1.Formulation Characteristics and Efficacy Classification of Chinese Patent Medicines for Cardiovascular and Cerebrovascular Diseases Based on Diagram of Tangye Jingfa Tu
Yuguang WANG ; Runtao ZHUANG ; Yanqing LIU ; Shen LI ; Xiaolan LIN ; Rui JIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):224-233
ObjectiveChinese patent medicines for cardiovascular and cerebrovascular diseases are diverse and complex in their efficacy. The traditional classification method based on efficacy categories has certain limitations and cannot meet the clinical needs for individualized drug selection and variety comparison. This article, based on the formulation compatibility analysis technology of "Tangye Jingfa Tu", clarifies the composition and efficacy characteristics of common Chinese patent medicines used for cardiovascular and cerebrovascular diseases, providing support for the precise selection of these medicines. MethodsFifty-six representative Chinese patent medicines, covering all the efficacy subcategories of "stasis-resolving agents" in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalogue (2023) (more than 50% of the total), were selected for the study. Within the knowledge system of "Tangye Jingfa Tu", the compatibility structure of herbal flavors and the proportion structure of herbal quantities for each Chinese patent medicine were determined. The correlation between these structures and the efficacy categories was analyzed to identify the similarities and differences among the selected Chinese patent medicines. Additionally, the efficacy was reclassified and compared according to the theoretical framework of tonifying and purging methods of five Zang organs in the "Tangye Jingfa Tu". ResultsThe representative Chinese patent medicines included in the analysis were Shexiang Baoxin pills, Danshen tablets, Qili Qiangxin capsules, Breviscapine tablets, etc., covering all the efficacy subcategories of "stasis-resolving agents". Among the 56 representative Chinese patent medicines, salty flavor was the most common (48), followed by pungent (33), and sweet (26). According to the dominant herbal flavor, salty flavor was the most common (37), followed by pungent (9), and sour (5). According to the dominant herbal quantity, salty flavor was the most common (27), followed by sour (7), and pungent (5). Furthermore, Chinese patent medicines with different efficacy subtypes showed different flavor characteristics. For example, most Qi-invigorating and blood-activating agents contained sweet drugs for tonifying the spleen (9/10), most Qi-moving and blood-activating agents contained pungent drugs for tonifying the liver (7/8), and all kidney-invigorating and blood-activating agents contained bitter drugs for tonifying the kidneys (6/6). However, the efficacy classification of individual medicines did not always align with the compatibility characteristics of their formulas, as seen with Dengyin Naotong capsules. ConclusionThe formulations of Chinese patent medicines for cardiovascular and cerebrovascular diseases predominantly feature salty, sour, and pungent flavors, which largely conform to the therapeutic principles of "nourishing the heart with salt and soothing the heart with sour" and the liver-heart, heart-spleen mother-child treatment relationship shown in the "Tangye Jingfa Tu". Using the "Tangye Jingfa Tu" framework to conduct research on the structure and efficacy characteristics of Chinese patent medicines is objective and effective.
