1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Application of double mediastinal drainage tubes in elderly patients with intrathoracic anastomotic leak after thoracoscopic Ivor-Lewis surgery
Chuanfei ZHAN ; Shilin CHEN ; Xiaokang SHEN ; Dongjie FENG ; Xiaojun WANG ; Weizhong SHEN ; Feng JIANG ; Qin ZHANG ; Lin XU
Chinese Journal of Geriatrics 2024;43(1):56-59
Objective:To investigate the clinical significance of intraoperative prepositioning of dual mediastinal drains in elderly patients developing anastomotic leakage(AL)after a total endoscopic Ivor-Lewis procedure.Methods:This retrospective case-control study analyzed the clinical data of 500 elderly patients who underwent total endoscopic Ivor-Lewis surgery for esophageal or cardia cancer from January 2020 to December 2022.In the control group, one mediastinal drainage tube was placed intraoperatively, while in the study group, two mediastinal drainage tubes were placed.Both groups had a chest tube placed conventionally.The study compared the incidence of anastomotic leak(AL)at 1 month postoperatively, inflammatory indexes in patients with AL, grading of AL, rate of nasal fistula placement, incision infection, anastomotic stenosis, and incidence of hoarseness.Additionally, it compared ICU occupancy, ventilator use, and ICU length of stay between the two groups.Results:The analysis included clinical data from 455 elderly patients.Among the patients who developed AL, the study group had significantly lower peak body temperature[(39.58±1.03)℃ vs.(38.05±0.56)℃, t=4.298, P<0.05], white blood cell count[(18.63±3.35)×10 9/L vs.(14.28±2.78)×10 9/L, t=3.450, P<0.05], and C-reactive protein(CRP)levels[(154.66±41.64)mg/L vs.(122.19±31.29)mg/L, t=2.131, P<0.05]. The study group also had a significantly lower grading of AL and rate of nasal fistula placement(82.4% vs.30.0%, P<0.05). In terms of ICU indicators, the study group had a significantly lower ICU admission rate(64.7% vs.10.0%, P<0.05), shorter period of ventilator use[(6.47±8.15)days vs.(0.90±2.23)days, t=2.62, P<0.05], and shorter ICU stay[(11.70±8.89)days vs.(4.70±6.27)days, t=2.184, P<0.05]. Conclusions:Double mediastinal drainage tubes, have been found to significantly alleviate inflammation, decrease the rate of nasal fistula placement and ICU admission, and shorten the length of ICU stay in elderly patients.Therefore, they are considered safe and deserving of clinical promotion.
3.Construction and validation of Nomogram model for secondary insomnia after adolescent depression
Yan XU ; Ouying SHEN ; Shilin CAO ; Yourang PAN
Chinese Journal of Practical Nursing 2024;40(15):1184-1189
Objective:The Nomogram prediction model of secondary insomnia in adolescent depression patients was constructed to provide reference and basis for clinical prevention of secondary insomnia in adolescent depression patients.Methods:A total of 158 adolescent depression patients who were treated in the Department of Pediatric Psychiatry of Shaoxing Seventh People′s Hospital from May 2021 to March 2022 were selected as the research objects by convenient sampling method. According to the Pittsburgh Sleep Quality Index (PSQI) score, the group was divided into a normal sleep group (PSQI ≤ 7 points) and a secondary insomnia group (PSQI>7 points). A cross-sectional survey was conducted using the Hamilton Depression Scale, Hamilton Anxiety Scaleand Social Support Rating Scale. Multivariate binary Logistic regression was used to analyze the influencing factors of secondary insomnia and construct a Nomogram prediction model for secondary insomnia in adolescents with depression. The accuracy of the model was judged by receiver operating characteristic curve. In addition, 70 adolescent depression patients who were treated in Shaoxing Seventh People′s Hospital from May 2022 to March 2023 were selected for success rate prediction. The results were compared with the actual observed results, and the fitting degree of the model was evaluated by Hosmer-Lemeshow test.Results:There were 72 cases in the normal sleep group, including 40 males and 32 females, aged (15.34 ± 2.62) years old, and 86 cases in the secondary insomnia group, including 51 males and 35 females, aged (14.89 ± 2.13) years old. The results of multivariate analysis showed that depression ( OR=6.381, 95 % CI 1.548-26.295, P<0.05), anxiety ( OR=6.248, 95 % CI 1.445-27.005, P<0.05) and social support ( OR=0.586, 95 % CI 0.346-0.994, P<0.05) were independent influencing factors for the occurrence of secondary insomnia in the two groups. On this basis, a risk prediction model was established. The AUC was 0.999, the sensitivity was 98.80 %, the specificity was 98.60 %, and the Youden index was 0.974. The total prediction accuracy of the external validation model was 99.80 %. Conclusions:The Nomogram prediction model of secondary insomnia in adolescent depression patients has excellent predictive efficacy. The degree of depression, anxiety and social support are the main influencing factors of secondary insomnia in patients. Medical staff should provide more effective psychological support for patients.
