1.Material Basis and Its Distribution in vivo of Qili Qiangxin Capsules Analyzed by UPLC-Q-Orbitrap-MS
Jianwei ZHANG ; Jiekai HUA ; Rongsheng LI ; Qin WANG ; Xinnan CHANG ; Wei LIU ; Jie SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):185-193
ObjectiveBased on ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high resolution mass spectrometry(UPLC-Q-Orbitrap-MS), the chemical constituents of Qili Qiangxin capsules was identified, and their distribution in vivo was analyzed. MethodsUPLC-Q-Orbitrap-MS was used to detect the sample solution of Qili Qiangxin capsules, as well as the serum, brain, heart, lung, spleen, liver and kidney tissues of mice after oral administration. Using the Thermo Xcalibur 2.2 software, the compound information database was constructed, and the molecular formulas of compounds corresponding to the quasi-molecular ions were fitted. Based on the information of retention time, accurate relative molecular mass and fragments, the compounds and their distribution in vivo were analyzed by comparing with the data of reference substances and literature. ResultsA total of 233 compounds, including 70 terpenoids, 60 flavonoids, 23 organic acids, 17 alkaloids, 20 steroids, 7 coumarins and 36 others, were identified or predicted from Qili Qiangxin capsules, 73 of which were identified matching with standard substances. Tissue distribution results showed that 71, 17, 38, 33, 32, 58 and 43 migrating components were detected in blood, brain, heart, lung, spleen, liver and kidney, respectively. Thirty-seven components were absorbed into the blood and heart, including quinic acid, benzoylaconitine benzoylmesaconine and so on. Fourteen components were absorbed into the blood and six tissues, including calycosin, methylnissolin, formononetin, alisol B, alisol A and so on. ConclusionThis study comprehensively analyzes the chemical components of Qili Qiangxin capsules and their distribution in vivo. Among them, astragaloside Ⅳ, salvianolic acid B, ginsenoside Rb1, ginsenoside Rb3, ginsenoside Rd, ginsenoside Rg3, calycosin-7-glucoside, and sinapine may be the important components for the treatment of heart failure, which can provide useful reference for its quality control and research on pharmacodynamic material basis.
2.Formulation and Analysis on the Standard of Pharmacy Administration in Emergencies
Jingjing RAO ; Jiancun ZHEN ; Wei ZHANG ; Dan MEI ; Liyan MIAO ; Mingkang ZHONG ; Shen GAO ; Rongsheng ZHAO ; Hanqiu ZHAN
Herald of Medicine 2024;43(7):1070-1074
The pharmacy department of medical institutions assumes important responsibilities in the emergency response work.The standard of pharmacy administration in emergencies is formulated based on the principles of scientificity,versatility,instructiveness,and operability,through sorting out problems,collecting opinions and expert argumentation.This standard has 49 standards of 9 key elements from three aspects:emergency mechanism,emergency support,and emergency services.This article aims to introduce the construction method and formulation process of the pharmacy administration in emergency standards,and analyzes the content,to guide for improving emergency response ability of the medical institutions'pharmacy department in emergency events.
3.Formulation and Analysis on the Standard of Automation and Information Technology
Xun YU ; Jiancun ZHEN ; Liyan MIAO ; Zongqi CHENG ; Wei ZHANG ; Rongsheng ZHAO ; Lan ZHANG ; Xiaoyang LU ; Jian ZHANG ; Dong LIU ; Aizong SHEN ; Weihua LAI ; Jingcheng HE
Herald of Medicine 2024;43(7):1074-1078
To improve patient-centered pharmaceutical management and pharmaceutical service capabilities in the pharmaceutical department of medical institutions,automation and information technology are indispensable.The Pharmacy Administration-Automation and Information Technology is one of the social organization standards of the Chinese Hospital Association as part 4-4 of Pharmaceutical Administration and Pharmaceutical Practice in Healthcare,which standardizes 32 key elements in four aspects:basic requirements for automation construction in medical institutions,construction of automation hardware equipment,construction of intelligent information platform,and quality management and continuous improvement.It can be used to guide medical institutions at all levels to select and optimize pharmacy automation equipment and information platforms.This article introduced the construction methods and contents of the pharmacy automation and information technology standards,to deepen the understanding of peers on this standard and promote its implementation.This article aimed to promote the modernization,informatization,and intelligence of pharmaceutical services in medical institutions,and improve the quality and efficiency of overall medical pharmaceutical administration and service.
