1.Evidence-based evaluation and hierarchical management of off-label use of 5-aminolevulinic acid in photodynamic therapy
Jing MA ; Tingting LIU ; Xiaoshuang GOU ; Xue YANG ; Chen LI ; Fang LIU ; Yao LIU
China Pharmacy 2026;37(8):1056-1061
OBJECTIVE To provide reference for medical institutions to establish the record management mode and review rules of off-label use of 5-aminolevulinic acid (ALA) in photodynamic therapy based on the level of evidence. METHODS All ALA-containing outpatient prescriptions in the rational drug use system in our hospital from January 1, 2024 to December 31, 2025 were retrospectively collected. Based on the drug instructions, the current status of off-label use of ALA in photodynamic therapy was identified . The relevant studies in Micromedex, PubMed, CNKI, Wanfang Data and other databases were systematically searched as the relevant evidence-based evidence of ALA off-label use. According to the Off-label Drug Use Filing Standard of the hospital,the evidence-based evaluation method was used to evaluate the evidence-based evidence of ALA off-label use and carry out hierarchical management. RESULTS A total of 1 803 effective prescriptions were included, of which 676 (37.49%) were off-label use, distributed in the dermatology department (564 prescriptions,83.43%) and the plastic surgery department (112 prescriptions,16.57%). All 676 prescriptions were off-indications medication, involving ten types of skin diseases, primarily including moderate to severe acne (39.94%), skin warts (25.44%), Bowen’s disease (11.98%), and others. According to evidence-based evidence,off-label uses such as moderate to severe acne, actinic keratosis, and Bowen’s disease were managed according to the evidence categoryⅠ orⅡ.The uses of extramammary Paget’s disease and rosacea were managed according to the evidence category Ⅲ.The uses of lichen sclerosus and keloids were managed according to the evidence category Ⅳ.The results of evidence-based evaluation showed that 92.01% of off-label use in our hospital had high-level evidence-based support ( evidence category was gradeⅠ-Ⅱ). CONCLUSIONS Off-label uses supported by high-level evidence, such as moderate to severe acne, skin warts, and Bowen’s disease, can be managed under filing category Ⅰ or Ⅱ. For the use of lichen sclerosus and keloids, evidence-based evidence is insufficient and should be strictly restricted.The vast majority of ALA off-label use in our hospital has sufficient evidence-based basis.
2.Network meta-analysis of pneumonitis and interstitial lung disease associated with antibody-drug conjugates in the treatment of breast cancer
Xiaohan WANG ; Wei CHEN ; Fang YANG ; Keming CAO ; Jingxin WANG ; Wenxin XUE
China Pharmacy 2026;37(10):1370-1375
OBJECTIVE To compare the risk of pneumonitis and interstitial lung disease (ILD) associated with different antibody-drug conjugates (ADC) in the treatment of breast cancer. METHODS CNKI, VIP, PubMed, Embase and other Chinese and English databases, and ClinicalTrials.gov were searched from the inception to June 15, 2025. Randomized controlled trials (RCT) about pneumonitis and ILD associated with ADC (T-DM1, T-DXd, SG, Dato-DXd, SHR-A1811,ARX788, and T-Duo) in the treatment of breast cancer were included. After literature screening, data extraction, and quality assessment, a network meta-analysis was conducted using Stata 17.0 software, and the surface under the cumulative ranking curve(SUCRA) of all interventions were ranked. RESULTS A total of 19 RCTs involving 10 556 patients were included. The overall incidence of pneumonitis with ARX788 and T-DXd was significantly higher than that with T-DM1, T-DM1 plus TPC(T-DM1combined with pertuzumab or atezolizumab), TPC(treatment of primary care), and SG ( P <0.05), for grade 1-2 pneumonitis, ARX788 and T-DXd showed significantly higher incidence than T-DM1, T-DM1 plus TPC, and TPC ( P <0.05). For both indicators, ARX788 and T-Duo were ranked as the top two by SUCRA. For the incidence of grade ≥3 pneumonitis, T-DXd and T-DM1 were significantly higher than SG ( P <0.05), T-Duo and Dato-DXd were ranked as the top two by SUCRA. For overall incidence of ILD, ARX788 was significantly higher than T-DM1, SHR-A1811, TPC, and SG ( P <0.05), for the incidence of grade 1-2 ILD, ARX788 was significantly higher than T-DM1, SHR-A1811, and TPC ( P <0.05), for the incidence of grade ≥3 ILD, ARX788 was significantly higher than TPC ( P <0.05). For three indicators above, ARX788 and T-DXd combined with pertuzumab were ranked as the top two by SUCRA. CONCLUSIONS Compared with other ADCs, ARX788 and T-Duo are associated with a higher risk of pneumonitis and ILD in patients with breast cancer.
