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.Key Techniques and Methodological Considerations for Formation of Traditional Chinese Medicine Syndrome Classification Standards
Guozhen ZHAO ; Xingyu ZONG ; Xueyao ZHAO ; Huizhen LI ; Feng ZHOU ; Xuanling ZENG ; Jiahao LIN ; Ning LIANG ; Haili ZHANG ; Qianzi CHE ; Bin LIU ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):257-261
The classification of traditional Chinese medicine (TCM) syndromes is one of the core technical elements in the industry standard of Specification of Diagnosis and Therapeutic Effect Evaluation of Diseases and Syndromes in TCM. In the past,when clinical standards for TCM were formulated,the determination of TCM syndrome classification relied heavily on textbooks and expert experience,lacking systematic research. This approach thus failed to reflect the advancement and scientificity of the standards,thereby affecting their implementation and application. This article reviewed the presentation forms and technical methods of TCM syndrome classification,including the two-tier syndrome classification model with primary and secondary symptoms,as well as the application of modern literature research,ancient literature research,Delphi method,in-depth expert interviews,consensus conferences,and real-world research. When syndrome classification standards are developed,it is necessary to build upon modern literature research,adopt a mixed approach combining qualitative research and quantitative analysis results,and reach expert consensus through consensus conferences. Through systematic research,the scientificity,applicability,and coordination of TCM syndrome classification standards can be enhanced,providing guidance for the standardization of TCM.
4.Effect of hypertension and dyslipidemia on cognition of urban elderly residents
Yiyi ZHANG ; Changyu NI ; Ying JIN ; Yaping HE ; Nannan FENG
Journal of Shanghai Jiaotong University(Medical Science) 2024;44(7):907-914
Objective·To explore the effects of hypertension and dyslipidemia on cognitive function in the elderly.Methods·A dynamic population cohort was established by using prospective cohort study methods.In 2019,a complete cohort was selected from residents aged 65 and above who voluntarily participated in a free physical examination program in a community in Shanghai,serving as the baseline cohort.In 2022,512 community-dwelling elderly aged 67 to 93 were randomly selected from the same community as the follow-up cohort for the study.The collected date included residents' health records,various physical examination measurements,and Mini-mental State Examination(MMSE)scale scores.Results·Of the 512 cases that were followed up,the valid sample size was reduced to 495 after data cleaning.According to the baseline and follow-up cognitive assessments and changes,the cases were categorized into three cognitive groups:the improvement group,the normal group,and the decline group.The prevalence of hypertension in the decline group was 43.14%higher than that in the improvement group and 24.39%higher than that in the normal group(66.67%in the decline group vs 23.53%in the improvement group,P=0.011;66.67%in the decline group vs 42.28%in the normal group,P=0.040).Total cholesterol(TC)in the improvement group was lower than that in the normal group[improvement group(4.38±1.04)mmol/L vs normal group(5.11±1.12)mmol/L,P=0.009].Additionally,TC in the decline group in 2022 was higher than that in 2019[paired difference(0.46±0.87)mmol/L,95%CI 0.08?0.84,P=0.021].LDL-Ch in the improvement group was lower than that in the normal group[improved group(2.51±0.92)mmol/L vs normal group(3.07±1.00)mmol/L,P=0.024],and their HDL-Ch in 2022 was higher than that in 2019[paired difference(0.16±0.20)mmol/L,95%CI 0.06?0.26,P=0.005].The results of multinomial Logistic regression showed:TC in the improved group was lower than that in the normal group[β=4.12,OR=61.64,95%CI 1.52?2494.07,P=0.029]and the decline group[β=5.88,OR=357.35,95%CI 4.54?28149.75,P=0.008];the TAG[β=1.85,OR=6.34,95%CI 1.05?38.43,P=0.045],LDL-Ch[β=5.61,OR=274.06,95%CI 3.65?20567.57,P=0.011],and hypertension[β=1.90,OR=6.69,95%CI 1.53?29.16,P=0.011]in the decline group were higher than those in the improvement group;the age of the decline group was greater than that of the normal group[β=0.08,OR=1.08,95%CI 1.00?1.16,P=0.041],and the education level was lower than that of the normal group[β=1.22,OR=3.39,95%CI 1.28?8.94,P=0.014].Conclusion·Low TC and LDL-Ch and high HDL-Ch are beneficial to cognitive improvement.Conversely,hypertension,high TC,high TAG,high LDL-Ch,low education level,and advanced ages are risk factors for cognitive decline.
