Objective To evaluate and select essential medicine for chronic obstructive pulmonary diseases (COPD) using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Nine guidelines were included (eight foreign guidelines, one domestic guideline; seven based on evidence, two based on expert consensus). (2) A result of one domestic RCT (n=72, high quality) indicated that tiotropium could significantly improve pulmonary function of severe COPD patient complicated with respiratory failure and increase their quality of life (SGRQ score: MD=–10.8%, 95%CI –12.2% to –9.4%). A result of one RCT (n=156, moderate quality) with 3-month follow-up indicated that tiotropium could significantly improve the proportion of measured value to expected value of FEV1 in patients with mild and moderate COPD in stationary phase (MD=10.3%, 95%CI 8.1% to 12.5%). A result of two RCTs (n=160, low quality) indicated that compound ipratropium bromide had efficiencies of 84.2% to 87.5% for moderate and severe COPD. A result of one RCT (n=60, moderate quality) indicated that salmeterol/fluticasone (inhalation) was superior to placebo for improving mild and moderate COPD in stationary phase. A result of one RCT (n=725, moderate quality) indicated that tiotropium combined with salmeterol/fluticasone for COPD in stationary phase was superior to tiotropium alone. A result of one RCT (n=110, low quality) indicated that nebulized budesonide inhalation had an efficiency of 86.8% for acute exacerbation of COPD (AECOPD) and an incidence of 7.9% as to adverse reaction that mainly included laryngo-pharyngeal irritation. (3) Imipenem, meropenem, cefoperazone/ sulbactam and ceftazidime were effective for COPD with low drug resistance rates in treating COPD caused by non-ICU pathogens (less than 8%). Conclusion (1) We offer a b recommendation for tiotropium, ipratropium, salbutamol, formoterol, salmeterol and theophylline used in the treatment of COPD in stationary and exacerbation phases, a b recommendation for streptococcus pneumoniae and influenza vaccines in preventing the deterioration of COPD, a b recommendation for inhaled corticosteroids (ICS) used in the treatment of COPD in stationary phase and a b recommendation for corticosteroids (for oral use) for AECOPD. (2) We offer a b recommendation for cefoperazone/sulbactam, imipenem and meropenem used in the treatment of moderate and severe AECOPD. (3) We offer a weak recommendation for ceftazidime, ciprofloxacin, lavofloxacin, moxifloxacin, amoxicillin amp; clavulanate potassium, amoxicillin, azithromycin, clarithromycin and doxycycline as first-line and second-line antibiotics for mild and moderate AECOPD, and a weak recommendation for compound sulfamethoxazole, cefatriaxone, cefotaxime and cefuroxime used in the treatment of severe and extremely severe COPD, mucolytic agents used in the treatment of stable COPD with difficult expectoration. (4) We make a recommendation against antibiotics, expectorants and corticosteroids (for oral use) as routine use in stationary phase of COPD.
Objective To review and evaluate the basic contents and development of the current global clinical guidelines for lung cancer practice so as to provide useful information for domestic study. Methods Six databases including PubMed (to June 2008) and relevant websites (both in Chinese and English) were searched. Articles were screened according to the predefined inclusion and exclusion criteria. The number of clinical guidelines was counted and the quality of guidelines was also assessed. Results A total of 208 articles were found to be clinical guideline-related and 133 were finally included. Of those, 78 were original versions and 55 were updated versions. And 86 articles mentioned guideline development methodology. The guidelines were issued by 14 countries/regions, mainly by USA (39.85%), Canada (24.81%) and France (8.27%). The earliest one was published by USA in 1984. 125 guidelines were issued by oncological or thoracic institutions, and the other 8 were not issued by specialized institutions or not specified. The 133 articles were classified into 3 major clinical categories: synthesis (24), multi-subject (21) and single-subject (88). As for quality evaluation, the average score of all guidelines was 72.09 (full score 100). The highest average score was found in 1996 which was 83.50, and the lowest in 1997 (66.80). The guidelines issued by France had the highest average score (79.80), and Japan, with the lowest average score (48.00). The average score of 4 categories of lung cancer were 73.54 (non-smallcell lung cancer), 65.74 (lung cancer), 74.72 (small-cell lung cancer), and 76.00 (bronchogenic lung cancer), respectively. Conclusion The number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries. The subjects included in the synthetic guidelines showed an expanding trend covering about 20 subjects from prevention to palliative care. A trend of multi-country contribution to the guidelines development and revision was noted. Researches became more focused on different types and stages. Evidence-based methodology was accepted globally in the clinical guideline development, but unfortunately very few applied the method of health technology assessment. China issued only 2 original guidelines, which were based on literature review and expert opinions, respectively. Due to the limitation of language restriction, inaccessibility of full-text articles and unavailability of authorized and specific quality evaluation protocols, the conclusions of this study should be interpreted with caution.
