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基于《第一批罕见病目录》的我国罕见病药物上市情况分析

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中国药房 2024年第11期35卷 1291-1295页

作者：彭菲菲蒋君好鲍宇健郑航重庆医科大学药学院重庆400016

目的考察我国罕见病药物的上市现状、一般特征以及时间发展趋势。方法基于《第一批罕见病目录》收纳的121种罕见病,从国家药品监督管理局药品审评中心和药智网数据库中获取相应适应证药物的名称和批准上市信息,提取相关特征变量进行... 详细信息

目的考察我国罕见病药物的上市现状、一般特征以及时间发展趋势。方法基于《第一批罕见病目录》收纳的121种罕见病,从国家药品监督管理局药品审评中心和药智网数据库中获取相应适应证药物的名称和批准上市信息,提取相关特征变量进行描述性统计分析。结果截至2022年12月31日,该目录收纳的121种罕见病中,有治疗药物上市的仅有32种,共涉及79个罕见病药物。其中,46.84%的药物是国产药,有88.61%的药物被批准成人和儿童都可用;化药占比为67.09%,注射剂占比为59.49%;按解剖学、治疗学及化学分类系统(ATC)分类,A类(消化系统用药)是最多的,占比为20.25%。每年上市的罕见病药物数量在2021年最多,2018-2021年总体呈上升趋势,2022年呈下降趋势。每年上市的罕见病药物中,按ATC分类,L类(抗肿瘤药及免疫用药)在2021年上市的数量最多,为5个;按剂型分类,口服制剂在2022年上市的数量最多,注射剂在2021年上市的数量最多。结论近年来我国罕见病药物上市数量不断增长,但是还远不能满足患者需求,并且上市的国产罕见病药物还非常缺乏。应进一步加快罕见病药物的研发,促进罕见病药物的进口与仿制。

关键词：罕见病罕见病药物第一批罕见病目录上市情况发展趋势

Redox dual-stimuli responsive drug delivery systems for improving tumor-targeting ability and reducing adverse side effects

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Asian Journal of Pharmaceutical Sciences 2020年第3期15卷 311-325页

作者： Ruirui Li feifei peng Jia Cai Dandan Yang peng Zhang School of Pharmacy Shenyang Pharmaceutical UniversityShenyang 110016China

Cancer is a big challenge that has plagued the human beings for ages and one of the most effective treatments is chemotherapy. However, the low tumor-targeting ability limits the wide clinical application of chemotherapy. The microenvironment plays a critical role in many aspects of tumor genesis. It generates the tumor vasculature and it is highly implicated in the progression to metastasis. To maintain a suitable environment for tumor progression, there are special microenvironment in tumor cell, such as low pH, high level of glutathione(GSH) and reactive oxygen species(ROS), and more special enzymes, which is different to normal cell. Microenvironment-targeted therapy strategy could create new opportunities for therapeutic targeting. Compared to other targeting strategies, microenvironment-targeted therapy strategy will control the drug release into tumor cells more accurately. Redox responsive drug delivery systems(DDSs) are developed based on the high level of GSH in tumor cells. However, there are also GSH in normal cell though its level is lower. In order to control the release of drugs more accurately and reduce side effects, other drug release stimuli have been introduced to redox responsive DDSs. Under the synergistic reaction of two stimuli, redox dual-stimuli responsive DDSs will control the release of drugs more accurately and quickly and even increase the accumulation. This review summarizes strategies of redox dual-stimuli responsive DDSs such as pH, light, enzyme, ROS, and magnetic guide to delivery chemotherapeutic agents more accurately, aiming at providing new ideas for further promoting the drug release,enhancing tumor-targeting and improving anticancer effects. To better illustrate the redox dual-stimuli responsive DDS, preparations of carriers are also briefly described in the review.

