With the increasing usage of drugs to remedy different diseases,drug safety has become crucial over the past few years.Often medicine from several companies is offered for a single disease that involves the same/simil...With the increasing usage of drugs to remedy different diseases,drug safety has become crucial over the past few years.Often medicine from several companies is offered for a single disease that involves the same/similar substances with slightly different formulae.Such diversification is both helpful and danger-ous as such medicine proves to be more effective or shows side effects to different patients.Despite clinical trials,side effects are reported when the medicine is used by the mass public,of which several such experiences are shared on social media platforms.A system capable of analyzing such reviews could be very helpful to assist healthcare professionals and companies for evaluating the safety of drugs after it has been marketed.Sentiment analysis of drug reviews has a large poten-tial for providing valuable insights into these cases.Therefore,this study proposes an approach to perform analysis on the drug safety reviews using lexicon-based and deep learning techniques.A dataset acquired from the‘Drugs.Com’contain-ing reviews of drug-related side effects and reactions,is used for experiments.A lexicon-based approach,Textblob is used to extract the positive,negative or neu-tral sentiment from the review text.Review classification is achieved using a novel hybrid deep learning model of convolutional neural networks and long short-term memory(CNN-LSTM)network.The CNN is used at thefirst level to extract the appropriate features while LSTM is used at the second level.Several well-known machine learning models including logistic regression,random for-est,decision tree,and AdaBoost are evaluated using term frequency-inverse docu-ment frequency(TF-IDF),a bag of words(BoW),feature union of(TF-IDF+BoW),and lexicon-based methods.Performance analysis with machine learning models,long short term memory and convolutional neural network models,and state-of-the-art approaches indicate that the proposed CNN-LSTM model shows superior performance with an 0.96 accuracy.We also performed a statistical sig-nificance T-test to show the significance of the proposed CNN-LSTM model in comparison with other approaches.展开更多
Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European ...Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.展开更多
Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the q...Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.展开更多
Irrational antibiotics/antibacterial (AB) drug use is a global problem, especially in developing countries. This results in an increased emergence of resistance to most common bacteria, higher cost of treatment, prolo...Irrational antibiotics/antibacterial (AB) drug use is a global problem, especially in developing countries. This results in an increased emergence of resistance to most common bacteria, higher cost of treatment, prolonged hospitalization and adverse drug reactions. Interventions measures have been instituted to avert the problem but it still persists. A systematic review was conducted to determine the effect of different interventions (education, managerial, diagnostic tests, regulatory, economic and multifaceted) on misuse of AB drugs in developing countries. A total of 722 articles were retrieved and 55 were reviewed. About 10.9% of the studies were from Africa, 63.6% from Asia, 9.1% from Latin America, and 16.4% from Southeastern Europe. A total of 52.7% of the studies were from hospital settings, 5.5% from outpatient departments, 21.8% were from public health care facilities, 12.7% from private pharmacies/drug stores, and 7.3% from the communities. Education intervention had 27.3% studies, managerial had 20%, managerial/education had 3.6%, regulatory had 9.1%, education/regulation had 9.1% and diagnostic had 3.6% studies. Multifaceted intervention had 27.3% studies, with 63% improvement in appropriate AB doses prescribed, 2.6% mean number of AB encounter reduction, 23% AB prescription reduction, 18.3% generic AB prescription improvement, 32.1% reduction in AB use, 89% reduction in AB use in acute respiratory infection, 82% in surgery, 62.7% mean reduction in deliveries, 39% in STDs, 36.3% mean reduction in diarrhea, 14.6% mean reduction AB use in malaria, and 6%-11% in the cost of treating bacteria-resistant organisms. Also noted was 6.3% reductions in mean AB encounters after 1 month of intervention, and then increased to 7.7% after 3 months thus lacking sustainability. Multifaceted interventions were effective in reducing irrational AB drug use in the various health facilities and communities as well as reduction in the emergence of resistance to the commonest bacteria in the developing countries though there was lack of sustainability or continuity of rational drug use over the time.展开更多
