1.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.
2.Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
Guozhen ZHAO ; Ziheng GAO ; Chen ZHAO ; Huizhen LI ; Ning LIANG ; Bin LIU ; Qianzi CHE ; Haili ZHANG ; Yixiang LI ; Feng ZHOU ; He LI ; Bo LI ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):120-126
As a supplement to randomized controlled trials, observational studies can provide evidence for the effectiveness of traditional Chinese medicine (TCM) treatment measures. They can also study influencing factors of diseases, etiology, and prognosis. However, there is a confounding effect due to the lack of randomization, which seriously affects the causal inference between the study factors and the outcome, resulting in confounding bias. Therefore, identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory, confounding factors can be categorized into measured and unmeasured confounding factors. In addition, attention must be paid to identifying confounding factors and intermediate variables, as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors, measured confounding factors can be controlled by stratification, multifactor analysis, propensity scores, and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods, difference-in-difference methods, and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups, and confounding bias can be reduced. In addition, methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM, observational studies of TCM face unique challenges in identifying and controlling confounding factors, including the ever-changing TCM treatment measures received by patients, the often-overlooked confounding effects in the four diagnostic information of TCM, and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues, providing a methodological basis for conducting higher-quality TCM observational studies, so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
3.Reference values of carotid intima-media thickness and arterial stiffness in Chinese adults based on ultrasound radio frequency signal: A nationwide, multicenter study
Changyang XING ; Xiujing XIE ; Yu WU ; Lei XU ; Xiangping GUAN ; Fan LI ; Xiaojun ZHAN ; Hengli YANG ; Jinsong LI ; Qi ZHOU ; Yuming MU ; Qing ZHOU ; Yunchuan DING ; Yingli WANG ; Xiangzhu WANG ; Yu ZHENG ; Xiaofeng SUN ; Hua LI ; Chaoxue ZHANG ; Cheng ZHAO ; Shaodong QIU ; Guozhen YAN ; Hong YANG ; Yinjuan MAO ; Weiwei ZHAN ; Chunyan MA ; Ying GU ; Wu CHEN ; Mingxing XIE ; Tianan JIANG ; Lijun YUAN
Chinese Medical Journal 2024;137(15):1802-1810
Background::Carotid intima-media thickness (IMT) and diameter, stiffness, and wave reflections, are independent and important clinical biomarkers and risk predictors for cardiovascular diseases. The purpose of the present study was to establish nationwide reference values of carotid properties for healthy Chinese adults and to explore potential clinical determinants.Methods::A total of 3053 healthy Han Chinese adults (1922 women) aged 18-79 years were enrolled at 28 collaborating tertiary centers throughout China between April 2021 and July 2022. The real-time tracking of common carotid artery walls was achieved by the radio frequency (RF) ultrasound system. The IMT, diameter, compliance coefficient, β stiffness, local pulse wave velocity (PWV), local systolic blood pressure, augmented pressure (AP), and augmentation index (AIx) were then automatically measured and reported. Data were stratified by age groups and sex. The relationships between age and carotid property parameters were analyzed by Jonckheere-Terpstra test and simple linear regressions. The major clinical determinants of carotid properties were identified by Pearson’s correlation, multiple linear regression, and analyses of covariance.Results::All the parameters of carotid properties demonstrated significantly age-related trajectories. Women showed thinner IMT, smaller carotid diameter, larger AP, and AIx than men. The β stiffness and PWV were significantly higher in men than women before forties, but the differences reversed after that. The increase rate of carotid IMT (5.5 μm/year in women and 5.8 μm/year in men) and diameter (0.03 mm/year in both men and women) were similar between men and women. For the stiffness and wave reflections, women showed significantly larger age-related variations than men as demonstrated by steeper regression slopes (all P for age by sex interaction <0.05). The blood pressures, body mass index (BMI), and triglyceride levels were identified as major clinical determinants of carotid properties with adjustment of age and sex. Conclusions::The age- and sex-specific reference values of carotid properties measured by RF ultrasound for healthy Chinese adults were established. The blood pressures, BMI, and triglyceride levels should be considered for clinical application of corresponding reference values.
