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 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.
Abstract Objective To investigate the disease constitution and hospitalization expenses in Songqiao Central Township Health Center (SqC) in Gaoyou City of Jiangsu Province in 2010, so as to provide the baseline data of disease burden for further study. Methods The inpatient records of SqC in 2010 were collected. The first discharge diagnoses were classified according to the International Classification of Disease 10 (ICD-10). The general information of the inpatients, discharge diagnosis, hospitalization expenses, disease category, age, gender, and reimbursement of expenses were described and analyzed by using Microsoft Excel 2003 and SPSS 13.0 software. Results a) The total number of inpatients was 1036 in 2010, and the gender ratio was about 1.0 (50.7% vs. 49.3%); b) The disease spectrum included 17 categories. The cumulative percents of the top 5 systematic diseases were 81.2%, including the respiratory, digestive, neoplasm, circulatory diseases, and injury, poisoning amp; external causes; c) The top 15 diseases were pneumonia, fracture, malignant neoplasm, benign neoplasm, acute bronchitis, cerebral infarction, hypertension, acute appendicitis, emphysema, cholecystolithias accompanied with cholecystitis, inguinal hernia, coronary heart disease, diabetes mellitus, chronic bronchitis and superficial injury; d) The patients suffering from pneumonia and acute bronchitis were mainly over 65 years old and younger than 5; e) The number of chronic diseases significantly increased with age, especially after the age of 35 years old, and reached the peak at the age over 65 years old; while the acute diseases were mainly distributed at the age younger than 15 yeas old and older than 65 years old. The average length of stay, the total hospitalization and out-of-pocket expenses per capita of the chronic diseases were more than those of the acute ones (13.8 days vs. 9.9 days, ? 3 082 vs. ? 2 615; ? 417 vs. ? 371, respectively); f)The length of stay and total hospitalization per capita were quite higher than the other township health centers (11.6 days vs. 5.2 days, ? 3 001.4 vs. ? 1 004.6); and g) Both of the total reimbursement and out-of-pocket expenses per capita accounted for 44%-57% of the total hospitalization expenses. Among the total reimbursement, the payment from New Cooperative Medical Scheme (NCMS) accounted for over 99%, while that from Medical Aid Scheme only accounted for less than 2%. Conclusion a) The top 3 systematic diseases of SqC are seen in respiratory system, digestive system and neoplasm. The acute diseases are mainly pneumonia and fracture; b) The number of acute or chronic diseases increases significantly with age, especially after 35 years old. Both adolescents and the aged suffer from the heaviest burden of diseases; c) The average length of stay and hospitalization expenses pre capita of SqC are much higher than those of the other township health centers; and d) NCMS is the major source of reimbursement. However, the proportion of out-of-pocket expenses and the burden of diseases are still very high and heavy. Thus the policy of NCMS needs to be adjusted step by step in future.
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 provide baseline data for further evidence-based evaluation and selection of essential medicine by analyzing the inpatient disease constitution in 8 pilot township health centers located in eastern, central and western China in 2010. Methods The analysis was performed to compare the similarities and differences of both systematic diseases and top 15 single diseases of inpatients in 8 pilot township health centers located in eastern, central and western China in 2010. The Microsoft Excel 2003 and SPSS 13.0 softwares were used for data classification and analysis, and the frequency and composition were used as describing statistical indicators. Results a) The top 5 systematic diseases were respiratory, digestive, circulatory, urinary tract and urogenital systems, as well as the trauma and toxicosis, with accumulative constituent ratio accounting for 71.0%-81.6%; b) The inpatients suffering from top 15 systematic diseases were 10 630, accounting for 61.10%. Each of the respiratory and digestive system contained 6 single diseases including 4 acute and 2 chronic ones, with inpatients accounting for 99.2% and 93.8%, respectively; the circulatory system contained 3 single diseases which were all chronic with inpatient ratio of 84.6%; and c) The chronic diseases were in majority within the top 15 single diseases, which were most commonly seen rather than acute diseases in the pilot township health centers in eastern and central China. The inpatients’ acute diseases were more often seen than chronic diseases in well-off and fundamental township health centers. Conclusion a) The top 5-6 systematic diseases are stable in the pilot township health centers in eastern, central and western China in 2010. The common single inpatient diseases are centralized, which benefits the selection and adjustment of essential medicine for the pilot township health centers in China; b) The capacity building of the western, fundamental and well-off township health centers to diagnose and treat inpatients suffering acute diseases should be promoted; c) The capacity building of the central and general township health centers to diagnose and manage inpatients suffering chronic diseases should be promoted; d) The capacity building of the eastern and well-off township health centers to provide outpatient service should be promoted. The function of the eastern township health centers needs further clarification and improvement; and e) More attention should be paid to diseases prevention, control and treatment for women, children, the elderly and the population with high burden of diseases.
