ObjectiveA series of single-case randomized controlled trials (N-of-1 trials), with placebo Chinese herbs used as a control, were conducted to observe the efficacy of the syndrome differentiation treatment formula in the stable phase of bronchiectasis by using a modified mixed-effects model (MEM) to detect the "carryover effects" of Chinese herbs, and to explore the establishment of an N-of-1 trial method that reflects the characteristics of syndrome differentiation treatment in traditional Chinese medicine (TCM). MethodsA single-center clinical trial was conducted in which a single case was studied in a multiple crossover, randomized controlled, and blinded manner. There were three rounds of the trial, each with two observation periods (treatment period and control period) of 4 weeks each. In the treatment period, an individualized formula based on syndrome differentiation was given, and in the control period, a placebo formula was administered. The primary indicator was the patients’ self-rated 7-point symptom Likert scale score, and other indicators included chronic obstructive pulmonary disease assessment test (CAT) score, 24 h sputum volume, TCM syndrome score, and safety index. Paired t test was used to analyze single case data and MEM designed for "carryover effects" was used to analyze group data. ResultsA total of 21 subjects were formally enrolled, and 15 (75%) completed three rounds of N-of-1 trials. Three of the cases showed statistically significant differences in overall symptom Likert scale score. At the group level, the MEM designed for "carryover effects" found statistically significant residual effects on three indicators (overall symptom score, respiratory symptom score, and CAT score). After excluding the "carryover effects", the model analyzed the statistically significant differences between the intervention effects of the two formulas on the overall symptom score, respiratory symptom score, CAT score and TCM syndrome score. The sensitivity of the MEM was higher than that of the meta-analysis when residual effects existed in the N-of-1 trials. ConclusionThe N-of-1 trials of Chinese herbs designed in this study can well demonstrate the characteristics of TCM syndrome differentiation and treatment. The modified MEM can detect the residual effects of TCM and improve the sensitivity of data statistics. However, due to the inherent nature of N-of-1 trials, the sensitivity of this study method at the individual level is low and more cases and diseases need to be studied for further improvement.
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。
高血压是我国重点防治的心血管疾病, 血压的控制率备受关注。在一些血压控制不良的患者中睡眠呼吸暂停是导致顽固性高血压的重要原因。以睡眠过程中反复、频繁出现呼吸暂停和低通气为特点的睡眠呼吸暂停低通气综合征( sleep apneahypopnea syndrome, SAHS) 自20 世纪80 年代以来也受到广泛关注, 临床和基础研究取得了迅速发展。目前, 多项临床、流行病学和基础研究证实SAHS可以导致和/ 或加重高血压, 与高血压的发生发展密切相关。
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.
ObjectiveTo analysis the regularity of prescriptions of Chinese Medicine for syndrome of intense fire and heat (syndrome of Shi-Re-Huo-Du), and to provide evidences for the clinical treatment.MethodsCNKI, Sinomed, WanFang Data, VIP and Chinese medical databases were electronically searched to collect literatures about traditional Chinese Medicine for syndrome of Shi-Re-Huo-Du from inception to October, 2018. Two reviewers independently screened literature and extracted data. Then BICOMS 2 software was used to generate the co-occurrence matrix, NetDraw software was used to draw network maps.ResultsA total of 381 literatures involving 335 patients were included. There were 716 prescriptions of Shi-Re-Huo-Du (390 Chinese medicinal herbs), in which the frequently used herb included radix glycyrrhizae (346), Scutellariae Radix (255), Fructus Gardeniae (241), Rehmanniae Radix (239), Moutan Cortex (218), etc. The classification was performed according to traditional efficacy, Qing-re herbs (73), Bu-xu herbs (47), and Hua-tan-zhi-ke-ping-chuan herbs (39), accounted for 40.77% of the total herbs. The results of the analysis showed that the top herbs in Degree and Betweenness were consistent with high-frequency herbs. Among them, Rehmanniae Radix, Fructus Gardeniae, Scutellariae Radix, Moutan Cortex are the most important traditional Chinese herbs. High-frequency herbs are mainly based on Qing-re herbs, and the highest frequency of the herbs combination is Scutellariae Radix-Fructus Gardeniae.ConclusionAlthough there are kinds of herbs for syndrome of Shi-Re-Huo-Du, the commonly used herbs are relatively concentrated, and there is obvious interaction between high-frequency herbs, which is in line with the principle of compatibility of Chinese medicine. The high-frequency Chinese herbs and herb pairs were main components of the Chinese patent medicines and classic prescription. It reflected the rule of medicine used and essence in the treatment of syndrome of Shi-Re-Huo-Du.