2.Formulation Characteristics and Efficacy Classification of Chinese Patent Medicines for Cardiovascular and Cerebrovascular Diseases Based on Diagram of Tangye Jingfa Tu
Yuguang WANG ; Runtao ZHUANG ; Yanqing LIU ; Shen LI ; Xiaolan LIN ; Rui JIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):224-233
ObjectiveChinese patent medicines for cardiovascular and cerebrovascular diseases are diverse and complex in their efficacy. The traditional classification method based on efficacy categories has certain limitations and cannot meet the clinical needs for individualized drug selection and variety comparison. This article, based on the formulation compatibility analysis technology of "Tangye Jingfa Tu", clarifies the composition and efficacy characteristics of common Chinese patent medicines used for cardiovascular and cerebrovascular diseases, providing support for the precise selection of these medicines. MethodsFifty-six representative Chinese patent medicines, covering all the efficacy subcategories of "stasis-resolving agents" in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalogue (2023) (more than 50% of the total), were selected for the study. Within the knowledge system of "Tangye Jingfa Tu", the compatibility structure of herbal flavors and the proportion structure of herbal quantities for each Chinese patent medicine were determined. The correlation between these structures and the efficacy categories was analyzed to identify the similarities and differences among the selected Chinese patent medicines. Additionally, the efficacy was reclassified and compared according to the theoretical framework of tonifying and purging methods of five Zang organs in the "Tangye Jingfa Tu". ResultsThe representative Chinese patent medicines included in the analysis were Shexiang Baoxin pills, Danshen tablets, Qili Qiangxin capsules, Breviscapine tablets, etc., covering all the efficacy subcategories of "stasis-resolving agents". Among the 56 representative Chinese patent medicines, salty flavor was the most common (48), followed by pungent (33), and sweet (26). According to the dominant herbal flavor, salty flavor was the most common (37), followed by pungent (9), and sour (5). According to the dominant herbal quantity, salty flavor was the most common (27), followed by sour (7), and pungent (5). Furthermore, Chinese patent medicines with different efficacy subtypes showed different flavor characteristics. For example, most Qi-invigorating and blood-activating agents contained sweet drugs for tonifying the spleen (9/10), most Qi-moving and blood-activating agents contained pungent drugs for tonifying the liver (7/8), and all kidney-invigorating and blood-activating agents contained bitter drugs for tonifying the kidneys (6/6). However, the efficacy classification of individual medicines did not always align with the compatibility characteristics of their formulas, as seen with Dengyin Naotong capsules. ConclusionThe formulations of Chinese patent medicines for cardiovascular and cerebrovascular diseases predominantly feature salty, sour, and pungent flavors, which largely conform to the therapeutic principles of "nourishing the heart with salt and soothing the heart with sour" and the liver-heart, heart-spleen mother-child treatment relationship shown in the "Tangye Jingfa Tu". Using the "Tangye Jingfa Tu" framework to conduct research on the structure and efficacy characteristics of Chinese patent medicines is objective and effective.
3.Efficacy and safety of tyrosine kinase inhibitors in the treatment of HER2-positive breast cancer:a meta-analysis
Yinxue XU ; Xiaolan SHEN ; Xiufen LU ; Xuehui ZHANG
China Pharmacy 2024;35(3):361-367
OBJECTIVE To evaluate the efficacy and safety of tyrosine kinase inhibitors (TKI) in the treatment of HER2- positive breast cancer in order to provide evidence-based evidence for clinical medication. METHODS Retrieved from CNKI, Wanfang database, VIP, PubMed, Cochrane Library, Embase and Web of Science, randomized controlled trial (RCT) about TKI (trial group) versus drugs excluding TKI (control group) in the treatment of HER2-positive breast cancer were collected from the establishment of the database to April 2023. Meta-analysis and sensitivity analysis were performed by using RevMan 5.4.1 and Stata 17 software. RESULTS Total of 24 RCT studies were included, involving 15 538 HER2-positive breast cancer patients. The meta- analysis results showed that compared with the control group, the progression-free survival (PFS) [HR=0.91, 95%CI (0.80, 1.02), P=0.12], overall survival (OS) [HR=0.95, 95%CI (0.89, 1.01), P=0.11], objective response rate (ORR) [OR=1.21, 95%CI (0.86, 1.69), P=0.27], and pathological complete response rate (pCR) [OR=1.44, 95%CI (0.91, 2.27), P=0.12] had no statistically significant difference in the trial group; among the 3/4 grade ADRs, the trial group had a higher incidence of anemia [OR=1.77, 95%CI (1.16,2.70), P=0.008], rash [OR=11.26, 95%CI (7.32,17.31), P<0.000 01], paronychia [OR=8.67, 95%CI(1.62,46.53), P=0.01], diarrhea [OR=10.17, 95%CI(5.03,20.58), P<0.000 01], oral mucositis inflammation [OR= 9.34, 95%CI (3.13, 27.83), P<0.000 1], elevated aspartate aminotransferase [OR=2.09, 95%CI (1.13,3.84), P=0.02], and hypokalemia [OR=2.37, 95%CI (1.31,4.30), P=0.005] than that of the control group. Subgroup analysis results showed that compared with the placebo group, TKI could improve OS and ORR (P<0.05), while compared with trastuzumab, TKI had no advantage in PFS, OS, ORR, and pCR, and TKI combined with trastuzumab could significantly improve PFS, OS, ORR, and pCR compared with the trastuzumab group (P< 0.05). Sensitivity analysis suggested that the results were relatively robust and the risk of publication bias was low. CONCLUSIONS Compared with trastuzumab, TKI has no advantages in PFS, OS, ORR and pCR in the treatment of HER2- positive breast cancer, but TKI combined with trastuzumab can significantly improve PFS, OS, ORR and pCR; TKI can increase the risk of grade 3/4 anemia, rash, paronychia, diarrhea, oral mucositis, elevated aspartate aminotransferase, and hypokalemia.
