Dee,in"Everyday Use",is portrayed as a negative character.Nevertheless,some critics suggest to re-interpret her for some reasonable causes.By using close-reading,this article try to re-evaluate Dee so to eva...Dee,in"Everyday Use",is portrayed as a negative character.Nevertheless,some critics suggest to re-interpret her for some reasonable causes.By using close-reading,this article try to re-evaluate Dee so to evalue Alice Walker’s valuable devotion in character depiction.展开更多
Purpose: Additional analyses of outcomes of laser-assisted subepithelial keratectomy (LASEK) are still necessary to improve the safety of LASEK. Therefore, in our study, outcomes were assessed retrospectively in 561 e...Purpose: Additional analyses of outcomes of laser-assisted subepithelial keratectomy (LASEK) are still necessary to improve the safety of LASEK. Therefore, in our study, outcomes were assessed retrospectively in 561 eyes that underwent LASEK treatment. Methods: Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA) and residual spherical equivalent were analyzed at 3 and 6 months postoperatively. We assessed four subgroups based on the degree of preoperative myopia considering mean BSCVA and loss of two or more lines. Results: Mean UCVAs and BSCVAs were obtained at 3 and 6 months postoperatively (1.23/1.35 and 1.23/1.37, respectively). The mean predictability was within ±0.125 diopters. Conversely, the safety indexes were 0.94 and 0.96 respectively, and the efficacy indexes were 0.86 and 0.86 at 3 and 6 months postoperatively, respectively. 8.4% eyes and 5.2% eyes lost two or more lines of BSCVA at 3 and 6 months postoperatively, respectively. The mean BSCVAs of the high or ultra-high groups were significantly lower than those of the low or mild groups both 3 months and 6 months postoperatively. The incidence rates of losing two or more lines of BSCVA in the high or ultra-high myopia groups were significantly greater than in the low or mild groups at 3 months and 6 months postoperatively. Conclusion: LASEK predictably corrected myopia achieving >1.2 in UCVA and BSCVA. However, the safety and efficacy indexes were <1.0, which were related to the loss of two or more lines of BSCVA. Since the incidence rates of losing two or more lines of BSCVA were greater in the high or ultra-high myopia groups, we consider LASEK as more safely performed in patients with low to mild preoperative myopia.展开更多
Objective: To re-evaluate the systematic review of Rheumatoid arthritis (RA) treatmentwith total glucosides of paeony (TGP) to provide evidence-based evidence for the treatmentof RA with TGP in the clinic. Methods: A ...Objective: To re-evaluate the systematic review of Rheumatoid arthritis (RA) treatmentwith total glucosides of paeony (TGP) to provide evidence-based evidence for the treatmentof RA with TGP in the clinic. Methods: A total of eight databases including CNKI, Wan FangData, CBM, VIP, PubMed, Embase, Cochrane Library, and Web of Science were searched bycomputer for the systematic reviews/meta-analyses concerning the treatment of RA withTGP. The retrieval period was from the establishment of the database to May 2, 2022.Literature screening was conducted based on the randomized controlled trial, and thematerials of the included literature were extracted. Using the preferred reporting items forsystematic reviews and meta-analyses statement. The a measurement tool to assesssystematic reviews 2 scale and grades of recommendation, assessment, development, andevaluation system evaluated the reporting quality, methodological quality, and outcomeindicators evidence levels included in the literature. Results: Six systematicreviews/meta-analysis literature were finally included. Evaluation of the preferred reportingitems for systematic reviews and meta-analyses statement showed that the overall reportingquality of included literature was low, and only one piece with high quality was included.The results of the a measurement tool to assess systematic reviews 2 scale evaluationshowed that the qualities of included literature were all low-level and highly low-level. Thegrades of recommendation, assessment, development, and evaluation evidence qualityevaluation showed a total of 39 outcome indicators in the six included literature, and alloutcome indicators were intermediate, low-level, and extremely low in evidence evaluation.Conclusion: Many pieces of evidence show that TGP has certain advantages in alleviatingclinical symptoms, reducing adverse reactions, and reducing hepatotoxicity in the treatmentof RA, but this conclusion lacks high-level evidence to support it, which needs to be provedby more studies in the future.展开更多
This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and technique...This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers.展开更多
