1.Rapid health technology assessment of serplulimab in the first-line treatment of small-cell lung cancer
Yibing HOU ; Shuo KANG ; Yuan GONG ; Xiaohui WANG ; Ying NIE ; Huanlong LIU
China Pharmacy 2025;36(11):1405-1410
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of serplulimab as a first-line treatment of small- cell lung cancer (SCLC), and provide an evidence-based basis for drug selection in hospitals. METHODS Rapid health technology assessment was adopted; PubMed, Cochrane Library, Embase, CNKI, Wanfang, VIP and official websites of domestic and international health technology assessment agencies were systematically searched from the inception to Oct. 2024. Two reviewers independently screened the literature, assessed the quality of included studies and carried out the qualitative analysis according to the inclusion and exclusion criteria. RESULTS A total of 13 systematic reviews/meta-analyses and 9 economic studies were included, and the literature quality was generally good. In terms of effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy significantly improved progression-free survival, overall survival, and objective response rate in patients with SCLC. In terms of safety, serplulimab combined with chemotherapy showed no significant difference in the incidence of ≥3 grade adverse events compared with chemotherapy alone in the treatment of SCLC, indicating a good safety profile; compared with combination therapies involving other immunosuppressive agents, the incidence rate of adverse events was also lower. In terms of cost-effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy is not cost- effective, which may be related to the high price of serplulimab. CONCLUSIONS Serplulimab is effective and safe in the treatment of SCLC, but has no obvious advantage in terms of cost-effectiveness.
2.Exploration of Decision-Making Methods Based on Syndrome Differentiation by “Data-Knowledge” Dual-Driven Models: A Case Study of Gastric Precancerous State
Weichao XU ; Yanru DU ; Xiaomeng LANG ; Yingying LOU ; Wenwen JIA ; Xin KANG ; Shuo GUO ; Kun ZHANG ; Chunzhi SU ; Junbiao TIAN ; Xiaona WEI ; Qian YANG
Journal of Traditional Chinese Medicine 2024;65(2):154-158
Data analysis models may assist the transmission of traditional Chinese medicine (TCM) experience and clinical diagnosis and treatment, and the possibility of constructing a “data-knowledge” dual-drive model was explored by taking gastric precancerous state as an example. Data-driven is to make clinical decisions around data analysis, and its syndrome-differentiation decision-making research relies on hidden structural models and partially observable Markov decision-making processes to identify the etiology of diseases, syndrome elements, evolution of pathogenesis, and syndrome differentiation protocols; knowledge-driven is to make use of data and information to promote decision-making and action processes, and its syndrome-differentiation decision-making research relies on convolutional neural networks to improve the accuracy of local disease identification and syndrome differentiation. The “data-knowledge” dual-driven model can make up for the shortcomings of single-drive numerical simulation accuracy, and achieve a balance between local disease identification and macroscopic syndrome differentiation. On the basis of previous research, we explored the construction method of diagnostic assisted decision-making platform for gastric precancerous state, and believed that the diagnostic and decision-making ability of doctors can be extended through the assistance of machines and algorithms. Meanwhile, the related research methods were integrated and the core features of gastric precancerous state based on TCM syndrome differentiation and endoscopic pathology diagnosis and prediction were obtained, and the elements of endoscopic pathology recognition based on TCM syndrome differentiation were explored, so as to provide ideas for the in-depth research and innovative application of cutting-edge data analysis technology in the field of intelligent TCM syndrome differentiation.
3.The effect of intrinsic capacity and comorbidity on adverse outcomes in community-dwelling older adults: path analysis based on structure equation model
Shuo LIU ; Xiaohong LIU ; Lin KANG ; Shan JIANG ; Jiaojiao LI ; Xinxiu YU
Chinese Journal of Geriatrics 2024;43(3):366-371
Objective:To examine the impact of intrinsic capacity(IC), comorbidity, and their interaction on the occurrence of adverse outcomes in community-dwelling older adults.Methods:This 2-year observational cohort study included 230 residents aged 75 and above who lived in the Beijing Taikang Yanyaun community active area from June to August 2018.The study evaluated the IC scale, Charlson comorbidity index(CCI), and activity of daily living(ADL).In September 2020, adverse outcomes such as functional decline(defined as a decline of at least one point on the ADL scores at 2-year follow-up compared with baseline)and falls were assessed.The structure equation model(SEM)path analysis was employed to examine the direct and indirect effects of IC and CCI on adverse outcomes.Results:Among the 212 older adults who completed a 2-year follow-up, aged 75-93(mean age 83.8±4.4)years, 59.4%(126 cases)were female.Out of these participants, 51.4%(109 cases)experienced functional decline and 33.5%(71 cases)had falls.Path analysis revealed that the direct effects of IC on functional decline and falls were significantly positive, with standardized coefficients of 0.430 and 0.369, respectively.However, the effect of CCI was not found to be significant.The multi-variable Logistic regression model showed that the total effect of IC on functional decline and falls remained significantly positive, with values of 1.184 and 0.915, respectively.CCI acted as a mediating factor, with indirect effects on functional decline and falls accounting for 5.4% and 0.8%, respectively.In terms of the relationship between age and adverse outcomes, the indirect effect of IC was significantly higher than that of CCI(functional decline: 0.192 vs.0.037; falls: 0.158 vs.0.017). Conclusions:The maintenance of IC in the health management of community-dwelling older adults should be given more attention as it can significantly affect the incidence of functional decline and falls.Comorbidity, on the other hand, has a weaker influence.
