Most ReadTo quantitative evaluate of selective Janus kinase inhibitors in treatment of atopic dermatitis, and provide scientific basis for drug selection and clinical rational drug use.
According to the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions （the Second Edition）, a comprehensive evaluation of upadacitinib and abrocitinib was conducted from five aspects of pharmaceutical characteristics, efficacy, safety, economy,and other attributes, and scores were assigned.
The total scores of upadacitinib and abrocitinib were 80.5 and 80.2 respectively. Upadacitinib and abrocitinib had definite therapeutic effects in terms of itching relief, and skin lesion clearance. But when combined with topical corticosteroids and other drugs, the improvement in efficacy of abrocitinib was better than that of upadacitinib. Upadacitinib had a wider range of applicability compared to abrocitinib, but the incidence of adverse reactions in the blood system of abrocitinib was lower than that of upadacitinib. Upadacitinib and abrocitinib were recommended for admission.
Abrocitinib is suitable for patients who seek quick results and build confidence, as well as those who need to flexibly adjust treatment plans based on their condition. Upadacitinib is preferred for adolescents over 12 years old, patients with severe renal insufficiency, or concomitant diseases such as rheumatoid arthritis and ulcerative colitis.
Risk minimisation measure （RMM） is a critical step to maximize the benefit-risk ratio of a medicinal product in pharmacovigilance activities. Through literature review and consulting the websites of major healthcare authorities in Europe Union, the USA, and Japan, this paper reviewed the RMM regulatory requirements and implementation status of these countries and regions. It was found that Europe, the USA, and Japan established relevant regulations earlier and accumulated valuable experience, and the specific implementation and supervision intensity of RMM varied among regions due to differences in medical systems. For example, additional risk minimization measures in Japan and the European Union are presented as risk evaluation and mitigation strategies in the USA. It is suggested that RMM-related regulations and supervision system should be continuously improved, and the marketing authorization holders in China should develop RMM implementation plans that conform to the actual conditions of China based on foreign experience and combined with the current situation of local medical system, and conduct feasible and efficient RMM effectiveness assessment to ensure patient medication safety.
Chimeric antigen receptor（CAR）- T cell therapy has changed the traditional treatment of hematological malignancies and has shown significant efficacy. However, the clinical application of CAR-T cells is limited by long production cycle, high price, and side effects such as cytokine storm, so it can not be widely used in clinical practice. Natural killer（NK）cells are an important part of the body’s innate immune response. Compared with CAR-T cells, CAR-NK cells can significantly reduce the probability of neurotoxicity, cytokine storm, and graft versus host diseases. CAR-NK cell therapy is gradually becoming a research hotspot, but there are still some urgent problems to be solved, and further optimization of the construction strategy is needed to achieve its clinical translation. This paper will review the construction strategy and the research progress in tumor immunotherapy based on the latest literatures at home and abroad, in order to provide valuable reference for application of NK cells in the treatment of malignant tumors.
Migraine is a recurrent neurological disorder recognized by the World Health Organization as the second leading cause of disability. Currently, most available pharmacological interventions for migraine prevention and treatment are either non-specific or associated with contraindications and serious adverse reactions. Recent research has focused on calcitonin gene-related peptide （CGRP）, which plays a pivotal role in the pathophysiological mechanisms underlying migraine. Targeted CGRP pathway inhibitors have been developed, including CGRP receptor antagonists （gepants） and anti-CGRP monoclonal antibodies. Current studies indicate that these agents demonstrate favorable safety profiles, efficacy,and tolerability. This paper reviewed relevant clinical trials and research findings of targeting the CGRP pathway, aiming to provide a foundation for future selection of domestic migraine therapeutics.
Despite the existence of preventive vaccines, hepatitis B virus infection remains a global health issue.In the past several years, significant progress has been made in the research and development of drugs for the treatment of chronic hepatitis B (CHB) , with the development of new targets and the adoption of new drug forms. On the basis of introducing the concept of functional cure of CHB, the paper elucidated the therapeutic targets of CHB and reviewed the important progress in developing antiviral drugs and immunotherapy drugs. The synergistic combination of these drugs with different mechanisms of action might be the key strategy and direction to achieve clinical cure of CHB.
