1.Development of a new paradigm for precision diagnosis and treatment in traditional Chinese medicine
Jingnian NI ; Mingqing WEI ; Ting LI ; Jing SHI ; Wei XIAO ; Jing CHENG ; Bin CONG ; Boli ZHANG ; Jinzhou TIAN
Journal of Beijing University of Traditional Chinese Medicine 2025;48(1):43-47
The development of traditional Chinese medicine (TCM) diagnosis and treatment has undergone multiple paradigms, evolving from sporadic experiential practices to systematic approaches in syndrome differentiation and treatment and further integration of disease and syndrome frameworks. TCM is a vital component of the medical system, valued alongside Western medicine. Treatment based on syndrome differentiation embodies both personalized treatment and holistic approaches; however, the inconsistency and lack of stability in syndrome differentiation limit clinical efficacy. The existing integration of diseases and syndromes primarily relies on patchwork and embedded systems, where the full advantages of synergy between Chinese and Western medicine are not fully realized. Recently, driven by the development of diagnosis and treatment concepts and advances in analytical technology, Western medicine has been rapidly transforming from a traditional biological model to a precision medicine model. TCM faces a similar need to progress beyond traditional syndrome differentiation and disease-syndrome integration toward a more precise diagnosis and treatment paradigm. Unlike the micro-level precision trend of Western medicine, precision diagnosis and treatment in TCM is primarily reflected in data-driven applications that incorporate information at various levels, including precise syndrome differentiation, medication, disease management, and efficacy evaluation. The current priority is to accelerate the development of TCM precision diagnosis and treatment technology platforms and advance discipline construction in this area.
2.Disease Burden and Indirect Economic Burden Due to Lung Cancer from 1981 to 2020 in Kunshan, Jiangsu Province, China
Yijun SHEN ; Wenbin HU ; Bin NI
Cancer Research on Prevention and Treatment 2024;51(2):121-126
Objective To identify the disease burden and indirect economic burden caused by lung cancer in Kunshan City, Jiangsu Province, from 1981 to 2020. Methods The incidence and death cases of lung cancer were obtained from cancer registry and death cause monitoring data. The disability adjusted life years (DALY) was used as the evaluation index for burden posed by lung cancer on health, and the indirect economic burden was calculated by a human capital method. Results From 1981 to 2020, a total of 9272 deaths due to lung cancer were reported in Kunshan, of which 7106 were males and 2166 were females. The DALY caused by lung cancer in the whole population were 3.81, 4.14, 4.38, and 9.46 in 1981–1990, 1991–2000, 2001–2010, and 2011–2020, respectively. The indirect economic burden caused by lung cancer was 10.515, 141.657, 813.794, and 6659.149 million yuan. From 2011 to 2020, the ratios of years of life lost due to premature mortality to DALY in males, females, and the general population were 92.42%, 95.15%, and 93.60%, respectively. Conclusion The health burden and indirect economic burden for lung cancer are substantial in the Kunshan City. Moreover, age-specific DALY and indirect economic burden are not exactly symmetrical, suggesting that an effective control strategy to lower cost is urgently needed, especially for individuals aged 40-59.
3.Interpretation of guidelines for the diagnosis and treatment of diabetes mellitus with hyperlipidemia combined with disease and syndrome
Ziqi ZHAO ; Yuntao MA ; Pai PANG ; Shentao WU ; Qing NI ; Bin WANG
International Journal of Traditional Chinese Medicine 2024;46(4):409-414
Along with the change in lifestyle and diet, diabetes mellitus with hyperlipidemia has been a major risk and death factor for cardiovascular disease with the increasing incidence of diabetes mellitus with hyperlipidemia year by year. In order to promote and make full use of unique characteristics and advantages of TCM, the guidance writing group adopted the pattern of combination with disease and syndrome to make a standardized approach to diagnosis and treatment based on emphasis on diagnosis and treatment. Guidelines for the Diagnosis and Treatment of Diabetes Mellitus with Hyperlipidemia Combined with Disease and Syndrome (hereinafter referred to as " the Guideline") was published in the World Chinese Medicine in August, 2021. Based on the pattern of combination with disease and syndrome, the Guideline highlights the significant characteristics, such as: precise diagnosis and treatment by combined with disease and syndrome, updating criteria, rehabilitation diet therapy and exercise and following the principles which include but not limited to evidence-based medicine. According to the evidence of evidence-based medicine and expert consensus, the Guideline gives recommendations for diagnosis, treatment and rehabilitation of diabetes mellitus with hyperlipidemia. In the article, the main contents and characteristics of the new guideline were interpreted in order to provide concise and practical guidance for clinicians and promote the clinical popularization and application of the Guideline.
