OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics （ 2026 edition ） in response to the challenges faced by such clinics in China， including uneven development， large discrepancies in service specifications， insufficient patient awareness， and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association， the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association， and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association， a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research， current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections： definition and connotation of pharmacist-managed clinics， establishment requirements， implementation and management， post competency， and practical research. Firstly， the definition and connotation included three operational forms of pharmacist-managed clinics （independent mode， physician-pharmacist joint mode， and online pharmacist-managed clinic mode） and classified service modes （specialty-specific， drug-specific， and disease-specific pharmacist-managed clinics）. The establishment requirements were further refined， covering system construction （pharmaceutical service management system， quality control and assessment mechanism）， personnel qualifications （professional credentials， continuing education and professional training， etc）， service recipients， as well as service venues and facilities. Subsequently， the implementation and management of pharmacist-managed clinics were proposed， involving service procedures， intervention measures， documentation and records， patient education and follow-up， humanistic care， as well as risk management and quality control. Finally， post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics， as well as the suggestions on teaching methods； practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment， management， teaching， and research， fill the guideline gap in this field， and can promote the high-quality development of pharmacist-managed clinics.

In recent years, with the exploration and development of machine learning algorithms in the medical scenario, their potential for application in clinical diagnosis and treatment has been gradually explored. Image-based machine learning algorithms have made a lot of progress in urological cancer-related research, and have been proven to have a positive effect on the diagnosis, treatment and prognosis of urological cancer. Despite the great impact of machine learning algorithms clinically, they are still in the exploratory stage, with many deficiencies and limitations.

In recent years, with the exploration and development of machine learning algorithms in the medical scenario, their potential for application in clinical diagnosis and treatment has been gradually explored. Image-based machine learning algorithms have made a lot of progress in urological cancer-related research, and have been proven to have a positive effect on the diagnosis, treatment and prognosis of urological cancer. Despite the great impact of machine learning algorithms clinically, they are still in the exploratory stage, with many deficiencies and limitations.

Artificial intelligence (AI) has emerged as a transformative force in healthcare, with applications spanning diagnostics to drug development. However, its integration into drug regulation remains nascent, with varying degrees of adoption and implementation across different regulatory bodies worldwide. This review aims to provide a comprehensive overview of the current state of AI in drug regulation, encapsulating AI-related policies, initiatives, and its practical application in regulatory agencies globally. It further discusses the challenges and future prospects of AI in this field. The findings reveal that numerous agencies have launched action plans and initiatives to incorporate AI, aiming to streamline regulatory processes and enhance data-driven regulatory decision-making. Moreover, AI's deployment in safety surveillance, workflow optimization, and regulatory science research is expanding, highlighting its increasing impact on drug regulation. Nonetheless, key challenges persist, such as data quality and reliability, technical limitations, talent shortage and the absence of standards. The review concludes that interdisciplinary collaboration is crucial to harness AI's full potential in drug regulation and overcoming its current limitations. In the future, AI may become a pivotal catalyst in drug regulation, promising a new era of enhanced scrutiny, efficiency, and innovation that will benefit public health on a global scale.

Objective:To explore the clinical effect of endoscopic radical thyroidectomy via three-port gasless intermuscular approach.Methods:This is a retrospective cohort study. The data of 148 patients who underwent radical thyroidectomy at the Fourth General Surgery Department of the Second Affiliated Hospital of Harbin Medical University from January to June 2024 were retrospectively analyzed. There were 31 males and 117 females,aging (43.5±9.6) years (range: 21 to 64 years). The surgical method was selected according to the needs and wishes of patients. Among them, 77 cases underwent endoscopic radical thyroidectomy via unilateral three-port gasless intermuscular approach (three-port gasless group),and 71 cases underwent unilateral conventional open radical thyroidectomy(open group). The surgical technique exploration curve of the three-port gasless group was drawn based on the operation time and the number of lymph node dissections,and the technical exploration period and the technical maturity period were divided. The clinical data of the cases in the three-port gasless group and the open group were compared during the technical maturity period. The independent sample t test was used to compare the quantitative data between the two groups, and the χ2 test or Fisher exact probability method was used to compare the categorical data, respectively. Results:According to the technical exploration curve,there were 11 cases in the technical exploration period of the three-port gasless group,and 66 cases in the technical maturity period. In the technical mature period,the injury rate of temporary recurrent laryngeal nerve in the three-port gasless group was 1.5% (1/65),and the number of lymph node dissections was 5.9±3.5(range:0 to 14),which was not statistically significant compared with 4.4% (3/68) and 5.8±3.7(range:0 to 16) in the open group (all P>0.05). In the technical mature period,the operation time of the three-port gasless group was (39.2±6.2)minutes(range:30 to 55 minutes) and the postoperative drainage volume was (57.6±11.8) ml(range:30 to 90 ml),which were lower than those of the open group((67.8±13.9) minutes (range: 30 to 105 minutes) and (82.9±22.4)ml(range:50 to 175 ml)),and the differences were statistically significant ( t=15.303, 8.177, both P>0.05). During the technical maturity period,the postoperative hospital stay in the three-port gasless group was (3.2±0.4)days(range:3 to 4 days), which was not statistically different from that of the open group((3.2±0.4)days(range:3 to 5 days))( P>0.05). The incision satisfaction of patients in the three-port gasless group one month after the operation was higher than that of the control group (100% vs. 62.0%) ( P<0.01). Conclusion:Compared with open surgery,endoscopic radical thyroidectomy via three-port gasless intermuscular approach has certain advantages in terms of operation time, postoperative drainage volume and patient cosmetic satisfaction.