4.Lower urinary tract injury in transvaginal reconstructive pelvic surgery
Wenjie SHEN ; Yongxian LU ; Ke NIU ; Yinghui ZHANG ; Wenying WANG ; Ying ZHAO ; Jing GE ; Xiaolan ZHANG
Chinese Journal of Obstetrics and Gynecology 2024;59(2):130-134
Objective:To explore the characteristics, prevention and treatment strategies of lower urinary tract injury in transvaginal reconstructive pelvic surgery (vRPS).Methods:A retrospective analysis was conducted on 24 patients who suffered lower urinary tract injuries occuring in vRPS from January 2005 to June 2021, among which 4 cases were referred to our hospital from other hospitals.Results:(1) In our hospital, 1 952 patients underwent vRPS for anterior and (or) middle pelvic organ prolapse during that study period, with a 1.0% (20/1 952) incidence of lower urinary tract injuries occurring in 20 cases. (2) Ureteral injuries were observed in 14 cases who underwent transvaginal high uterosacral ligament suspension (1.4%, 14/966). The symptoms were relieved after the removal of sutures. (3) Bladder injuries occurred in 6 cases in our hospital, with 4 cases (0.7%, 4/576) in anterior transvaginal mesh surgery (aTVM), one (0.4%, 1/260) in colpocleisis, and one (0.7%, 1/150) in apical suspension for fornix prolapse. An additional 4 cases of bladder injury were referred to our hospital after aTVM. Among the 8 cases of bladder injury during aTVM, 2 cases were intraoperative incidents. Cystoscopy confirmed that the superficial branch or puncture rod of anterior vaginal mesh had penetrated into the bladder. Re-puncturing and placement of the mesh were successfully performed. No abnormalities were observed during a follow-up period of 4-5 years. Postoperative bladder injuries were identified in 6 cases, characterized by mesh erosion into the bladder and formation of calculi. These injuries were confirmed between 6 months to 2 years after vRPS. The exposed mesh and calculi in the bladder were removed through laparotomy or cystoscopy, followed up for 2-12 years. One case experienced slight re-erosion of mesh to the bladder.Conclusions:Lower urinary tract injuries are difficult to avoid in vRPS, particularly in transvaginal high uterosacral ligament suspension and aTVM. However, the incidence is low. Lower urinary tract injuries during vRPS could be easily detected and managed intraoperatively because of the use of cystoscopy. As long-term postoperative complications, erosion of transvaginal mesh to lower urinary tract postoperatively could be treated correctly, seldom with severe sequelae.
5.Summary of best evidence for diarrhea assessment and management in hematopoietic stem cell transplantation patients
Xiaopei MAO ; Min XU ; Xiaolan ZHANG ; Min PENG ; Fang CHENG ; Wangfang SHEN ; Menghua YE
Chinese Journal of Modern Nursing 2024;30(30):4163-4170
Objective:To retrieve, evaluate, and summarize evidence on the assessment and management of diarrhea in hematopoietic stem cell transplantation (HSCT) patients both domestically and internationally, providing evidence-based support for clinical practice.Methods:According to the "6S" model, guidelines, clinical decisions, recommended practices, evidence summaries, systematic reviews, and expert consensus related to the assessment and management of diarrhea in HSCT patients were systematically retrieved from relevant databases and websites both domestically and internationally. The search period was from January 1, 2013 to November 30, 2023. Seven researchers conducted literature screening, quality evaluation, evidence extraction, and summarization.Results:A total of 15 articles were included, including four guidelines, three clinical decisions, two recommended practices, one evidence summary, two systematic reviews, and three expert consensus. Thirty-one pieces of evidence were summarized from seven aspects of multidisciplinary management, risk factor management, assessment and monitoring, medication intervention, diet and nutrition management, health education, and daily management.Conclusions:The best evidence for HSCT patient assessment and management summarized can provide reference for clinical practice, and nursing staff should carefully apply evidence based on the actual situation of patients.
