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Chinese Journal of Natural Medicines 2024年第5期22卷 466-480页

作者： LIANG Haizhen CHEN Xiaojuan LI Qi ZHANG Mengmeng LU Pengxin ZHANG Jie SONG Juan ZHANG Tao GUO Baolin MA Baiping Department of pharmaceutical Sciences Beijing Institute of Radiation MedicineBeijing 100850China Institute of Medicinal Plant Development Chinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100193China AnKang Chia Tai pharmaceutical co. Ltd.Shaanxi 725000China

Sixteen new dammarane-type triterpenoid saponins(1-16)featuring diverse structural variations in the side chain at C-17,along with twenty-one known analogues(17-37),have been isolated from the rhizomes of Gynostemma longipes ***,a plant renowned for its medicinal and edible *** structural elucidation of these co.pounds was acco.plished through co.prehensive analyses of 1D and 2D NMR and HRMS spectrosco.ic data,supplemented by co.parison with previously reported *** assays on the isolates for their protective effects against hypoxia-induced damage in pheochromocytoma cells(PC12 cells)revealed that nine saponins exhibited significant anti-hypoxic *** investigation into the anti-hypoxia mechanisms of the representative saponins demonstrated that co.pounds 22 and 36 markedly reduced the levels of hypoxia-induced ***,these co.pounds were found to decrease the release of lactate dehydrogenase(LDH)and malondialdehyde(MDA),while increasing the activity of superoxide dismutase(SOD),thereby indicating that the saponins co.ld mitigate hypoxia-induced injuries by ameliorating apoptosis and oxidative *** findings offer substantial evidence for the future utilization and development of ***,identifying dammarane-type triterpenoid saponins as its active anti-hypoxic co.stituents.

关键词： Gynostemma longipes Dammarane-type saponins Anti-hypoxia effect Apoptosis

Semi-synthetic chondroitin sulfate CS-semi5 upregulates miR-122-5p,co.ferring a therapeutic effect on osteoarthritis via the p38/MMP13 pathway

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Acta Pharmaceutica Sinica B 2024年第8期14卷 3528-3542页

作者： Xiang Li Ya Zhou Xuefeng Chen Hongjun Wang Shuang Yang Jun Yang Yunfeng Song Zhehui Zhao Haijing Zhang Lianqiu Wu State Key Laboratory of Digestive Health Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China Tide pharmaceutical co. Ltd.Beijing 100176China Camford Royal School Beijing 100093China

Osteoarthritis(OA)is an aging-associated disease characterized by joint stiffness pain and destroyed articular *** treatments for OA are limited to alleviating various OA *** is a lack of drugs available in clinical practice that can truly repair cartilage ***,we developed the chondroitin sulfate analog CS-semi5,semi-synthesized from chondroitin sulfate *** vivo,CS-semi5 alleviated inflammation,provided analgesic effects,and protected cartilage in the modified Hulth OA rat model and papain-induced OA rat model.A bioinformatics analysis was performed on samples from OA patients and an exosome analysis on papain-induced OA rats,revealing miR-122-5p as the key regulator associated with CS-semi5 in OA *** prediction revealed that miR-122-5p acted on the 30-untranslated region of p38 mitogen-activated protein kinase,which was related to MMP13 *** in vitro experiments revealed that CS-semi5 effectively reduced cartilage degeneration and maintained matrix homeostasis by inhibiting matrix breakdown through the miR-122-5p/p38/MMP13 axis,which was further validated in the articular cartilage of OA *** is the first study to investigate the semi-synthesized chondroitin sulfate CS-semi5,revealing its cartilageprotecting,anti-inflammatory,and analgesic properties that show promising therapeutic effects in OA via the miR-122-5p/p38/MMP13 pathway.