4.Bavachin induces apoptosis in colorectal cancer cells through Gadd45a via the MAPK signaling pathway.
Mengru WANG ; Baopeng TIAN ; Jie SHEN ; Shilin XU ; Cong LIU ; Ling GUAN ; Min GUO ; Jie DOU
Chinese Journal of Natural Medicines (English Ed.) 2023;21(1):36-46
Bavachin is a dihydroflavonoid compound isolated from Psoralea corylifolia, and exhibits anti-bacterial, anti-inflammatory, anti-tumor and lipid-lowering activities. Recent attention has gradually drawn on bavachin-induced apoptosis in many human cancer cell lines. However, the anti-cancer effects and related mechanisms in colorectal cancer remain unknown. Here, we investigated the effects of bavachin on colorectal cancer in vivo and in vitro. The results showed that bavachin inhibited the proliferation of human colorectal cancer cells and induce apoptosis. These changes were mediated by activating the MAPK signaling pathway, which significantly up-regulated the expression of Gadd45a. Furthermore, Gadd45a silencing obviously attenuated bavachin-mediated cell apoptosis. Inhibition of the MAPK signaling pathway by JNK/ERK/p38 inhibitors also weakened the up-regulation of Gadd45a by bavachin. The anticancer effect of bavachin was also validated using a mouse xenograft model of human colorectal cancer. In conclusion, these findings suggest that bavachin induces the apoptosis of colorectal cancer cells through activating the MAPK signaling pathway.
Humans
;
Signal Transduction
;
Flavonoids/pharmacology*
;
Proteins/pharmacology*
;
MAP Kinase Signaling System
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Colorectal Neoplasms/metabolism*
;
Apoptosis
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Cell Line, Tumor
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Cell Proliferation
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Cell Cycle Proteins/pharmacology*
5.Analysis of clinical features and genetic variants in a Chinese pedigree affected with tuberous sclerosis.
Haiyan MI ; Yongjun CHEN ; Shilin QI ; Xijin LIU ; Min LI ; Yang SHEN ; Shiyang LIU
Chinese Journal of Medical Genetics 2021;38(4):363-365
OBJECTIVE:
To analyze the clinical features of a Chinese pedigree affected with tuberculosis sclerosis and explore its molecular pathogenesis.
METHODS:
Clinical data of the proband and members of his pedigree were collected. Whole exome sequencing was carried out to detect variants of the TSC1 and TSC2 genes. Candidate variants was verified by Sanger sequencing and bioinformatic analysis.
RESULTS:
The proband and his mother, who also had mild features of tuberous sclerosis, were found to harbor a novel heterozygous c.4183C>T (p.Q1395X) variant of the TSC2 gene, which was absent in the 4 healthy relatives. Bioinformatic analysis suggested the variant to be likely pathogenic.
CONCLUSION
The heterozygous c.4183C>T (p.Q1395X) variant of the TSC2 gene probably underlay the disease in this pedigree. Above finding has expanded the spectrum of TSC2 gene variants. The more severe symptoms in the proband may be attributed to phenotypic heterogeneity of this disease.
China
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Humans
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Mutation
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Pedigree
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Tuberous Sclerosis/genetics*
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Tuberous Sclerosis Complex 2 Protein/genetics*
6.Research progress in contrast-induced nephropathy
Yuping WANG ; Shilin SHEN ; Dongjun SU ; Yuezhen HE ; Fuhuan CHEN
Journal of Interventional Radiology 2017;26(6):572-575
With the wide application of contrast media in modem medicine,contrast-induced nephropathy (CIN) has attracted more clinical attention.Renal ischemia and renal tubular toxicity have been considered to be the pathogenesis of CIN.The most promising biomarkers,except for serum creatinine,include neutrophil gelatinase associated lipocalin (NGAL),cystatin C (Cys C),kidney injury molecule-1 (KIM-1),urine N-acetyl beta-D amino glucosidase (NAG) and micro molecular RNA (microRNA).Before use of contrast media for angiography,both the patient's own risk factors and the contrast-associated risk factors should be carefully evaluated.The patient's own risk factors include basic renal function,diabetes,anemia,homocysteine,etc.The contrast-associated risk factors include the osmotic pressure,viscosity,dosage,application frequency of the used contrast agent,etc.At present,hydration therapy is still the main method for CIN,and other therapeutic methods include medication,such as statins,vasodilators,antioxidants,traditional Chinese medicine,etc.,and blood purification therapy.This paper aims to make a brief summary about the research progress in CIN,focusing on its diagnosis,pathogenesis,risk factors and preventive measures.