6.Research progress on mechanism of baicalin inhibiting synovial inflammation and clinical applications of rheumatoid arthritis
Xiaolan SHEN ; Xiaoman LIU ; Xiaoqiang HOU ; Huilian HUANG ; Zhitao FENG
The Journal of Practical Medicine 2024;40(22):3256-3261
Rheumatoid arthritis(RA)is a chronic and progressive autoimmune disease.Current clinical treatments for RA often exhibit inadequate drug responses and severe adverse effects,underscoring the necessity for alternative therapies.Baicalin,a flavonoid derived from Scutellaria baicalensis roots,possesses anti-inflammatory,antioxidant,and immunomodulatory properties.Research suggests that baicalin can inhibit the release of inflamma-tory mediators,thereby reducing inflammation.Moreover,it demonstrates antioxidant effects by decreasing reactive oxygen species production and mitigating synovial damage induced by oxidative stress.Baicalin may impede the activation of inflammatory cytokines through pathways such as NF-κB,MAPKs,and JAK-STAT signaling cascades while inducing apoptosis,regulating immune cell activity,and balancing immune mediators to impact synovitis progression.Clinically,both monotherapy with baicalin or its combination with other formulations have exhibited efficacy and safety profiles.The advancement in targeted drug delivery systems has improved its bioavailability further suggesting promising clinical applications.This review provides an overview of research progress on baicalin's mechanisms in inhibiting RA synovitis along with its clinical applications.
7.Machine-learning-based models assist the prediction of pulmonary embolism in autoimmune diseases: A retrospective, multicenter study
Ziwei HU ; Yangyang HU ; Shuoqi ZHANG ; Li DONG ; Xiaoqi CHEN ; Huiqin YANG ; Linchong SU ; Xiaoqiang HOU ; Xia HUANG ; Xiaolan SHEN ; Cong YE ; Wei TU ; Yu CHEN ; Yuxue CHEN ; Shaozhe CAI ; Jixin ZHONG ; Lingli DONG
Chinese Medical Journal 2024;137(15):1811-1822
Background::Pulmonary embolism (PE) is a severe and acute cardiovascular syndrome with high mortality among patients with autoimmune inflammatory rheumatic diseases (AIIRDs). Accurate prediction and timely intervention play a pivotal role in enhancing survival rates. However, there is a notable scarcity of practical early prediction and risk assessment systems of PE in patients with AIIRD.Methods::In the training cohort, 60 AIIRD with PE cases and 180 age-, gender-, and disease-matched AIIRD non-PE cases were identified from 7254 AIIRD cases in Tongji Hospital from 2014 to 2022. Univariable logistic regression (LR) and least absolute shrinkage and selection operator (LASSO) were used to select the clinical features for further training with machine learning (ML) methods, including random forest (RF), support vector machines (SVM), neural network (NN), logistic regression (LR), gradient boosted decision tree (GBDT), classification and regression trees (CART), and C5.0 models. The performances of these models were subsequently validated using a multicenter validation cohort.Results::In the training cohort, 24 and 13 clinical features were selected by univariable LR and LASSO strategies, respectively. The five ML models (RF, SVM, NN, LR, and GBDT) showed promising performances, with an area under the receiver operating characteristic (ROC) curve (AUC) of 0.962-1.000 in the training cohort and 0.969-0.999 in the validation cohort. CART and C5.0 models achieved AUCs of 0.850 and 0.932, respectively, in the training cohort. Using D-dimer as a pre-screening index, the refined C5.0 model achieved an AUC exceeding 0.948 in the training cohort and an AUC above 0.925 in the validation cohort. These results markedly outperformed the use of D-dimer levels alone.Conclusion::ML-based models are proven to be precise for predicting the onset of PE in patients with AIIRD exhibiting clinical suspicion of PE.Trial Registration::Chictr.org.cn: ChiCTR2200059599.
