Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.04.001
Jia Song
A review With the wide application and constantly advancing of traditional Chinese medicine(TCM) in the prevention and control of COVID-19, many innovative achievements have been made in the prevention and treatment of COVID-19 by TCM Analyzing the patent information of related innovations timely will not only help researcher to use patent information more quickly to mine and screen more effective drugs, but also help inspiring R&D personnel to strengthen patent protection for innovations This article is based on Chinese Clin Guidance for COVID-19 Diagnosis and Treatment (6th edition) published by National Health Commission of the People′s Republic of China, analyses related patent information on recommended Chinese patent medicines in medical observation period, and basic prescriptions, recommended prescriptions and recommended Chinese patent medicines in clin treatment period, describes the patent technol road map of recommended prescriptions and recommended Chinese patent medicines, analyzes key patent information, and tries to provide useful reference for scientific research of TCM
{"title":"Patent information analysis on traditional Chinese medicine for prevention and treatment of COVID-19","authors":"Jia Song","doi":"10.7501/j.issn.1674-6376.2020.04.001","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.04.001","url":null,"abstract":"A review With the wide application and constantly advancing of traditional Chinese medicine(TCM) in the prevention and control of COVID-19, many innovative achievements have been made in the prevention and treatment of COVID-19 by TCM Analyzing the patent information of related innovations timely will not only help researcher to use patent information more quickly to mine and screen more effective drugs, but also help inspiring R&D personnel to strengthen patent protection for innovations This article is based on Chinese Clin Guidance for COVID-19 Diagnosis and Treatment (6th edition) published by National Health Commission of the People′s Republic of China, analyses related patent information on recommended Chinese patent medicines in medical observation period, and basic prescriptions, recommended prescriptions and recommended Chinese patent medicines in clin treatment period, describes the patent technol road map of recommended prescriptions and recommended Chinese patent medicines, analyzes key patent information, and tries to provide useful reference for scientific research of TCM","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75127581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.04.005
Yan You
2019 novel coronavirus pneumonia is an acute infectious pneumonia outbreak at the end of 2019 in Wuhan, Hubei province. It belongs to the category of "epidemic disease" in TCM. Early intervention of traditional Chinese medicine has played an important role in this epidemic situation.In each stage, it has shown the advantages of treatment, accumulated rich experience, and initially formed a set of mechanism of Chinese medicine to prevent and treat acute infectious diseases. This article summarizes the classical prescriptions during each period of the disease, the screening methods of effective prescriptions and the clinical studies that have been carried out. This article can preliminarily showed the active part of traditional Chinese medicine in the treatment of 2019 novel coronavirus pneumonia.
{"title":"Therapeutic strategy of traditional Chinese medicine for COVID-19","authors":"Yan You","doi":"10.7501/j.issn.1674-6376.2020.04.005","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.04.005","url":null,"abstract":"2019 novel coronavirus pneumonia is an acute infectious pneumonia outbreak at the end of 2019 in Wuhan, Hubei province. It belongs to the category of \"epidemic disease\" in TCM. Early intervention of traditional Chinese medicine has played an important role in this epidemic situation.In each stage, it has shown the advantages of treatment, accumulated rich experience, and initially formed a set of mechanism of Chinese medicine to prevent and treat acute infectious diseases. This article summarizes the classical prescriptions during each period of the disease, the screening methods of effective prescriptions and the clinical studies that have been carried out. This article can preliminarily showed the active part of traditional Chinese medicine in the treatment of 2019 novel coronavirus pneumonia.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86593011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.12.009
Sheng Wang
The current Coronavirus Disease 2019 (COVID-19) public health crisis is posing unprecedented challenges on public health needs of European Union (EU). EU has updated Questions and Answers on Regulatory Expectations for Medicinal Products for human use during the COVID-19 Pandemic in July 2020, adjusted the regulatory expectations and flexibility related to marketing authorization, inspection, pharmacovigilance activities, products information and labelling, etc, during COVID-19 pandemic, articulated series of appropriate measures and provided flexibility legal tools such as exceptional change management process, distant assessment, postponing the testing, prioritisation of pharmacovigilance activities, to help manufacturers and distributors of pharmaceutical products to cope with the consequences of the pandemic, ensure the high standards of quality, safety, efficacy of medicines, and availability of medicinal products. The emergency management experience of EU was still useful for perfecting the drug emergency management system of China.