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 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 acute gastroenteritis 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 were included, two of which were evidence-based. (2) Recommended medicines included eight antidiarrheals (of four classes) and three antemetics. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we offered a weak recommendation for ondansetron, metoclopramide, smectite, racecadotril and loperamide applied in the treatment of acute gastroenteritis. We made a recommendation against antibiotics, dexamethasone, kaolin-pectin, activated charcoal, attapulgite and bismuth subsalicylate. (4) Evidence from domestic studies: a result of 14 CCTs (n=1 635, low quality) indicated that in the significant efficiency and total efficiency, smectite (smecta) was superior to routine liquid infusion, norfloxacin, gentamicin or furaxone. Among these 14 CCTs, two CCTs reported smectite (smecta) caused nausea and vomiting (three cases); one CCT reported pain and distention in the abdomen (one case) and general discomfort (one case); and the rest reported no adverse reaction. A result of 10 CCTs (n=1 017, low quality) indicated that for acute diarrhea, racecadotril was superior to routine treatment in the significant efficiency (OR=2.55, 95%CI 1.64 to 3.94, Plt;0.01) and total efficiency (OR=4.32, 95%CI 2.96 to 6.30, Plt;0.01). A result of two CCTs (n=344, low quality) indicated that racecadotril was superior to smectite in the total efficiency in treating acute diarrhea. A result of two CCTs (n=1 056, low quality) indicated that racecadotril was superior to routine treatment in the total efficiency in treating acute adult diarrhea (OR=5.19, 95%CI 3.54 to 7.63, Plt;0.01). A result of two CCTs (n=182, low quality) reported children presented with nausea (two cases). A result of one CCT (n=947, low quality) reported adults presented with constipation (fifteen cases), anorexia (four cases), headache (nine cases) and abdominal pain (one case). Conclusion For acute gastroentitis, we offer a weak recommendation for smectite (powder, for oral use) used in adults (once 3 g, tid., mixed with warm water before intake), child under one year of age (3 g daily, bid.), and child above one year of age (once 3 g, qd. or bid.). Retention enema could be appiled to children with acute gastroenteritis. We also offer a weak recommendation for racecadotril (capsule) used in adults (one capsule, tid., taken continuously less than seven days). Due to the lack of evidence from clinical trials, we make a recommendation against racecadotril applied to women with pregnancy and lactation or children. In order to produce high-quality local evidence, we propose that (1) Further clinical studies should be standardized in diagnosis and criteria. (2) The design and implementation quality of clinical studies should be improved. (3) Original studies on pharmacoeconomic studies and drug applicability are needed.
Objective To evaluate and select essential medicine for urolithiasis 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) Three evidence-based guidelines were included. Based on WHOEML (2011), NEML (2009), CNF (2010) and the quantity and quality of evidence, we made a recommendation for diclofenac sodium, nifedipine, allopurinol and ibuprofen used in symptomatic treatment of urolithiasis. (3) Results of domestic studies (including four RCTs, n=566; two observational studies, n=96) indicated that calculus-removed rates of diclofenac sodium, nifedipine and allopurinol were 91.5%, 86.4%~93.3% and 86.4% respectively with significant differences. Diclofenac sodium daily cost 7.00 to 8.57 yuan, nifedipine 1.48 to 4.44 yuan, and allopurinol 0.24 to 0.82 yuan. Ibuprofen had a total efficiency of 94.5% with a significant difference for alleviating renal colic, which cost 0.11 yuan daily. Four recommended medicines with safety, clinical efficacy, high economical efficiency and applicability had been marketed with specifications and dosage forms corresponding to guidelines in China. Conclusion For urolithiasis: (1) We offer a b recommendation for diclofenac sodium (capsule/tablet, 50 mg×24, or 25 mg×24) which is contradicted in patients with gastrointestinal bleeding and in pregnant women or women with planned pregnancy. (2) We offer a weak recommendation for nifedipine (tablet/capsule, 10 mg×100 or 10 mg×60) which is contraindicated in dialysis-receiving patients with malignant hypertension and should be cautiously used in patients with irreversible renal failure. (3) We offer a weak recommend allopurinol (tablet, 100 mg×100) which is contraindicated in patients with allergic reaction, severe insufficiency of the liver or kidney, or significant lack of blood cells. (4) We offer a b recommendation for ibuprofen (tablet, 20 mg×20) which is contraindicated in patients with allergic reaction to aspirin.
