional Chinese medicine(TCM), and expounds the multiple clinical values of new Chinese medicines such as therapeutic effects, adjuvant treatment effects, improvement of disease symptoms, improvement of quality of life, prevention of diseases, etc., so as to broaden the clinical indications of new Chinese medicines. It is pointed out that the clinical value of TCM determines the clinical efficacy evaluation method of new Chinese medicines, so as to construct a clinical evaluation system of new Chinese medicines with the characteristics of TCM. It is proposed that the clinical value of new Chinese medicines should be found under the guidance of TCM theo-ry and clinical practice, and the theoretical innovation of TCM should be emphasized. There is no difference in the clinical value of drugs, and the key is to meet the clinical needs of patients. The research and development of new Chinese medicines ignores the theoretical guidance of Chinese medicine, and relying solely on animal experiment data may lead to failure of clinical trials. Different from the individualized treatment of TCM clinical syndrome differentiation, summarizing the core pathogenesis of TCM is the basis for the development of new Chinese medicines. It is necessary to summarize the pathogenesis of the disease under the guidance of TCM theory and encourage the application of modern medical methods to clarify the diagnosis of the disease. In view of the characteristics of new Chinese medicine research and development, it is proposed that the supporting role of human experience should be emphasized, and the technical points of clinical trials of new syndrome-type Chinese medicines should be explained.The use of objective indicators for syndrome evaluation, the selection of appropriate scales, and the formulation of reasonable treatment courses are advocated. During the research and development of new Chinese medicines, it is not only necessary to pay attention to modern medical safety indicators, but also to observe the evolution of TCM syndromes and specific TCM symptoms.


Subject(s)
Humans , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Quality of Life , Research , Syndrome
16.
China Journal of Chinese Materia Medica ; (24): 1681-1685, 2021.
Article in Chinese | WPRIM | ID: wpr-879078

ABSTRACT

Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.


Subject(s)
Humans , Data Collection , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Prescriptions , Quality Control
17.
Chinese Journal of Postgraduates of Medicine ; (36): 969-972, 2020.
Article in Chinese | WPRIM | ID: wpr-865615

ABSTRACT

Objective:To evaluate the effect of washing red cell suspension before transfusion in the prevention of hyperkalemia in children undergoing scoliosis orthomorphia.Methods:Thirty-two children who had underwent scoliosis orthomorphia from January 2018 to December 2019 in Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University, were selected. The children were divided into experiment group and control group by random digits table method with 16 cases each. In experiment group, the red cell suspension was washed by cell-saver before transfusion; in control group, the red cell suspension was infused routinely. Potassium concentration before operation, before blood transfusion, after blood transfusion and after operation was detected. The operation time, autologous blood transfusion, urine output, bleeding volume, allogeneic blood transfusion volume, intake and output, intraoperative blood potassium>5.0 mmol/L and blood transfusion related adverse reactions were recorded.Results:There were no statistical differences in operation time, autologous blood transfusion, urine output, bleeding volume, allogeneic blood transfusion volume, intake and output between 2 groups ( P>0.05). There was no statistical difference in blood potassium before operation and before blood transfusion between 2 groups ( P>0.05). In control group, the blood potassium after blood transfusion and after operation was significantly higher than that before blood transfusion: (4.5 ± 0.7) and (3.9 ± 0.3) mmol/L vs. (3.7 ± 0.2) mmol/L, and there was statistical difference ( P<0.05); in experiment group, the blood potassium after blood transfusion was significantly higher than before blood transfusion: (3.9 ± 0.2) mmol/L vs. (3.8 ± 0.2) mmol/L, and there was statistical difference ( P<0.05); the blood potassium after blood transfusion in experiment group was significantly lower than that in control group, and there was statistical difference ( P<0.01); there was no statistical difference in blood potassium postoperative between 2 groups ( P>0.05). In control group, 3 cases had transient blood potassium>5.0 mmol/L, and 1 case had blood potassium>6.7 mmol/L and cardiac arrest occurred during the operation; there was no blood potassium>5.0 mmol/L in experiment group. No blood transfusion related adverse reactions occurred in 2 groups. Conclusions:The method of washing red cell suspension before transfusion used in pediatric scoliosis orthomorphia can significantly reduce blood potassium after blood transfusion and effectively avoid the occurrence of hyperkalemia during the operation.