5.Application of specialist nurse sharing of Respiratory Medicine Department in transitional care of patients with chronic obstructive pulmonary disease under medical integration mode
Nannan CAI ; Shengxi MA ; Liwei SUN ; Quanmei FENG
Chinese Journal of Modern Nursing 2021;27(30):4078-4082
Objective:To explore effects of specialist nurse sharing of Respiratory Medicine Department in transitional care of patients with chronic obstructive pulmonary disease (COPD) under medical integration mode.Methods:Using the convenient sampling method, a total of 134 COPD patients who were hospitalized in Respiratory Department of Xinxiang Central Hospital were selected from October 2018 to October 2019. They were randomly divided into the control group and the observation group, with 67 cases in each group. The patients in the control group were given routine management after they were discharged from the hospital, while patients in the observation group were given specialist nurse sharing of Respiratory Medicine Department under medical integration mode for a period of 1 year after they were discharged from the hospital. BODE index, COPD Assessment Test (CAT) scale score, readmission rate and average length of hospital stay within 1 year were compared between the two groups.Results:After intervention, percent predicted of forced expiratory volume in first second (FEV1% Predicted) and Six-Minute Walk Test (6MWT) in the observation group were higher than those in the control group and higher than those before the intervention, and the differences were statistically significant ( P<0.05) . After the intervention, mMRC score, BODE index and CAT score of the observation group were lower than those of the control group and were lower than those before the intervention, and the differences were statistically significant ( P<0.05) . The readmission rate within 1 year of the observation group and the control group were respectively 23.88% and 49.25%, and the difference between the two groups was statistically significant ( P<0.05) . The average length of hospital stay within a year in the observation group was shorter than that in the control group, and the difference between the two groups was statistically significant ( P<0.05) . Conclusions:Transitional care for COPD patients using specialist nurse sharing of Respiratory Medicine Department under medical integration mode can effectively alleviate the condition, improve quality of life, reduce the readmission rate and shorten the average length of hospital stay.
6.Potential risk factors for mild cognitive impairment in the elderly population in communities of Shanghai
Yuqing TANG ; Jingyu TAN ; Xin HU ; Guangcheng HUANG ; Jiaye GONG ; Qing XU ; Huiyong CAI ; Yulan QIU ; Nannan FENG
Journal of Public Health and Preventive Medicine 2020;31(2):126-130
Objective To investigate the potential risk factors for mild cognitive impairment (MCI) in the elderly population in the community, and to provide a basis for the primary prevention of MCI. Methods A cross-sectional study of elderly population in communities of Shanghai, China was conducted. A total of 368 subjects including both males and females, aged 65-80 years old, were selected to complete the mini-mental state examination (MMSE), basic information questionnaires, and physical examinations. Logistic regression analysis was used to analyze the potential risk factors of MCI. Results Of the 368 subjects participating in the study, 53 were found to have MCI and the prevalence rate was 14.4%. Univariate analysis found that older age, low education, no folic acid supplementation, stroke, osteoporosis and hyperlipidemia were risk factors of MCI. Multiple logistic regression analysis showed that advanced age [OR=1.146 (95%CI: 1.052-1.249)] and osteoporosis [OR=2.371 (95%CI: 1.042-5.396)] were the independent risk factors for MCI, while higher education [OR=0.073 (95%CI: 0.011-0.478)] was a protective factor. Age influenced all the aspects of MMSE scores (all P values <0.05). In addition, the analysis of the results suggested that subjects with regular folic acid supplementation got higher MMSE scores, especially in the aspect of language and praxis (P=0.002). On the contrary, patients with osteoporosis had lower attention and computing power scores (P=0.022). Conclusion The prevalence of MCI increased with age. Low education and osteoporosis may be the independent risk factors for MCI in the elderly population. Although no association was observed between folic acid supplementation and MCI, folic acid supplementation could improve the performance of language and praxis.
