1.Effects of Netupitant and palonosetron hydrochloride capsules on the pharmacokinetics of albumin-bound paclitaxel in rats under different intestinal microenvironments
Yuanman QIN ; Wenhao CHU ; Jiaqi XU ; Yutong LI ; Bo LIANG ; Xueliang ZHANG ; Jian LIU
China Pharmacy 2025;36(16):1993-1999
OBJECTIVE To investigate the impact of Netupitant and palonosetron hydrochloride capsules (NEPA) on the pharmacokinetics of Paclitaxel for injection (albumin bound) (i. e. albumin-bound paclitaxel) under different intestinal microenvironment conditions. METHODS Male SD rats were divided into a normal group and a model group (n=16). Rats in the model group were intragastrically administered vancomycin solution to establish an intestinal disorder model. The next day after modeling, intestinal microbiota diversity was analyzed, and the mRNA expressions of cytochrome P450 3A1 (CYP3A1) and CYP2C11 in small intestine and liver tissues as well as those protein expressions in liver tissue were measured. Male SD rats were grouped as described above (n=16). The normal group was subdivided into the TP chemotherapy group (TP-1 group) and the TP chemotherapy+NEPA group (TP+NEPA-1 group); the model group was subdivided into the TP chemotherapy group (TP-2 group) and the TP chemotherapy+NEPA group (TP+NEPA-2 group) (n=8). Rats in the TP+NEPA-1 and TP+NEPA-2 groups received a single intragastric dose of NEPA suspension (25.8 mg/kg, calculated by netupitant). One hour later, all four groups received a single tail vein injection of albumin-bound paclitaxel and cisplatin. Blood samples were collected at different time points after the last administration. Using azithromycin as the internal standard, plasma paclitaxel concentrations were determined by liquid chromatography-tandem mass spectrometry. The main pharmacokinetic parameters were calculated using DAS 2.0 software and compared between groups. RESULTS Compared with the normal group, the model group showed significantly decreased Chao1 and Shannon indexes (P<0.05), significant alterations in microbiota composition and relative abundance, and significantly downregulated expressions of CYP3A1 mRNA in liver tissue and CYP2C11 mRNA in both small intestine and liver tissues (P<0.05). Compared with the TP-1 group, the AUC0-t, AUC0-∞, MRT0-t of paclitaxel in the TP-2 group, the cmax, AUC0-t, AUC0-∞ of paclitaxel in the TP+NEPA-1 group and TP+NEPA-2 group were significantly increased or prolonged; CL of paclitaxel in the TP-2 group, Vd and CL of paclitaxel in the TP+NEPA-1 group and the TP+NEPA-2 group were significantly decreased or shortened (P<0.05). Compared with the TP-2 group, cmax of paclitaxel in the TP+NEPA-2 group was significantly increased, and Vd and MRT0-t were significantly decreased or shortened (P<0.05). CONCLUSIONS Intestinal microbiota disorder affects the mRNA expressions of CYP3A1 and CYP2C11, leading to decreased clearance and increased systemic exposure of paclitaxel. Concomitant administration of NEPA under normal intestinal microbiota condition increases paclitaxel exposure. However, under conditions of intestinal microbiota disorder, concomitant administration of NEPA has a limited impact on paclitaxel systemic exposure.
