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Objective:To investigate the clinical features, therapy and prognosis of human cytomegalovirus(HCMV)pneumonia in pediatric patients, and to analyze the diagnosis value of detecting HCMV DNA in bronchoalveolar lavage fluid(BALF)by real-time PCR.Methods:The clinical characteristics of 58 pediatric inpatients who were HCMV DNA positive in BALF were retrospectively reviewed.All the patients were from Shengjing Hospital of China Medical University from January 2015 to December 2019.Clinical, radiologic, laboratory and microbiologic data was collected for each patient.The study cohort was divided into HCMV productive infection and latent infection consisting of 22 and 36 patients respectively, based on the HCMV active infection in lung or not.Receiver operating characteristic(ROC)curve was used to assess utility of detecting HCMV DNA in BALF and establish a threshold for diagnosis.Results:(1)Compared with patients in latent infection group, the children in productive infection group had a lower age of onset( P<0.05), a higher proportion of male( P<0.05), and more prolonged hospitalization stay( P<0.05). Pulmonary rales, hypoxemia and higher AST, CK, LDH in serum were easier to detect in productive infection group( P<0.05). Higher HCMV DNA copies in BALF was also detected( P<0.01). Patients in productive infection group had significantly more exposure to additional oxygen treatment or mechanical ventilation and systemic hormone therapy( P<0.05), while with poorer outcomes( P<0.05). (2) ROC curve analysis showed that the AUC for HCMV DNA in BALF in diagnosis of HCMV pneumonia was 0.708 with a threshold of 8.83×10 3 copies/mL, a sensitivity of 77.27%, and a specificity of 58.33%. Conclusion:Those who are diagnosed HCMV pneumonia have a lower age of onset with higher male proportion.These children suffered severer clinical signs.The patients with HCMV DNA copies higher than 8.83×10 3 copies/mL in BALF would be more likely to be diagnosed as HCMV pneumonia.
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OBJECTIVE：To provide reference for improving th e availability of clinical medication for children in China. METHODS：Based on the current laws and regulations of China ，referring to the relevant excellent experience and mode of foreign countries，the definition and regulatory attributes of intermediate products and final small-sized children ’s preparations were analyzed，and the feasible regulatory pathway of children ’s medicine preparedby intermediate products entering medical institutions were discussed. RESULTS & CONCLUSIONS ：According to the clinical dosage and characteristics of medication ，small-sized preparations for children in medical institutions could be divided into preparations for children ’s medical institutions and personalized preparations for children. From the analysis of foreign experience ，legal policies and technical conditions ，it was feasible for medical institutions to use intermediate products to formulate children ’s small-sized preparations ，but they also faced certain difficulties as the difficulty to supervise ，unclear quality standards ，vague subject and scope of use ，etc. In terms of supervision，it wa s suggested that intermediate products should be taken as the main quality management object when children ’s small-sized preparations prepared by intermediate products entered medical institutions. Meanwhile ，quality risk management should be paid attention to it. In the management of small-sized preparations for children in medical institutions ，it is necessary to formulate the preparation specifications of small-sized preparations for children in medical institutions ，prepare guidelines for the use of excipients and improve the quality inspection standards of preparations ；in the aspect of preparation supervision ，the small-sized preparations for children in medical institutions with large clinical demand are strictly controlled ，and those with high personalized degree in medical institutions are under loose supervision ；in terms of registration and approval ，technical evaluation should be carried out at the same time as the implementation of registration/filing management ；in terms of price setting ，appropriate profit margins should be formulated according to the innovation degree ，clinical demand ，children’s family affordability and public opinion feedback of price of children ’s small-sized preparations in medical institutions. Indiviclualized preparations are forma- lated ased on the price of preparations inmedical institutions ， with reference to the differential price comparice rules. Mean- while，pharmaceutical service fees are charged to compensate pharmacists’time and labor ；in terms of medical insurancepayment，the drugs are classified and managed according to whether they are included in the medical insurance list ，so as to ensure the same drug availability for children and adults .
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OBJECTIVE：To provide reference for improving the level of pediatric pharmacoeconomic research in China. METHODS： Using “Pediatric”“Pharmacoeconomics”“Cost-effectiveness”“Cost-utility”“Cost-benefit”“Minimum cost ” as keywords，pediatric pharmacoeconomic research literatures published during Jan. 2009 to Dec. 2018 were retrieved from CNKI ， Wanfang，VIP and CBMdisc. The Pediatric Quality Appraisal Questionnaire was used to evaluate the quality of the literatures. The problems of these literatures were analyzed to put forward the suggestions. RESULTS & CONCLUSIONS ：Totally 140 literatures were eventually included. The number of published literatures was increasing and the distrubtion of journals was scattered. The first auther was mainly from medical institutions. Included literatures mainly involved respiratory disease and drug treatment ，etc. Among them ，15 literatures indicated the research angle ；research time limit of 109 literatures was equal to or less than one year ；6 literatures carried out sensitivity analysis. Most of them adopted cost-effectiveness analysis and decision analysis model. The results of quality evaluation showed that the economic evaluation ，camparators，target population ，outcomes，analysis and conclusions domains had high scores （0.62 to 1.00 score），time horizon and discounting domains had middle scroes （0.49 and 0.53 score respectively），but perspective ，costs and resource use ，incremental analysis ，sensitivity analysis and conflict of intrest domains had low scores （0.10 to 0.31 score）. The main problems of pediatric pharmacoeconomic literatures in China focused on selection of research perspective ，measurement of costs and clinical outcomes ，and selection of analytical methods. The quality of pediatric pharmacoeconomic evaluations in China need to improve. It is suggested to supplement the content of pediatric pharmacoeconomics in China Guidelines for Pharmacoeconomic Evaluations . It is also suggested for pediatric pharmacoeconomic evaluations to clarify the perspective ，standardize the cost identification ，reasonably select health outcome indicators and correctly apply analysis method in order to improve the quality.