Antibody drug conjugates (ADCs) are a new class of drugs that combine chemosynthetic drugs with antibody drugs through a linker. Antibody drug conjugates combine the targeting characteristics of traditional antibody d...Antibody drug conjugates (ADCs) are a new class of drugs that combine chemosynthetic drugs with antibody drugs through a linker. Antibody drug conjugates combine the targeting characteristics of traditional antibody drugs with the cytotoxic characteristics of small molecule drugs, while reducing the side effects of both drugs, making them a kind of “biological missile” and representing a relatively new and evolving class of anti-cancer drugs. Antibody-coupled drugs are currently used in many solid tumors, and this article reviews the clinical application of antibody-coupled drugs in HER2-positive gastric cancer.展开更多
Objective:To systematically evaluate the efficacy and safety of Hugan Tablets(护肝片)in the treatment of drug-induced liver injury.Methods:Totally seven Chinese and English databases,including CNKI,Wanfang,VIP,CBM,Pub...Objective:To systematically evaluate the efficacy and safety of Hugan Tablets(护肝片)in the treatment of drug-induced liver injury.Methods:Totally seven Chinese and English databases,including CNKI,Wanfang,VIP,CBM,PubMed,EMbase,Web of Science were searched for randomized controlled trials(RCTs)of Hugan Tablets(护肝片)for the treatment of drug-induced liver injury,which were published from the date of establishment to April 20,2019.The meta-analysis software RevMan 5.3 software and Excel were used to build a database into combine and analyze the studies that met the standards and to draw a forest plot.Results:Forty five RCTs were included with 7478 patients.The quality of included studies was uneven.Meta-analysis showed that the outcome index of liver injury rate was divided into seven subgroups.Hugan Tablets(护肝片)were used in the treatment of anti-tuberculosis drugs was superior to the conventional western medicine treatment group(RR=0.27,95%CI[0.22,0.33],P<0.00001).Which was also better than the without Hugan Tablets(护肝片)treatment group(RR=0.32,95%CI[0.20,0.52],P<0.00001).For the role of drug-induced liver injury in the treatment of type 2 diabetes,the Hugan Tablet+conventional treatment group is better than the conventional treatment group(RR=0.16,95%CI[0.03,0.88],P=0.03).The effect of drug-induced liver injury in the treatment of hypertension was superior to the conventional western medicine treatment group(RR=0.07,95%CI[0.03,0.14],P<0.00001).The effect of drug-induced liver injury during the treatment of hyperlipidemia was not statistically significant(RR=0.57,95%CI[0.33,1.00],P=0.05).There was no statistical difference between the two groups in the effect of drug-induced liver injury during the treatment of coronary heart disease(RR=0.09,95%CI[0.01,1.61],P=0.10).There was no significant difference between the two groups in the treatment of cerebral thrombosis for drug-induced liver injury(RR=0.11,95%CI[0.01,2.01],P=0.14).The effect of anti-hyperthyroidism on liver injury was better than that of conventional western medicine treatment group(RR=0.45,95%CI[0.25,0.82],P=0.009).Outcome index of total effective rate was divided into two subgroups.The effect of drug-induced liver injury caused by the type of drug was not mentioned was superior to the conventional western medicine treatment group(RR=0.78,95%CI[0.70,0.88],P<0.0001).There was no significant difference between the two groups in the liver injury caused by antipsychotic drugs(RR=0.97,95%CI[0.81,1.16],P=0.72).Conclusion:When used in the treatment of tuberculosis and psychiatric drug treatment,combineduse of Hugan Tablets(护肝片)can significantly reduce the incidence of drug-induced liver damage,and can significantly improve clinical symptoms caused by liver damage.In the treatment of hypertension,the addition of Hugan Tablets(护肝片)can significantly reduce the incidence of drug-induced liver injury,improving the safety of medication.In the treatment of drug-induced liver injury caused by which drug is not mentioned,Hugan Tablet has a therapeutic effect.Slight adverse reactions were reported,including rash,headache,palpitations,hypoglycemia,flushing,fatigue,nausea,bowel sounds,flatulence,diarrhea,and gastrointestinal discomfort.All studies reported minor adverse reactions that were well tolerated by patients and recovered without treatment after discontinuation.Oral administration of Hugan Tablets(护肝片)has positive effects on druginduced liver injury,but this conclusion still needs further evidences delete.It is necessary to adopt a larger sample,more design,and accord with the international standards to improve the quality of evidence.展开更多
