ObjectivesTo systematically evaluate the structure, publication type and contents of current guidelines for guideline development, so as to provide methodology references for guideline development in China. MethodsSix biomedical research literature databases, six guideline databases and 18 websites of academic institutions and health administrative departments were searched to locate guidelines for guideline development. We included the latest versions of guidelines from guideline development departments or academic institutions. We extracted information consisting of general guideline information, structure, principles, methods and procedure of guideline development. A descriptive analysis was conducted to analyze the general information, structure, principles, methods and procedure of guidelines among different guidelines for guideline development. ResultsAmong all the included 25 guidelines for guideline development published from 1998 to 2014, 50% of them were from North America. Structure of these guidelines were similar while detail levels of recommended guideline development methods and procedures were slightly different. The guideline development groups, systematic literature search, evidence assessment and recommendation formulation were vital part of guideline development. The ineffective promotion and implementation of guidelines for guideline development were common problems of current guidelines. ConclusionsProcedures recommended by current guidelines for guideline development are almost the same, but the methods and statements are different. We could develop our own guideline for guideline development based on the current relative high-quality guideline in order to provide guidance to the clinical guideline development in China.
Objective To explore the application of two methods of direct fecal detection ofClostridium difficilein patients with recurrent inflammatory bowel disease (IBD), including nucleic acid amplification test (NAAT) and enzyme immunoassay (EIA), in order to provide support for hospitals to prevent and control clostridium difficile infection (CDI). Methods Fresh feces of 48 patients with recurrent IBD treated between November 2014 and April 2015 were collected within 48 hours after admission. Anaerobic culture and identification, NAAT and EIA were used to test the same samples. Statistical analysis was performed using Kappa test. Results Among the 48 fecal samples,Clostridium difficilewas negative in 37 and positive in 11 including 2 (4.2%) with toxigenicClostridium difficile characterized as toxin type A+B+. Compared with anaerobic culture and identification, NAAT had a perfect correlation (Kappa=1.00,P<0.05), and EIA had an almost perfect correlation (Kappa=0.89,P<0.05). But EIA toxin test had missed detection of toxigenic samples. Conclusions For patients with recurrent IBD combined with CDI, both NAAT and EIA test may be applied to detctClostridium difficile in feces directly, while NAAT may show a better performance. Samples from highly suspected patients with negative toxin result tested by EIA should be confirmed by other methods such as NAAT.
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.
目的 比较股骨近端抗旋髓内钉（PFNA）与动力髋螺钉（DHS）两种方法内固定治疗高龄股骨粗隆间骨折的疗效。 方法 2007年1月－2011年1月分别采用PFNA、DHS治疗高龄股骨间粗隆骨折（EvansⅠ～Ⅳ型）共68例，其中PFNA组36例，平均年龄81.5岁；DHS组32例，平均年龄82.3岁。两组患者在年龄、性别、骨折分型、合并症以及受伤至手术时间方面比较差异均无统计学意义（P＞0.05），有可比性。 结果 术后68例患者均获随访，随访时间6～26个月。与DHS组比较，PFNA组手术时间短、术中出血少，差异有统计学意义（P＜0.05）；PFNA组骨性愈合时间短，但两组差异无统计学意义（P＞0.05）。术后DHS组出现1例髋内翻、1例拉力螺钉切出股骨头颈，PFNA组出现1例主钉退钉，两组术后并发症发生率比较差异有统计学意义（P＜0.01）。术后1年PFNA组髋关节Harris评分显著高于DHS组，差异有统计学意义（P＜0.01）。 结论 PFNA与DHS两种固定方法的骨性愈合时间短、术后并发症少、髋关节功能恢复好，是治疗股骨粗隆间骨折的良好方式，尤其是PFNA能减少手术时间和术中出血量，手术创伤小，对高龄且不能耐受较大手术者可作为一种首选术式。
Objective To determine the extent of off-label drug use in pediatric outpatients of West China Second University Hospital in 2010, and to analyze its possible risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China and developing policy of off-label drug use. Methods The stratified random sampling was conducted to select prescriptions of children aged 0 to 18 years in pediatric outpatients of the West China Second University Hospital in 2010. According to drug instructions, off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs. In addition, an analysis was conducted to check the relationship between off-label use and following possible risk factors: age, sex, essential medicines and over-the-counter drugs. Results A total of 2 640 prescriptions with 8 588 medical advices involving 329 drugs were extracted and analyzed, with incidence rates of off-label drug use accounting for 76.59%, 40.88% and 83.89%, respectively. The main categories of off-label drug use were no pediatric information (35.57%), indication (25.44%), and dosage (25.31%). The top 2 age groups with highest incidence rate of off-label drug were neonates (54.35%) and adolescents (49.64%). The top 4 drugs with highest incidence rate of off-label drug were respiratory system medicines (48.12%), Chinese patent medicines (48.12%), digestive and metabolic system medicines (33.36%), and systemic anti-infectives (16.27%). The off-label use risks in all age groups in the hospital were indifferent, and the essential medicines and prescription medicines were likely to present higher risks of drug off-label. Conclusion Off-label drug use in pediatric outpatients is common with growth trend in pediatric outpatients of the West China Second University Hospital. On the one hand, drug instructions lack pediatric information, and on the other hand, it’s badly in need of developing relevant legislation, regulations or guidelines to regulate off-label drug use, providing more evidence by conducting clinical trials on pediatric drugs, encouraging the development and production of the applicable drugs and dosage forms for children, and establishing the children essential medicine list, so as to avoid doctor’s professional risk and ensure the safety of pediatric drug use.
