1.Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine
Runze WANG ; Xuehan WEI ; Xiaoying CHEN ; Yingqian ZHANG ; Jin SUN ; Chunli LU
Journal of Traditional Chinese Medicine 2026;67(9):926-934
Traditional Chinese medicine (TCM) clinical trials face challenges such as low participant compliance, insufficient geographical coverage, and cost-effectiveness imbalances. Decentralized clinical trials (DCT), enabled by digital technology for remote data collection and monitoring, offer a new direction for TCM clinical trial research. This article systematically reviews three novel clinical trial design models. Combining the holistic concept and indivi-dualized treatment characteristics of TCM, it analyzes the challenges currently faced in TCM DCT practice, including the digitization and standardization of TCM theory, data security, privacy protection and patient engagement difficu-lties, insufficient ethical review and regulatory system adaptation, inadequate personnel training, and a shortage of interdisciplinary talent. Addressing these challenges, the article proposes methodological recommendations for DCT implementation that align with the principles of TCM diagnosis and treatment. These recommendations include promoting the intelligentization and standardization of TCM practices, constructing a full-chain data security and privacy protection system, improving the ethical framework and clarifying regulatory responsibilities, and cultivating and building interdisciplinary talent and capabilities, which provide theoretical and technical references for establishing standardized DCT practices in TCM.
2.Surgical treatment of hepatic alveolar echinococcosis: challenges and innovations
Pei ZHANG ; Lu ZHAO ; Yunfei FANG ; Hui YANG ; Yifan WANG ; Yanqiong MA ; Yu MENG
Organ Transplantation 2026;17(3):512-518
Hepatic alveolar echinococcosis is a highly invasive zoonotic parasitic disease with poor prognosis. Surgical intervention serves as the pivotal approach to achieve radical cure and improve the prognosis of hepatic alveolar echinococcosis patients. In recent years, with the popularization of the concept of precision surgery and the development of the multidisciplinary diagnosis and treatment model, the surgical treatment strategies for hepatic alveolar echinococcosis have been continuously enriched, and the selection of surgical procedures has become increasingly diversified. Although key surgical techniques such as radical hepatectomy, autologous liver transplantation and allogeneic liver transplantation have achieved remarkable progress in clinical application, many insurmountable challenges still remain. Therefore, by sorting out the latest evidence-based advances in the field of surgical treatment for hepatic alveolar echinococcosis, this article focuses on discussing the application status and bottlenecks of radical hepatectomy, autologous liver transplantation and allogeneic liver transplantation in hepatic alveolar echinococcosis, aiming to provide a reference for the clinical treatment of hepatic alveolar echinococcosis.
3.Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine
Runze WANG ; Xuehan WEI ; Xiaoying CHEN ; Yingqian ZHANG ; Jin SUN ; Chunli LU
Journal of Traditional Chinese Medicine 2026;67(9):926-934
Traditional Chinese medicine (TCM) clinical trials face challenges such as low participant compliance, insufficient geographical coverage, and cost-effectiveness imbalances. Decentralized clinical trials (DCT), enabled by digital technology for remote data collection and monitoring, offer a new direction for TCM clinical trial research. This article systematically reviews three novel clinical trial design models. Combining the holistic concept and indivi-dualized treatment characteristics of TCM, it analyzes the challenges currently faced in TCM DCT practice, including the digitization and standardization of TCM theory, data security, privacy protection and patient engagement difficu-lties, insufficient ethical review and regulatory system adaptation, inadequate personnel training, and a shortage of interdisciplinary talent. Addressing these challenges, the article proposes methodological recommendations for DCT implementation that align with the principles of TCM diagnosis and treatment. These recommendations include promoting the intelligentization and standardization of TCM practices, constructing a full-chain data security and privacy protection system, improving the ethical framework and clarifying regulatory responsibilities, and cultivating and building interdisciplinary talent and capabilities, which provide theoretical and technical references for establishing standardized DCT practices in TCM.