关键词： Chemotherapy Drug delivery system Redox responsive Dual-stimuli responsive Tumor-targeting

清气化痰丸加减联合丙卡特罗治疗痰热蕴肺证支气管哮喘的临床效果及对炎性因子的影响

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临床误诊误治 2024年第14期37卷 74-78页

作者：观云武蕾彭飞飞张萱河北省中医院呼吸重症科石家庄050013 河北省中医院呼吸科石家庄050013

目的评价清气化痰丸加减联合丙卡特罗治疗痰热蕴肺证支气管哮喘的临床效果。方法选取2022年1月至2023年12月收治的130例痰热蕴肺证支气管哮喘患者,采用随机数字表法分为观察组、对照组各65例,对照组采用丙卡特罗颗粒,观察组在对照组基... 详细信息

目的评价清气化痰丸加减联合丙卡特罗治疗痰热蕴肺证支气管哮喘的临床效果。方法选取2022年1月至2023年12月收治的130例痰热蕴肺证支气管哮喘患者,采用随机数字表法分为观察组、对照组各65例,对照组采用丙卡特罗颗粒,观察组在对照组基础上加服清气化痰丸加减方,2组均服用14 d。观察2组患者临床疗效,治疗前后中医症候积分、肺功能指标[第1秒用力呼气容积(FEV1)、FEV1/用力肺活量(FVC)、最大呼气流量(PEF)]、炎性因子[白细胞介素-6(IL-6)、白细胞介素-8(IL-8)、免疫球蛋白E(IgE)]、免疫指标(CD3+、CD4+、CD8+、CD4+/CD8+)水平,以及不良反应发生情况。结果治疗后,观察组总有效率为90.77%高于对照组的7385%(P<0.05)。治疗后,2组中医证候积分较治疗前降低,且观察组低于对照组(P<0.05,P<001)。治疗后2组FEV1/FVC、FEV1、PEF均上升,且观察组FEV1/FVC、FEV1、PEF改善更显著(P<0.05,P<001)。治疗后2组IL-6、IL-8、IgE水平均较前降低,且观察组改善更显著(P<0.05,P<001)。治疗后2组CD3+、CD4+、CD4+/CD8+水平升高,CD8+水平降低,且观察组上述指标变化较对照组明显(P<0.05,P<001)。2组治疗期间均未见不良反应发生。结论采用清气化痰丸加减方联合丙卡特罗治疗痰热蕴肺证支气管哮喘患者有较好的效果,能够明显改善患者临床症状、肺功能、免疫功能,减轻气道炎症,且具有较好的安全性。

关键词：支气管哮喘痰热蕴肺清气化痰丸第1秒用力呼气容积白细胞介素-6 CD3+ 药物毒性

The superhydrophobic sponge decorated with Ni-Co double layered oxides with thiol modification for continuous oil/water separation

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Chinese Journal of Chemical Engineering 2023年第2期54卷 296-305页

作者： Xiaodong Yang Na Yang Ziqiang Gong feifei peng Bin Jiang Yongli Sun Luhong Zhang School of Chemical Engineering and Technology Tianjin UniversityTianjin 300072China

In this paper, the superhydrophobic polyurethane sponge(SS-PU) was facilely fabricated by etching with Jones reagent to bind the nanoparticles of Ni-Co double layered oxides(LDOs) on the surface, and following modification with n-dodecyl mercaptan(DDT). This method provides a new strategy to fabricate superhydrophobic PU sponge with a water contact angle of 157° for absorbing oil with low cost and in large scale. It exhibits the strong absorption capacity and highly selective characteristic for various kinds of oils which can be recycled by simple squeezing. Besides, the as-prepared sponge can deal with the floating and underwater oils, indicating its application value in handling oil spills and domestic oily wastewater. The good self-cleaning ability shows the potential to clear the pollutants due to the ultralow adhesion to water. Especially, the most important point is that the superhydrophobic sponge can continuously and effectively separate the oil/water mixture against the condition of turbulent disturbance by using our designed device system, which exhibit its good superhydrophobicity, strong ***, the SS-PU still maintained stable absorption performance after 150 cycle tests without losing capacity obviously, showing excellent durability in long-term operation and significant potential as an efficient absorbent in large-scale dispose of oily water.