4.Efficacy and Safety of Lianhua Qingwen Preparation in Treatment of Community-acquired Pneumonia:A Systematic Review and Meta-analysis
Yanxiang HA ; Xin LIU ; Shiwei KANG ; Shuo WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(13):142-149
ObjectiveTo explore the efficacy and safety of Lianhua Qingwen preparation in the treatment of community-acquired pneumonia (CAP). MethodThe PubMed,Embase,Cochrane Collaboration,CNKI,VIP,and Wanfang Medical Network database (CBM) were systematically searched for all the randomized controlled clinical trials (RCTS) of Lianhua Qingwen Preparation in the treatment of CAP from the establishment of the databases to February 2023. The inclusion criteria were established, and the search results were screened. The risk assessment tool (ROB) scale was used to evaluate the methodological quality of the final included studies, and the R software was used for data integration and meta-analysis. ResultA total of 30 pieces of literature were included,involving 2 800 patients. The combined use of Lianhua Qingwen preparation on the basis of antibiotics and other conventional treatments showed that Lianhua Qingwen preparation could improve the cure rate [relative risk(RR)=1.32,95% confidence interval(95% CI)[1.23,1.42],P<0.000 1)] and shorten the time of fever remission [Mean difference(MD)=-1.45,95% CI [-1.93,-0.97],P<0.000 1],and the duration of fever reduction was divided into general population and special population subgroups. The results showed that Lianhua Qingwan preparation could shorten the duration of fever reduction (general population MD=-1.51,95%CI [-2.07,-0.94],P<0.000 1, special population MD=-1.22,95% CI [-2.16,-0.29],P=0.010 6)and does not increase the incidence of adverse reactions(RR=0.85,95%CI [0.62,1.15],P<0.000 1). After nine pieces of virtual literature with negative results were supplemented by the shear compensation method,the cure rate of CAP by Lianhua Qingwan preparation was still improved (RR=1.20,95%CI [1.13,1.29],P<0.000 1). ConclusionThe application of Lianhua Qingwen preparation on the basis of antibiotics in the treatment of CAP can improve the cure rate and shorten the time of fever reduction.
5.Preparation and identification of humanized monoclonal antibody against periostin
Xuejiao LI ; Hang ZHAO ; Shuo ZHANG ; Huiying KANG ; Yannan ZHOU ; Shuang JIA ; Xu LU ; Hongli ZHAO ; Yang HAI
Chinese Journal of Immunology 2024;40(12):2628-2633
Objective:To prepare a humanized monoclonal antibody against periostin and establish a stable cell line.Meth-ods:Based on anti-periostin mouse monoclonal antibody developed by our laboratory,total RNA was extracted,and variable region sequences were obtained by RT-PCR amplification of VH and VL genes.The mouse antibody CDR region was transplanted into the human antibody framework receptor region,and the gene was subcloned into the expression vector PATX-GS2,and stably transfected into CHO cells.Monoclonal cell lines were obtained by MSX pressure screening and limited dilution.Results:VH and VL genes were amplified by RT-PCR,and the sequence of the light and heavy chain variable region were determined.Antibody humanization were successfully stablished by CDR transplantation method a murine antibody to a human framework,and a eukaryotic expression plasmid was constructed,which was transfected into CHO cells for expression,and human anti-periostin antibody was successfully obtained.ELISA and Western blot results showed that the humanized antibody had good anti-periostin activities and binding affinity.Conclu-sion:In this study,anti-periostin humanized monoclonal antibody has been successfully prepared,which can specifically bind to peri-ostin proteins in vivo and have biological activity,providing scientific data for the precise treatment of retinal fibrosis,tissue and organ fibrosis,and malignant tumors.