4.Mechanism of Yigan huayu formula in alleviating liver fibrosis based on proteomics
Conghui WANG ; Guiping MA ; Longzhu WANG ; Fenping LU ; Yanfang LI ; Qiuhan GE ; Shiping HU
China Pharmacy 2026;37(9):1155-1160
OBJECTIVE To investigate the effects and mechanism of Yigan huayu formula in alleviating liver fibrosis in mice. METHODS Mice were randomly divided into blank group (normal saline), model group (normal saline), Yigan huayu formula low- and high-dose groups (28.98, 57.96 g/kg, calculated by crude drug), with 8 mice in each group. Except for the blank group, the liver fibrosis model was induced by intraperitoneal injection of 15%CCl 4 -olive oil solution. From the third week, the mice received the medicine/normal saline intragastrically, once a day, for 4 consecutive weeks. After the last medication, liver indexes were calculated, the activities of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in serum, as well as the hydroxyproline (HYP) content in liver tissue, were measured. Liver histopathology was evaluated. Differentially expressed proteins (DEPs) in liver tissue were analyzed based on proteomics, followed by bioinfo rmatics analysis. The expressions of core DEPs were validated using Western blot (WB) and immunohistochemistry (IHC) methods. RESULTS Compared with the blank group, the model group showed significantly elevated liver indexes, serum activities of ALT and AST, and hepatic HYP content ( P <0.05), along with obvious pathological damage and collagen deposition. Compared with the model group, the above indexes of mice in the Yigan huayu formula high-dose group were decreased significantly ( P <0.05), with marked improvement in liver pathological damage and collagen deposition. Proteomics identified 210 DEPs between the model group and Yigan huayu formula high-dose group. DEPs were significantly enriched in extracellular matrix (ECM)-receptor interaction and lipid metabolism pathways. WB and IHC confirmed that Yigan huayu formula could significantly inhibit the abnormally elevated expressions of collagen type Ⅳ alpha1 chain (COL4A1), secreted protein acidic and rich in cysteine (SPARC), vitronectin (VTN) and laminin subunit alpha5 (LAMA5) in liver tissue of mice ( P <0.05). CONCLUSIONS Yigan huayu formula may exert anti-hepatic fibrosis effects by inhibiting the expressions of proteins such as COL4A1, LAMA5, SPARC, and VTN, thereby blocking the ECM-receptor interaction signaling pathway, and subsequently suppressing excessive ECM deposition and basement membrane remodeling.
5.Meta-analysis of the effects of different doses of vitamin D supplementation on maternal and infant outcomes in vitamin D-deficient pregnant women
Xiaoxia SHI ; Weina WANG ; Rui LI ; Yaheng DU ; Lu LIU
China Pharmacy 2026;37(9):1215-1221
OBJECTIVE To systematically evaluate the effects of supplementation with different doses of vitamin D on maternal and infant outcomes in vitamin D-deficient pregnant women. METHODS Related literature on the effects of supplementing different doses of vitamin D on maternal and infant outcomes was searched in databases including CNKI, Wanfang Data, VIP, PubMed, Medline, the Cochrane Library, Embase from their inception to June 30, 2025. The risk of bias assessment tool from the Cochrane Handbook 5.1 was used to evaluate the quality of included literature. Meta-analysis of outcome indicators was performed by using RevMan 5.4 software. RESULTS A total of 15 studies were included, involving 4 664 patients [2 129 in the experimental group (daily dose >2 000 IU), 2 058 in control group 1 (daily dose ≤1 000 IU) and 477 in control group 2 (daily dose >1 000-≤2 000 IU) ] . Meta-analysis results showed that the incidence of preeclampsia (PE) [OR=0.71, 95%CI (0.53, 0.96), P =0.03 ] , gestational diabetes mellitus (GDM) [OR=0.60, 95%CI (0.43, 0.84), P =0.003 ] , low birth weight of newborn [OR=0.72, 95%CI (0.53, 0.97), P =0.03 ] and macrosomia [OR=0.53, 95%CI (0.29, 0.98), P =0.04 ] in the experimental group were significant lower than control group 1; but there was no significant difference in the incidence of premature delivery [OR=0.86, 95%CI (0.65, 1.13), P =0.28 ] , cesarean delivery [OR=0.92, 95%CI (0.74, 1.15), P =0.48 ] or stillbirth rate [OR=0.77, 95%CI (0.48, 1.24), P =0.29 ] . The incidence of low birth weight of ne wborn [OR=0.64, 95%CI (0.41, 0.98), P =0.04 ] in the experimental group was significant lower than control group 2; but there was no significant difference in the incidence of PE [OR=0.61, 95%CI (0.25, 1.49), P =0.28 ] , the incidence of GDM [OR=0.73, 95%CI (0.42, 1.24), P =0.24 ] , premature delivery rate [OR=0.90, 95%CI (0.59, 1.39), P =0.63 ] , cesarean delivery rate [OR=0.92, 95%CI (0.64, 1.33), P =0.66 ] , or stillbirth rate [OR=0.68, 95%CI (0.24, 1.94), P =0.48 ] . CONCLUSIONS Different doses of vitamin D supplementation in early pregnancy have a significant impact on maternal and infant pregnancy outcomes in vitamin D-deficient pregnant women; daily doses >2 000 IU have significant advantages in reducing the incidence of PE and GDM and improving the outcome of premature delivery.
6.Rectal cancer with liver metastases accompanied by severe coronary artery stenosis: a case report
Yinuo GUAN ; Jiahui CHEN ; Yan WANG ; Hao LU ; Leilei CHENG
Chinese Journal of Clinical Medicine 2026;33(1):147-153
To report diagnosis and treatment of a patient with rectal cancer and synchronous liver metastases, accompanied by severe coronary artery stenosis and cardiac insufficiency, and to provide a reference for clinical decision-making in such cases through introducing the treatment contradiction, the choice of systemic treatment plan and the timing of operation, and the final outcome. After definitive diagnosis, the patient received systemic therapy with cetuximab+irinotecan+oxaliplatin+raltitrexed, and along with oral medication to improve cardiac function, followed by elective coronary revascularization. After revascularization, the cardiac function of patient was fully improved. And the tumor lesion was effectively controlled after antitumor therapy. Once the cardiac condition of patient stabilized, two-stage surgical resection of the primary rectal cancer and liver metastases was performed, ultimately achieving tumor-free status, and discharged.