4.Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein
Xiaofeng NI ; Sha DIAO ; Siyi HE ; Xuefeng JIAO ; Xiao CHENG ; Zhe CHEN ; Zheng LIU ; Linan ZENG ; Deying KANG ; Bin WU ; Chaomin WAN ; Binwu YING ; Hui ZHANG ; Rongsheng ZHAO ; Liyan MIAO ; Zhuo WANG ; Xiaoyu LI ; Maobai LIU ; Benzhi CAI ; Feng QIU ; Feng SUN ; Naihui CHU ; Minggui LIN ; Wei SHA ; Lingli ZHANG
China Pharmacy 2023;34(4):391-396
OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.
5.Review and comment rules of national key monitoring drug prescriptions (medical orders)
Liu YANG ; Yong HAN ; Qing SHEN ; Yimeng ZHOU ; Wei REN ; Junfeng YAN ; Rongsheng TONG
China Pharmacy 2023;34(21):2561-2577
In order to standardize the review and comment of national key monitoring drug prescriptions (medical orders) by medical institutions at all levels, the Sichuan Academy of Medical Sciences·Sichuan Provincial People’s Hospital took the lead in compiling the Review and Comment Rules of National Key Monitoring Drugs prescriptions (Medical Orders) herein after referred to as the Rules in accordance with the Second Batch of National Key Monitoring Rational Drug Use List (hereinafter referred to as the List) issued by the National Health Commission confirmed in Jan. 13, 2023. According to the laws and drug instructions issued by the national drug regulatory department, clinical guidelines and expert consensus, combined with the actual situation of patients (including age, body weight, liver and kidney function), the writing group classified the common and unreasonable drug use problems for 30 kinds of drugs included in the List and develop the review and comment details. After two rounds of Delphi method questionnaire research and experts’ online meetings, and reviewed by the steering committee, the final Rules was formed. The Rules aim to provide reference for the evaluation of the rational use of drugs included in the List by medical institutions, so as to realize the standardized management of key monitoring drugs, promote the rational drug use in medical institutions, and ensure the safety of drug use for patients.
6.Epidemiological characteristics of Epstein-Barr virus infection in children
Qiwu ZHANG ; Deqiang HU ; Rongsheng WEI
Journal of Public Health and Preventive Medicine 2023;34(3):110-113
Objectives To describe the Epstein Barr virus (EBV) infection of children in Hefei, analyze its epidemiological characteristics, and explore the factors affecting EBV infection. Methods The children as the outpatient in the department of our hospital were recruited as the research subjects from June 2018 to June 2021. Epidemiological data of the research subjects were collected from medical records and the laboratory tests were performed to detect the related serological indicators of EBV. The distribution characteristics of different serological antibodies of EBV were described. According to the types of serological antibodies, all research subjects were divided into three states: primary infection, previous infection and non-infection. Logistics regression was used to analyze the factors affecting the infection status. Results There were 480 children in this study. The mean age and body mass index of all research subjects were 8.7±1.5 years and 20.78±3.2kg/m2, respectively. There were 276 boys(57.50%) and 204 girls(42.50%). 67 children(12.92%) were positive for VCA-IgM antibody. 326 children(67.92%) were positive for VCA-IgG antibody. 290 children(60.42%) were positive for NA-IgG antibody and 25 children(5.21%) were positive for EA-IgG antibody. There was no significant distribution difference of serological antibodies in gender, season of onset, disease duration, fever, angina and enlargement of lymph nodes. However, there were significant distribution differences of serological antibodies among different body mass index(χ2=50.207, P<0.001) and age(χ2=48.295, P<0.001). According to the types of serological antibodies, all research subjects were divided into three states. There were 78(16.25%) children with primary infection, 335(69.79%) with previous infection and 67(13.96%) with non-infection. Only age was the main factor affecting infection status by Logistic regression analysis(Pprimary infection vs. non-infection<0.001, ORprimary infection vs. non-infection=0.580; Pprevious infection vs. non-infection=0.038, ORprevious infection vs. non-infection=2.347). Conclusion The previous infection by EBV is the mainly infection type in children aged 6 to 12 year. The positive VCA-IgG antibody accounts for the most in previous infection. Age is the important influencing factor on EB infection. The younger the age, the higher the probability of primary infection. Besides, the positive VCA-IgM antibody is the main pattern of primary infection in children.