7.Primary retroperitoneal liposarcoma surgery in combination of bowel resection, a report of 24 cases
Jun CHEN ; Nannan YAN ; Lili FENG ; Mengmeng XIAO ; Mei HUANG ; Xiaobing CHEN ; Chenghua LUO
Chinese Journal of General Surgery 2020;35(10):778-781
Objective:To evaluate primary retroperitoneal liposarcoma surgeries in combination with involved bowel resection .Methods:Clinical data of primary retroperitoneal liposarcoma patients admitted for surgery at Peking University International Hospital from Jan 2015 to July 2019 were retrospectively reviewed.Results:Twenty-four patients undergoing resectional surgeries combining with bowel resection were included for the study, of which 6 cases underwent right hemicolectomy, 8 did left hemicolectomy, 6 did sigmoidectomy, 2 did proctectomy and 8 did small bowel resection. The post operative morbidity was 38%. 2 of 24 had anastomotic fistula. There was no mortality. Final pathology disclosed well differentiated liposarcoma in 13 and dedifferentiated liposarcoma in 11 cases. 18 cases were confirmed with bowel infiltration pathologically. All patients were followed up after the surgery. After a median of 25 months following up, 8 cases developed recurrences and 3 deceased. Two-year overall survival and progression free survival probability were 91% and 71% respectively. Dedifferentiated liposarcoma as a pathological type was found as the only risk factor associated to poor progression free survival ( Z=2.02, P=0.042). Conclusion:Combining resection of primary retroperitoneal liposarcoma with involved bowel was relatively safe, with low morbidity, increasing tumor clearance. Dedifferentiated liposarcoma is associated wth poor prognosis.
8.Analysis of diagnosis and treatment of solid pseudopapillary neoplasm of pancreas in 12 children
Bo MENG ; Chun PANG ; Ruihua BAI ; Nannan SHAO ; Kai ZHANG ; Yuan GU ; Feng HAN
Chinese Journal of Applied Clinical Pediatrics 2018;33(8):598-601
Objective To analyze the experience in diagnosis and surgical treatment for solid pseudopapillary neoplasm(SPN) of pancreas in children.Methods A retrospective study was performed in 12 pediatric patients with SPN who had been admitted to Affiliated Cancer Hospital of Zhengzhou University during January 2004 to December 2016,and their general data,demographic data,types of operations,postoperative complications and follow-up were analyzed.Results Among the 12 patients,3 cases were male and 8 cases were female,with average age 14.3 years old (11-17 years old).The main clinical manifestations included abdominal pain(4/12 cases,33.3%),abdominal mass (2/12 cases,16.7%) and trauma(2/12 cases,16.7%).In those 12 patients,33.3% (4/12 cases) SPN was located at the head of the pancreas,and 66.7% (8/12 cases) at the body and tail of it.The tumors were usually large,the largest diameter ranged from 4.0 to 15.3 cm(average largest diameter,8.2 cm).The color uhrasonography indicated heterogeneous echogenic mass and clear boundary.CT scanning indicated that the tumor was a low-density cystic mass with a clear boundary,with enhanced tumor real component and irregular reinforcement.No calcification was found in the patients.Dynamic enhanced magnetic resonance imaging scan revealed gradual strengthening solid components in tumor.All the patients received surgical resection,with distal pancreatectomy in 4 patients,pancreaticoduodenectomy in 4 patients,spleen-preserving distal pancreatectomy in 2 patients,Enucleation in 1 patient,and distal pancreatectomy and self-splenic slices transplantation in 1 patient.Lymphadenectomy was performed in 4 patients,and all the 21 removed lymph nodes were all negative.Pathological diagnosis confirmed the SPN in all the patients,among them 3 cases were malignant SPN,and one of them with tumor rupture and hemorrhage.The mean follow-up duration was 57.7 months(19-156 months) and no recurrence was found.Conclusion SPN is a rare neoplasm in children who go to see doctors because of clinical symptoms.Surgical resection,especially organs-preserving resection,may improve the long-term results.
