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.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
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Alzheimer Disease/drug therapy*
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Male
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Female
;
Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
3.Correlation between differences in starch gelatinization, water distribution, and terpenoid content during steaming process of Curcuma kwangsiensis root tubers by multivariate statistical analysis.
Yan LIANG ; Meng-Na YANG ; Xiao-Li QIN ; Zhi-Yong ZHANG ; Zhong-Nan SU ; Hou-Kang CAO ; Ke-Feng ZHANG ; Ming-Wei WANG ; Bo LI ; Shuo LI
China Journal of Chinese Materia Medica 2025;50(10):2684-2694
To elucidate the mechanism by which steaming affects the quality of Curcuma kwangsiensis root tubers, methods such as LSCM, RVA, dual-wavelength spectrophotometry, LF-NMR, and LC-MS were employed to qualitatively and quantitatively detect changes in starch gelatinization characteristics, water distribution, and material composition of C. kwangsiensis root tubers under different steaming durations. Based on multivariate statistical analysis, the correlation between differences in gelatinization parameters, water distribution, and terpenoid material composition was investigated. The results indicate that steaming affects both starch gelatinization and water distribution in C. kwangsiensis. During the steaming process, transformations occur between amylose and amylopectin, as well as between semi-bound water and free water. After 60 min of steaming, starch gelatinization and water distribution reached an equilibrium state. The content of amylopectin, the amylose-to-amylopectin ratio, and parameters such as gelatinization temperature, viscosity, breakdown value, and setback value were significantly correlated(P≤0.05). Additionally, the amylose-to-amylopectin ratio was significantly correlated with total free water and total water content(P≤0.05). Steaming induced differences in the material composition of C. kwangsiensis root tubers. Clustering of primary metabolites in the OPLS-DA model was distinct, while secondary metabolites were classified into 9 clusters using the K-means clustering algorithm. Differential terpenoid metabolites such as(-)-α-curcumene were significantly correlated with zerumbone, retinal, and all-trans-retinoic acid(P<0.05). Curcumenol was significantly correlated with isoalantolactone and ursolic acid(P<0.05), while all-trans-retinoic acid was significantly correlated with both zerumbone and retinal(P<0.05). Alpha-tocotrienol exhibited a significant correlation with retinal and all-trans-retinoic acid(P<0.05). Amylose was extremely significantly correlated with(-)-α-curcumene, curcumenol, zerumbone, retinal, all-trans-retinoic acid, and α-tocotrienol(P<0.05). Amylopectin was significantly correlated with zerumbone(P<0.05) and extremely significantly correlated with(-)-α-curcumene, curcumenol, zerumbone, retinal, all-trans-retinoic acid, and 9-cis-retinoic acid(P<0.01). The results provide scientific evidence for elucidating the mechanism of quality formation of steamed C. kwangsiensis root tubers as a medicinal material.
Curcuma/chemistry*
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Starch/chemistry*
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Multivariate Analysis
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Water/chemistry*
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Terpenes/analysis*
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Plant Roots/chemistry*
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Plant Tubers/chemistry*
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Drugs, Chinese Herbal/chemistry*
4.Research progress in etiology and prevention of bone cement implantation syndrome.
Guangtao HAN ; Qin WANG ; Shuo SUN ; Pengde KANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(2):237-242
OBJECTIVE:
To introduce the etiology and prevention of bone cement implantation syndrome (BCIS).
METHODS:
The literature about BCIS at home and abroad in recent years was extensively reviewed, and the incidence, clinical manifestations, etiology, and prevention of BCIS were summarized and analyzed.
RESULTS:
The clinical manifestations of BCIS are diverse. The etiology of BCIS is not completely clarified, and it may be related to circulating methyl methacrylate-mediated model, embolus-mediated model, histamine release and hypersensitivity response, complement activation and multimodal model. BCIS prevention begins with the identification of high-risk patients in preoperative evaluation and communication between surgeon and anesthesiologist about the choice of implant type, surgical procedure, and technique to minimize the risk of cardiovascular complications in high-risk patients with multiple or severe risk factors or comorbidities. Preoperative assessment and optimization of a patient's cardiovascular reserve is also critical to prevent BCIS.
CONCLUSION
BCIS is a possible complication after hip joint arthroplasty, and its pathogenesis needs to be further research in order to provide new ideas for prevention and treatment.
Humans
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Bone Cements/adverse effects*
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Postoperative Complications/etiology*
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Arthroplasty, Replacement, Hip/adverse effects*
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Risk Factors
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Syndrome
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Methylmethacrylate/adverse effects*
5.Mechanisms of the Masquelet technique to promote bone defect repair and its influencing factors.
Jiang-Hong WU ; Quan-Wei BAO ; Shao-Kang WANG ; Pan-Yu ZHOU ; Shuo-Gui XU
Chinese Journal of Traumatology 2025;28(3):157-163
The Masquelet technique, also known as the induced membrane technique, is a surgical technique for repairing large bone defects based on the use of a membrane generated by a foreign body reaction for bone grafting. This technique is not only simple to perform, with few complications and quick recovery, but also has excellent clinical results. To better understand the mechanisms by which this technique promotes bone defect repair and the factors that require special attention in practice, we examined and summarized the relevant research advances in this technique by searching, reading, and analysing the literature. Literature show that the Masquelet technique may promote the repair of bone defects through the physical septum and molecular barrier, vascular network, enrichment of mesenchymal stem cells, and high expression of bone-related growth factors, and the repair process is affected by the properties of spacers, the timing of bone graft, mechanical environment, intramembrane filling materials, artificial membrane, and pharmaceutical/biological agents/physical stimulation.
Humans
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Bone Transplantation/methods*
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Membranes, Artificial
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Bone Regeneration
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Animals
6.Nonsurgical Treatment of Chronic Subdural Hematoma Patients with Chinese Medicine: Case Report Series.
Kang-Ning LI ; Wei-Ming LIU ; Ying-Zhi HOU ; Run-Fa TIAN ; Shuo ZHANG ; Liang WU ; Long XU ; Jia-Ji QIU ; Yan-Ping TONG ; Tao YANG ; Yong-Ping FAN
Chinese journal of integrative medicine 2025;31(10):937-941
7.Advantages of Chinese Medicines for Diabetic Retinopathy and Mechanisms: Focused on Inflammation and Oxidative Stress.
Li-Shuo DONG ; Chong-Xiang XUE ; Jia-Qi GAO ; Yue HU ; Ze-Zheng KANG ; A-Ru SUN ; Jia-Rui LI ; Xiao-Lin TONG ; Xiu-Ge WANG ; Xiu-Yang LI
Chinese journal of integrative medicine 2025;31(11):1046-1055
8.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.
9.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.
10.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.

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