18.
Chinese Pharmaceutical Journal ; (24): 72-76, 2020.
Article in Chinese | WPRIM | ID: wpr-857817

ABSTRACT

OBJECTIVE: To analyse current situation of clinical drug use in diabetic retinopathy and provide reference for clinical rational drug use. METHODS: Two-stage sampling method was adopted which combines stratified sampling and holistic sampling, and conducted statistical analysis was conducted of with the clinical medication related data of diabetic retinopathy in 2018, which including 135 hospitals in 9 cities in “the cooperation project of hospital prescription analysis”. RESULTS: Seventeen Drugs for diabetic retinopathy were used in 135 hospitals in 2018, endocrinology contributed the most, and followed by ophthalmology, and outpatients accounted for 73.2%. The top 3 most frequently used drugs for diabetic retinopathy are calcium dobesilate, mecobalamin and pancreatic kininogenase, which accounted for 81.8% of the total 17 drugs prescription volume. It is lack of evidence for most drugs except for calcium dobesilate, and off-label use of DR drugs is common. CONCLUSION: The standardization of clinical medication for diabetic retinopathy needs to be further improved.

19.
Chinese Journal of Contemporary Pediatrics ; (12): 1273-1278, 2020.
Article in Chinese | WPRIM | ID: wpr-879789

ABSTRACT

OBJECTIVE@#To study the application of ponderal index (PI), body mass index (BMI), mid-arm circumference/head circumference (MAC/HC), and Clinical Assessment of Nutritional Status (CANS) score in assessing the nutritional status of neonates at birth, and to find a simple and reliable scheme for the assessment of fetal nutritional status.@*METHODS@#PI, BMI, MAC/HC, and CANS were used to assess the nutritional status of full-term infants and preterm infants shortly after birth. The assessment results of these methods were analyzed.@*RESULTS@#Among the 678 full-term infants, 61, 102, 47, and 131 were diagnosed with malnutrition by PI, BMI, MAC/HC, and CANS respectively. Among the 140 preterm infants, 30, 87, 9, and 112 were diagnosed with malnutrition by PI, BMI, MAC/HC, and CANS respectively. The combination of BMI and CANS had a detection rate of 99.3% in full-term infants and 100% in preterm infants. Compared with the single method, the combination significantly improved the detection rate of malnutrition (@*CONCLUSIONS@#The combination of BMI+CANS can reduce the rate of missed diagnosis of fetal malnutrition. It is therefore a simple and reliable method for the assessment of fetal malnutrition.


Subject(s)
Humans , Infant, Newborn , Body Mass Index , Fetal Nutrition Disorders/diagnosis , Infant, Premature , Nutrition Assessment , Nutritional Status
20.
Chinese Journal of Biotechnology ; (12): 1305-1313, 2020.
Article in Chinese | WPRIM | ID: wpr-826846

ABSTRACT

To improve the specific recognition and presentation of virus-like particle (VLPs), and to develop immune-targeted VLPs vaccine, the gene fragment encoding OVA₂₅₇₋₂₆₄ peptide was inserted into the VP3 gene of foot-and-mouth disease virus (FMDV) between the 171th and 172th amino acids (aa) or 173th and 174th aa by reverse PCR. The recombinant proteins were expressed by using Escherichia coli and assembled into chimeric VLP (VLP(OVA)) in vitro after purification. The VLP(OVA) was measured by dynamic light scattering and transmission electron microscopy. The recombinant protein and the assembled VLPs were evaluated by Western blotting, enzyme-linked immunosorbent assay and laser scanning confocal microscopy to confirm the insertion of OVA₂₅₇₋₂₆₄ peptide into VP3 and its location. The results show that insertion of OVA₂₅₇₋₂₆₄ into the 173th and 174th aa of FMDV VP3 did not affect the assembly of VLPs. The VLP(OVA) in size was larger than VLPs, and the OVA₂₅₇₋₂₆₄ peptide was located on the surface of VLP(OVA).


Subject(s)
Animals , Escherichia coli , Genetics , Foot-and-Mouth Disease , Virology , Foot-and-Mouth Disease Virus , Genetics , Recombinant Proteins , Genetics , Metabolism , Vaccines, Virus-Like Particle
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