Objective To observe the features of temporal macular thinning and its value for the diagnosis of Alport syndrome (AS) in young patients.Methods Eighty-one young patients with AS (81 eyes) from Peking University First Hospital during January 2016 and July 2017 were included in this study.There were 67 males (67 eyes) and 14 females (14 eyes),the aged from 3 to 17 years,with the mean age of 9.6 years.Among 81 patients (81 eyes),there were 64 patients with X-linked AS (XLAS,including 53 males and 11 females),17 patients with autosomal recessive AS (ARAS,including 14 males and 3 females).One hundred healthy subjects aged 4 to 17 years were included as controls.Clinical data were retrospectively evaluated,including visual acuity,slit-lamp microscopy,dilated fundus photography,and OCT.Retinal thickness was measured with an OCT scan and the temporal thinning index (TTI) was calculated as stated in a previous study.The TTI values of each group was compared by One-way ANOVA or independent sample t test.The receiver operating characteristic (ROC) curve was used to evaluate the diagnostic effectiveness for AS.Results The TTI of the control group,XLAS and ARAS patients were 6.46 ± 1.58,10.93 ± 3.77,12.14± 4.05,respectively.Compared with the control group,the TTI value of males were larger in the XLAS and ARAS group (F=45.056,P＜0.001),the TTI value of females were larger in the ARAS group (F=26.541,P＜0.001).The difference of TTI value in females was significant between the XLAS and ARAS groups (F=26.541,P＜0.001).In males,the area under the ROC curve was 0.896 (95％CI 0.837-0.955,P＜0.001).The optimal cutoff value of the TTI was determined as 9.47,with a sensitivity of 73.1％ and a specificity of 100％.Conclusions TTI is a common ocular finding in young patients with AS.In males,a TTI ＞ 9.47 may differentiate AS from normal males.

OBJECTIVETo summarize the experience of minimally invasive treatment in 520 patients with intracranial aneurysms on a retrospective study.

METHODSThe measures used in the treatment of 520 patients were reviewed in terms of timing of surgery, induced-hypotensive anesthesia, brain protection combined with temporal occlusion of the feeding artery, external drainage of CSF, dynamic monitoring of intracranial pressure, blood flow velocity, serum osmolality and CT scanning, anti-vasospasm therapy as well as selected interventional endovascular embolization of aneurysms.

RESULTSOf the 520 patients, 485 were treated with either direct clipping or endovascular embolization and 35 patients were treated non-surgically. In 449 patients undergoing direct clipping and 36 undergoing endovascular embolization, intraoperative rupture of aneurysm occurred in 27 (6.0%) and 0%, respectively. Death occurred in 13 (2.6%), hemiplegia in 8 (1.6%), and vegetative state in 2 (0.4%). The operative mortality of direct clipping was 3.8% in 210 patients before 1990 and 1.8% in 275 patients after 1990 (36 patients undergoing endovascular embolization, the operative mortality was 0%).

CONCLUSIONThe outcome of patients with intacranial aneurysms can be markedly improved and the operative mortality can be lowered by minimally invasive treatment.

Adult ; Aneurysm, Ruptured ; mortality ; therapy ; Embolization, Therapeutic ; Female ; Follow-Up Studies ; Humans ; Intracranial Aneurysm ; mortality ; surgery ; Intraoperative Complications ; mortality ; Male ; Microsurgery ; Middle Aged ; Minimally Invasive Surgical Procedures ; Retrospective Studies ; Survival Rate ; Treatment Outcome

