Objective To compare the 2009 edition national essential medicine list (part of basic medicine and heath institution ) in China and WHO model list of essential medicines for children update in 2010, so as to provide the evidence for model list of essential medicines for children of China. Methods We compared the diference in composition of content, the categories, speciic drugs, formulation, and introduction and sign of list by descriptive analysis. Results (1) WHO model list of essential medicines for children were comprised with core and complimentary lists, which were not in the 2009 edition national essential medicine list of China; (2) The 2009 edition essential medicine lists of China included 20 categories in WHO model list of essential medicines for children ,while lacked of antineoplastic agents, blood products, disinfectants, peritoneal dialysis luid and speciic medicines for neonatal care; (3) he average conincidence rate with WHO model list of essential medicines for children of the same drugs was 52.61%. here were 15 categories in the interval of 20%-80%, which accounted for 75%. he average conincidence rate with 2009 edition national essential medicine list of China was 44.19%. here were 11 categories in the interval of 20%-50%,which accounted for 55%. the same drugs of regulate water, electrolyte and acid-base balance in the two list accounted for more than 80% of WHO model list of essential medicines for children. Drugs of ear, nose and throat were totally diferent. (4) he 2009 edition essential medicine list of China didn’t have speciication and sign of drug for children, age limitation, instruction of list, suitable drug formulations for children such as suspension, syrup, drops, granules, scored tablets, etc. Conclusion 2009 edition national essential medicine list of China can’t meet the demand of children. WHO model list of essential medicines for children which bases on global burden of disease, can not be copied into China. We suggest to reference fromWHO model list of essential medicines for children to carry out selecting essential medicines for children in China, formulating essential medicine list for children in China which bases on burden of children disease and clinical demand in China to improve rationality of drugs in children.
Objective To provide evidence for the definition, current development and prospect of Evidence-based pharmacy through systematically assessing the extant literatures. Methods We searched CBM, VIP, CNKI, PubMed, EMbase, and Google for supplement. We extracted definitions of evidence-based pharmacy, types of studies, published year, topics of studies, and the author information from the included studies. We compared the definitions on different domains, and assessed the current development of evidence-based pharmacy literature. Results a) The definition of evidence-based pharmacy: We found 4 definitions, and there were great differences among them on the people who practiced evidence-based pharmacy as well as the methods and areas of the practice. b) The evidence-based pharmacy literature: 12 English and 202 Chinese articles were included in the review. The number of Chinese evidence-based pharmacy articles was increasing annually, especially in recent 3 years; Most of their authors were from hospitals, especially from pharmacy department; Their study orientations mostly involved clinical pharmacy and hospital pharmacy; The topics mainly refered to the practice and development of clinical pharmacy, rational drug use, and development of hospital pharmacy. Conclusion a) There is yet no consensus on the definition of evidence-based pharmacy. b) Few researchers worldwide know or show interest in evidence-based pharmacy, while, so far, more and more researchers are getting to know evidence-based pharmacy in China. c) Further efforts should be made to develop the theoretical system of evidence-based pharmacy and the pattern of its practice.
Objective To explore the ultrastructure characteristics of pulmonary arteries in smokers with normal lung function and with chronic obstructive pulmonary disease ( COPD) . Methods 33 patients who undertook surgery for peripheral lung cancer were collected. According to smoking history and pulmonary function, the patients were divided into three groups, ie. non-smokers with normal pulmonary function ( group A, n = 10) , smokers with normal pulmonary function ( group B, n = 13) , and smokers in stable phase of COPD ( group C, n = 10) . Normal lung tissues without cancer were sampled and observed under light and electric microscope. Results ①Compared with group A, the thickness of intimal layer of intra-acinar pulmonary muscular arteries of group B and C were significantly higher, the area of their lumenwas lower, and the proportion of their muscular arteries was higher( P lt; 0. 01) . ②Ultrastructure of small pulmonary arteries of group A showed that intimal layer was normal, so as to endothelial cells and smooth muscle cells. Collagen fiber was not increased. Ultrastructure observation of group B showed that endothelialcells were distorted, basal membrane was thick, and collagen fiber increased in vessels. Ultrastructure observation of group C showed that endothelial cells degenerated, vascular intima thickness increased, andsynthetic phenotype smooth muscle cells increased. ③ Smoking index was positively correlated with the proportion of muscular arteries and the proportion of intimal area( r =0. 464,0. 635, P lt;0. 05, respectively) ,and negatively correlated with the proportion of lumen area( r= - 0. 603, P lt;0. 05) . Conclusions Smokers with normal lung fuction and with COPD show the similar ultrastructural characterizations in endothelial cells, smooth muscle cells, and pulmonary arterial remodeling, which related closely to smoking.