{"title":"Discussion on EU medicinal products regulatory expectations and flexibility during COVID-19 public health emergency","authors":"Sheng Wang","doi":"10.7501/j.issn.1674-6376.2020.12.009","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.12.009","url":null,"abstract":"The current Coronavirus Disease 2019 (COVID-19) public health crisis is posing unprecedented challenges on public health needs of European Union (EU). EU has updated Questions and Answers on Regulatory Expectations for Medicinal Products for human use during the COVID-19 Pandemic in July 2020, adjusted the regulatory expectations and flexibility related to marketing authorization, inspection, pharmacovigilance activities, products information and labelling, etc, during COVID-19 pandemic, articulated series of appropriate measures and provided flexibility legal tools such as exceptional change management process, distant assessment, postponing the testing, prioritisation of pharmacovigilance activities, to help manufacturers and distributors of pharmaceutical products to cope with the consequences of the pandemic, ensure the high standards of quality, safety, efficacy of medicines, and availability of medicinal products. The emergency management experience of EU was still useful for perfecting the drug emergency management system of China.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84914583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.11.002
Shengpeng Wang
To ensure the stable supply of medicines in European Union (EU) during the coronavirus disease 2019 (COVID-19) public health emergency, EU has published Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak in April 2020. This guideline aimed to prompt EU Member States with concrete actions for the stable supply of medicines during the public health emergency. The guideline focused on the rational supply, allocation and use of medicines to treat COVID-19 patients but also covered any medicine at risk of shortage due to the pandemic. The main content of this guideline is introduced, which is expected to provide reference for perfecting the public health system of China.
{"title":"Introduction of EU guideline on optimal and rational supply of medicines in public health emergency","authors":"Shengpeng Wang","doi":"10.7501/j.issn.1674-6376.2020.11.002","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.11.002","url":null,"abstract":"To ensure the stable supply of medicines in European Union (EU) during the coronavirus disease 2019 (COVID-19) public health emergency, EU has published Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak in April 2020. This guideline aimed to prompt EU Member States with concrete actions for the stable supply of medicines during the public health emergency. The guideline focused on the rational supply, allocation and use of medicines to treat COVID-19 patients but also covered any medicine at risk of shortage due to the pandemic. The main content of this guideline is introduced, which is expected to provide reference for perfecting the public health system of China.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82711120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.06.002
Shengpeng Wang
In light of the Coronavirus Disease 2019 (COVID-19) public health emergency in America, FDA issued Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry in March 2020. This guidance aimed to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products, so as to ensure the stability of the medical product supply chain in America. This guidance was still useful for perfecting interruption in manufacturing reporting system of China.
{"title":"Introduction of FDA guidance for dealing with drug shortage in public health emergency","authors":"Shengpeng Wang","doi":"10.7501/j.issn.1674-6376.2020.06.002","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.06.002","url":null,"abstract":"In light of the Coronavirus Disease 2019 (COVID-19) public health emergency in America, FDA issued Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry in March 2020. This guidance aimed to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products, so as to ensure the stability of the medical product supply chain in America. This guidance was still useful for perfecting interruption in manufacturing reporting system of China.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79491255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.06.004
Zhi Qiu
Objective: This paper explores the management of donated drugs in public health emergencies, and establishes a set of operational management methods for donated drugs, so as to provide reference for the following similar events. Methods Review the relevant literature and management methods of donated drugs, summarize the management models and problems of donated drugs in other medical institutions, and formulate the selection list and management methods of donated medicines for New Crown Pneumonia to guide the donated medicines management work in our hospital by referring the new coronavirus pneumonia prevention and control program issued by the General Office of the National Health and Health Commission and our hospital's outpatient diagnosis and treatment program. Results A set of operational management measures for donated drugs was established, It includes the establishment and improvement of covid-19 donation drug management team, the development of donation drug selection catalog, donation drug receiving and qualification verification, the storage, distribution and use of donated drugs, donation drug accounting management and publicity, and the treatment of some remaining donated drugs. The total utilization rate of donated drugs was 86.64%. Conclusion In public health emergencies, Chinese pharmacists have accumulated a lot of experience in the management of donated drugs, and put forward some good management strategies. The development of guidelines for the selection and use of donated drugs and the informatization and systematization of the management of donated drugs need to be further strengthened and promoted.
