The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

A retrospective analysis was performed for the clinical data of a patient with GFAP astrocytopathy that was initially misdiagnosed as viral encephalitis， and the diagnostic and therapeutic experience of this disease was summarized through a literature review.The female patient， aged 39 years， presented with headache and fever after diarrhea for 1 day， with the main manifestations of distending pain in the brain， nausea， vomiting， low‑grade fever， and right‑sided ataxia. Physical examination showed papilledema in both eyes and neck stiffness； contrast-enhanced cranial MRI showed extensive leptomeningeal enhancement； cerebrospinal fluid （CSF） analysis showed a significant increase in opening pressure and lymphocytic‑predominant pleocytosis. The patient was tested negative for common infectious pathogens and autoimmune encephalitis antibodies， and therefore， she was once misdiagnosed with viral encephalitis. After unsuccessful antiviral and antibiotic therapies， CSF and serum samples were tested positive for GFAP‑IgG antibodies， and the patient was finally diagnosed with GFAP astrocytopathy. The patient symptoms were rapidly relieved after pulse therapy with methylprednisolone （1 g/day）， and imaging reexamination showed the disappearance of leptomeningeal enhancement， with significant improvements in both intracranial pressure and CSF parameters. The patient remained asymptomatic till the last follow‑up in July 2025， and negative conversion was observed for CSF GFAP antibodies.GFAP astrocytopathy lacks specific clinical manifestations， with leptomeningeal enhancement and lymphocytic predominance in CSF as crucial clues for early diagnosis， and detection of GFAP IgG antibodies in CSF and serum is the key to a confirmed diagnosis. This disease is highly sensitive to glucocorticoid therapy， and early identification followed by standardized treatment can help to achieve a good prognosis. This disease should be differentiated from common central nervous system infections such as viral encephalitis in clinical practice to avoid treatment delay due to missed diagnosis or misdiagnosis.

This article analyzes the development and current status of clinical pathways(CPs)in the United States,the European Union,and Japan.CPs are standardized treatment models based on medical evidence and guidelines,aiming to improve therapeutic outcomes,reduce costs,ensure treatment consistency,enhance medical service efficiency,and increase patient satisfaction.The United States has promoted CPs since 1985,driving their development through legislation and professional associations to improve service quality and reduce medical expenditures.The European Union supports the development and evaluation of CPs through the European Pathway Association,emphasizing the improvement of patient treatment outcomes.Japan uses CPs as a tool to improve the quality of medical services,with an emphasis on multidisciplinary collaboration.All three have shown positive effects of CPs in improving medical service efficiency and reducing costs.However,they also face challenges such as overemphasis on cost control,lack of transparency,and physician cooperation.China can draw on these experiences to promote the development of CPs and enhance the quality and efficiency of medical services.

Objective To analyze the development and implementation of nutritional drug treatment pathways abroad,and to provide insights for the establishment of similar pathways in China.Methods A search was conducted in international literature and guideline databases for studies on nutritional therapy pathways up until December 1st,2024.The search focused on aspects such as pathway development methods,the composition of development teams,and implementation outcomes.Results A total of 29 relevant articles were identified,including 12 clinical practice guidelines and 17 research papers.The guidelines were all issued by the European Society for Clinical Nutrition and Metabolism,while the research papers showed significant heterogeneity,spanning multiple countries,regions,and medical conditions,primarily from developed countries in Europe and North America.The analysis reveals that nutritional therapy pathways typically include components such as nutritional assessment,formulation of nutritional plans,integration with other drug therapies,development of follow-up plans,pathway implementation teams,and the reassessment and updating of pathways.Conclusions China can benefit from the practices of developed countries,particularly those in Europe and North America.Key recommendations include the establishment of multidisciplinary teams,the promotion of a tiered treatment model,and the involvement of medical associations in forming expert groups to develop and implement nutritional drug treatment pathways,thereby enhancing the quality of nutritional treatment in China.