Objective To assess the global situation of off-label drug use in outpatient children.Methods A search was conducted in PubMed, EMbase, CBM, CNKI and VIP for collecting studies on off-label drug use in outpatient children aged 0 to 18 years, and the publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies, and the descriptive analysis was performed to analyze the incidence of off-label drug use at all levels of medical institutes and different age groups, the common types of off-label used drugs, and the constitution ratio of off-label use drugs. Results A total of 20 cross-sectional studies were included, involving 1 933 760 children and 5 262 573 prescriptions. The results of descriptive analysis showed: a) The incidence of off-label drug use in outpatient children in primary care and tertiary care institutes were 19.5% (IQR 13.5%, 24.5%) and 26.0% (IQR 24.0%, 35.0%), respectively; b) The primary studies reported that neonate, infant and adolescent had the highest incidence of off-label drug use, while the other children had the lowest incidence; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were listed as the top 5 frequently used off-label drugs by more than half of the studies; d) The studies with issue of “lack of instruction for children” showed it was exactly the type with highest incidence of off-label use, while other studies without that issue showed the highest incidence was over aged off-label use. Conclusion a) Off-label drug use is common in outpatient children. The incidence of off-label drug use may be higher in tertiary care institutes than primary care institutes, and it is higher in neonate, infant and adolescent rather than other age groups of children; b) Incidence of off-label use may be higher in inpatient children than outpatient ones; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were most common types of off-label use; and d) Off-label use due to both “lack of instruction for children” and “over aged use” is more common. So it suggests that further studies trials should focus on fields in which clinical trials of drugs are totally absent.
Objective To analyze drug use for 23 sick and wounded hospitalized in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital, during one month after Lushan earthquake, so as to provide references for the drug use for the sick and wounded women and children. Methods Medication information was retrospectively investigated in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital during one month after Lushan earthquake. We extracted data including hospitalization duration, medication prescriptions, types and costs of essential medicines, types and costs of antibiotic medicines using the HIS system. Discharge diagnosis was standardized and classified according to ICD-10. Indicators of rational drug use included defined daily dose (DDD), defined daily dose statistic (DDDs), drug utilization index (DUI), children defined daily dose (cDDD), children drug utilization index (cDUI), proportion of essential medicines, proportion of antibiotic medicines, mismatch of medicine and diagnosis, repeated drug use, improper combination of drug, incorrect usage and dosage, and frequently drug change. Medication information was evaluated and discussed by the prescription working group. Discrepency was resolved by consulting with the panel. Results A total of 23 sick and wounded women and children were assessed during one month after Lushan Earthquake. There were 13 sick and wounded children in the department of pediatrics (mainly manifested as bronchial pneumonia) and 10 sick and wounded women in the department of gynaecology and obstetrics (mainly involved in cesarean delivery). Proportions of essential medicines were 13/13 in the department of pediatrics and 9/10 in the department of gynaecology and obstetrics. Proportions of antibiotic medicines were 10/13 in the department of pediatrics and 8/10 in the department of gynaecology and obstetrics. Irrational drug use was mainly caused by improper use of antibiotics. Conclusion The drug use for 23 hospitalized sick and wounded is rational in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital during one month after Lushan earthquake. Evaluation methods of rational drug use in high-risk population are urgently needed. Using cDDD and cDUI is an active exploration for the evaluation of pediatric drug use, which needs more practice to test and improve.