关键词： Superhydrophobic sponge Ni-Co double layered oxides Thiol modification Oil absorption Oil/water separation

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柑普茶加工工艺及其功能特性研究进展

中国茶叶 2024年第3期46卷 21-25页

作者：彭兴兴吴颖茹彭飞飞刘小玉陈晓丽张景秀江门职业技术学院材料与食品学院广东江门529030

柑普茶是一种由柑皮和普洱茶组成的特色再加工茶。文章综述了近年来有关柑普茶的研究进展,包括加工工艺、内含成分、功能特性和质量控制等。通过对这些研究的梳理和评价,旨在为柑普茶的进一步研究和应用提供参考。

关键词：柑普茶加工工艺化学成分功能特性质量控制

Transcriptomic and cellular decoding of scaffolds-induced suture mesenchyme regeneration

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International Journal of Oral Science 2024年第2期16卷 306-321页

作者： Jiayi Wu feifei Li peng Yu Changhao Yu Chuyi Han Yitian Wang Fanyuan Yu Ling Ye State Key Laboratory of Oral Diseases&National Center for Stomatology&National Clinical Research Center for Oral Diseases&West China Hospital of Stomatology Sichuan UniversityChengduChina State Key Laboratory of Oral Diseases&National Center for Stomatology&National Clinical Research Center for Oral Diseases&Department of Cariology and Endodontics West China Hospital of StomatologySichuan UniversityChengduChina State Key Laboratory of Oral Diseases&National Center for Stomatology&National Clinical Research Center for Oral Diseases&Department of Pediatric Dentistry West China Hospital of StomatologySichuan UniversityChengduChina

Precise orchestration of cell fate determination underlies the success of scaffold-based skeletal *** extensive studies on mineralized parenchymal tissue rebuilding,regenerating and maintaining undifferentiated mesenchyme within calvarial bone remain very challenging with limited advances *** knowledge has evidenced the indispensability of rebuilding suture mesenchymal stem cell niches to avoid severe brain or even systematic *** to date,the absence of promising therapeutic biomaterials/scaffolds *** reason lies in the shortage of fundamental knowledge and methodological evidence to understand the cellular fate regulations of *** address these issues,in this study,we systematically investigated the cellular fate determinations and transcriptomic mechanisms by distinct types of commonly used calvarial *** data elucidated the natural processes without scaffold transplantation and demonstrated how different scaffolds altered in vivo cellular responses.A feasible scaffold,polylactic acid electrospinning membrane(PLA),was next identified to precisely control mesenchymal ingrowth and self-renewal to rebuild non-osteogenic suture-like tissue at the defect center,meanwhile supporting proper osteointegration with defect bony ***,transcriptome analysis and cellular mechanisms underlying the well-orchestrated cell fate determination of PLA were *** study for the first time cellularly decoded the fate regulations of scaffolds in suture-bony composite defect healing,offering clinicians potential choices for regenerating such complicated injuries.

关键词： injuries healing suture

Gut microbiome-based thiamine metabolism contributes to the protective effect of one acidic polysaccharide from Selaginella uncinata(Desv.)Spring against inflammatory bowel disease

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Journal of Pharmaceutical Analysis 2024年第2期14卷 177-195页

作者： Haochen Hui Zhuoya Wang Xuerong Zhao Lina Xu Lianhong Yin feifei Wang Liping Qu Jinyong peng Department of Pharmaceutical Analysis College of PharmacyDalian Medical UniversityDalianLiaoning116044China Innovation Materials Research and Development Center Botanee Research InstituteYunnan Botanee Bio-technology Group Co.Ltd.Kunming650106China Department of Traditional Chinese Medicine Pharmacology School of PharmacyAnhui University of Chinese MedicineHefei230012China