{"title":"Practice and reflection on management of donated drugs during new crown pneumonia epidemic","authors":"Zhi Qiu","doi":"10.7501/j.issn.1674-6376.2020.06.004","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.06.004","url":null,"abstract":"Objective: This paper explores the management of donated drugs in public health emergencies, and establishes a set of operational management methods for donated drugs, so as to provide reference for the following similar events. Methods Review the relevant literature and management methods of donated drugs, summarize the management models and problems of donated drugs in other medical institutions, and formulate the selection list and management methods of donated medicines for New Crown Pneumonia to guide the donated medicines management work in our hospital by referring the new coronavirus pneumonia prevention and control program issued by the General Office of the National Health and Health Commission and our hospital's outpatient diagnosis and treatment program. Results A set of operational management measures for donated drugs was established, It includes the establishment and improvement of covid-19 donation drug management team, the development of donation drug selection catalog, donation drug receiving and qualification verification, the storage, distribution and use of donated drugs, donation drug accounting management and publicity, and the treatment of some remaining donated drugs. The total utilization rate of donated drugs was 86.64%. Conclusion In public health emergencies, Chinese pharmacists have accumulated a lot of experience in the management of donated drugs, and put forward some good management strategies. The development of guidelines for the selection and use of donated drugs and the informatization and systematization of the management of donated drugs need to be further strengthened and promoted.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86007033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.12.038
Jun Zhang Bei Zeng Fang Zhang Yu Liu YiHui Chen
Coronavirus disease 2019 (COVID-19) patients are particularly critically ill, often accompanied by D-djurogen elevation, easy to induce or aggravate the occurrence of ischemic stroke. Both diseases have similar symptoms such as headache, vomiting, fever and shortness of breath in the early stages of their medical history, which can easily lead to misdiagnosis, missed diagnosis, and mutual influence, resulting in prolonged course of illness. For patients with COVID-19, anti-venom treatment should be actively taken as soon as possible, combined with stroke patients, the indicator change of D-diamer should be closely monitored, according to its indicators to give patients appropriate anti-thrombosis treatment, once the D-diamer rises, it is recommended to start anticoagulant immediately, while controlling the patient's blood pressure lipids and other high-risk factors. In this paper, combined with the research on stroke-related drug use, this paper discusses the rational drug use strategy and pharmacological care of high-risk groups such as COVID-19 combined with stroke, and provides reasonable drug use reference for such patients.
{"title":"Rational use of drug and pharmaceutical care in patients with coronavirus disease 2019 combined with stroke","authors":"Jun Zhang Bei Zeng Fang Zhang Yu Liu YiHui Chen","doi":"10.7501/j.issn.1674-6376.2020.12.038","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.12.038","url":null,"abstract":"Coronavirus disease 2019 (COVID-19) patients are particularly critically ill, often accompanied by D-djurogen elevation, easy to induce or aggravate the occurrence of ischemic stroke. Both diseases have similar symptoms such as headache, vomiting, fever and shortness of breath in the early stages of their medical history, which can easily lead to misdiagnosis, missed diagnosis, and mutual influence, resulting in prolonged course of illness. For patients with COVID-19, anti-venom treatment should be actively taken as soon as possible, combined with stroke patients, the indicator change of D-diamer should be closely monitored, according to its indicators to give patients appropriate anti-thrombosis treatment, once the D-diamer rises, it is recommended to start anticoagulant immediately, while controlling the patient's blood pressure lipids and other high-risk factors. In this paper, combined with the research on stroke-related drug use, this paper discusses the rational drug use strategy and pharmacological care of high-risk groups such as COVID-19 combined with stroke, and provides reasonable drug use reference for such patients.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91241004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.09.004
Yaling Li
Objective: To find potential Traditional Chinese medicinal ingredients for treating novel coronavirus pneumonia (COVID- 19) based on database.
