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  • Ting-ting TANG, De-zhi SHI, Jie CAO, Lian-lian XIAO, Yu-tong FANG, Qiu-tong LI, Yun-feng ZHENG, Jing JI, Jian-ming CHENG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(11): 866-872.
    AIM

    To investigate the analgesic mechanism of the active constituents of Piper wallichii.

    METHODS

    The core targets related to analgesia of Piper wallichii were screened by network pharmacology, and GO functional enrichment and KEGG pathway enrichment analyses were carried out by DAVID database. The cationic elution site of Shinan vine was eluted by a silica gel column with a gradient(95:5-50:50)of petroleum ether-ethyl acetate separation system system to isolate the wallwort alkaloids, and the purity was determined by HPLC. Selected ICR mice were randomly divided into a blank group, positive control(aspirin 120 mg·kg-1)group, a model group, and low, medium, and high dose(150, 300, and 600 mg·kg-1)pellitorine groups(all n=8), and were administered continuously for 7 d. After the last administration, each group was injected intraperitoneally with 0.1 mL of 0.7% acetic acid for every 10 g of body weight except the blank group. The number of twisting responses and latency period in each group were examined. Serum levels of tumour necrosis factor(TNF)-α, interleukin(IL)-6 and IL-1β were detected by ELISA, and the concentrations of choline acetyltransferase(ChAT), acetylcholine(ACh), and acetylcholinesterase(AChE)were examined in brain tissues.

    RESULTS

    The network pharmacological results showed that Piper wallichii screened out the core components such as pellitorine and futoamide, and the key pathways such as nerve signalling pathway and cholinergic synaptic pathway. The purity of isolated pellitorine was 90.42%. Animal experiments showed that, compared with the model group, the number of twisting in the low, medium and high dose pellitorine groups was significantly reduced(P<0.05), and the content of TNF-α,IL-6 and IL-1β in serum was significantly reduced(P<0.01). ChAT in the brain tissues of the three dose pellitorine groups were significantly higher(P<0.01), and the concentration of ACh in the medium and high dose pellitorine groups were significantly higher(P<0.01), and the AChE concentration of low, middle and high dose pellitorine groups were significantly decreased(P<0.05).

    CONCLUSION

    The key active constituent in the analgesic effect of Piper wallichii is pellitorine, which is involved in the cholinergic synaptic pathway by up-regulating the activities of ChAT and ACh, and down-regulating AChE,thus reducing pain.

  • Mei-ling JING, Xing YU
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(11): 809-813.

    Antibody-drug conjugates(ADCs)consist of monoclonal antibodies, linkers, and cytotoxic drugs,representing a novel class of anti-cancer agents that combine target specificity with chemotherapeutic efficacy. ADCs have demonstrated significant efficacy not only in breast cancer, gastric cancer and lung cancer, and have also shown clinical benefits in ovarian cancer. This review discussed the structure, mechanism, and applications of ADCs in ovarian cancer,aiming to provide new insights for clinical treatment of ovarian cancer.

  • Yu-lu FAN, Zi-kun WU, Yi-xin XU, Zhong-jian FANG, Hong YAO, Yan-wen YU
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(11): 860-865.
    AIM

    To explore the current research progress, research status, and future development directions in the field of traditional Chinese medicine(TCM)innovation.

    METHODS

    CiteSpace software was used to analyze the paper trends and keywords in domestic journal articles between 1999 and 2023, and keyword clustering analysis, drawing timeline mapping,and emergent word analysis were used to visualize the field of Chinese medicine innovation in China.

    RESULTS

    The number of TCM innovation-related publications showed a fluctuating upward trend year by year. The research is still dominated by the researchers’ respective teams and lacks relevant team cooperation. The development of TCM research has entered a rapid development stage, which has envolved from the traditional research direction such as prescription research and development,it has developed to the construction of TCM data platform and intelligent production in the industry.