8.Efficacy and safety of antibody-drug conjugates in the treatment of breast cancer:a meta-analysis
Yinxue XU ; Lei ZHANG ; Xiwen QIAO ; Xiaolan SHEN ; Qian SHEN ; Xuehui ZHANG
China Pharmacy 2023;34(20):2540-2544
OBJECTIVE To evaluate the efficacy and safety of antibody-drug conjugates (ADC) in the treatment of breast cancer, so as to provide an evidence-based reference for clinical medication. METHODS Retrieved from CNKI, Wanfang database, VIP, PubMed, the Cochrane Library, Embase, and Web of Science, randomized controlled trials (RCTs) about trastuzumab emtansine, trastuzumab deruxtecan and sacituzumab govitecan (trial group) versus chemotherapy or other anti-tumor drugs (control group), were collected during the inception to April 2023. After screening the literature, extracting data, and evaluating the quality of the literature, a meta-analysis was conducted by using RevMan 5.4.1 software. RESULTS A total of 8 RCTs were included, with a total of 5 577 patients. The results of the meta-analysis showed that the progression-free survival (PFS) [HR=0.76, 95%CI (0.69, 0.83), P<0.000 01], overall survival (OS) [HR=0.87, 95%CI (0.81, 0.93), P<0.000 1], and clinical benefit rate (CBR) [OR=2.70, 95%CI (1.15, 6.33), P=0.02] of the trial group were significantly higher than control group. There was no statistically significant difference in objective response rate (ORR) between the two groups [OR=2.34, 95%CI (0.59, 9.33), P=0.23]. The results of subgroup analysis showed that the PFS of HER2-positive patients and HER2-negative patients, and the OS of HER2-positive patients in the trial group were significantly higher than control group (P<0.05). The incidence of anemia and increase of aspartic acid transaminase (AST) in the trial group was significantly higher than control group (P<0.05). The results of sensitivity analysis showed that the results obtained with PFS, OS, and ORR as indicators were relatively robust, while the results obtained with CBR as indicators lacked robustness. CONCLUSIONS ADC drugs have significant effects on breast cancer, but will increase the risk of anemia and elevated AST.
9.Epidemiological investigation of SARS-CoV-2 infection in maintenance hemodialysis patients in Jiangsu province during the outbreak of SARS-CoV-2
Guang YANG ; Yifei GE ; Yaoyu HUANG ; Jizhuang LOU ; Chunming JIANG ; Guoyuan LU ; Fengling CHEN ; Jiansong SHEN ; Xiaolan CHEN ; Houyong DAI ; Changhua LIU ; Min YANG ; Xiurong LI ; Zhuxing SUN ; Liang WANG ; Bin LIU ; Donghui ZHENG ; Yong XU ; Maojie CHEN ; Ling WANG ; Yilai ZHANG ; Xu ZHANG ; Jianqiang HE ; Liyuan ZHANG ; Huiting WAN ; Honglei GUO ; Jiahui YANG ; Wei XU ; Changying XING ; Huijuan MAO
Chinese Journal of Nephrology 2023;39(12):895-902
Objective:To investigate the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with maintenance hemodialysis (MHD) in Jiangsu province during SARS-CoV-2 pandemic in China from December 7, 2022 to January 27, 2023, and to analyze the influencing factors of all-cause death.Methods:It was a multi-center cross-sectional investigation. Structured questionnaire was used to collect patient information by medical staff of each hemodialysis center (room) as investigators. Part of the demography data and laboratory examination data came from the Jiangsu Province Hemodialysis Data Information System. MHD patients from hemodialysis centers (rooms) at all levels of medical institutions and independent hemodialysis institutions in Jiangsu province during the outbreak of SARS-CoV-2 infection were included, and the clinical characteristics and all-cause mortality of confirmed and suspected cases of SARS-CoV-2 infection were analyzed.Results:Questionnaire surveys and data analysis on 57 278 patients in 407 hemodialysis centers (rooms) were completed, accounting for 90.41% of the total number of MHD patients (63 357 