Objective To provide reference for medical risk management by evidence-based evaluation of the status of coal-mining risk management in China. Methods We searched databases of EI (1969 to 2005), SDOS (1995 to 2005), Vip (1989 to 2005), Wanfang (up to 2005), and CNKI (1994 to 2005), as well as some official websites, for English and Chinese articles related to coal-mining safety, risk management, precaution, and response to mine disasters in China. Results Total of 19 articles, including 9 official documents, 4 research articles, and 6 expert comments were included. Recently the number of coal-mining disasters has declined in China, but still much larger than that in US. The safety status of small coal mines (90% of total coal mines in China) was much more severe. The response and precaution system of coal mining disaster in China was poor. Conclusion Medical service in China may take the following measures based on lessons from coal mining industry to improve its risk management: ① Strengthen the management of small clinics (68.24% of total medical organizations in China); ② Train doctors and nurses to upgrade their perception of medical risk; ③ Establish self-report system of medical malpractices, errors, and accidents.
ObjectivesTo evaluate the characteristics, main contents, key elements and techniques of global drug value assessment tools, especially for those developed for antineoplastic agents, and to provide reference for the establishment of the first value assessment tool for antineoplastic agents in China.MethodsDatabases including MEDLINE, EMbase, CBM, CNKI, VIP, WanFang Data and 19 relevant websites of institutions and societies were searched from inception to October 31st, 2018 to identify all the drug value assessment tools worldwide. Two independent reviewers screened the literatures, extracted the data and cross-checked them according to the inclusion and exclusion criteria. A qualitative analysis was conducted to describe the characteristics of these drug value assessment tools, including the publishing organization, year of publication, country, applicable type of disease and drug category, result display, and etc. Key elements and techniques in terms of evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were compared.ResultsA total of 12 English drug value assessment tools were included, which were published in 2010 to 2018 exclusively from Europe and North America. The applicable types of diseases and drug categories are not identical. The target users and stakeholders of each tool were slightly different. Evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were vital issues in value evaluation for drugs.ConclusionsThe structures of existing drug value assessment tools were almost the identical. However, there is no consensus on value definitions, evaluation dimensions, sources of evidence and result display. Methods and procedures to form the tool are not well described. It is urgent to explore and develop a value-oriented, focused and feasible drug assessment tool for antineoplastic agents in order to satisfy the strategic requirements of value-based post-marketing drug reevaluation.
Objective To evaluate and select essential medicine for community-acquired pneumonia (CAP) using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Eleven guidelines were included (nine foreign guidelines, two domestic guidelines; nine based on evidence, two based on expert consensus). For CAP, amoxicillin amp; clavulanate potassium had efficiencies of 77.1% and an incidence of 18.8% as to adverse reaction that mainly included gastrointestinal reaction, skin rashes, etc. Piperacillin/tazobactam had an efficiency of 92.1% and a bacterial clearance rate of 88.9%. Cefuroxime had an efficiency of 89% and a bacterial clearance rate of 85.5%. There was no statistical significance between azithromycin and cefuroxime for CAP (RR=0.98, 95%CI 0.9 to 1.06); however, azithromycin was superior to cefuroxime in shortening fever-relief time (MD=–0.98, 95%CI –1.24 to –0.55) and cough-relief time (MD=–1.36, 95%CI –1.94 to –0.78). Efficiencies of ceftriaxone, cefotaxime, moxifloxacin and lavofloxacin were all more than 80% and among the three, moxifloxacin was the most efficient (RR=1.08, 95%CI 1.02 to 1.13, P=0.004). Meropenem had an efficiency of 90%, a bacterial clearance rate of 83.3% and an incidence of 3.33% as to adverse reaction that mainly included diarrhea. Conclusion (1) We offer a b recommendation for antibiotics such as amoxicillin, amoxicillin amp; clavulanate potassium, ampicillin/sulbactam, piperacillin/tazobactam, doxycycline, azithromycin, clarithromycin, cefuroxim, ceftriaxone, cefotaxime, lavofloxacin, moxifloxacin, ertapenem, meropenem, imipenem and vancocin. (2) We offer a weak recommendation for penicillin G, ciprofloxacin and erythromycin. (3) We propose that doctor should choose optimal antibiotics based on commonly-seen pathogenic bacteria that cause CAP, local criteria of antibiotic susceptibility, severity of CAP, and risk factors of patients.
