1.Advances in Sequential Multiple Assignment Randomized Trial Methodology and Considerations for Its Application in Traditional Chinese Medicine
Wenxin MA ; Xuehui WANG ; Yuyi WANG ; Yuan SUN ; Yike SONG ; Zhijun BU ; Zeyang SHI ; Jianping LIU ; Zhaolan LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1530-1539
Traditional Chinese Medicine(TCM)emphasizes syndrome differentiation and treatment,characterized by"maintaining the prescription if effective"and"changing the prescription if ineffective".Traditional randomized controlled trials(RCTs)are inadequate for evaluating the efficacy of dynamic treatment adjustments.The Sequential Multiple Assignment Randomized Trial(SMART)is an emerging adaptive research design that incorporates randomization at multiple stages,allowing for adjustments in subsequent interventions based on treatment responses.This approach is suitable for evaluating dynamic treatment regimens while retaining the low bias risk of traditional RCTs,making it highly promising for clinical research in TCM.This paper summarizes recent methodological advancements in SMART design,including different sample size estimation and statistical analysis methods for primary effect objectives,embedded adaptive intervention objectives,and optimization objectives,along with providing corresponding operational software.Additionally,it offers considerations for applying SMART design in TCM research,such as the selection of disease types,interventions,decision points,tailoring variables,sample size calculation,statistical methods,the importance of pilot trials,ethical considerations,and limitations.The aim is to promote the exploration and practice of this method in the field of TCM,thereby contributing to the generation of high-quality evidence-based evidence for TCM.
2.Expert consensus on integrated diagnosis and treatment techniques for oropharyngeal squamous cell carcinoma
Wei SHANG ; Haoyue XU ; Zongxuan HE ; Xiaoying LI ; Haijun LU ; Xiaohong ZHAN ; Dapeng HAO ; Yan SUN ; Wei GUO ; Zhangui TANG ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Jie ZHANG ; Jichen LI ; Yue HE ; Chunjie LI ; Jianhua WEI ; Lizheng QIN ; Yaowu YANG ; Qing XI ; Wei WU ; Kai YANG ; Bing HAN ; Lingxue BU ; Shuangyi WANG ; Kai SONG ; Jiaqi ZHU ; Hongyu HAN ; Yu KONG ; Jieying LI ; Man HU ; Mingjin XU ; Moyi SUN
Journal of Practical Stomatology 2025;41(6):725-736
In recent decades,the incidence of human papillomavirus(HPV)-associated oropharyngeal squamous cell carcinoma(OPSCC)has shown a marked increase.Significant changes have also occurred in the OPSCC diagnosis and treatment paradigm.Deter-mining HPV status prior to treatment is now essential,and radiotherapy/chemotherapy,immunotherapy,and minimally invasive surgical techniques have progressively emerged as key modalities for managing OPSCC.However,alongside these paradigm shifts,a comprehen-sive technical consensus guiding the entire diagnostic and therapeutic process for OPSCC patients is currently lacking.Given China's large population base and the rising incidence of OPSCC,an expert panel convened to develop a clinical technical consensus on OPSCC diagno-sis and management tailored to China's specific context.This consensus aims to further enhance and standardize understanding of OPSCC management techniques among relevant healthcare professionals.
