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  • Hai-qiang HUANG, Bo GONG, Da-jiu AN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 518-522.
    AIM

    To analyze the usage of “dual channel” drugs in designated pharmacies and medical institutions, and to provide a basis for better implementation of the national negotiation drug “dual channel” management mechanism.

    METHODS

    The relevant policies of the “dual channel” management mechanism for Shanghai medical insurance were reviewed. The growth rate and coverage of “dual channel” drug costs, the proportion of different types of drug costs, and the ranking of drug costs within the Shanghai medical security intelligent supervision system from January 2022 to December 2023 were analyzed.

    RESULTS

    The cost of medication costs have increased significantly with the expansion of the scope of “dual channel” management drugs. Antitumor drugs account for the highest cost proportion among all “dual channel” drugs. There were some problems in the implementation of the policy, such as difficulties in prescription circulation, security vulnerabilities in medical insurance funds caused by paper prescriptions.

    CONCLUSION

    Since the implementation of the“dual channel” management mechanism, the supply guarantee level of the national negotiation drug has been effectively improved through two different channels of designated pharmacies and medical institutions. To further demonstrate policy effects, it is recommended to strengthen the allocation of “dual channel” drugs, increase the service layout of designated pharmacies and strengthen the supervision of drug usage.

  • Wan-yan ZHOU, Qin-yu LÜ, Zheng-hui YI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 514-517.

    The new antidepressant toludesvenlafaxine, also known as ansofaxine, is a triple monoaminergic reuptake inhibitor independently developed in China. It can play an antidepressant effects by blocking the reuptake of the three neurotransmitters by combining with the serotonin transporter, noradrenaline, and dopamine transporter. Toludesvenlafaxine has a rapid effect, which can significantly improve the low mood, anhedonia, lack of motivation and other symptoms of patients with depressive disorders, relieve the associated anxiety symptoms, and is not easy to lead to sexual dysfunction and other adverse reactions in the treatment process. While using toludesvenlafaxine, clinicians should start titration with a low dose and assess the risk of mania during the course of treatment, and pay attention to whether the drug could cause psychotic symptoms, since it acts on the dopamine pathway.

  • Dan MEI, Jun GONG, Hui-fang WANG, Mei-xin NI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 556-560.
  • Jia-tong LI, Bo SUN, Yu-ran CAO, Ya-ning WANG, Jing MA, Jing ZHANG, Xiang-jun CHEN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 481-488.

    Amyotrophic lateral sclerosis (ALS) is a rare neurodegenerative disease characterized by the degeneration of upper and lower motor neurons. Clinically, it manifests as progressive muscle weakness and atrophy, ultimately leading to death, imposing a significant burden on patients’ families and society. The pathogenesis of ALS remains unclear. Currently, several ALS treatment drugs have failed to significantly extend survival or alter the outcome. In recent years, cell therapy has been increasingly applied to refractory or incurable diseases. Various types of stem cell therapies have been developed for ALS treatment, undergoing preclinical research and clinical trials. This article provides an overview of the application of cell therapy in ALS, with a detailed examination of the research and development history of the representative cell therapy NurOwn in ALS. And the achievements and challenges of current ALS cell therapy, suggesting the optimization of cell type selection and efficacy evaluation metrics in future ALS cell therapy research were further discussed. This optimization aims to guide the development, approval, and market entry of ALS cell therapies, benefiting patients and their families.

  • Bing WU, Xiao-peng TIAN, Shao-jun JING
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 547-551.
    AIM

    To investigate the protective mechanism of berberine against Polygonum multiflorum thunb.induced liver injury.

    METHODS

    SD rats were randomly divided into sham group, PM (Polygonum multiflorum thunb. 40 g·kg-1) group, PM+NS (saline 1 mL) group, PM+BBR (berberine 50 mg·kg-1) group (n=12 in each group). Another 24 rats were divided into PM+BBR+sh-PPAR-γ group and PM+BBR+sh-NC group, which were injected with 100 μL of shRNA-PPAR-γ and 100 μL of shRNA-NC into the tail vein. The administration of each group lasted for 8 weeks. HE staining was used to observe the pathological changes in liver tissue, and serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) levels and the levels of IL-1β, IL-6 and IL-10 in liver tissues were detected by ELISA. PPAR-γ expression was knockdown by transfecting shRNA-PPARγ into rats. The expression levels of PPAR-γ in rat liver tissues was detected by RT-qPCR and Western blot.

