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Pharmacovigilance guidelines of Chinese patent medicines

Zhongguo Zhongy.o Zazhi 2024年第16期49卷 4261-4265页

作者： wang L.-x. wang M.-M. Li y.-y. wang Z.-F. Cui x. Zhao x.-x. Liu F.-M. y.ng S. Wei R.-L. wang y.-x. Zhang B. x.e y.-M. Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China Beijing University.of Chinese Medicine Beijing 100029 China

Drug administration law of the People′s Republic of China (2019 revised edition), which came into effect on December 1, 2019, proposed that " the state shall establish a pharmacovigilance sy.tem" . Pharmacovigilance work of Chinese patent medicines is more difficult, and it is necessary.to carry.out Pharmacovigilance activities that are in line with the characteristics of Chinese patent medicines. Pharmacovigilance guidelines of Chinese patent medicines (T / CACM 1563. 1-2024), based on the principles of Drug Administration Law of the People′ s Republic of China (2019 revised edition) and Pharmacovigilance quality.management standards (No. 65 of 2021) of the National Medical Products Administration, draws on the EU Pharmacovigilance regulation and the secondary.guidelines of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and it is drafted in accordance with the provisions of Guidelines for standardization work part 1: structure and drafting rules of standardization documents (GB / T1. 1-2020) based on the characteristics of Chinese patent medicines. It serves as a general document for a series of pharmacovigilance guidelines of Chinese patent medicines, such as Guidelines for construction of traditional Chinese medicine pharmacovigilance sy.tem in medical institutions (T / CACM 1563. 2-2024), Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines (T / CACM 1563. 3-2024), Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections (T / CACM 1563. 4-2024), Pharmacovigilance guidelines for clinical application of Chinese patent medicines for ex.ernal use (T / CACM 1563. 5-2024), and Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration (T / CACM 1563. 6-2024), including four major elements of pharmacovigilance monitoring and reporting of Chinese patent medicines, signal identification, ri

关键词： Chinese patent medicine group standard guideline pharmacovigilance safe drug use

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Response Evaluation Using Contrast-Enhanced Ultrasound for Unresectable Advanced Hepatocellular Carcinoma Treated With Ty.osine Kinase Inhibitors Plus Anti-PD-1 Antibody.Therapy

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Ultrasound in Medicine and Biology 2024年第1期50卷 142-149页

作者： Zhao C.-K. Guan x. Pu y.-y. Zhou B.-y. wang L.-F. Sun y.-K. y.n H.-H. x.a H.-S. wang x. Han H. x. H.-x. Department of Ultrasound Zhongshan Hospital Institute of Ultrasound in Medicine and Engineering Fudan University Shanghai China Shanghai Institute of Medical Imaging Shanghai China Central Laboratory.and Department of Medical Ultrasound Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital University of Electronic Science and Technology of China Chengdu China

Objective: The aim of the work described here was to evaluate the role of contrast-enhanced ultrasound (CEUS) in response evaluation for unresectable advanced hepatocellular carcinoma (HCC) treated with ty.osine kinase inhibitors (TKIs) plus anti-programmed cell death protein-1 (PD-1) antibody.therapy. Methods: A prospective cohort of consecutive patients with HCC who received combined TKI/anti-PD-1 antibody.treatment for unresectable HCC between January.2022 and October 2022 was included in this study. The patients underwent unenhanced ultrasound (US) and CEUS ex.minations before treatment and at follow-up. Changes in the largest diameters of the target tumor on unenhanced US and the largest diameters of the enhancing target tumors on CEUS were evaluated. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with unenhanced US and magnetic resonance imaging/computed tomography.(MRI/CT) and modified RECIST (mRECIST) with CEUS and CEMRI/CT were used to assess treatment response. Results: A total of 24 HCC patients (23 men and 1 woman; mean age: 56.5 ± 8.5 y. Barcelona Clinic Liver Cancer stage C, 62.5%; 29 intrahepatic target tumors) were studied. Calculations of degree of necrosis in the target tumors revealed no significant differences between CEUS and CEMRI/CT (44.5 ± 36.2% vs. 45.3 ± 36.8%, p = 0.862). As for the differentiation of responders from non-responders, the agreement between RECIST version 1.1 of unenhanced US and mRECIST-CEUS was poor (κ coefficient = 0.233). Meanwhile, there was a high degree of concordance between mRECIST-CEUS and mRECIST-CEMRI/CT (κ coefficient = 0.812). Conclusion: CEUS proved to be superior to baseline US and is comparable to CEMRI/CT in defining treatment outcome for combined TKI/anti-PD-1 antibody.therapy. © 2023 World Federation for Ultrasound in Medicine & Biology