Objective To evaluate and select essential medicine for the treatment of coronary heart disease by means of evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) 11 clinical guidelines on coronary heart disease were included, three of which are evidence-based guidelines. (2) Totally, those guidelines contained 61 medicines (of 13 classes). (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we made a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin as essential medicine for coronary heart disease. We made a weak recommendation for amlodipine, clopidogrel, heparin, propranolol, simvastatin and streptokinase. (4) 13 recommended medicines have been marketed in China and their prices were affordable. (5) Results of domestic low-quality studies indicated that nitroglycerin, isosorbide dinitrate, metoprolol, aspirin and heparin were effective for coronary heart disease. We didn’t find systematic reviews or pharmacoeconomic studies on the recommended medicines in Chinese literature databases. Conclusion For coronary heart disease: (1) We offer a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin and a weak recommendation for propranolol, amlodipine, clopidogrel, heparin, simvastatin and streptokinase. (2) There is lack of high-quality evidence from relevant domestic studies, especially on pharmacoeconomic evaluation. (3) We propose that more studies should be carried out on clinical guideline of coronary heart disease and pharmacoeconomic comparison should be also made between recommended medicine and medicine of the same class.
Objective To evaluate and select essential medicine for uterine neoplasms using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Six guidelines were included, three of which were evidence-based. (2) Retrieved guidelines related to nine medicines (of three classes) for uterine neoplasms and five adjuvant drugs (of three classes) used after relevant surgery. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guideline and the quantity and quality of evidence, we offered a b recommendation for medroxyprogesterone acetate, oxytocin, ergometrine and a weak recommendation for testosterone propionate, methyltestosterone, tamoxifen, mifepristone, tranexamic acid, leonurus heterophyllus used in the treatment of uterine neoplasms. We offered a recommendation against danazol and aromatase inhibitors. (4) We found relevant domestic literature on mifepristone, methyltestosterone, tamoxifen, oxytocin and leonurus heterophyllus. Mifepriston combined with methyltestosterone or tamoxifen was recommended to use as a conservative therapy for uterine neoplasms. Oxytocin,and leonurus heterophyllus were used to reduce bleeding after the surgery of uterine neoplasms. As to daily expense, mifepriston (25 mg/d) cost 13.0 to 27.5 yuan, methyltestosterone (5 mg/d) 0.074 yuan, tamoxifen (20 mg/d) 0.6 to 1.4 yuan, leonurus heterophyllus (injection, 1 mL) 15 yuan and oxytocin (injection, 20 U) 1.5 yuan. (5) Results of domestic studies indicated that mifepristone, mifepristone plus methyltestosterone, and mifepristone plus tamoxifen were proved to be safe and applicable for the treatment of uterine neoplasms. Oxytocin and leonurus heterophyllus are effective in preventing postoperative bleeding and the combination of two effectively and safely promoted uterine contraction. Conclusion (1) We offer a recommendation for three medication plans used in the treatment uterine neoplasms during perimenopause, including: a) Mifepristone (25 mg/ tablet, once daily); b) Mifepristone (25 mg/ tablet, once daily) plus methyltestosterone (5 mg/tablet, once daily); c) Mifepristone (25 mg/ tablet, once daily) plus tamoxifen (10 mg/tablet, twice daily). The three plans mentioned above should be used from first day of menstrual cycle, continuously for three months. (2) Adjuvant drugs such as oxytocin (injection, 1 to 2 mL) and leonurus heterophyllus (injection, 10 U) can be applied to reduce vaginal bleeding flow after the surgery of uterine neoplasms. (3) Personnel in elementary healthcare institution should stick to drug indication, carefully make follow-up, and dynamically monitor the change of uterine neoplasms and menstruation so as to adjust medication plan according to patients’ situation.
Objective To provide the evidence on the selection and related policies of essential medicine for policy-makers through systematic review of the National Essential Medicine List(NEML) around the world. Method We systematically searched the official websites of the health authorities, like the departments of health and pharmaceutical administrations. We selected the published NEML. Two reviewers independently selected literature and extracted data. We analyzed the time of NEML published and updated, NEML committees, selection criteria, medicine category, number of medicines, and medicine information in NEML and standard treatment guidelines (STGs) as well. Results Thirty-six NEMLs from 25 countries were included with 34 in English and 2 in Chinese. From 1982 to 2009, Twenty-five countries developed their NEMLs respectively. They were updated from four months to eight years. The NEML committee members came from central government, ministry of health, pharmaceutical administrations, ministry of public health, ministry of education, essential medicine division, etc. The committees were composed of clinical specialists, health officials, pharmacists (pharmacologists), medicine educators, economist, statisticians, epidemiologist and experts from WHO/UNICEF, etc. Most of the countries took the WHO’s concept of essential medicine and selection criteria as standard. The applications of essential medicine were reviewed by considering the following aspects: safety, effectiveness, economic characteristics, the main disease burden, rational use of drug and supply. The medicines in NEMLs of 25 countries varied from 103 to 2 033, and the median is 447. The Anatomical Therapeutic Chemical (ATC) classification was used to classify the medicines in NEMLs of 12 countries. The drug information was provided, including generic name, dosage, form of medication and administration route as well. The STGs or formularies covered from 73 to 167 common diseases, including the diagnosis, treatments, rational use of drug, contraindications, adverse effects, etc. Conclusions The NEMLs in 25 countries have shown great differences because of the variation of the social and economic developments, disease burdens and the developments of health care systems in different countries. We can learn from the experience of other countries, like Australia and South Africa, in the selection and use of essential medicines, STGs and related policies. We should develop the national essential medicine system for policy making and administration, especially the national essential medicine list for common diseases base on the high quality evidence, the local disease burden as well as specific demands in different areas.
