Background/objective: A nationwide survey on the resistance to first line anti-tuberculosis (anti-TB) drugs was conducted in Ghana from 2007-2008 by Noguchi Memorial Institute for Medical Research in collaboration wit...Background/objective: A nationwide survey on the resistance to first line anti-tuberculosis (anti-TB) drugs was conducted in Ghana from 2007-2008 by Noguchi Memorial Institute for Medical Research in collaboration with the National Tuberculosis Control Programme. We aimed to characterize mycobacterial species causing pulmonary tuberculosis (PTB) and determine the resistance pattern to first line anti-TB drugs among newly diagnosed and previously treated PTB patients in Ghana. Methods: Two sputum samples from consented new smear positive PTB patients who had never been treated for TB or had been on anti-TB treatment for less than a month and patients who had been treated for TB previously for more than a month in selected diagnostic centres nationwide were collected for culture, identification and drug susceptibility test. Culture positive isolates were tested against streptomycin (S), isoniazid (H), rifampicin (R) and ethambutol (E) using the simplified proportion method and line probe assay (LPA). The LPA was performed in mid-2017. Results: Among 410 samples, 345 positive cultures were obtained and identified as Mycobacterium tuberculosis complex (MTBC). Of the 345 isolates, 133 were further differentiated by GenoType MTBC®as M. tuberculosis, 126 (94.7%) and M. africanum 7 (5.3%). The overall drug resistance patterns were as follows: 43/345 (12.5%), 6/345 (1.7%), 9/345 (2.6%) and 71/345 (20.6%) were resistant to H, R, E and S respectively and 5/345 (1.4%) were multi-drug resistant (MDR). Conclusion: The results indicate high levels of resistance to S and H among new and previously treated TB patients. We recommend adequate surveillance systems including periodic national anti-TB drug resistance surveys.展开更多
Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being dis...Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and developed.Although several high-quality reviews on clinical antibacterial drug pipelines from a global perspective were published recently,none provides comprehensive information on original antibacterial drugs at clinical stages in China.In this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since 2019.Information was obtained by consulting official websites,searching commercial databases,retrieving literature,asking personnel from institutions or companies,and other means,and a considerable part of the data covered here has not been included in other reviews.As of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and updated.Among them,two new antibacterial drugs that belong to traditional antibiotic classes were approved by the National Medical Products Administration(NMPA)in China in 2019 and 2021,respectively,and 18 antibacterial agents are in clinical development,with one under regulatory evaluation,five in phase-3,six in phase-2,and six in phase-1.Most of the clinical candidates are new analogs or monocomponents of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibiotics and a recombinant antibacterial protein.Overall,despite there being 17 antibacterial clinical candidates,our analysis indicates that there are still relatively few clinically differentiated antibacterial agents in stages of clinical development in China.Hopefully,Chinese pharmaceutical companies and institutions will develop more innovative and clinically differentiated candidates with good market potential in the future research and development(R&D)of original antibacterial drugs.展开更多
<b><span style="font-family:Verdana;">Background</span></b><span style="font-family:;" "=""><span style="font-family:Verdana;">: Inappro...<b><span style="font-family:Verdana;">Background</span></b><span style="font-family:;" "=""><span style="font-family:Verdana;">: Inappropriate use of medicines is a global concern with serious con</span><span style="font-family:Verdana;">sequences related to prescribing, dispensing, and use. WHO estimate</span><span style="font-family:Verdana;">d that 50% of medicines are not used correctly on their journey from the facility to home. </span><b><span style="font-family:Verdana;">Objective</span></b><span style="font-family:Verdana;">: To assess medicines use using WHO drug core indicators rega</span><span><span style="font-family:Verdana;">rding prescribing, patient, and facilities. </span><b><span style="font-family:Verdana;">Setting</span></b><span style="font-family:Verdana;">: Outpatients, Hea</span></span><span style="font-family:Verdana;">lth centers in Wadmadani locality (Urban area) in Gezira State, Sudan. </span><b><span style="font-family:Verdana;">Method</span></b><span style="font-family:Verdana;">: A cross-sectional, prospective, analytical study was conducted in 30 health centers and 60 patients from each center were selected using a simple random sampling technique. WHO indicators form was used to collect data containing different variables. T-test at a level of confidence of 95% was used to test differences between indicators. Statistical Package for Social Science (SPSS) was used for data analysis. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> The main prescribing indicators were 2.5 ± 0.6 for drugs per encounter, 44.1% ± 14.2%. Generic 54 ± 18.0 antibiotics, 12.0% ± 9.3% injectable, and 95.2% ± 11.5% of drugs were prescribed according to the NHIF-EML. The main patient’s indicators were, 2.9 ± 0.8 minutes for consultation time, 99.5 ± 36.8 seconds for dispensing time, and 72.5% ± 16.0% for medicines actually dispensed, 49.0% ± 18.0% for medicines adequately labeled, and 22.5% ± 7.3% of the patient’s knowledge about the correct dose. The Facility specific indicators were 66.7% for the availability of a copy of EML, while the percentage of key drugs in the stock was 75.3% ± 11.6%. No statistically significant differences were found between direct and indirect facilities except in generic prescribing. </span><b><span style="font-family:Verdana;">Main Outcome Measure</span></b><span style="font-family:Verdana;">: <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> Interventions to improve Generic and antibiotics prescribing indicators. <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> The patient-to-physician ratio should be revised to optimize consultation time. <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> The availability of key drugs should be improved to make sure effective treatment. <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> The pharmacy cadre should be oriented and trained to improve patients’ compliance. </span><b><span style="font-family:Verdana;">Conclusion</span></b><span style="font-family:Verdana;">: The study concluded that there was irrational use of medicines when investigated by WHO drug core indicators. So, the study recommended interventions to improve the rationale prescribing, dispensing, and use of medicines.</span></span>展开更多
Objective To explore the factors influencing the implementation of drug standards improvement in China,and to offer some suggestions for improving drug standards.Methods Factor analysis was used to investigate the inf...Objective To explore the factors influencing the implementation of drug standards improvement in China,and to offer some suggestions for improving drug standards.Methods Factor analysis was used to investigate the influencing factors by referring to the literatures,experts’interview and collecting data through questionnaire,and then data were analyzed by SPSS21.0 statistical software.Results and Conclusion The results showed that there were four factors that affecting the plan of the national drug standards improvement.They were mechanism factor,design factor,constraint factor and motivation factor.And corresponding management suggestions for improving the efficiency of the plan were put forward.展开更多
文摘Background/objective: A nationwide survey on the resistance to first line anti-tuberculosis (anti-TB) drugs was conducted in Ghana from 2007-2008 by Noguchi Memorial Institute for Medical Research in collaboration with the National Tuberculosis Control Programme. We aimed to characterize mycobacterial species causing pulmonary tuberculosis (PTB) and determine the resistance pattern to first line anti-TB drugs among newly diagnosed and previously treated PTB patients in Ghana. Methods: Two sputum samples from consented new smear positive PTB patients who had never been treated for TB or had been on anti-TB treatment for less than a month and patients who had been treated for TB previously for more than a month in selected diagnostic centres nationwide were collected for culture, identification and drug susceptibility test. Culture positive isolates were tested against streptomycin (S), isoniazid (H), rifampicin (R) and ethambutol (E) using the simplified proportion method and line probe assay (LPA). The LPA was performed in mid-2017. Results: Among 410 samples, 345 positive cultures were obtained and identified as Mycobacterium tuberculosis complex (MTBC). Of the 345 isolates, 133 were further differentiated by GenoType MTBC®as M. tuberculosis, 126 (94.7%) and M. africanum 7 (5.3%). The overall drug resistance patterns were as follows: 43/345 (12.5%), 6/345 (1.7%), 9/345 (2.6%) and 71/345 (20.6%) were resistant to H, R, E and S respectively and 5/345 (1.4%) were multi-drug resistant (MDR). Conclusion: The results indicate high levels of resistance to S and H among new and previously treated TB patients. We recommend adequate surveillance systems including periodic national anti-TB drug resistance surveys.
基金supported by the National Natural Science Foundation of China(32141003 and 82330110)the CAMS Innovation Fund for Medical Sciences(CIFMS+2 种基金2021-I2M-1-039)the National Science and Technology Infrastructure of China(National Pathogen Resource Center-NPRC-32)the Fundamental Research Funds for the Central Universities(2021-PT350-001).