7.Analysis on correlation between RBC and blood lipid indexes in early returning to plain of Han high altitude immigration
Yuhe WANG ; Ping WANG ; Shilin XU ; Yue SHEN ; Wei YANG ; Peng NING ; Fengcang ZHAO
International Journal of Laboratory Medicine 2016;37(23):3258-3259
Objective To investigate the changes of red blood cells (RBC) and blood lipid in Han high altitude immigration dur‐ing the process of altitude acclimatization and their correlation .Methods Forty male Han nationality teachers entering Xizang Ali area and working for 1 year were selected .The blood samples were collected before entering plateau and within 3 d after returning to plain .The blood routine and the blood lipid level were detected .Results In the early return to plain ,the RBC ,TG ,CHO and LDL‐C levels in the research subjects were increased ,in which RBC and TG were significantly increased (P< 0 .01) ,HDL‐C was significantly decreased .After returning to plain ,RBC was positively correlated with TG and CHO (r=0 .46 ,P<0 .01 and r=0 .36 , P<0 .05) .Conclusion High altitude hypoxia environment is the primary cause leading to the change of RBC and blood lipid inde‐xes in the plain population after entering the plateau environment .
8.Laparoscopic retroperitoneal adrenalectomy for adrenal mass:report of 130 cases
Fangning WAN ; Hailiang ZHANG ; Dingwei YE ; Guiming ZHANG ; Chengyuan GU ; Bo DAI ; Shilin ZHANG ; Yijun SHEN ; Yao ZHU ; Guohai SHI ; Yiping ZHU
China Oncology 2015;(10):828-831
Background and purpose:Laparoscopic retroperitoneal adrenalectomy makes access to the adrenal glands easier and less invasive than open surgery. The aim of this study was to evaluate the clinical efifcacy of laparoscopic retroperitoneal adrenalectomy.Methods:A total of 130 patients who underwent retroperitoneal adrenalectomy for adrenal mass from Jan. 2007 to Dec. 2012 in Fudan University Shanghai Cancer Center were retrospectively assessed. Their clinicopathological factors, perioperative complications and short-term prognostic data were retrieved from the medical records.Results:One hundred and twenty-seven of 130 patients underwent retroperitoneal adrenalectomy successfully, and 3 patients were converted to open surgery due to severe bleeding. Among 130 patients, 63 were male and 67 were female, with the mean age 50.0 years. The pathological results of the 130 patients indicated adrenocortical adenoma in 68, pheochromocytoma in 15, medullary lipoma in 13, adrenal cysts in 10 , ganglioneuroma in 7, metastatic cancer in 5, adrenal hyperplasia in 4, schwannoma in 3, lymphangioma in 2, adrenal hematoma in 1, adrenal cortical carcinoma in 1, adrenal angiosarcoma in 1 and the deputy spleen in 1 (one patient suffering from both pheochromocytoma and ganglioneuroma). The maximum diameters were ranging from 0.5 to 9.0 cm, and mean diameter was 3.48 cm. The average blood loss in surgery was 62.73 mL. Mean length of stay in hospital was 7 d. GradeⅠ complications occurred in 5 patients, including 2 of fever, 1 of food allergy, 1 of drug allergy and 1 of hypokalemia.Conclusion: Retroperitoneal adrenalectomy should be considered as the procedure of choice for the resection of most adrenal tumors in skilled centers with the advantages of minimal invasion, increased safety and faster recovery.