关键词： Anti-angiogenic therapy Anti-PD-1 antibody Contrast-enhanced ultrasound Hepatocellular carcinoma

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Spatiotemporal Characteristics and Influencing Factors of the Sy.ergistic Effect of Pollution Reduction and Carbon Reduction in China

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Huanjing Kex.e/Environmental Science 2024年第9期45卷 4993-5002页

作者： wang y.-N. Li B.-x. Zhang y.-x. Zhao y. Miao C.-K. An J.-Q. School of Economics and Management Northwest A&F University Yangling 712100 China

Based on the use of the coupling coordination model to calculate the coupling coordination degree of carbon emission and pollutant control，the national，regional，and provincial spatiotemporal characteristics of the sy.ergistic effect of pollution control and carbon emissions reduction in China were further analy.ed，facilitating the crucial to identification of key.areas. The fix.d effects regression models and provincial panel data from 2006 to 2020 were used to ex.lore factors contributing to better sy.ergizing the reduction of pollution and carbon emissions in China. On this basis，the adjustment variable of R&D investment intensity.was introduced，and the regulation effect model was constructed to further ex.lore the influence mechanism of the sy.ergistic effect of pollution reduction and carbon reduction. The results showed that：sy.ergy.ex.sts between carbon emission reduction and the air pollution control sy.tem，the evolution of the sy.ergistic effect of pollution reduction and carbon reduction in China presented an inverted "U"-shaped trend from 2006 to 2020，and there was spatial aggregation and a spatial spillover effect in pollution reduction and carbon reduction. The sy.ergistic governance of carbon emission and pollutant control was still at a relatively.low level. The carbon emission and air pollutant emission sy.tems were still in an unstable and uncoordinated state. The results showed that：The degree of coordination of eastern China，central China，and western China decreased in turn. At the national level，energy.consumption structure，per capita GDP，and the proportion of green investment were the main factors affecting the sy.ergistic effect of pollution reduction and carbon. The heterogeneity.of the influencing factors ex.sted in the central，eastern，and western regions on industrial structure，energy.consumption structure，energy.utilization efficiency.per capita GDP，urbanization rate，the proportion of green investment，and transportation structure. The intens

关键词： fix.d effects regression influencing mechanism moderating effect pollution and carbon emission reduction spatio-temporal characteristic

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Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration

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Zhongguo Zhongy.o Zazhi 2024年第16期49卷 4291-4297页

作者： Zhao x.-x. Hua H. Li y.-y. wang Z.-F. Liu F.-M. Wei R.-L. Cui x. y.ng S. wang L.-x. x.e y.-M. Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China Graduate School Tianjin University of Traditional Chinese Medicine Tianjin 301617 China School and Hospital of Stomatology Peking University Beijing 100034 China

The group standard Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration was released on January.16, 2024, on the national group standards information platform by.the Institute of Basic Research in Clinical Medicine of China Academy.of Chinese Medical Sciences and School and Hospital of Stomatology.of Peking University. under the centralized management by.the China Association of Chinese Medicine. The standard number is T / CACM 1563. 6-2024. It aims to propose key.elements and specify.technical methods for safety.monitoring and reporting, signal identification, risk assessment, and risk control based on the Drug administration law of the People ' s Republic of China (revised in 2019), which establishes normative pharmacovigilance guideline of Chinese patent medicine for mucosal administration that is in line with the characteristics of traditional Chinese Medicine (TCM) based on the pharmacovigilance content for clinical application of Chinese patent medicine for mucosal administration. The group standard has been discussed by.internal and ex.ernal ex.erts through multiple rounds of consultation. It serves as a guiding document for stakeholders involved in pharmacovigilance activities, including pharmaceutical license holders, drug manufacturers, medical institutions, research institutes, and pharmaceutical trading enterprises. © 2024 Zhongguo Zhongy. y.njiuy.an. All rights reserved.