Inflammatory bowel disease(IBD)is a serious disorder,and exploration of active compounds to treat it is *** acidic polysaccharide named SUSP-4 was purified from Selaginella uncinata(Desv.)Spring,which contained galacturonic acid,galactose,xylose,arabinose,and rhamnose with the main chain structure of→4)-α-d-GalAp-(1→and→6)-β-d-Galp-(1→and the branched structure of→5)-α-l-Araf-(1→.Animal experiments showed that compared with Model group,SUSP-4 significantly improved body weight status,disease activity index(DAI),colonic shortening,and histopathological damage,and elevated occludin and zonula occludens protein 1(ZO-1)expression in mice induced by dextran sulfate sodium salt(DSS).16S ribosomal RNA(rRNA)sequencing indicated that SUSP-4 markedly downregulated the level of Akkermansia and *** results confirmed that SUSP-4 obviously elevated thiamine levels compared with Model mice by adjusting thiamine metabolism,which was further confirmed by a targeted metabolism *** transplantation experiments showed that SUSP-4 exerted an anti-IBD effect by altering the intestinal flora in mice.A mechanistic study showed that SUSP-4 markedly inhibited macrophage activation by decreasing the levels of phospho-nuclear factor kappa-B(p-NF-κB)and cyclooxygenase-2(COX-2)and elevating NF-E2-related factor 2(Nrf2)levels compared with Model *** conclusion,SUSP-4 affected thiamine metabolism by regulating Akkermania and inhibited macrophage activation to adjust NF-κB/Nrf2/COX-2-mediated inflammation and oxidative stress against *** is the first time that plant polysaccharides have been shown to affect thiamine metabolism against IBD,showing great potential for in-depth research and development applications.

关键词： Gut microbiota Inflammatory bowel disease Polysaccharide Selaginella uncinata(Desv.)Spring Thiamine metabolism

The generation and use of animal models of osteosarcoma in cancer research

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Genes & Diseases 2024年第2期11卷 664-674页

作者： feifei Pu Haoyu Guo Deyao Shi Fengxia Chen Yizhong peng Xin Huang Jianxiang Liu Zhicai Zhang Zengwu Shao Department of Orthopedics Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430022China Department of Orthopedics Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430022China Department of Radiation and Medical Oncology Zhongnan HospitalWuhan UniversityWuhanHubei 430071China Hubei Cancer Clinical Study Center Zhongnan HospitalWuhan UniversityWuhanHubei 430071China

Osteosarcoma is the most common malignant bone tumor affecting children and ***,the most common treatment is surgery combined with neoadjuvant *** the survival rate of patients with osteosarcoma has improved in recent years,it remains poor when the tumor(s)progress and distant metastases ***,better animal models that more accurately replicate the natural progression of the disease are needed to develop improved prognostic and diagnostic markers,as well as targeted therapies for both primary and metastatic *** present review described animal models currently being used in research investigating osteosarcoma,and their characteristics,advantages,and *** models may help elucidate the pathogenic mechanism(s)of osteosarcoma and provide evidence to support and develop clinical treatment strategies.

关键词： Animal model Cancer Osteosarcoma Pathogenic mechanism Translational research

血清Lp-PLA2、Aβ_(1-42)联合Fazekas评分对脑小血管病认知障碍的预测价值

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临床医学工程 2024年第4期31卷 471-472页

作者：王丹慧崔滨孙丽霞王松林彭斐斐于江涛王孟乐许自强许昌市中心医院神经内科河南许昌461000 航空总医院神经外科北京100012

目的探讨血清Lp-PLA2、Aβ_(1-42)联合Fazekas评分对脑小血管病患者认知障碍的预测价值。方法选取2021年3月至2022年12月我院收治的94例脑小血管病患者,根据蒙特利尔认知评估量表评分分为认知障碍组和认知正常组,比较两组的Lp-PLA2、Aβ... 详细信息

目的探讨血清Lp-PLA2、Aβ_(1-42)联合Fazekas评分对脑小血管病患者认知障碍的预测价值。方法选取2021年3月至2022年12月我院收治的94例脑小血管病患者,根据蒙特利尔认知评估量表评分分为认知障碍组和认知正常组,比较两组的Lp-PLA2、Aβ_(1-42)水平以及Fazekas评分,分析Lp-PLA2、Aβ_(1-42)水平联合Fazekas评分预测脑小血管病患者发生认知障碍的效能。结果认知障碍组的Lp-PLA2、Aβ_(1-42)水平及Fazekas评分均高于认知正常组(P<0.05)。ROC曲线显示,Lp-PLA2、Aβ_(1-42)水平联合Fazekas评分预测脑小血管病患者认知障碍的效能高于单一指标(P<0.05)。结论血清Lp-PLA2、Aβ_(1-42)水平联合Fazekas评分预测脑小血管病患者发生认知障碍的应用价值高。

关键词： Lp-PLA2 Aβ_(1-42) Fazekas评分脑小血管病认知障碍