6.Left Atrial Myocardial Fibrosis Assessment by 3D High-resolution Late Gadolinium Enhancement MRI in Patients With Atrial Fibrillation:a Feasibility Study
Leyi ZHU ; Shuo YUAN ; Yining WANG ; Kang AN ; Wenjing YANG ; Haojie LI ; Gang YIN ; Shihua ZHAO ; Minjie LU ; Zhe ZHENG
Chinese Circulation Journal 2024;39(7):703-709
Objectives:To investigate the clinical feasibility of three-dimensional(3D)high-resolution late gadolinium enhancement(LGE)MRI in accessing left atrial myocardial fibrosis in patients with atrial fibrillation(AF). Methods:A total of 34 AF patients referred for hybrid surgical ablation were retrospectively enrolled in this study.3D-LGE-MRI images were acquired by Siemens 3.0 T machine and analyzed by ADAS post-processing software by two experienced radiologists to obtain parameters such as the area and the area percentage of LGE.Regional analysis was performed by one of the two radiologists at ten left atrial segments.The Kappa test was used to assess the agreement for scoring image quality,and the interclass correlation coefficient(ICC)was used to evaluate the interobserver agreement of LGE parameters.The parameters of left atrial morphology,area(and area percentage)of LGE,and location of LGE were compared between patients with persistent AF and paroxysmal AF. Results:Images of all 34 patients were considered to have diagnostic value.The scores of the overall image quality and the clarity of the left atrial wall evaluated by two radiologists were(2.88±0.64)points and(3.26±0.75)points(radiologist 1),(2.97±0.58)points and(3.24±0.70)points(radiologist 2),respectively.The corresponding Kappa values were 0.724 and 0.859.Both the area and the area percentage of LGE showed good consistency among observers,and the ICCs were 0.969 and 0.950,respectively.The difference in the area of LGE and the area percentage of LGE between patients with paroxysmal and persistent atrial fibrillation was similar(both P>0.05).Compared with patients with paroxysmal AF,patients with persistent AF had a higher Utah stage and more severe myocardial fibrosis in the right inferior pulmonary vein antrum and the left atrial septum(all P<0.05). Conclusions:3D high-resolution LGE-MRI provides a non-invasive way to visualize and quantify left atrial myocardial fibrosis.The extent of left atrial fibrosis in patients with persistent AF is more severe than that in patients with paroxysmal AF,with a preferential distribution in the right inferior pulmonary vein antrum and the left atrial septum.
7.Role and mechanism of neuronal restriction silencing factor REST/NRSF in regulation of epilepsy
Hui LIU ; Bai-Hui YU ; Ya-Qi WANG ; Yi-Ling CHEN ; Zi-Hao CHENG ; Jia-Rui MA ; Zi-Shuo KANG ; Fan ZHANG
Chinese Pharmacological Bulletin 2024;40(9):1727-1734
Aim To investigate the effect and role of neuronal restriction silencing factor(REST/NRSF)in epilepsy disorder.Methods Immunohistochemistry,immunofluorescence,Western blot and qPCR tech-niques were used to detect REST/NRSF expression levels in hippocampal tissues of mice induced by kainic acid and human brain tissue.Viral injections,EEG re-cordings and behavioral methods were used to test the effects on epileptic mice after knockdown and overex-pression of REST/NRSF in the hippocampal CA1 re-gion,respectively.Results The positive rate of REST/NRSF in the lesions of epileptic patients was significantly higher compared with that in the control group.The levels of REST/NRSF protein and mRNA in the CA1 region of the hippocampus of mice in the KA model group were significantly higher.Kv7.2 and Kv7.3 potassium channel mRNA expression levels were significantly down-regulated.Significant up-regu-lation of REST/NRSF expression levels was observed in mouse hippocampus after NMDA injection.Knock-down of REST/NRSF in the CA1 region of hippocam-pus significantly elevated the expression levels of Kv7.2 and Kv7.3 potassium channel mRNAs.The fre-quency of EEG spiking and sharp-wave issuance and epileptic seizure grade were significantly lower.Over-expression of REST/NRSF in the CA1 region of hippo-campus significantly reduced the mRNA expression lev-els of Kv7.2 and Kv7.3 potassium channels.The fre-quency of EEG spiking and sharp-wave issuance was significantly higher and epileptic symptoms were exac-erbated.Conclusion REST/NRSF in mouse hipp-ocampal brain regions is involved in epileptic disease development through transcriptional regulation of Kv7.2 and Kv7.3 potassium channels.
