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  • Ya-dan LIU, Shu-xun YAN, Bin WANG, Pai PANG, Yun-tao MA, Bin WANG, Cui-juan SHI, Hong-en ZHENG, Yu-qi LUO
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(10): 751-758. doi:10.14109/j.cnki.xyylc.2024.10.05

    As the first dual receptor agonist of glucose-dependent insulin-stimulating polypeptide and glucagon-like peptide-1 used for chronic weight management, tirzepatide achieves weight loss by delaying gastric emptying and reducing energy intake, and its therapeutic effect on obesity is significant and its safety is high. Tirzepatide can also improve a variety of cardiometabolic risk factors, such as reducing blood sugar, lowering blood pressure, and improving blood lipids. In the future,it is expected to treat obesity with cardiovascular and cerebrovascular diseases, respiratory diseases, liver diseases, etc, with broad application prospects. This article reviewed the pharmacokinetics, mechanism of weight loss, clinical application and safety of tirzepatide.

  • Yue ZHAO, Hao-tian YANG, Chao-jun XUE, Xiao LI, Xiao-yu JU, Qian ZHAO, Zhan-jun DONG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 374-379. doi:10.14109/j.cnki.xyylc.2024.05.11
    AIM

    To quantitative evaluate of selective Janus kinase inhibitors in treatment of atopic dermatitis, and provide scientific basis for drug selection and clinical rational drug use.

    METHODS

    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.

    RESULTS

    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.

    CONCLUSION

    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.

  • Qing HUANG, Jia QI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 489-494. doi:10.14109/j.cnki.xyylc.2024.07.02

    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.

  • Wan-yan ZHOU, Qin-yu LÜ, Zheng-hui YI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(7): 514-517. doi:10.14109/j.cnki.xyylc.2024.07.06

    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.

  • Qiu LI, Qian-wei GE, Li-ming SHAO
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(1): 4-11. doi:10.14109/j.cnki.xyylc.2024.01.02

    To comprehend the current status of new drug development in China, this article examines the new drug applications (NDAs) approved by the National Medical Products Administration (NMPA) in 2023. The analysis is conducted based on drug category, therapeutic area, target, and priority review and approval, providing a valuable reference for researchers in fields related to pharmaceutical innovation. As of December 31, 2023, the NMPA had approved a total of 190 NDAs, comprising 117 chemical drugs, 64 biological products, and 9 traditional Chinese medicines. Among these,37 were categorized as new drugs in Class 1, and 117 were improved new drugs. Notably, anti-tumor drugs maintained a dominant position, accounting for 34.2% of the total approvals. Furthermore, there was a significant increase in approvals for pediatric drugs and drugs targeting rare diseases.

  • Zhi-hui HUA, Yi ZHANG, Yuan FANG, Xiu-mei LIU, Qing-yu YANG, Chun-li GE, Nan CHEN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 380-386. doi:10.14109/j.cnki.xyylc.2024.05.12
    AIM

    To provide reference for selection and clinical rational use of third-generation anti-seizure medications in medical institutions through a comprehensive evaluation of perampanel and lacosamide.

    METHODS

    A percentage based evaluation system was developed based on the Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition). Referring to drug instructions, clinical treatment guidelines, and relevant literature, perampanel and lacosamide were quantitatively scored from five dimensions of pharmaceutical characteristics,effectiveness, safety, economy, and other attributes.

    RESULTS

    The final evaluation score was 77.41 for perampanel and 69.06 for lacosamide. The score of perampanel was higher than 70, so the recommendation for entering the drug use catalog of medical institutions was “strong recommendation”. There was a significant difference in effectiveness and economy between the two drugs. Perampanel had more evidence-based proofs and indications for the treatment of drug-resistant epilepsy and lower average daily treatment cost, so the effectiveness and economy of perampanel was slightly better than that of lacosamide. However, in terms of safety, perampanel had a Boxed Warning from the U. S. Food and Drug Administration about severe psychiatric and behavioral reactions, and it was not as recommended as lacosamide in patients with pregnancy or liver dysfunction.

