1.Explosion on the core outcome set (COS) in the clinical evaluation in the TCM clinical studies
Yanan SUN ; Changhe YU ; Wenqiang CHEN ; Xiaobo HUANG
International Journal of Traditional Chinese Medicine 2017;39(8):676-680
Recently, more systemic reviews and randomized controlled trials were published to prove the effectiveness of TCM,and some of those were included by Cochrane Library. But due to the potential selective reporting bias and publication bias, few trials were included in the meta analysis, which failed to prove the evidence for the TCM treatment. The difference of reported outcomes comes to the big problem of the comparison between interventions. Such problem of difference was gradually brought to the attention. Therefore, Core Outcome Sets(COS), which stands for that the minimum standardized outcome set that must be repoted, may be the solusion to that problem. In this research we've introduced the formation and development of core outcome sets in TCM.
2.Comparative Study of Criteria on Quality of Questionnaire Development and Psychometric Property Evaluation
Changhe YU ; Yanan SUN ; Liyun HE ; Baoyan LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2015;(6):1127-1135
This study was aimed to compare the criteria on quality of questionnaire development and psychometric property evaluation. The references listed in the ISOQOL and consequent included criteria were searched. Two reviewers independently screened papers to include articles with inclusion criteria as follows: fully evaluating the questionnaire development and/or psychometric property; published or unpublished, but not book. Two reviewers independently extracted the information which contained criteria name, types of questionnaire assessed, criteria purpose, research methods, content, evaluation method and etc. Qualitative analysis was conducted to synthesize common characteristics of criteria, and to compare what each criterion emphasized on. The results showed that 9 included criteria sharing the same purpose which evaluated the questionnaire development process and/or psychometric properties of the health related quality of life questionnaire or patient reported outcome. Experts consensus based on previous studies were the criteria development methods. The standard content included conceptual framework, targeted population, content validity, internal consistency, test-retest reliability, structure validity and responsiveness with interpretability. Assessment scoring system used in the criteria was categorized as 2- or 4-point Likert scales. Or document of evaluation evidence was required to be provided. It was concluded that nine criteria can be used to develop new questionnaires, evaluate existed/new questionnaires, or choose the right questionnaires for clinic, based on the following elements such as their research purpose, trials types, questionnaire types or questionnaire administrations.
3.Intrahepatic tracking of bone marrow-derived endothelial progenitor cells after transplanting into rats with liver fibrosis
Ling LAN ; Jing YU ; Ran LIU ; Bowei LIU ; Hao ZHANG ; Yuan YUAN ; Changhe JIA
Chinese Journal of Organ Transplantation 2012;(11):684-688
Objective To establish a method of PKH26 labeled bone marrow-derived endothelial progenitor cells (EPCs) into rats with liver fibrosis and observe cell immigration and differentiation in the liver after transplantation.Methods Bone marrow-derived EPCs were isolated and cultured from rats with liver fibrosis,and then labeled with PKH26 in vitro.Under the scanning confocal microscopy and flow cytometry,PKH26 fluorescent labeling rate and cell survival rate were measured.EPCs of PKH26 fluorescent labeling were transplanted into rats with liver fibrosis via the tail vein,and the migration situation was observed in the liver.Endothelial cell markers CD31 and von willebrand factor (vWF) were detected by using immunofluorescence.Results The PKH26-labeled EPCs appeared red fluorescence and the labeling rate was 96.65 %.As compared with unlabeled cells,the labeled cells grew well,and had no significant changes in the growth curve.After transplantation into the liver of rats,the PKH26 labeled cells were mainly distributed in blood vessel endothelium along fibers and hepatic sinusoids in hepatic lobule.Endothelial cell-specific antigens such as CD31 and vWF could be detected along the vascular walls.Conclusion PKH26 could be used to label and track EPCs in the liver of rats with liver fibrosis in vitro.The PKH26-labeled cells may migrate to the surrounding of the hepatic vessels and differentiate into mature endothelial cells.
4.Theoretical Exploration of Intervention Component Analysis(ICA)Identifying the Critical Features of Traditional Chinese Medicine Complex Interventions——Application of ICA on Tuina Treatment for Knee Osteoarthritis as an Example
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(8):2851-2857
Complex intervention of traditional Chinese medicine has the characteristics of individuality,dynamic and time space view.That how to implement process standardization,how to explain the mechanism of action of different interventions in complex treatment and how to establish the theoretical basis of the complex intervention become the key point of TCM complex intervention study.Intervention Component Analysis(ICA)is a qualitative Analysis technique to identify key characteristics of different interventions affecting outcome changes.It is suitable for situations where existing theories cannot explain the impact of Intervention schemes on outcome,or intervention information description is incomplete in methodological evaluation.ICA could not solve complex intervention in clinical trials of traditional Chinese medicine report fully and analyzes in-depth problems such as insufficient understanding,background factors,to assist the key feature of complex intervention affect curative effect of traditional Chinese medicine and its theoretical basis.In this paper,the application of ICA in the treatment of knee osteoarthritis by Tuina was explored,the evidence of the effectiveness of Tuina in the treatment of KOA was comprehensively compared,the characteristics of Tuina in the treatment of KOA were identified,and the mechanism of Tuina in the treatment of KOA was elucidated,and the key elements of Tuina in the treatment of KOA were clarified.Among them,the targeted areas,the purpose of treatment and the application of corresponding manipulations were the key factors affecting the efficacy.The strength of manipulations during treatment,the changes of the patient's condition and the risk factors after treatment were the key factors to maintain the efficacy and ensure the safety.However,the application of acupuncture points and complex traditional Chinese medicine prescriptions in ICA has not been carried out.Therefore,researchers need to further improve the ICA to suit the best conditions for the research and analysis of TCM interventions.Criticism and corrections from academic colleagues are welcome.
