The scientific research on prevention and control of coronavirus disease 2019 (COVID-19) has been a major and urgent task, of which clinical trials occupy a pivotal position in the entire prevention and control system. 204 relative clinical trials of traditional Chinese medicine (TCM) have been registered on Chinese Clinical Trial Registry. Through the analysis of all online public protocols of registered trials, it is found that the clinical studies of TCM in China showed lack of research foundation, tight time and heavy tasks, difficult clinical implementation, and disturbance by changes of the epidemic status. Based on these characteristics, this paper put forward several thoughts and suggestions on the quality management and design improvement for clinical trials of TCM preventing and treating COVID-19, in order to improve the quality of clinical trials in China, provide effective supports for the public health decision-making on the epidemic, and also give a reference for the prevention and control of epidemics in the future.
Alzheimer’s disease (AD) is a progressive and irreversible neurodegenerative disease. Neuroimaging based on magnetic resonance imaging (MRI) is one of the most intuitive and reliable methods to perform AD screening and diagnosis. Clinical head MRI detection generates multimodal image data, and to solve the problem of multimodal MRI processing and information fusion, this paper proposes a structural and functional MRI feature extraction and fusion method based on generalized convolutional neural networks (gCNN). The method includes a three-dimensional residual U-shaped network based on hybrid attention mechanism (3D HA-ResUNet) for feature representation and classification for structural MRI, and a U-shaped graph convolutional neural network (U-GCN) for node feature representation and classification of brain functional networks for functional MRI. Based on the fusion of the two types of image features, the optimal feature subset is selected based on discrete binary particle swarm optimization, and the prediction results are output by a machine learning classifier. The validation results of multimodal dataset from the AD Neuroimaging Initiative (ADNI) open-source database show that the proposed models have superior performance in their respective data domains. The gCNN framework combines the advantages of these two models and further improves the performance of the methods using single-modal MRI, improving the classification accuracy and sensitivity by 5.56% and 11.11%, respectively. In conclusion, the gCNN-based multimodal MRI classification method proposed in this paper can provide a technical basis for the auxiliary diagnosis of Alzheimer’s disease.
Objective To investigate the application of magnetic resonance imaging (MRI) in preoperative assessment of rectal cancer. Methods Combined with the literatures, the MRI features and measurements of rectal tumor staging, extramural vascular invasion, circumferential margin involvement, and the distance between distal margin of the tumor from the anorectal ring and the anal margin were described. Results On T2-weighted images (T2WI), T1 staging-tumors were those in which the normal submucosa was replaced by the iso-intensity of tumor tissue without invasion of muscularis propria; T2 staging-tumors were those with extension into the muscularis propria, but not invaded the high-intensity of mesorectal fat; T3 staging-tumors manifested as the rectal tumor penetrated into the muscularis propria and invaded the high-intensity of mesorectal fat; T4 staging-tumors manifested as the tumor invaded adjacent structures or organs. The metastatic lymph nodes were showed with irregular boundaries and mixed signals on T2WI. The tumor signals could be found in the extramural vascular on T1-weighted images (T1WI), accompanied by irregular distortion and expansion of the blood vessels. On T2WI, metastatic lymph nodes, extramural vascular invasion, and the distance between the residual tumor and the low-signal of mesorectal fascia was within 1 mm, indicated the positive circumferential margin. On T2WI, the distal margin of the tumor was located at the junction of hyperintense submucosa and iso-signal of tumor, the tip of the iso-signal puborectal muscle was the apex of the anorectal ring, and the lowest point of the iso-signal external sphincter was the anal margin. Conclusion MRI can provide reliable imaging information for preoperative staging, height measurement, and prognosis of rectal cancer, and it is helpful for early diagnosis and treatment of rectal cancer.