3.Neoadjuvant Sintilimab Combined with Gemcitabine and Cisplatin for Muscle-Invasive Bladder Cancer Patients Followed by Selective Bladder Sparing Surgery: A Phase 2 Trial
Zhou TONG ; Guanghou FU ; Feng ZHOU ; Xiaoyan LIU ; Xing XUE ; Hangyu ZHANG ; Yimin WANG ; Xudong ZHU ; Yang GAO ; Lulu LIU ; Xuanwen BAO ; Yi ZHENG ; Weijia FANG ; Peng ZHAO ; Baiye JIN
Cancer Research and Treatment 2026;58(2):581-590
Purpose:
This study aimed to evaluate the safety and efficacy of gemcitabine and cisplatin (GP) regimen in combination with immune checkpoint inhibitor sintilimab as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) patients and the feasibility of the following selective bladder sparing surgery.
Materials and Methods:
Patients with histopathologically confirmed urothelial carcinoma without distant metastases (T2-4a, N ≤ 1, M0, American Joint Committee of Cancer 8th) and with adequate organ function will be enrolled. The therapeutic regimen was sintilimab 200 mg once on day 8, gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 once on days 1 and 8, every 21 days for four cycles. The primary endpoint was pathologic complete response (pCR, pT0N0) rate. The secondary end points were ypT < 2 rate, R0 resection rate, event-free survival, and safety.
Results:
From May 4, 2020, to May 20, 2023, 55 patients were enrolled. Forty-six patients were evaluated for efficacy. Among the 42 patients who underwent surgery, 16 patients (38.0%) achieved pCR. Thirty-three patients (78.6%) achieved pT < 2. With a median follow-up of 15.7 months, the 1-year event-free survival was 91.3%. Notwithstanding the poor pathological baseline characteristic of a high T3-T4a proportion (39.1%), a promising bladder preservation (including 22 patients transurethral resection of bladder tumor, 5 patients partial cystectomy, and 4 surveillances) rate was achieved (67.4%). The most common grade ≥ 3 treatment-related adverse events was neutropenia (n=15, 27.3%), which was related to chemotherapy. There were no grade 3 immune-related adverse events.
Conclusion
Neoadjuvant GP plus sintilimab is a promising regimen for MIBC patients, with relatively high pT < 2 rate and triggering the emerging roles for the multi-disciplinary team decision-making for bladder sparing surgery.