3.Comparison of the effect of delaying pediatric myopia progression between defocus incorporated multiple segments spectacle lenses combined with low-dose atropine and orthokeratology lenses
Desheng SONG ; Yuxin ZHANG ; Guangfeng LONG ; Zhijun CHEN
Recent Advances in Ophthalmology 2025;45(4):291-297
Objective To compare the efficacy of controlling pediatric myopia progression between defocus incorpo-rated multiple segments(DIMS)spectacle lenses combined with low-concentration atropine(0.1 g·L-1)(DIMSA)and orthokeratology(OK)lenses.Methods A prospective cohort study was conducted on myopic children treated at the De-partment of Ophthalmology,Children's Hospital of Nanjing Medical University between January 2022 and February 2023.Participants were divided into a DIMSA group(88 cases)and an OK lens group(73 cases).Only right eye data were in-cluded for statistical analysis,and the children were followed up for 1 year.The axial length(AL)and spherical equivalent refraction(SER)were measured for the DIMSA group while only AL was measured for the OK lens group at baseline and each follow-up visit.The AL regression rate[(AL regression rate=the number of AL regression cases/total cases in the group)× 100%]and axial elongation(AE)were calculated to compare the myopia control efficacy between the two groups.Results The baseline age of the OK lens group was significantly larger than that of the DIMSA group(P=0.001).The AE value in the DIMSA group was significantly smaller than that in the OK lens group after following up for 6 months,following up for 1 year,and adjusting for baseline age(all P<0.05).Multiple linear regression analysis revealed that baseline age was the only factor influencing the AE value[OK lens group:unstandardized β=-0.024,standardizedβ=-0.266(P=0.022);DIMSA group:unstandardized β=-0.052,standardized β=-0.487(P<0.001)].There was a negative correlation between AE and baseline age(OK lens group:r=-0.30,P<0.001;DIMSA group:r=-0.42,P<0.001).In the DIMSA group,baseline age was positively correlated with SER progression(r=0.28,P=0.001 5).After following up for 1 year,the proportions of children with different AE velocities differed significantly between the two groups(x2=11.09,P=0.004).AE was controlled better in the DIMSA group than that in the OK lens group.AL regression rates in the DIMSA group were significantly higher than those in the OK lens group after 6 months and 1 year of follow-up(all P<0.05).No severe ocular adverse events occurred in either group.Conclusion DIMSA demonstrates superior effi-cacy over OK lenses in controlling myopia progression in children with mild-to-moderate myopia.Ophthalmologists should tailor myopia control strategies based on individual needs and characteristics.
4.Advances in Sequential Multiple Assignment Randomized Trial Methodology and Considerations for Its Application in Traditional Chinese Medicine
Wenxin MA ; Xuehui WANG ; Yuyi WANG ; Yuan SUN ; Yike SONG ; Zhijun BU ; Zeyang SHI ; Jianping LIU ; Zhaolan LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1530-1539
Traditional Chinese Medicine(TCM)emphasizes syndrome differentiation and treatment,characterized by"maintaining the prescription if effective"and"changing the prescription if ineffective".Traditional randomized controlled trials(RCTs)are inadequate for evaluating the efficacy of dynamic treatment adjustments.The Sequential Multiple Assignment Randomized Trial(SMART)is an emerging adaptive research design that incorporates randomization at multiple stages,allowing for adjustments in subsequent interventions based on treatment responses.This approach is suitable for evaluating dynamic treatment regimens while retaining the low bias risk of traditional RCTs,making it highly promising for clinical research in TCM.This paper summarizes recent methodological advancements in SMART design,including different sample size estimation and statistical analysis methods for primary effect objectives,embedded adaptive intervention objectives,and optimization objectives,along with providing corresponding operational software.Additionally,it offers considerations for applying SMART design in TCM research,such as the selection of disease types,interventions,decision points,tailoring variables,sample size calculation,statistical methods,the importance of pilot trials,ethical considerations,and limitations.The aim is to promote the exploration and practice of this method in the field of TCM,thereby contributing to the generation of high-quality evidence-based evidence for TCM.
5.Progress on the Main Mechanism Affecting Flap Survival
Jinpeng LI ; Jie GUO ; Tao LIU ; Xiaotao WEI ; Yuan SONG ; Weiwei WANG ; Zhijun HE
Medical Journal of Peking Union Medical College Hospital 2025;16(2):416-422
Flap surgery is a complex surgical procedure that has become an effective method for the treatment of many diseases and traumas.Flap survival is closely related to a variety of factors including cellular autophagy,oxidative stress,inflammatory response,mesenchymal stem cells(MSCs)function,and vascular regeneration.Cellular autophagy maintains intracellular homeostasis and plays a key role in reducing oxidative stress and inflammation and promoting injury repair.Excessive oxidative stress and inflammatory responses pose a threat to flaps,affecting their survival and successful transplantation.Endothelial cells are involved in vascu-lar regeneration through proliferation,migration,and production of angiogenic factors,and vascular endothelial growth factor directly promotes blood vessel formation and maintains endothelial cell function.MSCs play an important role in promoting flap survival and tissue repair due to their unique biological properties and multiple mechanisms of action.The multiple roles played by cellular autophagy,oxidative stress,inflammatory response,MSCs function,and vascular regeneration in influencing postoperative flap survival are hereby elaborated.The aim is to provide a basis for the clinical application of regulating the above factors to improve postoperative flap survival,improve the success rate of flap surgery,reduce complications,and bring more hope for the recovery and quality of life of patients.
