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。
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.
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 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.
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)
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.
ObjectiveTo evaluate the predictive value of critical illness scores for hospital mortality of severe respiratory diseases in respiratory intensive care unit (ICU).MethodsThe clinical data of the patients who needed intensive care and primary diagnosed with respiratory diseases from June, 2001 to Octomber, 2012 were extracted from MIMIC-Ⅲ database. The Acute Physiology Score (APS) Ⅲ, Simplified Acute Physiology Score (SAPS) Ⅱ, Oxford Acute Severity of Illness Score (OASIS), Logistic Organ Dysfunction System (LODS), Systemic Inflammatory Response Syndrome (SIRS) and Sequential Organ Failure Assessment (SOFA) were calculated according to the requirements of each scoring system. ICU mortality was set up as primary outcome and receiver operating characteristic (ROC) analysis was performed to evaluate the predictive performances by comparing the areas under ROC curve (AUC). According to whether they received invasive mechanical ventilation during ICU, the patients were divided into two groups (group A: without invasive mechanical ventilation group; group B: with invasive mechanical ventilation group). The AUCs of six scoring systems were calculated for groups A and B, and the ROC curves were compared independently.ResultsA total of 2988 patients were recruited, male accounted for 49.4%, median age was 67 (55, 79), and ICU mortality was 13.2%. The AUCs of SAPSⅡ, LODS, APSⅢ, OASIS, SOFA and SIRS were 0.73 (0.70, 0.75), 0.71 (0.68, 0.73), 0.69 (0.67, 0.72), 0.69 (0.67, 0.72), 0.67 (0.64, 0.70) and 0.58 (0.56, 0.62). Subgroup analysis showed that in group A, the AUCs of OASIS, SAPSⅡ, LODS, APSⅢ, SOFA and SIRS were 0.81 (0.76, 0.85), 0.80 (0.75, 0.85), 0.77 (0.72, 0.83), 0.75 (0.70, 0.80), 0.73 (0.68, 0.78) and 0.63 (0.56, 0.69) in the prediction of ICU mortality; in group B, the AUCs of SAPSⅡ, APSⅢ, LODS, SOFA, OASIS and SIRS were 0.68 (0.64, 0.71), 0.67 (0.63, 0.70), 0.65 (0.62, 0.69), 0.62 (0.59, 0.66), 0.62 (0.58, 0.65) and 0.57 (0.54, 0.61) in the prediction of ICU mortality. The results of independent ROC curve showed that the AUC differences between groups A and B were statistically significant in terms of OASIS, SAPSⅡ, LODS, APSⅢ and SOFA, but there were no significant differences in SIRS.ConclusionsThe predictive values of six critical illness scores for ICU mortality in respiratory intensive care are low. Lack of ability to predict ICU mortality of patients with invasive mechanical ventilation should hold primary responsibility.
ObjectiveTo analyze the association between the acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (syndrome of phlegm-heat obstructing lung) and clinical indicators related to COPD. MethodAECOPD in-patients and out-patients were enrolled from the Third People's Hospital of Chengdu from January 2013 to January 2014. The patients were grouped to Tanre Syndrome and non-Tanre Syndrome according to their clinical symptoms, signs and tongue, pulse. All patients underwent the following tests including routine blood test, erythrocyte sedimentation rate, lung function, blood gas analysis, C-reaction protein (CRP), procalcitonin (PCT) and other clinically relevant indicators. The association between AECOPD and clinically relevant indicators were analyzed by using SPSS 19.0 software. ResultsA total of 194 AECOPD patients were included, of which 88 patients were syndrome of phlegm-heat obstructing lung and 106 were non syndrome of phlegm-heat obstructing lung according to the traditional Chinese medicine (TCM) classifications. The results of single factor analysis showed that age (Z=-4.848, P=0.000) and course of disease (Z=-2.455, P=0.014) were associated with syndrome of phlegm-heat obstructing lung. While further logistic regression analysis showed that age (r=0.090, P=0.000) and the level of CRP (r=-0.008, P=0.000) were associated with syndrome of phlegm-heat obstructing lung. ConclusionSyndrome of phlegm-heat obstructing lung is the major clinical TCM syndrome of AECOPD. Syndrome of phlegm-heat obstructing lung is associated with age and level of CRP.
Objective To detect the clinical manifestations, diagnos is and treatment of painful ophthalmoplegia syndrome. Methods The data of onset, clinical m anifestations, laboratory examination, imaging and treatment from 12 patients with painful ophthalmoplegia, hospitalized from Mar, 2000 to Aug. 2005, were retro spectively analyzed. Results Multiple characters and extents of the headache were found in these 12 patients. The involved cranial nerves included the Ⅲ,Ⅳ, V1-2 and Ⅵ, especially the cranial nerve Ⅲ(83.3%). Several simultaneously in volved cranial nerves were frequently found (75%). Diseases which could cause hea dache along with ophthalmoplegia must be excluded before the diagnosis of the painful ophthalmoplegia syndrome was established. The examination of imaging was important for the diagnosis of painful ophthalmoplegia syndrome. Patients were sensitively responsive to cortico-steoid therapy. The cure rate was 75%. Conclusion The features of clinical manifestations, imaging results and the patients response to cortico-steoid therapy accorded with the etiology of nonspecific inflammation granuloma. Cortico-steoid therapy is effective after the definitude of the disease. (Chin J Ocul Fundus Dis, 2006,22:385-386)
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.