1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Silencing PTPN2 with nanoparticle-delivered small interfering RNA remodels tumor microenvironment to sensitize immunotherapy in hepatocellular carcinoma.
Fu WANG ; Haoyu YOU ; Huahua LIU ; Zhuoran QI ; Xuan SHI ; Zhiping JIN ; Qingyang ZHONG ; Taotao LIU ; Xizhong SHEN ; Sergii RUDIUK ; Jimin ZHU ; Tao SUN ; Chen JIANG
Acta Pharmaceutica Sinica B 2025;15(6):2915-2929
Protein tyrosine phosphatase nonreceptor type 2 (PTPN2) is a promising target for sensitizing solid tumors to immune checkpoint blockades. However, the highly polar active sites of PTPN2 hinder drug discovery efforts. Leveraging small interfering RNA (siRNA) technology, we developed a novel glutathione-responsive nano-platform HPssPT (HA/PEIss@siPtpn2) to silence PTPN2 and enhance immunotherapy efficacy in hepatocellular carcinoma (HCC). HPssPT showed potent transfection and favorable safety profiles. PTPN2 deficiency induced by HPssPT amplified the interferon γ signaling in HCC cells by increasing the phosphorylation of Janus-activated kinase 1 and signal transducer and activator of transcription 1, resulting in enhanced antigen presentation and T cell activation. The nano-platform was also able to promote the M1-like polarization of macrophages in vitro. The unique tropism of HPssPT towards tumor-associated macrophages, facilitated by hyaluronic acid coating and CD44 receptor targeting, allowed for simultaneous reprogramming of both tumor cells and tumor-associated macrophages, thereby synergistically reshaping tumor microenvironment to an immunostimulatory state. In HCC, colorectal cancer, and melanoma animal models, HPssPT monotherapy provoked robust antitumor immunity, thereby sensitizing tumors to PD-1 blockade, which provided new inspiration for siRNA-based drug discovery and tumor immunotherapy.
3.Increased risk of subsequent primary lung cancer among female hormone-related cancer patients: A meta-analysis based on over four million cases
Yan WANG ; Wenpeng SONG ; Haoyu WANG ; Guonian ZHU ; Yangqian LI ; Zhoufeng WANG ; Weimin LI ; Guowei CHE
Chinese Medical Journal 2024;137(15):1790-1801
Background::The incidence rate of lung cancer in women has significantly increased over the past decade, and previous evidence has indicated a significant relationship between the elevated levels of sex hormones and the risk of lung cancer. Therefore, we hypothesized that female hormone-related cancer (FHRC) patients, including breast, endometrial, cervical, and ovarian cancer patients, may experience a higher risk of developing subsequent lung cancer. This meta-analysis aimed to identify the risk of lung cancer among FHRC patients compared to the general population.Methods::The PubMed, Web of Science, EMBASE, Cochrane Library, and CNKI databases were searched up to May 11, 2022. Standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) were used to identify the risk of subsequent lung cancer after FHRC. Subgroup analyses based on the follow-up time and tumor type were also conducted.Results::A total of 58 retrospective cohort studies involving 4,360,723 FHRC participants were included. The pooled results demonstrated that FHRC patients had a significantly increased risk of developing subsequent primary lung cancer (SIR = 1.61, 95% CI: 1.48-1.76, P <0.001). Subgroup analysis revealed an obvious trend of increasing lung cancer risk over time (SIRs for <5 years, ≥5 years, ≥10 years, ≥20 years, and ≥30 years after FHRC: 1.32, 1.59, 1.57, 1.68, and 1.95, respectively). In addition, subgroup analysis stratified by tumor type indicated an increased risk of developing subsequent lung cancer after breast (SIR = 1.25, P <0.001), endometrial (SIR = 1.40, P = 0.019), cervical (SIR = 2.56, P <0.001), and ovarian cancer (SIR = 1.50, P = 0.010). Conclusion::FHRC patients are more likely to develop lung cancer than the general population. Furthermore, the increased risk of subsequent primary lung cancer is more obvious with a longer survival time and is observed in all types of hormone-related cancer.Registration::International Platform of Registered Systematic Review and Meta-analysis Protocols: No. INPLASY202270044; https://inplasy.com/
4.Research progress on drug literacy in stroke patients
Haoyu ZHU ; Linlin HOU ; Qiuhuan JIANG
Chinese Journal of Modern Nursing 2024;30(10):1390-1395
This paper reviewed literature at home and abroad, clarified the definition of drug literacy, elucidated the association between drug literacy and secondary preventive drug in stroke patients, analyzed the feasibility and limitations of existing drug literacy assessment tools in stroke patients, summarized the research status of drug literacy in stroke patients, so as to provide reference for the evaluation and intervention of drug literacy in stroke patients in China.
