Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

As the number of patients with compromised immune function increases and fungal resistance develops, so does the risk of contracting deadly fungi in humans. Both fungi and humans are eukaryotes, so identifying unique targets for antifungal drug development is difficult. In addition, the existing antifungal drugs are limited by toxicity, drug interaction and drug resistance in practical application, which leads to the increasing incidence and fatal rate of fungal infections. Therefore, it is urgent to develop new antifungal drugs. The semi-synthetic technology using microbial fermentation products from natural sources as lead compounds has become the most used method in structural modification of antifungal drugs due to its advantages of few reaction steps and easy operation. This paper will introduce the current status of natural antifungal drugs in clinical use, as well as the latest progress in the research and development of new semi-synthetic antifungal drugs, and summarize their mechanism of action, structural modifications, advantages and disadvantages, so as to provide reference for the subsequent development of new antifungal drugs.

Acute lateral ankle sprain (ALAS) is one of the most common sport injuries, with high incidence, recurrence and disability rates. Currently, exercise rehabilitation-based non-surgical treatment is the primary management approach for ALAS. However, there remain improper practices such as excessive immobilization or uncontrolled activity, which contribute to recurrent sprains and chronic ankle instability, significantly impairing patients′ athletic function and quality of life. To standardize the non-surgical management of ALAS, improve the cure rates, and reduce the recurrence and disability rates, Chinese Sports Rehabilitation Medicine Training Project of Chinese Medical Association, Foot and Ankle Basics and Orthopedics Group, Orthopedic Branch of Chinese Medical Doctor Association, and Sports Medicine Branch of Jiangsu Medical Association organized relevant experts to formulate Expert consensus on non-surgical treatment for acute lateral ankle sprain ( version 2025), following the principles of scientific vigor, practicality, and innovation. Thirteen recommendations were proposed for standardized treatment protocols across different healing phases, aiming to provide references for standard management of ALAS and improve the therapeutic outcomes.

Thoracolumbar spine fracture often leads to severe pain, functional impairments, and neurological deficits, for which open reduction and internal fixation can effectively restore the spinal structural stability. Open decompression and reduction with internal fixation can help relieve spinal cord compression and improve spinal function in cases of concomitant cord injury. Although spinal stability can be restored through surgery, patients often face chronic pain and functional impairments postoperatively. A postoperative rehabilitation program is critical in optimizing therapeutic outcomes, reducing complications, and minimizing the risk of secondary injuries. However, current rehabilitation methods, such as physical therapy, functional training, and pain management, are confronted with problems in clinical practice, including significant variation in efficacy, poor patient adherence, and prolonged rehabilitation period. There is an urgent need for a unified rehabilitation strategy to address these problems. To this end, the Spinal Trauma Group of the Orthopedic Physicians Branch of the Chinese Medical Association and the Spine Health Professional Committee of the Chinese Human Health Technology Promotion Association organized experts from relevant fields to formulate Evidence-based guidelines for rehabilitation treatment after internal fixation of thoracolumbar spine fracture in adults ( version 2025) by integrating evidences from clinical researches and advanced rehabilitation concepts at home and abroad. A total number of 14 recommendations concerning the rehabilitation treatment with multimodal analgesia, psychological intervention, deep vein thrombosis prevention, core muscle and extremity exercise, appropriate use of braces, early weight-bearing, device-aided rehabilitation exercise, neuroregulatory therapy, rehabilitation team were put forward, aiming to standardize the post-operative rehabilitation process following internal fixation, promote the functional recovery, and enhance patients′ quality of life.

Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.