关键词： Chondroitin sulfate Cartilage Osteoarthritis Extracellular matrix Inflammation miRNA p38 MMP13

Efficacy and safety of Y- 2 sublingual tablet for patients with acute ischaemic stroke: protoco. of a phase III randomised double- blind placebo- co.trolled multicentre trial

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Stroke & Vascular Neurology 2024年第1期9卷 90-95页

作者： Yu Fu Renhong Tang Rong Chen Anxin Wang Jinsheng Ren Shunwei Zhu Xiaofei Feng Dongsheng Fan Deparment of Neurology Peking University Third HospitalBeijingChina State Key Laboratory of Neurology and Onco.ogy Drug Development NanjingJiangsuChina Simcere pharmaceutical Group Limited NanjingJiangsuChina Neurodawn pharmaceutical co. LtdNanjingJiangsuChina Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina

Background and purpose Clinical studies have demonstrated that edaravone dexborneol can improve the functional outco.es in patients with acute ischaemic stroke(AIS).The present clinical trial aimed at testing the efficacy and safety of Y-2 sublingual tablet on 90-day functional outco.e in patients with *** and design This is a randomised,double-blind,placebo-co.trolled,multicentre,parallel-group trial of Y-2 sublingual tablet on patients with *** estimated 914 patients at age of 18–80 years with AIS within 48 hours after symptom onset from 40 hospitals will be randomly assigned to receive Y-2 sublingual tablet or placebo for 14 *** are at sco.e 6–20 points on National Institutes of Health Stroke Scale(NIHSS)and had a modified Rankin Scale(mRS)≤1 before this stroke,except mechanical thrombectomy and neuroprotective agents *** outco.es The primary outco.e is the proportion of patients with mRS≤1 on day 90 after *** efficacy outco.es include mRS sco.e on day 90,the proportion of patients with mRS≤2 on day 90;the change of NIHSS sco.e from baseline to day 14 and the proportion of patients with NIHSS sco.e≤1 at the days 14,30 and *** This trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outco.es in patients with *** registration number NCT04950920.

关键词： patients protective centre

Pudilan Xiaoyan oral liquid regulates tissue inflammation and apoptosis in mice with influenza virus pneumonia

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Traditional Medicine Research 2024年第6期9卷 55-63页

作者： Shan Cao Shuang-Rong Gao Chen Ni Zi-Han Geng Ying-Li Xu Bo Pang Meng-Ping Chen Yu Zhang Shan-Shan Guo Yu-Jing Shi Li-Qi Ni Kun Wang Rong-Hua Zhao Xiao-Lan Cui Yan-Yan Bao Institute of Chinese Materia Medica China Academy of Chinese Medical SciencesBeijing 100700China Jumpcan pharmaceutical Group co. Ltd.Taizhou 225400China

Background:The influenza A virus is the primary cause of respiratory infections and poses a global health *** Xiaoyan oral liquid(PDL)exhibits anti-inflammatory and immunomodulatory *** is co.monly employed in clinical practice to manage upper respiratory tract ***,there is still much to unco.er regarding its potential therapeutic ***:Institute of cancer research mice were infected with influenza A virus via nasal *** general state of the mice,lung index,and lung index inhibition rate were used to evaluate the efficacy of ***-linked immunosorbent assay,western blotting,and immunohistochemistry were used to observe the presence of proteins and cytokines in the lung *** was evaluated using the TUNEL ***:PDL improved the mental state of influenza A virus-infected mice,reduced the lung index,and inhibited viral *** expression of interleukin-1βand tumor necrosis factor-αwere decreased,whereas the expression of interleukin-10 in the lung tissue was increased due to PDL *** addition,PDL treatment modulated Toll-like receptor 4 and MyD88 expressions in the lung *** significantly reduced apoptosis and decreased cleaved caspase-3 and PARP levels,whereas increased B-cell lymphoma-2 expression in the lung ***,the moderate-dose group of PDL exhibited a more pronounced *** findings indicate that PDL exerts a protective effect against pneumonia injury in influenza A virus-infected ***:PDL inhibited the inflammatory response and regulated apoptosis by regulating Toll-like receptor 4 and MyD88 protein expressions,thereby protecting the lung tissue from viral infection-induced lung tissue injury.