Objective To assess the global situation of off-label drug use in hospitalized children. Methods The databases such as PubMed, EMbase, CBM, CNKI and VIP were searched to collect studies on off-label drug use in hospitalized children at age of 0 to 18 years old. The publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies. The incidence of off-label drug use was described in different wards and age groups, and the proportion of different off-label used drugs was analyzed. Results The total 29 cross-sectional studies were included, involving 8 560 children and 41 655 prescriptions. a) Median (IQR) of off-label use incidence: Neonatal ICU 52.5% (23.0% to 44.8%), Pediatric ICU 43.5% (34.5% to 60%), General pediatric ward 35.5% (23.8% to 43.3%), Pediatric surgical ward 27.5% (23.0% to 44.8%); b) The results of off-label incidence in different age groups were inconsistent among different studies; and c) The off-label drug use for “no pediatric information” had the largest proportion, followed by dose and age. Conclusion a) Off-label drug use exists widely around the world, but the incidence varies a lot in different countries and different types of wards; b) The incidence of off-label drug use may be higher in ICU than in non-ICU, and higher in the neonatal ward than the pediatric ward; c) The off-label drug use for no pediatric information is the commonest type, and further clinical studies should focus on areas in which high quality evidence is totally absent; and d) The multi-center studies with unified design on off-label drug use in hospitalized children in China are urgently needed to provide evidence for policy-making.
Objective To evaluate the related laws, regulations and guidelines about off-label drug use in several countries, so as to provide evidence for regulating off-label drug use in China. Methods The following 3 Chinese databases as CBM, CNKI and VIP, 11 foreign databases including EMbase, PubMed and so on, 15 countries’ official websites of pharmaceutical administration department or academic organization, and WHO website were searched to obtain the related laws, regulations and guidelines about off-label drug use. By adopting the system evaluation method and self-defined index evaluation, the quality of the included literatures was evaluated in three aspects: literatures’ type, content relevance and timeliness. Seven researchers independently extracted data by Excel which included basic information of literatures, preconditions of off-label drug use, medicines categories that could be off-labelly used, regulations and legal responsibility in off-label drug use. And finally the descriptive analysis was conducted. Results A total of 4 735 literatures were retrieved, 104 of which were finally included, including 89 at grade A quality level (85.58%) and 15 was at grade B (14.42%). The analysis showed that, a) Seven countries had laws related to off-label drug use: America, Germany, Italy, Netherland, New Zealand, India and Japan. Except India, the rational off-label drug use was allowed in the other 6 countries. The right to prescribe off-label drug was defined in Britain and Ireland; b) Medical staff had to take the responsibility of off-label drug use in the country where the duty regulations were formulated; and c) Ten countries published guidelines or statements related to off label drug use by their official departments and academic organizations. And the regulation included the following procedures: firstly, to obtain the relative information and evidence; secondly, to get the informed consent; thirdly, to be approved by the ethics committee and/or pharmacy administration committee; fourthly, to record the reasons and effectiveness of off-label use; fifthly, to monitor the adverse reactions of off-label drug use. Besides monitoring the medical institutes, the pharmaceutical companies had also be monitored which included the following 3 aspects: a) to require companies to train specialized staffs to answer the questions related to off-label drug use; b) to open the contact information of medical departments of companies; and c) to prohibit preaching and advertising the off-label drug use. Conclusion Off-label drug use has its rationality and necessity. To protect the safety of patients, avoid the risk for hospitals and medical staffs, it requires formulating relative regulations soon in order to manage the off-label drug use in China. As a developing country, China is different from the developed countries in health care system. Therefore, when formulating the regulations, it is necessary to perform evidence-based evaluation on each country’s laws, regulations and guidelines about off-label drug use, with Chinese national conditions and experts’ opinions in combination. After a regulation is preliminarily drawn up, it needs to be put into pilot practice, and then revised and spread to the whole country.
Objective To investigate and analyze the status of clinical guidelines of children in China, so as to regulate the development of children’s evidence-based clinical guidelines and provide recommendations for children’s clinical guidelines. Methods Names of guidelines, year and institution of publication, methodology of development and reference number were descriptively analyzed. Years of publication and diseases of guidelines were analyzed with statistical graphs. AGREE instrument was used to evaluate the evidence-based guidelines of children. Results a) Of 91 clinical guidelines of children, 62 were translations. Of 29 guidelines ourselves, nine were traditional Chinese medicine guidelines and five (17%) were evidence-based guidelines; b) Guideline on Rational Use of Antibiotics in Acute Respiratory Infections (Probation), the first guideline of children, was published in 1999. Guidelines of children was not published until 2005. Then, the number of guidelines was increasing each year and reached a peak in 2008. Of 13 guidelines in 2008, seven were traditional Chinese medicine guidelines. Guidelines on respiratory diseases were 14 ranked as the top; c) Guidelines on congenital deformity and chromosomal abnormalities, tumor, circulatory system disease, blood disease and western guideline on communicable disease were not formulated in China; and d) Average scores on six domain of five evidence-based guidelines were 84.4%, 37.5%, 74.3%, 90.0%, 22.2%, 46.6%, respectively. Guide on Diagnosis and Treatment of Children Aged 0 to 5 with Acute Fever of Unknown Etiology was bly recommended, Guide on Management of Children with Community-Acquired Pneumonia, Evidence-Based Guide on Diagnosis and Treatment of Children with Common Kidney Disease, Guide on Nutrition Support of Newborn, Guide on Diagnosis and Treatment of Children with Chronic Cough were recommended. Conclusion Clinical guidelines of children in China begin late, develop slowly and are lack of update. A standard on development of guidelines is needed. The government should increase the fund of development, implementation and promotion of guidelines. Recommendations for high-quality guidelines should be included in procedure of medical quality assurance. Compliance of guidelines should be provided by organization which formulatesd the guideline, so as to promote the application of high-quality guidelines.
