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ObjectiveTo analyze the utilization of outcome indexes and other trial design elements in randomized controlled trials （RCTs） of Chinese medicine for diabetic kidney disease （DKD） and provide a basis for the design of clinical trials and the development of core outcome index sets for Chinese medicine treatment of DKD. MethodSeven medical databases （CNKI， Wanfang Data， VIP， SinoMed， etc.） and two clinical trial registration centers （clinicaltrials.gov and chinadrugtrials.org.cn） were searched for RCTs of Chinese medicine for DKD published in the past 5 years. The included studies were assessed for risk of bias using the Cochrane Handbook for Systematic Reviews of Interventions， and the outcome indexes and other trial design elements were statistically analyzed. ResultNinety-seven RCTs were enrolled， including five trial registration protocols. The overall risk of bias was found to be high in the included studies. Stage Ⅲ DKD （36 studies， 41.38%） and the Qi-Yin deficiency with blood stasis syndrome （16 studies， 26.23%） were the top DKD stage and traditional Chinese medicine （TCM） syndrome， respectively. The treatment duration ranged from 2 weeks to 96 weeks， with 12 weeks being the most common duration （52 studies， 56.52%）. A total of 152 outcome indexes were used in 92 RCTs and five registered trials， with a frequency of 1 040 times. These indexes were classified into eight categories： Laboratory tests （blood）， laboratory tests （urine）， clinical efficacy， TCM syndrome score， quality of life scales， vital signs， other indexes， and other events. The most frequently used outcome indexes were serum creatinine （68 times， 70.10%）， clinical response rate （55 times， 56.70%）， fasting blood glucose （51 times， 52.58%）， blood urea nitrogen （48 times， 49.48%）， total cholesterol （47 times， 48.45%）， and 24-hour urinary protein excretion （43 times， 44.33%）. Safety indexes were used in 56 RCTs and two registered trials， with 53 different indexes and a frequency of 227 times. The most frequently used safety indexes were adverse reactions （49 times， 84.48%）， liver function （28 times， 48.28%）， complete blood count （24 times， 41.38%）， electrocardiogram （17 times， 29.31%）， and urinalysis （14 times， 24.14%）. Ten RCTs and five registered trials reported primary outcome indexes， and 54 RCTs reported clinical response rates. ConclusionThe current design of outcome indexes in RCTs of Chinese medicine for DKD is not standardized. In the future， efforts should be made to develop core outcome index sets that highlight the characteristics of TCM， improve the quality of clinical research， and enhance the applicability of trial results.
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Objective:To investigate the clinical features and multimodal imaging features of eyes with perifoveal exudative vascular anomalous complex (PEVAC).Methods:A retrospective case study. From February 2014 to November 2020, 7 eyes of 7 patients with PEVAC diagnosed by ophthalmology examination in Department of Ophthalmologyof Peking University People's Hospital were included in this study. There were 6 males and 1 female. The age was 60.1±9.1 years. All were monocular. The chief complaints of visual deformation and vision loss were 3 and 1 cases, respectively. All patients underwent best corrected visual acuity (BCVA), fundus color photography, optical coherence tomography (OCT), fundus fluorescein angiography (FFA). BCVA examination was performed using the standard logarithmic visual acuity chart, which was converted to logarithm of the minimum angle of resolution (logMAR) visual acuity. OCT angiography (OCTA) and indocyanine green angiography (ICGA) were performed in 4 and 2 eyes, respectively. Three eyes were treated with intravitreal injection of anti-vascular endothelial growth factor (VEGF) combined with local laser photocoagulation. Two eyes were treated with laser photocoagulation alone. The follow-up time was 16.7±19.1 months. During follow-up, relevant examinations were performed with the same equipment and methods as at the initial diagnosis. The multimodal imaging characteristics and treatment response of the affected eyes were observed.Results:The baseline logMAR BCVA was 0.33±0.19 (0.20-0.80). All eyes showed isolated hemangiomatous lesions in the macular fovea with rigid retinal