AIM To explore the effect of Ginkgo biloba diterpene lactone glucamine injection on inflammation and oxidative indicators and proteins related to the phosphatidylinositol 3-kinase （PI3K）/serine-threonine protein kinase（Akt） signaling pathway in the blood of patients with post-stroke epilepsy. METHODS A total of 150 patients with post-stroke epilepsy in our hospital form May 2021 to April 2023 were randomly divided into two groups, each containing 75 cases. The control group was given sodium valproate for 3 months, and on this basis, the observation group was given Ginkgo biloba diterpene lactone glucamine injection for 2 weeks. The clinical efficacy and adverse reactions of the two groups were compared, as well as seizure number, duration, serum interleukin-1β （IL-1β）, matrix metalloproteinase-9 （MMP-9）,superoxide dismutase （SOD）, tumor necrosis factor-alpha （TNF-α）, glutathione peroxidase （GSH-Px）, malondialdehyde（MDA）, and protein expression related to PI3K/Akt signaling pathway before and after the treatment. RESULTS The total clinical effective rate of the observation group was 92%, which was higher than 72% of the control group （P<0.05）. After 3 months of treatment, the number of seizures and seizure duration in the observation group were less than those in the control group （P<0.05）. After 2 weeks and 3 months of treatment, the levels of IL-1β, MMP-9, MDA, TNF-α, and the expression of PI3K and Akt proteins in the observation group were lower than those in the control group, while the activities of SOD and GSH-Px were higher than those in the control group （P<0.05）. There was no significant difference in the incidence of adverse reactions between the two groups （P>0.05）. CONCLUSION Ginkgo biloba diterpene lactone glucamine injection can reduce the inflammatory level and oxidative stress response in patients with epilepsy after stroke, and regulate the PI3K/Akt signaling pathway, thereby effectively controlling seizures, with significant effects.
AIM To analyze the potential adverse drug interactions （pADIs） of non-vitamin K antagonist oral anticoagulants （NOAC）, and to promote rational drug use. METHODS Outpatient prescriptions of using NOAC in combination with other drugs were surveyed from January 1, 2024 to May 31, 2024 through the information system of the third people's hospital of Bengbu, and pADIs were identified and their severities were graded. Refined prescription pre-review rules were developed by rational drug software. RESULTS Among 1 153 NOAC combined prescriptions, 406 prescriptions had 511 cases of pADIs, including 180 cases of dabigatran etexilate, 288 cases of rivaroxaban and 43 cases of apixaban.The combined drugs involved antiepileptic, antiplatelet, Chinese medicines containing salvia/ginseng/ginkgo biloba and antiarrhythmic drugs. Rivaroxaban + phenobarbital severity classification was contraindicated. Refined rules included 1 interception rule and 10 alert information + double-signature rules and 8 attention information rules. CONCLUSION There are pADIs between NOAC and other drugs in the hospital. The medication risks can be prevented through targeted intervention based on evidence-based refined prescription pre-review rules.
To analyze the approval for marketing, drug characteristics, and differences of novel hematological antineoplastic drugs between China and the United States, and provide reference for pharmaceutical management, drug research and development, drug review and approval in China.
The websites of the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration of China and package insert of drug were searched, and the novel hematological antineoplastic drugs approved for marketing in the United States from 1997 to 2021 and China from 1999 to 2021 were collected. The drug names, approval types, approval dates, accelerated drug marketing registration procedures, drug action mechanism and indications were extracted, and the approval status and timeliness of new drugs, as well as the number of approvals for different types of drugs were analyzed.