4.Comparative analysis of the characteristics of imported malaria cases in Nanning City in 2024 and the same period of the previous year
Shu-lin WEI ; Zhi-qiang QU ; Yuan-yuan LUO ; Yan-cui HUANG ; Shu-qin DIAO ; Xue LI ; Sheng-long YANG ; Xiao-yu HUANG ; Mi-fang LUO
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):81-84
Objective To investigate the epidemiological characteristics of malaria and provide a basis for developing improved prevention and control measures. Methods Data were obtained from the Chinese Disease Prevention and Control Information System. Malaria surveillance data for Nanning City from January 1,2023, to December 31,2024, were exported from the Infectious Disease Reporting Information Management Subsystem. The characteristics of the two groups of malaria cases were compared. Results A total of 103 imported malaria cases were reported in Nanning City in 2024, representing a 38.32% decrease compared with the same period of the previous year. No statistically significant difference were observed between cases reported in 2023 and 2024 in terms of average age, gender ratio, proportion of parasite species, and monthly reporting distribution;however, statistically significant differences were found in the proportion of reporting areas and current residence areas(χ2= 13.572 and 10.355, respectively; P = 0.001 and 0.035, respectively). The proportion of cases reported in Shanglin County and the proportion of cases residing in Shanglin County were both lower than those during the same period of the previous year. Conclusions The high aggregation of imported malaria cases in Nanning City has decreased. Medical institutions in areas other than Shanglin County should strengthen their vigilance against malaria.
5.Construction and evaluation of a perioperative pharmaceutical care model for orthopedic joint replacement
Ting XIANG ; Yao LIU ; Xue YANG ; Fang LIU ; Xia YANG
China Pharmacy 2026;37(18):2424-2429
OBJECTIVE To construct and evaluate a perioperative pharmaceutical care model for orthopedic joint replacement based on clinical pharmacy specialty collaboration and medication therapy management (MTM), so as to provide a reference for improving the level of clinical rational drug use and reducing medical costs.METHODS Patients undergoing orthopedic joint replacement were taken as the research subjects. A specialized collaboration group was established, consisting of the head of the clinical pharmacy group, ward-based clinical pharmacists, and multi-specialty clinical pharmacists. The practice path, service contents,and workflow of MTM for the perioperative period of orthopedic joint replacement were clarified,and a perioperative pharmaceutical care model for orthopedic joint replacement was developed. Data of patients in the orthopedic diagnosis-related groups (DRG)-IC29 group of the department of orthopedics in Daping Hospital,Army Medical University were collected from July 2022 to June 2023 (pre-intervention, 581 cases) and from July 2023 to June 2024 (post-intervention, 843 cases). The work-implementation indicators in the post-intervention period were counted, and the efficiency indicators and pharmaceutical management indicators were compared between the pre- and post-intervention periods. Meanwhile,200 patients were randomly selected from the pre-intervention and post-intervention groups, respectively, to evaluate the rate of rational medical orders.RESULTS From July 2023 to June 2024, the collaboration group implemented MTM for 843 patients undergoing orthopedic joint replacement via the established perioperative pharmaceutical care model. A total of 1 163 drug‑related problems (DRPs) were identified, and 79 patients with high medication‑related risks were screened out. The most common types of DRPs included (possible) adverse drug events/reactions (48.93%), unnecessary drug therapy (21.58%), and ineffective drug therapy (16.25%). Among the 1 163 DRPs, 895 (76.96%) were completely resolved. Compared with the pre‑intervention period, the post‑intervention period showed reductions in average hospitalization cost per case, average drug cost per case, average length of hospital stay, proportion of drug cost, utilization rate and use intensity of antibacterial agents, and per‑capita drug cost of six main drug categories. The rate of rational medical orders increased from 78.25% to 98.11%.CONCLUSIONS The perioperative pharmaceutical care model for orthopedic joint replacement based on clinical pharmacy specialty collaboration and MTM can help pharmacists identify and resolve DRPs during the perioperative period of orthopedic joint replacement,improve the level of clinical rational drug use,and reduce treatment costs.
6.Temporal therapy utilizing exosomes derived from M2 macrophages demonstrates enhanced efficacy in alleviating neuropathic pain in diabetic rats
Wei WEI ; Jun FANG ; Baozhong YANG ; Chenlong CUI ; Jiacheng WEI ; Yating XUE
The Korean Journal of Pain 2025;38(1):14-28
Background:
Diabetic pain patients have increased pain at night. Exosomes can relieve neuropathic pain. This study aimed to investigate the efficacy of exosome administration at different time points in relieving diabetic neuropathic pain (DNP) in rats.