BACKGROUND: As one of the most common endocrinal disorders for women at childbearing age, the diagnostic criteria of polycystic ovary syndrome (PCOS) have been defined differently among different international health organizations. Phenotypic heterogeneity of PCOS also brings about difficulties for its diagnosis and management assessment. Therefore, more efficient biomarkers representing the progression of PCOS are expected to be integrated into the monitoring of management process using metabolomic approaches. METHODS: In this prospective randomized controlled trial, 117 PCOS patients were enrolled from December 2016 to September 2017. Classical diagnostic parameters, blood glucose, and metabolome were measured in these patients before and at 2 months and 3 months of different medical interventions. The receiver operating characteristic (ROC) curves were built based on multivariate statistical analysis using data at baseline and 3 months' management, and combinational biomarkers with appreciable sensitivity and specificity were selected, which then validated with data collected at 2 months. RESULTS: A set of metabolites including glutamic acid, aspartic acid, 1-methylnicotinamide, acetylcarnitine, glycerophosphocholine, and oleamide were filtered out with high performance in representing the improvement through 3-month management of PCOS with high sensitivity and specificity in ROC analysis and validation with other two groups showed an appreciable area under the curve over 0.96. CONCLUSIONS: The six metabolites were representative of the remission of PCOS through medical intervention, making them a set of potential biomarkers for assessing the outcome of PCOS management. TRIAL REGISTRATION ClinicalTrials.gov, NCT03264638.
Biomarkers ; Female ; Humans ; Metabolomics ; Polycystic Ovary Syndrome/diagnosis* ; Prospective Studies ; ROC Curve

OBJECTIVE To provide ideas for solving the dispute of trans-provincial distribution of traditional Chinese medicine （TCM） decoction pieces in accordance with provincial standards （hereinafter referred to as “local TCM decoction pieces”）. METHODS Through simulation scenarios and collecting actual cases ，the conditions of trans-provincial distribution of local TCM decoction pieces were listed ；the official websites were searched or relevant personnel of drug supervision were interviewed；the current situation of trans-provincial distribution supervision of local TCM decoction pieces in China were sorted out. Based on the stakeholder theory ，the benefits and risks of main stakeholders were discussed to put forward relevant suggestions from the perspective of benefit /risk balance. RESULTS & CONCLUSIONS The conditions of trans-provincial distribution of local TCM decoction pieces in China included enterprises in B province produced TCM decoction pieces according to the A provincial standards，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the B provincial standards ，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the C provincial standards ，sold and used them in A province. At present ，there are no clear relevant provisions of national laws about trans-provincial distribution supervision of local TCM decoction pieces. Local regulatory opinions mainly come from the reply of the official website of drug regulatory department to online consultation ，and only Shandong ，Shanghai，Liaoning and Jiangxi have issued replies or normative documents. Totally 41.9％，38.7％ and 32.3％ of the provinces respectively allow the trans-provincial distrbution of local TCM decoction pieces in the above 3 conditions；in addition ，32.3％，16.1％ and 22.6％ provinces have unclear regulatory attitudes towards the 3 conditions. The benefits and risks analysis of relevant stakeholders shows that it is more in line with the scientific regulatory concept of benefit/risk balance to conditionally allow trans-provincial distribution of local TCM decoction pieces ，but the regulatory effect depends on the scientificity of the regulatory strategy. It is suggested that the drug regulatory departments clarify the relationship between the national and local standards for TCM decoction pieces and dingrl375@163.com differentiate the varieties of collection ；clear the regulatory requirements for trans-provincial distribution of local TCM decoction pieces by issuing high-level legal d ocuments；enrich regulatory measures and means ，and gradually adjust the requirements of trans-provincial distribution of local TCM decoction pieces .

