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

Zhongguo Zhongyao 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. Yang 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 Zhongyi Yanjiuyuan. All rights reserved.

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

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Pharmacovigilance guidelines of Chinese patent medicines

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Zhongguo Zhongyao 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. Yang 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 system" . 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 system 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 Tyrosine 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. Yin 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 tyrosine 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 Synergistic 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 synergistic effect of pollution control and carbon emissions reduction in China were further analyzed，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 synergizing 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 synergistic effect of pollution reduction and carbon reduction. The results showed that：synergy ex.sts between carbon emission reduction and the air pollution control system，the evolution of the synergistic 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 synergistic governance of carbon emission and pollutant control was still at a relatively low level. The carbon emission and air pollutant emission systems 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 synergistic 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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Tribological Behavior of 15# Aviation Hydraulic Oil

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Mocax.e x.ebao/Tribology 2024年第8期44卷 1136-1150页

作者： zhao H. Shan L. Cao H. Wen x. Wei P. Bai P. Meng Y. Tian Y. State Key Laboratory of Tribology in Advanced Equipment Tsinghua University Beijing 100084 China AVIC x.’an Flight Automatic Control Research Institute Shaanxi Xi’an 710069 China

15# aviation hydraulic oil as a specific type of hydraulic oil has been widely applied in aviation field. In this paper, viscosity-temperature curve of 15# aviation hydraulic oil was measured utilizing MCR302 rheometer. Investigating the effects of varying operational parameters, a methodical single-factor analysis was conducted. A four-ball tester, equipped with high-grade GCr15 steel balls, provided a rigorous ex.mination of the oil's tribological behavior under different loads, temperatures, and sliding speeds. This analysis was crucial for understanding how each factor independently impacted the friction and wear properties of the hydraulic oil. To elucidate the underlying mechanisms of wear observed under these conditions, a multi-technique approach was adopted for surface analysis. Wear scars were meticulously ex.mined with an optical microscope, which offered a clear initial assessment of the surface topography. For more in-depth analysis, a scanning electron microscope (SEM) provided high-resolution imaging to reveal microstructural details. A white-light interferometer allowed for precise measurements of the wear scar volumes, offering quantitative data on the ex.ent of material removal. Additionally, an x.ray photoelectron spectroscopy (x.S) analysis was employed to identify any chemical alterations on the worn surfaces. The ex.erimental results were revealing. Under increasing load conditions, the 15# aviation hydraulic oil maintained a relatively consistent friction coefficient. However, the physical dimensions of wear scars —both their radius and depth —intensified, suggesting a higher material removal rate. This phenomenon indicated that while the oil maintains stable friction, its wear protection capabilities were compromised under heavy loading. In ex.eriments with high loads, the dissipated energy required for plastic deformation and the creation of new interfaces within the work of friction increases compared to ex.eriments with low loads. This res

关键词： 15# aviation hydraulic oil four-ball tribometer friction load speed temperature wear

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STCF conceptual design report (Volume 1): Physics & detector

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Frontiers of physics 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.Barnyakov V.Blinov V.Bobrovnikov D.Bodrov A.Bogomyagkov A.Bondar I.Boyko 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.Lyu x.R.Lyu 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.Ouyang 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.Pyata 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 Physics Novosibirsk 630090Russia CAS Key Laboratory of Theoretical Physics 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 Polytechnique 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 Physics 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 Physics Chinese Academy of SciencesBeijing 100049China Institute of Modern Physics Chinese Academy of SciencesLanzhou 730000China Institute of Physics Academia SinicaTaipeiTaiwan 11529China Institute of Theoretical Physics Chinese Academy of SciencesBeijing 100190China Jilin University Changch

The superτ-charm facility(STCF)is an electron–positron collider proposed by the Chinese particle physics *** 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 asymmetry 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 physics beyond the Standard *** STCF project in China is under development with an ex.ensive R&D *** document presents the physics opportunities at the STCF,describes conceptual designs of the STCF detector system,and discusses future plans for detector R&D and physics case studies.