Research has shown that there has been a significant change in the quantitative relationship between urbanization and economic development over the past 50 years. As a result of this change, the Chenery model is no lo...Research has shown that there has been a significant change in the quantitative relationship between urbanization and economic development over the past 50 years. As a result of this change, the Chenery model is no longer capable of performing a comparative analysis of these parameters. We carried out a regression analysis of the normal form of the relation between urbanization and economic development on the basis of the Chenery model. We used empirical data from 149 countries and regions from 1990 to 2009 and adopted the double logarithmic model, introducing a time series variable for urbanization. From 1990 to 2009, with a per capita gross national income remaining between USD 1000 and 10,000, the urbanization rate changed from 17.78 to 60.36% and the relational matching data changed accordingly, although the upper limit of the rate of urbanization remained at about 75%. Urbanization in countries with a smaller population size was more affected by economic development than urbanization in countries with large and medium sized populations.展开更多
Based upon studies from randomized clinical trials, the extended (D2) lymph node dissection is now recommended as a standard procedure for local advanced gastric cancer worldwide. However, the rational extent lympha...Based upon studies from randomized clinical trials, the extended (D2) lymph node dissection is now recommended as a standard procedure for local advanced gastric cancer worldwide. However, the rational extent lymphadenectomy for local advanced gastric cancer has remained a topic of debate in the past decades. Due to the limitation of low metastatic rate in para-aortic nodes (PAN) in JCOG9501, the clinical benefit of D2+ para-aortic nodal dissection (PAND) for patients with stage T4 and/or stage N3 disease, which is very common in China and other countries except Japan and Korea, cannot be determined. Furthermore, the role of splenectomy for complete resection of No.10 and No.l I nodes has been controversial, and however, the final results from the randomized trial ofJCOG0110 have yet to be completed. Gastric cancer with the No.14 and No.13 lymph node metastasis is defined as MI stage in the current version of the Japanese classification. We propose that D2~No.14v and +No.13 lymphadenectomy may be an option in a potentially curative gastrectomy for tumors with apparent metastasis to the No.6 nodes or infiltrate to duodenum. The examined lymph node and extranodal metastasis are significantly associated with the survival of gastric cancer patients.展开更多
AIM: To improve the diagnostic accuracy in patients with symptoms and signs of appendicitis, but without confirmative computed tomography (CT) findings.
OOV term translation plays an important role in natural language processing. Although many researchers in the past have endeavored to solve the OOV term translation problems, but none existing methods offer definition...OOV term translation plays an important role in natural language processing. Although many researchers in the past have endeavored to solve the OOV term translation problems, but none existing methods offer definition or context information of OOV terms. Furthermore, non-existing methods focus on cross-language definition retrieval for OOV terms. Never the less, it has always been so difficult to evaluate the correctness of an OOV term translation without domain specific knowledge and correct references. Our English definition ranking method differentiate the types of OOV terms, and applies different methods for translation extraction. Our English definition ranking method also extracts multilingual context information and monolingual definitions of OOV terms. In addition, we propose a novel cross-language definition retrieval system for OOV terms. Never the less, we propose an auto re-evaluation method to evaluate the correctness of OOV translations and definitions. Our methods achieve high performances against existing methods.展开更多
