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 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 antihypertensive medicine 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) Five clinical guidelines on hypertension were included, two of which were evidence-based. (2) Totally there were nine classes and 70 antihypertensive medicines listed in the guidelines. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines, and the quantity and quality of evidence, we offered a b recommendation for nifedipine, verapamil and enalapril and a weak recommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, metoprolol and amlodipine. We made a recommendation against furosemide and timolol due to the lack of evidence from guidelines. (4) Nine recommended medicines have been marketed with the dosage forms and specifications corresponding to guidelines in China. The prices of metoprolol, amlodipine and enalapril were higher than those of other six (daily cost: metoprolol 3.80 to 7.60 yuan, amlodipine 2.16 to 4.32 yuan, and enalapril 0.86 to 6.88 yuan). As a whole, the prices of recommended antihypertensive medicine were affordable. (5) Results of domestic studies indicated that three bly-recommended medicines (including nifedipine, verapamil and enalapril) were safe, effective, economical and applicable. Conclusion (1) We offer a b recommendation for nifedipine, verapamil and enalapril as antihypertensive medicine and a weak recommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, metoprolol and amlodipine. (2) There is lack of high-quality evidence from relevant domestic studies, especially on long-term safety and pharmacoeconomic evidence. (3) We propose that more studies should be carried out on the safety, efficacy and pharmacoeconomics of six medicines for which we make a weak recommendation to produce high-quality local evidence.
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 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.
Objective To evaluate evidence from American medical risk monitoring and precaution system (AMRMPS) which may affect the construction of Chinese medical risk monitoring and precaution system (CMRMPS). Methods We searched relevant databases and Internet resources to identify literature on AMRMPS, medical errors, and patient safety. We used the quality evaluation system for medical risk management literature to extract and evaluate data. Results In 1999, a report from the Institute of Medicine (IOM) not only showed the severity and cause of medical errors in America but also gave the solution of it. In 2000, the Quality Interagency Coordination Task Force (QuIC) was appointed to assess the IOM report and take specific steps to improve AMRMPS. After 5 years, a well-developed medical risk management system was established with the improvement in the public awareness of medical errors, patient safety, performance criteria of medical safety, information technology and error reporting system. There was still some weakness of this system in risk precaution and prevention. Conclusion The experience from AMRMPS can be used to establish the CMRMPS. Firstly, we should disseminate and strengthen the awareness of medical risk and patient safety in public. Secondly, we should establish hospital audit system which includes auditing of medical staff and course of medical risk in continuing and academic education. Thirdly, we should develop regulations and guidelines on health care, medical purchase and drug supply which will benefit in management of regular work. Fourthly, we should develop computer information system for hospital which will regulate the management without the disturbance from human. Lastly, we should emphasize outcome evaluations and strive for perfection during the process.
Objective To evaluate and select essential medicine for acute and chronic gastritis 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) Five guidelines for acute gastritis and seven guidelines for chronic gastritis were included. The recommended included omeprazole, ranitidine and domperidone. (2) A result of three CCTs (n=315, low quality) indicated that omeprazole was superior to famotidine and ranitidine in alleviating symptoms of chronic gastritis such as pain or discomfort in the upper abdomen, regurgitation, a burning sensation in the heart, distention and fullness in the upper abdomen (71.2% vs. 47.3%, 94.4% vs. 84.3%, Plt;0.05). A result of one RCT (n=100, low quality) and two CCTs (n=213, low quality) indicated that in HP eradication rates, omeprazole triple therapy and the control intervention had no significant difference (OR=1.09, 95%CI 0.44 to 2.70, Pgt;0.05). A result of one RCT (n=100, low quality) indicated that omeprazole caused no adverse reaction. A result of five CCTs (n=528, low quality) indicated that adverse reaction of omeprazole included poor appetite (two cases), nausea and vomiting (four cases), headache or vertigo (one case) and increased transaminase (one case). Omeprazole cost eight yuan (tablet) or four yuan (capsule) daily. (3) HP eradication rates of ranitidine bismuth citrate was higher than the control group (OR=2.05, 95%CI 1.29 to 3.25, P=0.002). A result of 15 RCTs (n=3 638, high quality) indicated adverse reaction of ranitidine bismuth citrate mainly included symptoms in the digestive system. A result of one RCT (n=100, low quality) indicated ranitidine bismuth citrate and omeprazole triple therapy had no significant difference (Pgt;0.05) and ranitidine bismuth citrate caused no adverse reaction. Ranitidine cost 0.36 yuan (tablet), 0.40 yuan (capsule) or 2.7 to 5.4 yuan (injection) daily. (4) A result of two CCTs (n=133, low quality) indicated that compared with the control intervention, domperidone was more efficient without adverse reaction in improving indigestion, promoting gastric emptying effect, and alleviating pain and distention in the upper abdomen, belching and regurgitation. Domperidone cost 1 to 1.3 yuan daily. (5) All kinds of recommended medicines are listed and legalized in China Pharmacopoeia (2010) and CNF (2010). (6) In clinical setting, above-recommended medicines should be applied strictly according to the CNF (2010) and the National Clinical Prescription Guidelines for Essential Medicine. Conclusion For acute and chronic gastritis, indigestion and HP eradication: (1) We offer a b recommendation for omeprazole (immediate release tablet/capsule for oral use, 10 mg/tablet) which should be cautiously used in children, elderly people, and women during pregnancy or lactation. (2) We offer a b recommendation for ranitidine (immediate release tablet/capsule for oral use, 150 mg/tablet) which should be cautiously used in patients with severe insufficiency in the liver or kidney, women in the pregnancy or lactation, and children under eight years of age.
