OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial （IIT）. METHODS With benchmarking analysis， based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai， a thorough review was conducted， involving relevant laws， regulations， and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects， a detailed comparative analysis of key processes was carried out， such as the receipt， storage， distribution， use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing， the training before project implementation was insufficient， and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems， improvement measures were put forward， including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs， etc. The related systems were improved， and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established， which helps to improve the institutional X2023076） framework of medical institutions in this field.

Psychological factors have become significant contributors to the onset and progression of insomnia. This article explored the treatment of insomnia from the perspective of “liver governs wei qi （defensive qi）”. The concept of “liver governs wei qi （defensive qi）” is summarized in three aspects， firstly， the liver assists the spleen and stomach in transformation and transportation， governing the generation of wei qi； secondly， the liver aids lung qi diffusion and dispersion， governing the distribution of wei qi； thirdly， the liver regulates circadian rhythms， governing the circulation of wei qi. It is proposed that the clinical treatment of insomnia should focus on the following methods： for regulating the liver to harmonize the five viscera， and facilitate the circulation of wei qi， medicinals entering the liver channel include Chaihu （Bupleuri radix）， Baishao （Paeoniae Radix Alba）， Zhizi （Gardeniae Fructus）， and Suanzaoren （Ziziphi Spinosae Semen） could be commonly used； for nourishing the liver， the treatment should align with the day-night rhythm， and herbs such as Baihe （Lilium）， Hehuan （Albizia julibrissin）， and Yejiaoteng （Polygoni multiflori caulis） are commonly used； for soothing the liver and address both mental and physical health to calm wei qi， treatment should advocate verbal counseling， psychological regulation， and health education. Ultimately， this treatment approach can free liver qi to flow， soothe qi movement， restore the motion of wei qi， regulate during day and night， balance yin and yang， and resolve insomnia effectively.

OBJECTIVE To provide suggestions for improving the path and system construction of patient engagement in drug regulation in China. METHODS By reviewing initiatives and experiences from the United States （U. S.）， European Union （EU）， and Japan in promoting patient engagement， this study summarizes the roles and contributions of patients in the entire drug regulatory process internationally. Combining China’s current progress and challenges in patient engagement， specific proposals are formulated to refine regulatory pathways and institutional systems. RESULTS & CONCLUSIONS With growing global emphasis on patient engagement as a regulatory strategy， countries or regions such as the U.S.， EU， and Japan have established clear policies， designated oversight agencies， and developed diversified pathways for patient engagement. Patients contribute to regulatory processes through advisory meetings， direct decision-making roles， and leveraging lived experiences and expertise to optimize drug evaluation and monitoring. In contrast， China’s patient engagement remains primarily limited to clinical value- oriented drug development， lacking formal policy guidance. It is recommended that China， based on its existing policy system， further strengthen the construction of a safeguard system for patient engagement， improve the capacity building and pathway models for patient participation in pharmaceutical regulation， and promote the continuous development of patient engagement in pharmaceutical regulation in our country.

Objective: To explore the intervention effect of schoolbased horticultural activities combined with fancy rope skipping on the health behaviour of fourthgrade primary school students, so as to provide a reference method for childrens health promotion. Methods: Eightyfive primary school students in grade 4 of a primary school in Changsha City were selected in March 2023 by using multistage cluster random sampling method and randomly divided into an intervention group (43 students) and a control group (42 students). The intervention group implemented a 12week comprehensive intervention of "schoolbased gardening combined with pattern skipping, once a week 90 min/time including routine practice (weeks 1-5,7-11; the contents were vegetable and plant management, theoretical knowledge learning of pattern skipping practice, etc.) and parent-child activities (weeks 6 and 12; vegetable salad making, synchronized jumping rope competition, etc.), and the control group maintained the regular curriculum. Moderate to vigorous physical activity (MVPA) and sleep duration were monitored by accelerometers in grade 4 primary school students, combined with questionnaires to assess fruit and vegetable intake and video screen behaviour, and generalised estimating equations were used to analyse the data. Results: After the intervention, there were interaction effect for school day MVPA time (Wald χ2group×time=8.27), vegetable intake (Wald χ2group×time=4.35), and video screen time (Wald χ2group×time=13.27) in both groups (P<0.01). After the intervention, the MVPA time in the intervention group increased from 30.00 (20.00,60.00) min to 40.00 (30.00, 60.00) min from school day; vegetable intake increased from 99.85 (33.95, 229.48) g to 190.15 (131.05, 279.48) g; and video screen time increased from 225.00 (110.00, 313.75) min to 60.00 (30.00, 142.50) min (Z=-4.51, -2.00, -3.84, P<0.05). However, there were no statistical differences in MVPA time, fruit intake and sleep time before and after intervention in the intervention group on weekends (Z=-1.35, -0.85, -0.24, P>0.05). Conclusion Schoolbased horticultural activities combined with an integrated intervention of fancy rope skipping can significantly improve physical activity, vegetable intake and video screen behaviours on weekdays in grade 4 primary school children, in order to provide a basis for multidimensional health promotion.

