1.Clinical rapid evaluation of proprotein convertase subtilisin/kexin type 9 inhibitors for hypercholesterolemia
Xin YAO ; Fengjiao KANG ; Qinan YIN ; Lizhu HAN ; Yuan BIAN
China Pharmacy 2026;37(2):149-154
OBJECTIVE To conduct a clinical rapid evaluation of the marketed proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in China, including evolocumab, tafolecimab, recaticimab, ebronucimab, ongericimab and inclisiran. METHODS Based on the Rapid Guide for Drug Evaluation and Selection in Chinese Medical Institutions (second edition), drug instructions, clinical diagnosis and treatment guidelines, and literature for six drugs were retrieved from CNKI, Wanfang Data, VIP, PubMed, Embase, Cochrane Library and related official websites. The clinical rapid evaluation was conducted from five aspects: pharmaceutical characteristics, effectiveness, safety, economy, and other attributes. RESULTS The pharmaceutical characteristics, effectiveness, safety, economy, other attributes, and total score of evolocumab scored 24, 27, 15.7, 10, 5.3, and 82 points, respectively. Tafolecimab scored 23.5, 23, 11.5, 9.97, 4.6, and 72.57 points, respectively. Recaticimab scored 20.5, 22, 15.5, 6.37, 3.5, and 67.87 points. Ebronucimab scored 20, 23, 11, 6.48, 3.5, and 63.98 points. Ongericimab scored 20.5, 23, 8.5, 4.83, 3.5, and 60.33 points. Inclisiran scored 25.5, 24, 13, 6.48, 5, and 73.98 points. CONCLUSIONS Evolocumab is the optimal choice for treating hypercholesterolemia and is recommended as the first-line option. Tafolecimab is the second-line option, and recaticimab is suitable for patients who are sensitive to drug adverse reactions. Inclisiran is suitable for patients with poor compliance. Ebronucimab and ongericimab are weakly recommended due to their later market introduction. Clinicians should make individualized drug selections based on factors such as patient risk level and compliance requirements.
2.Expert consensus on clinical application of parenteral direct thrombin inhibitors in perioperative period
Mingyu JIANG ; Yuan BIAN ; Lizhu HAN ; Qinan YIN ; Fengjiao KANG ; Anhua WEI ; Danjie ZHAO ; Lin WANG ; Ying SHAO ; Li TANG ; Yi WANG ; Shuhong LIANG ; Huijuan LIU ; Guirong XIAO ; Yue LI
China Pharmacy 2026;37(6):689-699
OBJECTIVE To form an expert consensus on the clinical application of parenteral direct thrombin inhibitors (DTIs) in patients during the perioperative period. METHODS Led by Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital (the Affiliated Hospital of UESTC), a multidisciplinary working group was established. Through literature review and the Delphi method, clinical questions related to the rational perioperative use of parenteral DTIs were identified. A structured design was adopted using the “Population-Intervention-Comparison-Outcome” framework; systematic searches were conducted in CNKI, Medline, Embase and other databases. Relevant evidence from randomized controlled trials and cohort studies was included and synthesized. Evidence quality was assessed using the Grades of Recommendations Assessment,Development and Evaluation (GRADE) approach, and recommendations were formulated through multiple rounds of Delphi surveys and expert consensus meetings. RESULTS &CONCLUSIONS Seven recommendations (each with an expert consensus rate exceeding 90%) on the use of parenteral DTIs in perioperative patients were developed. These recommendations specify drug selection, dosing ranges, key monitoring points, and safety management strategies for parenteral DTIs in various scenarios, including the perioperative period of ventricular assist device implantation, the perioperative period of cardiac surgery, perioperative patients with lower-extremity atherosclerotic disease, the perioperative period of percutaneous coronary intervention in patients with acute coronary syndrome, the perioperative period of carotid artery stenting in patients with carotid stenosis, the perioperative period of patients with right heart thrombosis, and patients who develop related thrombosis and dysfunction after a central venous catheter insertion. In addition, warning and management pathways for perioperative bleeding and thrombotic events were proposed. This expert consensus, which is formulated based on the best available evidence, provides evidence-based guidance for standardized and individualized use of parenteral DTIs in perioperative period.