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OBJECTIVE： To explore the current situation of service ability and pharmaceutical service construction of primary healthcare institutions in Jiangsu province. METHODS： Questionnaire survey was conducted among primary healthcare institutions of 13 prefecture level cities in Jiangsu province， involving basic service information （such as serving mode， medical departments）， resource allocation （such as hardware， human resource） and pharmaceutical care construction （such as the leaders of the drug procurement， pharmaceutical departments allocation， mediation safety management）. The current situation of service ability and pharmaceutical service construction was evaluated in primary healthcare institutions of Jiangsu province. RESULTS： A total of 579 primary healthcare institutions in Jiangsu province were investigated and 579 questionnaires were collected （some items in the questionnaires were not answered）. Outpatient service （543/555，97.8％） was the main mode of service provided by primary healthcare institutions in Jiangsu province， followed by emergency call （321/555，57.8％） and hospitalization （292/555，52.6％）； the frequently established department in primary healthcare institutions was the medical department for all （452/568，79.6％）， preventive healthcare department（401/568，70.6％）， internal medicine department （365/568，64.3％）； 16.1％ （93/533）of the primary healthcare institutions had no beds； 36.4％ （211/579）of the institutions had no chief physician； 20.9％ （111/532）of the primary healthcare institutions medicine procurement were managed by pharmacists； 42.5％ （212/499）of the institutions had no pharmaceutical departments； physicians were responsible for patients' medication safety in 43.9％ （236/537） of the primary healthcare institutions and pharmacists were responsible for patients' medication safety in only 16.2％ （87/537）of the institutions. CONCLUSIONS： Primary healthcare institutions in Jiangsu province have made some achievements in service capability building. Human resources， equipment and facilities， pharmaceutical care construction and other aspects still need to be improved.
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OBJECTIVE： To provide reference for improving pediatric medication of National Essential Medicine List （NEML） and establishing Chinese essential medicine list for children. METHODS： NEML （2018 edition） were compared with WHO Essential Medicines List for Children （WHO EMLc） in respects of target population， special symbols， categories and varieties， dosage form and specification. The related suggestions were put forward. RESULTS & CONCLUSIONS： WHO EMLc is specifically used for children under 12 years old， and defines specific age and body mass. NEML is applicable to all age groups （including children）. WHO EMLc includes 4 types of special symbols， i.e. “□” （the drug with the best efficacy and safety in the same kind of drugs， which matches the selection principle of NEML）， “a” （limited age or body weight， not found in NEML）， “*” （special dosage， specially emphasized indications and age not recommended for use， listing substitute drugs， not found in NEML）， “[c]” （placed next to a drug or a specification indicating that they are only used by children； and placed next to a supplementary list indicating that they need expert diagnosis， monitoring facilities， medical care for children， similar to the “Δ” in NEML）. NEML in China includes chemical drugs and biological products， Chinese patent medicines and TCM decoction pieces. Among them， there are 26 categories and 417 types of chemical drugs and biological products. Compared with WHO EMLc， NEML has no blood products and special drugs for newborns. As far as antimicrobial agents are concerned， WHO EMLc has strict limits and classifications. However， due to the lack of guidelines for special antimicrobial agents for children in China， the application of NEML antimicrobial agents in pediatrics is still difficult to define and classify. The number of coincident varieties in the 2 lists was 149， and the coincidence rate was 35.2％. In terms of drug dosage， WHO EMLc’s dosage form are more abundant and flexible， such as scored tablet， compressible fragments， intramuscular injections， and oral solutions suitable for children which are not included in NEML. In terms of drug specifications， 2 lists basically consider about the special needs of children taking small dosage and to some extent take into account the complementarity of dosage forms and specifications. The author suggests that the relevant departments in China should draw lessons from the mature experience of WHO EMLc， add new labeling symbols in NEML， expand drug dosage forms， implement classified management of antimicrobial drugs， and timely launch Chinese Essential Medicines List for Children so as to lay a solid foundation for further improving the accessibility and safety of essential medicines for children in China.