Objective:To analyze the characteristics of Fournier gangrene (FG) induced by sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide reference for clinical safe drug use.Methods:CNKI, Wanfang Med Online, VIP, PubMed, Web of Science and other databases (up to January 2024) were retrieved and clinical data on patients with FG associated with the 5 kinds of SGLT2i currently used in clinical practice in China were collected and descriptively analyzed, including gender, age, comorbidities, concomitant medications, onset time and clinical manifestations of SGLT2i-related FG, laboratory and imaging examination results, treatment and outcomes, etc.Results:A total of 15 documents were included in the analysis, involving 15 patients, with 12 males and 3 females. The age of these patients ranged from 34 to 72 years, with 11 cases being over 50 years. Dapagliflozin was used in 7 cases, empagliflozin in 6 cases, canagliflozin in 2 cases, and no related reports on ertugliflozin and henagliflozin were collected. The main clinical manifestations of the 15 patients were redness, swelling, pain, abscess or purulent discharge in perineum, scrotum and perianal, etc. The time from application of SGLT2i to onset of FG ranged from 1 month to 6 years. Wound secretion bacterial culture was performed in 10 patients, and the results were all positive, including 9 cases of bacterial infection and 1 case of mixed infection of bacteria and fungi. All 13 patients who underwent imaging examinations had imaging manifestations related to FG. SGLT2i were discontinued in all patients. After treatments with broad-spectrum antibiotics and surgery, 14 cases were improved and 1 case was cured.Conclusions:SGLT2i has the risk of causing FG, which is more common in males. The clinical use of SGLT2i should be monitored closely. Secretion culture and imaging examination are helpful for the diagnosis of FG. The patient′s prognosis is good after discontinuation of medication, symptomatic treatment, and surgery.

This report presents a case of a 75-year-old patient with newly diagnosed gastric cancer,who had repeated symptoms of fatigue,confusion,and hyponatremia after 2 cycles of chemotherapy combined with nivolumab as neoadjuvant treat-ment and was later diagnosed with adrenal cortical insufficiency.After applying corticosteroid replacement therapy,there was im-provement,but cortisol remained low,and long-term corticosteroid therapy is needed.

This report presents a case of a 75-year-old patient with newly diagnosed gastric cancer,who had repeated symptoms of fatigue,confusion,and hyponatremia after 2 cycles of chemotherapy combined with nivolumab as neoadjuvant treat-ment and was later diagnosed with adrenal cortical insufficiency.After applying corticosteroid replacement therapy,there was im-provement,but cortisol remained low,and long-term corticosteroid therapy is needed.

Objective:To analyze the characteristics of Fournier gangrene (FG) induced by sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide reference for clinical safe drug use.Methods:CNKI, Wanfang Med Online, VIP, PubMed, Web of Science and other databases (up to January 2024) were retrieved and clinical data on patients with FG associated with the 5 kinds of SGLT2i currently used in clinical practice in China were collected and descriptively analyzed, including gender, age, comorbidities, concomitant medications, onset time and clinical manifestations of SGLT2i-related FG, laboratory and imaging examination results, treatment and outcomes, etc.Results:A total of 15 documents were included in the analysis, involving 15 patients, with 12 males and 3 females. The age of these patients ranged from 34 to 72 years, with 11 cases being over 50 years. Dapagliflozin was used in 7 cases, empagliflozin in 6 cases, canagliflozin in 2 cases, and no related reports on ertugliflozin and henagliflozin were collected. The main clinical manifestations of the 15 patients were redness, swelling, pain, abscess or purulent discharge in perineum, scrotum and perianal, etc. The time from application of SGLT2i to onset of FG ranged from 1 month to 6 years. Wound secretion bacterial culture was performed in 10 patients, and the results were all positive, including 9 cases of bacterial infection and 1 case of mixed infection of bacteria and fungi. All 13 patients who underwent imaging examinations had imaging manifestations related to FG. SGLT2i were discontinued in all patients. After treatments with broad-spectrum antibiotics and surgery, 14 cases were improved and 1 case was cured.Conclusions:SGLT2i has the risk of causing FG, which is more common in males. The clinical use of SGLT2i should be monitored closely. Secretion culture and imaging examination are helpful for the diagnosis of FG. The patient′s prognosis is good after discontinuation of medication, symptomatic treatment, and surgery.