Objective To investigate the off-label prescriptions in pediatrics in West China Second University Hospital and to analyze the reasons and performance, so as to provide the baseline data for improving the rationality drug use in pediatrics in China. Methods The prescriptions of pediatrics outpatient department were randomly selected from May 2008 to April 2009; and the off-label use was analyzed according to the package inserts in the following aspects, the types of off-label use, the rate of off-label use in different age groups and categories of medicine. Results Of the total 2 400 prescriptions, 1 398 (58.25%) involving off-label use. All sample prescriptions contained 6028 records, 1 923 (31.90%) involving off-label use. The problems such as dosage (45.98%), frequency (21.17%) and age (18.19%) were the top-three types of off-label use. The rate in different age groups ranked as the top-three were school-age (61.56%), followed by preschool (60.77%) and infants (57.56). The top-five categories of medicines in off-label use were anti-allergy drugs (49.45%), digestive system drugs (49.32%), externally applied drugs (41.49%), Chinese patent drugs (34.60%) and nervous system drugs (33.78%). Conclusion The off-label drug use is widespread in pediatrics outpatient department. It is an effective approach to reduce off-label use and improve drug safety through strictly abiding by the instruction of usage and dosage as well as selecting a suitable dosage form.
Objective To assess the quality of current domestic literature about enzyme-linked immunosorbent assay (ELISA) for invasive aspergillosis diagnosis by detecting Aspergillus galactomannan (GM) antigen, and to analyze the sources of bias and variability, as well as the diagnostic ability of different thresholds. Methods Both computer-based online search and manual retrieval were employed to identify relevant articles. The statistical information and quality of science were assessed and classified. The data were analyzed using Meta Disc 1.4 software. The best cutoff value for defining a positive test result was selected by summarizing the following statistical indicators as sensitivity, specificity, likelihood ratio (LR) and summary receiver operating characteristic curve (SROC curve), and by calculating the area under the curve (AUC) as well. Results A total of 20 studies among 2658 literatures were included in accordance with the inclusion criteria, and were divided into different groups based on different cutoff values. Though heterogeneity tests showed no threshold effect, and there were other reasons of heterogeneity. So the data were analyzed by random effects model. The results showed that, compared with other groups, the one with cutoff value set at 0.7 (AUC=0.9456, Q= 0.884 6) showed the best accuracy in diagnosing. Conclusion ELISA detection of Aspergillus GM antigen with cutoff value set at 0.7 has important significance in the early diagnosis of invasive aspergillosis, and it can be conducive to reduce mortality in patients at high risk for Aspergillus infection.
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.
ObjectiveTo build the list of appropriate dosage forms and specifications of essential medicines for children which is subsistent abroad and absent in China. MethodsBased on the authoritative data and expert consultation, we established the selection methodology which included the standard of essential medicine for children, the standard of appropriate dosage for children, the standard of appropriate specifications for children, the standard of urgent classification, the standard of urgent level. ResultsThe list of appropriate dosage forms and specifications included 61 medicines which included 20 dosage forms and 112 specifications. 112 specifications included 27 specifications which belong to level Ⅱ, and 85 specifications which belong to level Ⅲ. ConclusionThe established list can be included by the green channel.