1.Analysis of the efficacy of mepolizumab for maintenance therapy following endoscopic sinus surgery in patients with eosinophilic chronic rhinosinusitis with nasal polyps
Rui DING ; Li CHEN ; Boyu CAI ; Yan LIANG
China Pharmacy 2026;37(16):2150-2155
OBJECTIVE To investigate the clinical efficacy of mepolizumab as postoperative maintenance therapy after endoscopic sinus surgery (ESS) in patients with eosinophilic chronic rhinosinusitis with nasal polyps (EosCRSwNP).METHODS A retrospective cohort study was conducted to collect clinical data from patients with EosCRSwNP who underwent ESS at the Dept. of Otolaryngology in Xuzhou First People’s Hospital, from January 1 to May 31, 2025. Patients were divided into a control group (56 cases, treated with intranasal corticosteroids postoperatively) and an observation group (51 cases, treated with mepolizumab postoperatively) based on their postoperative maintenance therapy regimens. The nasal function parameters [nasal cavity volume (NCV), distance from the minimum cross-sectional area to the anterior nostril (DCAN), nasal minimum cross-sectional area (NMCA), saccharin clearance time, nasal mucociliary clearance rate, mucociliary clearance velocity], and the indicators related to nasal mucosal remodeling [peripheral blood eosinophil (EOS) percentage, serum levels of transforming growth factor-β 1 (TGF-β 1 ) and vascular endothelial growth factor (VEGF)] were compared between the two groups at 2 weeks and 3, 6 months after surgery. The assessment indicators of the inflammation status of nasal mucositis [modified Lund-Kennedy Endoscopic Scoring System (MLK) score], the degree of nasal polyp recurrence[nasal polyp score (NPS)], and the quality of life [Sino-nasal Outcome Test-20 (SNOT-20) score] were compared at 2 weeks and 6 months after surgery. Adverse events were also recorded and compared between the two groups.RESULTS At 2 weeks after surgery, there were no statistically significant differences in the aforementioned indicators/scores between the two groups ( P >0.05). Compared with the same group at 2 weeks postoperatively, both groups showed significant increases in NCV, NMCA, nasal mucociliary clearance rate, and mucociliary clearance velocity at 3 and 6 months postoperatively; significant decreases or reductions were observed in DCAN, saccharin clearance time, EOS percentage, TGF-β 1 and VEGF levels at 3 and 6 months postoperatively, while in MLK score, NPS, SNOT-20 score were all significantly reduced or shortened ( P <0.05). Furthermore, the improvements in these indicators in the observation group were significantly greater than those in the control group during the same time periods ( P <0.05). The overall incidence of adverse reactions was comparable between the two groups ( P >0.05), but the incidence of injection-site reactions was significantly higher in the observation group than in the control group ( P <0.05).CONCLUSIONS The use of mepolizumab for postoperative maintenance therapy following ESS in patients with EosCRSwNP promotes the recovery of nasal function, improves indicators of nasal mucosal remodeling, reduces inflammation, lowers polyp score, and enhances quality of life. Its efficacy is superior to that of intranasal corticosteroids; however, clinicians should be mindful of the risk of injection-site reactions of mepolizumab.
2.Association of blood selenium exposure with sex hormones among men aged 18-79 years in China
Zheng LI ; Yingli QU ; Yawei LI ; Saisai JI ; Haocan SONG ; Qi SUN ; Miao ZHANG ; Wenli ZHANG ; Jiayi CAI ; Liang DING ; Ying ZHU ; Feng ZHAO ; Zhaojin CAO ; Yuebin LYU ; Lu WANG ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2025;59(10):1632-1639
Objective:To investigate the association between blood selenium levels and sex hormones in Chinese men aged 18-79 years.Methods:Data were derived from the China National Human Biomonitoring survey conducted in 2017-2018, with a final sample size of 5 414 men. General demographic characteristics, behavioral habits, and dietary frequency were collected through questionnaires and physical examinations. Fasting blood samples were collected to measure blood lead, serum testosterone, and estradiol levels. Complex sampling linear regression models were used to analyze the associations between blood selenium levels and testosterone, estradiol, and the testosterone/estradiol ratio, adjusting for confounding factors including age, education level, marital status, smoking status, alcohol consumption, seafood intake, soy product intake, protein supplement intake, BMI, and diabetes status.Results:The mean age of the 5 414 participants was (46.85±27.91) years; 4 774 (91.65%) were of Han ethnicity and 4 505 (86.68%) were married. The median ( Q1, Q3) blood selenium concentration in men was 97.80 (80.64, 116.99) μg/L. After adjusting for confounding factors, the complex sampling linear regression model revealed negative associations between blood selenium levels and both testosterone levels and the testosterone/estradiol ratio, with a significant linear trend ( Ptrend<0.05). Compared with the Q1 group, the β (95% CI) values for testosterone in the Q2, Q3, and Q4 groups were -0.02 (-0.06 to 0.02), -0.03 (-0.08 to 0.01), and -0.06 (-0.09 to -0.02), respectively. Similarly, the β (95% CI) values for the testosterone/estradiol ratio in the Q2, Q3, and Q4 groups were -0.01 (-0.03 to 0.02), -0.01 (-0.04 to 0.04), and -0.03 (-0.06 to -0.01), respectively. Subgroup analysis indicated stronger associations between blood selenium levels and testosterone/estradiol levels in non-smoking and obese men (BMI≥28 kg/m2). Conclusion:Blood selenium levels are negatively associated with testosterone levels and the testosterone/estradiol ratio in Chinese adult males.
