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 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.

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.

PI3K/Akt, Wnt/β-catenin, TGF-β, Nrf2 and Notch signaling pathways are mainly involved in the TCM treatment of chronic refractory wounds (CRW). Chinese materia medica monomers and compound preparations can inhibit protein kinases related to signaling pathways in wound tissue and promote wound healing; reduce the expression of inflammatory factors and inhibit the occurrence of inflammatory response; promote the proliferation and differentiation of growth factors and epidermal stem cells, accelerate the regeneration of granulation tissue, and play a role in repairing wound regeneration.

Objective:To visually analyze the research literature on the analysis of TCM compounds; To explore the research hotspots and trends in this field.Methods:The literature related to the disassembly analysis of TCM compounds was retrieved from CNKI, Chongqing VIP, Wanfang Data, SinoMed, and China Medical Journal Full-text Database from January 1, 1981 to December 31, 2024. CiteSpace 6.4.R1 software was used to visualize the number of articles, authors, institutions and keywords, and to draw the cooperation network diagram of authors and institutions, keyword co-occurrence, clustering, timeline and burst map.Results:A total of 1 728 Chinese articles were included, and the number of publications showed a fluctuating upward trend. A comparatively high number of publications was in 2007 and 2016, followed by a slight decline but maintained at a high level. There is a trend of recovery in 2024. The author with the highest number of articles was Professor Fang Zhaoqin, and the institution with the highest number of articles was Beijing University of Chinese Medicine. High frequency keywords included rats, compatibility, experimental research, cell apoptosis, TCM compound, and a total of 19 clusters and 25 emergent keywords were formed.Conclusions:The research contents and methods of the research on the disassembly of TCM compounds are relatively rich, and there are many explorations on classical prescriptions. The study of disassembled prescriptions has played a driving role in the modernization of TCM compounds. In the future, high-quality cooperation between regions, institutions, and authors, combination with modern medicine and scientific methods, will further improve the quality of research in this field.

Objective:To observe the clinical efficacy of Xinyue Decoction combined with fluoxetine hydrochloride in the treatment of cognitive impairment of senile depression.Methods:A randomized controlled trial study was conducted. Totally 116 elderly patients with depression accompanied by cognitive impairment were set as observation subjects, and were divided into a control group and an experimental group using random number table method, with 58 patients in each. The control group received treatment with fluoxetine hydrochloride capsules, while the experimental group was administered Xinyue Decoction Granules in addition to the treatment regimen of the control group. The treatment lasted for 8 weeks for both groups. Comparison was made between the two groups regarding the changes in TCM syndrome scores. Hamilton Depression Scale (HAMD-24) was used to assess the degree of depression, and Montreal Cognitive Assessment (MoCA BJ) was used to assess cognitive ability; the serum levels of brain-derived neurotrophic factor (BDNF), IL-1β, IL-6 and TNF-α were detected by ELISA; the adverse reactions during treatment were observed and recorded, and the clinical efficacy was evaluated.Results:The total effective rate of TCM syndromes was 90.4% (47/52) in the experimental group and 75.5% (40/53) in the control group, with statistical significance ( χ2=4.11, P<0.05); the total effective rate of MoCA-BJ was 76.9% (40/52) in the experimental group and 58.5% (31/53) in the control group, with statistical significance ( χ2=4.61, P<0.05); the total effective rate of HAMD-24 was 88.5% (46/52) in the experimental group and 71.7% (38/53) in the control group, with statistical significance ( χ2=4.07, P<0.05). After treatment, the TCM syndrome score, HAMD-24 and MoCA-BJ scores of the experimental group were lower than those in the control group ( t=-3.51, -5.11, 2.39, P<0.01 or P<0.05); the level of serum BDNF [(10.49±1.76) ng/L vs. (9.61±1.85) ng/L, t=2.28] in the observation group was higher than that of the control group ( P<0.05), and the levels of IL-1β, IL-6 and TNF-α were lower than those in the control group ( t=-2.50, -2.46, -2.18, P<0.05). During the treatment, the incidence of adverse reactions was 5.77% (3/52) in the experimental group and 7.55% (4/53) in the control group, without statistical significance ( χ2=0.13, P>0.05). Conclusion:Xinyue Decoction combined with fluoxetine hydrochloride can reduce the degree of depression in elderly patients with cognitive impairment of depression, improve the cognitive ability of patients and clinical efficacy.