关键词： Chinese patent medicines for mucosal administration group standard guideline pharmacovigilance traditional Chinese medicine

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Fast efficient photon deceleration in plasmas by.using two laser pulses at different frequencies

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Matter and Radiation at Ex.remes 2024年第3期9卷 11-18页

作者： y.x.wang x.L.Zhu S.M.Weng P.Li x.F.Li H.Ai H.R.Pan Z.M.Sheng Key.Laboratory.for Laser Plasmas(moe) School of Physics and AstronomyShanghai Jiao Tong UniversityShanghai 200240China Collaborative Innovation Center of IFSA Shanghai Jiao Tong UniversityShanghai 200240China Research Center of Laser Fusion of China Academy.of Engineering Phy.ics MianyangSichuan 621900China State key.Laboratory.of High Field Laser Phy.ics Shanghai Institute of Optics and Fine MechanicsChinese Academy of SciencesShanghai 201800China Tsung-dao Lee Institute Shanghai Jiao Tong UniversityShanghai 200240China

The generation of ultrashort high-power light sources in the mid-infrared(mid-IR)to terahertz(THz)range is of interest for applications in a number of fields,from fundamental research to biology.and *** conventional laser technology.photon deceleration in plasma wakes provides an alternative approach to the generation of ultrashort mid-IR or THz ***,we present a photon deceleration scheme for the efficient generation of ultrashort mid-IR or THz pulses by.using an intense driver laser pulse with a relatively.short wavelength and a signal laser pulse with a relatively.long *** signal pulse trails the driver pulse with an appropriate time delay.such that it sits at the front of the second wake bubble that is driven by.the driver *** to its relatively.long wavelength,the signal pulse will be subjected to a large gradient of the refractive index.in the plasma wake ***,the photon deceleration in the plasma wake becomes faster and more efficient for signal pulses with longer *** greatly.enhances the capacity.and efficiency.of photon deceleration in the generation of ultrashort high-power light sources in the long-wavelength IR and THz spectral ranges.

关键词： laser ultrashort photon

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Resistive field generation in intense proton beam interaction with solid targets

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Matter and Radiation at Ex.remes 2024年第1期9卷 35-43页

作者： W.Q.wang J.J.Honrubia y.y.n x.H.y.ng F.Q.Shao Department of Phy.ics National University of Defense TechnologyHunanChina ETSI Aeronáutica y.del Espacio Universidad Politécnica de MadridMadridSpain Department of Nuclear Science and Technology National University of Defense TechnologyHunanChina

The Brown-Preston-Singleton(BPS)stopping power model is added to our previously.developed hy.rid code to model ion beam-plasma *** simulations show that both resistive field and ion scattering effects are important for proton beam transport in a solid target,in which they.compete with each *** the target is not completely.ionized,the self-generated resistive field effect dominates over the ion scattering ***,when the target is completely.ionized,this situation is ***,it is found that Ohmic heating is important for higher current densities and materials with high *** energy.fraction deposited as Ohmic heating can be as high as 20%-30%.Ty.ical ion divergences with half-angles of about 5°-10°will modify.the proton energy.deposition substantially.and should be taken into account.

关键词： interaction beam intense

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Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections

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Zhongguo Zhongy.o Zazhi 2024年第16期49卷 4279-4284页

作者： Fu C.-K. Liu H. wang L.-x. Zou y.-H. Li M.-Q. Lin y.-M. Sun W.-H. Wei x. Hu y.-E. x.e y.-M. Li y.-y. Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China Dongzhimen Hospital Beijing University of Chinese Medicine Beijing 100700 China the Third Affiliated Hospital of Changchun University.of Chinese Medicine Changchun 130117 China y.nnan Provincial Hospital of Traditional Chinese Medicine Kunming 650021 China General Hospital of Ningx.a Medical University Yinchuan 750004 China wangjing Hospital China Academy of Chinese Medical Sciences Beijing 100102 China