    CONCLUSION

    Perampanel and lacosamide each have advantages in different attributes, and medical institutions can decide whether to introduce them based on the characteristics of patient population and the availability of alternative drugs.

  • Xiu-zhen ZHANG, Ying CHEN, Xiu-ying LI, Hong CHEN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(3): 192-196. doi:10.14109/j.cnki.xyylc.2024.03.06
    AIM

    To investigate the efficacy and safety of amisulpride combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and concomitant hyperprolactinemia in acute phase.

    METHODS

    A total of 72 patients who had poor efficacy and increased prolactin levels after a 8-week treatment of amisulpride were randomly divided into control group and study group, with 36 patients in each group. The patients in the control group continued to be treated with amisulpride (400 - 1 200 mg·d-1), while the patients in the study group received aripiprazole (the initial dose was 5 mg·d-1, which could be increased to 10-30 mg·d-1) on the basis of amsulpride, for an additional 8 weeks of treatment. The scores of Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) and the levels of serum prolactin were compared between the two groups at the time of enrollment and different time points of treatment.

    RESULTS

    Two cases were dropped out in each group and 34 cases were completed in each group. The effective rate of the study group was significantly higher than that of the control group at the 2nd, 4th, and 8th weekend of treatment (P<0.05). At the end of 4 and 8 weeks, the total PANSS score in the study group was significantly lower than that in the control group (P<0.01), and significantly decreased compared with that at the time of enrollment (P<0.01). At the end of treatment, the reduction of PANSS total score, positive score, and psychopathology score of the study group were significantly higher than those of the control group (P<0.01). The prolactin levels in the study group was significantly lower than that in the control group at the 4th and 8th weekend of treatment (P<0.01), and was also significantly lower than that at the time of enrollment (P<0.01). The increase of serum prolactin in female patients in the study group was more significant than that in male patients (P<0.01) after 8 weeks of treatment with amisulpride, and the decrease of serum prolactin in female patients was also more significant than that in male patients (P<0.01) after treatment combined with aripiprazole. There were no significant difference in TESS score and incidence rate of adverse reactions between the two groups (P>0.05).

    CONCLUSION

    After combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and elevated serum prolactin, the therapeutic effect can be increased, the serum prolactin level can be reduced, and the benefits are more obvious in female patients, with no significant increase in adverse reactions.

  • Zhao-ming GUAN, Miao YU, Tao LIANG, Si-yu LI, Dan HAN, Zhong-hua JI, Ying-lin WANG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(4): 253-256. doi:10.14109/j.cnki.xyylc.2024.04.03

    Cyclopofol is a new type of intravenous anesthesia drug, with drug characteristics similar to propofol.At present, multiple clinical trials have confirmed that cyclopofol has the characteristics of fast onset and recovery, and can be used for general anesthesia induction, painless gastroscopy, fiberoptic bronchoscopy, etc. It has certain advantages in the application of intensive care units and elderly patients. The safety of cyclopofol is relatively high, and the incidence of injection pain caused by cyclopofol is significantly lower than that of propofol. With the gradual application of cyclopofol in clinical practice, its scope of application, mechanism of action, and advantages are worthy of further research.

  • Yan YIN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(4): 263-267. doi:10.14109/j.cnki.xyylc.2024.04.05

    Investigator-initiated-trial(IIT)is the most important part of clinical researches. Based on the IIT management practice of one 3A grade hospital in Beijing, this paper analyzed the organizational structure of clinical research,the key points of scientific review and ethical review, recordation filling, contract verification and quality control, which were compared with the IIT management measures issued by the NHC one by one. According to the above , this paper puts forward some corresponding countermeasures, aiming at improving the management level and promoting high-quality development of clinical research.

  • Long WANG, Li ZHANG, Ling-na ZHU, Jun CHENG
    Chinese Journal of New Drugs and Clinical Remedies. 2025, 44(4): 299-306. doi:10.14109/j.cnki.xyylc.2025.04.10

    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.