7.Efficacy of entecavir versus tenofovir disoproxil fumarate in treatment of chronic hepatitis B patients with high viral load
Huikun ZHOU ; Jianning JIANG ; Minghua SU ; Rongming WANG ; Bobin HU ; Deli DENG ; Huilan WEI ; Xianshuai LIANG ; Wenming HE ; Rongsheng GUO
Journal of Clinical Hepatology 2022;38(3):532-536
Objective To investigate the efficacy of entecavir (ETV) versus tenofovir disoproxil fumarate (TDF) and the treatment measures for poor response in previously untreated chronic hepatitis B (CHB) patients with high viral load. Methods A total of 165 CHB patients who received antiviral therapy and met the inclusion criteria in Department of Infectious Diseases, The First Affiliated Hospital of Guangxi Medical University, from June 2016 to July 2021 were enrolled. The patients enrolled had a baseline HBV DNA level of > 6lg copies/ml and were previously untreated CHB patients who had used ETV or TDF for 48 weeks, and quantitative real-time PCR was used to measure HBV DNA. Virologic response rate was calculated after 48 weeks of treatment; a logistic regression analysis was used to investigate the influencing factors for the response of HBV DNA < 500 copies/mL and HBV DNA < 100 copies /mL at 48 weeks; a stratified analysis was performed to compare the virologic response rate of HBV DNA < 500 copies /ml and HBV DNA < 100 copies/ml after 48 weeks between the patients with different ages, sexes, baseline HBV DNA levels, baseline alanine aminotransferase (ALT) levels, types of first-line medication, and HBeAg statuses. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups, and the binary logistic regression model was used for multivariate analysis. Results After 48 weeks of treatment, 85.5% (141/165) of the patients achieved an HBV DNA load of < 500 copies/mL, and 66.1% (109/165) of the patients achieved an HBV DNA load of < 100 copies /mL, with no significant difference in treatment outcome between the ETV group and the TDF group. The multivariate logistic regression analysis showed that sex( OR =2.793, 95% CI : 1.197-6.517), baseline HBV DNA( OR =0.369, 95% CI : 0.142-0.959), baseline ALT( OR =4.556, 95% CI : 1.770-11.732), and baseline HBeAg( OR =0.120, 95% CI : 0.033-0.429) were influencing factors for complete virologic response(all P < 0.05). For the patients with normal ALT (≤40 U/L) at baseline, 75.6% (34/45) achieved an HBV DNA load of < 500 copies/mL after 48 weeks of treatment, and 53.3% (24/45) achieved an HBV DNA load of < 100 copies/mL, with no significant difference in treatment outcome between the ETV group and the TDF group. For the patients with abnormal ALT (> 40 U/L) at baseline, 89.2% (107/120) achieved an HBV DNA load of < 500 copies/mL after 48 weeks of treatment, and the proportion of such patients in the TDF group was significantly higher than that in the ETV group (96.1% vs 84.1%, χ 2 =4.386, P =0.036); 70.8% (85/120) achieved an HBV DNA load of < 100 copies/mL, the proportion of such patients was no significant difference between