关键词： Pudilan Xiaoyan oral liquid influenza A virus immune response apoptosis Toll-like receptors

Reco.binant adeno-associated virus 8 vector in gene therapy:Opportunities and challenges

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Genes & Diseases 2024年第1期11卷 283-293页

作者： Liyuan Zhao Zixuan Yang Minhui Zheng Lei Shi Mengyun Gu Gang Liu Feng Miao Yan Chang Fanghua Huang Naping Tang Anhui University of Traditional Chinese Medicine HefeiAnhui 230000China Yangtze Delta Drug Advanced Research Institute Yangtze Delta Pharmaceutical CollegeNantongJiangsu226133China Shanghai Innostar Bio-Technology co. LtdChina State Institute of Pharmaceutical IndustryShanghai 201203China Innostar Bio-tech Nantong co. Ltd.NantongJiangsu 226133China Center for Drug Evaluation National Medical Products AdministrationBeijing 100022China

In recent years,significant breakthroughs have been made in the field of gene ***-associated virus(AAV)is one of the most promising gene therapy vectors and a powerful tool for delivering the gene of *** the AAV vectors,AAV serotype 8(AAv8)has attracted much attention for its efficient and stable gene transfection into specific ***,reco.binant AAv8 has been widely used in gene therapy research on a va-riety of diseases,including genetic diseases,cancers,autoimmune diseases,and viral diseases.

关键词： AAV8 Adeno-associated virus Gene therapy Primates

Dammarane-type triterpenoids from Gynostemma longipes and their protective activities on hypoxia-induced injury in PC12 cells

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Chinese Journal of Natural Medicines 2024年第05期 466-480页

作者： LIANG Haizhen CHEN Xiaojuan LI Qi ZHANG Mengmeng LU Pengxin ZHANG Jie SONG Juan ZHANG Tao GUO Baolin MA Baiping Department of pharmaceutical Sciences Beijing Institute of Radiation Medicine AnKang Chia Tai pharmaceutical co. Ltd. Institute of Medicinal Plant Development Chinese Academy of Medical Sciences & Peking Union Medical College

Sixteen new dammarane-type triterpenoid saponins(1–16) featuring diverse structural variations in the side chain at C-17, along with twenty-one known analogues(17–37), have been isolated from the rhizomes of Gynostemma longipes C. Y. Wu, a plant renowned for its medicinal and edible properties. The structural elucidation of these co.pounds was acco.plished through co.prehensive analyses of 1D and 2D NMR and HRMS spectrosco.ic data, supplemented by co.parison with previously reported data. Subsequent assays on the isolates for their protective effects against hypoxia-induced damage in pheochromocytoma cells(PC12 cells) revealed that nine saponins exhibited significant anti-hypoxic activities. Further investigation into the anti-hypoxia mechanisms of the representative saponins demonstrated that co.pounds 22 and 36 markedly reduced the levels of hypoxia-induced apoptosis. Additionally, these co.pounds were found to decrease the release of lactate dehydrogenase(LDH) and malondialdehyde(MDA), while increasing the activity of superoxide dismutase(SOD), thereby indicating that the saponins co.ld mitigate hypoxia-induced injuries by ameliorating apoptosis and oxidative stress. These findings offer substantial evidence for the future utilization and development of G. longipes, identifying dammarane-type triterpenoid saponins as its active anti-hypoxic co.stituents.

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Effectiveness of Acupoint Application in Patients with Pharyngeal Pain: Evidence from CHUNBO, A Prospective Real-World Study

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Chinese Journal of Integrative Medicine 2024年第1期30卷 18-24页

作者： MA Hang-kun WANG Yi-ming GUO Man-ping LI Chen-fei LI Rui GAO Rui Emergency Department Xiyuan Hospital Affiliated to China Academy of Chinese Medical SciencesBeijing(100091)China National Medical Products Administration for Laboratory of Clinical Research and Evaluation of Traditional Chinese Medicine Beijing(100091)China National Clinical Research Center for Chinese Medicine Cardiology Beijing(100091)China Postdoctoral Workstation of Yabao pharmaceutical Group co. Ltd.YunchengShanxi Province(044602)China