Methods:
M2 macrophages from bone marrow were induced in mice and exosomes were extracted. A diabetic rat model was induced using streptozotocin, with the mechanical withdrawal threshold (MWT) of the rats beingmeasured at ≤ 80% of the basal value after 14 days, indicating successful construction of the DNP rat model.Exosomes were administered on three consecutive days at ZT0 (zeitgeber time) and ZT12. Parameters including blood glucose levels, body weight, MWT, and thermal withdrawal latency (TWL) were assessed in the rats. The lumbar spinal cord of rats was examined on days 21 and 28 to measure inflammatory factors and observe the expression of M1 and M2 microglia. Furthermore, microglia were exposed to lipopolysaccharide (LPS) and LPS + exosomes in a controlled in vitro setting to assess alterations in microglia phenotype involving the NF-kB p65 andIKBα inflammatory signaling pathways.
Results:
The findings revealed that administration of exosomes during the rat resting period at ZT12 resulted in increased MWT and TWL, as well as a shift in microglia polarization towards the M2 phenotype. In vitro analysis indicated that exosomes influenced microglia polarization and suppressed the phosphorylation of NF-kB p65 andIKBα.
Conclusions
Temporal therapy with exosomes effectively reduces pain in DNP rats by polarizing microglia andaffecting NF-kB p65 and IKBα signaling pathways.
7.Temporal therapy utilizing exosomes derived from M2 macrophages demonstrates enhanced efficacy in alleviating neuropathic pain in diabetic rats
Wei WEI ; Jun FANG ; Baozhong YANG ; Chenlong CUI ; Jiacheng WEI ; Yating XUE
The Korean Journal of Pain 2025;38(1):14-28
Background:
Diabetic pain patients have increased pain at night. Exosomes can relieve neuropathic pain. This study aimed to investigate the efficacy of exosome administration at different time points in relieving diabetic neuropathic pain (DNP) in rats.
Methods:
M2 macrophages from bone marrow were induced in mice and exosomes were extracted. A diabetic rat model was induced using streptozotocin, with the mechanical withdrawal threshold (MWT) of the rats beingmeasured at ≤ 80% of the basal value after 14 days, indicating successful construction of the DNP rat model.Exosomes were administered on three consecutive days at ZT0 (zeitgeber time) and ZT12. Parameters including blood glucose levels, body weight, MWT, and thermal withdrawal latency (TWL) were assessed in the rats. The lumbar spinal cord of rats was examined on days 21 and 28 to measure inflammatory factors and observe the expression of M1 and M2 microglia. Furthermore, microglia were exposed to lipopolysaccharide (LPS) and LPS + exosomes in a controlled in vitro setting to assess alterations in microglia phenotype involving the NF-kB p65 andIKBα inflammatory signaling pathways.
Results:
The findings revealed that administration of exosomes during the rat resting period at ZT12 resulted in increased MWT and TWL, as well as a shift in microglia polarization towards the M2 phenotype. In vitro analysis indicated that exosomes influenced microglia polarization and suppressed the phosphorylation of NF-kB p65 andIKBα.
Conclusions
Temporal therapy with exosomes effectively reduces pain in DNP rats by polarizing microglia andaffecting NF-kB p65 and IKBα signaling pathways.