2.Radiation dose and establishment of a regression model for dose estimation in pediatric chest CT
Ziyu ZHAO ; Yu LIANG ; Yutong ZHANG ; Zifan WEI ; Xinxing MA
Chinese Journal of Radiological Health 2025;34(5):654-659
Objective To investigate the differences in radiation dose during chest CT examinations among children of different age groups and establish dose estimation regression models. Methods Chest CT data from 135 children aged 4 to 15 years were retrospectively collected from the First Affiliated Hospital of Soochow University between January 2022 and December 2023. The children were divided into three age groups: 4-5 years, 6-10 years and 11-15 years. CT scanning parameters (tube voltage, tube current, scan range) and dosimetry parameters including volume CT dose index (CTDIvol) dose length product (DLP), and size-specific dose estimate (SSDE) were recorded. The Kruskal-Wallis test was used to compare intergroup differences. A Pearson correlation analysis was performed to assess the relationship between age and dose indicators. Both linear and nonlinear regression models were constructed. Results Age showed a weak positive correlation with CTDIvol (r = 0.27), a moderate positive correlation with DLP (r = 0.60), and a moderate negative correlation with SSDE (r = −0.55). Linear regression analysis revealed that DLP increased with age (y = 117.85 + 9.81x, R2 = 0.36), while SSDE decreased with age (y = 12.4 − 0.18x, R2 = 0.32). Using orthogonal distance regression, the goodness-of-fit of the nonlinear models for DLP and SSDE significantly improved (R2 = 0.99 and 0.94, respectively). Conclusion In pediatric chest CT dose assessment, CTDIvol underestimates radiation dose compared to SSDE and fails to account for patient body size. The dose estimation models constructed with orthogonal distance regression outperform those established using the least squares method, demonstrating higher fitting accuracy, and can serve as a reference for personalized dose management in pediatric CT examinations.
3.Unveiling the renoprotective mechanisms of self-assembled herbal nanoparticles from Scutellaria barbata and Scleromitrion diffusum in acute kidney injury: A nano-TCM approach.
Lunyue XIA ; Qunfang YANG ; Kangzhe FU ; Yutong YANG ; Kaiyue DING ; Yuexue HUO ; Lanfang ZHANG ; Yunong LI ; Borong ZHU ; Peiyu LI ; Yijie HUO ; Liang SUN ; Ya LIU ; Haigang ZHANG ; Tao LIU ; Wenjun SHAN ; Lin ZHANG
Acta Pharmaceutica Sinica B 2025;15(8):4265-4284
Acute kidney injury (AKI) is a critical clinical condition characterized by rapid renal function decline, with high morbidity, mortality, and healthcare costs. Traditional Chinese medicine (TCM) has shown potential effects on mitigating oxidative stress and programmed cell death in AKI models. Scutellaria barbata D. Don (SB) and Scleromitrion diffusum (Willd.) R. J. Wang (SD), a classic TCM herbal pair exhibited anti-inflammatory and antioxidant activities. Using advanced chromatographic separation technology, we enriched the effective fractions of water extracts from SB-SD, obtaining self-assembled herbal nanoparticles (SB and SD nanoparticles, SSNPs) rich in flavonoids and terpenoids. These SSNPs demonstrated robust antioxidant properties in vitro and mitigated AKI progression in vivo by activating the nuclear factor erythroid 2-related factor 2 (Nrf2) signaling pathway. Oral administration of SSNPs in mice resulted in absorption into the bloodstream, formation of a protein corona, reduced macrophage phagocytosis, and enhanced bioavailability and renal targeting. Furthermore, we investigated the self-assembly principle of SSNPs using representative flavonoids and terpenoids. Kinetic studies and in situ transmission electron microscopy (in situ TEM) revealed that these compounds self-assemble via supramolecular forces like hydrogen bonding and π-π interactions, forming stable nanostructures. This study elucidates the renoprotective effects and mechanisms of SB and SD, and provides a novel approach for the development of TCM-based nanomedicines, highlighting the potential of nano-TCM in AKI treatment.
