Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
ObjectiveTo observe and analyze the multimodal imaging characteristics of fundus in patients with idiopathic retinal vasculitis, aneurysms and neuroretinitis (IRVAN) syndrome. MethodsA retrospective study. From June 2015 to March 2024, 6 patients (11 eyes) diagnosed with IRVAN syndrome in Shaanxi Eye Hospital were included in the study. All patients underwent examinations including best-corrected visual acuity (BCVA), color fundus photography, fluorescein fundus angiography (FFA), optical coherence tomography (OCT) and OCT angiography (OCTA). At the same time, FFA combined with indocyanine green angiography (ICGA) was performed in 6 eyes. Follow-up ranged from 2 to 23 months. Multimodal imaging features were analyzed retrospectively. The number of retinal aneurysms detected by FFA, ICGA, and OCTA was compared by using the Wilcoxon signed-rank test. ResultsIn 11 eyes of 6 cases, a total of 1 male (2 eyes) and 5 females (9 eyes) with the mean age of (31.67±12.91) years were included in this cohort. Color fundus photography showed clear optic disc boundaries in 5 eyes, optic disc aneurysms in 8 eyes, retinal aneurysms in 4 eyes; exudation in 9 eyes, localized around aneurysms. On OCT, vitreous high reflective dots and epiretinal membrane on optic disc in all 11 eyes, and macular epiretinal membrane in 3 eyes were revealed. FFA showed optic disc aneurysms and retinal aneurysms in 9 eyes, late optic disc hyperfluorescence in 11 eyes; local arterial leakage in 3 eyes, local venous leakage in 8 eyes, non-perfusion area in all 11 eyes, and retina neovascularization in 3 eyes. Optic disc aneurysms and retinal aneurysms in 5 eyes (total 18 aneurysms) on ICGA were shown compared with optic disc aneurysms in 4 eyes and retinal aneurysms in 5 eyes (total 13 aneurysms) on simultaneous FFA. OCTA revealed neovascularization on the optic disc in 2 eyes, optic disc aneurysmsin 8 eyes, retinal aneurysms in 1 eye (total 2 aneurysms); while on simultaneous FFA, optic disc aneurysms in 8 eyes and retinal aneurysms in 3 eyes (total 5 aneurysms) with no optic disc were displayed. During OCTA follow-up, new aneurysms appeared at the bifurcation of arteries with an increasing angle between them and non-perfusion area enlargement on FFA. Compared with FFA and ICGA, OCTA in detecting the number of aneurysms had no statistics significance (Z=−1.342, −1.342; P＞0.05). ConclusionMultimodal imaging can demonstrate characteristics of IRVAN syndrome, ICGA provides superior visualization of optic disc and retinal aneurysms, while OCTA confirms optic disc neovascularization and enlargement of artery angles at arterial bifurcations.
Objective To observe the clinical characteristics of idiopathic retinal vasculitis, aneurysms, and neuroretinitis (IRVAN) syndrome. Methods The clinical data of 3 patients with IRVAN syndrome which were diagnosed by systemic examination, fundus photography and fundus fluorescein angiography (FFA) were retrospectively analyzed. Results Idiopathic retinal vasculitis, which was induced by retinal arterial inflammation, multiple macroaneurysms of optic disc and retinal vessels, edema of optic disc, and exudation around the optic disc, was found in all of the 3 patients, multiple arteriolar aneurysms of optic disc and retinal vascular and exudative neuroretinitis. Two patients had peripheral retinal vascular nonperfusion area, which belonged to typical IRVAN syndrome. Conclusions The clinical characteristics of IRVAN syndrome include idiopathic retinal vasculitis which only involved in artery, multiple retinal macroaneurysms which located on the dissepiment of optic disc and retinal artery, and the neuroretinitis induced by exudation of retina and optic disc because of vasculitis and aneurysms. (Chin J Ocul Fundus Dis, 2007, 23: 180-183)
ObjectivesTo systematically review the efficacy and safety of catheter-directed thrombolysis (CDT) versus anti-coagulation (AC) for deep vein thrombosis (DVT). MethodsWe searched PubMed, EMbase, The Cochrane Library, Web of Science, WanFang Data and CNKI databases to collect randomized clinical trials (RCTs) about CDT versus AC for DVT from inception to March 2018. Two reviewers independently screened literature, extracted data and evaluated the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. ResultsA total of 5 RCTs and 989 patients were included. Meta-analysis showed that there was no significant difference between the two group in incidence of post-thrombotic syndrome (RR=0.73, 95%CI 0.49 to 1.09, P=0.13), iliofemoral venous patency rate (RR=2.57, 95%CI 0.59 to 11.24, P=0.21), bleeding (RR=2.03, 95%CI 0.50 to 8.28, P=0.32), severe bleeding (RR=1.77, 95%CI 0.91 to 3.42, P=0.09) and recurrence rate of venous thromboembolism (RR=1.00, 95%CI 0.42 to 2.36, P=0.99). However, the incidence of moderate-severe PTS decreased in CDT group was lower than that in the control group (RR=0.70, 95%CI 0.53 to 0.92, P=0.01). ConclusionsCompared with the control group, catheter-directed thrombolysis does not reduce the incidence of PTS and VTE recurrence rate, cannot improve the long-term patency of the iliofemoral vein, yet can prevent the occurrence of moderate to severe PTS. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To investigate the characteristics of images of angiography in uveal effusion syndrome (UES). Methods The clinical data of fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) in 11 patients (17 eyes) with UES were retrospectively analyzed, and 4 patients (7 eyes) underwent angiography again 1 month to 28 months after segmental sclerectomy. Result The results of FFA and ICGA showed papilledema and venous tortuosity and dilation in 12 eyes, leakage spots at the post pole of ocular fundus in 2 eyes, leopard spots in 14 eyes, linear or meshy pigment stripes in 8 eyes. The results of ICGA showed uneven flecked hyperfluorescence lasted to later stage in 4 patients (5 eyes), a triangle hypofluorescence area at the inferior fundus in 1 eye, and a geographic pattern hypofluorescence at the posterior pole in 1 eye. Segmental sclerectomy was performed on 5 patients (8 eyes), and after surgery, cilia-choroidal detachment was gradually alleviated and even disappeared, the status of choroidal hyperpermeability was alleviated, and the leakage spots disappeared. The subretinal fluid increased in only 1 eye 2 years after the surgery. Conclusion The characteristics of aniography for UES are venous tortuosity and dilation, papilledema, leopard spots, and linear or meshy pigmentary stripes, which may deepen our understanding about the disease and help to diagnose it. (Chin J Ocul Fundus Dis, 2007, 23: 189-192)