Objective:To explore the clinical effect of endoscopic radical thyroidectomy via three-port gasless intermuscular approach.Methods:This is a retrospective cohort study. The data of 148 patients who underwent radical thyroidectomy at the Fourth General Surgery Department of the Second Affiliated Hospital of Harbin Medical University from January to June 2024 were retrospectively analyzed. There were 31 males and 117 females,aging (43.5±9.6) years (range: 21 to 64 years). The surgical method was selected according to the needs and wishes of patients. Among them, 77 cases underwent endoscopic radical thyroidectomy via unilateral three-port gasless intermuscular approach (three-port gasless group),and 71 cases underwent unilateral conventional open radical thyroidectomy(open group). The surgical technique exploration curve of the three-port gasless group was drawn based on the operation time and the number of lymph node dissections,and the technical exploration period and the technical maturity period were divided. The clinical data of the cases in the three-port gasless group and the open group were compared during the technical maturity period. The independent sample t test was used to compare the quantitative data between the two groups, and the χ2 test or Fisher exact probability method was used to compare the categorical data, respectively. Results:According to the technical exploration curve,there were 11 cases in the technical exploration period of the three-port gasless group,and 66 cases in the technical maturity period. In the technical mature period,the injury rate of temporary recurrent laryngeal nerve in the three-port gasless group was 1.5% (1/65),and the number of lymph node dissections was 5.9±3.5(range:0 to 14),which was not statistically significant compared with 4.4% (3/68) and 5.8±3.7(range:0 to 16) in the open group (all P>0.05). In the technical mature period,the operation time of the three-port gasless group was (39.2±6.2)minutes(range:30 to 55 minutes) and the postoperative drainage volume was (57.6±11.8) ml(range:30 to 90 ml),which were lower than those of the open group((67.8±13.9) minutes (range: 30 to 105 minutes) and (82.9±22.4)ml(range:50 to 175 ml)),and the differences were statistically significant ( t=15.303, 8.177, both P>0.05). During the technical maturity period,the postoperative hospital stay in the three-port gasless group was (3.2±0.4)days(range:3 to 4 days), which was not statistically different from that of the open group((3.2±0.4)days(range:3 to 5 days))( P>0.05). The incision satisfaction of patients in the three-port gasless group one month after the operation was higher than that of the control group (100% vs. 62.0%) ( P<0.01). Conclusion:Compared with open surgery,endoscopic radical thyroidectomy via three-port gasless intermuscular approach has certain advantages in terms of operation time, postoperative drainage volume and patient cosmetic satisfaction.

In recent years,in order to meet urgent clinical needs alleviate the shortage of rare disease drugs in China,a series of policies encouraging the research and development of rare disease drugs has been introduced.Enzyme replacement therapy(ERT)is a standard treatment for rare congenital metabolic disorders,especially for enzyme deficiency diseases.Due to the complexity and heterogeneity of drug molecules for rare enzyme replacement therapy,the evaluation of animal models is a major challenge in non-clinical development and evaluation.This article introduces the latest research progress in the development of rare enzyme replacement therapy drugs at home and abroad,put forward some thoughts and suggestions on the non-clinical evaluation(pharmacology,pharmacokinetics,and toxicology)of such products based on representative literature,combined with review practice.

Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans ; Anti-Bacterial Agents/therapeutic use* ; China ; Drug Monitoring/methods* ; Polymyxin B ; Practice Guidelines as Topic