3.Expert consensus on the clinical application of parenteral direct thrombin inhibitors in special populations
Xin YAO ; Yuan BIAN ; Lizhu HAN ; Qinan YIN ; Yang LEI ; Zimeng WAN ; Luyao HUANG ; Danjie ZHAO ; Yu YAN ; Qin LI ; Baorong HU
China Pharmacy 2026;37(8):965-975
OBJECTIVE To form an expert consensus addressing clinical issues regarding the use of parenteral direct thrombin inhibitors (DTIs) in special populations. METHODS Led by the Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital(the Affiliated Hospital of UESTC), a multidisciplinary working group was formed comprising experts from multiple fields, including clinical pharmacy, cardiac surgery, obstetrics, pediatrics and evidence-based medicine. Through literature review and the Delphi method, clinical questions regarding the efficacy and safety of parenteral DTIs used in special populations were identified. A structured design was adopted using the “Population-Intervention-Comparison-Outcome” (PICO) framework;systematic searches were conducted in CJFD, PubMed, Embase and other databases. Relevant evidence from randomized controlled trials,cohort studies and systematic reviews were included and synthesized. Evidence quality was assessed using the Grading of Recommendations Assessment,Development and Evaluation (GRADE) approach, and recommendations were formulated through three rounds of Delphi surveys and expert consensus meetings. RESULTS &CONCLUSIONS Seven clinical questions were ultimately selected (with a consensus rate exceeding 90%), resulting in the formulation of seven recommendations on the use of parenteral DTIs in special populations, including children, pregnant women, patients with hepatic or renal impairment, patients with mesenteric venous thrombosis, and individuals with thrombophilia. These recommendations clarify the preferred agents, dosing ranges, monitoring parameters, and safety management strategies for parenteral DTIs in these special populations. This expert consensus, which is formulated based on the best available evidence, provides evidence-based guidance for standardized and individualized use of parenteral DTIs in special populations.
4.Oral garlic-derived nanoparticles improve cancer immunotherapy.
Kun YANG ; Jinming ZHANG ; Bo XIAO
Acta Pharmaceutica Sinica B 2025;15(2):1199-1201
6.Blades and barriers: Oral vaccines for conquering cancers and warding off infectious diseases.
Kun YANG ; Jinhua LIU ; Yi ZHAO ; Haiting XU ; Menghang ZU ; Baoyi LI ; Xiaoxiao SHI ; Rui L REIS ; Subhas C KUNDU ; Bo XIAO
Acta Pharmaceutica Sinica B 2025;15(8):3925-3950
Global public health faces substantial challenges from malignant tumors and infectious diseases. Vaccination provides an approach for treating and preventing these diseases. Oral vaccinations are particularly advantageous in disease treatment and prevention due to their non-invasive nature, high patient compliance, convenience, cost-effectiveness, and capacity to stimulate comprehensive and adaptive immune responses. However, the overwhelming majority of oral vaccines remain in experimental development, struggling with clinical and commercial translation due to their suboptimal efficacy. Thus, enhancing scientists' understanding of the interaction between vaccines and gastrointestinal immune system, creating antigen delivery systems suitable for the gut mucosal environment, developing more potent antigenic epitopes, and using personalized combination therapies are critical for advancing the next generation of oral vaccines. This article explores the fundamental principles and applications of current oral anti-tumor and anti-infective vaccines and discusses considerations necessary for designing future oral vaccines.
7.Safety analysis of fondaparinux in pregnancy based on case report literature
Yin WANG ; Fengqun CAI ; Fengjiao KANG ; Liuyun WU ; Hulin WANG ; Lizhu HAN ; Qinan YIN ; Yong YANG ; Yuan BIAN
China Pharmacy 2025;36(9):1099-1104
OBJECTIVE To evaluate the safety of fondaparinux in pregnancy and provide reference for its rational clinical application. METHODS A search was conducted in databases including CNKI, Wanfang, PubMed, Embase, and Elsevier (the search time was from the construction of the database to December 17, 2024) to collect case report literature on fondaparinux use during pregnancy. Patient demographic information, fondaparinux use during pregnancy, concomitant medications, clinical manifestations, and treatment details were extracted for descriptive statistical analysis. RESULTS A total of 17 case reports regarding the use of fondaparinux during pregnancy were collected, involving 42 patients from 11 countries and 47 pregnancy records. Among these, 20 cases involved the use of fondaparinux for the prevention of pregnancy-related venous thromboembolism (VTE), while 27 cases were fondaparinux treatment due to related conditions. A total of 29 occurrences of the patients were treated with fondaparinux due to a (family) history of VTE. Nine occurrences of complicated pregnancies were reported, and 35 patients had records of comorbidities or relevant medical histories. The adverse events that occurred during pregnancy with the use of fondaparinux include postpartum hemorrhage (7 cases) and excessive anticoagulation caused by inappropriate dosage (1 case). Among the 7 cases of postpartum hemorrhage, 3 cases had a blood loss of no less than 1 000 mL (including 2 cases with uterine atony), 3 cases had a drug discontinuation time of ≤12 h. CONCLUSIONS Based on the existing literature, the safety of fondaparinux during pregnancy is generally manageable, with the main adverse event being postpartum hemorrhage. The dosage, interval between discontinuation,comorbidities/medical history, and concomitant medications of fondaparinux may be the main causes of its adverse events.