8.Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome (version 2024)
Junyu WANG ; Hai JIN ; Danfeng ZHANG ; Rutong YU ; Mingkun YU ; Yijie MA ; Yue MA ; Ning WANG ; Chunhong WANG ; Chunhui WANG ; Qing WANG ; Xinyu WANG ; Xinjun WANG ; Hengli TIAN ; Xinhua TIAN ; Yijun BAO ; Hua FENG ; Wa DA ; Liquan LYU ; Haijun REN ; Jinfang LIU ; Guodong LIU ; Chunhui LIU ; Junwen GUAN ; Rongcai JIANG ; Yiming LI ; Lihong LI ; Zhenxing LI ; Jinglian LI ; Jun YANG ; Chaohua YANG ; Xiao BU ; Xuehai WU ; Li BIE ; Binghui QIU ; Yongming ZHANG ; Qingjiu ZHANG ; Bo ZHANG ; Xiangtong ZHANG ; Rongbin CHEN ; Chao LIN ; Hu JIN ; Weiming ZHENG ; Mingliang ZHAO ; Liang ZHAO ; Rong HU ; Jixin DUAN ; Jiemin YAO ; Hechun XIA ; Ye GU ; Tao QIAN ; Suokai QIAN ; Tao XU ; Guoyi GAO ; Xiaoping TANG ; Qibing HUANG ; Rong FU ; Jun KANG ; Guobiao LIANG ; Kaiwei HAN ; Zhenmin HAN ; Shuo HAN ; Jun PU ; Lijun HENG ; Junji WEI ; Lijun HOU
Chinese Journal of Trauma 2024;40(5):385-396
Traumatic supraorbital fissure syndrome (TSOFS) is a symptom complex caused by nerve entrapment in the supraorbital fissure after skull base trauma. If the compressed cranial nerve in the supraorbital fissure is not decompressed surgically, ptosis, diplopia and eye movement disorder may exist for a long time and seriously affect the patients′ quality of life. Since its overall incidence is not high, it is not familiarized with the majority of neurosurgeons and some TSOFS may be complicated with skull base vascular injury. If the supraorbital fissure surgery is performed without treatment of vascular injury, it may cause massive hemorrhage, and disability and even life-threatening in severe cases. At present, there is no consensus or guideline on the diagnosis and treatment of TSOFS that can be referred to both domestically and internationally. To improve the understanding of TSOFS among clinical physicians and establish standardized diagnosis and treatment plans, the Skull Base Trauma Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association, Neurotrauma Group of the Neurosurgery Branch of the Chinese Medical Association, Neurotrauma Group of the Traumatology Branch of the Chinese Medical Association, and Editorial Committee of Chinese Journal of Trauma organized relevant experts to formulate Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome ( version 2024) based on evidence of evidence-based medicine and clinical experience of diagnosis and treatment. This consensus puts forward 12 recommendations on the diagnosis, classification, treatment, efficacy evaluation and follow-up of TSOFS, aiming to provide references for neurosurgeons from hospitals of all levels to standardize the diagnosis and treatment of TSOFS.
9.The imaging characteristics of primary intestinal lymphoma
Bing KANG ; Shuo ZHANG ; Ximing WANG ; Cong SUN
Chinese Journal of Radiology 2024;58(10):1075-1079
Objective:To summarize the imaging characteristics of primary intestinal lymphoma (PIL).Methods:As a cross-sectional study, a total of 103 consecutive patients diagnosed as PIL by pathology were retrospectively enrolled at Affiliated Shandong Provincial Hospital of Shandong First Medical University between January 2013 to December 2023. Ninety-four patients underwent CT plain and enhanced scans, and the remaining 9 patients only underwent MRI examination. Imaging features were evaluated, including the location and shape of the tumor, the shape of the intestinal wall and lumen, abdominal lymph nodes, the density or signal intensity of the tumor, and the degree and mode of enhancement after the enhancement scan.Results:The most frequent location of PIL was the ileum (43.7%, 45/103), followed by the ascending colon (20.4%, 21/103). Ninety-one patients had a single lesion (88.3%), while the other 12 patients had multiple lesions (11.7%). Diffuse large B-cell lymphoma was the most common histopathological type of the PIL (65.0%, 67/103), followed by mucosa-associated lymphoid tissue lymphoma (9.7%, 10/103). Generally, PIL classically presented intestinal wall thickening (81.6%, 84/103) and exophytic mass (28.2%, 29/103). Aneurysmal dilatation of the lumen appeared in 19 patients. Nineteen tumors (18.4%) grew out of the lumen, and perforation was shown in 3 patients. Bulky mesenteric or retroperitoneal adenopathy occurred in 28 patients (27.2%). Seventy-two tumors (69.9%) showed homogeneous enhancement, and 75 (72.8%) showed mild-to-moderate enhancement. In DWI images, all 9 tumors showed significant diffusion limitation.Conclusions:The most frequent location of PIL was the ileum. The main imaging characteristics were segmental intestinal wall thickening, which showed mild-to-moderate homogeneous enhancement and restricted diffusion.

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