Objective To Investigate the disease constitution and hospitalization expense in Luxi township health center (LxC) in Yongxi county of Jiangxi Province in 2010, to make clear about the local burden of diseases and to provide the baseline data for further study. Methods The inpatient records of LxC in 2010 were collected. Based on the primary diagnosis on hospital discharge record, the diseases were standardized and classified according to the International Classification of Disease, 10th Edition (ICD-10). Data including general information of the inpatients, discharge diagnosis, hospitalization expense and usage of essential medicine etc, were reorganized and analyzed by using Microsoft Excel 2003 and SPSS 13.0 software. Results a) The total number of inpatients were 925 in 2010, with male/female ratio of 0.8; b) The disease spectrum included 17 categories, accounting for 81% of the ICD-10; c) The top 5 diseases were in respiratory, digestive, injury, poisoning amp; external causes, circulatory and genitourinary system, totally accounting for 82.27%; d) The top 15 single diseases were upper respiratory infection, fracture, chronic obstructive lung disease (COPD), chronic gastroenteritis, cerebrovascular disease (CVD), calculi in urinary system, rheumatoid arthritis, intervertebral discs diseases, cholecyslithiasis accompanied with cholecystitis, cardiac disease, reproductive organ diseases, injury amp; poisoning, pneumonia, hypertension and peptic ulcer; e) The patients with upper respiratory infection and pneumonia were mostly older than 65 or younger than 5 years old. With the exception of calculi in urinary system and peptic ulcer, all the other 8 chronic diseases were mainly seen in patients over 65 years old; f) Among the 15 single diseases as listed above, the chronic diseases were associated with shorter average hospital stay and low average expense compared with the acute diseases (4.8 d vs. 11.6 d; ?439.1 vs. ?666.9); and g) The hospitalization expense of LxC, although increasing year by year, was still far below that of the national township health centers (?542.3 vs. ?1 004.6). Conclusion a) The top 3 in inpatients systematic diseases of LxC are respiratory system, digestive system, and injury and poisoning; the former 2 diseases attack more often in females, and the acute diseases are mainly infection and fracture; b) Except for rheumatoid arthritis, cholecyslithiasis accompanied cholecystitis, cardiac diseases, reproductive organ diseases and peptic ulcer, all the other 10 of the top 15 single diseases are similar to Yong’an township health center (YaC) in Sichuan Province in 2010; c) The acute diseases mainly focus on respiratory system, and injury and poisoning, and the chronic diseases mainly focus on digestive system, circulatory system, genitourinary system, the musculoskeletal system and connective tissue system; d) The number of patients who suffer from chronic diseases increases significantly when over of 35 years old, especially, often seen in female rather than male. The acute burden diseases is serious in patients less than 15 or more than 45 years old; e) The upper respiratory infection and pneumonia mainly affect the old and children; f) Compared with Xintian township health center (XtC) in Gansu Province, the average hospital stay of fracture patients is longer (43.7 d vs. 9.0 d), the hospitalization expense is higher (?1 948.0 vs. ?1 648.3), and the diseases is burden heavier (8.1% vs. 4.9%); and g) The average hospital stay of patients with acute diseases is longer than YaC and XtC (11.6 d vs. 3.7 d, 6.2 d), but the hospitalization expense is lower than both of them (?666.9 vs. ?850.4, ?906.9).