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 compare the national essential medicines list (EML) and national essential insurance medicine list (EIML) of China with that of the WHO, so as to provide reasonable evidence for the adjustment of new EML and EIML of China. Methods The similarities and differences in the selection, updating, categories, subcategories and the amounts of medicines in the EML and EIML of China and the WHO EML were compared and analyzed. Results There are some differences among the three lists in selecting principles, updating of medicines .The latest version of WHO EML (version in 2007) has 27 categories, including 340 medicines; China EML (version in 2004) has 23 categories and 773 western medicines, containing 23 categories and 225 (66.17%) similar medicines of WHO EML, which accounts for 29.11% of EML of China. China EIML (version in 2005) has 23 categories and 1 031 western medicines, containing 22 categories and 227 (66.76%) of WHO EML, which accounts for 22.02% of EIML of China. China EIML was developed based on China EML. There is little difference in selecting, updating, categories of medicines. Conclusion The difference was obviously found in medicine selection, updating and categories between China EML, EIML and WHO EML. We suggested that our national EML and EIML should be more reasonably selected and updated base on the principals of WHO EML.
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 investigate the disease constitution and drug application of inpatients in Yong’an Central Township Health Center (YaC) in Shuangliu County of Sichuan province in 2009, so as to provide baseline data for further research. Method Questionnaire and focus interview were carried out, case records and drug application information of YaC inpatients in 2009 were collected. The diseases were classified according to ICD-10 based on first diagnose. Drug application was analyzed based on pharmaceutical dosage form, pharmaceutical effect, cost, and clinical departments. Data including general information of the inpatients, discharge diagnosis, hospitalization expenses, and drug cost etc. were rearranged and analyzed by Excel software. Result a) The total number of inpatients was 4 335 and the female/male was 55.59% vs. 44.1%, their disease spectrum included 18 categories, which accounted for 85% of disease classes of ICD-10; b) The inpatients suffered from top 5 systematic diseases were 3 531, accounted for 81.45%, which included the respiratory, digestive, urinary tract and urogenital, circulatory systems, as well as trauma and toxicosis. Except the trauma and toxicosis, the female was more than the male in all the rest main systematic diseases; c) The top 15 single diseases were chronic bronchitis in acute stage, acute upper respiratory infection, pneumonia, acute gastroenteritis, chronic bronchitis, urinary stone, acute appendicitis, chronic gastritis, acute gastritis, vertebrobasilar ischemia, cesarean section, fracture, acute urticaria, and meniere disease; d) The total inpatients with top 15 single diseases accounted for 59.81%, including 6 chronic diseases and 9 acute diseases. The patients’ average costs of chronic disease were higher than that of acute disease; and e) The proportion of western medicine cost accounted for 80% to 90% of total cost, and the cost of anti-microbial drugs and drugs of humoral regulation ranked as the top two. Conclusion a) The inpatients in 2009 are mainly in age of 25 to 59, and over 60 years old as well. The top two diseases mainly attacked are in respiratory and digestive systems, acute diseases are more than the chronic; b) Except for pneumonia, urinary stone, uroschesis, urinary stone, trauma, and toxicosis, the female inpatients are more than the male for complaining all other diseases; c) The number of inpatients received hysterotomy is as 4.24 times as that of natural labor, and the rationality should be paid attention to; d) The commonly used drugs, according to the costs, involve in 4 kinds of drugs and 1 kind of vaccine, which are in accordance with the main burden of the diseases; e) Supervision should be focused on the drugs of high cost or the one most frequently used; and f) The 0.9% Sodium chloride injection, Glucose injection and Cefuroxime listed in the EML (2009) satisfy the needs of treatment for YaC inpatients in 2009.
Objective Healthcare risk has become a popular topic in medical research field all over the world. With the increasing of healthcare safety adverse events and medical conflict cases every year, publications about this topic have been rapidly increased in China, but research on the essentials and categories of healthcare risk are still lacked. This paper aims to summarize the essentials and categories of healthcare risk research systematically through analyzing domestic studies in healthcare risk over the past decade, so as to provide decision-making evidences and policy suggenstions on healthcare risk management in China. Methods We searched the China Academic Journal Network Publishing Database of CNKI (1999-2010), in which those papers’ title containing the phrase of healthcare risk had been brought into our research, then we summerized the domestic concepts and contents in healthcare risk by essential analysis and frequency statistics. Results 255 papers were included, including 26 Class B papers (accounting for 10.20%), six Class C papers (accounting for 2.35%) and 223 Class D papers (accounting for 87.45%); but there were only 79 papers (accounting for 35.11% ) which had a clear definition of healthcare risk. From these papers, we found the essentials of healthcare risk included object, consequences, process and causes, and the research category of healthcare risk included prevention and treatment of risk, causes and effects of factors, risk sharing mechanisms, healthcare risk of special diseases, concept and characteristics, education and training, management method, risks of medical appliances, the species and object of healthcare risk, the category of healthcare risk, the research methods of healthcare risk etc. Conclusion At present, the study of healthcare risk focuses on the risk control and how to release risks from the results, besides, systematic studies are lacked, and the unified definition of healthcare risk has not been formed, Therefore, we recommend that systematic study of the healthcare risks should be strengthened, the definition of healthcare risk should be unified, and the early warning, monitoring, evaluating, and identifying methods should be positively developed, providing decision-making evidences to establish healthcare risk management system in China.
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.