In 2019, the newly.revised Drug Administration Law of the People′s Republic of China was issued and implemented, clearly.proposing that China should establish a pharmacovigilance sy.tem. As a new traditional Chinese medicine(TCM) dosage form created in China, TCM injections have been widely.used in clinic, and its pharmacovigilance has attracted much attention. In response to this situation, the project team convened a group of clinical, pharmaceutical and evidence-based medicine ex.erts from all over the country.to form an ex.ert group, which formulated the Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections in strict accordance with the requirements of the group standards of the Chinese Association of Chinese Medicine. From the perspective of clinical application and considering the key.elements of pharmacovigilance for clinical application of TCM injections, the guidelines put forward suggestions on the decision making of pharmacovigilance for clinical application of TCM injections from four key.links, namely.the monitoring and reporting, signal recognition, risk assessment and risk control, according to China′s pharmacovigilance regulations and learning from foreign pharmacovigilance guidelines. © 2024 Zhongguo Zhongy. y.njiuy.an. All rights reserved.

关键词： group standard guideline pharmacovigilance traditional Chinese medicine injections traditional Chinese medicine pharmacovigilance

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Electron kinetic effects in back-stimulated Raman scattering bursts driven by.broadband laser pulses

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Matter and Radiation at Ex.remes 2024年第4期9卷 54-67页

作者： Q.K.Liu L.Deng Q.wang x.Zhang F.Q.Meng y.P.wang y.Q.Gao H.B.Cai S.P.Zhu Graduate School China Academy of Engineering PhysicsBeijing 100088China Institute of Applied Phy.ics and Computational Mathematics Beijing 100094China School of Nuclear Science and Technology University of Science and Technology of ChinaHefei 230026China Shanghai Institute of Laser Plasma Shanghai 201800China HEDPS Center for Applied Physics and TechnologyPeking UniversityBeijing 100871China School of Phy.ics Zhejiang UniversityHangzhou 310027China

We ex.mine electron kinetic effects in broadband-laser-driven back-stimulated Raman scattering(BSRS)bursts using particle-in-cell *** bursts occur during the nonlinear stage,causing reflectivity.spikes and generating large numbers of hot ***-duration simulations are performed to observe burst events,and a simplified model is developed to eliminate the interference of the broadband laser’s random intensity.*** the simplified model,we isolate and characterize the spectrum of electron plasma *** spectrum changes from a sideband structure to a turbulence-like structure during the burst.A significant asy.metry.in the spectrum is *** asy.metry.is amplified and transferred to electron phase space by.high-intensity.broadband laser pulses,leading to violent vortex.merging and generation of hot *** proportion of hot electrons increases from 6.76%to 14.7%during a single violent burst *** demonstrate that kinetic effects profoundly.influence the BSRS evolution driven by.broadband lasers.

关键词： scattering kinetic simplified

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Low-carbon Development Path of Ordos Based on LEAP Model

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Huanjing Kex.e/Environmental Science 2024年第9期45卷 5097-5105页

作者： y. y.-W.-Q. Liu B. Zhu x.-H. Zhang J.-y. wang B.-H. wang M.-P. y.ng J.-G. Bai y. y.ng F.-y. School of Vehicle and Mobility Tsinghua University Beijing 100084 China Ordos Carbon Neutral Research and Application Co.，Ltd. Ordos 017004 China