8.Advances in pharmacological mechanism and toxicology of gambogic acid.
Ke-Rong TU ; Shang-Qin YANG ; Qi-Qi XU ; Liang-Liang LYU ; Xian-Mei JIANG ; Yao QI ; Huan-Huan DING ; Hong-Mei LIU ; Lu-Lu CAI ; Qiang SUN
China Journal of Chinese Materia Medica 2024;49(24):6593-6603
Gambogic acid, a caged xanthone compound derived from Garcinia, has been proven to be an important substance basis for the pharmacological effects of the plant. In recent years, it has received continuous attention due to its broad and significant pharmacological activities. Modern pharmacological investigations have demonstrated that gambogic acid endows various therapeutic effects such as anti-inflammatory, antioxidant, and anti-tumor activities, as well as benefits in retinopathy, organ protection, anti-microbial infection, bone protection, and neuropathic pain relief. Nevertheless, there is currently a lack of systematic summary and integration of the pharmacological effects and mechanisms of gambogic acid, which is critical for advancing the clinical application of this natural product. In addition, current research has raised concerns about potential safety risks associated with gambogic acid, such as organ toxicity, developmental toxicity, and hemolysis. Given this, this paper systematically reviewed and summarized the pharmacological effects, mechanisms, and toxicological profiles of gambogic acid, aiming to provide reference and data support for its clinical translation.
Xanthones/toxicity*
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Humans
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Animals
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Drugs, Chinese Herbal/toxicity*
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Garcinia/chemistry*
9.Targeting NTCP for liver disease treatment:A promising strategy
Tan XIN ; Xiang YU ; Shi JIANYOU ; Chen LU ; Yu DONGKE
Journal of Pharmaceutical Analysis 2024;14(9):1267-1281
The sodium taurocholate co-transporting polypeptide(NTCP),a bile acids transporter,has been identi-fied as a new therapeutic target for the treatment of liver disease.This paper thoroughly investigates the function of NTCP for regulating bile acid regulation,its correlation with hepatitis B and D infections,and its association with various liver diseases.Additionally,in this review we examine recent breakthroughs in creating NTCP inhibitors and their prospective applications in liver disease treatment.While this review emphasizes the promising potential of targeting NTCP,it concurrently underscores the need for broader and more detailed research to fully understand the long-term implications and potential side effects associated with NTCP inhibition.
10.Pharmacy Practice Guidelines for the Prevention and Treatment of Thromboembolic Diseases in Children
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital ; School of Medicine,University of Electronic Science and Technology of China ; Personalized Drug Therapy Key Laboratory of Sichuan Province ; Clinical Pharmacy Branch,Chinese Medical Association ; Cardiovascular Pharmacy Branch,Chinese Society of Cardiothoracic and Vascular Anesthesiology
Herald of Medicine 2024;43(7):1017-1038
Objective In order to improve the rationalization of medication use for thrombosis prevention and treatment in children,the guideline aims to develop a comprehensive and practical guideline for pharmacy practice in the prevention and treatment of thromboembolic diseases in children.Through a systematic review of the available evidence-based medical evidence,specific recommendations for drug prevention and treatment are presented.Methods The World Health Organization(WHO)guideline development manual was used for the study design of the guideline.A systematic search and extensive collection of common medication problems for the prevention and treatment of thrombosis in children existed nationwide,and the Delphi method was used to research experts and determine the final clinical problems to be included.Then,a systematic literature search was conducted to comprehensively assess the existing original studies,systematic evaluations,and guidelines or consensus of professional organizations.Quality evaluation was conducted according to the grades of recommendations assessment,development and evaluation(GRADE)method,and consensus on the recommendations and level of evidence was reached again through the Delphi method,which ultimately led to the formation of the pharmacy practice guidelines for the prevention and treatment of thromboembolic diseases in children.Results A total of 29 clinical problems assessed by 74 experts in clinical pharmacy and clinical medicine were collected during the development of the guideline;15 clinical problems were screened through two rounds of questionnaires;and 15 clinical medication recommendations were developed under the supervision of two methodologists.Conclusion By comprehensively evaluating the feasibility and safety of clinical practice,the guideline will provide specific antithrombotic medication recommendations for pediatric healthcare professionals,which will help improve the prevention and treatment of thrombosis in children and promote more standardized and effective medical practice.

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