After 38 years of development, the procedure of selection and evaluation of the World Health Organization Essential Medicine List (WHO EML) is increasingly scientific and formal. However, peer review for the applications of WHO EML is always required in a short period. It is necessary to build up a set of methods and processes for rapid review. The most important items for the rapid review of WHO EML peer reviewers are: 1) to confirm the requirements and identify the purposes; 2) to establish the research questions and translate the questions into the ‘Participants, Interventions, Comparators, Outcomes, Study design' (PICOS) format; 3) to search and screen available evidence, for which high-level evidence is preferred, such as systematic reviews or meta-analyses, health technology assessment (HTA), clinical guidelines; 4) to extract data, where we extract primary information based on the purposes; 5) to synthesize data by qualitative methods, assess the quality of evidence, and compare the results; 6) to provide the answers to the applications, quality of evidences and strength of recommendations. Our study established a set of methods and processes for the rapid review of WHO EML peer review, and our findings were used to guide the reviewers to fulfill the 19th WHO EML peer review. The methods and processes were feasible and met the necessary requirements in terms of time and quality. Continuous improvement and evaluation in practice are warranted.
Objective To investigate current situation of medical service and management in Gaozha Central Township Health Center (GzC), so as to provide baseline data for township health centers in both key techniques research and product development of drugs allocation and delivery. Methods A questionnaire combined with a special interview was carried out, which included the general information, human resources, medical service and management, and the practice of essential medicine list. Results a) The hardware condition of GzC was not good enough, and the economic status of the service recipients was lower than the average level of both Wuzhong City and China mainland; b) The constituent ratio of general practitioner (GP) and nurse, and GP and laboratorian were all lower than those of national level, while, the constituent ratio of GP and technician was a little bit higher. GzC was in short of medical technical personnel and, especially, the professional pharmacists. The logistics technical workers were as the same proportion as the nurses. The medical technical personnel without professional education background accounted for 3.4%, and about 38% of the staff members had no college degree, about 86.2% had at most primary profession titles. There was no personnel turnover of GzC in recently years; c) The bed utilization ratio was lower than national level (46.4% vs. 60.7%), while the average duration of stay and the in-patient and out-patient service workload of GP were longer or heavier than national level (8 vs. 4.8, 9 vs. 8.3, 4 vs. 1.3); d) The out-patient service in 2010 decreased 26.9% compared to 2009; and the in-patient service in 2010 decreased 42.4%; e) The average medical expense per outpatient and per inpatient increased 127.3% and 56.2%, respectively in 2010 compared to 2009; and f) Essential medicine list was put into practice in April 1st of 2010 and there was only 195 species available in GzC, which has not met the requirements of the national essential medicine list. Conclusion In order to meet the standards of general rural township health center in western China, GzC needs to cope with challenges of insufficient hardware conditions, short of staff, unreasonable personnel structure, low educational background and professional title of the staff, none human resources flow and low technical level of medical service. GzC dose well in drug expenses control, and the hospitalization costs are lower than those of the national level. However, it increases rapidly in 2010. The management of GzC may be influenced by zero-profit sale of the essential drugs, and appropriate subsidy and policy support are necessary to maintain its service quality. And it is required to complement the medicine based on the evidences, to carry out staff training and usage guidance of essential medicine, and to finally guarantee the safe and reasonable use of medicines.
ObjectivesTo systematically review the implementation effects of the full coverage policy for medicines, and to provide evidence for the improvement of National Essential Medicine Policy in China.MethodsWe searched databases including ProQuest, PubMed, CNKI and WanFang Data databases from inception to June 30th 2018 to collect the studies on full coverage policy for medicines. Two reviewers screened literature and extracted related information independently. Then, qualitative analyses were applied to evaluate the impact of the full coverage policy for medicines.ResultsA total of 35 studies on the full coverage policy for medicines were included. Ten studies evaluated the effects of disease control, 12 studies evaluated the impact of the compliance of the patients, 9 studies evaluated the impact on medical expenses and drug costs, 2 studies evaluated the effects of equality, 7 studies evaluated economics, and 11 studies described the improper use and waste of medicines.ConclusionsIn the content of perfecting the selection mechanism and management system, the implementation of the full coverage policy for essential medicines is conducive to promoting equality and accessibility, enhancing drug compliance, improving the diagnosis and treatment of patient diseases ultimately, and making the policy more economical.
Objective To observe the effect of combination of antihypertensive and lipid lowering therapy on arterial stiffness in elderly patients with mild to moderate essential hypertension. Methods A total of 216 elderly patients with mild to moderate essential hypertension were enrolled and treated by hydrochlorothiazide as the basic therapy for two weeks. Then the patients were randomly divided into four groups. Namely, the intensified antihypertensive and lipid lowering therapy group (hydrochlorothiazide 25 mg/d, Candesartan 8 mg/d, Rosuvastatin 10 mg/d, n=54), the intensified antihypertensive treatment group (hydrochlorothiazide 25 mg/d, Candesartan 8 mg/d, n=54), the antihypertensive and lipid lowering therapy group (hydrochlorothiazide 25 mg/d, Rosuvastatin 10 mg/d, n=54), and the control group (hydrochlorothiazide 25 mg/d, n=54). After 12-month treatment, the blood pressure, blood lipid and carotid-radial pulse wave velocity (crPWV) of each group were recorded. Results Twelve months later, the SBP, DBP, PP and crPWV of each group were significantly lower than before (Plt;0.05). There was interactive effect of antihypertensive and lipid lowering therapy in lowering SBP, DBP, PP and crPWV (F=40.765, 4.869, 24.829, and 53.149, respectively, all Рlt;0.05). Conclusion The combination of antihypertensive and lipid lowering therapy can significantly lower the crPWV of elderly patients with hypertension and improve the arterial stiffness; it is superior to single treatment of either antihypertensive or lipid lowering.