目的:利用数据库寻找治疗新型冠状病毒肺炎(COVID- 19)的潜在中药成分。
{"title":"Investigated potential traditional Chinese medicinal ingredients in treatment on COVID-19 based on database","authors":"Yaling Li","doi":"10.7501/j.issn.1674-6376.2020.09.004","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.09.004","url":null,"abstract":"Objective: To find potential Traditional Chinese medicinal ingredients for treating novel coronavirus pneumonia (COVID- 19) based on database.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75516974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.11.034
T. Zhao
Since the end of 2019, the spread of the corona virus disease 2019 (COVID-19) has caused serious economic shocks and social impacts. The development of clinical trials of drugs has also brought many difficulties and challenges. Based on the particularity of the population and process of the Phase I clinical trials of the drug, it caused us to think about the management of the subjects in the Phase I clinical trials under the influence of the COVID-19. It proposes various strategies from the different stages of subject recruitment, screening, and admission, to subject education, diet management, and observation of adverse events. It aims to discuss how to protect the safety and rights of subjects better under the normalization of epidemic prevention and control, strengthen the risk control of clinical trials, and ensure the successful completion of trials.
{"title":"Reflections on management of subjects in phase I clinical trials of drugs under influence of COVID-19","authors":"T. Zhao","doi":"10.7501/j.issn.1674-6376.2020.11.034","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.11.034","url":null,"abstract":"Since the end of 2019, the spread of the corona virus disease 2019 (COVID-19) has caused serious economic shocks and social impacts. The development of clinical trials of drugs has also brought many difficulties and challenges. Based on the particularity of the population and process of the Phase I clinical trials of the drug, it caused us to think about the management of the subjects in the Phase I clinical trials under the influence of the COVID-19. It proposes various strategies from the different stages of subject recruitment, screening, and admission, to subject education, diet management, and observation of adverse events. It aims to discuss how to protect the safety and rights of subjects better under the normalization of epidemic prevention and control, strengthen the risk control of clinical trials, and ensure the successful completion of trials.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77865136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.7501/j.issn.1674-6376.2020.06.006
Wei He
Viral infectious disease have the characteristics of high pathogenicity, strong infectivity and great damage, which pose great threats to human health, and even to social development and stability. Therefore, discovering preventive and therapeutic drugs has always been the focus of society. Chloroquine and hydroxychloroquine are common drugs approved by the US Food and Drug Administration for the treatment of malaria and rheumatic immune disease, with low-budget as well as high safety. This review analyzed studies about the antiviral activity of chloroquine and hydroxychloroquine, including laboratory experiments and clinical trials about human coronavirus, HIV, Zika virus, and enterovirus E-7. The effects of many types of viruses suggestted that chloroquine and hydroxychloroquine possess great clinical application potential.
{"title":"Research progress on antiviral pharmacology and clinical research of chloroquine and hydroxychloroquine","authors":"Wei He","doi":"10.7501/j.issn.1674-6376.2020.06.006","DOIUrl":"https://doi.org/10.7501/j.issn.1674-6376.2020.06.006","url":null,"abstract":"Viral infectious disease have the characteristics of high pathogenicity, strong infectivity and great damage, which pose great threats to human health, and even to social development and stability. Therefore, discovering preventive and therapeutic drugs has always been the focus of society. Chloroquine and hydroxychloroquine are common drugs approved by the US Food and Drug Administration for the treatment of malaria and rheumatic immune disease, with low-budget as well as high safety. This review analyzed studies about the antiviral activity of chloroquine and hydroxychloroquine, including laboratory experiments and clinical trials about human coronavirus, HIV, Zika virus, and enterovirus E-7. The effects of many types of viruses suggestted that chloroquine and hydroxychloroquine possess great clinical application potential.","PeriodicalId":11302,"journal":{"name":"药物评价研究","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88689818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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