From 1997 to 2021, a total of 69 novel hematological antineoplastic drugs approved in the United States, which included 42 new molecular entities and 27 new therapeutic biologics. Sixty-five drugs were approved through expedited development and review pathways. From 1999 to 2021, China approved a total of 36 novel hematological antineoplastic drugs, including 24, 11, and 1 for chemical drugs, biologics products, and traditional Chinese medicine, respectively. Twenty-five drugs were approved to use accelerated drug marketing registration procedures. The number of approved drugs in both countries has significantly increased from 2017 to 2021, with 26 (87%) out of 30 novel hematological antineoplastic drugs in the United States being the first global approval drugs, and 8 (32%) out of 25 novel hematological antineoplastic drugs in China being the first global approval drugs, and the average approval time for the other 17 drugs was 6 years later than that of the United States. The novel hematological antineoplastic drugs approved in China covered multiple drug targets, which were closer to the targets of new molecular entities approved in the United States and could be used to treat multiple types of hematology neoplasms. However, the biological targets were still limited compared with the United States, which mainly used for lymphoid tissue tumors. There were no drugs used for myeloid tumors, and the types were relatively single. From 2017 to 2021, among the 17 novel hematological antineoplastic drugs approved for marketing in China had been approved in the United States, only 6 drugs had the same indications as the United States, and one drug had more indications than the United States.
In recent years, the number of novel hematological antineoplastic drugs approved for marketing in China has significantly increased. Diverse accelerated drug marketing registration procedures has been used for the review and approval of novel hematological antineoplastic drugs. The target types of approved novel hematological antineoplastic drugs have increased, but the timeliness of new drug review and approval and the international influence of domestic drugs still need to be enhanced. The research and development of domestic novel hematological antineoplastic drugs should avoid single target aggregation, and pay attention to the exploration of new indications of drugs and new combined treatment schemes.
Innovative biologics are the most powerful tools for preventing and treating infectious diseases. During the containment of major public health emergencies, ensuring the production and supply of clinically urgent medications through post-approval changes carries dual requirements of compliance and urgency. This study was conducted from the perspective of enhancing prevention and control of public health emergencies. The needs and difficulties of emergency changes were analyzed, with a focus on how marketing authorization holders can efficiently carry out emergency changes to expand production capacity and accelerate release testing. Based on the analysis, relevant recommendations were proposed, such as conducting pre-research on changes, building “dual-use for routine and emergency” capabilities, implementing graded and categorized management, optimizing registration testing, and promoting the rapid microbiological methods and AI.
AIM To evaluate the efficacy and safety of oxycodone in acute heart failure （AHF）. METHODS In this prospective randomized controlled trial, 50 AHF patients admitted to the ICU between January 2022 and December 2023 were allocated to morphine group （n=25） or oxycodone group （n=25） using random number table, received intravenous injection of 5 mg morphine or oxycodone based non-invasive ventilation, respectively. Effectiveness outcomes （comfort score,NT-proBNP, oxygenation index （OI）, ICU length of stay, non-invasive ventilation duration, and hospitalization outcomes）and safety parameters （mean arterial pressure （MAP）, heart rate （HR）, respiratory rate （RR）, minute ventilation （MV）,intubation rate, and respiratory depression） were assessed at baseline （T0）, 10 min （T1）, 20 min （T2）, 30 min （T3）,and 24 h （T4） post-treatment in the two groups. RESULTS Both groups showed significant reduction in comfort scores at T3 and increased OI at T4 compared with those of T0 （P<0.01）, and the oxycodone group demonstrated significantly lower NT-proBNP at T4 （P<0.05）, with no significant differences between the two groups（P>0.05）. No between-group differences were observed in ICU stay or ventilation duration. MAP decreased transiently in both groups: the morphine group maintained lower MAP in T1-T3 than T0（P<0.05）, whereas the oxycodone group only showed reductions at T1 and T2 （P<0.05）,with significantly higher MAP than the morphine group during T1-T3 （P<0.05）. HR exhibited biphasic changes while RR and MV progressively declined. The morphine group showed sustained RR reduction in T1-T3 than T0（P<0.05）, and the oxycodone group showed reduction at T2 and T3 （P<0.05）. Neither group required intubation or developed respiratory depression. CONCLUSION Oxycodone demonstrates favorable hemodynamic stability and potential prognostic benefits in AHF management, suggesting its promise as a novel therapeutic option.
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