Objective To re-evaluate the systematic review of the safety and effectiveness of epidural analgesia(EA)for labor analgesia.Methods The Cochrane database,PubMed,EMBASE,EBSCO,Web of Science,ScienceDirect,China Biomedic...Objective To re-evaluate the systematic review of the safety and effectiveness of epidural analgesia(EA)for labor analgesia.Methods The Cochrane database,PubMed,EMBASE,EBSCO,Web of Science,ScienceDirect,China Biomedical Literature database,CNKI,Wanfang and VIP databases were searched,and the search time was limited to August 2020.Two researchers screened the literature and extracted data according to the inclusion criteria.AMSTAR was used to evaluate the methodological quality of the included studies.Pain intensity and pain relief satisfaction were used as the main indicators for re-evaluation of the effectiveness.Midwifery rate,cesarean section rate,back pain,fever,nausea and vomiting,umbilical artery pH value,and newborn Apgar score were used as the main indicators to re-evaluate the safety.Results and Conclusion A total of 9 meta-analyses were included.The safety and effectiveness of EA and opioid intravenous analgesia,acupuncture stimulation,inhalation analgesia,no analgesia,and continuous delivery were evaluated separately.The included systematic reviews showed that EA could increase the rate of device-assisted delivery,causing maternal fever,and prolonging the first and second stages of labor.But the incidence of back pain,nausea,and vomiting was lower.Therefore,analgesia had a good effect with better satisfactory degree.Current evidence shows that EA is safe and effective for labor analgesia,but the quality of the reports of current studies is not high.展开更多
The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significane...The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.展开更多
OBJECTIVE:Toidentify the potential risk factors associated with Shenqifuzheng injection(SFI), a solution made of Dangshen(Radix Codonopsis) and Huangqi(Radix Astragali Mongolici), for the timely provision of informati...OBJECTIVE:Toidentify the potential risk factors associated with Shenqifuzheng injection(SFI), a solution made of Dangshen(Radix Codonopsis) and Huangqi(Radix Astragali Mongolici), for the timely provision of information to regulatory authorities.METHODS: A comprehensive analysis of the production process, quality standards, pharmacology,post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions(ADR), case analyses, and systematic reviews,intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital in-formationsystem(HIS).RESULTS: Sub-acute toxicity tests suggesting that a dose of 15 mL/kg(concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85‰. From March to November 2013,of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI ata dosageanda treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash,chills,feeling cold,palpitation,dyspnea,edemaofa lower extremity, palpebral edema, and superficial vein in flammation,among others.CONCLUSION: This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors.It supports the safety of SFI for clinical, research, and production uses based on objec-tive, reliable, and scientific information to provide safe medication.展开更多
The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not...The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.展开更多
It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Ad...It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.展开更多
文摘Dee,in"Everyday Use",is portrayed as a negative character.Nevertheless,some critics suggest to re-interpret her for some reasonable causes.By using close-reading,this article try to re-evaluate Dee so to evalue Alice Walker’s valuable devotion in character depiction.
文摘Purpose: Additional analyses of outcomes of laser-assisted subepithelial keratectomy (LASEK) are still necessary to improve the safety of LASEK. Therefore, in our study, outcomes were assessed retrospectively in 561 eyes that underwent LASEK treatment. Methods: Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA) and residual spherical equivalent were analyzed at 3 and 6 months postoperatively. We assessed four subgroups based on the degree of preoperative myopia considering mean BSCVA and loss of two or more lines. Results: Mean UCVAs and BSCVAs were obtained at 3 and 6 months postoperatively (1.23/1.35 and 1.23/1.37, respectively). The mean predictability was within ±0.125 diopters. Conversely, the safety indexes were 0.94 and 0.96 respectively, and the efficacy indexes were 0.86 and 0.86 at 3 and 6 months postoperatively, respectively. 8.4% eyes and 5.2% eyes lost two or more lines of BSCVA at 3 and 6 months postoperatively, respectively. The mean BSCVAs of the high or ultra-high groups were significantly lower than those of the low or mild groups both 3 months and 6 months postoperatively. The incidence rates of losing two or more lines of BSCVA in the high or ultra-high myopia groups were significantly greater than in the low or mild groups at 3 months and 6 months postoperatively. Conclusion: LASEK predictably corrected myopia achieving >1.2 in UCVA and BSCVA. However, the safety and efficacy indexes were <1.0, which were related to the loss of two or more lines of BSCVA. Since the incidence rates of losing two or more lines of BSCVA were greater in the high or ultra-high myopia groups, we consider LASEK as more safely performed in patients with low to mild preoperative myopia.