the TDF group and the ETV group (78.4% vs 65.2%). The response of HBV DNA < 100 copies/ml of the normal baseline ALT group and the abnormal baseline ALT group, there were no significant differences between the patients aged≤30 years and aged > 30 years (77.8% vs 47.2%, 85.2% vs 66.7%). For the patients who did not achieve complete virologic response (HBV DNA ≥100 copies/mL) after 48 weeks of treatment, 87.9% (29/33) achieved complete virologic response after the original treatment regimen was prolonged for 48 weeks, and 100% (9/9) of the patients achieved complete virologic response after switching to or adding the first-line nucleos(t)ide analogues (NUCs) without cross-resistance sites with the original regimen for another 48 weeks. Conclusion The patients aged > 30 years should receive antiviral therapy as early as possible, regardless of viral load and ALT level, especially those with a family history of liver cirrhosis or hepatocellular carcinoma; the patients aged ≤30 years who have a normal ALT level and a high viral load should consider initiating antiviral therapy after providing informed consent. For the patients with poor response after 48 weeks of treatment, first-line NUCs without cross-resistance sites with the original regimen should be switched to or added in time.
8.Comparing the clinical characteristics and prognosis of seropositive and seronegative rheumatoid arthritis patients in China: a real-world study
Yehua JIN ; Ting JIANG ; Xiaolei FAN ; Rongsheng WANG ; Yuanyuan ZHANG ; Peng CHENG ; Yingying QIN ; Mengjie HONG ; Mengru GUO ; Qingqing CHENG ; Zhaoyi LIU ; Runrun ZHANG ; Cen CHANG ; Lingxia XU ; Linshuai XU ; Ying GU ; Chunrong HU ; Xiao SU ; Luan XUE ; Yongfei FANG ; Li SU ; Mingli GAO ; Jiangyun PENG ; Qianghua WEI ; Jie SHEN ; Qi ZHU ; Hongxia LIU ; Dongyi HE
Chinese Journal of Rheumatology 2021;25(5):307-315
Objective:In general, patients with seropositive rheumatoid arthritis (RA) are considered to show an aggressive disease course. However, the relationship between the two subgroups in disease severity is controversial. Our study is aimed to compare the clinical characteristics and prognosis of double-seropositive and seronegative RA in China through a real-world large scale study.Methods:RA patients who met the 1987 American College of Rheumatology (ACR) classification criteria or the 2010 ACR/European Anti-Rheumatism Alliance RA classification criteria, and who attended the 10 hospitals across the country from September 2015 to January 2020, were enrolled. According to the serological status, patients were divided into 4 subgroups [rheumatoid factor (RF)(-) anti-cyclic citrullinated peptide (CCP) antibody (-), RF(+), RF(+) anti-CCP antibody(+), anti-CCP antibody(+)] and compared the disease characteristics and treatment response. One-way analysis of variance was used for measurement data that conformed to normal distribution, Kruskal-Wallis H test was used for measurement data that did not conform to normal distribution; paired