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.
ObjectiveComparing the worldwide Essential Medicines Lists for Children (EMLcs) and National Essential Medicine List (NEML) of China (2012 edition), to provide evidence for establishing EMLc of China. MethodWe searched the official websites of WHO and Ministry of Health of some countries to identify published EMLcs. We compared the situation of updating, the number and classification of medicines, and the dosage forms between these EMLcs and NEML of China (2012). ResultBy August 2013, the WHO, India and South Africa had established EMLc. The number of medicines of NEML of China (2012) ranked first in the four lists. The WHO, India and China classified the medicines by pharmacologic action, while South Africa classified it by anatomical therapeutic chemical (ATC) classification. Except the WHO, India, South Africa and China did not have specific medicines for neonatal care or medicines for diseases of joints. The main administration routes in these four lists were oral administration, injection, and topical application. There were medicine restrictions in EMLcs of WHO and India, while no medicine restrictions in lists of South Africa and China. ConclusionMedicines listed in NEML of China (2012) do not match children's disease burden of China. The applicable dosage forms for children are few and the medicine restrictions are absent for the list. So this list is not suitable for Children.
Objective To evaluate and select essential medicine for uterine neoplasms 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) Six guidelines were included, three of which were evidence-based. (2) Retrieved guidelines related to nine medicines (of three classes) for uterine neoplasms and five adjuvant drugs (of three classes) used after relevant 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 medroxyprogesterone acetate, oxytocin, ergometrine and a weak recommendation for testosterone propionate, methyltestosterone, tamoxifen, mifepristone, tranexamic acid, leonurus heterophyllus used in the treatment of uterine neoplasms. We offered a recommendation against danazol and aromatase inhibitors. (4) We found relevant domestic literature on mifepristone, methyltestosterone, tamoxifen, oxytocin and leonurus heterophyllus. Mifepriston combined with methyltestosterone or tamoxifen was recommended to use as a conservative therapy for uterine neoplasms. Oxytocin,and leonurus heterophyllus were used to reduce bleeding after the surgery of uterine neoplasms. As to daily expense, mifepriston (25 mg/d) cost 13.0 to 27.5 yuan, methyltestosterone (5 mg/d) 0.074 yuan, tamoxifen (20 mg/d) 0.6 to 1.4 yuan, leonurus heterophyllus (injection, 1 mL) 15 yuan and oxytocin (injection, 20 U) 1.5 yuan. (5) Results of domestic studies indicated that mifepristone, mifepristone plus methyltestosterone, and mifepristone plus tamoxifen were proved to be safe and applicable for the treatment of uterine neoplasms. Oxytocin and leonurus heterophyllus are effective in preventing postoperative bleeding and the combination of two effectively and safely promoted uterine contraction. Conclusion (1) We offer a recommendation for three medication plans used in the treatment uterine neoplasms during perimenopause, including: a) Mifepristone (25 mg/ tablet, once daily); b) Mifepristone (25 mg/ tablet, once daily) plus methyltestosterone (5 mg/tablet, once daily); c) Mifepristone (25 mg/ tablet, once daily) plus tamoxifen (10 mg/tablet, twice daily). The three plans mentioned above should be used from first day of menstrual cycle, continuously for three months. (2) Adjuvant drugs such as oxytocin (injection, 1 to 2 mL) and leonurus heterophyllus (injection, 10 U) can be applied to reduce vaginal bleeding flow after the surgery of uterine neoplasms. (3) Personnel in elementary healthcare institution should stick to drug indication, carefully make follow-up, and dynamically monitor the change of uterine neoplasms and menstruation so as to adjust medication plan according to patients’ situation.
Objective To systematically review the diseases constitution of children in Chinese medical institutions from 2010 to 2016, and to provide evidence for establishing essential medicine list for children (EMLc) of China. Methods We searched PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Data from January 2010 to February 2016 to collect studies about diseases constitution of Chinese children. Two reviewers independently screened literature, extracted data, and assessed the risk bias of included studies, then data was descriptively analyzed. Results A total of 33 studies of diseases constitution were included, involving 1 797 696 children among 0 to 18 years from 17 provinces of China. Neonatal hyperbilirubinemia, neonatal pneumonia and premature were the main diseases of inpatient newborns. The main diseases of children hospitalized were pneumonia, upper respiratory tract infection and tumor. Upper respiratory tract infection, bronchopneumonia, bronchitis and diarrhea were the main diseases of outpatients. Hyperspasmia, upper respiratory tract infection and pneumonia were the main diseases of emergency patients. Diseases constitution of different medical institution: the main diseases were pathological jaundice, neonatal asphyxia and neonatal pneumonia in both tertiary and secondary medical institution in the newborn group. In the children group, the main diseases were pneumonia, upper respiratory tract infection and bronchitis in both tertiary and secondary medical institution. Besides these diseases, indigestion and fever of unknown origin were also the main diseases of primary medical institution. Disease constitution of different areas: in the newborn group, pathological jaundice, neonatal pneumonia and neonatal hyperbilirubinemia were the main diseases in coastal areas. Neonatal pneumonia, neonatal hyperbilirubinemia and premature were the main diseases in inland areas. Neonatal hyperbilirubinemia, neonatal pneumonia and neonatal hypoxic-ischemic encephalopathy were the main diseases in remote areas. In children group, pneumonia, bronchitis and premature were the main diseases in coastal areas. Pneumonia, bronchitis and hand-foot-and-mouth disease were the main diseases in inland areas. Upper respiratory tract infection, bronchopneumonia and bronchitis were the main diseases in remote areas. Conclusion Diseases constitutions of children vary in different medical institution, and because of extreme lack of date from primary medical institution, we suggest to carry out investigation in primary medical institution to provide evidence for EMLc. Diseases constitutions of children vary in different area, additions should be made according to local conditions when essential drugs of children selected. Newborn, as a special group of children, should be considered separately when EMLc of China established.
