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 assess the efficacy and safety of rosiglitazone in treating type 2 diabetes mellitus (T2DM) with essential hypertension (HBP). Methods Such databases as The Cochrane Library (Issue 4, 2009), PubMed (1970 to May 2010), CBM (1978 to May 2010), CNKI (1996 to May 2010), WanFang Database (1999 to May 2010), VIP (1996 to May 2010), and Google Scholar were searched on computer, and the relevant journals such as Chinese Journal of Diabetes Mellitus were also hand researched to investigate references and collect randomized controlled trials (RCTs) about rosiglitazone (experimental group) compared with non-rosiglitazone (control group) in treating T2DM with HBP. The data were extracted according to the inclusion and exclusion criteria by two reviewers independently, the quality of the included studies was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0, and meta-analysis was conducted by using RevMan 5.0 software. Results Among 10 RCTs involving 738 patients, one was in English from Greece, while nine were in Chinese. The average score quality of the included studies was in C level. The results of meta-analyses showed that the experimental group was more effective than the control group in lowering blood pressure levels (SBP: WMD= –17.83 mmHg, 95%CI –27.63 to –8.02; DBP: WMD=–7.81 mmHg, 95%CI –10.18 to –5.44), blood glucose levels (FBG: WMD= –1.66 mmol/L, 95%CI –3.08 to –0.23; PBG: WMD= –2.38 mmol/L, 95%CI – 4.12 to –0.64), triglyceride (TG) levels (WMD= –0.29 mmol/L, 95%CI –0.43 to –0.14), low-density lipoprotein cholesterol (LDL-C) levels (WMD= –0.76 mmol/L, 95%CI –1.02 to –0.50), insulin levels (FINS: WMD= –7.06 mU/L, 95%CI –9.47 to –4.65; PINS: WMD= –98.86 mU/L, 95%CI –116.38 to –81.34), glycosylated hemoglobin (HbA1c) levels (WMD=–0.75%, 95%CI –1.07 to –0.42), and insulin resistance index (HOMA-IR) (WMD= –1.61, 95%CI –2.18 to –1.05); the experimental group was more effective than the control group in increaseing the high-density lipoprotein cholesterol levels (HDL-C) (WMD=0.21 mmol/L, 95%CI 0.12 to 0.30), and insulin sensitivity index (ISI) (WMD=1.64, 95%CI 1.48 to 1.80); the therapeutic effect for hypertension was greater in the experimental group than in the control group (OR=9.35, 95%CI 4.76 to 18.35); there were no significant differences in cholesterol levels (TC) (WMD= –0.22 mmol/L, 95%CI –0.55 to 0.10), body mass index (BMI) (WMD= –0.26 kg/m2, 95%CI –0.86 to 0.33), heart rates (HR) (WMD=0.50 bpm, 95%CI –4.98 to 5.98), and urine albumin excretion (UAE) (WMD= –16.00mg/24h, 95%CI –37.90 to 5.90); additionally, there were also no significant differences in adverse reactions between the two groups, such as edema (OR=3.01, 95%CI 0.62 to 14.54), gastro-intestinal discomfort (OR=1.19, 95%CI 0.63 to 2.24), headache and fatigue (OR=9.79, 95%CI 0.51 to 186.95), and anemia (OR=2.38, 95%CI 0.09 to 59.90). Conclusion To treating patients suffering from T2DM with HBP, the rosiglitazone is much effective than the control group in lowering blood pressure, blood glucose and lipid, reducing insulin resistance and improving β-cell function.
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.
ObjectiveTo investigate the relationship of 24-hour ambulatory pulse pressure (24hPP) with left ventricular mass index (LVMI) in elderly essential hypertension patients. MethodsThe data of 110 elderly patients with essential hypertension from January to December 2012 were collected in the study. All patients received 24-hour ambulatory blood pressure monitoring and echoeardiographic examination 24hPP and LVMI were calculated according to the results of 24-hour ambulatory blood pressure monitoring and echocardiographic measurements. The patients were divided into group A [24hPP<60 mm Hg (1 mm Hg=0.133 kPa), n=70] and group B (24hPP≥60 mm Hg, n=40). ResultsThe 24-hour systolic blood pressure and 24hPP for patients in group B were significantly higher than those in group A (P<0.001). Compared with group A patients, the interventricular septal thickness, left ventricular posterior wall thickness, left ventricular mass and left ventricular mass index were significantly higher in group B (P<0.05). Pearson correlation analysis showed that 24hPP had a positive correlation with LVMI in the elderly essential hypertension patients (r=0.33, P<0.001). Multiple stepwise regression analysis showed that 24hPP was the main factor for the increase of LVMI in elderly essential hypertension patients (β=0.90, P<0.001). ConclusionThe 24hPP is positively correlated with LVMI in elderly essential hypertension patients. The 24hPP is an important risk factor for left ventricular structural damage in elderly essential hypertensive patients.
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 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.
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.
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 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.