4.Chinesization of the HEMO-FISS-QoL questionnaire and its reliability and validity
Songpeng SUN ; Shan JIA ; Fangfang XU ; Tianyu LI ; Zhiyun ZHANG ; Qiaorong CAO ; Xinjian LI ; Yao WU ; Weiping WAN ; Bin SHI ; Jianguo WANG ; Hong NI ; Longyu LIANG ; Xingxiao HUO ; Tianqing YANG ; Lei TIAN ; Ying TIAN ; Mei LIN ; Zhanjun WANG ; Yangyang ZHOU ; Hongchuan CHU ; Riyu LIAO ; Kuerban XIEYIDA ; Junhong LONG ; Shuxin ZHANG
Chinese Journal of Behavioral Medicine and Brain Science 2024;33(1):75-82
Objective:To evaluate the reliability and validity of the Chinese version of HEMO-FISS-QoL(HF-QoL) questionnaire (HF-QoL-C) in the Chinese population with hemorrhoids.Methods:From November 2021 to November 2022, a self-constructed general information questionnaire, HF-QoL-C, and the 36-item short form health survey (SF-36), Goligher classification, and Giordano severity of hemorrhoid symptom questionnaire (GSQ) were used to conduct a questionnaire survey on 760 hemorrhoid patients in the anorectal department of six hospitals. The data was analyzed for reliability and validity using SPSS 21.0 and AMOS 26.0 software.Results:The Cronbach's α coefficient of HF-QoL-C and its dimension ranged from 0.831 to 0.960, and the split coefficient was 0.832-0.915. Four common factors were extracted through principal component exploratory factor analysis. Confirmatory factor analysis indicated acceptable structural validity( χ2/ df=8.152, RSMEA=0.097, CFI=0.881, IFI=0.881, NFI=0.867). HF-QoL-C was correlated with SF36 and GSQ( r=-0.694, 0.501, both P<0.01). There were differences in the total score and dimensional scores of HF-QoL-C between surgical and drug treated patients, different grades of Goligher classification for hemorrhoidal disease, and different ranges of hemorrhoid prolapse (all P<0.001). No ceiling effect was found in the total score and the scores of each dimension(0.3%-2.0%). There was a floor effect in both psychological function and sexual activity dimensions (16.7%, 35.1%). Conclusion:HF-QoL-C has good reliability and validity, which can be used to measure the quality of life of Chinese hemorrhoid patients.
5.Research progress in therapy drug monitoring of levetiracetam
Chang GAO ; Bin NI ; Fanghui CHEN ; Chunyu GUO ; Guilin WEI
China Pharmacy 2024;35(2):251-256
Levetiracetam (LEV) is the second generation of broad-spectrum anti-epileptic drug. LEV has the advantages of rapid absorption, short half-life, precise efficacy, good tolerance and few drug interactions. In order to improve the clinical efficacy of LEV, and reduce the occurrence of adverse reactions, children, pregnant women, the elderly, and patients with renal insufficiency should receive therapeutic drug monitoring (TDM). Clinically, the samples are usually plasma or serum, and the TDM methods are mostly immunoassay or chromatography. There is currently no consensus on the effective concentration range of LEV, and the correlation between plasma concentration and adverse reactions is also unclear. The main factors affecting LEV plasma concentration include age, pregnancy, and patient compliance. How to interpret TDM results and adjust dosage based on the results will be the focus of future work.