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

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Automatic modeling algorithm of stochastic error for inertial sensors

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Control Theory and Technology 2024年第1期22卷 81-91页

作者： Luodi zhao Long zhao School of Automation Science and Electrical Engineering Beihang UniversityBeijing100191China Digital Navigation Center Beihang UniversityBeijing100191China Science and Technology on Aircraft Control Laboratory Beihang UniversityBeijing100191China

This paper proposes an automatic algorithm to determine the properties of stochastic processes and their parameters for inertial error. The proposed approach is based on a recently developed method called the generalized method of wavelet moments (GMWM), whose estimator was proven to be consistent and asymptotically normally distributed. This algorithm is suitable mainly (but not only) for the combination of several stochastic processes, where the model identification and parameter estimation are quite difficult for the traditional methods, such as the Allan variance and the power spectral density analysis. This algorithm further ex.lores the complete stochastic error models and the candidate model ranking criterion to realize automatic model identification and determination. The best model is selected by making the trade-off between the model accuracy and the model complex.ty. The validation of this approach is verified by practical ex.mples of model selection for MEMS-IMUs (micro-electro-mechanical system inertial measurement units) in varying dynamic conditions.

关键词： GMWM Stochastic process Inertial sensor Sensor calibration Error model Allan variance

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Meeting the challenges of invasive alien species

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National Science Review 2024年第3期11卷 296-298页

作者： Weijie zhao NSR news

The x.njiang Uygur Autonomous Region of China is famous for its tomato production. Abundant sunshine, large day–night temperature difference and the abundant irrigation by snowmelt from the Tianshan Mountains produce...

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Ling-Ling Chen: RNA has its own features;don't study it as a protein

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National Science Review 2024年第2期11卷 301-305页

作者： Weijie zhao NSR

Non-coding RNA(ncRNA) has been a very active research area over the past 30 years. From small nc RNA – the discovery of RNA interference won the lead researchers the Nobel Prize, to long ncRNA(lncRNA), which has attracted much attention in recent years, various nc RNAs participate in all kinds of biological processes and show a variety of biomedical application prospects.

关键词： RNA

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One dimensional CeO_(2) nanorods/poly(ethylene ox.de) solid composite electrolyte for all-solid-state lithium-ion batteries

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Journal of Rare Earths 2024年第3期42卷 570-577,I0005页

作者： Yudi Guo Erqing zhao x.aofang zhao Shuailei Liu School of Chemistry and Materials Engineering Xinxiang UniversityXinxiang453003China School of Chemistry and Chemical Engineering Henan Institute of Science and TechnologyXinxiang453003China

The research of poly(ethylene ox.de)(PEO)-based solid composite electrolyte with high ionic conductivity and ex.ellent interfacial stability is the key to the development of all-solid-state lithium-ion batteries(ASSLIBs). Herein, uniform nanorod structured CeO_(2) fillers were controllably synthesized by electrospinning, which were subsequently filled into PEO polymer to prepare CeO_(2)/PEO solid composite electrolyte. The addition of CeO_(2) nanorods can reduce both the glass transition temperature and the melting point of PEO polymer, and also interact with PEO and lithium bis(trifluoromethanesulphonyl)imide(LITFSI) by Lewis acid—base reaction. Therefore, the solid composite electrolyte ex.ibits a high ionic conductivity of 4.52 × 10^(-4)S/cm, a wide electrochemical stability window of about 4.8 V, and a good interfacial stability with Li at 55℃. Moreover, the LiFePO_4/Li ASSLIB divulges the discharging specific capacity of 165, 162, 156 and 146 mA,h/g at 0.2, 0.5, 1 and 2 C, respectively, and achieves the capacity retention of 90.3% after 150 cycles at 0.5 C. Consequently, one dimensional CeO_(2) nanorods can be considered as an alternative filler for polymeric solid electrolyte.

关键词： Poly(ethylene ox.de) Solid composite electrolyte CeO_(2)nanorods Ionic conductivity Rare earths

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