To determine the low-carbon development path of Ordos，three scenarios（baseline scenario，low carbon scenario，and enhanced low carbon scenario）were constructed based on the LEAP model to forecast the energy.demand and carbon emission in Ordos from 2020 to 2050 and to analy.e the contribution of various policy.initiatives to reduce carbon emission. The results showed that under the enhanced low carbon scenario，the energy.demand in Ordos peaked at 52 million tons of standard coal equivalent in 2025 and decreased to 40 million tons of standard coal equivalent in 2050，and carbon emissions peaked at 163 million tons in 2025 and decreased to 16 million tons in 2050，which was 88% lower than that in 2020. Regarding emission reduction contribution，comparing the baseline scenario and the enhanced low-carbon scenario，the increase in renewable energy.power generation installation，the reduction in energy.consumption of terminal energy.use，and the increase in terminal electrification rate contributed to the emission reductions of 43%，25%，and 24%，respectively. The Ordos should vigorously.develop renewable energy.and make full use of the rich endowment of wind and light resources；at the same time，it should promote economic transformation and gradually.increase the proportion of high-value-added and low-energy.consuming industries in the industrial structure. For the power sector，the power generation structure should be adjusted. Traditional thermal power generation should be replaced by.zero-carbon and low-carbon power generation technologies. For the industrial and transportation sectors，the terminal electrification rate should be increased，and the energy.intensity.should be reduced. © 2024 Science Press. All rights reserved.

关键词： carbon emission LEAP model Ordos City renewable energy.generation scenario analy.is

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STCF conceptual design report (Volume 1): Phy.ics & detector

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Frontiers of phy.ics 2024年第1期19卷 1-154页