6.Establishment and Exploration of Core Competency Oriented Training Program for Neurology Resident
Lixin ZHOU ; Ying TAN ; Fei HAN ; Ming YAO ; Linzhi LUO ; Jun NI ; Bin PENG ; Liying CUI ; Yicheng ZHU
Medical Journal of Peking Union Medical College Hospital 2024;15(4):973-980
Resident training is a necessary path to cultivate excellent clinical doctors. Based on the
7.Bioequivalence study of tenofovir alafenamide fumarate tablets in Chinese healthy subjects
Xiao-Bin LI ; Nan WANG ; Ni-Na HU ; Ning WANG ; Chen-Dong DONG ; Xiao-Tong CUI ; He XIE ; Yan TIAN ; Wen-Ping WANG
The Chinese Journal of Clinical Pharmacology 2024;40(14):2113-2117
Objective To evaluate the pharmacokinetics(PK)of tenofovir alafenamide Fumarate tablets(25 mg)in healthy Chinese subjects after single oral administration to provide a basis for bioequivalence evaluation.Methods Using a single-dose,randomized,open-lable,two-period,two-way crossover design under fasting condition,while three-way crossover design under fed condition,42 healthy subjects respectively for fasting and fed study were enrolled,and randomized into two groups to receive a single dose of test product(T)or reference product(R)25 mg.Plasma concentration of tenofovir alafenamide and tenofovir were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS)method.The pharmacokinetic parameters were calculated by WinNonlin software(8.1 version)using non-compartmental model,and bioequivalence evaluation was performed for the two preparations.Relevant safety evaluations were performed during the trial.Results The test product and the reference product under fasting study,the main PK parameters of tenofovir alafenamide were as follows:Cmax were(215.17±94.24)and(199.30±71.11)ng·mL-1;AUC0-t were(135.44±71.60)and(123.91±53.82)h·ng·mL-1;the main PK parameters of tenofovir were as follows:Cmax were(7.30±2.27)and(7.12±1.74)ng·mL-1,AUC0-t of tenofovir were(237.16±47.09)and(230.06±43.41)h·ng·mL-1,respectively.The test product and the reference product under fed study,the main PK parameters of tenofovir were as follows:Cmax were(197.69±82.19)and(197.10±110.54)ng·mL-1;AUC0-t were(197.69±82.19)and(197.10±110.54)h·ng·mL-1;the main PK parameters of tenofovir were as follows:CMax were(2.57±1.37)and(2.58±1.31)ng·mL-1;AUC0-t were(227.08±74.33)and(238.51±128.30)h·ng·mL-1,respectively.The 90%confidence interval for geometric mean ratio of Cmax,AUC0-tof T and R under fed condition were between 80.00%-125.00%,respectively.The incidence of adverse events in fasting and fed tests was 21.43%and 30.95%,respectively,and no serious adverse event was reported.Conclusion The test formulation and reference formulation of tenofovir alafenamide fumarate tablets were equivalent and was safe.
8.Prognostic factors of patients with muscle invasive bladder cancer with intermediate-to-high risk prostate cancer
Junyong OU ; Kunming NI ; Lulin MA ; Guoliang WANG ; Ye YAN ; Bin YANG ; Gengwu LI ; Haodong SONG ; Min LU ; Jianfei YE ; Shudong ZHANG
Journal of Peking University(Health Sciences) 2024;56(4):582-588
Objective:To investigate the prognostic factors for all-cause mortality in patients with muscle-invasive bladder cancer(MIBC)with intermediate-to-high-risk primary prostate cancer.Methods:From January 2012 to October 2023,the clinical data of the patients with MIBC with intermediate-to-high-risk primary prostate cancer in Peking University Third Hospital were retrospectively analyzed.All the patients were monitored and the occurrence of all-cause death was documented as the outcome event in the prognostic study.Univariate and multivariate Cox proportional risk regression analysis models were implemented to search for independent influences on the prognosis of patients.For significant influencing factors(pathological T stage,M stage and perineural invasion of bladder cancer),survival curves were plotted before and after multifactorial Cox regression adjusting for confounding factors.Results:A total of 32 patients were included in this study.The mean age was(72.5±6.6)years;the median preoperative total prostate specific antigen(tPSA)was 6.68(2.47,6.84)μg/L;the mean preoperative creatinine was(95±36)μmol/L,and the median survival time was 65 months.The majority of the patients(87.5%)had high-grade bladder cancer,53.1%had lymphatic invasion,and 31.3%had perineural invasion.Prostate involvement was observed in 25.0%of the cases,and the positive rate of soft-tissue surgical margin was 37.5%.Multivariate Cox analysis revealed that preoperative creatinine level(HR=1.02,95%CI:1.01-1.04),pathological stage of bladder cancer T3(HR=11.58,95%CI:1.38-97.36)and T4(HR=19.53,95%CI:4.26-89.52)metastasis of bladder cancer(HR=9.44,95%CI:1.26-70.49)and perineural invasion of bladder cancer(HR=6.26,95%CI:1.39-28.27)were independent prognostic factors(P<0.05).Survival curves with Log-rank test after adjusting for confounding factors demonstrated that bladder cancer pathology T3,T4,M1,and perineural invasion were unfavorable factors affecting the patients'survival prognosis(P<0.05).Conclusion:Patients with MIBC with intermediate-to-high risk primary prostate cancer generally portends a poor prognosis.High preoperative serum creatinine,T3 or T4 pathological stage of bladder cancer,metastasis of bladder cancer and bladder cancer perineural invasion are poor prognostic factors for patients with MIBC with intermediate-to-high risk primary prostate cancer.