6.Consensus on informed consent for orthodontic treatment
Yang CAO ; Bing FANG ; Zuolin JIN ; Hong HE ; Yuxing BAI ; Lin WANG ; Haiping LU ; Zhihe ZHAO ; Tianmin XU ; Weiran LI ; Min HU ; Jinlin SONG ; Jun WANG ; Fang JIN ; Ding BAI ; Xianglong HAN ; Yuehua LIU ; Bin YAN ; Jie GUO ; Jiejun SHI ; Yongming LI ; Zhihua LI ; Xiuping WU ; Jiangtian HU ; Linyu XU ; Lin LIU ; Yi LIU ; Yanqin LU ; Wensheng MA ; Shuixue MO ; Liling REN ; Shuxia CUI ; Yongjie FAN ; Jianguang XU ; Lulu XU ; Zhijun ZHENG ; Peijun WANG ; Rui ZOU ; Chufeng LIU ; Lunguo XIA ; Li HU ; Weicai WANG ; Liping WU ; Xiaoxing KOU ; Jiali TAN ; Yuanbo LIU ; Bowen MENG ; Yuantao HAO ; Lili CHEN
Chinese Journal of Stomatology 2025;60(12):1327-1336
This consensus was developed by the Orthodontic Society of the Chinese Stomatological Association to provide a systematic, scientific, and practical guideline for informed consent in orthodontic care. Orthodontic treatment is typically lengthy, highly individualized, and involves multiple factors such as growth and development, occlusal function, and facial esthetics. Rapid technological advances and diverse risk profiles make the traditional reliance on orthodontist experience or institutional templates insufficient to ensure patients′ full understanding and autonomous decision-making. To address this, the expert panel conducted extensive reviews of domestic and international guidelines, analyzed representative dispute cases, and performed multicenter patient-clinician surveys. Using a multi-round Delphi method, the group established a standardized informed consent framework covering the initial consultation, treatment, and retention phases. The consensus emphasizes that informed consent is not only a fundamental legal and ethical requirement but also a key step in building trust, improving patient compliance, and enhancing treatment satisfaction. Orthodontists should clearly and comprehensively explain treatment plans, potential risks, uncertainties, and associated costs, while respecting the autonomy of patients or guardians, and maintain continuous communication and dynamic evaluation throughout the treatment process. The release of this consensus provides unified and authoritative guidance for clinical orthodontics, helping to standardize informed consent, enhance its transparency, safeguard patient rights, reduce medical risks, and promote high-quality, sustainable development of orthodontic practice.