5.Neuraminidase gene profiling of influenza B virus in Shangrao
Yanyan ZHANG ; Yu LAI ; Lin ZHU ; Ying XIONG ; Jianxiong LI ; Changhe CHENG
Chinese Journal of Infection and Chemotherapy 2017;17(5):538-540
Objective To characterize the neuraminidase (NA) genes of influenza B virus in Shangrao.Methods The specimens of nasopharyngeal swabs were collected from patients with influenza-like symptoms in influenza sentinel hospital.Seven strains of influenza B virus were randomly selected for culture and isolation in Madin-Darby Canine Kidney Epithelial Cells (MDCK Line).Viral RNA was extracted.Fragments of NA genes were amplified by one-step RT-PCR and then were sequenced.The data obtained were analyzed with software DNAStar 6.0 and Mage 5.0.The deduced amino acid sequences were examined to explore the features ofNA gene.Results The NA gene showed high homology ofnucleotides between the 7 strains of influenza B virus.No amino acid substitution was found in catalytic or framework residues of the deduced amino acid sequences of NA gene.Conclusions All the 7 strains of influenza B virus were sensitive to neuraminidase inhibitors.However,ongoing resistance surveillance is necessary for control and prevention of influenza.
6.Expert consensus on the comprehensive individualized assessment and protocol of modern Gongting Lijinshu for nonspecific low back pain
Yanchao LIU ; Dianping JIA ; Hao JIANG ; Hai SHANG ; Changhe YU ; Changxin LIU
International Journal of Traditional Chinese Medicine 2018;40(6):486-489
On the basis of relevant literature, according to the clinical experience of Tuina specialists, a preliminary plan of Tuina for nonspecific low back pain has been formed. An expert consensus meeting was used to form a non-specific low back pain assessment program and 3 modern Gongting Lijinshu (Tuina massage) for the treatment of nonspecific low back pain. The treatment has showed to be clinically repeatable and suitable for the RCT study.
7.The expression and clinical significance of epithelial cell adhesion molecule and Claudin18 in gastric cancer
Changhe JIA ; Yi XIE ; Xiaoxia SONG ; Yuan YUAN ; Bowei LIU ; Jiabei XIE ; Jing YU
Chinese Journal of Geriatrics 2019;38(6):649-653
Objective To investigate the expression and clinical significance of epithelial cell adhesion molecule(EpCAM) and Claudin-18 in gastric cancer.Methods Surgical specimens of gastric cancer were taken from 64 patients.The histological diagnostic criteria were based on WHO standards.Immunohistochemical staining was used to detect expression levels of EpCAM and Claudin-18 in all samples.The relationship between the expression of EpCAM and Claudin-18 and clinicopathological parameters of gastric cancer was analyzed.Correlations of the prognosis of gastric cancer patients with EpCAM and Claudin-18 expression were analyzed using the Cox proportional hazards regression model.Results The positive expression rate of EpCAM was elevated with the increase in tumor size and the occurrence of distant metastasis(x2 =4.526 and 36.090,P=0.033 and 0.000).There were significant differences in Claudin-18 protein expression among different age,TNM stage,growth pattern,depth of invasion and distant metastasis patients(all P<0.05).Cox regression model analysis showed that tumor size and distant metastasis were the main risk factors affecting the survival of patients with gastric cancer (RR =50.076 and 1.617,P =0.016 and 0.032),while levels of EpCAM and Claudin-18 were not independent risk factors (both P > 0.05).Conclusions EpCAM and Claudin-18 are closely related to the invasiveness of gastric cancer,but abnormally high levels of EpCAM and Claudin-18 are not independent risk factors for the prognosis of gastric cancer patients.