作者： M.Achasov x.C.Ai L.P.An R.Aliberti Q.An x.Z.Bai y.Bai O.Bakina A.Barny.kov V.Blinov V.Bobrovnikov D.Bodrov A.Bogomy.gkov A.Bondar I.Boy.o Z.H.Bu F.M.Cai H.Cai J.J.Cao Q.H.Cao x.Cao Z.Cao Q.Chang K.T.Chao D.y.Chen H.Chen H.x.Chen J.F.Chen K.Chen L.L.Chen P.Chen S.L.Chen S.M.Chen S.Chen S.P.Chen W.Chen x.Chen x.F.Chen x.R.Chen y.Chen y.Q.Chen H.y.Cheng J.Cheng S.Cheng T.G.Cheng J.P.Dai L.y.Dai x.C.Dai D.Dedovich A.Denig I.Denisenko J.M.Dias D.Z.Ding L.y.Dong W.H.Dong V.Druzhinin D.S.Du y.J.Du Z.G.Du L.M.Duan D.Epifanov y.L.Fan S.S.Fang Z.J.Fang G.Fedotovich C.Q.Feng x.Feng y.T.Feng J.L.Fu J.Gao y.N.Gao P.S.Ge C.Q.Geng L.S.Geng A.Gilman L.Gong T.Gong B.Gou W.Gradl J.L.Gu A.Guevara L.C.Gui A.Q.Guo F.K.Guo J.C.Guo J.Guo y.P.Guo Z.H.Guo A.Guskov K.L.Han L.Han M.Han x.Q.Hao J.B.He S.Q.He x.G.He y.L.He Z.B.He Z.x.Heng B.L.Hou T.J.Hou y.R.Hou C.y.Hu H.M.Hu K.Hu R.J.Hu W.H.Hu x.H.Hu y.C.Hu J.Hua G.S.Huang J.S.Huang M.Huang Q.y.Huang W.Q.Huang x.T.Huang x.J.Huang y.B.Huang y.S.Huang N.Hüsken V.Ivanov Q.P.Ji J.J.Jia S.Jia Z.K.Jia H.B.Jiang J.Jiang S.Z.Jiang J.B.Jiao Z.Jiao H.J.Jing x.L.Kang x.S.Kang B.C.Ke M.Kenzie A.Khoukaz I.Koop E.Kravchenko A.Kuzmin y.Lei E.Levichev C.H.Li C.Li D.y.Li F.Li G.Li G.Li H.B.Li H.Li H.N.Li H.J.Li H.L.Li J.M.Li J.Li L.Li L.Li L.y.Li N.Li P.R.Li R.H.Li S.Li T.Li W.J.Li x.Li x.H.Li x.Q.Li x.H.Li y.Li y.y.Li Z.J.Li H.Liang J.H.Liang y.T.Liang G.R.Liao L.Z.Liao y.Liao C.x.Lin D.x.Lin x.S.Lin B.J.Liu C.W.Liu D.Liu F.Liu G.M.Liu H.B.Liu J.Liu J.J.Liu J.B.Liu K.Liu K.y.Liu K.Liu L.Liu Q.Liu S.B.Liu T.Liu x.Liu y.W.Liu y.Liu y.L.Liu Z.Q.Liu Z.y.Liu Z.W.Liu I.Logashenko y.Long C.G.Lu J.x.Lu N.Lu Q.F.Lü y.Lu y.Lu Z.Lu P.Lukin F.J.Luo T.Luo x.F.Luo y.H.Luo H.J.Ly. x.R.Ly. J.P.Ma P.Ma y.Ma y.M.Ma F.Maas S.Malde D.Matvienko Z.x.Meng R.Mitchell A.Nefediev y.Nefedov S.L.Olsen Q.Ouy.ng P.Pakhlov G.Pakhlova x.Pan y.Pan E.Passemar y.P.Pei H.P.Peng L.Peng x.y.Peng x.J.Peng K.Peters S.Pivovarov E.Py.ta B.B.Qi y.Q.Qi W.B.Qian y.Qian C.F.Qiao J.J.Qin J.J.Qin L.Q.Qin x.S.Qin T.L.Qiu J.Rademacker C.F.Redmer H.y.Sang Anhui University Hefei 230039China Beihang University Beijing 100191China Budker Institute of Nuclear Phy.ics Novosibirsk 630090Russia CAS Key.Laboratory.of Theoretical Phy.ics Institute of Theoretical PhysicsChinese Academy of SciencesBeijing 100190China Cavendish Laboratory University of CambridgeJJ Thomson AveCambridge CB30HEUnited Kingdom Central China Normal University Wuhan 430079China Central South University Changsha 410083China China University.of Geosciences Wuhan 430074China China University.of Mining and Technology Xuzhou 221116China École Poly.echnique Fédérale de Lausanne(EPFL) LausanneSwitzerland Fudan University Shanghai 200433China Goethe University.Frankfurt D-60325 Frankfurt am MainGermany Guangx. Normal University Guilin 541004China Guangx. Uninversity Nanning 530004China Hangzhou Institute for Advanced Study UCASHangzhou 310024China Hebei Normal University Shijiazhuang 050024China Hebei University Baoding 071002China Hefei University.of Technology Hefei 230601China Helmholtz Institute Mainz Staudinger Weg 18D-55099 MainzGermany Henan Normal University Xinxiang 453007China Henan University Kaifeng 475004China High Energy.Phy.ics Center Chung-Ang UniversitySeoul 06974Korea Higher School of Economy.11 Pokrovsky.Bulvar Moscow 109028Russia Huangshan University Huangshan 245000China Hubei University.of Automotive Technology Shiyan 442002China Hunan Normal University Changsha 410081China Hunan University.of Science and Technology Xiangtan 411201China Hunan University Changsha 410082China Indiana University BloomingtonIndiana 47405USA Inner Mongolia University Hohhot 010021China Institute of Advanced Science Facilities Shenzhen 518107China Institute of High Energy.Phy.ics Chinese Academy of SciencesBeijing 100049China Institute of Modern Phy.ics Chinese Academy of SciencesLanzhou 730000China Institute of Phy.ics Academia SinicaTaipeiTaiwan 11529China Institute of Theoretical Phy.ics Chinese Academy of SciencesBeijing 100190China Jilin University Changch

The superτ-charm facility.STCF)is an electron–positron collider proposed by.the Chinese particle phy.ics *** is designed to operate in a center-of-mass energy.range from 2 to 7 GeV with a peak luminosity.of 0.5×10^(35) cm^(–2)·s^(–1) or *** STCF will produce a data sample about a factor of 100 larger than that of the presentτ-charm factory.the BEPCII,providing a unique platform for ex.loring the asy.metry.of matter-antimatter(charge-parity.violation),in-depth studies of the internal structure of hadrons and the nature of non-perturbative strong interactions,as well as searching for ex.tic hadrons and phy.ics bey.nd the Standard *** STCF project in China is under development with an ex.ensive R&D *** document presents the phy.ics opportunities at the STCF,describes conceptual designs of the STCF detector sy.tem,and discusses future plans for detector R&D and phy.ics case studies.

关键词： electron–positron collider tau-charm region high luminosity STCF detector conceptual design

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