目的 研究盐酸氨基葡萄糖联合双醋瑞因在伴有骨髓水肿（BME）的膝骨关节炎（KOA）中的疗效评估。 方法 依据MRI检查结果，选取2011年1月－2012年6月入院60例伴BME的KOA患者随机分入A组（口服盐酸氨基葡萄糖）、B组（口服双醋瑞因）、C组（口服盐酸氨基葡萄糖和双醋瑞因），每组各20例；另纳入同期30例不伴BME的KOA患者30例为D组（口服盐酸氨基葡萄糖和双醋瑞因）。完成标准方案后24周，随访临床疗效和影像学评分及炎症因子变化。 结果 治疗24周后4组在20 m 步行后视觉模拟评分（VAS）、关节压痛VAS评分较治疗前有改善（P＜0.05）；在BME改善方面，C组容积积分和程度积分均优于A、B两组（P＜0.05）；在炎症因子方面，治疗24周后4组白细胞介素（IL）-1β、IL-6和肿瘤坏死因子α表达水平明显降低（P＜0.05）。 结论 盐酸氨基葡萄糖联合双醋瑞因能有效改善伴有BME的KOA患者临床症状、降低炎症因子表达水平以及促进BME在影像学方面的改善。
Objective To investigate the correlation of elderly knee osteoarthritis with bone marrow edema and osteoprotegerin, DKK-1 (dickkopf-1), sclerostin. Methods A total of 100 elderly patients with knee osteoarthritis in Sichuan Province Orthopedic Hospital from September 2017 to December 2018 were selected and divided into bone marrow edema group (50 cases) and non-bone marrow edema group (50 cases). The patients’ basic data, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores and Visual Analogue Scale scores were collected. The patients’ serum osteoprotegerin, DKK-1, sclerostin, C-reactive protein, and erythrocyte sedimentation rate were tested, and the differences between the two groups were compared. The correlation of the detection indicators and bone marrow edema and its clinical indicators was explored. Results There was no significant difference in age, gender, course of disease, C-reactive protein and erythrocyte sedimentation rate between the two groups (P>0.05). WOMAC scores (76.1±5.4 vs. 67.5±6.6), Visual Analogue Scale scores (8.4±1.1 vs. 5.5±0.9), proportion of synovitis (84.0% vs. 52.0%), osteoprotegerin [(1.3±1.1) vs. (0.6±0.5) μg/L], DKK-1 [(18.4±16.9) vs. (6.9±6.0) μg/L] and sclerostin [(147.3±119.4) vs. (99.7±70.7) pg/mL] in the bone marrow edema group were higher than those in the non-bone marrow edema group (P<0.05). There was no statistically significant correlation of the bone marrow edema volume score and degree score and serum osteoprotegerin of patients in the bone marrow edema group (P>0.05). The bone marrow edema volume score and degree score of patients in the bone marrow edema group were positively correlated with serum DKK-1 (volume score rs=0.464, P=0.001; degree score rs=0.379, P=0.007) and sclerostin (volume score rs=0.316, P=0.025; degree score rs=0.461, P=0.003). Conclusion In elderly patients with knee osteoarthritis and bone marrow edema, the local bone metabolism indicators of osteoprotegerin, DKK-1 and sclerostin are up-regulated, especially DKK-1 and sclerostin are related to the severity of bone marrow edema.