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 To evaluate and select essential medicine for diabetes mellitus 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 and published from 2006 to 2011. (2) Five recommended medicines were included according to recommendations and evidence of WHOEML (2011), NEML (2009), CNF (2010) and other guidelines. They were metformin, glibenclamide, glipizide, rosiglitazone and pioglitazone. Domestic evidence of the first three drugs was evaluated. (3) The first three have been marketed with the specifications and dosage forms corresponding to guidelines in China. The FBG cost-effectiveness ratios of metformin with different dosage forms as immediate release compressed tablet, enteric-coated tablet and sustained release capsule were 3.37, 3.76 and 3.50 respectively. 2-hour BG cost-effectiveness ratios of metformin were 3.74, 4.00 and 3.71 respectively. The cost-effectiveness ratio of glibenclamide and glimepiride were 11.23 and 13.81 respectively. Conclusion We offer a recommendation for: (1) Metformin (immediate release tablet/capsule for oral use, 0.25 g), contraindicated in patients with renal insufficiency. (2) Glibenclamide (tablet, 2.5 mg; capsule, 1.75 mg) and glipizide (tablet, 2.5 or 5mg; dispersible tablet, 5 mg), contraindicated in children, women during pregnancy or lactation, patients in the perioperative period of major operation, patients after total pancreatectomy, and patients allergic or adversely reacted to sulfa drug. (3) Evidence-based and standardized primary healthcare guidelines as well as clinical and pharmacoeconomic studies on diabetes mellitus (large-scale, multi-centre, randomized and double-blinded) are needed to produce high-quality local evidence.
Objective To evaluate and select essential medicine for acute exacerbation of chronic bronchitis (AECB) 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) Five guidelines were included (four foreign guidelines, one domestic guideline; three based on evidence, two based on expert consensus). (2) Medicines recommended at least twice by the National Essential Medicine List (NEML, 2009 version) and Chinese National Formulary (CNF) contained: ipratropium bromide (four times), amoxicillin amp; clavulanate potassium (three times), and corticosteroid (three times), cefuroxime (twice), ciprofloxacin (twice), levofloxacin (twice), salbutamol (twice) and dextromethorphan (twice). (3) As for domestic study evidence, a result of one RCT indicated that amoxicillin amp; clavulanate potassium had efficiencies of 92.3% to 94.7% (n=77, low quality). A result of three RCTs (n=275, low quality) indicated that cefuroxime had efficiencies of 67.6% to 90% and an incidence of 5% as to adverse reaction that mainly included skin rashes, diarrhea, etc. A result of two RCTs (n=120, low quality) indicated that ciprofloxacin had efficiencies of 78.3% to 86.6%, bacterial clearance rates of 72.7% to 86.5% and the incidences of 8.7% to 16.2% as to adverse reaction that mainly included gastrointestinal reaction, skin rashes, etc. A result of seven RCTs (n=523, low quality) indicated that levofloxacin had efficiencies of 72.5% to 94.5%, bacterial clearance rates of 82.1% to 95.8% and the incidences of 5% to 7.5% as to adverse reaction. A result of two RCTs (n=239, low quality) indicated that salbutamol had efficiencies of 85.4% to 96.7%. A result of one RCT (n=95, low quality) indicated that ipratropium bromide had efficiencies of 98%. A result of five RCTs (n=466, low quality) indicated that the combined use of budesonide and bronchodilators had efficiencies of 93.4% to 97.8%. Conclusion (1) We offer a b recommendation for cefuroxime, amoxicillin amp; clavulanate potassium, ciprofloxacin and levofloxacin used in the treatment of AECB. (2) We offer a b recommendation for glucocorticoid (budesonide, aerosol) and anticholinergic bronchodilator (ipratropium bromide) and a weak recommendation for short-acting β2-agonist bronchodilator (salbutamol) and antitussive agent (dextromethorphan) for alleviating symptoms due to AECB. (3) We make a recommendation against mucolytic agents and theophylline as routine use. (4) More large-scale, multi-center, double-blinded RCTs are needed in clinical and pharmacoeconomic studies on AECB and outcome indicator should be improved in order to produce high-quality local evidence.
Objective To evaluate and select essential medicine for middle-aged and elderly women with primary osteoporosis 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) 18 guidelines were included, 14 of which were evidence-based or based on expert consensus. Recommended medicines included bisphosphonates, calcitonin, estrogen, parathyroid hormone, selective estrogen receptor modulator, strontium and Chinese patent drug. (2) A result of one quasi-RCT (very low quality) indicated that caltrate D had a better effect on elderly women with primary osteoporosis than calcium gluconate in improving bone mineral density (BMD) (MD=0.04, 95%CI 0.02 to 0.06) and ameliorating bone ache ( RR=2.64, 95%CI 1.40 to 4.96). A few cases treated by caltrate D presented with adverse reaction such as gastrointestinal discomfort, poor appetite, constipation and nausea which disappeared later. Caltrate D (calcium carbonate D3) with good applicability cost 1.00 yuan daily. (3) A result of one RCT (low quality) indicated that alendronate had a better effect than caltrate D in improving L2-L4 BMD (MD=0.06, 95%CI 0.017 to 0.10) and ameliorating bone ache (RR=1.8, 95%CI 1.40 to 2.52). A result of two RCTs (moderate quality) indicated that alendronate plus calcium carbonate plus vitamin D6 had a better effect than calcium carbonate plus vitamin D in improving L2-L4 BMD (MD=0.05, 95%CI 0.02 to 0.08) and reducing blood alkaline phosphatase (MD=–31.9, 95%CI –54.99 to –8.81). There were slight adverse effects mainly including gastrointestinal reaction. Alendronate with fairly poor applicability cost 2.67 yuan daily. (4) A result of one RCT (moderate quality) indicated that after a 3-month treatment, Xian Ling Gu Bao Jiao Nang (name of a Chinese patent drug, abbreviated as XLGB) plus calcium preparation had a better effect than calcium preparation alone (MD=10, 95%CI 0.05 to 0.15). A result of one RCT (moderate quality) indicated that given for 3 to 6 months, XLGB plus calcium preparation was superior to calcium preparation alone in increasing the density of Ward’s triangle and the great femoral trochanter. A result of one RCT (low quality) indicated that XLGB plus calcitriol had a better effect than calcitriol alone in pain relief (RR=1.26, 95%CI 1.04 to 1.52). There were slight adverse effects mainly including reaction in the digestive system, the circulatory system and the skin. XLGB with good applicability cost 4.58 yuan daily. Conclusion We offer a weak recommendation for alendronate applied to middle-aged and elderly women with primary osteoporosis and pain and fracture caused by primary osteoporosis. We also offer a b recommendation for caltrate D and XLGB applied to middle-aged and elderly women with primary osteoporosis and pain and fracture caused by primary osteoporosis. In addition, we propose that the census on elder people with osteoporosis in rural areas should be carried out. More clinical and pharmacoeconomic studies of large-sample, high-quality on alendronate and its calcium preparation for adult osteoporosis are needed in China.