4.Application of ME-FICE combined with small ultrasound probe in the diagnosis of early gastric cancer and precancerous lesions
Wei HU ; Jiuyang LIU ; Xi CHEN ; Qin DENG ; Guozhen LI
China Medical Equipment 2024;21(8):65-69
Objective:To explore the application value of magnifying endoscope and flexible spectral imaging colour enhancement(ME-FICE)combined with small ultrasound probe in the diagnosis of early gastric cancer and precancerous lesions.Methods:A total of 80 patients with suspected gastric cancer who admitted to Wuhan Red Cross Hospital from April 2021 to April 2022 were selected,and the ME-FICE was used to distinguish positive and/or negative lesions,and then,small ultrasound probe with high-frequency were used to explore the depth of the infiltration of the lesions.After the examination,biopsy should be performed on the obvious position of lesion under FICE mode.The endoscopic mucosal resection(EMR),endoscopic submucosal dissection(ESD)or surgical resection were performed on the lesions according to the different intentions of the positive patients.The result of postoperatively pathological examination was the"gold standard"for diagnosis.Kappa consistency test was used to evaluate the consistency of benign and malignant diagnosis,the assessment of infiltration depth under endoscope and the assessment of infiltration depth after surgery between ME-FICE combined with small ultrasound probe and pathological examination.Results:The sensitivity,specificity and accuracy of ME-FICE combined with small ultrasound probe were respectively 90.63%,79.17%and 83.75%for benign and malignant diagnosis,which were at higher levels.The Kappa value of that was 0.887,which had favorable consistency with the result of biopsy for cases.The sensitivity,specificity and accuracy of ME-FICE combined with small ultrasound probe were respectively 66.67%,90.00%and 81.25%for the assessment of infiltration degree,indicating poor sensitivity and higher level of other indicators,with a Kappa value of 0.803,which had favorable consistency with postoperatively pathological results.Conclusion:ME-FICE combined with small ultrasound probe is suitable for the diagnosis of early gastric cancer and precancerous lesions,which can improve the sensitivity and accuracy of disease diagnosis,and more accurately assess the degree of infiltration before surgery,and provide guidance for subsequently surgical selection and treatment.
5.Association between volatile organic compounds and mortality risk of stroke
Siru YANG ; Lin HUANG ; Hang DONG ; Di LIU ; Zhou YANG ; Sujuan CHEN ; Guozhen LIN ; Boguang WANG ; Jun YANG
Chinese Journal of Epidemiology 2023;44(8):1216-1223
Objective:To investigate the effect of volatile organic compounds (VOCs) exposure in the atmosphere on the risk of daily death from stroke in Guangzhou.Methods:Daily average concentrations of twelve atmospheric VOCs, meteorological factors, and daily deaths for stroke and its subtypes (including ischemic and hemorrhagic stroke) in Guangzhou from 2020 to 2021 were collected. The time-series Poisson generalized additive model was established to analyze the relationship between daily average concentrations of atmospheric VOCs and daily mortality from a stroke on different lag days. The season, gender, and age group further performed stratification analysis.Results:Toluene and n-pentane were associated with a higher mortality risk from stroke and its subtypes. For each interquartile range ( IQR) increment in toluene concentration at lag0- 1 days, the RRs for mortality from stroke and hemorrhagic stroke were 1.060 (95% CI: 1.036-1.085) and 1.071 (95% CI: 1.030-1.113), respectively. For each IQR increment in n-pentane concentration, the RR for mortality from ischemic stroke was 1.064 (95% CI: 1.030-1.099). The effect estimates of VOCs may be higher during the cold season and among women and people aged ≥75 years. For each IQR increment in toluene concentration, the RRs for mortality risk of stroke in the cold season and women were 1.099 (95% CI: 1.056-1.143) and 1.085 (95% CI: 1.050-1.120), respectively. For n-pentane, the RR for death risk of stroke in people aged ≥75 years old was 1.072 (95% CI: 1.036-1.109). Results of sensitivity analysis showed that the effect estimates fluctuated less when PM 2.5 and O 3 were separately introduced for the two-pollutant model, as well as changing the degrees of freedom for covariates. Conclusions:This study suggests that VOCs may be an independent risk factor for daily mortality from stroke. Moreover, Toluene presented the most significant health impact.