OBJECTIVE：To provide reference f or optimizing the curriculum management system of continuing education for licensed pharmacists in China. METHODS ： The content and implementation system of continuing education curriculum management for licensed pharmacists in the United States was introduced ，and policy suggestions were put forward for the curriculum construction and management system optimization of continuing education for licensed pharmacists in China. RESULTS & CONCLUSIONS ：The curriculum management of continuing education for licensed pharmacists in the United States has clear curriculum objectives ，missions and plans ，and evaluates the basic situation of the trainees before continuing education starts ，so as to carry out modular management of the curriculum （including continuing education courses based on knowledge ，application and practice）. In terms of the implementation system of continuing education in the United States ，ACPE has put forward a lifelong learning model （pharmacist continuing career development model ）that emphasizes autonomy and personalization ，and has detailed regulations on teaching methods ，learning cycle and fees. At the same time ，ACPE requires that the feedback of participants on the curriculum must be collected. Combined with the practice in China ，it is suggested that the relevant departments should formulate the Curriculum Standard of Continuing Education for Licensed Pharmacists ， implement standardized management of the curriculum，improve the assessment mechanism of continuing education curriculum ，flexibly grant credits based on the actual education effect ，constantly update the concept and mode of continuing education ，and localize the international theory ，so as to continuously improve the continuing education management system of licensed pharmacists in China.

OBJECTIVE：To provide reference a nd ideas for improving the organizational system of continuing education and management system of teaching institutions for licensed pharmacists in China. METHODS ：By introducing the general situation of pharmaceutical education ， the legal basis and subject of continuing education organization and management of licensed pharmacists，and the situation of teaching institutions in the United States ，the existing problems in organizing continuing education institutions and managing teaching institutions for licensed pharmacists in China were analyzed ，and some suggestions were put forward. RESULTS & CONCLUSIONS ：The continuing education for licensed pharmacists in the United States is supported and promoted by state laws ；the organizational system of continuing education is relatively clear ，the responsibilities of each management subject are clear and the relationship is coordinated ；the teaching institutions have a relatively complete management system and process. However ，the management subject of continuing education for licensed pharmacists in China is inconsistent. It is difficult to establish a unified supervision system ，and there is a lack of unified management standard. And because the qualifications of teaching institutions vary greatly ，the quality of education is difficult to guarantee. It is suggested that China should learn from the experience of the United States and use higher-level legal documents to ensure the clarity of the organization and system of continuing education for licensed pharmacists ；establish a scientific and complete management system and access standards for continuing education institutions ；choose the appropriate management mode of continuing education based on the national conditions.

OBJECTIVE To sort out the common presentation forms and components of the framework of domestic and foreign essential medicine lists （EMLs）， in order to provide reference for optimizing the framework of the Chinese EML. METHODS The latest edition of the EMLs of WHO， China， South Africa， India， Malaysia and other typical countries were compared， and the similarities and differences of the presentation form and constituent elements of the list framework were analyzed. RESULTS & CONCLUSIONS The common presentation forms of WHO and typical countries’ EMLs included version， classifications and symbols， of which management ideas， functions， and implementation difficulties varied； common framework elements included target population， hospital levels， drug use conditions， core and supplementary lists and procurement priority. Through comparison， it was found that the information covered by the Chinese EML was relatively thin， and the framework design had not yet fully played the ideal role in guiding clinical rational drug use and optimizing the allocation of health resources， and there was still some room for improvement. It is recommended that China clarify the characteristics and roles of different presentation forms of the EML， and reasonably set the EML framework based on national conditions and development needs； the multi-dimensional drug information should be supplemented， such as clinical use， economy， and policy attributes of drugs in the EML， to ensure the rational use of essential drugs； it is also necessary to add “the level of hospitals” in the framework of the EML， refine the management requirements for the allocation and use of essential medicine， and optimize the resource allocation of hospitals.