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 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 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.
Objective To evaluate and select essential medicine for children with fever and adult gastrointestinal flu caused by common cold using 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) 12 guidelines were included, 11 of which were evidence-based or based on expert consensus. We offered a recommendation for medicines used in the treatment including analgesics and antipyretics, decongestants, antihistamines, cough-relieving drug, phlegm-removing drug and drug for gastrointestinal symptoms. (2) A result of four RCTs (very low quality) indicated that in the treatment of children with cold, ibuprofen suspension had an antipyretic effect similar to paracetamol solution (for oral use) with a pooled result of 6-hour efficiency in relieving fever (RR 1.48, 95%CI 0.66 to 3.30, P=0.34). The major adverse effects of ibuprofen suspension included gastrointestinal reaction and profuse sweats (RR=1.23, 95%CI 0.72 to 2.11, P=0.45). With good applicability, ibuprofen suspension (for oral use with no need to be supervised) cost 1.93 yuan daily. (3) A result of three RCTs (low quality) indicated that after given for 30 minutes and one hour, paracetamol solution (suppository) was fairly superior to ibuprofen suspension in lowering the high temperature caused by fever (given for 30 min: MD= –0.16°C, 95%CI –0.21 to –0.11, Plt;0.01; given for one hour: MD= –0.19°C, 95%CI –0.28 to 0.10, Plt;0.01). As to adverse reaction, paracetamol solution (suppository) mainly included anal irritation, skin rashes and profuse sweats, which had a comparative result of incidence with ibuprofen suspension (RR=1.84, 95%CI 0.62 to 5.44, P=0.27). For children with fever, paracetamol solution (suppository) cost 0.90 yuan daily. With good applicability, paracetamol solution (suppository) was administered via the anus. Conclusion (1) We offer a b recommendation for ibuprofen suspension (2 g/100 mL) or acetaminophen (0.1 g/suppository) as symptomatic treatment used in children with fever, pain and discomfort caused by common cold, and for Huo Xiang Zheng Qi Jiao Nang (0.3 g/ capsule) used in adults with gastrointestinal flu. We also offer a weak recommendation for acetylcysteine (injection, 300 mg/mL, 10 mL/ampoule) used in patients with paracetamol poisoning. (2) In order to produce high-quality local evidence, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on ibuprofen suspension and acetaminophen suppository in the treatment of children with fever, pain and discomfort caused by common cold should be further carried out. Besides, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on Chinese patent drugs of Huo Xiang Zheng Qi used in chidren and Huo Xiang Zheng Qi Jiao Nang used in adults should further carried out. Moreover, we suggest that epidemiological investigation as well as clinical and pharmacoeconomic studies of acetylcysteine injection for paracetamol poisoning should be carried out and the instructions of acetylcysteine injection should be added in the guidelines of essential medicine in China. Finally, further studies on evidence of oxymetazoline, dextromethorphan and other Chinese patent drugs with the effect of relieving cough and treating cold should be carried out.
Objective To evaluate and select essential medicine for herniated lumbar disc 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) Six clinical guidelines on herniated lumbar disc were included, five of which were evidence-based. (2) In total, there were 35 medicines (of four classes) listed in the guidelines. (3) We offer a b recommendation for paracetamol and ibuprofen as essential medicine and a weak recommendation for aspirin, indometacin and diazepam according to WHOEML (2011), NEML (2009), CNF (2010), clinical guidelines and the quantity and quality of evidence. (4) Five recommended medicines have been marketed in China with the dosage forms and specifications corresponding to guidelines and their prices were affordable (0.31 to 3.38 yuan daily). (5) Results of domestic low-quality studies indicated that ibuprofen and aspirin were effective with efficiencies of 63% to 84.5%; however, both of which were less effective than other trial medicines (efficiencies: 88.60% to 95.2%). We didn’t find any efficacy or pharmacoeconomic evidence of other medicines in Chinese literature databases. Conclusion (1) Pharmacotherapy should focus on symptomatic treatment of herniated lumbar disc. (2) We offer a b recommendation for paracetamol and ibuprofen used in the treatment of herniated lumbar disc and a weak recommendation for aspirin, indometacin and diazepam. (3) There is lack of evidence and high-quality guidelines on pharmacotherapy of lumbar intervertebral disc in China, especially pharmacoeconomic evidence. (4) We propose that guidelines should be established in basis of evidence so as to effectively direct clinical treatment. The effect of medicine in clinical practice should be based on current evidence from inside and outside China.
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.