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.Improvement of Quality Standard for Mongolian Medicine Artemisia sacrorum
Xiaohong YUAN ; Kejian PANG ; Hui TANG ; Hong ZHANG ; Feng WEI ; Lele LIU ; Guozhen JIANG
China Pharmacy 2021;32(5):536-541
OBJECTIVE:To improve the quality standard of M ongolian med icine Artemisia sacrorum ,and to provide scientific basis for comprehensive quality evaluation. METHODS :The appearance and microscopic characteristics of A. sacrorum were identified;scopoletin,chlorogenic acid ,caffeic acid ,scopoletin and 3,5-dicaffeoylquinic acid were identified quantitatively by TLC;the contents of above 5 components were determined by HPLC. The water content ,total ash and extract were examined. RESULTS:The stem of A. sacrorum was cylindrical ,and its surface was purple or purple-brown or cyan-brown ;the leaves were ovate or oblong-ovate ,fragrant;the flowers were yellow ,head-shaped,subglobose or hemispherical. The powder was green or yellow-green,its pollen grain had three germination ;the parenchymal cell clusters with sharp edges and numerous threaded ducts , occasionally having marginal pitted ducts ;its wood fibers were in bundles mostly. Results of TLC showed that the spots of the same color were found in the corresponding positions of chromatogram for 5 substance control and samples. The linear range of scopoletin, chlorogenic acid , caffeic acid , scopolactone and 3,5-dicaffeoylquinic acid were 85.60-428.00, 10.16-101.60, 10.20-102.00,40.84-408.40 and 40.80-408.00 μg/mL(all r>0.999 0). RSDs of precision ,stability,repeatability tests were all less than 3.00%(n=6). The average recoveries were 103.07%,99.66%,98.37%,97.78%,98.40%(all RSDs <3.00%,n=6). The contents of the above-mentioned 5 compounds in 10 batches of samples were 0.36%-1.23%,0.09%-0.51%,0.04%-0.13%, 0.61% -1.13% ,0.12% -1.11% ,respectively;the average com contents of water ,total ash and water soluble extract were 6.25%,5.86%,26.50%,respectively. CONCLU SIONS:O the basis of the original quality standard of A. sacrorum , microscopic identification,TLC identification ,content determination and examination items of water ,total ash and extract are added. The method shows good precision ,accuracy and stability ,which can provide reference for more scientific and standardized evaluation of the quality of this medicinal material.
5.Prevalence investigation of solitary plasmacytoma in China: A calculation based on national urban medical insurance in 2016
Lu XU ; Yang LIU ; Xuefeng LAI ; Jingnan FENG ; Guozhen LIU ; Siyan ZHAN ; Xiaojun HUANG ; Shengfeng WANG ; Jin LU
Chinese Journal of Hematology 2020;41(6):451-455
Objective:The aim of this study is to analyze the distribution features of patients with solitary plasmacytoma and calculate the prevalence of solitary plasmacytoma in China in the year 2016.Methods:This study was based on China’s urban employees’ basic medical insurance and the urban residences’ basic medical insurance from 21 provinces from January 1, 2016 to December 31, 2016. Patients with solitary plasmacytoma were identified by disease names and codes. Subgroup analyses were carried out by sex, region, and age. Furthermore, sensitivity analyses were performed to test the robustness of the results. Age-adjusted prevalence was calculated based on the 2010 Chinese census data, the 2013 Revised European Standard Population, the 2010 US population, and the 2011 Australian population.Results:In 2016, the prevalence of solitary plasmacytoma in China was 1.18 per 100 000 population (95% CI, 1.06-1.31) , with 1.26 per 100 000 population (95% CI, 1.10-1.43) and 1.10 per 100 000 population (95% CI, 0.93-1.29) for males and females, respectively. The age-adjusted prevalence based on the 2010 Chinese census data was 0.85 per 100 000 population (95% CI, 0.82-0.88) . Conclusion:This study estimated the prevalence of solitary plasmacytoma in China on the basis of the national urban medical insurance, which can provide clues for the enactment of solitary plasmacytoma-related medical policies and basic studies about solitary plasmacytoma.