    RESULTS

    Compared with the sham group, the levels of serum ALT, AST, ALP were significantly increased, the levels of IL-1β, IL-6 in liver tissue were increased and IL-10 level was decreased, and PPAR-γ expression was significantly downregulated in the PM group and PM+NS group (all P<0.05). Compared with the PM+NS group, serum ALT, AST, ALP levels were significantly decreased, IL-1β and IL-6 levels were significantly decreased, IL-10 level was significantly increased, and PPAR-γ expression was significantly increased in the PM+BBR group (all P<0.05). Compared with the PM+BBR+sh-NC group, PPAR-γ expression was significantly decreased, serum ALT, AST, ALP levels were significantly increased, IL-1β and IL-6 levels were significantly increased, IL-10 level was significantly decreased in the PM+BBR+sh-PPAR-γ group (all P<0.05).

    CONCLUSION

    Berberine may alleviate hepatic injury induced by Polygonum multiflorum thunb. by up-regulating PPAR-γ expression.

  • Qian-ru CUI, Yong WU, Ji FENG, Jing ZHOU, Guo-dong LU
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 540-546.
    AIM

    To investigate the effect of canagliflozin on liver cancer cells and its regulatory mechanism.

    METHODS

    The effects of canagliflozin on the proliferation of liver cancer cell HepG2, Huh7 and HCCM were detected by cell clone formation assay and CCK-8 assay. Flow cytometry was used to measure changes in reactive oxygen species (ROS) levels, both intracellular and mitochondrial ROS levels, as well as alterations in mitochondrial membrane potential. Western blot was employed to assess the expression of proteins related with proliferation and cGAS-STING pathway. Mitochondrial DNA (mtDNA) release and inflammatory factor mRNA expression level were detected by RT-qPCR.

    RESULTS

    Compared with human normal liver cell MIHA, the inhibitory effect of canagliflozin on HepG2 cell proliferation was more significant (P<0.05,semi-inhibitory concentrations were >40 μmol·L-1 and 15 μmol·L-1, respectively). Compared with the control group, the clone number of liver cancer cells and the expression of proliferation-related proteins in the canagliflozin group were decreased in a concentration dependent manner (P<0.05). Additionally, the intracellular and mitochondrial ROS levels were increased, the mitochondrial membrane potential was decreased, and the cytoplasmic mtDNA release level, cGAS-STING pathway-related protein expression and pro-inflammatory factor mRNA levels were increased (all P<0.05). Compared with the canagliflozin group, the intracellular and mitochondrial ROS levels, cytoplasmic mtDNA release levels, cGAS-STING pathway-related protein expression and pro-inflammatory factor mRNA levels in the N-acetyl-L-cysteine (NAC) +canagliflozin group were decreased (all P<0.05). Compared with the canagliflozin group, the proliferation activity and the expression of proliferation-related proteins in the cGAS inhibitor RU.521 + canagliflozin group were significantly increased (all P<0.05).

    CONCLUSION

    Canagliflozin induces oxidative stress in liver cancer cells, leading to the accumulation of ROS within cells and mitochondria, impairment of mitochondrial function, leakage of mtDNA into the cytoplasm, activation of the cGAS-STING pathway, and subsequent release of intracellular pro-inflammatory factors. These processes collectively contribute to the modulation of liver cancer cells proliferation.

  • Qing HUANG, Jia QI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 489-494.

    Preeclampsia is a common hypertensive disorder of pregnancy, which seriously endangers the health of mothers and infants. The early application of low-dose aspirin can effectively prevent preeclampsia, and effectively reduce the probability of hemolysis, elevated liver function and low platelet count syndrome, placental abruption, and fetal distress. In recent years, with the deepening of research, more experimental evidences show that there is a correlation between gene polymorphisms and aspirin resistance. Because some patients have gene polymorphisms, the expected therapeutic effect cannot be achieved. This paper reviewed the research progress of precision medication of aspirin in high-risk pregnant women with preeclampsia, in order to guide the medication of aspirin in special groups such as pregnant women with preeclampsia and improve pregnancy outcomes.