7.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
8.The role of establishing the concept of"liver and pancreas co-management"in the treatment of pancreatic diseases
Kongyuan WEI ; Canitano NICOLA ; Shuo WANG ; Zipeng LU ; Kuirong JIANG ; Zhenhua MA ; Zheng WU ; Qingyong MA ; Marchegiani GIOVANNI ; Hackert THILO ; Zheng WANG
Chinese Journal of Surgery 2026;64(1):79-82
With the continuous development of new surgical technology, new equipment and new concepts, the research focused in the field of surgery is also in constant change. Among them, there are still confusion and controversies in the current clinical practice when facing the one-stop proposition of benefit population screening, advantageous surgical indication decision-making, surgical intervention timing selection, postoperative complication prediction and management. Therefore, our team tries to analyze whether the concept of"co-management of liver and pancreas"exists in clinical practice from the aspects of anatomy, physiology, histology and embryology of liver and pancreas, as well as the interaction between liver and pancreas, and explore the relationship between liver and pancreas in anatomy and tissue embryonic development, and the relationship between the concept of"co-management of liver and pancreas"and pancreatitis and pancreatic tumors as well as the concept of “co-management of liver and pancreas” applied in neoadjuvant chemoradiotherapy, and attempts to establish a new treatment pathway for pancreatic diseases based on this concept, in order to provide a new idea, new scheme and new possibility for the clinical research of pancreatic diseases and pancreatic surgery.
9.Methodological establishment of red blood cell lysis method for handling Rh typing double group samples
Lu LI ; Bin WANG ; Junjie WEI ; Xiaolin SUN ; Haiyun LIU ; Weixin WU ; Yinze ZHANG
Chinese Journal of Blood Transfusion 2026;39(1):114-117
Objective: To establish an accurate and rapid typing method for Rh typing of samples from patients who have received recent blood transfusions by utilizing the difference in osmotic fragility between fresh and old red blood cells. Methods: A lysing solution suitable for destroying old RBCs was prepared. Sixty-one samples collected in our hospital in 2024 with Rh typing of double groups were treated with the lysing solution to remove the old allogeneic red blood cells while preserving the patient's own fresh red blood cells, followed by repeat Rh typing tests. Results: For 61 samples with Rh typing in double groups, 41 were accurately detected identified through the red blood cell lysis method, yielding an identification rate of 67.21%. No significant difference was observed compared to the detection rate of the commonly used capillary centrifugation modified method (χ
=0.103, P>0.05). Conclusion: The red blood cell lysis method provides a novel and rapid experimental approach for clinical use in processing Rh-typed samples that are of double groups, thereby offering a basis for Rh compatibility blood transfusion.
10.Overview of Diagnosis,Treatment and Mechanism Research of Functional Dyspepsia by Integrated Traditional Chinese and Western Medicine
Shengsheng ZHANG ; Zhaohong SHI ; Xiaofang LU ; Luqing ZHAO ; Danyan LI ; Shu ZHANG ; Lu ZHAO ; Yudi ZHUO ; Nian WANG ; Fan LIU ; Shuangyi LI ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(4):397-403
Functional dyspepsia (FD) is a prioritized disease category where traditional Chinese medicine (TCM) demonstrates distinct therapeutic advantages. The current western medicine treatment for FD is mainly based on proton pump inhibitors and prokinetic agents, with digestive enzymes, probiotics and antidepressants serving as adjuvant medication, yet such therapies still have certain limitations. TCM treatment for FD includes oral administration of Chinese herbal formulas and Chinese patent medicines, as well as external TCM therapies such as acupuncture and moxibustion, acupoint application, hot medicinal compress therapy, rubbing with ointment, medicinal iontophoresis, auricular acupoint therapy and tui na (Chinese medical massage). The combined treatment of FD with integrated TCM and western medicine can significantly improve clinical effectiveness and reduce adverse reactions. The common mechanisms underlying the therapeutic effects of both TCM and western medicine revolve around the core pathological processes of FD, mainly focusing on restoring gastrointestinal motility, regulating the levels of brain-gut peptides, modulating intestinal microecology, and ameliorating inflammatory status. The differential mechanisms lie in the precise targeting feature of western medicine versus the holistic-regulating and multi-target characteristics of TCM, and the two approaches exert a synergistic effect to enhance efficacy. This paper proposes to leverage the advantages of TCM in holistic regulation and the strengths of western medicine in targeted treatment, so as to provide personalized and comprehensive treatment regimens for FD patients.

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