Edema， as a common pathological phenomenon， is essentially the abnormal accumulation of body fluids in the interstitial spaces of human tissues and is often a direct manifestation of various underlying diseases， such as heart failure， impaired renal filtration function， or liver metabolic disorders. In the Western medical system， strategies for treating edema primarily focus on the use of diuretics to promote the excretion of excess fluid in the body， while simultaneously addressing the underlying causes through targeted treatment. However， long-term reliance on the use of diuretics may lead to a decrease in drug sensitivity and induce side effects， including electrolyte disorders such as hypokalemia and hypercalcemia， posing a potential threat to patients' overall health. Compared with Western medicine， traditional Chinese medicine （TCM） has demonstrated well-recognized and sustained efficacy in treating edema with its unique theoretical system. Zhulingtang， as a classic and commonly used TCM formula， is widely applied as it can effectively relieve edema and related symptoms. In recent years， ongoing in-depth studies on the treatment of edema with Zhulingtang have revealed multiple mechanisms of action of Zhulingtang， including the regulation of water metabolism and the reduction of inflammatory responses， thereby providing a solid theoretical basis for clinical practice. This review summarized the research progress on the treatment of edema with Zhulingtang in recent years and analyzed the active ingredients and action pathways of Zhulingtang. Additionally， the primary mechanisms of action and efficacy were systematically analyzed， so as to provide references for the clinical application of Zhulingtang in treating various types of edema， such as cardiogenic edema， renal edema， and hepatogenic edema. This review aims to offer theoretical support and practical guidance for clinicians in deciding treatment approaches， as well as references for subsequent in-depth studies， thereby promoting further development of TCM in the treatment of edema.

Edema， as a common pathological phenomenon， is essentially the abnormal accumulation of body fluids in the interstitial spaces of human tissues and is often a direct manifestation of various underlying diseases， such as heart failure， impaired renal filtration function， or liver metabolic disorders. In the Western medical system， strategies for treating edema primarily focus on the use of diuretics to promote the excretion of excess fluid in the body， while simultaneously addressing the underlying causes through targeted treatment. However， long-term reliance on the use of diuretics may lead to a decrease in drug sensitivity and induce side effects， including electrolyte disorders such as hypokalemia and hypercalcemia， posing a potential threat to patients' overall health. Compared with Western medicine， traditional Chinese medicine （TCM） has demonstrated well-recognized and sustained efficacy in treating edema with its unique theoretical system. Zhulingtang， as a classic and commonly used TCM formula， is widely applied as it can effectively relieve edema and related symptoms. In recent years， ongoing in-depth studies on the treatment of edema with Zhulingtang have revealed multiple mechanisms of action of Zhulingtang， including the regulation of water metabolism and the reduction of inflammatory responses， thereby providing a solid theoretical basis for clinical practice. This review summarized the research progress on the treatment of edema with Zhulingtang in recent years and analyzed the active ingredients and action pathways of Zhulingtang. Additionally， the primary mechanisms of action and efficacy were systematically analyzed， so as to provide references for the clinical application of Zhulingtang in treating various types of edema， such as cardiogenic edema， renal edema， and hepatogenic edema. This review aims to offer theoretical support and practical guidance for clinicians in deciding treatment approaches， as well as references for subsequent in-depth studies， thereby promoting further development of TCM in the treatment of edema.

To analyze inpatient mortality cases in a tertiary general hospital in Beijing based on diagnosis-related groups (DRG), with the aim of providing references for healthcare quality management.