文摘With the increasing usage of drugs to remedy different diseases,drug safety has become crucial over the past few years.Often medicine from several companies is offered for a single disease that involves the same/similar substances with slightly different formulae.Such diversification is both helpful and danger-ous as such medicine proves to be more effective or shows side effects to different patients.Despite clinical trials,side effects are reported when the medicine is used by the mass public,of which several such experiences are shared on social media platforms.A system capable of analyzing such reviews could be very helpful to assist healthcare professionals and companies for evaluating the safety of drugs after it has been marketed.Sentiment analysis of drug reviews has a large poten-tial for providing valuable insights into these cases.Therefore,this study proposes an approach to perform analysis on the drug safety reviews using lexicon-based and deep learning techniques.A dataset acquired from the‘Drugs.Com’contain-ing reviews of drug-related side effects and reactions,is used for experiments.A lexicon-based approach,Textblob is used to extract the positive,negative or neu-tral sentiment from the review text.Review classification is achieved using a novel hybrid deep learning model of convolutional neural networks and long short-term memory(CNN-LSTM)network.The CNN is used at thefirst level to extract the appropriate features while LSTM is used at the second level.Several well-known machine learning models including logistic regression,random for-est,decision tree,and AdaBoost are evaluated using term frequency-inverse docu-ment frequency(TF-IDF),a bag of words(BoW),feature union of(TF-IDF+BoW),and lexicon-based methods.Performance analysis with machine learning models,long short term memory and convolutional neural network models,and state-of-the-art approaches indicate that the proposed CNN-LSTM model shows superior performance with an 0.96 accuracy.We also performed a statistical sig-nificance T-test to show the significance of the proposed CNN-LSTM model in comparison with other approaches.
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.
文摘Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.
文摘Irrational antibiotics/antibacterial (AB) drug use is a global problem, especially in developing countries. This results in an increased emergence of resistance to most common bacteria, higher cost of treatment, prolonged hospitalization and adverse drug reactions. Interventions measures have been instituted to avert the problem but it still persists. A systematic review was conducted to determine the effect of different interventions (education, managerial, diagnostic tests, regulatory, economic and multifaceted) on misuse of AB drugs in developing countries. A total of 722 articles were retrieved and 55 were reviewed. About 10.9% of the studies were from Africa, 63.6% from Asia, 9.1% from Latin America, and 16.4% from Southeastern Europe. A total of 52.7% of the studies were from hospital settings, 5.5% from outpatient departments, 21.8% were from public health care facilities, 12.7% from private pharmacies/drug stores, and 7.3% from the communities. Education intervention had 27.3% studies, managerial had 20%, managerial/education had 3.6%, regulatory had 9.1%, education/regulation had 9.1% and diagnostic had 3.6% studies. Multifaceted intervention had 27.3% studies, with 63% improvement in appropriate AB doses prescribed, 2.6% mean number of AB encounter reduction, 23% AB prescription reduction, 18.3% generic AB prescription improvement, 32.1% reduction in AB use, 89% reduction in AB use in acute respiratory infection, 82% in surgery, 62.7% mean reduction in deliveries, 39% in STDs, 36.3% mean reduction in diarrhea, 14.6% mean reduction AB use in malaria, and 6%-11% in the cost of treating bacteria-resistant organisms. Also noted was 6.3% reductions in mean AB encounters after 1 month of intervention, and then increased to 7.7% after 3 months thus lacking sustainability. Multifaceted interventions were effective in reducing irrational AB drug use in the various health facilities and communities as well as reduction in the emergence of resistance to the commonest bacteria in the developing countries though there was lack of sustainability or continuity of rational drug use over the time.