基金National Natural Science Foundation of China(NO.81804050)Henan province traditional Chinese medicine scientific research special major subject(NO.20-21ZYZD05)Henan province traditional Chinese medicine scientific research special general subject(NO.2022ZY1062).
文摘Objective: To re-evaluate the systematic review of Rheumatoid arthritis (RA) treatmentwith total glucosides of paeony (TGP) to provide evidence-based evidence for the treatmentof RA with TGP in the clinic. Methods: A total of eight databases including CNKI, Wan FangData, CBM, VIP, PubMed, Embase, Cochrane Library, and Web of Science were searched bycomputer for the systematic reviews/meta-analyses concerning the treatment of RA withTGP. The retrieval period was from the establishment of the database to May 2, 2022.Literature screening was conducted based on the randomized controlled trial, and thematerials of the included literature were extracted. Using the preferred reporting items forsystematic reviews and meta-analyses statement. The a measurement tool to assesssystematic reviews 2 scale and grades of recommendation, assessment, development, andevaluation system evaluated the reporting quality, methodological quality, and outcomeindicators evidence levels included in the literature. Results: Six systematicreviews/meta-analysis literature were finally included. Evaluation of the preferred reportingitems for systematic reviews and meta-analyses statement showed that the overall reportingquality of included literature was low, and only one piece with high quality was included.The results of the a measurement tool to assess systematic reviews 2 scale evaluationshowed that the qualities of included literature were all low-level and highly low-level. Thegrades of recommendation, assessment, development, and evaluation evidence qualityevaluation showed a total of 39 outcome indicators in the six included literature, and alloutcome indicators were intermediate, low-level, and extremely low in evidence evaluation.Conclusion: Many pieces of evidence show that TGP has certain advantages in alleviatingclinical symptoms, reducing adverse reactions, and reducing hepatotoxicity in the treatmentof RA, but this conclusion lacks high-level evidence to support it, which needs to be provedby more studies in the future.
基金Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicines,the Ministry of Science and Technology(No.2009ZX09502-030)the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No. Z0215)
文摘This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers.
基金National Natural Science Foundation of China, No.41001080 No.41271184+1 种基金 No.40971075 No.40771054
文摘Research has shown that there has been a significant change in the quantitative relationship between urbanization and economic development over the past 50 years. As a result of this change, the Chenery model is no longer capable of performing a comparative analysis of these parameters. We carried out a regression analysis of the normal form of the relation between urbanization and economic development on the basis of the Chenery model. We used empirical data from 149 countries and regions from 1990 to 2009 and adopted the double logarithmic model, introducing a time series variable for urbanization. From 1990 to 2009, with a per capita gross national income remaining between USD 1000 and 10,000, the urbanization rate changed from 17.78 to 60.36% and the relational matching data changed accordingly, although the upper limit of the rate of urbanization remained at about 75%. Urbanization in countries with a smaller population size was more affected by economic development than urbanization in countries with large and medium sized populations.