9.The value of preoperative platelet to lymphocyte ratio in predicting of clinical stage and prognosis in upper tract urothelial carcinoma
Jian LI ; Dingwei YE ; Xudong YAO ; Shilin ZHANG ; Bo DAI ; Hailiang ZHANG ; Yijun SHEN ; Yao ZHU ; Guohai SHI ; Yiping ZHU ; Chunguang MA ; Xiaojian QIN ; Guowen LIN ; Wenjun XIAO
China Oncology 2013;(6):457-461
Background and purpose: Platelet to lymphocyte ratio (PLR) is an important factor reflected systematic inflammation. The clinical value of PLR has not been confirmed. The present study was to explore the value of preoperative PLR in predicting clinical stage and prognosis in upper tract urothelial carcinoma. Methods:Patients who underwent surgical therapy with postoperative pathology upper tract urothelial carcinoma without metastasis from Jan. 2007 to Mar. 2012, were collected. Following up was done by telephone and clinic work, 150 vs 1 was taken as the threshold value of PLR, and the association of PLR with tumor stage, whether suffered bladder cancer as comorbidity, recurrent or metastasis, overall survival, tumor lesion, preoperative hematuria, gender and age was analyzed. We further analyzed the association difference of disease free survival (DFS) time and overall survival (OS) time between different PLR groups. Results:Fifty-one cases of UTUC were collected, and the postoperative mean following up time is 21 (9–51) months. Twenty cases recurred or metastasis and 9 cases died. The mean DFS time was 15 (2–51) months,and the mean OS time was 21 (9–51) months. One-factor analysis of variance showed that preoperative PLR was associated with tumor stage, overall survival rate, hematuria and gender, and the P value were 0.028, 0.008, 0.045, 0.036 respectively. High PLR group was intended to be non-organ confined disease, the sensitivity was 57%and the specificity was 74%. Survival analysis by Kaplan-Meier method showed there is no statistical difference in DFS between high and low PLR groups (P=0.155). But OS time in high PLR group was significantly less than that in low PLR group (P=0.006). Cox regression confirmed that only tumor stage is an independent prognostic factor of OS (P=0.029). Conclusion:PLR has potential clinical value in predicting advanced stage disease and Cox regression confirmed that only tumor stage is an independent prognostic factor of OS.
10.Validation of the MSKCC score model in advanced renal cell carcinoma patients treated with VEGF-targeted agents in China
Yaping HONG ; Yao ZHU ; Xudong YAO ; Shilin ZHANG ; Bo DAI ; Hailiang ZHANG ; Yijun SHEN ; Yiping ZHU ; Chunguang MA ; Wenjun XIAO ; Xiaojian QIN ; Guowen LIN ; Dingwei YE
Chinese Journal of Urology 2013;(2):143-146
Objective To validate the Memorial Sloan-Kettering Cancer Center(MSKCC)score model and evaluate the clinical efficacy of vascular endothelial growth factor(VEGF)-targeted agents in the treatment of advanced renal cell carcinoma(RCC)in China.Methods Three hundred and forty-five patients with advanced RCC and average age of 57(17-90)years were treated with VEGF-targeted agents.There were 306 cases of clear cell RCC,20 cases of papillary RCC,4 cases of chromophobe RCC,5 cases of renal collecting duct carcinoma,3 cases of medullary carcinoma and 7 cases of unclassified RCC.The main metastatic lesions were located at lung,bone and lymph nodes.Of them,205 cases were given the treatment of sorafenib 400 mg bid without off treatment,while 140 cases received sunitinib treatment in repeated six week cycles consisting of four weeks of sunitinib 50 mg daily followed by two weeks off treatment.Overall survival(OS)was estimated by the Kaplan-Meier method.Log-rank test and Harrell concordance index analysis were used to validate the MSKCC score model.Results The median follow-up period were 23(1-68)months in the whole group.The OS was 33 months,and survival rates at 1,2,3 year were 77.6%,59.3%,46.6%,respectively.According to the MSKCC score model,the patients were segregated into three risk categories: the favorable-risk group(no prognostic factors;n =169;49.0%),in which median OS(mOS)was 46 months and 2 year OS was 75.8%;the imtermediate-risk group(one or two prognostic factors;n =150;43.5%),in which mOS was 24 months and 2 year OS was 47.7%;and the poorrisk group(three to five prognostic factors;n =26;7.5%),in which mOS was 8 months and 2 year OS was 10.1%(log-rank P < 0.01).The concordance index was 0.687.Conclusions VEGF-targeted agents are effective in Chinese advanced RCC patients.The MSKCC score model can be incorporated into judging individualizing tumor prognosis and communicating about the treatment options with patients who are using VEGF-targeted agents.


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