OBJECTIVE To explore the characteristics of adverse drug reaction （ADR） induced by semaglutide and provide a reference for clinically safe medication. METHODS Using search terms such as “semaglutide” and “adverse reactions” in both Chinese and English， the case reports about ADRs caused by semaglutide were searched and analyzed from PubMed， Web of Science， SpringerLink， CNKI， Chinese Medical Journal Full-text Database， Wanfang Medical Network and VMIS. RESULTS Overall 14 literature were included， involving 17 patients. Among 17 patients， 9 were female and 8 were male， with the age ranging from 25 to 80 years. Eight patients were given two or more drugs， and eight patients took 0.25 mg as the initial dose； the ADR occurred most frequently within 6 months （94.12%）. Sixteen patients’ symptoms improved or recovered after drug withdrawal and symptomatic treatment. Eleven patients did not mention whether to continue to use semaglutide in the future. Nine patients underwent ADR correlation evaluation， and 1， 3， 1 and 4 cases were determined to be “definite”，“ probable”，“ possible”， and “doubtful” respectively. Semaglutide-induced ADRs involved multiple organs or systems， most of which were the digestive system （35.29%）， followed by skin tissue （29.41%）. Among them， acute gastric dilation， severe liver injury， calculous cholecystitis， bullous pemphigoid， eosinophilic fasciitis， acute kidney injury， acute interstitial nephritis， depression and acute hemolytic anemia were not mentioned in the instruction. CONCLUSIONS ADRs caused by semaglutide can occur in all ages， mainly within 6 months after medication， and mainly involve the digestive system， skin tissue， etc. Great attention should be paid to pharmaceutical care for those patients with liver and kidney dysfunction， neuropsychiatric diseases， glucose-6-phosphate dehydrogenase deficiency， etc. When ADR occurs， drug withdrawal and symptomatic treatment should be performed promptly to ensure patients’ medication safety.

OBJECTIVE To introduce a case of interstitial pneumonia induced by vedolizumab （VDZ）， summarize and analyze the characteristics of the occurrence of VDZ-associated lung toxicity， and provide a reference for the clinically safe use of drugs. METHODS From the perspective of clinical pharmacists， the diagnosis and treatment of a case of VDZ-induced interstitial pneumonia were retrospectively analyzed， and the association of adverse drug reactions （ADR） was analyzed. Retrieving from Chinese and English databases such as CNKI， VIP， PubMed and Web of Science， case reports of VDZ-associated lung toxicity were summarized and analyzed. RESULTS The patient developed interstitial pneumonia during the use of VDZ and empirical anti- infective therapy with antibiotics was ineffective. After withdrawal of VDZ and treatment with methylprednisolone， symptoms and imaging examinations improved， but interstitial pneumonia still existed. According to Naranjo’s ADR evaluation scale and based on China Adverse Drug Reaction Reporting and Monitoring Manual， the association between VDZ and interstitial pneumonia was “very likely”. Results of the literature analysis showed that among 29 involved patients （including the patient reported in this article）， there were 19 males and 10 females， with an average age of （49.24±17.06） years. Lung toxicity mainly included VDZ- associated pneumonia， eosinophilic pneumonia， pulmonary granulomas or necrobiotic nodules， interstitial lung injury， etc.， which mostly occurred ≤24 weeks after medication （58.62%）. The main clinical manifestations included cough， dyspnea and fever. The vast majority of patients improved or recovered after drug withdrawal and/or glucocorticoid treatment， but one patient died of respiratory failure. CONCLUSIONS Lung toxicity is a rare ADR of VDZ with insidious onset and nonspecific symptoms. Once patients experience symptoms such as cough and dyspnea， early diagnosis，timely drug withdrawal，and symptomatic treatment measures such as glucocorticoid should be taken to ensure medication safety.