9.Effect of minocycline on polarization of types M1/M2 microglia in spinal cord in rats after spinal nerve ligation
Zhihong CHENG ; Song FENG ; Xia WANG ; Ruinan NI ; Yang GUO ; Yu XIANG ; Zhengwei YANG ; Bin PENG
Journal of Army Medical University 2024;46(15):1740-1750
Objective To investigate the effect of minocycline(Mino)on the polarization of types M1/M2 microglia(pro-and anti-inflammatory type)in the spinal dorsal horn of rats with neuropathic pain(NP)induced by spinal nerve ligation(SNL)and its underlying mechanism.Methods A total of 36 adult male SD rats were randomly stratified into Sham-operation(Sham)group,SNL group and Mino+SNL group by stratified random sampling based on body weight.Mechanical pain threshold and cold nociceptive thresholds of rat hind paw were measured in 1 d before and 14 d after modelling.Spinal cord tissue at the lumbar 5(L5)segment was taken at 14 d after modelling,and the total number of microglia as well as the numbers of M1 and M2 microglia in the spinal dorsal horn were measured with immunohistochemistry and stereology.With aid of bioinformatics techniques,the core target in the spinal cord,Cst7,was selected.Then,the protein levels of microglia marker Iba-1,M1 microglia marker iNOS,M2 microglia marker CD206,Cst7 encoded protein cystatin F(CF)and pathway CatS/CX3CL1/CX3CR1 were detected with Western blotting.The expression levels of TNF-α,IL-6 and IL-10 in the spinal cord tissues were measured with ELISA.Results The mechanical pain and cold nociceptive thresholds were both significantly higher in the M+SNL group than the SNL group at 7~14 d after modelling(P<0.01).The total number of microglia and the numbers of M1/M2 microglia in the spinal dorsal horn as well as the expression levels of CatS,CX3CL1,CX3CR1,TNF-α,IL-6,and IL-10 in the spinal cord tissues were obviously increased,and the expression level of CF was notably decreased in the SNL model group than the Sham group(P<0.01).While,Mino treatment remarkably reversed above phenomena,with decreased total number of microglia and number of M1 microglia as well as expression levels of CatS,CX3CL1,CX3CR1,TNF-α and IL-6,and increased number of M2 microglia as well as CF and IL-10 levels when compared with the SNL group(P<0.05).Conclusion Mino alleviates SNL induced neuropathic pain,probably through up-regulating CF in the microglia,and thus inhibiting the CatS/CX3CL1/CX3CR1 signaling pathway,promoting the conversion of microglia from type M1 to M2 to balance the imbalance in the M1/M2 polarization,and thus reducing neuroinflammation.
10.A real-world study of first-line albumin-bound paclitaxel in the treatment of advanced pancreatic cancer in China
Juan DU ; Xin QIU ; Jiayao NI ; Qiaoli WANG ; Fan TONG ; Huizi SHA ; Yahui ZHU ; Liang QI ; Wei CAI ; Chao GAO ; Xiaowei WEI ; Minbin CHEN ; Zhuyin QIAN ; Maohuai CAI ; Min TAO ; Cailian WANG ; Guocan ZHENG ; Hua JIANG ; Anwei DAI ; Jun WU ; Minghong ZHAO ; Xiaoqin LI ; Bin LU ; Chunbin WANG ; Baorui LIU
Chinese Journal of Oncology 2024;46(11):1038-1048
Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P<0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.


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