Objective To explore the clinical characteristics of Crohn’s disease (CD) with perianal fistula by analyzing the clinical data of them. Methods A total of 139 cases of CD with perianal fistula who got treatment from January 2010 to January 2017 in The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine were analyzed retrospectively. Results The proportion of males and females in 139 patients was about 3.3∶1.0, the age was (28±8) years, and 47.5% of patients had perianal fistula before CD diagnosis. The percents of patients with perianal surgery history and medication history were 64.7% and 74.1%, respectively. The ratio of L3 type (diseased position) was 49.6%. The ratios of inflammatory type (B1 type) and stenotic type (B2 type) of the disease were 51.8% and 41.0%, respectively. The complex perianal fistula accounted for 90.6%, and 31.7% of patients combined analrectal stricture. Symptoms of diarrhea were found in 46.0% of patients and perianal lesions alone in 29.5% of patients; 54.0% of patients combined with abnormal BMI; 64.7% of patients were in the active stage of Crohn’s disease activity index (CDAI) and 94.2 % of patients were in the active period of perianal disease activity index (PDAI). The patients with erythrocyte sedimentation rate (ESR) higher than normal were 53.2%. The results of logistic showed that, age and degree of CDAI were influencing factors for CD with stenosis of perianal fistula. Conclusions Characteristics of patients with CD combined with perianal fistula include: young, men predominant, high prevalence of ileocolic position involvement, as well as inflammation and stenosis disease behavior. Fistula symptoms often preced the intestinal symptoms and diarrhea is the most common intestinal performance. History of perianal abscess and fistula operation are common. The anorectal stricture are complicated usually. Intestinal inflammation is active. Some patients show abnormal laboratory indicators of inflammation. This suggests that patients with perianal fistula with these clinical features should be alert to the possibility of CD, so as toavoid the consequences of blind surgery. The higher CDAI score and the older the diagnosis age, the higher the risk ofrectal stenosis.
Objective To explore the effect of local injection of high concentration of glucose when removing setons of perianal fistulizing in Crohn’s disease (CD). Methods Thirty cases of CD combined with anal fistula admitted to the Affiliated Hospital of Nanjing University of Chinese Medicine from August 2015 to July 2017 were collected prospectively, 12 cases were divided into experimental group and 18 cases were divided into control group. Cases of the experimental group received demolition of drainage seton+IFX+local injection of high concentration of glucose treatment, cases of the control group received the drainage setons removing+IFX only. Before treatment, and at 6, 14, 22, and 30 weeks after IFX treatment, the laboratory indicators of the 2 groups were detected, and BMI, Crohn’s diseaseactivity index (CDAI), perianal disease activity index (PDAI), and clinical efficacy were evaluated. Results Therewas no significant difference on the group effect and interaction of group and time (P>0.05), but time (P<0.05). Both in the experimental group and the control group, compared with before treatment group, the counts of WBC and platelet, levels of C reaction protein (CRP) and erythrocyte sedimentation rate (ESR), CDAI, and PDAI at 6 months after IFX therapy decreased and maintained at the latter period, but the level of hemoglobin (Hb) and BMI increased at 6 weeks after IFX therapy and maintained at the latter period. On the clinical effect, there was no significant difference at the time points of 14, 22, and 30 weeks of IFX therapy (P>0.05). Conclusion The treatment of local injection of high concentration of glucose when removing setons has not shown any positive effect to CD combined with anal fistula, this conclusion needs to be further studied.
ObjectiveTo investigate long-term efficacy of infliximab (IFX) combined with seton placement in treatment of perianal fistulizing Crohn disease (CD) and to analyze factors affecting its clinical healing and recurrence.MethodsThe patients with perianal fistulizing CD underwent the IFX combined with seton placement therapy from July 2010 to January 2017 were collected from the HIS database of the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine. The healing and recurrence of perianal fistulizing CD were counted and their influencing factors were analyzed.ResultsA total of 103 patients with perianal fistulizing CD were included in the study. After a median follow-up of 36 months, 64 patients (62.1%) had a complete fistula healing, 34 patients (33.0%) relapsed. The cumulative recurrence rates of fistula in the 1, 3, and 5 years was 21.8%, 32.6%, and 37.4%, respectively. The multivariate analysis showed that the Montreal classification B1 ［HR=3.987, 95% CI (1.640, 9.694), P=0.023］ and without abscess ［HR=2.724, 95% CI (1.101, 6.740), P=0.030］ were positively associated with the long-term healing of fistula, and the IFX maintenance treatment >3 times ［HR=5.497, 95% CI (1.197, 25.251), P=0.028］ was a risk factor for the recurrence of the fistula.ConclusionsLong-term healing rate of fistula by IFX combined with seton placement therapy is higher. Montreal classification B1, without abscess, and IFX maintenance treatment less than 3 times are expected to have a better long-term efficacy.