5.Research progressin biological functions of saikosaponins
Lin YUAN ; Wanli LI ; Wei JIN ; Haoyu WANG ; Jinhua ZHU
Chinese Journal of Veterinary Science 2024;44(6):1307-1315
Radix Bupleuri has been used in traditional Chinese medicine for over 2000 years with functions of relieving exterior syndrome,clearing heat,regulating liver-qi,and lifting yang-qi.Its medicinal properties have been widely used in Eurasia and North Africa.As the main bioactive compounds in Radix Bupleuri,saikosaponins(especially saikosaponin A and saikosaponin D)have anti-inflammatory,anti-tumor,antioxidant,antivirus,immune regulatory,and liver protective effects.This article reviews the pharmacological activity,mechanism of action,and current applica-tion status of saikosaponins,in order to provide new insights for further research and development of Radix Bupleuri.
6.Cytokines expression in intraocular fluid in neovascular glaucoma: a meta-analysis
Shuqing ZHU ; Jinyuan CHEN ; Mengtian ZHOU ; Jie DU ; Shuxia XU ; Haoyu LI ; Yuanbo LIANG
Chinese Journal of Experimental Ophthalmology 2024;42(6):538-546
Objective:To systemically evaluate the characteristics of cytokine levels in intraocular fluid of neovascular glaucoma (NVG).Methods:Literature on the detection of cytokine levels in NVG published before June 2022 was searched in PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang databases, and China Science and Technology Journal Database (VIP).Two investigators independently completed the literature search, inclusion, and data extraction following the inclusion and exclusion criteria.Quantitative analyses were performed using Stata 16.0 software.Study heterogeneity was assessed using the I2 test, and effects were combined using the appropriate effect model to complete the meta-analysis. Results:A total of 24 studies were screened, including 771 NVG cases and 727 age-related cataract cases (control group).The standardized mean difference ( SMD) of the combined effect value of vascular endothelial growth factor (VEGF) mass concentration in the aqueous humor between the two groups was 8.79, with a 95% confidence interval ( CI) of 6.43 to 11.14.The SMD of interleukin-6 (IL-6) between the two groups was 12.50, with a 95% CI of 9.41 to 15.58.The VEGF and IL-6 levels in aqueous humor and vitreous humor were significantly higher in NVG group than in control group (all at P<0.05).The pigment epithelium-derived factor (PEDF) level in aqueous humor was lower in NVG group than in control group ( SMD: -3.03, 95% CI: -5.50--0.55, P<0.05).The levels of IL-8 ( SMD: 3.99, 95% CI: 1.14-6.85), erythropoietin (EPO) ( SMD: 9.62, 95% CI: 0.44-18.79), placental growth factor (PIGF) ( SMD: 2.62, 95% CI: 1.38-3.86), tumor necrosis factor-α (TNF-α) ( SMD: 3.37, 95% CI: 1.87-4.87) were all significantly higher in NVG group than in control group (all at P<0.05).There was no significant difference in IL-1β level in aqueous humor between the two groups ( P>0.05). Conclusions:In NVG patients, VEGF, IL-6, IL-8, EPO, PIGF, TNF-α levels are obviously increased and PEDF level is obviously decreased.These biomarkers can be used as potential predictors or therapeutic targets for NVG.
7.Impact of changes in cognitive load of anesthesia residents on the effectiveness of high-fidelity scenario simulation teaching
Haoyu PEI ; Yi HU ; Li WANG ; Juan DAI ; Qi SUN ; Xing ZHU ; Xiaoli RAN ; Qiuping WU ; Qingxiang MAO
Chinese Journal of Medical Education Research 2024;23(4):548-555
Objective:To investigate the influence of changes in the cognitive load of anesthesia residents on the teaching effectiveness of high-fidelity scenario simulation.Methods:Eighty-seven anesthesia residents in a grade-A tertiary hospital from February to November 2022 were divided into groups A, B, and C according to the random number method. Three cases were selected from the anesthesia crisis resource teaching case library for high-fidelity simulation training for the three groups, respectively, using the crossover design to control the order of the cases. Each round of training consisted of pre-training instruction, simulation teaching, and post-training summarization and analysis. After three rounds of simulation teaching, cognitive load, anxiety status, test scores, and non-technical skills were evaluated for all the study participants. SPSS 20.0 was used to perform analysis of variance with repeated measures and Pearson's correlation analysis.Results:All the three groups showed significantly higher cognitive load and anxiety scores during the first-round simulation training than during the second-round and third-round simulation trianing. The test scores were significantly lower in the first round [(87.07±5.66), (88.38±5.41), (89.07±6.17)] than in the second round [(95.69±2.29), (96.10±2.08), (96.07±2.60)] and the third round [(96.34±1.45), (96.38±1.50), (96.17±1.73); all P<0.05]. The non-technical skill scores were also significantly lower in the first round [(37.24±7.58), (38.69±7.27), (39.24±8.74)] than in the second round [(46.17±5.55), (47.07±5.59), (47.59±6.74)] and the third round [(47.17±5.21), (48.48±5.38), (48.24±6.83); all P<0.05]. For simulations with the same cases, the trainees showed significantly higher cognitive load and anxiety scores and significantly lower test scores and non-technical skill scores in the first round than in the second and third rounds ( P<0.05). Conclusions:Anesthesia residents have higher levels of cognitive load and anxiety in the first scenario simulation training, which can reduce learning outcomes, and repeated simulation training can reduce trainees' cognitive load and anxiety.