9.Infection in patients with acute leukemia during initial induction chemotherapy and its relation to therapeutic efficacy
Nannan ZHANG ; Ruijuan ZHANG ; Linhua YANG ; Yang CHEN ; Jing XU ; Feng XUE ; Bin YIN ; Feng GAO
Chinese Journal of General Practitioners 2017;16(12):937-940
Objective To analyze the infection features,risk factors,and the relationship with the efficacy in patients with acute leukemia during initial induction chemotherapy.Methods The clinical data of 200 patients with newly diagnosed acute leukemia from January 2015 to February 2016 in the Second Hospital of Shanxi Medical University were retrospectively analyzed.Results The infection rate of patients with acute leukemia under induction chemotherapy was 84.0% (168/200).Among 168 patients with infection,159 cases (94.6%) had known infection sites,the top three infection sites were the lungs,gastrointestinal tract and the oral cavity.Total 213 strains of pathogens were identified,Gram-negative bacilli accounted for 39.0% (n =83),Gram-positive cocci for 34.3% (n =73),fungi for 23.5% (n =50) and the virus for 3.3% (n =7).Multivariate regression analysis showed that agranulocytosis was the independent risk factor for acute leukemia patients during induction chemotherapy (OR =14.370,95% CI:2.576-116.518,P < 0.01).The rate of complete remission (CR) and CR with incomplete hematologic recovery (CRi) in infection group was 74.4% (125/168),and the rate of CR + CRi in non-infected group was 87.5% (28/32),and there was no significant difference between the two groups.(χ2 =2.564,P =0.109).Conclusion During the induction therapy for acute leukemia patients,the rate of infection and the rate of fungal infection are high;lung is the most common site,Gram-negative bacteria is more common;agranulocytosis increases the chance of infection;and the infection may not affect the disease remission rate.
10.Renal transplantation in patients with diabetes mellitus-induced end-stage nephropathy
Gongkuo QIU ; Wanling PEN ; Jia ZHENG ; Hecheng FENG ; Dongdong TANG ; Qiuju YIN ; Nannan LI ; Yaofang WANG
Chinese Journal of Organ Transplantation 2017;38(12):726-728
Objective To explore the clinical characteristics of renal transplantation in patients with diabetes mellitus (DM)-induced end-stage nephropathy.Methods The clinical data of 408 cases who underwent renal transplantation in our center from 2009 to 2013 were retrospectively analyzed.The patients were divided into DM group (n =82) and non-DM group (n =326).The postoperative infection,delayed graft function (DGF),adverse events,and the survival rate of patients/kidneys were comparatively analyzed.Results The incidence of postoperative infection,DGF and adverse events was significantly higher in DM group than in non-DM group (23.2% vs.15.6%,P =0.04;17.1% vs.8.6 %,P =0.04;13.4% vs.8.3 %,P =0.03).No significant difference was found in the 1-,2-,and 3-year survival rate of patients and kidneys between the two groups after operation (P> 0.05).Conclusion The incidence of postoperative infection,DGF and adverse events is higher in DM patients.The DM does not affect the survival rate of patients/kidneys through appropriate treatment.It is important to prevent complications in DM patients after renal transplantation.


Result Analysis
Print
Save
E-mail