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 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 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.
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; ......
ObjectiveTo learn the development and implementation of orphan drug policies, in order to provide decision-making references for the establishment of orphan drug policy according with China's national conditions. MethodsWe electronically searched databases including CBM, CNKI, VIP, EMbase, PubMed, Web of Knowledge, National Library of Medicine, CRD database, The Campbell Library, The Cochrane Library and the drug administration websites of USA, Canada, UK, Ireland, the Netherlands, Germany, Spain, France, Australia, New Zealand, China, India, South Korea, Japan, and South Africa to collect studies about orphan drug policy. The search date was up to February 2014. Two reviewers independently screened literature, and extracted data. Then, all included orphan drug policies were summarized and a comparative analysis was performed. ResultsA total of 110 studies were included. USA, Singapore, Japan, Australia, European Union, Chinese Taiwan and South Korea had introduced orphan drugs incentive policies. South Africa, India, Canada, New Zealand and Chinese Hongkong were producing orphan drugs policy frameworks. The main items of orphan drug policy included marketing exclusivity, tax incentives, technical assistance, grant funding, expedite approval process and prolong re-evaluated time. ConclusionIn mainland China, there is no orphan disease management policy. China should establish specific organization and working procedures, promote orphan drug policy related legislative work, clarify the definition and prevalence of orphan diseases, provide incentive mechanism to promote the research and development of orphan drugs, provide enterprises to develop compensation mechanism to safeguard the rights and interests of patients, as well as establish patients register network platform to track the processes of the diseases.
Objective To evaluate and select essential medicine for bone fracture 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) 17 guidelines were included, six of which were evidence-based or based on expert consensus. We found that for fracture, global guidelines recommended surgical treatment and analgesics, while domestic guidelines recommended Chinese patent drugs. (2) A result of one RCT (low quality) indicated that Shang Ke Jie Gu Pian (name of a Chinese patent drug) shortened the clinical recovery time of fracture (MD=–4.2, 95%CI –5.25 to –3.14). A result of one RCT indicated that Shang Ke Jiu Ji Pian had a higher total clinical efficiency compared with San Qi Pian (name of a Chinese patent drug) (RR=1.28, 95%CI 1.11 to 1.47). A result of one RCT (low quality) indicated that Shang Ke Jiu Ji Pian (name of a Chinese patent drug) had a better effect than Shenyang Hong Yao Pian (name of a Chinese patent drug) in promoting the growth of osteotylus (RR=1.48, 95%CI 1.27 to 1.73) and also it had a higher clinical recovery rate (RR=1.62, 95%CI 1.37 to 1.9) compared to Shenyang Hong Yao Pian. A result of one RCT (moderate quality) indicated that Shang Ke Jiu Ji Pian was slightly better than Die Da Wan (name of Chinese patent drug) in regard to the recovery score of fracture (MD=0.25, 95%CI 0.026 to 0.47). A result of one RCT (low quality) indicated that compared to fracture reduction alone Shang Ke Jiu Ji Pian efficiently relieved pain (MD=–25.9, 95% –32.6 to –19.19) and shortened pain time (MD=–38.6, 95% –41.44 to –35.77). A result of one quasi-RCT (low quality) indicated that Shang Ke Jiu Ji Pian had a higher efficiency in relieving pain than benorylate (RR=1.13, 95%CI 1.04 to 1.23). A result of one RCT (low quality) indicated that Shang Ke Jiu Ji Pian had a higher efficiency than Shenyang Hong Yao Pian in relieving pain and swelling (RR=2.4, 95%CI 1.88 to 3.02). A result of one RCT (moderate quality) indicated that Shang Ke Jiu Ji Pian was superior to Die Da Wan in relieving pain and swelling (MD=–0.4, 95%CI –0.60 to –0.2). A result of two RCT (n=198) indicated that Shang Ke Jie Gu Pian caused no adverse reaction. With good applicability, Shang Ke Jie Gu Pian (taken with warm water or rice wine) cost 7.47 yuan daily. Conclusion (1) We offer a b recommendation for Shang Ke Jie Gu Pian and Jie Gu Qi Li Pian used in the treatment of adult fracture. (2) We should carry out more large-sample and controlled trials and improve outcome indicator in order to produce high-quality local evidence.
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 systematically evaluate the structure, publication type and contents of current guidelines for guideline development, so as to provide methodology references for guideline development in China. MethodsSix biomedical research literature databases, six guideline databases and 18 websites of academic institutions and health administrative departments were searched to locate guidelines for guideline development. We included the latest versions of guidelines from guideline development departments or academic institutions. We extracted information consisting of general guideline information, structure, principles, methods and procedure of guideline development. A descriptive analysis was conducted to analyze the general information, structure, principles, methods and procedure of guidelines among different guidelines for guideline development. ResultsAmong all the included 25 guidelines for guideline development published from 1998 to 2014, 50% of them were from North America. Structure of these guidelines were similar while detail levels of recommended guideline development methods and procedures were slightly different. The guideline development groups, systematic literature search, evidence assessment and recommendation formulation were vital part of guideline development. The ineffective promotion and implementation of guidelines for guideline development were common problems of current guidelines. ConclusionsProcedures recommended by current guidelines for guideline development are almost the same, but the methods and statements are different. We could develop our own guideline for guideline development based on the current relative high-quality guideline in order to provide guidance to the clinical guideline development in China.
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.