Degenerative cervical myelopathy(DCM)is a group of diseases caused by cervical spine degeneration that compresses the spinal cord.It is a major cause of spinal cord dysfunction in adults,and its incidence is increasing globally.In the late stage,DCM could lead to paralysis due to spinal cord injury,which makes rapid,effective,and accurate medical diagnosis clinically significant.Deep learning(DL)technology can assist physicians in the rapid and accurate diagnosis of DCM by analyzing and processing a large amount of imaging data to extract features of the affected regions.In recent years,DL algorithm models have been leveraged for DCM-related research,which has become a focal point of intelligent medical development.In this review,domestic and international literature is surveyed,and the research progress and application of DL technology in the auxiliary diagnosis and prognosis evaluation of DCM are systematically summarized,aiming to provide a reference for intelligent diagnosis in clinical practice.

Objective:To describe the trend of changes in the disease burden of age-related hearing loss in China and globally from 1990 to 2021,to forecast the prevalence and years lived with disability(YLD)rates of age-related hearing loss from 2022 to 2036,and to provide a reference for the prevention and control of the disease burden associated with age-related hearing loss.Methods:Using the Global Burden of Disease 2021(GBD2021)data,this study selected age-standardized prevalence rate(ASPR)and YLD as indicators.The disease burden and long-term trends of age-related hearing loss in China and globally from 1990 to 2021 were described by different socio-demographic index(SDI)and gender.Joinpoint regression was used to calculate the average annual percent change(AAPC)to assess the trend changes in the disease burden.Decomposition analysis was applied to explore the relative im-pacts of aging,population growth,and epidemiological changes on the variation in disease burden.An autoregressive integrated moving average(ARIMA)model was used to forecast the age-standardized pre-valence rate and YLD rates from 2022 to 2036.Results:The prevalence of age-related hearing loss in China in 2021 was 82 162.49(73 288.08-89 187.21)per 100 000,higher than the global SDI level of 66 238.16(59 982.54-72 669.82)per 100 000,the high SDI region's level of 57 650.42(52 059.12-63 889.02)per 100 000,the upper-middle SDI region's level of 69 115.59(62 494.18-75 340.64)per 100 000,the middle SDI region's level of 72 365.56(65 181.43-78 912.01)per 100 000,the lower-middle SDI region's level of 64 439.66(58 368.22-71 468.27)per 100 000,and the low SDI region's level of 61 725.25(55 749.18-68 477.67)per 100 000.The age-related hearing loss YLD rate in China was 2 762.98[95％uncertainty interval(UI):1 855.28-3 880.68]per100000,higher than the global SDI level of 2 236.75(95％UI:1 511.56-3 155.88)per 100 000,the high SDI region's level of 1 805.79(95％UI:1 212.69-2 577.17)per 100 000,the upper-middle SDI re-gion's level of 2 316.58(95％UI:1 557.53-3 274.87)per 100 000,the middle SDI region's level of 2 480.99(95％UI:1 678.17-3 489.24)per 100 000,the lower-middle SDI region's level of 2 313.28(95％UI:1 578.35-3 271.50)per 100 000,and the low SDI region's level of 2 383.55(95％UI:1 623.66-3 365.68)per 100 000.From 1990 to 2021,both the prevalence and YLD rate of age-related hearing loss in China showed an increasing trend,rising by an average of 0.18％(95％CI:0.16％-0.19％)and 0.29％(95％CI:0.27％-0.30％)per year,respectively.The rates of in-crease in prevalence were the same for both men and women,with men showing a 0.18％increase(95％CI:0.17％-0.19％,P＜0.001)and women showing a 0.18％increase(95％CI:0.16％-0.19％,P＜0.001).However,the YLD rate increase was faster in men than in women,with men experiencing a 0.32％increase(95％CI:0.27％-0.37％,P＜0.001)and women experiencing a 0.27％increase(95％CI:0.26％-0.28％,P＜0.001).Decomposition analysis showed that population growth was the main factor driving the increase in prevalence and YLD rate globally and across different SDI regions.However,aging was the primary factor contributing to the increase in prevalence and YLD rate in China.ARIMA model predictions suggested that the prevalence and YLD rate of age-related hearing loss would continue to rise from 2022 to 2036,with the predicted prevalence and YLD rate in 2036 reaching 89 723.99 per 100 000 and 2 872.47 per 100 000,respectively.Conclusion:The prevalence and disease burden of age-related hearing loss in individuals aged 60 and above in China rank first globally.From 1990 to 2021,both the prevalence and YLD rate of age-related hearing loss have shown a continuous upward trend,consistently surpassing the levels observed in various SDI regions worldwide.The prevalence and disease burden of age-related hearing loss are particularly significant among elderly men.Moreover,projections indicate that the disease burden of age-related hearing loss will continue to rise over the next 15 years.Therefore,it is urgent to pay close attention to age-related hearing loss in this specific population,and early intervention measures are crucial to reduce the disease burden associated with age-related hearing loss.