cases) in Jiangsu province during the same period. There were 24 038 cases (41.97%) of SARS-CoV-2 infection and 14 805 cases (25.85%) of suspected infection, which were widely distributed in all dialysis centers in Jiangsu province. After clinical classification of 38 843 confirmed and suspected SARS-CoV-2 infection cases, 3 662 cases were severe and critical cases, accounting for 9.43% of the infected and suspected cases. Among the patients who had completed the questionnaires, there were 1 812 all-cause deaths, with an all-cause mortality rate of 3.16%. Multivariate logistic regression analysis showed that elderly (taking ≤50 years as a reference, 51-59 years: OR=1.583, 95% CI 1.279-1.933, P=0.001; 60-69 years: OR=3.972, 95% CI 3.271-4.858, P<0.001; 70-79 years: OR=7.236, 95% CI 5.917-8.698, P<0.001; ≥80 years: OR=11.738, 95% CI 9.459-14.663, P<0.001), male ( OR=1.371, 95% CI 1.229-1.529, P<0.001), and co-infection with hepatitis B virus (HBV) (positive serum HBV surface antigen, OR=0.629, 95% CI 0.484-0.817, P<0.001) were independent influencing factors for all cause mortality. Receiver-operating characteristic curve analysis showed that the area under the curve for male, age and current HBV infection prediction of all-cause death was 0.529 ( P<0.001), 0.724 ( P<0.001) and 0.514 ( P=0.042), respectively, and the cut-off value for age prediction of all-cause death was 65.5 years old. Compared with patients without HBV infection, MHD patients with HBV infection significantly reduced the proportion of severe and critically ill patients, all-cause hospitalizations and all cause deaths when infected with SARS-CoV-2 (4.99% vs. 6.41%, χ2=6.136, P=0.013; 8.90% vs. 11.44%, χ2=11.662, P<0.001; 2.01% vs. 3.37%, χ2=10.713, P=0.001, respectively). Conclusion:The MHD patients in Jiangsu province are susceptible to SARS-CoV-2. Elderly age and male gender are independent risk factors for death in MHD patients during the epidemic, while the HBV infection may be a protective factor for death of MHD patients infected with SARS-CoV-2.
10.CHINA PH ARMACY Volume 33,Number 6,March 30,2022 Semimonthly Table of Contents Guideline for the evaluation of medicine list in Chinese med ical instituti ons
Hui CHEN ; Guangquan SU ; Xiao LIU ; Fangyuan TIAN ; Yingyun GUAN ; Ngting Ti CHEN ; Yingnan ZHAO ; Linlin LIU ; Xiaolan BIAN ; Ting XU ; Xiaoyu LI ; Ong Aiz SHEN ; Lihong LIU
China Pharmacy 2022;33(6):641-652
In order to improve the management level of medicine list of medical institutions in China ,and help medical institutions build a medicine list of medical institutions with reasonable drug use structure ,standardized adjustment procedures , convenient operation and application and scientific evaluation methods ,so as to meet the needs of clinical rational drug use to the greatest extent ,with the support of the Pharmaceutical Care Professional Committee of the Chinese Pharmaceutical Association , China-Japan Friendship Hospital and the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital )jointly initiate and complete Guideline for the Evaluation of Medicine List in Chinese Medical Institutions jointly with a number of medical institutions. In strict accordance with the methodological requirements of World Health Organization standard guidelines ,based on the Delphi method ,the guideline formulation working group has constructed the quality evaluation index system and quantitative scoring table of medicine list management in medical institutions from the 5 dimensions of organization and management ,structure,adjustment,application and e valuation of the list. It is used to help medical institutions evaluate the quality of their medicine list management ,so asto play a positive role in the fine management of medicine list in medical institutions.

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