8.Study on rapid identification of Cremastrae Pseudobulbus Pleiones Pseudobulbus and its adulterants with Fourier exchange infrared spectroscopy
Yu XUE ; Huqiang FANG ; Tao XIE ; Jia SONG ; Shimao CHEN ; Zixuan JIANG ; Wangxing CHENG ; Qingshan YANG ; Tangyi PENG
International Journal of Traditional Chinese Medicine 2025;47(11):1574-1580
Objective:To establish a Fourier transform infrared spectroscopy (FT-IR) method for rapid identification of Cremastrae Pseudobulbus Pleiones Pseudobulbus and its adulterants.Methods:The Fourier transform infrared spectra of Cremastrae Pseudobulbus Pleiones Pseudobulbus and its adulterants were established, and the second derivative spectral analysis, clustering analysis, principal component analysis, opls-da and cluster independent soft mode classification model were analyzed to explore the difference characteristic peaks of Cremastrae Pseudobulbus Pleiones Pseudobulbus and its adulterants.Results:The first order infrared spectrum showed that the peak shape and peak intensity of Cremastrae Pseudobulbus Pleiones Pseudobulbus and its adulterants were different. Clustering analysis, principal component analysis and OPLS-DA results showed that Cremastrae Pseudobulbus Pleiones Pseudobulbus and its adulterants showed good clustering characteristics. SIMCA method was used to construct the model, and the accuracy of the training set and the verification set were 100%, which further verified the feasibility of this method in identifying the authenticity of Cremastrae Pseudobulbus Pleiones Pseudobulbus.Conclusions:The second-order infrared spectroscopy can accurately distinguish the differences between Cremastrae Pseudobulbus Pleiones Pseudobulbus and its adulterants. The method is fast and accurate, and can be used for the authenticity identification of Cremastrae Pseudobulbus Pleiones Pseudobulbus.
9.Temporal therapy utilizing exosomes derived from M2 macrophages demonstrates enhanced efficacy in alleviating neuropathic pain in diabetic rats
Wei WEI ; Jun FANG ; Baozhong YANG ; Chenlong CUI ; Jiacheng WEI ; Yating XUE
The Korean Journal of Pain 2025;38(1):14-28
Background:
Diabetic pain patients have increased pain at night. Exosomes can relieve neuropathic pain. This study aimed to investigate the efficacy of exosome administration at different time points in relieving diabetic neuropathic pain (DNP) in rats.
Methods:
M2 macrophages from bone marrow were induced in mice and exosomes were extracted. A diabetic rat model was induced using streptozotocin, with the mechanical withdrawal threshold (MWT) of the rats beingmeasured at ≤ 80% of the basal value after 14 days, indicating successful construction of the DNP rat model.Exosomes were administered on three consecutive days at ZT0 (zeitgeber time) and ZT12. Parameters including blood glucose levels, body weight, MWT, and thermal withdrawal latency (TWL) were assessed in the rats. The lumbar spinal cord of rats was examined on days 21 and 28 to measure inflammatory factors and observe the expression of M1 and M2 microglia. Furthermore, microglia were exposed to lipopolysaccharide (LPS) and LPS + exosomes in a controlled in vitro setting to assess alterations in microglia phenotype involving the NF-kB p65 andIKBα inflammatory signaling pathways.
Results:
The findings revealed that administration of exosomes during the rat resting period at ZT12 resulted in increased MWT and TWL, as well as a shift in microglia polarization towards the M2 phenotype. In vitro analysis indicated that exosomes influenced microglia polarization and suppressed the phosphorylation of NF-kB p65 andIKBα.
Conclusions
Temporal therapy with exosomes effectively reduces pain in DNP rats by polarizing microglia andaffecting NF-kB p65 and IKBα signaling pathways.
10.Potential utility of albumin-bilirubin and body mass index-based logistic model to predict survival outcome in non-small cell lung cancer with liver metastasis treated with immune checkpoint inhibitors.
Lianxi SONG ; Qinqin XU ; Ting ZHONG ; Wenhuan GUO ; Shaoding LIN ; Wenjuan JIANG ; Zhan WANG ; Li DENG ; Zhe HUANG ; Haoyue QIN ; Huan YAN ; Xing ZHANG ; Fan TONG ; Ruiguang ZHANG ; Zhaoyi LIU ; Lin ZHANG ; Xiaorong DONG ; Ting LI ; Chao FANG ; Xue CHEN ; Jun DENG ; Jing WANG ; Nong YANG ; Liang ZENG ; Yongchang ZHANG
Chinese Medical Journal 2025;138(4):478-480


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