In February 2023, the National Health Commission, together with the Ministry of Science and Technology, the Ministry of Education, and the State Administration of Traditional Chinese Medicine issued the Ethical Review Measures for Life Science and Medical Research Involving Humans, which emphasizes that research participants involving vulnerable groups such as children, intellectual disabilities, and mental disabilities should be given special protection. This paper expounded the current situation of protecting vulnerable groups from six aspects: inadequate protection of vulnerable groups by relevant laws and regulations, unclear definition of vulnerable groups, insufficient supervision by relevant departments, insufficient review ability of ethics committee to satisfy the protection of vulnerable groups, difficulty in fair inclusion of vulnerable groups, and the need to improve the ethical awareness of researchers and vulnerable groups. This paper also analyzed the new requirements for the protection of vulnerable groups in the Ethical Review Measures for Life Science and Medical Research Involving Humans from the following three aspects: expanding attention to potentially vulnerable research participants, paying more attention to the consent of research participants without or with limited capacity for civil conduct, and re-informed consent after the improvement of civil capacity level. Finally, suggestions on strengthening the protection of vulnerable groups were put forward from six aspects: improving the relevant legal system, clarifying the category of vulnerable groups, strengthening the implementation by regulatory departments, establishing a research participant protection system by research institutions, improving the ethical review capacity of ethics committees, formulating review guidelines by industry associations, and strengthening the education and training of all parties, so as to minimize the risk of vulnerable groups participating in clinical research and boost the quality and speed of clinical research in China.

OBJECTIVE To provide reference for the application of patient preference information in China by studying the application of patient preference information in the premarketing decision-making of medical products in the United States. METHODS The literature research method was used to explore the general situation， legal basis， and participants of the collection and application of patient preference information in the United States， analyze the application of patient preference information in premarketing decision-making of medical products in detail， and analyze the application status and challenges of patient preference information in China， so as to put forward suggestions. RESULTS & CONCLUSIONS United States has promoted the collection and application of patient preference information through several patient participation projects and legislation. The patient preference information is used to support premarketing decision-making of medical products： providing information for medical product development and design， and assisting clinical trial design in the research and development process； helping to support FDA’s marketing approval decisions， identifying patient groups whose benefits outweigh risks， and included in medical product descriptions in the marketing approval process. The application of patient preference information in China lacks the guidance of higher-level legal documents， and there are no targeted guidance documents. It is suggested that China should learn from the experience of the United States and clearly encourage the research and application of patient preference in higher-level legal documents； develop specific guidance documents for the collection and application of patient preference information； determine the weight and form of patient preference information to be considered in regulatory decision-making according to national conditions.

OBJECTIVE：To provide reference for improving the continuing education system for licensed pharmacists in China by learning from the mature experience of the continuing education system of licensed pharmacists in the UK. METHODS ： Literature research method was adopted to summarize and analyze the organizational structure ，specific contents and implementation methods of the continuing education system for licensed pharmacists in the UK by combing the English and Chinese literatures ， official policies and reports of the continuing education system for licensed pharmacists in the UK. The suggestions and reflections were put forward to improve the continuing education system of licensed pharmacists in China. RESULTS & CONCLUSIONS ：The management organization of continuing education system for licensed pharmacists in the UK is mainly UK Association of Boards of Pharmacy，the organizations of which provide continuing education include pharmacy associations ，pharmaceutical education institutions，pharmaceutical colleges and universities. Continuing education system of licensed pharmacists in the UK is relatively perfect，including personal needs analysis ，systematic continuing education courses ，self-education and evaluation reflection of licensed pharmacists ，forming a systematic circulation system ；continuing education is carried out for pharmacists in different practicing fields ，with equal emphasis on theory and practice. In terms of continuing education ，the UK focuses on face-to-face ， one-to-one training ，and provides many free continuing education courses. Compared with the UK ，the continuing education system of licensed pharmacists in China still has some gaps. For example ，the self-education and self-evaluation awareness of licensed pharmacists is not strong ，the content and form of continuing education lack of pertinence and practicality ，and the re-registration management of pharmacists ’practicing qualifications is more formalistic. It is recommended that licensed pharmacists in China establish the concept of self-education ，strengthen the practicality of continuing education for pharmacists ，carry out refined continuing education for pharmacists in different fields of practice ，and strengthen the management of re-registration of licensed pharmacists，so as to form a systematic and effective circulation system for continuing education of licensed pharmacists in China.