8.Predicting the histological type of thymoma based on CT radiomics nomogram
Qingsong BU ; Haoyu ZHU ; Tao WANG ; Lei HU ; Xiang WANG ; Xiaofeng LIU ; Jiangning DONG ; Xingzhi CHEN ; Shujian WU
Journal of Practical Radiology 2024;40(10):1615-1619
Objective To investigate the value of a nomogram model based on contrast-enhanced CT radiomics in predicting the histological type of thymoma.Methods A total of 154 patients(101 in low-risk group and 53 in high-risk group)with thymoma confirmed by pathology were retrospectively selected.The cases were randomly divided into training set(n=107)and validation set(n=47)at a ratio of 7∶3.The three-dimensional volume of interest(VOI)of the whole lesion on the image from the arterial phase of contrast-enhanced CT was manually delineated,and the radiomics features were extracted.Based on the selected radiomics features,the radiomics model was constructed and the model Radiomics score(Radscore)was calculated.Clinical risk factors were screened to construct a clinical model,and a nomogram model was constructed by fusing Radscore and clinical risk factors.The receiver operating characteristic(ROC)curve,area under the curve(AUC),accuracy,sensitivity and specificity were compared to analyze the predictive efficacy and difference of different models for high-risk and low-risk thymoma.The decision curve and calibration curve were drawn to evaluate the clinical value and fitting performance of the nomogram model.Results Eleven radiomics features were selected to construct the radiomics model,and five clinical risk factors[myasthenia gravis(MG),morphology,border,surrounding tissue invasion and CT value in arterial phase]were used to construct the clinical model.In the training set,the AUC of the nomogram model(0.88)was higher than that of the radiomics model(0.80)and the clinical model(0.79),and the difference was statistically significant(Z=2.233,2.713,P=0.026,0.007,respectively).In the validation set,the AUC of the nomogram model was higher than that of the radiomics and clinical models,but the difference was not statistically significant.The calibration curve showed that the nomogram model had good fitting performance,and the decision curve showed that the nomogram model had high clinical benefit.Conclusion The nomogram model based on contrast-enhanced CT can effectively predict high-risk and low-risk thymoma,which is helpful to guide clinicians to make relevant decisions.
9.Construction of digital intelligent minimally invasive research-oriented hepatobiliary and pancreatic surgery discipline
Jian YANG ; Xiwen WU ; Wen ZHU ; Haoyu HU ; Nan XIANG ; Ning ZENG ; Zhihao LIU ; Xuequan FANG ; Chihua FANG
Chinese Journal of Digestive Surgery 2024;23(1):91-97
The emergence and evolution of digital intelligent technology has profoundly influenced the development of minimally invasive research-oriented hepatobiliary and pancreatic surgery discipline. Over various periods, our team has always adhered to the principle of "being oriented by clinical issues and driven by clinical needs", continuously carried out innovative research across interdisciplinary boundaries, propelling the evolution of digital intelligent technology. Spanning over two decades, this journey includes the progression from digital virtual human, three-dimensional visualization, molecular fluorescence imaging, augmented reality and mixed reality, artificial intelligence, to the realm of human visualization meta-universe. This evolution facilitates the shift from two-dimensional empirical diagnoses of hepatobiliary and pancreatic surgical diseases to deep learning intelligent diagnostics, the transition from morphology-based tumor diagnoses to molecular imaging-based diagnostics, and from conventional empirical surgery to intelligent navigation surgery. The authors provide a comprehensive review of our developmental process and achievements within the realm of digital intelligent diagnostic and therapeutic technologies, with the aims to promote the development and application of digital intelligent medicine.
10.Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults (version 2024)
Qingde WANG ; Yuan HE ; Bohua CHEN ; Tongwei CHU ; Jinpeng DU ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Hua GUO ; Yong HAI ; Lijun HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Zhaoming YE ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Wei MEI ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2024;40(2):97-106
Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.

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