    CONCLUSION

    Research in the field of TCM innovation in China is developing steadily and undergoing a transformation towards diversification,digitization, and intelligence.

  • Mei-jing JIN, Hui CHENG, Xiao-ying FENG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(11): 814-819.

    Integrins play an important role in mediating the entry of lymphocytes into the intestines leading to the development of inflammatory bowel disease(IBD), and their binding to the corresponding ligands mediates the intestinal homing and retention of lymphocytes. Currently, the anti-integrin drug vedolizumab has been used in clinical practice, and several other anti-integrin drugs are under development, such as abrilumab, AJM300, PTG-100, and milategrast. Clinical studies have shown that gut-selective anti-integrin agents may be a safe and effective option for the treatment of IBD.

  • Xu-dong WANG, Long WANG, Pei-wen HUANG, Li ZHANG, Lei GE, Ji QIU
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(11): 845-851.
    AIM

    To evaluate the rationality of irinotecan application based on weighted TOPSIS method.

    METHODS

    Based on the drug label of irinotecan, combined with relevant guidelines and literatures, weighted TOPSIS method was used to establish the evaluation criteria for the rationality of irinotecan clinical application, with “indications,contraindications, application and dosage, solvent selection, baseline examination, pretreatment, administration sequence,blood routine monitoring, dosage adjustment and ADR monitoring” as evaluation indicators. The archived medical records of inpatients who had used irinotecan in Binhu Hospital of Hefei from January 1, 2022 to May 31, 2023 were evaluated for the rationary of irinotecan administration.

    RESULTS

    Among the 10 evaluation indicators, the highest relative weighted index was indication(0.133 1), while the lowest was pretreatment(0.084 9). Among the included 97 cases, 10 cases(10%)had relative proximity(Ci)≥0.8, with the evaluation result as rational drug application; 79 cases(81%)had 0.6≤ Ci< 0.8,with the evaluation result as basic rational drug application; 8 cases(8%)had 0.4≤Ci < 0.6, with the evaluation result as irrational drug application.

    CONCLUSION

    The weighted TOPSIS method can be used to evaluate the rational usage of irinotecan. In our hospital, the use of irinotecan is basically reasonable, however, there are still some problems about baseline examination, blood routine monitoring and unreasonable indications.

  • Hong-xin JI, Shi-qiong HE, Yun-liang CAI, Jia-wei WANG, Qian ZHANG, Tang-qi QIN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(11): 837-841.
    AIM

    To investigate the effect of ultrasound-guided lateral quadratus lumborum block(QLB-1)on the median effective dosage(ED50)of butorphanol by patient controlled intravenous analgesia(PCIA)performed after cesarean section under general anesthesia.

    METHODS

    Parturients were scheduled for cesarean section under general anesthesia,gestation 37-42 weeks, ASA physical status Ⅱ were assigned into two groups, group Q(QLB-1 combined with butorphanol PCIA)and group C(butorphanol PCIA). Each group was expected to have 35 cases. Both groups were administered general anesthesia with endotracheal intubation. The group Q: 0.3% ropivacaine with 25 mL were injected in the QLB-1 in each side respectively under ultrasound guidance before extubation at the end of the surgery. The group C: no nerve block.The two groups underwent PCIA after extubation. The scores of resting visual analogue scale(VAS)≤3 points or VAS of motion state ≤4 points within 48 hours after operation were used as the criteria of analgesia satisfaction. The initial dose of butorphanol with PCIA was 4 μg·kg-1·h-1, adjusted by the modified Dixon’s up-and-down method with a dose gradient of 0.25 μg·kg-1·h-1. Probit analysis was used for calculating ED50 and 95% confidence interval(CI)of butorphanol PCIA for satisfactory analgesia.