Objective:To establish a prescription pre-audit system based on the structure-process-outcome (SPO) model in the the Affiliated Hospital of Qingdao University and explore its application effect.Methods:Based on the structural dimension of SPO model, the organizational structure, pharmaceutical team, management system of pharmaceutical prescription audit, and audit environment of the prescription pre-audit system were established. Based on the process dimension of SPO model, the pre-audit process, medication knowledge base, and audit rule base were established, quality monitoring and control were implemented, and relevant personnel training were conducted. Based on the outcome dimension of SPO model, the review rate, manual review rate, clinician acceptance rate of prescription review, reasonable rate of outpatient and emergency prescription comments, and intervention rate of inpatient medical order were verified after the prescription pre-audit system application.Results:The prescription pre-audit system was first launched in the main hospital area of the Affiliated Hospital of Qingdao University in March 2021, and achieved full coverage in all five hospital areas by May 2023. The review rates of outpatient and emergency prescriptions and inpatient medical orders had been increasing year by year from 2021 to 2023, and all reached more than 99% of the expected rates in 2023. Compared with 2021, the proportions of outpatient and emergency prescriptions and inpatient medical orders submitted to manual review decreased in 2023 [1.2% (112 206/9 509 430) vs. 2.9% (16 214/549 672), 2.9% (206 258/7 152 620) vs. 3.9% (147 679/3 814 929), the proportions of prescriptions that failed to be reviewed in time decreased [0.7% (62 382/9 509 430) vs. 1.4% (7 429/549 672), 0.3% (22 816/7 152 620) vs. 2.2% (83 303/3 814 929)], and the acceptance rates of outpatient and emergency prescription review and inpatient medical orders review by clinicians increased [76.1% (2 421/3 180) vs. 57.0% (339/595), 94.3% (1 000/1 060) vs. 70.7% (797/1 128)], with statistically significant differences (all P<0.001). But there were still some prescriptions and orders that needed manual review but were not reviewed in time and finally missed review. Compared with 2021, the reasonable rates of outpatient and emergency prescription comments increased in 2023 [96.7% (924 558/956 252) vs. 92.2% (983 827/1 067 357), 98.7% (518 307/525 227) vs. 98.0% (181 296/185 069)], and the intervention rate of inpatient medical orders decreased [0.7% (196 522/26 751 992) vs. 0.9% (195 660/22 631 289)], with statistically significant differences (all P<0.001). Conclusions:Applying the SPO model can improve the organization and management of the prescription pre-audit system, and ensure the smooth launch and safe operation of the system. After verification, the operating speed of the prescription pre-audit system and prescription review speed of pharmacists could basically meet the clinical needs, the indicators of rational drug use in the hospitals were improved, and the professional and technical ability of pharmacists were enhanced.

As the first domestically originated cell cycle protein-dependent kinase 4/6 inhibitor,dalpiciclib has been approved by the State Drug Ad-ministration for the treatment of hormone recep-tor-positive/human epidermal growth factor recep-tor 2-negative advanced or metastatic breast can-cer in combination with fulvestrant or aromatase inhibitors.This article focuses on the progress of dalpiciclib research in breast cancer,summarizing the drug's mechanism of action,phase Ⅰ-Ⅲ clinical trials,and drug safety issues.

Drug conditional approval refers to the accelerated approval and marketing of clinically urgently needed drugs with outstanding therapeutic value through the form of "approval first, verification later" before completing complete clinical trials. Since the 1990s, the United States, Canada, the European Union, Japan, Australia, and the United Kingdom have successively implemented drug conditional approval for marketing. In 2017, the application for conditional approval of drugs was implemented in China. In this paper, the pre-market conditions and requirements, post-market monitoring and supervision of drugs in China are compared with other countries/regions. Based on the comparison results, the possible optimization directions of China′s drug conditional approval system are summarized and explored.

Drug conditional approval refers to the accelerated approval and marketing of clinically urgently needed drugs with outstanding therapeutic value through the form of "approval first, verification later" before completing complete clinical trials. Since the 1990s, the United States, Canada, the European Union, Japan, Australia, and the United Kingdom have successively implemented drug conditional approval for marketing. In 2017, the application for conditional approval of drugs was implemented in China. In this paper, the pre-market conditions and requirements, post-market monitoring and supervision of drugs in China are compared with other countries/regions. Based on the comparison results, the possible optimization directions of China′s drug conditional approval system are summarized and explored.