exudation, and 2 adjacent isolated hemangiomatous lesions were observed in 1 eye. FFA and ICGA examination showed that all eyes with macular hemangiomatous lesions showed clear boundary and strong fluorescence in the early stage. No other retinal or choroidal vascular abnormalities were observed. On OCT examination, circular lumen-like structures with strong reflective wall near the fovea were observed in the macular region of all eyes, accompanied by intraretinal cystic lumen. The macular central retinal thickness (CMT) was 326±125 (207-479) μm. In the four eyes examined by OCTA, blood flow signals were observed in the circular lumenoid structures with strong reflective walls adjacent to the fovea. Blood flow signals were observed in the superficial capillary layer (SCP) and deep capillary layer (DCP) of the retina in 3 eyes. SCP showed blood flow signal in 1 eye. In 4 eyes treated with intravitreal injection of anti-VEGF drugs, there was no significant improvement in the intraretinal capsule space after treatment. Subretinal fluid absorption, retinal cystoid edema persisted, and rigid exudation decreased in 1 eye. CMT decreased and BCVA increased in 5 eyes treated with laser photocoagulation or laser photocoagulation alone. At last follow-up, logMAR BCVA was 0.16±0.06 (0.10-0.20) and CMT was 212±34 (154-252) μm. Compared with baseline, the difference of BCVA was statistically significant ( t=2.661, P=0.037). Conclusions:The fundus of PEVAC patients is characterized by solitary or multiple solitary hemangiomatous lesions in the macular fovea. Round lumenoid structures with strong reflective walls, with or without intraretinal cystic lumen, rigid exudate, and subretinal fluid, in which blood flow signals can be seen in OCT.
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Introducing the continuing education of the dental hygienist in eight states of the U.S.,to understand the the category of practice,professional ability,curriculum, teaching methods and teaching evaluation standard. To analyze the continuing education in eight states to provide a reference for constructing a curriculum system that is suitable for China.
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Objective@#To analyze the clinical value of SPECT/CT in diagnosis of skull base bone invasion and clinical decision-making for nasopharyngeal carcinoma (NPC), and to compare their diagnostic value with SPECT/CT, CT, MRI, and MRI combined with SPECT (MRI-SPECT) for skull base bone invasion.@*Methods@#Before treatment, among 348 newly diagnosed NPC patients, CT scan was performed in 186 patients (group A) and the remaining 162 patients received MRI scan (group B). Clinical doctors then made clinical management decisions according to the CT or MRI results. After that, all patients underwent 99Tcm-MDP SPECT/CT examination for nasopharyngeal local tomography, and the results were provided to the clinical doctors to make clinical management decisions again. The changes between the two clinical management decisions were scored according to diagnosis, range of lesion, staging, treatment regimens, and auxiliary examination. The diagnostic value of CT scan, MRI scan, SPECT/CT and MRI-SPECT for skull base bone invasion was then evaluated and compared.@*Results@#In terms of changes in scores of clinical management decisions, the score of group A was 1.387 and group B was 0.951, showing a significant difference between the two groups by Wilcoxon test (Z=6.570, P<0.001). By χ2 test, there were correlations between CT and SPECT/CT (χ2 =98.495, P<0.001), and between MRI and SPECT/CT (χ2 =32.662, P<0.001). The consistency of CT and SPECT/CT (Kappa=0.713) was greater than MRI and SPECT (Kappa=0.449). The sensitivity of CT, MRI, SPECT/CT and MRI-SPECT was 67.1%, 84.5%, 90.8% and 100%, the specificity was 73.3%, 92.3%, 85.6% and 84.6%, and the area under the ROC curve was 0.702, 0.884, 0.882 and 0.923, respectively.@*Conclusions@#SPECT/CT has important impact on clinical management decision for NPC. In the judgement of skull base invasion, the diagnostic value of SPECT/CT is significantly higher than CT and approximately equal to MRI. SPECT/CT should be one of the routine examination methods of nasopharyngeal carcinoma. In addition, in view of its greater diagnostic value, MRI combined with SPECT should be the focus of future imaging studies.