6.Influence of character strengths of nursing interns on work engagement: a chain intermediary effect of perceived social support and professional identity
Chen LI ; Zhengyin DAI ; Guozhen SUN
Chinese Journal of Modern Nursing 2023;29(8):1097-1102
Objective:To explore the influence of character strengths of nursing interns on work engagement, and the chain intermediary effect of perceived social support and professional identity.Methods:From November to December 2021, 551 nursing interns from 4 ClassⅢ Grade A hospitals in Nanjing were selected by convenient sampling. The General Information Questionnaire, Three-dimensional Inventory of Character Strengths (TICS) , Perceived Social Support Scale (PSSS) , Professional Identity Scale (PIS) and Utrecht Work Engagement Scale (UWES) were used to investigate nursing students. A total of 551 questionnaires were distributed and 511 valid questionnaires were recovered, with a valid recovery rate of 92.74% (511/551) .Results:Among 511 nursing interns, the overall scores of character strength, perceived social support, professional identity and work engagement were higher than the theoretical median. Pearson correlation analysis showed that there were positive correlations between character strength, perceived social support, professional identity and work engagement ( r=0.293-0.666, P<0.01) . The intermediary effect analysis showed that character strength could positively predict work engagement, and the direct effect was 0.271, accounting for 48.57% of the total effect. The intermediary effect of perceived social support between character strength and work engagement was significant, and the indirect effect was 0.147, accounting for 26.34% of the total effect. The intermediary effect of professional identity between character strength and work engagement was significant, and the indirect effect was 0.048, accounting for 8.60% of the total effect. Perceived social support and professional identity had a significant chain intermediary effect between character strength and work engagement, with an indirect effect of 0.092, accounting for 16.49% of the total effect. The total indirect effect of character strength on work engagement was 0.287, accounting for 51.43% of the total effect. Conclusions:The chain intermediary effect of perceived social support and professional identity on the character strengths and work engagement of nursing interns is established. Helping nursing interns identify and use their character strengths, paying attention to the care measures for nursing interns, and scientifically constructing the professional identity training system can enhance the work input of nursing interns.
7.Status and influencing factors of participation in cardiac rehabilitation of cardiovascular nurses
Guozhen SUN ; Yunlan LU ; Yuan CHEN ; Ying WANG ; Li ZHU ; Guiying YOU ; Qi YE ; Jie WANG ; Yi ZHANG ; Guojie LIU ; Guihua HOU
Chinese Journal of Modern Nursing 2023;29(14):1827-1832
Objective:To explore the status and influencing factors of participation in cardiac rehabilitation of cardiovascular nurses.Methods:This is a cross-sectional study. From January to February 2022, a total of 3 047 cardiovascular nurses in members of China Cardiovascular Health Alliance were selected as research objects by convenience sampling method. General data questionnaire and Cardiovascular Nurses Participated in the Cardiac Rehabilitation Questionnaire (CNPCRQ) were used to investigate cardiovascular nurses. Multiple linear regression analysis was used to investigate the influencing factors of participation in cardiac rehabilitation of cardiovascular nurses. A total of 3 047 questionnaires were distributed in this study, and 2 704 valid questionnaires were effectively received, with an effective recovery rate of 88.74%.Results:The total score of CNPCRQ of cardiovascular nurses was (93.23±31.58), which was at a moderate level. Multiple linear regression analysis results showed that age, education, professional title, hospital location, hospital level, position type and hospital type were the influencing factors of participation in cardiac rehabilitation of cardiovascular nurses.Conclusions:The status of participation in cardiac rehabilitation of cardiovascular nurses in China needs to be improved. Role and job content of cardiovascular nurses should be further clarified, and cardiac rehabilitation knowledge and skills training should be strengthened in the future, so as to promote the profession development of cardiac rehabilitation and improve patients' health outcomes.
8.Aristolochic acids exposure was not the main cause of liver tumorigenesis in adulthood.
Shuzhen CHEN ; Yaping DONG ; Xinming QI ; Qiqi CAO ; Tao LUO ; Zhaofang BAI ; Huisi HE ; Zhecai FAN ; Lingyan XU ; Guozhen XING ; Chunyu WANG ; Zhichao JIN ; Zhixuan LI ; Lei CHEN ; Yishan ZHONG ; Jiao WANG ; Jia GE ; Xiaohe XIAO ; Xiuwu BIAN ; Wen WEN ; Jin REN ; Hongyang WANG
Acta Pharmaceutica Sinica B 2022;12(5):2252-2267
Aristolochic acids (AAs) have long been considered as a potent carcinogen due to its nephrotoxicity. Aristolochic acid I (AAI) reacts with DNA to form covalent aristolactam (AL)-DNA adducts, leading to subsequent A to T transversion mutation, commonly referred as AA mutational signature. Previous research inferred that AAs were widely implicated in liver cancer throughout Asia. In this study, we explored whether AAs exposure was the main cause of liver cancer in the context of HBV infection in mainland China. Totally 1256 liver cancer samples were randomly retrieved from 3 medical centers and a refined bioanalytical method was used to detect AAI-DNA adducts. 5.10% of these samples could be identified as AAI positive exposure. Whole genome sequencing suggested 8.41% of 107 liver cancer patients exhibited the dominant AA mutational signature, indicating a relatively low overall AAI exposure rate. In animal models, long-term administration of AAI barely increased liver tumorigenesis in adult mice, opposite from its tumor-inducing role when subjected to infant mice. Furthermore, AAI induced dose-dependent accumulation of AA-DNA adduct in target organs in adult mice, with the most detected in kidney instead of liver. Taken together, our data indicate that AA exposure was not the major threat of liver cancer in adulthood.