6.Effect of body composition on dialysis quality(Kt/V): a single center study
Guocun HOU ; Hua GAN ; Xiuli SUN ; Jing LI ; Aizhen CHEN ; Qiang WEN ; Aiying LIU ; Guozhen FENG ; Haixia YAN ; Huixia LI
Chinese Journal of Nephrology 2018;34(6):418-423
Objective To investigate the relationship between body composition and adequacy of dialysis,and analyze the related risk factors for inadequate delivery of hemodialysis.Methods In a prospective clinical trial,two different methods determining dialysis dose were simultaneously applied:Kt/Vdau (conventional method with Daugirdas' formula) and Kt/Vbem [online clearance monitoring (OCM) measurement with Ⅴ measured by body composition monitor (BCM)].Using the value of 1.27 as the boundary,the patients were divided into two groups:Kt/Vbcm < 1.27 group and Kt/Vbcm≥ 1.27 group.Clinical indices were compared between the two groups.Multiple linear regression was applied to analyze the potential impact factors of the difference between Kt/V values calculated by the two methods.Receiver operator characteristic (ROC) curve was applied to analyze meaningful factors.Results A total of 138 maintenance hemodialysis patients with age of (54.9±12.7) years old were enrolled,and 55.1% of them were males.There was no significant difference between Kt/Vdau and Kt/Vbcm [1.432(1.235,1.718) vs 1.434 (1.244,1.642),P=0.823].Kt/Vdau was incidentally prone to falsely high values due to operative errors,whereas in these cases OCM-based measurement Kt/Vbcm delivered realistic values.An excellent correlation was observed between Kt/Vdau and Kt/Vbcm;the mean difference was 0.07,95%CI (-0.66-0.79);the correlation coefficient was 0.842(0.821-0.862).The patients in Kt/Vbcm≥ 1.27 group had older age,lower body mass index (BMI),lower height and weight,lower total body water (TBW),lower extracellular water,lower intracellular water,and lower lean tissue index (LTI) compared to those in Kt/Vbcm < 1.27 group.Excellent correlations were observed between Kt/Vbcm and TBW or LTI (r=-0.834,P < 0.001;r=-0.721,P < 0.001).ROC curve analysis showed that the sensitivity and specificity of predicting inadequate delivery of hemodialysis were 87.1% and 86.5%,with a threshold of 30 L for TBW.It also showed that the sensitivity and specificity of predicting inadequate delivery of hemodialysis were 60.4% and 94.6%,with a threshold of 11.05 kg/m2 for LTI.Conclusions BCM can give more accurate parameters of urea distribution volume,thus modifying the result of Kt/V.TBW and LTI are important risk influencing factors for inadequately dialysis,and special attention should be paid to patients with TBW > 30 L or LTI > 11.05 kg/m2.
7. Follow-up study of 116 cases of transjugular intrahepatic portosystemic shunt in the treatment of cirrhotic portal hypertension
Manhua LIU ; Feng ZHOU ; Xiaobing WANG ; Liping CHEN ; Guozhen LI ; Qiu ZHAO
Chinese Journal of Hepatology 2018;26(8):596-600
Objective:
To investigate the incidence rate of transjugular intrahepatic portosystemic shunt (TIPS) complications in the treatment of cirrhotic portal hypertension, and analyze the cause of complication to management methods.
Methods:
Data of 116 patients obtained from Zhongnan Hospital of Wuhan University were retrospectively analyzed. Portal venous pressure, routine blood test, coagulation test, liver and kidney function test, ammonia blood test, imaging and endoscopy reports were collected before and after procedure. The incidence rate of hepatic encephalopathy, gastrointestinal bleeding, ascites and shunt dysfunctions were observed. Data were expressed as mean ± Standard deviation and analyzed by t-test. A chi-squared test was used for comparison between categorical variables.
Results:
The success rate of TIPS operation was 97.41% (113/116). Two patients underwent prompt TIPS procedure due to active bleeding. Bleeding was successfully stopped. Portal venous pressure of 113 patients decreased from (42.73 ± 7.64) cmH2O to (24.92 ± 7.60) cmH2O, and the difference was statistically significant (
8. Initiation, development, and achievements of burn rehabilitation therapy in China
Zhenrong GUO ; Feng LI ; Haixia TU ; Guozhen GAO ; Xiaolin CUI ; Bo ZHANG ; Changhong LU ; Ping ZHANG
Chinese Journal of Burns 2018;34(12):835-839
Burn rehabilitation in China started from compression therapy in the mid-1970s, which showed the dual effects of prevention and treatment of hypertrophic scars. It not only promoted functional rehabilitation but also strengthened the confidence of patients in rehabilitation treatment. Thereafter, more therapies were brought into practice, such as intra-scar injection of triamcinolone acetonide, application of plastic splints, hydrotherapy, exercises with equipment, skin care, local therapeutic massage, active and passive exercises, as well as external use of drugs for inhibiting scars and pigments. Since the beginning of the 21st century, rehabilitation therapies have been gradually increasing. Psychological rehabilitation, occupational therapy, external use of silicone gel, wax therapy and sound, light, electricity, and radiation therapy have been carried out. Many hospitals have established foundations and held summer camps for children. As far as the whole country is concerned, compared with the huge demand, we still face a number of problems such as shortage of working staff, limited working space, capital chain rupture, lack of multi-disciplinary cooperation, untimely treatment, and incomplete rehabilitation. Nowadays, with increasing knowledge of burn rehabilitation and number of practitioners, improvement of equipment and economic situation, the pace of rehabilitation has accelerated, and the overall implementation of burn rehabilitation therapy has shown great vitality. Patients with burn injury involving over 80% total burn surface area (TBSA) of total burn area or full-thickness burn over 60% TBSA were cured and recovered in different levels of hospitals nationwide, which not only reflects the superb level of burn treatment in China but also reflects the overall improvement of rehabilitation level of the country.