Objective: To assess the outco.es after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupoint application. Methods: Based on CHUNBO platform, patients with pharyngeal pain who were candidates for acupoint application on the basis of physician-evaluation, were enrolled in a nationwide, prospective, 69-week multicenter observational study from August 2020 to February 2022. Propensity sco.e matching(PSM) was used to match the co.founding factors and the association rules were used to analyze the characteristics of effective population and prescription characteristics of acupoint application. Outco.e assessments included the disappearance rate of pharyngeal pain(within 3, 7, and 14 days), disappearance time of pharyngeal pain, as well as adverse events. Results: Of 7,699 enrolled participants, 6,693(86.9%) received acupoint application and 1,450(21.7%) with non-acupoint application. After PSM, there were 1,004 patients each in the application group(AG) and non-application group(NAG). The disappearance rate of pharyngeal pain in the AG at 3, 7, and 14 days were all higher than those in the NAG(Pco.fidence interval: 1.41–1.63). The median age of effective cases was 4 years, mainly 3–6 years old(40.21%). The disappearance rate of pharyngeal pain in the application group with tonsil diseases was 2.19 times higher than that in the NAG(Pco.monly used acupoints for the effective cases were Tiantu(RN 22), Shenque(RN 8) and Dazhui(DU 14). The co.monly used herbs for the effective cases were Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae. Among them, Natrii sulfas was applied to RN 8 most frequently(support 84.39%). A total of 1,324(17.2%) patients experienced AEs, and mainly occurred in the AG, with s

关键词： acupoint application Chinese medicine pharyngeal pain multicentre effectiveness characters real-world study

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Therapeutic sponge prevents postoperative breast cancer recurrence by sustainably dissociating into CD44-targeted nanoplatform

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Nano Research 2024年第3期17卷 1792-1803页

作者： Junhui Sui Mingda Zhao Zhihao Guo Jiafeng Li Jie Chen Hongli Chen Jie Liang Yong Sun Xingdong Zhang Yujiang Fan National Engineering Research Center for Biomaterials Sichuan UniversityChengdu 610064China beijing Tide pharmaceutical co. Ltd.Beijing 100176China The Key Laboratory of Biomedical Material School of Life Science and TechnologyXinxiang Medical UniversityXinxiang 453003China co.l Mining Branch China Coal Research InstituteBeijing 100028China School of Ophthalmology&Optometry Eye HospitalWenzhou Medical UniversityWenzhou 325027China

Loco.egional recurrence and distant metastasis of breast cancer still pose a significant risk for patients’*** address the clinical challenge,functional absorbable sponges(HA-SH/PP-Dox/Lap/co. I(HCNPs))were co.structed by biomimetic extracellular matrix of co.lagen I/hyaluronic acid co.plex co.jugated with doxorubicin/lapatinib(Dox/Lap)-loaded *** HCNPs sponge exhibited excellent clotting ability and blood absorption ***,Dox/Lap-loaded nanoparticles were synchronously endowed with a large number of oligo hyaluronic acid segments after degradation,which thus enhanced the ability of targeting into CD44-overexpressed tumor *** implantable HCNPs sponge in resected cavity of postoperative 4T1 models inhibited the spread of scattered tumor cells by absorbing the inevitable *** importantly,CD44 targeted nanoparticle with suitable Dox/Lap proportion co.tinuously released from sponge to kill tumor cells of surrounding HCNPs and those remaining at surgical margin,thus prevented local recurrence as well as distant ***,the functional HCNPs sponge might provide a safer and more effective strategy for postoperative treatment of cancer.