Objective To investigate the performance of Essential Medicine List (EML) policy over the past one year in Xintian Township Health Center (XTHC), so as to provide references for the delivery, storage and compensation mechanism of essential medicine for township hospitals. Methods Focus interview combined with a questionnaire was carried out to investigate the supply and usage of EML, the situation of both diagnosis-treatment services and the income-expenditure change before and after EML policy. Results a) It showed that there was an increasing trend with the preparation rate of EML from 62.2% before implementation to 87.3% after, and the proportion of EML income to total medicine expenses increased from 39.3% to 90.6% in XTHC. But problems still existed such as incomplete and old variety of medicine; b) The numbers of outpatient-time and inpatient-time kept growing, while medical cost for both average clinic cost and average hospitalization cost decreased to different extent; c) Although the gross income increased slightly, this center was still running in the red with the limited amount of financial assistance; and d) The proportion of medical care and drug kept decreasing while the proportion of drug cost and examination cost kept increasing. Compared with the situation in 2009, the proportion of examination cost from 2010 to 2011 had increased by 30%, and it still remained at the previous level after EML implementation. Conclusion The implementation of EML does not completely change the predicament of “Make compensation for doctors by selling drugs” in township health center. Owing to the sale policy of zero price difference and the poor performance of compensation for township health centers, XTHC is still running under deficit. Evidence-based medicine selection and research on compensation mechanism for underdeveloped areas are urgently needed.
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 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 hospitalization cost in Yong’an Central Township Health Center (YaC) in Shuangliu County of Sichuan Province from 2008 to 2010, so as to provide baseline data for further research. Methods Questionnaire and focus interview were carried out; case records and cost information of YaC inpatients in 2008, 2009 and 2010 were collected. The diseases were classified according to 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 inpatients were 4 236, 4 335 and 4 844 in 2008, 2009 and 2010, respectively. Females were more than males (56.99% vs. 42.96%, 55.59% vs. 44.1%, 54.36% vs. 45.62%), and their disease spectrum included 20 categories, which accounted for 95% of disease classes of ICD-10; b) The inpatients suffering from top three systematic diseases accounted for 62.74% to 72.31%, which included the respiratory, digestive, urinary tract and urogenital systematic disease; c) The top 15 single diseases were upper respiratory infection, acute bronchitis, pulmonary infection, acute gastroenteritis, fracture, acute appendicitis, chronic bronchitis, calculi in urinary system, cerebral vascular insufficiency, lumbar vertebra disease, acute gastritis, superficial injury, chronic gastritis, hypertension, and cholecytolithiasis or cholecystitis; d) The number of inpatients in the group of over 15-24 ages with chronic diseases increased with age and females were more than males. The acute disease burden of inpatients in 0-4 age group was the heaviest, who only suffered from acute diseases and males were more than females. The inpatients in 25-54 age group suffered from more acute diseases than chronic diseases and females were more than males; and e) The inpatients’ average costs of chronic diseases were higher than those of acute diseases in 2010 (1 564.45 yuan vs. 1 104.11 yuan) and those of either Xintian Central Township Health Center (1 311.81 yuan) or Gaozha Central Township Health Center (1 002.99 yuan). Conclusion a) In recent three years, the main systematic diseases that inpatients suffer are digestive, respiratory, and urinary tract and urogenital system diseases; the acute diseases are more than the chronic; the acute diseases mainly include infection and injury; b) During the past three years, the top 15 diseases have been stable and the same diseases include upper respiratory infection, pulmonary infection, acute bronchitis, acute appendicitis, acute gastritis, acute gastroenteritis, fracture, chronic gastritis, chronic bronchitis, and calculi in urinary system; c) It should be paid attention to the inpatients with chronic diseases in over 15-24 age group and the inpatients with acute diseases in 0-4 age group; and d) The inpatients’ average costs of top 15 diseases in 2010 were higher than those of either XtC or GzC, and consideration on rationality of the hospitalization cost should be paid attention to.
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 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.