文摘Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and developed.Although several high-quality reviews on clinical antibacterial drug pipelines from a global perspective were published recently,none provides comprehensive information on original antibacterial drugs at clinical stages in China.In this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since 2019.Information was obtained by consulting official websites,searching commercial databases,retrieving literature,asking personnel from institutions or companies,and other means,and a considerable part of the data covered here has not been included in other reviews.As of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and updated.Among them,two new antibacterial drugs that belong to traditional antibiotic classes were approved by the National Medical Products Administration(NMPA)in China in 2019 and 2021,respectively,and 18 antibacterial agents are in clinical development,with one under regulatory evaluation,five in phase-3,six in phase-2,and six in phase-1.Most of the clinical candidates are new analogs or monocomponents of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibiotics and a recombinant antibacterial protein.Overall,despite there being 17 antibacterial clinical candidates,our analysis indicates that there are still relatively few clinically differentiated antibacterial agents in stages of clinical development in China.Hopefully,Chinese pharmaceutical companies and institutions will develop more innovative and clinically differentiated candidates with good market potential in the future research and development(R&D)of original antibacterial drugs.
文摘<b><span style="font-family:Verdana;">Background</span></b><span style="font-family:;" "=""><span style="font-family:Verdana;">: Inappropriate use of medicines is a global concern with serious con</span><span style="font-family:Verdana;">sequences related to prescribing, dispensing, and use. WHO estimate</span><span style="font-family:Verdana;">d that 50% of medicines are not used correctly on their journey from the facility to home. </span><b><span style="font-family:Verdana;">Objective</span></b><span style="font-family:Verdana;">: To assess medicines use using WHO drug core indicators rega</span><span><span style="font-family:Verdana;">rding prescribing, patient, and facilities. </span><b><span style="font-family:Verdana;">Setting</span></b><span style="font-family:Verdana;">: Outpatients, Hea</span></span><span style="font-family:Verdana;">lth centers in Wadmadani locality (Urban area) in Gezira State, Sudan. </span><b><span style="font-family:Verdana;">Method</span></b><span style="font-family:Verdana;">: A cross-sectional, prospective, analytical study was conducted in 30 health centers and 60 patients from each center were selected using a simple random sampling technique. WHO indicators form was used to collect data containing different variables. T-test at a level of confidence of 95% was used to test differences between indicators. Statistical Package for Social Science (SPSS) was used for data analysis. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> The main prescribing indicators were 2.5 ± 0.6 for drugs per encounter, 44.1% ± 14.2%. Generic 54 ± 18.0 antibiotics, 12.0% ± 9.3% injectable, and 95.2% ± 11.5% of drugs were prescribed according to the NHIF-EML. The main patient’s indicators were, 2.9 ± 0.8 minutes for consultation time, 99.5 ± 36.8 seconds for dispensing time, and 72.5% ± 16.0% for medicines actually dispensed, 49.0% ± 18.0% for medicines adequately labeled, and 22.5% ± 7.3% of the patient’s knowledge about the correct dose. The Facility specific indicators were 66.7% for the availability of a copy of EML, while the percentage of key drugs in the stock was 75.3% ± 11.6%. No statistically significant differences were found between direct and indirect facilities except in generic prescribing. </span><b><span style="font-family:Verdana;">Main Outcome Measure</span></b><span style="font-family:Verdana;">: <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> Interventions to improve Generic and antibiotics prescribing indicators. <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> The patient-to-physician ratio should be revised to optimize consultation time. <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> The availability of key drugs should be improved to make sure effective treatment. <span style="white-space:nowrap;"><span style="white-space:nowrap;">•</span></span> The pharmacy cadre should be oriented and trained to improve patients’ compliance. </span><b><span style="font-family:Verdana;">Conclusion</span></b><span style="font-family:Verdana;">: The study concluded that there was irrational use of medicines when investigated by WHO drug core indicators. So, the study recommended interventions to improve the rationale prescribing, dispensing, and use of medicines.</span></span>
文摘Objective To explore the factors influencing the implementation of drug standards improvement in China,and to offer some suggestions for improving drug standards.Methods Factor analysis was used to investigate the influencing factors by referring to the literatures,experts’interview and collecting data through questionnaire,and then data were analyzed by SPSS21.0 statistical software.Results and Conclusion The results showed that there were four factors that affecting the plan of the national drug standards improvement.They were mechanism factor,design factor,constraint factor and motivation factor.And corresponding management suggestions for improving the efficiency of the plan were put forward.