3.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
4.Association of blood selenium exposure with sex hormones among men aged 18-79 years in China
Zheng LI ; Yingli QU ; Yawei LI ; Saisai JI ; Haocan SONG ; Qi SUN ; Miao ZHANG ; Wenli ZHANG ; Jiayi CAI ; Liang DING ; Ying ZHU ; Feng ZHAO ; Zhaojin CAO ; Yuebin LYU ; Lu WANG ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2025;59(10):1632-1639
Objective:To investigate the association between blood selenium levels and sex hormones in Chinese men aged 18-79 years.Methods:Data were derived from the China National Human Biomonitoring survey conducted in 2017-2018, with a final sample size of 5 414 men. General demographic characteristics, behavioral habits, and dietary frequency were collected through questionnaires and physical examinations. Fasting blood samples were collected to measure blood lead, serum testosterone, and estradiol levels. Complex sampling linear regression models were used to analyze the associations between blood selenium levels and testosterone, estradiol, and the testosterone/estradiol ratio, adjusting for confounding factors including age, education level, marital status, smoking status, alcohol consumption, seafood intake, soy product intake, protein supplement intake, BMI, and diabetes status.Results:The mean age of the 5 414 participants was (46.85±27.91) years; 4 774 (91.65%) were of Han ethnicity and 4 505 (86.68%) were married. The median ( Q1, Q3) blood selenium concentration in men was 97.80 (80.64, 116.99) μg/L. After adjusting for confounding factors, the complex sampling linear regression model revealed negative associations between blood selenium levels and both testosterone levels and the testosterone/estradiol ratio, with a significant linear trend ( Ptrend<0.05). Compared with the Q1 group, the β (95% CI) values for testosterone in the Q2, Q3, and Q4 groups were -0.02 (-0.06 to 0.02), -0.03 (-0.08 to 0.01), and -0.06 (-0.09 to -0.02), respectively. Similarly, the β (95% CI) values for the testosterone/estradiol ratio in the Q2, Q3, and Q4 groups were -0.01 (-0.03 to 0.02), -0.01 (-0.04 to 0.04), and -0.03 (-0.06 to -0.01), respectively. Subgroup analysis indicated stronger associations between blood selenium levels and testosterone/estradiol levels in non-smoking and obese men (BMI≥28 kg/m2). Conclusion:Blood selenium levels are negatively associated with testosterone levels and the testosterone/estradiol ratio in Chinese adult males.
5.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
6.Unilateral biportal endoscopy-assisted decompression strategy for lateral lumbar spinal stenosis.
Xuyang XU ; Zhiqiang ZHANG ; Zijie WANG ; Liang ZHANG ; Jun CAI ; Xinmin FENG ; Yu DING ; Yi ZHANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(5):612-619
OBJECTIVE:
To explore decompression strategies for lateral lumbar spinal stenosis under unilateral biportal endoscopy (UBE) assistance.
METHODS:
A clinical data of 86 patients with lateral lumbar stenosis treated with UBE-assisted intervertebral decompression between September 2022 and December 2023 was retrospectively analyzed. There were 42 males and 44 females with an average age of 63.6 years (range, 45-79 years). The disease duration ranged from 6 to 14 months (mean, 8.5 months). Surgical levels included L 2, 3 in 3 cases, L 3, 4 in 26 cases, L 4, 5 in 42 cases, and L 5, S 1 in 15 cases. According to Lee's grading system, there were 21 cases of grade 1, 37 cases of grade 2, and 28 cases of grade 3 for lumbar spinal stenosis. Based on the location of stenosis and clinical symptoms, the 33 cases underwent interlaminar approach, 7 cases underwent interlaminar approach with auxiliary third incision, 26 cases underwent contralateral inclinatory approach, and 20 cases underwent paraspinal approach; then, the corresponding decompression procedures were performed. Visual analogue scale (VAS) score was used to evaluate lower back/leg pain before operation and at 1 and 3 months after operation, while Oswestry disability index (ODI) was used to evaluate spinal function. At 3 months after operation, the effectiveness was evaluated using the modified MacNab evaluation criteria. The spinal stenosis and decompression were evaluated based on Lee's grading system using lumbar MRI before operation and at 3 months after operation.