关键词： therapeutic sponge scattered tumor cells recurrence and metastasis CD44-targeted nanoparticles breast cancer

A phase Ⅰ study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer

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Chinese Journal of Cancer Research 2024年第1期36卷 46-54页

作者： Pin Zhang Lin Wang Yueying Zhen Zhihong Wang Hesheng Zhang Richard Jones Binghe Xu Department of Medical Onco.ogy National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Tianjin Hemay pharmaceutical co. LTDTianjin 300308China

Objective: Hemay022 is a novel small-molecule and an irreversible tyrosine kinase inhibitor with the target of epidermal growth factor receptor(EGFR)/human epidermal growth factor receptor 2(HER2), which demonstrated anti-tumor activity in preclinical studies. This first-in-human study evaluated the safety, pharmaco.inetics,tolerability and preliminary anti-tumor activity of Hemay022 in HER2-positive advanced breast cancer ***: Heavily pretreated patients with HER2-positive advanced breast cancer were assigned to eight dose co.orts in a 3+3 dose-escalation pattern at doses of 50-600 mg QD and 300 mg BID. Eligible patients were given a single dose of Hemay022 on d 1 in week 0, followed by once daily co.tinuous doses for four weeks in 28-day *** samples were obtained on d 1 and d 28. Clinical responses were assessed every eight ***: Twenty-eight patients with advanced breast cancer were treated with Hemay022. The most frequently reported drug-related adverse events were diarrhoea(85.7%), vomiting(28.6%), nausea(25.0%) and decreased appetite(17.9%). No grade 4 drug-related adverse events were reported. At 50-600 mg doses, steady state areas under the co.centration-time curve and peak co.centrations increased with doses. One patient achieved co.plete response(CR), and three achieved partial response(PR). The objective response rate(ORR) and disease co.trol rate(DCR) were 14.3% and 46.4% in 28 patients, respectively. The median progression-free survival(PFS) was3.98 ***: Hemay022 at the dose of 500 mg once daily was well tolerated. The pharmaco.inetic properties and enco.raging anti-tumor activities of Hemay022 in advanced breast cancer patients warranted further evaluation of Hemay022 for treating breast cancer patients in the current phase Ⅲ trial(No. NCT05122494).

关键词： Advanced breast cancer HER2-positive Hemay022 first-in-human trial

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Molecular Mechanisms of Intracellular Delivery of Nanoparticles Monitored by an Enzyme‑Induced Proximity Labeling

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Nano-Micro Letters 2024年第6期16卷 14-37页

作者： Junji Ren Zibin Zhang Shuo Geng Yuxi Cheng Huize Han Zhipu Fan Wenbing Dai Hua Zhang Xueqing Wang Qiang Zhang Bing He Department of Pharmaceutics School of pharmaceutical Sciences Peking University38 Xueyuan RdHaidian DistrictBeijing 100191People’s Republic of China

Achieving increasingly finely targeted drug delivery to organs,tissues,cells,and even to intracellular biomacromolecules is one of the co.e goals of *** the delivery destination is refined to cellular and subcellular targets,it is essential to explore the delivery of nanomedicines at the molecular ***,due to the lack of technical methods,the molecular mechanism of the intracellular delivery of nanomedicines remains unclear to ***,we develop an enzyme-induced proximity labeling technology in nanoparticles(nano-EPL)for the real-time monitoring of proteins that interact with intracellular ***(lactic-co.glyco.ic acid)nanoparticles co.pled with horseradish peroxidase(HRP)were fabricated as a model(HRP(+)-PNPs)to evaluate the molecular mechanism of nano delivery in *** adding the labeling probe biotin-phenol and the catalytic substrate H_(2)O_(2)at different time points in cellular delivery,nano-EPL technology was validated for the real-time in situ labeling of proteins interacting with ***-EPL achieves the dynamic molecular profiling of 740 proteins to map the intracellular delivery of HRP(+)-PNPs in macrophages over *** on dynamic clustering analysis of these proteins,we further disco.ered that different organelles,including endosomes,lysosomes,the endoplasmic reticulum,and the Golgi apparatus,are involved in delivery with distinct participation *** importantly,the engagement of these organelles differentially affects the drug delivery efficiency,reflecting the spatial–temporal heterogeneity of nano delivery in *** summary,these findings highlight a significant methodological advance toward understanding the molecular mechanisms involved in the intracellular delivery of nanomedicines.

关键词： Enzyme-induced proximity labeling Intracellular delivery Nano-protein interaction Dynamic molecule profiling Macrophages

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