    RESULTS

    The sample size included in group Q and group C were 31 and 28 cases, respectively.The ED50 of butorphanol PCIA for satisfactory analgesia was 3.81 μg·kg-1·h-1 for the group C(95%CI: 2.87 to 4.25 μg·kg-1·h-1)and 2.45 μg·kg-1·h-1 for the group Q(95%CI: 2.16 to 2.70 μg·kg-1·h-1). In the parturients with satisfactory analgesia of the two groups, the incidence of drowsiness, dizziness and nausea was higher in the group C than that in the group Q(P<0.05).

    CONCLUSION

    The ED50 of butorphanol PCIA combined with QLB-1 for satisfactory relieve postoperative analgesia after cesarean section under general anesthesia reduce butorphanol PCIA alone by 36% and reduce the incidence of adverse reactions.

  • Tian-zhu ZENG, Jian-zhou YAN, Rong SHAO
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(10): 759-764.

    The diversity of clinical trial population is the key to ensure the generalizability of drug safety and efficacy assessment results obtained from clinical trials, and plays an important role in advancing research on new drugs and strengthening the regulation of marketed drugs to improve the quality of life for patients. The United States has accumulated rich experience in improving the diversity of clinical trial population. Regulatory authorities have established a policy system for improving research practice, reducing patient participation barriers, and promoting data collection and sharing, and have provided diversified clinical trial information to the public. Clinical trial institutions have promoted the participation of patients from different backgrounds in clinical trials by strengthening inter-agency cooperation, facilitating community involvement, and improving the cultural inclusiveness of employees. China can learn from the relevant experience of the United States, improve the supervision system of clinical trial population diversity, promote the capacity building of clinical trial institutions to serve diverse populations, and strengthen the publicity and education of clinical trials, so as to improve the diversity of clinical trial population.

  • Yi-feng SHEN, Li-xia HUANG, Long QIN, Quan-yu SU, Hua-fang LI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(10): 721-727.

    A scale is an important tool for diagnosing and evaluating patients in the field of mental health. The vigorous development of decentralized clinical trials has promoted the rise of electronic scales. The electronization of scales refers to the process of converting clinical outcome assessment tools such as traditional paper scales or questionnaire survey tools into digital formats through electronic technology, making the administration of scales more convenient, timely, and accurate, and data-collecting more complete, regular, and secure. This article outlined the process of electronic migration of scales and proposed corresponding precautions, aiming to provide guidance and suggestions for the electronization of scales in clinical research on mental and psychological diseases in China.

  • Yu-huan YANG, Xing-xing SUN, Hong-tao LI, Mei-xiang ZHOU, Cong TIAN, Hong-ling ZHU, Qing-yu CHEN, Huan-huan SONG, Zan SHEN, Da-liu MIN, Kun HAN, Bai-lin LI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(10): 779-783.
    AIM

    To evaluate the efficacy and safety of anlotinib combined with gemcitabine + docetaxel as second-line or later therapy in patients with lung metastasis of osteosarcoma.

    METHODS

    Case data of 23 patients with lung metastasis of osteosarcoma received anlotinib combined with gemcitabine + docetaxel as second-line or later therapy in the department of oncology of Shanghai Sixth People’s Hospital from January 2016 to December 2022 were analysed retrospectively. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate, disease control rate (DCR) and safety.

    RESULTS

    In the 23 patients with lung metastasis of osteosarcoma, 17 patients (74%)achieved stable disease and 6 patients (26%) achieved progress disease, with DCR 74%. Median PFS was 10.8 months (95% CI: 1.4 to 20.2 months). All 23 patients experienced adverse reactions. Grade 3 or 4 adverse reactions included thrombocytopenia (17%),hypothyroidism (9%), hypertension (4%), hand-foot reaction (4%), fatigue (4%), diarrhea (4%), leukopenia (4%), and pneumothorax (4%).

    CONCLUSION

    Anlotinib combined with gemcitabine + docetaxel as second-line or later therapy can be used as an effective treatment with manageable toxicities for patients with lung metastasis of osteosarcoma.

  • Xiao-yu ZHU, Gui-juan WU, Zhu LAN, Yu-zhang WU, Ji ZHANG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(10): 728-735.

    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.