Objective To evaluate and select essential medicine for acute and chronic gastritis using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five guidelines for acute gastritis and seven guidelines for chronic gastritis were included. The recommended included omeprazole, ranitidine and domperidone. (2) A result of three CCTs (n=315, low quality) indicated that omeprazole was superior to famotidine and ranitidine in alleviating symptoms of chronic gastritis such as pain or discomfort in the upper abdomen, regurgitation, a burning sensation in the heart, distention and fullness in the upper abdomen (71.2% vs. 47.3%, 94.4% vs. 84.3%, Plt;0.05). A result of one RCT (n=100, low quality) and two CCTs (n=213, low quality) indicated that in HP eradication rates, omeprazole triple therapy and the control intervention had no significant difference (OR=1.09, 95%CI 0.44 to 2.70, Pgt;0.05). A result of one RCT (n=100, low quality) indicated that omeprazole caused no adverse reaction. A result of five CCTs (n=528, low quality) indicated that adverse reaction of omeprazole included poor appetite (two cases), nausea and vomiting (four cases), headache or vertigo (one case) and increased transaminase (one case). Omeprazole cost eight yuan (tablet) or four yuan (capsule) daily. (3) HP eradication rates of ranitidine bismuth citrate was higher than the control group (OR=2.05, 95%CI 1.29 to 3.25, P=0.002). A result of 15 RCTs (n=3 638, high quality) indicated adverse reaction of ranitidine bismuth citrate mainly included symptoms in the digestive system. A result of one RCT (n=100, low quality) indicated ranitidine bismuth citrate and omeprazole triple therapy had no significant difference (Pgt;0.05) and ranitidine bismuth citrate caused no adverse reaction. Ranitidine cost 0.36 yuan (tablet), 0.40 yuan (capsule) or 2.7 to 5.4 yuan (injection) daily. (4) A result of two CCTs (n=133, low quality) indicated that compared with the control intervention, domperidone was more efficient without adverse reaction in improving indigestion, promoting gastric emptying effect, and alleviating pain and distention in the upper abdomen, belching and regurgitation. Domperidone cost 1 to 1.3 yuan daily. (5) All kinds of recommended medicines are listed and legalized in China Pharmacopoeia (2010) and CNF (2010). (6) In clinical setting, above-recommended medicines should be applied strictly according to the CNF (2010) and the National Clinical Prescription Guidelines for Essential Medicine. Conclusion For acute and chronic gastritis, indigestion and HP eradication: (1) We offer a b recommendation for omeprazole (immediate release tablet/capsule for oral use, 10 mg/tablet) which should be cautiously used in children, elderly people, and women during pregnancy or lactation. (2) We offer a b recommendation for ranitidine (immediate release tablet/capsule for oral use, 150 mg/tablet) which should be cautiously used in patients with severe insufficiency in the liver or kidney, women in the pregnancy or lactation, and children under eight years of age.
Objective To evaluate and select essential medicine for 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.
Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections (CMIs) on the national essential medicine list (2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs, particularly pharmacovigilance and risk management of CMIs. Methods We electronically searched Chinese Biomedical Literature Database (CBM, Jan. 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, Jan. 1979-April 2009), Chinese Science and Technology Periodical Database (VIP, Jan. 1989-April 2009) and the Traditional Chinese Medicine Database (Jan. 1984 April 2009). We also retrieved the websites of Ministry of Health and State Food and Drug Administration, to collect data about CMIs ADRs reports and regulations from “Newsletter of Adverse Drug Reactions” (Issue 1 to 22). Then we descriptively analyzed all the results on the year published, periodicals and types of study design of included ADR literatures, the major CMIs as well as the regulations about their ADRs. Results (1) There were 5 405 citations found in total and 2160 were removed because of duplication. After screening the title, abstract and full text of the selected papers, 1 010 studies finally met the eligible criteria. (2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time. (3) The included 1,010 articles were scattered among 297 periodicals. A total of 55 journals on pharmaceutical medicine, containing 399 articles, accounted for 39.50% of total; 64 journals on traditional Chinese medicine and pharmaceutical medicine, containing only 197 articles, amounted for 19.50% of total. Only 22 periodicals were included on the core journals of the Beijing University List (2008 edition) (8.94% of the total journals in the list), which published 129 articles (12.77% of the total articles published). (4) We categorized the articles included into eight categories based on their content and study methodology. There were: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized controlled trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). (5) In the three of top ten journals, "Adverse Drug Reactions Journal", "China Medical Herald", and "Chinese Pharmaceuticals" published literature accounted for 5.84%, 3.76% and 2.67% of the total respectively. (6) The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for CMIs (All the three injections had more than 200 articles, accounting for 41.95% of the total). The Ministry of Health and the State Food and Drug Administration took measures to supervise them. (7) The four kinds of CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale. The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them. Conclusions (1) Articles published on CMIs ADRs increased year by year, but overall the research is of low quality and is scattered in a large number of sources. (2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management. (3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.
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.