文摘Antibody drug conjugates (ADCs) are a new class of drugs that combine chemosynthetic drugs with antibody drugs through a linker. Antibody drug conjugates combine the targeting characteristics of traditional antibody drugs with the cytotoxic characteristics of small molecule drugs, while reducing the side effects of both drugs, making them a kind of “biological missile” and representing a relatively new and evolving class of anti-cancer drugs. Antibody-coupled drugs are currently used in many solid tumors, and this article reviews the clinical application of antibody-coupled drugs in HER2-positive gastric cancer.
基金National Key Research and Development Program of China(2018YFC1707400)Research Project of Graduate Education and Teaching Reform of China Academy of Chinese Medical Sciences(JG201703)
文摘Objective:To systematically evaluate the efficacy and safety of Hugan Tablets(护肝片)in the treatment of drug-induced liver injury.Methods:Totally seven Chinese and English databases,including CNKI,Wanfang,VIP,CBM,PubMed,EMbase,Web of Science were searched for randomized controlled trials(RCTs)of Hugan Tablets(护肝片)for the treatment of drug-induced liver injury,which were published from the date of establishment to April 20,2019.The meta-analysis software RevMan 5.3 software and Excel were used to build a database into combine and analyze the studies that met the standards and to draw a forest plot.Results:Forty five RCTs were included with 7478 patients.The quality of included studies was uneven.Meta-analysis showed that the outcome index of liver injury rate was divided into seven subgroups.Hugan Tablets(护肝片)were used in the treatment of anti-tuberculosis drugs was superior to the conventional western medicine treatment group(RR=0.27,95%CI[0.22,0.33],P<0.00001).Which was also better than the without Hugan Tablets(护肝片)treatment group(RR=0.32,95%CI[0.20,0.52],P<0.00001).For the role of drug-induced liver injury in the treatment of type 2 diabetes,the Hugan Tablet+conventional treatment group is better than the conventional treatment group(RR=0.16,95%CI[0.03,0.88],P=0.03).The effect of drug-induced liver injury in the treatment of hypertension was superior to the conventional western medicine treatment group(RR=0.07,95%CI[0.03,0.14],P<0.00001).The effect of drug-induced liver injury during the treatment of hyperlipidemia was not statistically significant(RR=0.57,95%CI[0.33,1.00],P=0.05).There was no statistical difference between the two groups in the effect of drug-induced liver injury during the treatment of coronary heart disease(RR=0.09,95%CI[0.01,1.61],P=0.10).There was no significant difference between the two groups in the treatment of cerebral thrombosis for drug-induced liver injury(RR=0.11,95%CI[0.01,2.01],P=0.14).The effect of anti-hyperthyroidism on liver injury was better than that of conventional western medicine treatment group(RR=0.45,95%CI[0.25,0.82],P=0.009).Outcome index of total effective rate was divided into two subgroups.The effect of drug-induced liver injury caused by the type of drug was not mentioned was superior to the conventional western medicine treatment group(RR=0.78,95%CI[0.70,0.88],P<0.0001).There was no significant difference between the two groups in the liver injury caused by antipsychotic drugs(RR=0.97,95%CI[0.81,1.16],P=0.72).Conclusion:When used in the treatment of tuberculosis and psychiatric drug treatment,combineduse of Hugan Tablets(护肝片)can significantly reduce the incidence of drug-induced liver damage,and can significantly improve clinical symptoms caused by liver damage.In the treatment of hypertension,the addition of Hugan Tablets(护肝片)can significantly reduce the incidence of drug-induced liver injury,improving the safety of medication.In the treatment of drug-induced liver injury caused by which drug is not mentioned,Hugan Tablet has a therapeutic effect.Slight adverse reactions were reported,including rash,headache,palpitations,hypoglycemia,flushing,fatigue,nausea,bowel sounds,flatulence,diarrhea,and gastrointestinal discomfort.All studies reported minor adverse reactions that were well tolerated by patients and recovered without treatment after discontinuation.Oral administration of Hugan Tablets(护肝片)has positive effects on druginduced liver injury,but this conclusion still needs further evidences delete.It is necessary to adopt a larger sample,more design,and accord with the international standards to improve the quality of evidence.