Objective To review and evaluate the global clinical research literatures about the surgical management for prostatic abscess in the past decade, so as to provide useful information for clinical practice. Methods Based on the principles of evidence-based medicine, and the methods of bibliometrics, the PubMed database was searched from January 1st 2000 to April 10th 2011. The literatures about prostatic abscess were screened according to the predefined inclusion and exclusion criteria, the quality was assessed, the valid data were extracted and then systematical evaluation was performed after the establishment of the database with OpenOffice.org 3.8 Calc. Results a) A total of 205 articles were found initially and 81 were finally included with the total 388 cases involved (on average, 4.79 cases per paper). The patients’ ages ranged from 10 days to 83 years old. Two studies were diagnostic tests, and all the other 79 were surgical intervention studies; b) There was no controlled clinical trail. A total of 16 studies involving more than 5 cases for each and 311 cases in all which were retrospective case analyses, all the other 65 were individual case reports; c) American scholars published 13 papers (16.5%), ranked as the first. American and European scientists published 36 papers (44.44%). Chinese scholars published quite fewer studies, of which only 2 were in English; d) The incidence increased in younger patients gradually. The pathogens included fungi and bacteria. Most bacteria were gram-positive cocci (such as Staphylococci), followed by gram-negative bacillus (such as Klebsiella). There were also some minority pathogens. The pathogens were complex and quite diverse in different districts. The predisposing factors included both regional and systematic conditions, with diabetes mellitus, hepatocirrhosis, manipulations of lower urinary tract and urinary tract infections as the common; e) The diagnostic procedures included evaluation on symptoms and signs, physical examination, identification of pathogens, and medical imaging examinations (TRUS, CT, MRI). The therapeutic options included routine managements, conservative antibiotic therapies and surgical drainages. The surgical routes were transcutaneous, transperineal, transrectal, and transurethral. The fine needle aspiration, indwelling catheter drainage, or incision and drainage were performed under the guidance of TRUS, EUS or CT through transperineal or transrectal routes. The TUR, TURP or TUIP drainages were performed through transurethral route. The failed cases of fine needle aspiration were then treated by transurethral or transperineal incision and drainages, and some patients were also treated by urinary diversion; f) The best surgical method could not be concluded for lack of controlled data; and g) Few cases died from severe complications, and the outcomes of the majority cases were good. Conclusion a) The literatures about prostatic abscess are abundant but of low quality, with all retrospective studies or individual case reports, and most are published by American and European scholars; b) The prostatic abscess affects all ages but tends to increase in the young. Most pathogens are the gram-positive cocci (such as Staphylococci) ranked as the top and followed by gram-negative bacillus (such as Klebsiella), and the pathogens are obviously diverse in different districts; c) The predisposing factors are commonly seen as diabetes mellitus, hepatocirrhosis, manipulations of lower urinary tract and urinary tract infections; ......
Objective By reviewing and analyzing the experiences and lessons of American hurricane risk management, this study aims to explore the possible application of constructing the system for medical risk management in China. Methods We searched the EI database (1969 to 2005), OVID database (1966 to 2005), Superstar electronic library and some websites such as Federal Emergency Management Agency (FEMA), National Oceanic and Atmospheric Administration (NOAA), and Centre for Disease Control and Prevention (CDC). The retrieved articles were screened independently by two reviewers according to the inclusion and exclusion criteria. The included articles were classified and the quality was ranked. Results Total of 227 articles and 1 book met the eligibility criteria. The articles related to risk prediction occupy 73.13%. The American hurricane database can be traced back to 1886. Disaster Relief Act was promulgated in 1950, and there were various types of policies for disaster risk management. The FEMA, set up in 1979, played a key role in disaster risk management. The precaution was announced according to the different levels of hurricane risk, and the forecasts were mainly made by NOAA. The American government and some non-governmental organizations were involved in hurricane emergent responses concerning both physical and mental health of the public. In addition, there were many methods to evaluate and predict hurricane risk. The main lessons from hurricane Katrina risk management lay inunderestimation of the risk and political discrimination. Conclusion There are both distinctive advantages and disadvantages in the present status of American hurricane risk management. As the monitoring and precaution system of medical risk management in China are still in an initial stage, we can learn the experience and lessons from American hurricane risk management to construct and run our system of medical risk management better.