ObjectiveThe aim of this study was to investigate the value of Artificial Neural Networks (ANNs) in predicting the occurrence of Venous Thromboembolism (VTE) in patients with Obstructive Sleep Apnea (OSA), and to compare it with traditional Logistic regression models to assess its predictive efficacy, providing theoretical basis for the prediction of VTE risk in OSA patients. MethodsA retrospective analysis was conducted on patients diagnosed with OSA and hospitalized in the Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Kunming Medical University, from January 2018 to August 2023. Patients were divided into OSA combined with VTE group (n=128) and pure OSA control group (n=680). The dataset was randomly divided into a training set (n=646) and an independent validation set (n=162). The Synthetic Minority Oversampling Technique (SMOTE) was employed to address the issue of data imbalance. Artificial Neural Networks and Logistic regression models were then built on training sets with and without SMOTE. Finally, the performance of each model was evaluated using accuracy, sensitivity, specificity, Youden's index, and Area Under the Receiver Operating Characteristic Curve (AUC). Results When oversampling was conducted using SMOTE on the training set, both the Artificial Neural Network and Logistic regression models showed improved AUC. The Artificial Neural Network model with SMOTE performed the best with an AUC value of 0.935 (95%CI: 0.898–0.961), achieving an accuracy of 90.15%, specificity of 87.32%, sensitivity of 93.44%, and Youden’s index of 0.808 at the optimal cutoff point. The Logistic regression model with SMOTE yielded an AUC value of 0.817 (95%CI: 0.765–0.861), with an accuracy of 77.27%, specificity of 83.80%, sensitivity of 69.67%, and Youden's index of 0.535. The difference in AUC between the Artificial Neural Network model and Logistic regression model was statistically significant after employing SMOTE (P<0.05). Conclusions The Artificial Neural Network model demonstrates high effectiveness in predicting VTE formation in OSA patients, particularly with the further improvement in predictive performance when utilizing SMOTE oversampling technique, rendering it more accurate and stable compared to the traditional Logistic regression model.
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.
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.
Objective To investigate the clinical manifestations and possible reasons of the missed and inaccurate diagnosis of Fuchs syndrome. Methods The clinical data of 85 patients with Fuchs syndrome who were diagnosed and treated from June 1999 to December 2003 were retrospectively analyzed. The disease history of each patient was carefully recorded. Slit-lamp microscopy was performed on the patients. The character and distribution of keratic precipitates (KP), color of the iris, depigmentation, and complications were noted in detail. The data recorded in other hospitals were analyzed and the reasons of missed and inaccurate diagnosis were statistically analyzed. Results The age of the patients ranged from 13 to 72 years, and binocular involvement was noted in 76 patients. None of the patients showed ciliary congestion and iris synechiae. Middle-sized or stellated KP was found. Triangle-distributed KP was seen in 13 patients, and diffuse distribution behind the corneal or in the pupil area was in 72. Anterior-chamber flare was observed in all of the patients, while anterior-chamber cells were only noted in 42 patients. The iris with different degrees of depigmentation was found in all the patients. Complicated cataract and increased intraocular pressure occured in 44 and 19 patients, respectively. The diagnosis in other hospitals mainly included uveitis, anterior uveitis and complicated cataract. Conclusions Fuchs syndrome is characterized by depigmented iris and typical KP. Missed and inaccurate diagnosis is mainly due to the unawareness of its clinical features. (Chin J Ocul Fundus Dis, 2005, 21: 360-362)
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.