t test was used for comparison before and after treatment within the group if the data was normally distributed else paired rank sum test was used; χ2 test was used for count data. Results:① A total of 2 461 patients were included, including 1 813 RF(+) anti-CCP antibody(+) patients (73.67%), 129 RF(+) patients (5.24%), 245 RF(-) anti-CCP antibody(-) patients (9.96%), 74 anti-CCP antibody(+) patients (11.13%). ② Regardless of the CCP status, RF(+) patients had an early age of onset [RF(-) anti-CCP antibody(-) (51±14) years old, anti-CCP antibody(+) (50±15) years old, RF(+) anti-CCP antibody(+) (48±14) years old, RF(+)(48±13) years old, F=3.003, P=0.029], longer disease duration [RF(-) anti-CCP antibody(-) 50 (20, 126) months, anti-CCP antibody(+) 60(24, 150) months, RF(+) anti-CCP antibody(+) 89(35, 179) months, RF(+) 83(25, 160) months, H=22.001, P<0.01], more joint swelling counts (SJC) [RF(-) anti-CCP antibody(-) 2(0, 6), Anti-CCP antibody(+) 2(0, 5), RF(+) anti-CCP antibody(+) 2(0, 7), RF(+) 2(0, 6), H=8.939, P=0.03] and tender joint counts (TJC) [RF(-) anti-CCP antibody(-) 3(0, 8), anti-CCP antibody(+) 2(0, 6), RF(+) anti-CCP antibody(+) 3(1, 9), RF(+) 2(0, 8), H=11.341, P=0.01] and the morning stiff time was longer [RF(-) anti-CCP antibody(-) 30(0, 60) min, anti-CCP antibody(+) 20(0, 60) min, RF(+) anti-CCP antibody(+) 30(10, 60) min, RF(+) 30(10, 60) min, H=13.32, P<0.01]; ESR [RF(-) anti-CCP antibody(-) 17(9, 38) mm/1 h, anti-CCP antibody(+) 20(10, 35) mm/1 h, RF(+) anti-CCP antibody(+) 26(14, 45) mm/1 h, RF(+) 28(14, 50) mm/1 h, H=37.084, P<0.01] and CRP [RF(-) anti-CCP antibody(-) 2.3 (0.8, 15.9) mm/L, Anti-CCP antibody(+) 2.7(0.7, 12.1) mm/L, RF(+) anti-CCP antibody(+) 5.2(1.3, 17.2) mm/L, RF (+) 5.2(0.9, 16.2) mm/L, H=22.141, P<0.01] of the RF(+)patients were significantly higher than RF(-) patients, and RF(+) patients had higher disease severity(DAS28-ESR) [RF(-) anti-CCP antibody(-) (4.0±1.8), anti-CCP antibody(+) (3.8±1.6), RF(+) anti-CCP antibody(+) (4.3±1.8), RF(+) (4.1±1.7), F=7.269, P<0.01]. ③ The RF(+) anti-CCP antibody(+) patients were divided into 4 subgroups, and it was found that RF-H anti-CCP antibody-L patients had higher disease severity [RF-H anti-CCP antibody-H 4.3(2.9, 5.6), RF-L anti-CCP antibody-L 4.5(3.0, 5.7), RF-H anti-CCP antibody-L 4.9(3.1, 6.2), RF-L anti-CCP antibody-H 2.8(1.8, 3.9), H=20.374, P<0.01]. ④ After 3-month follow up, the clinical characteristics of the four groups were improved, but there was no significant difference in the improvement of the four groups, indicating that the RF and anti-CCP antibody status did not affect the remission within 3 months. Conclusion:Among RA patients, the disease activity of RA patients is closely related to RF and the RF(+) patients have more severe disease than RF(-) patients. Patients with higher RF titer also have more severe disease than that of patients with low RF titer. After 3 months of medication treatment, the antibody status does not affect the disease remission rate.