Objective To investigate the therapeutic efficacy of artesunate(AS)on polycystic ovary syndrome(PCOS)in mice and explore the potential mechanism primarily.Methods Twenty-five female C57BL/6J mice were randomly divided into Control group,model group(PCOS group),low-and high-dose AS groups(AS15 and AS30 groups)and metformin group(Met group).In addition to the Control group,the mouse model of PCOS was established by subcutaneous injection of dehydroepiandrosterone(DHEA,60 mg/kg)following by a high-fat diet for 21 d.After modeling,AS of 15 and 30 mg/kg was intraperitoneally injected into the mice of the AS 15 and AS30 groups,respectively,and 200 mg/kg Met was given to those of the Met group by gavage,once per day,for 6 weeks.ELISA was used to detect serum testosterone(T),fasting insulin(FINS),luteinizing hormone(LH)and follicle-stimulating hormone(FSH),and the LH/FSH ratio was calculated.The levels of fasting blood glucose(FBG),triglyceride(TG)and total cholesterol(TC)were detected by automatic biochemical analyzer,and the homeostasis model assessment of insulin resistance(HOMA-IR)was calculated.The estrous cycle was observed,and HE staining was performed for pathological changes in the ovary and uterus.Immunofluorescence assay was employed to measure the expression of p-eIF2α,ATF4 and CHOP in the ovarian tissue.After steroidogenic human granulosa-like tumor cell line KGN were exposed to 100 μmol/L DHEA to simulate the hyperandrogen environment of PCOS,and then treated with 5 and 10 μg/mL AS for 24 h,the protein levels of endoplasmic reticulum stress signaling pathway was detected by Western blotting.Results Compared with the Control group,the PCOS mice had disturbed estrous cycle,polycystic changes in the ovaries,and significantly increased serum T level and LH/FSH ratio(P＜0.05),and obviously elevated HOMA-IR,TC and TG levels in terms of metabolism(P＜0.01).The expression levels of p-eIF2α,ATF4 and CHOP were notably up-regulated in the ovarian granulosa cells of PCOS mice and KGN cells after DHEA exposure(P＜0.05).Additionally,AS treatment attenuated the pathological changes of ovary and uterine expression,decreased the serum T level and the LH/FSH ratio(P＜0.05),and reduced HOMA-IR,TC and TG levels(P＜0.05)when compared with the PCOS mice.Moreover,the expression levels of p-eIF2α,ATF4 and CHOP were significantly down-regulated after AS treatment in both ovarian granulosa cells of PCOS mice and KGN cells(P＜0.05).Conclusion AS significantly improves glycolipid metabolic disorder and reproductive dysfunction in PCOS mice,which may be associated with its suppressing endoplasmic reticulum stress by inhibiting the PERK/eIF2α/ATF4/CHOP pathway.

Objective:To develop a simple and effective subretinal injection pipeline system to enhance the accuracy and precision of subretinal injection volume control.Methods:A retrospective case series study. From May to October 2023, 18 patients (18 eyes) with submacular hemorrhage (SMH) who continuously received modified subretinal injection treatment in Department of Ophthalmology of Peking Union Medical College Hospital were included in the study. Among them, there were 10 males and 8 females. The mean age was (60.00±7.41) years. The primary causes included polypoid choroidal vasculopathy (14 cases), retinal macroaneurysm (2 cases), traumatic retinopathy (1 case), and Valsalva retinopathy (1 case). Hemorrhage affected 14 eyes of the fovea centralis. All affected eyes underwent standard three-channel 25G vitrectomy via the flat part of the ciliary body combined with modified subretinal injection of recombinant tissue plasminogen activator. The improved injection system consisted of a 1 ml syringe, a Q-Syte TM connector, a 41G subretinal microinjection needle, a converter and a viscoelastic substance control pipeline. The drug preparation time for subretinal injection (i.e., the time consumed by the system connection step), the injection time, whether bubbles occur during the injection process, and the perioperative complications were recorded and analyzed. Results:The preparation time prior to drug injection ranged from 230 to 335 seconds, while the injection completion time varied between 43 and 75 seconds. Both times decreased progressively as operator proficiency improved. Among the treated eyes, five received a target injection dose of 0.05 ml and thirteen received 0.10 ml, with all eyes achieving the preset dose accurately. No subretinal bubbles were observed during the injection procedure. Additionally, no intraoperative complications such as retinal hemorrhage or tear secondary to mechanical trauma at the injection site were recorded. Postoperatively, one eye developed anterior chamber hemorrhage, which resolved following intraocular pressure-lowering treatment. No other postoperative complications, including hemorrhage, rhegmatogenous retinal detachment, or infection, were observed in the remaining eyes.Conclusion:The retinal drug injection system developed in this study has a simple structure, safe and stable operation, can achieve precise drug injection, and effectively avoid the formation of bubbles.

Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmaco-poeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results ①Overdose:Among the 1 378 reviewed formulas,146(10.60％)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated dai-ly dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were ob-served among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30％ lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per compo-nent,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Strychnos nux-vomica(Maqianzi)listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strych-nosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg.Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the"Dosage and Administration"section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses(including:Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)."For CPM containing tox-ic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.

OBJECTIVE To explore the construction path and effectiveness of dynamic zoning management model during dengue fever pandemic,and to provide evidence for optimizing hospital-acquired infection control strategies.METHODS Retrospective analysis method was conducted,the practical data of dengue fever epidemic prevention and control in a tertiary general hospital in 2024 as the sample,to evaluate the application effect of the"zoned treatment-dynamic allocation-environmental coordination"trinity prevention and control model.Based on the optimized infection prevention and control strategies implemented during the epidemic,such as the"core ward-specialist collaboration"dynamic zoning,flexible ward expansion,hierarchical disinfection,real-time dynamic re-source allocation mechanism,and precise environmental intervention,a comprehensive evaluation of prevention and control efficiency was conducted across key dimensions including infection control,resource utilization,pre-vention and control costs and patient outcomes.RESULTS Through the construction of flexible wards,the number of expanded isolation beds accounted for 44.13％(331/750)of the total beds,including 144 beds(19.20％)in core wards and 187 beds(24.93％)in specialist collaborative wards.The expansion of specialist collaborative wards increased the isolation admission capacity by 129.86％.The two types of wards admitted 57.27％of single-disease dengue patients and 42.73％of isolated patients with combined diagnosis and treatment needs from inter-nal medicine,surgery,obstetrics,gynecology,and pediatrics.The minimum ratio of flexible buffer isolation beds was 6.34％(21/331),with a maximum daily treatment capacity of 310 patients.Data showed:hospital infec-tion incidence rate was 0,peak adult mosquito density was 0.13 mosquitoes/trap·night,prevention and control cost was 95.22 yuan per case,and patient satisfaction increased by 1.98％(95.09 vs.93.24,P=0.014).CONCLUSIONS The"dynamic zoning"model achieves rapid spatial elastic reconstruction of inpatient wards for"peace-epidemic conversion"through the coordination of three links.Based on effectively blocking in-hospital transmission,it ensures the needs of multi-specialty treatment,enabling the hospital to strike a balance between the bottom line of prevention and control safety and the fulfillment of diversified medical service requirements dur-ing the epidemic outbreak period.It can provide standardized prevention and control solutions for medical institu-tions to respond to public health emergencies of vector-borne infectious diseases,and achieve the goal of zero cross infection of hospital-acquired Dengue.

Volatile organic compounds (VOCs) are a type of organic compounds that exist in the form of vapor in the air at room temperature, and are common pollutants in industrial production and living environments. The health hazards caused by exposure to VOCs are gradually gaining recognition and social attention. At present, the research on the harm of VOCs to human health mainly involves the respiratory system, cardiovascular system and nervous system. However, in recent years, people have realized that VOCs can induce glucose metabolism disorder through insulin resistance, oxidative stress and oxidative damage, inflammatory reaction and liver damage, leading to increased blood sugar and increased potential risk of diabetes, and even increased the risk of complications of diabetes. This review summarizes the epidemiology and related mechanisms of VOCs, diabetes and its complications, providing a reference for effective prevention and control of VOC induced diabetes.