9.The clinical significance of the injury and functional change of hypothalamic-pituitary-adrenal axis after acute severely traumatic brain injury in the rats
Zhongzhen CHEN ; Sirong WU ; Weihua LING ; Xiangdong LI ; Lidong SHAN ; Jun WANG ; Feng XU ; Guozhen HUI
Chinese Journal of Emergency Medicine 2012;(12):1308-1313
Objective To study the clinical significance of the injury and functional change of hypothalamic-pituitary-adrenal (HPA) axis after acute severe traumatic brain injury (TBI) in the rats.Methods A total of 60 adult healthy male Spraque-Dawley rats were randomly (random number) divided into 3 groups (n =20 in each group):sham operation group,model group and treatment group.The TBI models of rats were established by Feeney' s method.A low dose of dexamethasone (0.6 mg/kg) was injected into the abdominal cavity 20 minutes,24 hours and 48 hours after injury in treatment group,while rats of sham operation group and model group received equal volume of normal saline instead.All the rats were injected 1 μg adrenocorticotropic hormone (ACTH) into the abdominal cavity.The related parameters were detected at four time points,3 hours,12 hours,24 hours and 72 hours after cerebral contusion.The plasma corticosterone (CORT) and ACTH levels were measured by chemiluminescence.The hypothalamic,pituitary and adrenal of the rats were taken out for observing interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) expression detecting by immunohistochemical techniques at 72nd hour after TBI.One-way ANOVA and SNK-q test were used to analyze the results with SPSS 17.0 software package.Results The levels of ACTH and CORT on 3rd hour of model group raised remarkably compared with that of sham operation group,then they reduced gradually.The levels of CORT were lower than that of sham operation group at every time points after ACTH stimulation test (P <0.05 or P <0.01).The levels of CORT at all time points of treatment group were changed remarkably compared with that of model group.However,the ACTH levels of treatment group on 24 h increased slightly than that of model group.And the tendency of them was similar to model group (P < 0.05 or P < 0.01).The number of the hypothalamus and pituitary cells which express IL-6 and TNF-α in model group was more significantly increased when compared with that in sham operation group (P < 0.01),while the number of this kind of cell in treatment group was significantly decreased than that in model group (P < 0.01).The number of the adrenal cortex cells which express IL-6 in treatment group was more significantly decreased when compared with that in model group (P< 0.01),while the number of this kind of cell in model group was significantly increased than that in sham operation group (P < 0.01).However,there was no significant difference of the TNF-α between all the groups (P > 0.05).Conclusions Functional change of adrenal occurs early in the severe acute traumatic brain injury rats,and the response of adrenal to ACTH decreased as time goes by.Low-dose,short-course dexamethasone can delay the pathological changes,reduce the inflammatory response of HPA axis and increase the sensitivity of adrenal response to ACTH.
10.Diagnosis value of immunophenotype and karyotypes in the de novo chronic lymphocytic leukemia
Jixia QIN ; Meiyun FANG ; Guozhen SUN ; Hongju PENG ; Guang SUN ; Yuejian LIU ; Yuan JING ; Feng JIANG
Journal of Leukemia & Lymphoma 2012;21(11):681-683,696
Objective To investigate the diagnosis value of immunophenotype and karyotypes in newly diagnosed chronic lymphocytic leukemia (CLL).Methods To retrospect the flow cytometry (FCM) immunophenotype and karyotypes characteristics in newly diagnosed 70 CLL cases.Results In all cases,the positive rates of CD19,CD20,CD5,CD23,CD22 were 100 %,88.5 % (54/61),77.1% (54/70),67.6 % (23/34)and 51.9 % (27/52),respectively.And 6 were misdiagnosed,2 was CD+5CD+19(+),but CD20,CD22 were strongly positive,final diagnosed as mantle cell lymphoma (MCL) by FISH t(11;14) examination and CyclinDl; CD+5CD+19(-) CLL were 16 cases (22.9 %),but 4 were misdiagnosed,the misdiagnosis rate was 25 %,significantly higher than that of CD+5CD+19(-) CLL (P =0.030).59 cases were examined by conventional cytogcnetic (CC),and 13 cases were with abnormal karyotypes,positive rate was 22.0 %,with complex karyotypes in 5 cases (8.5 %); 10 cases combined with FISH abnormalities karyotype examination rate was 60 %.Conclusion Typical CLL immunophenotypic characteristics were CD5,CD19,CD23 co-expression,and CD-5 CLL with higher misdiagnosis rate,combined with CD20 (,) CD22 expression and karyotype analysis helps to CLL and other B lymphoid proliferative diseases (B-LPD) identification.Conventional cytogenetic detection combined with FISH scan can improve the recognition ability of abnormal chromosome.

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