9.Interpretation of Novel Coronavirus Infection :Expert Consensus on Guidance and Prevention Strategies for Hospi tal Pharmacists and the Pharmacy Workforce
Rongsheng ZHAO ; Yiheng YANG ; Li YANG ; Zijian LI ; Fang LIU ; Zhenyu REN ; Wei LIU ; Zhanmiao YI ; Yingqiu YING ; Xiaoxiao LI ; Yingying YAN ; Huibo LI ; Shujie DONG ; Weilong SHI ; Xiaohan XU ; Pengxiang ZHOU ; Zaiwei SONG ; Siqian ZHENG ; Ying LIU ; Shen ZHOU ; Suodi ZHAI
China Pharmacy 2020;31(4):385-389
OBJECTIVE:To provid e reference for pharmaceutical workers to better understand Novel Coronavirus Infection : Expert Consensus on Guidance and Prevention Strategies for Hospital Pharmacists and the Pharmacy Workforce (hereinafter referred to as “expert consensus ”),and to apply and practice in specific work ,so as to give full play to the role of pharmacists to help fight the epidemic.METHODS :The background of the formulation and revision of the expert consensus were introduced ,and its main contents and viewpoints were interpreted. RESULTS & CONCLUSIONS :The text of expert consensus is divided into 8 parts,mainly including disease diagnosis and treatment [SARS-CoV- 2 infection related background ,clinical manifestations and diagnosis, treatment],hospital pharmacy (prevention and control strategy ,work guidance ),drug and facility support management(key drug/facility/equipment support ,management and use of the drug in special circumstances ),information sources and related resources ,etc.,which comprehensively and detailedly provide information ,guidance and strategies for coronavirus SARS-CoV-2 infection prevention and control to play the role of pharmacists in hospital pharmacy well ,do well in the protection of staff in different pharmaceutical posts ,drug security work in response to epidemic situation ,and develop pharmaceutical care. So far,the understanding of SARS-CoV- 2 in the pharmaceutical industry is relatively limited. Based on the accumulated experience and progress in epidemic prevention and control ,the expert consensus will be updated and improved continuously ,so as to provide guidance and help for hospital pharmaceutical personnel.
10.Construction of Integrated Emergency Management Model for Novel Coronavirus Pneumonia Epidemic Prevention and Control in Hospital Pharmacy Department
Shujie DONG ; Li YANG ; Chen CHEN ; Xianwei KONG ; Zheng CAI ; Yawei DU ; Fang LIU ; Jinping ZHU ; Hua JIANG ; Jing HUANG ; Xianhua ZHANG ; Jian WEN ; Xue LI ; Tao HAN ; Hongying GUO ; Jing CUI ; Yuan SHUAI ; Jing LI ; Yingying YAN ; Wei LIU ; Huibo LI ; Yiheng YANG ; Zijian LI ; Rongsheng ZHAO
China Pharmacy 2020;31(5):513-517
OBJECTIVE: To provide reference for improving emergency capacity of the hospital pharmacy department in response to the novel coronavirus pneumonia (COVID-19) epidemic. METHODS :According to the related regulations and requirements of Law of the People ’s Republic of China on the Prevention and Control of Infectious Diseases ,combined with the situation of COVID- 19 epidemic prevention and control ,and management experience of relevant hospitals ,on the basis of in-depth analysis of drug supply and quality assurance ,drug dispensing management ,provision of clinical pharmaceutical services and other related material support of hospital pharmacy department,integrated emergency management model was constructed for COVID- 19 epidemic prevention and control ,and the precautions and response measures of each link were sorted out. RESULTS :Integruted emergency management mode for COVID-19 epidemic prevention and control in hospital pharmacy department included but was not limited to human resource management,drug and disinfection products supply management (mainly including key treatment drugs and disinfection product list formulation,control,inventory increase ,etc.);drug dispensing management (mainly including prescription ,pharmacy window , planning quantitative reserve , drug return , etc.);clinical pharmaceutical care management (mainly including providing pharmaceutical information support ,online pharmaceutical service ,monitoring drug safety ,etc.);personnel protection and disinfection (mainly including personnel protection ,environment and window ,equipment and container ,paper prescription disinfection,etc.);special management of donated drugs ;prevention and control knowledge training ;pharmaceutical education and scientific research management ,etc. CONCLUSIONS :The integrated emergency management model for epidemic prevention and control is helpful for hospital pharmacy to manage public health emergencies. During the outbreak of COVID- 19,hospital pharmacy department should start integrated emergency management mode for epidemic prevention and control ,strengthen the risk control of each link ,and play a good role in the key functional departments in the special period.


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