文摘Based upon studies from randomized clinical trials, the extended (D2) lymph node dissection is now recommended as a standard procedure for local advanced gastric cancer worldwide. However, the rational extent lymphadenectomy for local advanced gastric cancer has remained a topic of debate in the past decades. Due to the limitation of low metastatic rate in para-aortic nodes (PAN) in JCOG9501, the clinical benefit of D2+ para-aortic nodal dissection (PAND) for patients with stage T4 and/or stage N3 disease, which is very common in China and other countries except Japan and Korea, cannot be determined. Furthermore, the role of splenectomy for complete resection of No.10 and No.l I nodes has been controversial, and however, the final results from the randomized trial ofJCOG0110 have yet to be completed. Gastric cancer with the No.14 and No.13 lymph node metastasis is defined as MI stage in the current version of the Japanese classification. We propose that D2~No.14v and +No.13 lymphadenectomy may be an option in a potentially curative gastrectomy for tumors with apparent metastasis to the No.6 nodes or infiltrate to duodenum. The examined lymph node and extranodal metastasis are significantly associated with the survival of gastric cancer patients.
文摘AIM: To improve the diagnostic accuracy in patients with symptoms and signs of appendicitis, but without confirmative computed tomography (CT) findings.
文摘OOV term translation plays an important role in natural language processing. Although many researchers in the past have endeavored to solve the OOV term translation problems, but none existing methods offer definition or context information of OOV terms. Furthermore, non-existing methods focus on cross-language definition retrieval for OOV terms. Never the less, it has always been so difficult to evaluate the correctness of an OOV term translation without domain specific knowledge and correct references. Our English definition ranking method differentiate the types of OOV terms, and applies different methods for translation extraction. Our English definition ranking method also extracts multilingual context information and monolingual definitions of OOV terms. In addition, we propose a novel cross-language definition retrieval system for OOV terms. Never the less, we propose an auto re-evaluation method to evaluate the correctness of OOV translations and definitions. Our methods achieve high performances against existing methods.
文摘Objective To re-evaluate the systematic review of the safety and effectiveness of epidural analgesia(EA)for labor analgesia.Methods The Cochrane database,PubMed,EMBASE,EBSCO,Web of Science,ScienceDirect,China Biomedical Literature database,CNKI,Wanfang and VIP databases were searched,and the search time was limited to August 2020.Two researchers screened the literature and extracted data according to the inclusion criteria.AMSTAR was used to evaluate the methodological quality of the included studies.Pain intensity and pain relief satisfaction were used as the main indicators for re-evaluation of the effectiveness.Midwifery rate,cesarean section rate,back pain,fever,nausea and vomiting,umbilical artery pH value,and newborn Apgar score were used as the main indicators to re-evaluate the safety.Results and Conclusion A total of 9 meta-analyses were included.The safety and effectiveness of EA and opioid intravenous analgesia,acupuncture stimulation,inhalation analgesia,no analgesia,and continuous delivery were evaluated separately.The included systematic reviews showed that EA could increase the rate of device-assisted delivery,causing maternal fever,and prolonging the first and second stages of labor.But the incidence of back pain,nausea,and vomiting was lower.Therefore,analgesia had a good effect with better satisfactory degree.Current evidence shows that EA is safe and effective for labor analgesia,but the quality of the reports of current studies is not high.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.
基金Supported by National Science and Technology Major Projects for "Major New Drugs Innovation and Development":Study on Key Technologies of Post-marketing Evaluation for Chinese Medicine(No.2009ZX09502-030)
文摘OBJECTIVE:Toidentify the potential risk factors associated with Shenqifuzheng injection(SFI), a solution made of Dangshen(Radix Codonopsis) and Huangqi(Radix Astragali Mongolici), for the timely provision of information to regulatory authorities.METHODS: A comprehensive analysis of the production process, quality standards, pharmacology,post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions(ADR), case analyses, and systematic reviews,intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital in-formationsystem(HIS).RESULTS: Sub-acute toxicity tests suggesting that a dose of 15 mL/kg(concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85‰. From March to November 2013,of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI ata dosageanda treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash,chills,feeling cold,palpitation,dyspnea,edemaofa lower extremity, palpebral edema, and superficial vein in flammation,among others.CONCLUSION: This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors.It supports the safety of SFI for clinical, research, and production uses based on objec-tive, reliable, and scientific information to provide safe medication.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.