Optimizing heat pump unit selection for recirculating aquaculture workshops through computational fluid dynamics.

The selection of water temperature regulation equipment plays a crucial role in the design of workshops. At present, the choice of water temperature control equipment is usually based on the volume of the fish pond and thermal parameter calculation, combined with aquaculture experience. Empirical formulas only work in specific conditions due to factors like the environment, climate, and fish types,resulting in inaccurate equipment selection outcomes. Recognizing this limitation, this paper proposes to apply CFD simulation of the temperature field to accurately calculate the heat exchange value between indoor air and water, thereby predicting the heat exchange values during aquaculture activities in the aquaculture workshop. providing a new approach for equipment selection. This paper selects a puffer fish breeding workshop in Dalian as the simulation object, establishing a 3D unsteady-state Computational Fluid Dynamics model. The model considers outdoor temperature, solar radiation, and phase-change heat transfer in water. Comparison with experimental data reveals a root mean square error of 0.46°C for the simulated results. During summer, the highest cooling load occurs at 16:00, reaching 94.6 kW. It is recommended to employ the Daikin GCHP-40MAH ground source heat pump as the water temperature control equipment. CFD simulation validates its effectiveness in shaping the indoor temperature field post-installation. the investment in water temperature control equipment can be reduced to a certain degree. This provides a reference value for the selection of water temperature equipment in aquaculture workshops.

Organ Donation in the New Era under the Influence of Traditional Culture / 中国医学伦理学

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.

Technical points of human use experience of ethnic medicine / 中国中药杂志

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.

Allergic reactions of COVID-19 vaccine based on mRNA-LNP and its pharmacokinetics in vivo / 药学学报

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.

Correlation between axial lengths and anterior segment parameters evaluated by swept-source optical coherence tomography / 国际眼科杂志(Guoji Yanke Zazhi)

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.

Construction of clinical efficacy evaluation system based on optimal clinical experience / 中国中药杂志

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.

Quality requirements of human use experience research on traditional Chinese medicine / 中国中药杂志

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.

Expression of Glutathione Peroxidases and Its Effect on Clinical Prognosis in Glioma Patients / 中国医学科学院学报

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.

Analysis of Specific Chromatogram of Wenjingtang Reference Sample / 中国实验方剂学杂志

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>ⁿ</italic>）. Chromatographic separation was performed on ACQUITY UPLC BEH C₁₈ 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^-1. 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.

Clinical efficacy of Toric ICL implantation and its effect on corneal astigmatism and aberration / 国际眼科杂志(Guoji Yanke Zazhi)

@#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.

Application of add-on-design in post-marketing evaluation of traditional Chinese medicine / 中国中药杂志

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.

Development of clinical trial of new drugs of traditional Chinese medicines / 中国中药杂志

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.

Theoretical thinking on guiding research and development of new drugs of traditional Chinese medicine / 中国中药杂志

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.

Data collection, quality and evidence formation for human use experience of traditional Chinese medicine / 中国中药杂志

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.

Suitable planting area of Poria cocos in Jinzhai county of Dabie Mountains region / 中国中药杂志

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.

Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs / 中国中药杂志

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.

Study on determination and quantity transfer of multi index components in Wenjing Decoction / 中国中药杂志

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.

Prevalence of HIV in patients hospitalized for COVID-19 and associated outcomes: a systematic review and meta-analysis