Objective With reference to the method of operationalization of concept in the field of sociology, this study developed a methodological framework for intervention trials of Chinese medicine (CM) under the mode of syndrome dominating disease. Methods First, an operational definition of the syndrome dominating disease research model was clarified to provide the scope and direction of the methodological framework construction. Then a scoping review was conducted to identify the design features of clinical researches under the model to summarize the basic structure and content of the framework; furthermore, in-depth interviews were carried out to collect the views and suggestions of CM experts on this type of study, which added details to the framework. Finally, a survey was conducted to evaluate the rationality and feasibility of the methodological framework. Results A total of 74 studies were included and 12 CM experts were interviewed, and the results of the literature and interview study were synthesized to form a preliminary methodological framework. Thirty-two experts participated in the survey and most of them held a positive assessment of the rationality of the framework, then according to the experts’ suggestions, the final methodological framework which was a four-level structure with 25 items was established. Conclusion Following the internationally recognized methods and steps, this study develops a rational and feasible methodological framework for CM trials under the mode of syndrome dominating disease, which can provide references for future studies’ design, implementation and evaluation.
由于高血压的高患病率与高致残致死率, 已经成为我国重点防治的心血管疾病和社会普遍关注的重大公共卫生问题之一。大量流行病学、临床和基础研究已证实睡眠呼吸暂停低通气综合征( sleep apnea-hypopnea syndrome, SAHS) 与高血压发病和疗效关系密切[ 1-8 ] , 是高血压发生的主要病因之一, 由此“睡眠呼吸暂停相关性高血压”一词便应运而生[ 9-1 0] , 它是指由SAHS 引发和加重的高血压。本期刊载的“阻塞性睡眠呼吸暂停相关性高血压临床诊断和治疗专家共识”( 以下简称共识) , 为睡眠呼吸暂停相关性高血压的诊治提供了规范性的指导意见, 对推动我国该领域的防治水平有重要作用。我们期望“共识”能为读者认识和防治睡眠呼吸暂停相关性高血压提供必要的指导和帮助, 使我国为数众多的睡眠呼吸暂停相关性高血压患者得到规范的诊治。
Objective A series of N-of-1 trials were conducted to evaluate the effects of traditional Chinese medicine (TCM) individualized syndrome differentiation on stable bronchiectasis, and to explore a clinical trial method that is consistent with the characteristics of TCM. Methods The original plan consisted of 3 cycles, with each cycle consisting of two observation periods: experimental and control. Take the medication for 3 weeks each period and then stop for 1 week. Because the results were not as expected, another cycle of trials was added (a total of 4 cycles). The trial period was treated with individualized syndrome differentiation prescription and the control period was treated with placebo. The outcome measures were Likert scale score of general symptoms (primary outcome), Likert scale score of respiratory symptoms, CAT score, 24h sputum volume and TCM symptom score. Data analysis (including residual effects and stage effects analysis) used group-designed independent sample t tests, paired t tests or non-parametric tests, mixed effects models, and Bayesian analysis. Results A total of 31 participants were formally enrolled, with 24 completing all four cycles. Independent sample t-tests and mixed-effects models showed no significant period or carryover effects. Bayesian analysis showed that there were residual effects on some outcome measures of some individuals. Six participants showed statistically significant differences in overall symptom Likert scale scores (P<0.05). Bayesian analysis found that TCM was more effective than placebo in more individuals. No significant differences were found between individualized TCM and placebo at the group level for any of the outcome measures. Conclusion This study method highly simulates the clinical practice of TCM, with good operability and patient compliance, and has no obvious residual effect of TCM on the whole, which can provide the best individualized evidence-based medicine evidence of short-term efficacy of TCM. Bayesian analysis can improve the sensitivity of individual statistics.
Under the global background of the accelerated reconstruction of the smart healthcare ecosystem, artificial intelligence technology is deeply driving the transformation of the healthcare paradigm from experience-driven to data-knowledge dual-wheel driven. As a treasure of Chinese civilization, the core value of traditional Chinese medicine lies in the individualized diagnosis and treatment system based on "syndrome differentiation and treatment". The integration of multimodal diagnosis and treatment data and the construction of intelligent decision-making models will become the key path to break through the bottleneck of the modernization of traditional Chinese medicine. This research is based on the strategic orientation of "Healthy China 2030" and relies on the national science and technology major project of the team. It explores the establishment of a "three-stage four-dimensional" model of "data layer - knowledge layer - decision-making layer" and "feature extraction - relationship reasoning - dynamic correction - clinical verification" through a closed-loop verification mechanism of "human-machine collaboration - knowledge iteration", to promote the digital and intelligent transformation of traditional Chinese medicine.