7.Surgical indications and application techniques of oblique lateral lumbar interbody fuion for the treatment of lumbar degenerative diseases
Shunwu FAN ; Zhijun HU ; Honghai SONG
Chinese Journal of Orthopaedics 2025;45(18):1161-1168
Oblique lateral interbody fusion (OLIF) is a minimally invasive fusion technique developed over the past decade. It employs a retroperitoneal approach, accessing the target intervertebral disc through the natural anatomical corridor between the abdominal vascular sheath and the anterior margin of the psoas muscle, thereby avoiding interference with the intraspinal neural structures. Surgical exposure is the cornerstone of the OLIF technique. Imaging and anatomical studies indicate that the natural space between the anterior psoas and the abdominal vessels is relatively narrow, generally smaller than the diameter of OLIF working channel. A direct visualization technique for anterior-inferior psoas exposure by dissecting and retracting the anterior psoas border, can expand this gap by dissecting and retracting the anterior psoas border, making the operation of OLIF techniques in various complex anatomies safer. Currently, OLIF is widely used for various lumbar degenerative diseases, such as discogenic low back pain, lumbar spinal stenosis, lumbar spondylolisthesis, lumbar segmental instability, degenerative lumbar scoliosis, and revision surgery after posterior lumbar surgeries. In the treatment of lumbar spinal stenosis, OLIF achieves indirect decompression of the spinal canal through disc space distraction and stabilization, avoiding intraspinal neural manipulation and related complications. However, it is crucial to select appropriate cases where the disc space has potential for distraction or exhibits intervertebral instability. For degenerative lumbar scoliosis, the corrective principle of OLIF is to restore intervertebral balance and segmental lordosis, thereby reconstructing coronal and sagittal balance of the spine. However, OLIF is not suitable for correcting deformities in patients with rigid posterior lumbar scoliosis or those with type C coronal imbalance. The stand-alone OLIF technique best embodies the minimally invasive concept of OLIF technology, but it has a narrow range of indications and is only applicable to cases where the vertebral endplate strength is sufficiently high (with normal bone mineral density or endplate sclerosis). Supplemental posterior instrumentation is strongly recommended in cases of: reduced bone density (T-score<-1.0), intraoperative endplate injury, multi-level fusion (≥3 segments), isthmic spondylolisthesis, grade II degenerative spondylolisthesis or higher, dynamic instability confirmed by dynamic X-ray films, adjacent segment disease distal to prior fused segments, intraoperative trial implant loosening. There are various options for internal fixation in the OLIF technique; however, bilateral posterior pedicle screw fixation remains the current gold standard for rigid fixation. For some cases with normal bone mineral density and sufficient support strength of the cage, lateral fixation can be used instead of posterior internal fixation to prevent cage displacement. As a novel minimally invasive lumbar fusion technique, OLIF requires ongoing refinement of clinical experience. Through multi-center and large-scale case studies, the standardization and homogenization of its application should be explored.
8.Correlation between Glycolytic Pathway of Monocytes and Intracranial Pressure and Clinical Prognosis in Patients with Hypertensive Cerebral Hemorrhage
Hongsha PEI ; Mingyang XU ; Baoming JIA ; Jianlong SU ; Yigong FENG ; Sibo XUE ; Zhijun SONG
Journal of Kunming Medical University 2025;46(5):110-117
Objective To explore the correlation between glycolysis related indexes of peripheral blood mononuclear cells(PBMCs)[glucose transporter 1(GLUT1),fructose-2,6-diphosphatase 3(PFKFB3)and lactate kinase M2(PKM2)]and intracranial pressure and clinical prognosis of patients with hypertensive cerebral hemorrhage(HICH)who broke into the ventricle.Methods 85 HICH patients hospitalized in our hospital from January 2021 to June 2022 were retrospectively collected as the research participants.The levels of PKM2,GLUT1 and PFKFB3 in PBMCs were analyzed by enzyme-linked immunosorbent assay kit.Six months after the onset of HICH,the short-term outcome was evaluated by modified Rankin scale(mRS),and the patients were divided into good prognosis(mRS score≤2)and poor prognosis(mRS score≥3).Results The levels of PKM2,PFKFB3 and GLUT1 in PBMCs of HICH patients with ventricular rupture were further lower than those of the patients without ventricular rupture(P<0.05).Six months after discharge,8 patients(22.9%)with HICH in non-ventricular rupture group had poor prognosis,while 28 patients(56.0%)with HICH in ventricular rupture group had poor prognosis,and the difference was statistically significant(χ2=9.263,P=0.002).Compared with the group with good prognosis,the levels of PKM2 and GLUT1 in PBMCs of HICH patients with poor prognosis were lower(P<0.05).Compared with the good prognosis group,the levels of PKM2 and GLUT1 in PBMCs of HICH patients with poor prognosis group were lower in HICH patients with ventricular rupture(P<0.05).In HICH patients who broke into the ventricle,the AUC of PKM2 and GLUT1 in predicting the poor prognosis of HICH patients were 0.879(95%CI:0.807~0.951)and 0.897(95%CI:0.831~0.963),respectively.Conclusion The levels of PKM2 and GLUT1 in PBMCs of patients with HICH breaking into ventricles decrease significantly,and are negatively correlated with intracranial pressure,which can be used to predict the short-term prognosis of the patients.