4.Application of Ancient Books in Clinical Practice Guidelines and Expert Consensus of Traditional Chinese Medicine: Current Status and Methodological Recommendations
Changhao LIANG ; Dingran YIN ; Jing CUI ; Xinshuai YAO ; Xinyi GU ; Yifei YAN ; Wanting LIU ; Yingqiao WANG ; Yingqi CHANG ; Haoyu DONG ; Mengqi LI ; Yuanyuan LI ; Yutong FEI
Journal of Traditional Chinese Medicine 2024;65(8):801-809
ObjectiveTo explore the current status and issues regarding the application of ancient books in clinical practice guidelines and expert consensus of traditional Chinese medicine (TCM) published in China, and to provide methodological recommendations for the incorporation of ancient books in the development of TCM guidelines. MethodsWe searched China National Knowledge Infrastructure (CNKI), WanFang Data, VIP, SinoMed, PubMed, Embase, as well as six industry websites including China Association of Chinese Medicine, National Group Standards Information Platform, and Chinese Association of the Integration of Traditional and Western Medicine,etc. TCM clinical practice guidelines or expert consensus issued during January 1st, 2017, to November 26th, 2022 were searched. Clinical practice guidelines or expert consensus that explicitly referred to ancient books were included, and the content regarding the searching for ancient books, sources of access to ancient books, methods of evaluating the level of evidence, methods of evaluating the level of recommendation, and methods of evaluating the evidence for the ancient books were analysed. ResultsA total of 1,215 TCM clinical practice guidelines or expert consensus were retrieved, with 442 articles explicitly mentioning the application of ancient books, including 300 (67.87%) clinical practice guidelines and 142 (32.13%) expert consensus. Sixty of the 442 publications explicitly reported that ancient books searching had been conducted (13.57%); among these 60 publications 27 (45.00%) explicitly reported ancient books searching strategies, and the most frequent method was manual searching with a total of 24 articles (40.00%). The most popular search source was Chinese Medical Dictionary, a TCM classics database, with a total of 18 articles. 197 articles (44.57%) explicitly reported the evaluation criteria for the level of evidence, of which 141 articles (71.57%) involved the evaluation criteria for the ancient books; 413 articles (93.44%) mentioned ancient books in the recommendations, and only the source of formula name was mentioned in 409 (99.03%) of the publications. ConclusionThe current application of ancient books in TCM clinical practice guidelines and expert consensus is limited, with issues of non-standard searching and evaluation methods. Standar-dization and uniformity are needed in evidence grading and recommendation standards. Future research should clarify the scope and methods of applying ancient book, emphasize their integration with modern research evidence, and enhance their value and quality in the development of TCM clinical practice guidelines.
5.Protocol for the Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Children with Upper Airway cough Syndrome
Lingyun ZHANG ; Xiyou WANG ; Daxin LIU ; Qiang HE ; Xuefeng WANG ; Xun LI ; Yutong FEI ; Yi XIAO ; Xiaoxue LAN ; Yuanwen LIANG ; Xiaoxuan LIN ; Rong ZHOU ; Sirui GU ; Ying ZHANG ; Yue WANG ; Xingzhu YE ; Wenke LIU ; Hong CHEN ; Changhe YU
International Journal of Traditional Chinese Medicine 2024;46(8):961-966
In order to standardize the clinical diagnosis and treatment of upper airway cough syndrome (UACS) for children in China, Dongzhimen Hospital of Beijing University of Chinese Medicine and Affiliated Hospital of Liaoning University of Traditional Chinese Medicine initiated the development of this Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Children with Upper Airway cough Syndrome based on evidence-based medical evidence. This guideline will process registration, write a plan, and develop relevant processes and writing norms, develop and publish official documents. This plan mainly introduces the scope of the guidelines, the purpose and significance, the composition of the guidelines working group, the management of conflicts of interest, the collection, selection and determination of clinical problems, the retrieval, screening and rating of evidence, and the consensus of recommendations. Registration information: This study has been registered in the international practice guidelines registry platform with the registration code of PREPARE-2023CN087.