9.Prognostic value of pretreatment systemic immune-inflammation index and lactate dydrogenasein nasopharyngeal carcinoma
Fengge ZHOU ; Liting LIU ; Xiaodong HUANG ; Shiran SUN ; Xuesong CHEN ; Qiuyan CHEN ; Linquan TANG ; Haiqiang MAI ; Kai WANG ; Yuan QU ; Runye WU ; Ye ZHANG ; Qingfeng LIU ; Jianghu ZHANG ; Jingwei LUO ; Jianping XIAO ; Li GAO ; Guozhen XU ; Jingbo WANG ; Junlin YI
Chinese Journal of Oncology 2022;44(8):842-850
Objective:To evaluate the prognostic value of pretreatment systemic immune-inflammation index (SII) and lactate dehydrogenase (LDH) in non-metastatic nasopharyngeal carcinoma (NPC).Methods:We retrospectively collected the data of 839 patients with non-metastatic NPC from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital and Sun Yat-sen University Cancer Center between January 2007 and October 2015. All patients received intensity modulated radiation based treatment. Optimal cutoff value of SII and LDH were determined by X-title software. The association between SII, LDH and clinical prognosis of non-metastatic NPC patients were analyzed. Kaplan-Meier method was used for survival analysis, and Log rank test was used for comparison of survival rates between groups. Propensity score matching (PSM) analysis was carried out to minimize the effects of confounding factors. The risk stratification model of prognosis by combining N stage, SII and LDH was constructed to compare the prognosis of patients in high risk group, middle risk group and low risk group, and the receiver operating characteristic (ROC) curve analysis was used to evaluate its prognostic value.Results:The optimal cutoff value of SII is 447.2×10 9/L for predicting the 5-year overall survival (OS) of NPC patients, and the best cutoff value of LDH is 198.9 U/L. The proportion of patients with stage T3-4 and stage III-IVB in high SII group was higher than that in low SII group ( P<0.001). Multivariate Cox regression analysis showed that N stage, SII and LDH were independent factors of OS, progression-free survival (PFS) and distant metastasis-free survival (DMFS) of NPC patients (N stage, HR=1.705, 95% CI: 1.247-2.332; HR=1.755, 95% CI: 1.342-2.295; HR=2.161, 95% CI: 1.515-3.082. SII, HR=1.525, 95% CI: 1.097-2.119; HR=1.518, 95% CI: 1.150-2.004; HR=1.837, 95% CI: 1.272-2.653. LDH, HR=2.041, 95% CI: 1.403-2.968; HR=1.725, 95% CI: 1.233-2.414; HR=2.492, 95% CI: 1.690-3.672, respectively). After PSM, SII was still an independent prognostic factor of OS, PFS and DMFS in NPC patients ( HR=1.52, 95% CI: 1.09-2.12; HR=1.52, 95% CI: 1.15-2.00; HR=1.82, 95% CI: 1.26-2.63, respectively). Combined with N 2-3 stage, SII (>447.2×10 9/L), and LDH (>198.9 U/L), patients were divided into high-(3 risk factors), intermediate- (2 risk factors) and low-risk (0-1 risk factors) groups. The 5-year OS rates of patients in low-, intermediate- and high-risk groups were 86.1%, 79.8% and 41.2% respectively, the 5-year PFS rates were 80.7%, 70.2% and 33.9% respectively, and the 5-year DMFS rates were 88.9%, 79.2% and 47.5% respectively. There were significant differences in OS, PFS and DMFS among these three groups ( P<0.001). Distant metastasis was the main failure pattern in low-, intermediate- and high-risk groups, and the highest rate of distant metastasis was 83.3% (15/31) in high-risk group. ROC curve of the risk stratification model for predicting 5-year OS of NPC patients is 0.610, which is higher than TNM stage (0.609), SII (0.574) and LDH (0.558). Conclusions:Pretreatment SII and LDH are significantly correlated with the prognosis of patients with non-metastatic NPC. The combination of SII, LDH and N stage can stratify the prognostic risk of NPC patients. The risk stratification model can enhance the accuracy of prognosis.
