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.
Objective To provide baseline datum for further evidence-based selecting essential health technology or essential medicine by comparing the top 15 inpatient diseases in the three pilot township clinics in western China from 2008 to 2010. Methods With the key words as disease spectrum, constitution of disease, inpatient disease category, inpatient diseases and so on, such databases as CBM, CNKI, VIP, WanFang and official websites of Ministry of Health were searched on computer, and the manual search was also conducted in combination to extract the related datum of provinces where the pilot township health centers were situated. The Excel software was used for data classification and analyses. Results (1) Among the 16 included literatures including 15 journal papers and 1 master thesis, 4 scored from zero to 3.5, 9 scored from 3.5 to 6.75, and the left 3 scored 7 or more than 7; (2) The common inpatient diseases in the township health centers in eastern, central and western regions in China were different. The upper respiratory tract infection, acute/chronic bronchitis, acute/chronic gastritis and appendicitis were the common inpatient diseases in the township health centers throughout China. The pneumonia, emphysema, cholelithiasis, cholecystitis, and acute/chronic gastroenteritis were the common inpatient diseases in the township health centers in southwest and northwest regions. The top 15 inpatient diseases in the three pilot township clinics in this study covered all the common inpatient diseases in the township health centers in southwest and northwest regions in China; (3) The total number of the top 15 inpatient diseases of the three pilot township health centers in western China between 2008 and 2010 was 35, including 20 chronic and 15 acute diseases. The chronic diseases were chronic bronchitis, chronic gastritis, hypertension, lumbar/cervical disease, cholelithiasis or cholecystitis, coronary heart disease, chronic pulmonary heart disease, urinary calculi, pelvic inflammation, vertebrobasilar insufficiency, arthritis, acute exacerbation of chronic bronchitis, Meniere’s disease, chronic obstructive emphysema, myocardial ischemia, prostatitis, etc.. The acute diseases were upper respiratory tract infection, pulmonary infection, fracture, superficial injury, acute appendicitis, acute bronchitis, urinary tract infection, acute gastritis, acute gastroenteritis, delivery amp; cesarean section, soft tissue injury, acute urticaria, etc.; and (4) While the common inpatient disease categories were relatively centralized and stable, but some of them were different in regions, inpatients’ age and sex structure. Conclusion (1) There are some differences in the common inpatient diseases in the township health centers among eastern, central and western regions in China, thus it is necessary to select essential health technology and essential medicine according to local conditions; (2) As a good representation, the common inpatients diseases in the three pilot township health centers in western China can provide the baseline evidence for selecting essential health technology and essential medicine for the township health centers in western China; (3) There are lack of national/regional statistics, survey data and evidence-based research on disease spectrum of the township health centers currently. While the investigation methods or statistics measurements/quality of these included studies are variable without standard regulation; and (4) It suggests that the state and every provinces should implement and improve the statistic analysis of disease spectrum of the township health centers, train staffs and fulfill the construction of information system.
Objective To evaluate and select essential medicine for the treatment of coronary heart disease by means of evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) 11 clinical guidelines on coronary heart disease were included, three of which are evidence-based guidelines. (2) Totally, those guidelines contained 61 medicines (of 13 classes). (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we made a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin as essential medicine for coronary heart disease. We made a weak recommendation for amlodipine, clopidogrel, heparin, propranolol, simvastatin and streptokinase. (4) 13 recommended medicines have been marketed in China and their prices were affordable. (5) Results of domestic low-quality studies indicated that nitroglycerin, isosorbide dinitrate, metoprolol, aspirin and heparin were effective for coronary heart disease. We didn’t find systematic reviews or pharmacoeconomic studies on the recommended medicines in Chinese literature databases. Conclusion For coronary heart disease: (1) We offer a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin and a weak recommendation for propranolol, amlodipine, clopidogrel, heparin, simvastatin and streptokinase. (2) There is lack of high-quality evidence from relevant domestic studies, especially on pharmacoeconomic evaluation. (3) We propose that more studies should be carried out on clinical guideline of coronary heart disease and pharmacoeconomic comparison should be also made between recommended medicine and medicine of the same class.
Objective To evaluate and select essential medicine for 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 analyze the dynamic efficiency of township hospitals. Methods Based on the DEA-Malmquist index, this research analyzed the change of the total factor productivity indices and the decomposition items of 281 township hospitals in Hunan province with panel data from 2000 to 2008. Results Among 281 township hospitals, less than half increased their scale efficiency, while more than half increased their total factor productivity, technology, whole efficiency and technical efficiency. Increasing technology and whole efficiency was the best way to improve total factor productivity. Besides, increasing technical efficiency and scale efficiency was the best way to improve whole efficiency. Conclusions The improvement of scale efficiency is key to developing the central township hospitals, while the improvement of technology is the key to developing general township hospitals.
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 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).
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.