RESULTS:
All procedures were successfully completed with mean operation time of 95.1 minutes (range, 57-166 minutes). Dural tears occurred in 2 cases treated with interlaminar approach with auxiliary third incision. All incisions healed by first intention. All patients were followed up 3-10 months (mean, 5.9 months). The clinical symptoms of the patients relieved to varying degrees. The VAS scores and ODI of lower back and leg pain at 1 and 3 months after operation significantly improved compared to preoperative levels ( P<0.05), and the indicators at 3 months significantly improved than that at 1 month ( P<0.05). According to the modified MacNab evaluation criteria, the effectiveness at 3 months after operation was rated as excellent in 52 cases, good in 21 cases, and poor in 13 cases, with an excellent and good rate of 84.9%. No lumbar instability was detected on flexion-extension X-ray films during follow-up. The Lee's grading of lateral lumbar stenosis at 2 days after operation showed significant improvement compared to preoperative grading ( P<0.05).
CONCLUSION
For lateral lumbar spinal stenosis, UBE-assisted decompression of the spinal canal requires the selection of interlaminar approach, interlaminar approach with auxiliary third incision, contralateral inclinatory approach, and paraspinal approach based on preoperative imaging findings and clinical symptoms to achieve better effectiveness.
Humans
;
Spinal Stenosis/diagnostic imaging*
;
Female
;
Male
;
Middle Aged
;
Decompression, Surgical/methods*
;
Aged
;
Lumbar Vertebrae/surgery*
;
Endoscopy/methods*
;
Retrospective Studies
;
Treatment Outcome
7.Analysis of information labeling in instructions of antitussive and expectorant drugs in 34 children’s medical institutions
Zhen DING ; Hai LIANG ; Wenyi RUAN ; Heping CAI
China Pharmacy 2024;35(5):607-611
OBJECTIVE To understand the information labeling of children’s medication in the instructions of antitussive and expectorant drugs commonly used in children’s medical institutions, analyze the existing problems, and propose relevant suggestions. METHODS The instructions for 100 antitussive and expectorant drugs commonly used in 20 tertiary children’s hospitals (centers) and 14 maternal and child health hospitals (centers) with regional representativeness in China were collected, and the information labeling of children’s medication in the instructions was investigated and analyzed. RESULTS There were only 7 kinds of antitussive and expectorant drugs for children, and the others were non-specific drugs for children. Among antitussive and expectorant drugs, tablets accounted for 18.00%, injections for 18.00%, and capsules for 4.00%. Among 100 antitussive and expectorant drugs, 72 (72.00%) labeled the usage and dosage for children, 63 (63.00%) labeled the medication items for children, 59 (59.00%) indicated the information of children in the precautions, and pharmacokinetic parameters for children were absent. Compared with imported antitussive and expectorant drugs or the drugs manufactured by joint ventures, there were many missing labeling of medication information for children with Chinese drugs. Among 63 kinds of drug instructions labeled with medication items for children, various instructions information had little guiding significance. CONCLUSIONS There is a lack of labeling in the instructions of antitussive and expectorant drugs for children, and the proportion of special drugs for children remains low. Pediatric drug information in the instructions has little guiding significance for pediatric medication. Relevant departments should further promote the completeness of pediatric medication information in the instructions of antitussive and expectorant drugs to ensure the rational use of children’s medication.