OBJECTIVE To explore the mechanism of Kuaisong yin in the prevention and treatment of constipation. METHODS Slow transit constipation （STC） model was established with Compound difenoxylate tablet in mice and rats. Two batches of mice were divided into blank group， model group， positive control group （Maren soft capsule， 0.64 g/kg）， Kuaisong yin low-dose， medium-dose and high-dose groups （3.2， 6.4， 12.8 g/kg）， with 10 mice in each group. The effect of Kuaisong yin on constipation in mice was evaluated by intestinal propulsion experiment and defecation experiment. Rats were divided into blank group， model group， positive control group （Maren soft capsule，0.36 g/kg）， Kuaisong yin low-dose and high-dose groups （2.4， 4.8 g/kg）， with 7 or 8 rats in each group. They were given relevant medicine once a day for 1 week. The metabonomics of serum and urine of rats were analyzed by UPLC-Q-TOF-MS/MS technology. RESULTS Compared with model group， the ink propulsion rate and 5 h defecation volume of mice in Kuaisong yin high-dose group were significantly increased （P＜0.05）； the first defecation time of mice in Kuaisong yin medium-dose and high-dose groups was significantly shortened， and the quality of defecation was significantly reduced within 5 h （P＜0.05 or P＜0.01）. Serum metabonomics screened 16 compounds （such as proline， propionylcarnitine， hemolytic phosphatidylcholine， etc.） and 6 metabolic pathways （such as sphingomyelin metabolism， arginine and proline metabolism， sphingolipid biosynthesis-lactose and neolactone series）. Urine metabonomics screened 20 different metabolites （such as prostaglandin A2， L-valine， phosphatidylcholine， sphingomyelin， etc.） and 8 metabolic pathways （such as valine， leucine and isoleucine biosynthesis， sphingomyelin metabolism， pyruvate metabolism， etc.）. CONCLUSIONS Kuaisong yin can play a role in improving constipation by regulating different metabolites such as hemolytic phosphatidylcholine， phosphatidylcholine， prostaglandin A2， L-valine， proline， and regulating metabolic pathways such as multiple amino acid metabolism， sphingomyelin metabolism， etc.

Objective:To investigate the prognostic value of early serum lactate, albumin, and lactate/albumin ratio (L/A) on the 28-day prognosis of adult patients with sepsis.Methods:A retrospective cohort study was conducted among adult patients with sepsis admitted to the First Affiliated Hospital of Xinjiang Medical University from January to December in 2020. Gender, age, comorbidities, lactate within 24 hours of admission, albumin, L/A, interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and 28-day prognosis were recorded. The receiver operator characteristic curve (ROC curve) was drawn to analyze the predictive value of lactate, albumin and L/A for 28-day mortality in patients with sepsis. Subgroup analysis of patients was performed according to the best cut-off value, Kaplan-Meier survival curves were drawn, and the 28-day cumulative survival of patients with sepsis was analyzed.Results:A total of 274 patients with sepsis were included, and 122 patients died at 28 days, with a 28-day mortality of 44.53%. Compared with the survival group, the age, the proportion of pulmonary infection, the proportion of shock, lactate, L/A and IL-6 in the death group were significantly increased, and albumin was significantly decreased [age (years): 65 (51, 79) vs. 57 (48, 73), pulmonary infection: 75.4% vs. 53.3%, shock: 37.7% vs. 15.1%, lactate (mmol/L): 4.76 (2.95, 9.23) vs. 2.21 (1.44, 3.19), L/A: 0.18 (0.10, 0.35) vs. 0.08 (0.05, 0.11), IL-6 (ng/L): 337.00 (97.73, 2 318.50) vs. 55.88 (25.26, 150.65), albumin (g/L): 27.68 (21.02, 33.03) vs. 29.62 (25.25, 34.23), all P < 0.05]. The area under the ROC curve (AUC) and 95% confidence interval (95% CI) of lactate, albumin, and L/A were 0.794 (95% CI was 0.741-0.840), 0.589 (95% CI was 0.528-0.647), 0.807 (95% CI was 0.755-0.852) for predicting 28-day mortality in sepsis patients. The optimal diagnostic cut-off value of lactate was 4.07 mmol/L, the sensitivity was 57.38%, the specificity was 92.76%. The optimal diagnostic cut-off value of albumin was 22.28 g/L, the sensitivity was 31.15%, the specificity was 92.76%. The optimal diagnostic cut-off of L/A was 0.16, the sensitivity was 54.92%, and the specificity was 95.39%. Subgroup analysis showed that the 28-day mortality of sepsis patients in the L/A > 0.16 group was significantly higher than that in the L/A ≤ 0.16 group [90.5% (67/74) vs. 27.5% (55/200), P < 0.001]. The 28-day mortality of sepsis patients in the albumin ≤ 22.28 g/L group was significantly higher than that in the albumin > 22.28 g/L group [77.6% (38/49) vs. 37.3% (84/225), P < 0.001]. The 28-day mortality in the group with lactate > 4.07 mmol/L was significantly higher than that in the group with lactate ≤ 4.07 mmol/L [86.4% (70/81) vs. 26.9% (52/193), P < 0.001]. The three were consistent with the analysis results of Kaplan-Meier survival curve. Conclusion:The early serum lactate, albumin, and L/A were all valuable in predicting the 28-day prognosis of patients with sepsis, and L/A was better than lactate and albumin.