  • Cui YANG, Qi-xiu SONG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 551-555.
    AIM

    To investigate the use of new oral anticoagulants (NOACs) and clinically relevant drug-related problems (DRPs) in hospitalized patients, in order to provide a reference for promoting the rational use of NOACs.

    METHODS

    A total of 586 medical records of inpatients using NOACs at the First Affiliated Hospital of Anhui Medical University from October 2021 to September 2022 were collected. Retrospective reviews were conducted according to relevant guidelines and regulations. The summary analysis of the observed DRPs was performed with reference to the criteria used in the Chinese Classification System for Drug-Related Problems (V1.0), which is adapted to the Chinese population and healthcare model.

    RESULTS

    Among the 586 cases, the majority were females (52.4%), and the average age was (69.5±12.6) years old. The most common indication for the use of NOACs was nonvalvular atrial fibrillation (272 cases, 46.4%), which involved three varieties and eight criteria. DRPs occurred in 358 patients, with a total of 389 DRPs identified, including 213 (54.8%) DRP1.1, 72 (18.5%) DRP2.1, 4 (1.0%) DRP3.1, 65 (16.7%) DRP3.2, and 35 (9.0%) DRP3.3.

    CONCLUSION

    The use of NOACs in our hospital are mainly manifested as low single doses, infrequent administration, and lack of indication for medication.

  • Xiao-yan GUAN, Han-yu CHANG, Mei-qi WANG, Guang-sheng LIANG, Ni YUAN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 523-528.

    As a new therapeutic modality, gene therapy drugs (GTDs) play a therapeutic role and also have many risks, which brings challenges to the regulation of GTDs. The United States (US) and the European Union (EU) have established a relatively perfect system in terms of the regulatory body, regulatory basis and listing regulation, which is worthy of China’s reference. China’s regulation of GTDs still exists in the regulatory basis level is not detailed, the regulatory content is not mature and transparent, the main body of the regulatory implementation and the body of the responsibility is not clear enough and other issues. It is suggested that our country can learn from the advanced experience of the US and the EU, divide and control the risk of GTDs, set up an expert technical team, establish an advisory committee, and strengthen international communication and exchange, so as to improve the regulatory system of GTDs and enhance the safety of such drugs in China.

  • Guo-li WANG, Quan-yang LIN, Qing-qi ZHENG, Bao-xin MA
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(6): 446-449.
    AIM

    To investigate the effects of sub-anesthetic doses of esketamine on cerebral oxygenation and hemodynamics in elderly patients undergoing hip arthroplasty.

    METHODS

    Sixty patients ( age ≥ 65 years and ASA classification Ⅱ to Ⅲ) for elective hip arthroplasty were selected and randomly divided into 2 groups of 30 patients each.Anesthesia was induced and maintained essentially in the same way in the two groups, with the addition of esketamine 0.5 mg·kg-1 intravenously at the time of induction followed by continuous pumping with esketamine 0.25 mg·kg-1·h-1 in the experimental group, and an equal amount of sodium chloride injection given at the corresponding time point in the control group. The mean arterial pressure (MAP), heart rate (HR), surgical volume index (SPI), and regional cerebral oxygen saturation (rSO2) were collected at the patient’s admission to the operating room (T0), 3 min after the procedure of induction (T1), intubation were immediately applied (T2), 10 min after induction (T3), skin incision (T4) and 1 h after surgery (T5). The intraoperative drug use and recovery quality during awakening were observed.

    RESULTS

    Compared with that at T0, MAP (except T4 in the experimental group) and SPI was significantly lower (P<0.05) and rSO2 was significantly higher (P<0.05) at all time points from T1 to T5 in the two groups. Compared with the control group, MAP was significantly increased at T1, T2, T3 in the experimental group (P<0.05). There was no significant difference in SPI, HR, and rSO2 between the two groups from T1 to T5 (P>0.05). The intraoperative usage rates of atropine and ephedrine, and the dosages of propofol and remifentanil in the experimental group were significantly lower than those in the control group (P<0.05).There was no significant difference in postoperative eye opening time and extubation time between the two groups (P>0.05).

    CONCLUSION

    The sub-anesthetic doses of esketamine has no significant effect on the rSO2 in elderly patients undergoing hip arthroplasty, which can provide more stable hemodynamics for patients undergoing anesthesia, and help maintain the balance between supply and demand of oxygen in brain tissue during perioperative period.