Objective To evaluate and select essential medicine for the treatment of cerebral circulation insufficiency by means of evidence-based approaches based on the burden of disease for township health centers located in the 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) Five clinical guidelines on transient ischaemic attack/ischaemic stroke were included, all of which were evidence-based clinical guidelines. (2) In total, there were 13 medicines (of five classes) listed in these guidelines. (3) We offer a b recommendation for aspirin as essential medicine for cerebral circulation insufficiency and a weak recommendation for warfarin, clopidogrel, heparin, paracetamol, insulin, normal saline and glucose/dextrose. We made a recommendation against tPA, GPⅡb/Ⅲa and antibiotics according to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence. (4) Recommended medicines have been marketed in China and their prices were affordable except Clopidogrel’s. (5) Some results of domestic low-quality studies indicated that recommend medicines were safe and effective, which had significant differences compared to high-quality evidence from foreign studies. Further studies were needed to be confirmed. Conclusion (1) We offer a b recommendation for aspirin and a weak recommendation for warfarin, clopidogrel, heparin, paracetamol, insulin, normal saline and glucose/dextrose. We make a recommendation against tPA, GPⅡb/Ⅲa and antibiotics. (2) There is lack of high-quality evidence from relevant domestic studies, especially on long-term safety and pharmacoeconomic evidence. (3) We propose that more studies should be carried out on the safety, special efficacy and pharmacoeconomic of Chinese medicine, Chinese medicinals and medicine with special efficacy. Besides, we also compare recommended medicine with those of the same class and construct Level 1 to 2 systems of preventing and treating cerebral vascular diseases.
Objective To evaluate and select essential medicine for abortion using evidence-based approaches 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) Four guidelines on medicine for abortion were included, two of which are based on evidence. (2) Included guidelines referred to eight essential medicines used in drug abortion and four antibiotics used after abortion 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 misoprostol, mifepristone, oxytocin except prostaglandins used in abortion. (4) Published literature on oxytocin, misoprostol and mifepristone were found. Oxytocin with the dosage form and specification corresponding to guidelines has been marketed in China. Oxytocin (in vial, 10 U∶1 mL) cost 1.5 yuan/injection. Mifepristone (tablet, 25 mg×1) cost 13.0 to 27.5 yuan/tablet. Misoprostol (0.2 mg×3) cost 2.8 to 3.7 yuan/ tablet. (5) Results of domestic studies indicated that mifepristone combined with misoprostol and oxytocin was safe, efficient, convenient and applicable to the treatment of abortion. Conclusion For abortion: (1) We make a recommendation for mifepristone plus misoprostol. Mifepristone (25 to 50 mg/tablet) is orally taken twice a day, continually for 2 to 3 days, the total dose of 150 mg for three days. Misoprostol (0.2 mg/ tablet) 0.6 mg is orally given on an empty stomach within 36 to 48 hours after the intake of mifepristone. (2) Oxytocin (5 to 10 U in vial) injected after delivering the placenta can reduce the volume and time of vaginal bleeding. In future, clinical study should be standardized in order to improve design and implementation quality.
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.