Objective To estimate the prevalence of calcified nodule(CN)among patients with coronary artery disease(CAD)and identify the possible risk factors associated with an increased CN risk.Methods Databases include PubMed,Web of Science and Embase was conducted to identify studies reporting the prevalence and/or risk factors of CN.For this databases,the search was from inception to January 1,2024.Data analyses was performed using R statistical Software 4.2.2.Results A total of 46 studies involving 17 926 patients were included.Among them,13 studies with 4 187 patients reported both the prevalence and associated risk factors.The overall prevalence of CN was found to be 5.72％(95％CI 4.47％-7.31％),while in studies reporting both the prevalence and risk factors,the CN prevalence was slightly higher at 8.72％(95％CI 6.43％-11.71％).Hypertension(OR 1.75,95％CI 1.29-2.37),diabetes(OR 1.84,95％CI 1.46-2.33),chronic kidney disease(OR 2.50,95％CI 1.67-3.74),and hemodialysis(OR 7.77,95％CI 4.77-12.67)were associated with an elevated CN risk(all P＜0.001).Conversely,obesity(OR 0.39,95％CI 0.18-0.83)and history of smoking(OR 0.61,95％CI 0.47-0.80)were linked to a decreased CN risk(both P＜0.05).Conclusions The overall prevalence of CN is relatively low among patients with CAD.However,the prevalence of CN is influenced by a variety of clinical factors.Further research is warranted to elucidate the underlying mechanisms.

Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Background/Aims: This study assessed the long-term efficacy and safety of tenofovir alafenamide (TAF) in real-world settings. Methods: Patients who were candidates for TAF treatment and were followed up at 12-week intervals over 192 weeks were enrolled in this study. Results: One hundred and forty-four patients (50 treatment-naive and 94 treatment-experienced) were included in this study. The cumulative incidence rates of cirrhosis and hepatocellular carcinoma at 192 weeks were 3.9% and 0.7%, respectively. In treatment-naive patients, the rates of a virological response, HBeAg conversion, and HBsAg loss at 192 weeks were 100%, 33.3%, and 2%, respectively. The treatment-naive patients exhibited higher baseline HBsAg levels than the treatment-experienced patients (4.31 log10IU/mL vs. 3.97 log10IU/mL). A significant decrease in the HBsAg levels from the baseline was observed at 144 and 192 weeks in the treatment-naive patients (p=0.01). The baseline body mass index (BMI) <25 kg/m2 (p=0.02) and HBsAg <3.3 log10IU/mL (p=0.04) were identified as predictive factors for a decrease in HBsAg ≥0.5 log10IU/mL at 48 weeks. The eGFR levels were consistently lower in the treatment-experienced patients throughout the study. Although the treatment-naive patients showed no abnormal increases in urinary URBP, the treatment-experienced patients showed elevated urinary β2MG and NAG levels at the baseline, which decreased over the treatment course. The total cholesterol, triglyceride, and low-density lipoprotein levels were similar in both groups. Conclusions Prolonging the TAF treatment duration enhances the virological response rate. The decline in HBsAg levels was more significant in the treatment-naive patients than in the treatment-experienced patients. The baseline BMI <25 kg/m2 and HBsAg <3.3 log10IU/mL were predictive factors for a significant decline in HBsAg at 48 weeks. TAF has high renal safety and no significant impact on lipid levels.