ObjectiveTo conduct a systematic review and meta-analysis of the prevalence of HIV in patients hospitalized for COVID-19 and delineating clinical outcomes including mortality. Design/MethodsMEDLINE, SCOPUS, OVID, and Cochrane Library databases and medrxiv.org were searched from January 1st, 2020, to June 15th, 2020. Data were extracted from studies reporting the prevalence of HIV among hospitalized COVID-19 patients and their clinical outcomes. Analyses were performed using random-effects models on log-transformed proportions and risk ratio estimates, and heterogeneity was quantified. ResultsA total of 144,795 hospitalized COVID-19 patients were identified from 14 studies in North America, Europe, and Asia. Median age was 55 years, and 66% were male. The pooled prevalence of HIV in COVID-19 patients was 1.22% [95% confidence interval (CI): 0.61%-2.43%)] translating to a 2-fold increase compared to the respective local-level pooled HIV prevalence in the general population of 0.65% (95% CI: 0.48%-0.89%). When stratified by country, the pooled HIV prevalence among COVID-19 patients in United States (1.43%, 95% CI: 0.98%-2.07%) was significantly higher compared to Spain (0.26%, 95% CI: 0.23%-0.29%) but was not different from China (0.99%, 95% CI: 0.25%-3.85%). The pooled mortality rate in HIV-positive patients hospitalized for COVID-19 was 14.1% (95% CI: 5.78%-30.50%) and was substantially higher in the United States compared to other countries. ConclusionsThe prevalence of HIV among COVID-19 patients appeared higher than the general population, suggesting a greater susceptibility to COVID-19 for PLWH. The pooled mortality rate is high, but the rates vary significantly across countries. Suggested ReviewersNelson Sewankambo, MD, PhD Makerere University College of Health Sciences Opposed Reviewers

Renin-angiotensin-aldosterone system inhibitors and mortality in patients with hypertension hospitalized for COVID-19: a systematic review and meta-analysis

ObjectiveThe association between renin-angiotensin-aldosterone (RAAS) inhibitors and Coronavirus diseases 2019 (COVID-19) mortality is unclear. We aimed to explore the association of RAAS inhibitors, including angiotensin-converting inhibitors (ACEi) and angiotensin II receptor blockers (ARBs) with COVID-19 mortality in patients with hypertension. MethodsMEDLINE, SCOPUS, OVID, and Cochrane Library were searched for the period of January 1, 2020 to May 20, 2020. Studies reporting the association of RAAS inhibitors (ACEi and ARBs) and mortality in patients with hypertension, hospitalized for COVID-19 were extracted. Two reviewers independently extracted appropriate data of interest and assessed the risk of bias. All analyses were performed using random-effects models on log-transformed risk ratio estimates, and heterogeneity was quantified. ResultsData were collected on 2,065,805 individuals (mean age, 58.73 years; 53.4% male). Patients with hypertension taking RAAS inhibitors were 35% less likely to die from COVID-19 compared to patients with hypertension not taking RAAS inhibitors (pooled RR= 0.65, 95% Confidence Intervals (CI): 0.45-0.94). To explore the association of COVID-19 and specific classes of RAAS inhibitors, we conducted a subgroup analysis of ARBs and ACEi separately from studies that provided them. Pooled risk ratio estimates from ARBs and ACEi showed a lower but not significant risk of death from COVID-19 (RR=0.93, 95% CI: 0.70-1.22) and ACEi (RR=0.65, 95% CI: 0.32-1.30). ConclusionsIn this meta-analysis, it was discovered that taking RAAS inhibitors, significantly decreased the risk of COVID-19 mortality in patients with hypertension. This indicates a potential protective role that RAAS-inhibitors may have in COVID-19 patients with hypertension. Key QuestionsO_ST_ABSWhat is already known about this subject?C_ST_ABSSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the recent coronavirus disease 2019 (COVID-19) pandemic, interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2 (ACE2). Recent studies have questioned whether RAAS inhibitors are safe in patients with COVID-19. However, observational studies involving patients hospitalized with COVID-19 that report the association of RAAS-inhibitors and COVID-19 severity or death have yielded conflicting findings. What does this study add?This systematic review and meta-analysis discovered that RAAS inhibitors reduced the risk of mortality by 35% in patients with hypertension hospitalized for COVID-19 (RR= 0.65, 95% CI 0.45-0.94). How might this impact clinical practice?Patients taking RAAS-inhibitors to manage their hypertension should continue to do as per current treatment guidelines.

Investigation and Analysis of Medications for Diabetic Retinopathy in 135 Hospitals / 中国药学杂志

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.