8.Factors influencing the outcomes of the traditional Chinese medicine percutaneous release treatment for the stenosal tendosynovitis
Changhe YU ; Tao LUO ; Zhiwen WENG ; Changxin LIU ; Yujie ZHAO ; Xiyou WANG ; Jing LIU ; Fu WANG ; Yang ZHANG
International Journal of Traditional Chinese Medicine 2018;40(4):314-318
Objective The aim of this study is to analyze the factors influencing the outcomes of the traditional Chinese medicine (TCM) percutaneous release treatment for the stenosal tendosynovitis. Methods A total of 119 eligible participants, from outpatient of Dongzhimen Hospital during June, 2014 to April, 2017, were included into the study. The participants received TCM percutaneous release treatment, and were followed-up and assessed outcomes at 27 w. Responders were defined as participants with normal movement in week 27 compared with the baseline period. The NRS assessment in both groups was described, and the baseline characteristics of participants potentially related to cure response were mainly analyzed using Logistic regression analysis. Results Cure group and non-cure group were determined according to the cure response. And the outcomes of pain relief along the timeframe showed the feasibility of criteria of cure response. The uni-factor Logistic regression analysis showed that the factors age,course of disease,interventions and pain severity were significantly different between the cure and non-cure groups,and the multi-factor Logistic regression confirmed the four factors influenced the cure response of the TCM percutaneous release treatment for the stenosal tendosynovitis. The cutting knife was 5.85 fold than the traditional needling knife at increasing the cure response (OR=5.853,95% CI 1.853-18.485;P=0.003).All the factors that age equal to or older than 60 years(OR=6.170, 95% CI 1.890-20.141; P=0.003), course of disease more than six months (OR=4.696, 95% CI 1.371-16.085;P=0.014)and pain severity from 6 to 7(OR=5.184,95% CI 1.416-18.975;P=0.013)were negatively associated with clinical response. Conclusions The patients with increasing age, long course of disease and distinct pain severity may be less likely to respond to the TCM percutaneous release treatment. These findings contribute to guiding clinical practice in terms of pretreatment patient selection. Further research is needed to confirm the association.
9.Expert consensus on the comprehensive individualized protocol of Tuina therapy for knee osteoarthritis
Lunxue QING ; Bin WANG ; Jiaqi LIU ; Duoduo LI ; Hao JIANG ; Xiaoming YANG ; Yanyan SUN ; Changxin LIU ; Xiyou WANG ; Changhe YU
International Journal of Traditional Chinese Medicine 2018;40(5):385-389
In order to form the expert consensus which researched on the comprehensive individualized protocol of Tuina therapy for Knee osteoarthritis, the preliminary protocol was summarized and formed by analyzing the interviews and published paper. And then the expert consensus method was applied for the protocols of Tuina therapy for KOA. After discussions, the consensus of three protocols according to the classification of KOA main symptomes was researched. In the protocols, 75%~80% of the entries were considered as strong recommendation, and the others were weak recommended. Thus, it is believed that the comprehensive protocols for the treatment of KOA with different Tuina manipulations is feasible and reproducible after standardization.
10.Blood-letting and herbal-cupping therapy for lumbar spinal stenosis: prospective case series study
Changxin LIU ; Xingzhi WANG ; Xiyou WANG ; Xu WANG ; Lunxue QING ; Zhiwen WENG ; Yuan LEI ; Dongdan PENG ; Xiaofang CHENG ; Changhe YU
International Journal of Traditional Chinese Medicine 2018;40(9):799-804
Objective The purpose of study was to evaluate the safety and effectiveness of theblood-letting and herbal-cupping therapy for lumbar spinal stenosis.Methods A multi-center prospective case series was performed.The LSS patients meeting the inclusion criteria received 8 treatments as a course and 4 courses in total.The primary outcomes were the symptom severity and physical function scale ofthe Swiss Spinal Stenosis Measurement (SSM,total score 0-5 for each domain).The secondary outcomes were thethe 12-item short form health survey (SF-12,total score 0-100),and Oswestry disability index (ODI,total score 0-100) at time of baseline,completion of last treatment of each course.The minimal clinically important differences (MCIDs) were calculated for estimating the percentage of improvement in the population.The adverse events were reported at any time of the intra-and post-operation.This was a phrase analysis of the studyat seven months.Results Forty-eight patientswere included,with 64.6% (31/48) of LSS showing neurogenic claudication (walking distance ≤200 m).The average age was 63.1 ± 11.7 years,19 (39.6%) female,and the average BMI was 25.3 ± 3.3 kg/m2.The scores of symptom severity scale of SSM were 2.8 ± 0.6,2.6 ± 0.7,2.3 ± 0.6,1.9 ± 0.2 at baseline,1st,2nd,3rd course,and the scores of physical function scale were 2.5 ± 0.8,2.4 ± 0.7,2.1 ± 0.5,1.8 ± 0.3,and all the changes between baseline and each course showed significant improvement.The patient satisfaction of SSM,ODI and SF-12 showed significantimprovements after the 1st,2nd,3rd course (P<0.05).The SF-12 subgroup physical composite scores after 3rd course and mental composite score after 1st showed no significant improvement.The minimal clinically important difference for the “SymptomSeverity scale” in the SSM was achieved withimprovement of 18.8%,40.6%,83.3% in the LSS patient population after 1st,2nd,3rd course;and the "physical function scale" in SSM was achieved withimprovement of 22.9%,31.3%,50.0%.A total of 15 patients felt pain when they were micro-punctured with little blood at first time,but the symptom wereimmediately relieved without any treatment.Conelusions The Blood-letting and herbal-cupping therapy could benefit patients with lumbar spinal stenosis after third course of treatment in the fields of symptom relief and quality of life with no severe adverse event.However,this was a phrase analysis,so more evidence of this study and large comparative researches should be warranted in future.