8.Analysis of the therapeutic effect of ultrasound-guided microwave ablation in the treatment of liver metastasis from breast cancer and the selection of beneficiaries
Ran JI ; Yuqing DAI ; Qian CAI ; Xiaopeng GAO ; Wenzhen DING ; Ping LIANG ; Jie YU
Chinese Journal of Ultrasonography 2024;33(12):1016-1022
Objective:To evaluate the therapeutic effect of ultrasound-guided microwave ablation (MWA) in the treatment of breast cancer liver metastases (BCLM), and to select the beneficiaries.Methods:A retrospective study was performed in 63 patients with BCLM who underwent ultrasound-guided microwave ablation in Department of Interventional Ultrasound, the Fifth Medical Center of Chinese PLA General Hospital, and had detailed follow-up data from February 2010 to October 2022. General patient data and laboratory results were collected. Univariate and multivariate Cox regression analyses were performed to determine the independent influencing factors for prognosis in patients with BCLM. A nomogram model was established to predict the survival rates of patients after operation.Calibration curve and decision curve were plotted to evaluate the calibration degree and the clinical benefit of the model, respectively. Time-dependent ROC curve was plotted to evaluate the predicting ability of the model. All patients were divided into high-risk group and low-risk group according to prognostic index. Survival curves were plotted to compare differences in survival between the two groups.Results:Multivariate Cox regression analysis showed that tumor burden score(TBS) and the presence of extrahepatic metastasis before MWA were independent influencing factors for prognosis of BCLM(all P<0.001). The combined prediction model was established based on TBS, extrahepatic metastasis and axillary nodal metastases. The areas under the 1-year, 2-year and 3-year ROC curves were 0.849, 0.855 and 0.878, respectively, suggesting that the model had good predicting ability. The calibration curve showed that the model had good calibration degree, while the decision curve showed that the model had good clinical practicability. The median survival time between the two groups was statistically significant[13.5 (9, 20) months vs 63.0 (39, 140) months, P<0.001]. Conclusions:Low-risk patients with BCLM gain significant clinical benefits after microwave ablation treatment, while high-risk patients do not exhibit a noticeable survival advantage.
9.Advances in pharmacological mechanism and toxicology of gambogic acid.
Ke-Rong TU ; Shang-Qin YANG ; Qi-Qi XU ; Liang-Liang LYU ; Xian-Mei JIANG ; Yao QI ; Huan-Huan DING ; Hong-Mei LIU ; Lu-Lu CAI ; Qiang SUN
China Journal of Chinese Materia Medica 2024;49(24):6593-6603
Gambogic acid, a caged xanthone compound derived from Garcinia, has been proven to be an important substance basis for the pharmacological effects of the plant. In recent years, it has received continuous attention due to its broad and significant pharmacological activities. Modern pharmacological investigations have demonstrated that gambogic acid endows various therapeutic effects such as anti-inflammatory, antioxidant, and anti-tumor activities, as well as benefits in retinopathy, organ protection, anti-microbial infection, bone protection, and neuropathic pain relief. Nevertheless, there is currently a lack of systematic summary and integration of the pharmacological effects and mechanisms of gambogic acid, which is critical for advancing the clinical application of this natural product. In addition, current research has raised concerns about potential safety risks associated with gambogic acid, such as organ toxicity, developmental toxicity, and hemolysis. Given this, this paper systematically reviewed and summarized the pharmacological effects, mechanisms, and toxicological profiles of gambogic acid, aiming to provide reference and data support for its clinical translation.
Xanthones/toxicity*
;
Humans
;
Animals
;
Drugs, Chinese Herbal/toxicity*
;
Garcinia/chemistry*
10.Analysis of the therapeutic effect of ultrasound-guided microwave ablation in the treatment of liver metastasis from breast cancer and the selection of beneficiaries
Ran JI ; Yuqing DAI ; Qian CAI ; Xiaopeng GAO ; Wenzhen DING ; Ping LIANG ; Jie YU
Chinese Journal of Ultrasonography 2024;33(12):1016-1022
Objective:To evaluate the therapeutic effect of ultrasound-guided microwave ablation (MWA) in the treatment of breast cancer liver metastases (BCLM), and to select the beneficiaries.Methods:A retrospective study was performed in 63 patients with BCLM who underwent ultrasound-guided microwave ablation in Department of Interventional Ultrasound, the Fifth Medical Center of Chinese PLA General Hospital, and had detailed follow-up data from February 2010 to October 2022. General patient data and laboratory results were collected. Univariate and multivariate Cox regression analyses were performed to determine the independent influencing factors for prognosis in patients with BCLM. A nomogram model was established to predict the survival rates of patients after operation.Calibration curve and decision curve were plotted to evaluate the calibration degree and the clinical benefit of the model, respectively. Time-dependent ROC curve was plotted to evaluate the predicting ability of the model. All patients were divided into high-risk group and low-risk group according to prognostic index. Survival curves were plotted to compare differences in survival between the two groups.Results:Multivariate Cox regression analysis showed that tumor burden score(TBS) and the presence of extrahepatic metastasis before MWA were independent influencing factors for prognosis of BCLM(all P<0.001). The combined prediction model was established based on TBS, extrahepatic metastasis and axillary nodal metastases. The areas under the 1-year, 2-year and 3-year ROC curves were 0.849, 0.855 and 0.878, respectively, suggesting that the model had good predicting ability. The calibration curve showed that the model had good calibration degree, while the decision curve showed that the model had good clinical practicability. The median survival time between the two groups was statistically significant[13.5 (9, 20) months vs 63.0 (39, 140) months, P<0.001]. Conclusions:Low-risk patients with BCLM gain significant clinical benefits after microwave ablation treatment, while high-risk patients do not exhibit a noticeable survival advantage.

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