9.Research progress on immunomodulatory effects and role of bile acids and bile acid receptors in the occurrence and development of colorectal cancer
Zhijun LIU ; Lili CUI ; Fengjing XU ; Xinhua SONG ; Zhipeng WANG ; Shouhong GAO
Journal of Pharmaceutical Practice and Service 2025;43(12):583-590
Colorectal cancer is one of the most common malignant tumors, which is a great threat to human life and health. The change of bile acid homeostasis can activate their corresponding receptors to regulate the immune functions, which is closely related to the occurrence of colorectal cancer. In addition, some bile acids can directly induce colorectal cancer and play an important role in the development of colorectal cancer. In this paper, the metabolic process of bile acids in vivo and the immunomodulatory role of bile acid receptors were reviewed, and the evidence of associations between bile acids and colorectal cancer were summarized, which showed the rebalancing the bile acid levels might play a role in the prevention or treatment of colorectal cancer.
10.GPSM2 is highly expressed in gastric cancer to affect patient prognosis by promoting tumor cell proliferation.
Xue SONG ; Yue CHEN ; Min ZHANG ; Nuo ZHANG ; Lugen ZUO ; Jing LI ; Zhijun GENG ; Xiaofeng ZHANG ; Yueyue WANG ; Lian WANG ; Jianguo HU
Journal of Southern Medical University 2025;45(2):229-238
OBJECTIVES:
To explore the association between GPSM2 expression level and gastric cancer progression and analyze the functional pathways and action mechanism of GPSM2.
METHODS:
We analyzed GPSM2 expression levels in gastric cancer tumors based on data from the GEPIA database and the clinical data of 109 patients. Public databases enrichment analysis were used to assess the impact of GPSM2 expression level on survival outcomes and the functional pathways and action mechanism of GPSM2. We further observed the effects of GPSM2 knockdown and overexpression on proliferation, migration and apoptosis of MGC803 cells using CCK-8 assay, colony formation assay, flow cytometry and immunoblotting and on the growth of MGC803 cell xenografts in nude mice.
RESULTS:
Bioinformatic analysis and immunohistochemical staining of the clinical specimens both revealed high GPSM2 expressions in gastric cancer (P<0.01). A high GPSM2 expression was significantly correlated with T3-4 stages, N2-3 stages, a carcinoembryonic antigen (CEA) level ≥5 μg/L, and a carbohydrate antigen (CA) 19-9 level ≥37 kU/L (P<0.05). Cox regression analysis identified high GPSM2 expression as an independent risk factor affecting 5-year survival of the patients (P<0.05). Gene ontology (GO) analysis suggested that GPSM2 was involved in cell cycle regulation. In MGC803 cells, GPSM2 overexpression significantly promoted cell proliferation and G1/S transition and xenograft growth in nude mice. KEGG pathway enrichment analysis indicated that GPSM2 executed its biological functions by regulating the p53 signaling pathway, which was confirmed by the results of immunoblotting experiments showing suppression of p53 signaling pathway activity in GPSM2-over expressing MGC803 cells.
CONCLUSIONS
GPSM2 is highly expressed in gastric cancer to affect patient prognosis by promoting tumor cell proliferation and G1/S transition possibly via inhibiting the p53 pathway.
Stomach Neoplasms/metabolism*
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Humans
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Cell Proliferation
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Prognosis
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Animals
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Mice, Nude
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Cell Line, Tumor
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Mice
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Apoptosis
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Tumor Suppressor Protein p53/metabolism*
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Cell Movement

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