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Objective To investigate the diagnostic efficacy of 13N-NH3 and 18F-FDG PET/CT in the evaluation of untreated gliomas.Methods A total of 45 consecutive patients (29 males,16 females;age range 14-75 years,average age (47.47± 15.64) years) with final diagnosis of glioma from August 2009 to May 2012 were retrospectively analyzed.PET/CT imaging was performed with both 18F-FDG and 13N-NH3.Imaging results were analyzed by tumor-to-gray matter (T/G) ratios.ROC curve analysis was conducted to determine the optimal T/G cutoff values between low-grade and high-grade gliomas.One-way analysis of variance was applied to assess the differential efficacy of the two tracers in different grade of glioma.Results Forty-eight separate lesions were identified (WHO grade Ⅱ,n=16;grade Ⅲ,n=12;and grade Ⅳ,n=20).The sensitivities of 13N-NH3 PET/CT and 18F-FDG PET/CT on predicting high-grade gliomas were 91％(29/32) and 66％ (21/32),respectively.The optimal T/G cutoff values for 18F-FDG and 13N-NH3 were 0.64 and 0.86 with the AUC of 0.910 and 0.943,respectively.The sensitivity and positive predictive value of predicting high-grade gliomas with optimal cutoff values were 84％ (27/32) and 93％ (27/29)for 18F-FDG PET/CT,those for 13N-NH3 PET/CT were 94％ (30/32) and 94％ (30/32),respectively.Conclusion 13N-NH3 PET/CT is superior to 18F-FDG PET/CT not only in separating low-grade gliomas from high-grade ones,but also in the detection of high-grade gliomas for better tumor to normal gray matter contrast.
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Objective To analyze the risk factors of hepatocellular carcinoma (HCC) recurrence after liver transplantation based on 18F-FDG PET/CT.Method We respectively analyzed 54 cases of HCC patients who accepted liver transplantation from 2008 September to 2012 November.The clinicopathological features of 54 patients were analyzed by univariate and multivariate analysis to determine the risk factors of HCC recurrence after liver transplantation.The ROC curve was drawn to determine the optimal cutoff value of T/B that affects HCC recurrence after liver transplantation.Result The total incidence of HCC recurrence was 48.1％ (26/54); the disease-free survival (DFS) rate of 0.5 year,1 year and 2 years after transplantation in 54 patients was 92.6％,66.7％,52.2％,49.1 ％ and 49.1％ respectively.The univariate analysis results showed that there were 5 variables to affect HCC recurrence,namely PET imaging,tumor size,tumor number,preoperative AFP level,and tumor degree.On ROC curve analysis,the optimal cutoff value for T/B was 1.69.The multivariate analysis concluded that T/B,and preoperative AFP level were independent factors.Conclusion T/B ＞1.69 and preoperative AFP level ＞400 μg/L are important biological factors of HCC recurrence after liver transplantation.