6.Mechanism of NF-κB Signaling Pathway in Regulating Lung Cancer and Intervention of Traditional Chinese Medicine: A Review
Xue GENG ; Wencheng CHI ; Xiaoyue LIN ; Yutong SUI ; Hua LIANG ; Jiakang JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(16):207-216
Lung cancer is the leading cause of cancer-related deaths, and standard treatments for lung cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy, have shown significant clinical effects. However, current available treatment strategies are still unable to cure the disease. Since the majority of lung cancer patients are diagnosed at an advanced stage, surgical options are often lost, and the primary approach is typically a combination of radiotherapy and chemotherapy. However, the adverse reactions associated with these treatments limit their effectiveness and application, and the damage caused to normal tissues is often more severe than that inflicted on the tumor. Currently, traditional Chinese medicine (TCM) has been used as part of combination therapy for cancer treatment due to its unique system of syndrome differentiation, flexible compatibility, and safety and efficacy. TCM prescriptions and single drugs with multiple components and targets can simultaneously regulate multiple pathways. As reported, among numerous pathways involved in the regulation of lung cancer, the nuclear factor-κB (NF-κB) signaling pathway plays a key role in inducing cell transcription and is one of the main pathways involved in the occurrence and development of lung cancer. It can specifically regulate inflammatory responses, cell proliferation, apoptosis, invasion and metastasis, angiogenesis, and multidrug resistance in lung cancer. TCM prescriptions and single drugs can inhibit lung cancer cell proliferation, invasion, and metastasis, induce apoptosis and autophagy in lung cancer cells, suppress angiogenesis, regulate immune function, and treat multidrug resistance by regulating the NF-κB signaling pathway. Therefore, they play a role in intervening in lung cancer. However, there is currently a lack of systematic literature research that comprehensively summarizes and elucidates these aspects in China and abroad. Therefore, it is important to provide a systematic elucidation of the mechanism underlying the regulation of the NF-κB signaling pathway in lung cancer and review TCM interventions in lung cancer based on the NF-κB signaling pathway. This study is expected to provide references for the clinical application of lung cancer therapeutic drugs and the development of new drugs.
7.Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
Mengyan WANG ; Yu XUE ; Fang DU ; Lili MA ; Liang-Jing LU ; Lindi JIANG ; Yi-Li TAO ; Chengde YANG ; Hui SHI ; Honglei LIU ; Xiaobing CHENG ; Junna YE ; Yutong SU ; Dongbao ZHAO ; Sheng-Ming DAI ; Jialin TENG ; Qiongyi HU
Chinese Medical Journal 2023;136(3):331-340
BACKGROUND:
Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.
METHODS:
The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.
RESULTS:
Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.
CONCLUSION:
Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.
TRIAL REGISTRATION
Chictr.org, ChiCTR2000039799.
Humans
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Quality of Life
;
China
;
Arthritis, Rheumatoid/drug therapy*
;
Piperidines/therapeutic use*
;
Treatment Outcome
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Antirheumatic Agents/therapeutic use*
;
Pyrroles/therapeutic use*
8.Exploring the Essential Factors of Applying the Consensus Methods in the Development of Traditional Chinese Medicine Guidelines: A Qualitative Interview
Changhao LIANG ; Dingran YIN ; Meijun LIU ; Guanxiang YIN ; Xun LI ; Yaqi WANG ; Siqi LIU ; Min TONG ; Pengwei LIU ; Xiangfei SU ; Yutong FEI
Medical Journal of Peking Union Medical College Hospital 2023;15(4):942-952
This study delves into the pivotal factors influencing the consensus process within traditional Chinese medicine guideline development, with the objective of augmenting the quality of this process through methodological recommendations aimed at elevating standardization. Semi-structured qualitative interviews were used to interview guideline leaders, working groups and consensus groups to explore the pertinent elements impacting the credibility of consensus and gather insights into the constitution and progression of the consensus methodology. The study encompassed interviews with 26 participants, yielding 212 codes that were subsequently categorized into five domains: establishment of the consensus group, integration of patient participation, adeptness of the meeting moderator, preparation for consensus formulation, and overarching factors influencing consensus. The research distilled three fundamental phases for forming a consensus group and delineated 17 fundamental tenets for applying the consensus methodology. In forthcoming guideline development endeavors, it is advisable to bolster methodological training ahead of the consensus process while ensuring comprehensive engagement of methodologists. Encouraging experts to navigate differences judiciously and prioritizing meticulous methodology and evidentiary groundwork are recommended. The process should involve openly disclosing the selection of consensus group members, heightening the involvement of patients, and effective management and disclosure of conflicts of interest. This collective approach helps curtail bias, enhance transparency, bolster reliability, and fortify the scientific rigor of consensus outcomes.