OBJECTIVE: To explore the characteristics and rules of the locations of acupoints selected in weight loss after syndrome differentiation of acupuncture and moxibustion, and provide quantitative evidence for the location specificity of acupoint selection in weight loss. METHODS: Clinical research articles on acupoint selection based on syndrome differentiation of acupuncture and moxibustion in weight loss were retrieved in China National Knowledge Infrastructure (CNKI), from the inception to September 20th, 2024, and the data about acupoints and differentiated syndromes were extracted. Based on graph theory, the acupoint-syndrome network was established and its topological parameters such as node degree, value of betweenness centrality, description length and number of community were calculated. RESULTS: ①The description length of the limbs was 4 255.592, and that of the trunk was 3 274.312. The information contained in the acupoint-syndrome network for the acupoints on the limbs was greater than that for those on the trunk. ②The value of betweenness centrality and node degree showed a nonlinear relationship, with R²of 0.812 1 for the trunk and 0.321 8 for the limbs. The values of betweenness centrality for the acupoints on the trunk were uniformly distributed, and the difference among these values was much smaller than that for the acupoints on the limbs. It suggested that the distance from each trunk acupoint to network center was similar, and the importance among these acupoints to network was similar, while the importance among acupoints located on the limbs was different significantly. ③The frequency proportion of acupoints on the trunk showed uniform distribution among different syndromes, while that of some acupoints located on the limbs such as Taichong (LR3), Neiting (ST44) and Taixi (KI3) presented a correlation with the syndromes. CONCLUSION In weight loss with acupuncture and moxibustion, the correlation between the limb acupoints and syndromes is more diverse and specific than that between the trunk acupoints and syndromes. The differences in acupoint selection for simple obesity treated with acupuncture and moxibustion are mostly reflected in the acupoints on the four limbs rather than those on the trunk. It provides an approach to acupoint selection for "local weight loss" and "general regulation" in treatment with acupuncture and moxibustion.
Humans ; Acupuncture Points ; Moxibustion ; Weight Loss ; Acupuncture Therapy ; Obesity/physiopathology*

The Solomon four-group design， a critical method for improving internal validity in clinical research， can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results， which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design， summarized its applications in clinical research at home and abroad， explored its advantages and limitations， and discussed the potential value in traditional Chinese medicine （TCM） clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies， and reduce the bias in the evaluation of subjective indicators. Meanwhile， given the complexity of the Solomon four-group design and the particularity of TCM clinical research， it is proposed that future TCM clinical studies should focus on using psychological scales， know-ledge， attitude， and behavior measurements， and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.

OBJECTIVE To investigate the improvement effects and mechanism of Zhichi suanzaoren decoction （ZSD） on hippocampal oxidative stress injury in hippocampal neurons of mice with perimenopausal insomnia. METHODS The potential targets of active ingredients in ZSD were predicted using TCMSP and TCMIP databases； the targets related to insomnia were searched through GeneCards， OMIM and DisGeNET databases； protein-protein interaction network of intersecting targets of ZSD ingredients and insomnia was constructed； Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analyses were conducted on key targets. Sixty mice were divided into sham operation group， model group， ZSD low-， medium-， and high-dose groups （11， 22， and 33 g/kg）， and eszopiclone group （positive control， 1 mg/kg）. Except for sham operation group， the perimenopausal insomnia model was constructed by ovariectomy （OVX） in the other groups. After successful modeling， mice in each group were gavaged with normal saline or the corresponding drug solution， once a day， for three consecutive weeks. The sleep status of mice was evaluated through the pentobarbital sodium sleep synergy experiment， and the pathological changes of hippocampal neurons and the expressions of related genes and proteins in mice were observed by HE staining， immunohistochemistry staining， immunofluorescence staining， transcriptome sequencing technology and Western blot. RESULTS The results of network pharmacology showed that there were 296 intersection targets between ZSD and perimenopausal insomnia. Protein kinase B1 （Akt1） was a key target for treating insomnia with ZSD. After administration of ZSD， the sleep latency of mice was shortened， the sleep duration was prolonged significantly， and the mean optical density value of neuron-specific nuclear protein in the hippocampal CA1 region was significantly increased （P＜0.01）. Additionally， hippocampal neuron damage in OVX mice was significantly alleviated. The results of transcriptome sequencing showed that ZSD significantly upregulated the transcriptional levels of Nfe2l2 gene in hippocampal tissue of OVX mice （P＜0.05）. After administration of ZSD， protein expressions of nuclear factor E2 related factor 2 （Nrf2） and heme oxygenase-1 （HO-1） in hippocampal tissue of OVX mice， as well as the phosphorylated Akt level， were increased significantly （P＜0.01）. CONCLUSIONS ZSD can ameliorate hippocampal oxidative stress injury of hippocampal neurons in perimenopausal insomnia mice by activating the Akt/Nrf2/HO-1 signaling pathway.