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Objective To explore the value of 18F-FDG PET/CT in predicting tumor recurrence for hepatocellular carcinoma (HCC) after liver transplantation (LT).Method We respectively analyzed 52 patients with HCC who underwent the 18F-FDG PET/CT examination before LT.In terms of tumor recurrence,all patients were divided into recurrence group and non-recurrence group.According to the degree of 18F-FDG uptake,all patients were divided into PET(-) group and PET (+) group.The SUVmax of primary tumor/the SUVmax of normal-liver background (T/B) was calculated by 18F FDG PET/CT.All patients were then divided into T/B≤1.15 group and T/B＞1.15 group.Result During the follow-up period,25 out of 52 patients (48.1％) developed posttransplant HCC recurrence and 27 (51.9％) had no recurrence.T/B of patients with recurrence (2.51 ± 0.95) was significantly higher than that of patients with non-recurrence (1.37 ± 0.46),t =4.12,P＜0.001.The disease-free survival rate of 0.5 year,1 year,2 years and 3 years after LT in PET(-) group and PET(+) group was 100.0％,92.3％,92.3％ and 92.3％,and 89.7％,59.0％,43.6％ and 35.7％ respectively.Log-rank test revealed that disease-free survival rate in PET(-) group was significantly higher than that in PET(+) group,x2 =17.8,P=0.003.The disease-free survival rate of 0.5 year,1 year,2 years and 3 years after LT in T/B≤1.15 group and T/B＞1.15 group was 100.0％,92.3％,92.3％ and 92.3％,and 89.5％,59.7％,42.1％ and 33.7％ respectively.Log-rank test showed that disease-free survival rate of T/B≤1.15 group was significantly higher than that of T/B＞1.15 group,x2 =10.24,P =0.001.Conclusion 18F-FDG PET/CT can predict HCC recurrence after LT.PET(-)and T/B≤1.15 of the 18F-FDG PET/CT in patients with HCC after LT were associated with a good prognosis,and PET(+) and T/B＞1.15 of the 18F-FDG PET/CT in patients with HCC after LT with a poor prognosis.
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Objective The purpose of the study was to assess the quality of life in children and adolescents with type 1 diabetes.Methods 89 patients with type 1 diabetes admitted by Beijing children's hospital and 196 matched healthy children and adolescents were involved.QOL was assessed using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scale.Results Children and adolescents with type 1 diabetes had lower general HRQOL compared with the healthy matched children and adolescents,especially in emotional functioning and school functioning,HRQOL in girls was significantly lower than HRQOL in boys regarding social functioning.Conclusions The QOL of children and adolescents with type 1 diabetes was impaired.
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Eleven env mutants were designed and generated by site-directed mutagenesis of the regions around Nab epitopes and deletions of variable regions in env.The immunogenicities of the generated mutants were evaluated using single-cycle infection neutralization assays with two pseudoviruses and IFN-γELISPOT.Overall,five mutants(dWt,M2,M5-2,M5-1 and dM7)induced highed neutralization activities for both pseudoviruses than plasmid Wt,while only two of the mutants(dWt and M5-2)showed significant differences(P<0.05).Two mutants(M2 and dM2)induced more Env-specific T cells than plasmid Wt.Statistically however,significance was only reached for mutant M2.Thus,properly modified HIV-1 Env may have the potential to induce potent cellular and humoral immune responses.
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Objective: To observe the protective effect of BushenHuoxueFang on renal interstitial fibrosis in rats and try to explore the mechanism. Methods: The renal obstruction model of rats was established by unilateralureteral obstruction ,and then they were divided into four groups randomly, including sham-opration group,model group,Lotensin group, BushenHuoxueFang high-dose and low dose group.The morphological changes of kidney tissue were observed,the level of PDGF-BB was detected by Western-blot on the third,seventh,fourteenth and twenty first,twenty eighth day Results: Compared with the sham-operation group, there were different degrees of kidney lesions in UUO group and the treatment groups. The level of PDGF-BB in UUO group was significantly higher than that in sham-operation group from the third day(P
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Objective: To investigate the protective influence and mechanism of Yishen Huayu Formula on the expression of connective tissue growth factor (CTGF)in the rat with renal interstitial fibrosis. Methods: 150 rats were randomly divided into sham-opration group, model group, Lotensin treatment group, Yishen Huayu high low dose treatment groups. The rat models with renal interstitial fibrosis were induced by unilateral ureteral obstruction. The expressions of CTGF in the kidneys were observed on 3rd, 7th, 14th, 21st, 28th day. The alterations of renal the expressions of CTGF in the kidneys were observed with the ?-actin as intrinsic control. Results: Compared with the control group,the expression of CTGF increased signifi cantly in model group(P