9.Chinese expert consensus on diagnosis, treatment and prevention of venous thrombus embolism associated with chest trauma (2022 version)
Kaibin LIU ; Yi YANG ; Hui LI ; Yonten TSRING ; Zhiming CHEN ; Hao CHEN ; Xinglong FAN ; Congrong GAO ; Chundong GU ; Yutong GU ; Guangwei GUO ; Zhanlin GUO ; Jian HU ; Ping HU ; Hai HUANG ; Lijun HUANG ; Weiwei HE ; Longyu JIN ; Baoli JING ; Zhigang LIANG ; Feng LIN ; Wenpan LIU ; Danqing LI ; Xiaoliang LI ; Zhenyu LI ; Haitao MA ; Guibin QIAO ; Zheng RUAN ; Gang SUI ; Dongbin WANG ; Mingsong WANG ; Lei XUE ; Fei XIA ; Enwu XU ; Quan XU ; Jun YI ; Yunfeng YI ; Jianguo ZHANG ; Dongsheng ZHANG ; Qiang ZHANG ; Zhiming ZHOU ; Zhiqiang ZOU
Chinese Journal of Trauma 2022;38(7):581-591
Chest trauma is one of the most common injuries. Venous thromboembolism (VTE) as a common complication of chest trauma seriously affects the quality of patients′ life and even leads to death. Although there are some consensus and guidelines on the prevention and treatment of VTE at home and abroad, the current literatures lack specificity considering the diagnosis, treatment and prevention of VTE in patients with chest trauma have their own characteristics, especially for those with blunt trauma. Accordingly, China Chest Injury Research Society and editorial board of Chinese Journal of Traumatology organized relevant domestic experts to jointly formulate the Chinese expert consensus on the diagnosis, treatment and prevention of chest trauma venous thromboembolism associated with chest trauma (2022 version). This consensus provides expert recommendations of different levels as academic guidance in terms of the characteristics, clinical manifestations, risk assessment, diagnosis, treatment, and prevention of chest trauma-related VTE, so as to offer a reference for clinical application.
10.Comparison of clinical effects of three criteria for postoperative pulmonary complications
Yutong ZHANG ; Liang JIN ; Hong YU ; Xuefei LI ; Hai YU
Chinese Journal of Anesthesiology 2022;42(9):1054-1058
Objective:To compare the clinical effects of the three criteria for postoperative pulmonary complications (PPCs).Methods:The clinical data of patients underwent thoracoscopic lung resection between January 2021 and July 2021 in our hospital were retrospectively analyzed.PPCs were assessed using the Melbourne Group Scale (MGS), European Perioperative Clinical Outcome (EPCO) and Standardized Endpoints for Perioperative Medicine (StEP) criteria.The patients were divided into PPC group and non-PPC group according to the above criteria.The diagnostic rates of PPCs of the three criteria were recorded.Cohen′s weighted kappa coefficient was used to evaluate the agreement between the three criteria.Logistic regression method was used to analyze the association between PPCs diagnosed by different criteria and risk of adverse prognostic events developed.Results:A total of 397 patients who underwent thoracoscopic lung surgery were included in this study.The rate of PPCs diagnosed by MGS criterion was significantly lower than those by EPCO and StEP criteria ( P<0.001), and the rate of PPCs diagnosed by EPCO criterion was significantly higher than those by StEP criterion ( P<0.001). The diagnostic agreement between EPCO criterion and StEP criterion was good ( κ=0.624, P<0.001), while the diagnostic agreement between EPCO criterion, StEP criterion and MGS criterion was poor ( κ=0.101, P<0.001; κ=0.210, P<0.001). Univariate and multivariate logistic regression analysis showed that PPCs diagnosed by EPCO and StEP criteria increased the risk of adverse prognostic events developed ( P<0.001). Conclusions:The EPCO and StEP criteria are superior to MGS criterion with regard to the diagnostic and prognostic value for pulmonary complications following thoracoscopic lung resection, and the EPCO criterion had a higher sensitivity.

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