10.Prognostic value of pretreatment systemic immune-inflammation index and lactate dydrogenasein nasopharyngeal carcinoma
Fengge ZHOU ; Liting LIU ; Xiaodong HUANG ; Shiran SUN ; Xuesong CHEN ; Qiuyan CHEN ; Linquan TANG ; Haiqiang MAI ; Kai WANG ; Yuan QU ; Runye WU ; Ye ZHANG ; Qingfeng LIU ; Jianghu ZHANG ; Jingwei LUO ; Jianping XIAO ; Li GAO ; Guozhen XU ; Jingbo WANG ; Junlin YI
Chinese Journal of Oncology 2022;44(8):842-850
Objective:To evaluate the prognostic value of pretreatment systemic immune-inflammation index (SII) and lactate dehydrogenase (LDH) in non-metastatic nasopharyngeal carcinoma (NPC).Methods:We retrospectively collected the data of 839 patients with non-metastatic NPC from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital and Sun Yat-sen University Cancer Center between January 2007 and October 2015. All patients received intensity modulated radiation based treatment. Optimal cutoff value of SII and LDH were determined by X-title software. The association between SII, LDH and clinical prognosis of non-metastatic NPC patients were analyzed. Kaplan-Meier method was used for survival analysis, and Log rank test was used for comparison of survival rates between groups. Propensity score matching (PSM) analysis was carried out to minimize the effects of confounding factors. The risk stratification model of prognosis by combining N stage, SII and LDH was constructed to compare the prognosis of patients in high risk group, middle risk group and low risk group, and the receiver operating characteristic (ROC) curve analysis was used to evaluate its prognostic value.Results:The optimal cutoff value of SII is 447.2×10 9/L for predicting the 5-year overall survival (OS) of NPC patients, and the best cutoff value of LDH is 198.9 U/L. The proportion of patients with stage T3-4 and stage III-IVB in high SII group was higher than that in low SII group ( P<0.001). Multivariate Cox regression analysis showed that N stage, SII and LDH were independent factors of OS, progression-free survival (PFS) and distant metastasis-free survival (DMFS) of NPC patients (N stage, HR=1.705, 95% CI: 1.247-2.332; HR=1.755, 95% CI: 1.342-2.295; HR=2.161, 95% CI: 1.515-3.082. SII, HR=1.525, 95% CI: 1.097-2.119; HR=1.518, 95% CI: 1.150-2.004; HR=1.837, 95% CI: 1.272-2.653. LDH, HR=2.041, 95% CI: 1.403-2.968; HR=1.725, 95% CI: 1.233-2.414; HR=2.492, 95% CI: 1.690-3.672, respectively). After PSM, SII was still an independent prognostic factor of OS, PFS and DMFS in NPC patients ( HR=1.52, 95% CI: 1.09-2.12; HR=1.52, 95% CI: 1.15-2.00; HR=1.82, 95% CI: 1.26-2.63, respectively). Combined with N 2-3 stage, SII (>447.2×10 9/L), and LDH (>198.9 U/L), patients were divided into high-(3 risk factors), intermediate- (2 risk factors) and low-risk (0-1 risk factors) groups. The 5-year OS rates of patients in low-, intermediate- and high-risk groups were 86.1%, 79.8% and 41.2% respectively, the 5-year PFS rates were 80.7%, 70.2% and 33.9% respectively, and the 5-year DMFS rates were 88.9%, 79.2% and 47.5% respectively. There were significant differences in OS, PFS and DMFS among these three groups ( P<0.001). Distant metastasis was the main failure pattern in low-, intermediate- and high-risk groups, and the highest rate of distant metastasis was 83.3% (15/31) in high-risk group. ROC curve of the risk stratification model for predicting 5-year OS of NPC patients is 0.610, which is higher than TNM stage (0.609), SII (0.574) and LDH (0.558). Conclusions:Pretreatment SII and LDH are significantly correlated with the prognosis of patients with non-metastatic NPC. The combination of SII, LDH and N stage can stratify the prognostic risk of NPC patients. The risk stratification model can enhance the accuracy of prognosis.

Result Analysis
Print
Save
E-mail