Objective To investigate the disease constitution and cost of inpatients in Gaozha Central Township Health Center (GzC) in Wuzhong City of Ningxia Hui Autonomous Region from 2008 to 2010, so as to provide baseline data for further research. Methods A questionnaire combined with a special interview was carried out, and case records and cost information of GzC inpatients in 2008, 2009 and 2010 (from January to November) were collected. The diseases in discharge record were classified according to International Classification of Diseases (ICD-10) based on the first diagnose and the cost was analyzed. Data including general information of the inpatients, discharge diagnosis, hospitalization expenses, and drug cost etc. were rearranged and analyzed by Excel software. Results a) The total number of the inpatients was 1124, 642 and 747 in 2008, 2009 and 2010, respectively. The female was more than the male in both 2008 (59.34% vs. 40.66%) and 2009 (60.75% vs. 39.25%), and their disease spectrum included 17 categories, which accounted for 81% of ICD-10; b) The top six most commonly seen systematic diseases with a constituent ratio from 86.63% to 92.06% in recent three years were as follows: the respiratory system, digestive system, circulatory system, genitourinary system, injury and toxicosis, skeletal musculature and connective tissue disease. Except the injury and toxicosis, the other five systematic diseases were commonly seen in females rather than in males; c) The top 15 monopathies in recent three years were pulmonary infection, tracheitis or bronchitis, coronary heart disease, soft tissue injury, gastritis or chronic gastritis, upper respiratory infection, hypertension, urinary tract infection, prolapse of lumbar intervertebral disc, pelvic inflammation, fracture, pneumocardial diseases, superficial injury, chronic cholecystitis and arthritis; d) The main burdens of disease for inpatients focused on 35-54 age groups, then followed by the age groups above 55 in 2008 and 2009. Except the injury and toxicosis, the other diseases were commonly seen in females rather than in males. Pulmonary infection focused on the age groups above 35; the onset of hypertension increased obviously and a sharp rise of hypertension existed in the 45-54 age groups in 2008, but the hypertention focused on 35-44 age groups in 2009; e) The total inpatients with top 15 monopathies accounted for 64.06% to 71.21%, including 8-9 chronic diseases ranking higher in 2010, and 6-7 acute diseases focusing on infection and injury; and f) The average costs of chronic diseases were higher than those of acute diseases. Conclusion a) There is a big gap between GzC and Yong’an Central Township Health Center (YaC) regarding the level of the regional economic development, the situation of disease burden and cost of inpatients. The former is demonstrated as general Central Township Health Center, while the latter as affluent Central Township Health Center in western China; b) In recent three years, the main systematic diseases are in respiratory, circulatory and digestive system; the inpatients suffer from more chronic diseases rather than acute diseases in their young age; the acute diseases mainly include infection and injury, and the pulmonary infection has ranked as the first during the past three years; c) The inpatients in 2008 and 2009 are mainly in ages of 35 to 54, and then are over 55 years old. Except the injury and toxicosis, the other diseases were commonly seen in females rather than in males; d) The patients’ average costs of chronic diseases for hospitalization and drug in 2010 were lower than those of YaC. Consideration on reasonable constitution of the cost for hospitalization should be paid attention to; and e) It is urgent to strengthen the construction of infrastructure and informatization in GzC.
Objective To understand current situation of medical service and management in Yong’an Central Township Health Center (YaC) through on-the-spot investigation, in order to provide references for personal employment and essential medicines list implement in township health centers. Methods Questionnaire and focus interview were carried out, which included the general information, human resources, medical service and management, and the practice of essential medicines list. Results The hardware equipments of YaC were fine, and the target population had fairly good health and economy status. The ratio of General Practitioner (GP)/ nurse and GP/ pharmacist were all above the national average level. The members with college degree and above accounted for 61.6%, and about 88% staffs were with or below primary profession titles. There was a balance between personnel flow out and in. The drug income accounted for 53.6% of the whole in 2009 and the medical expenses increased compared to 2008. Essential medicines list was put into practice in April 1st of 2010 with no relevant technical documents as correspondence. Conclusion YaC, as a good representative of fairly well-off rural Township Health Center in western China, needs to cope with challenges of irrational personnel structure, low educational background and professional title of the staff and human resources flow, and requires developing policy and adopting measures step by step. The management of YaC may be influenced by zero-profit price of the essential medicine, and appropriate subsidy and policy support are necessary to maintain current service quality.
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.
ObjectiveTo compare the recommended medicines from malignancy guidelines/consensuses with essential medicines from the 2023 World Health Organization Model List of Essential Medicines (WHO-EML) and the 2018 National Essential Medicine List (NEML) in differences and similarities. MethodsTen guideline databases/association websites including Guidelines International Network, and the American Cancer Society, etc. were systematically searched until July 2023. The latest guidelines/consensuses for ten malignant tumors were screened, including lung cancer, liver cancer, stomach cancer, and other cancers. Recommended medicines were extracted from guidelines/consensuses and compared with WHO and Chinese essential medicines. ResultsA total of 163 guidelines/consensuses were included, extracting 244 recommended medicines, 12 categories, mainly antineoplastic and immunomodulating agents (190 medicines, 10 subcategories). For the 244 recommended medicines, 29.92% (73/244) were included in WHO-EML and 23.36% (57/244) were included in NEML, among which 45 medicines were included both in WHO-EML and NEML, 27 in WHO-EML only, 11 in NEML only, and 161 in neither. ConclusionThe number of recommended medicines in WHO-EML/NEML for ten malignancies is low, and the number in NEML is even much lower than that in WHO-EML. When adjusting medicines for malignant tumors in NEML, reference can be made to specific guidelines/consensuses and WHO-EML to ensure timely inclusion of applicable medicines and strengthen the role of essential medicines in meeting basic medical needs and rational use.
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.