Objective:To explore the clinical efficacy of scalp acupuncture plus speech rehabilitation in treating Broca's aphasia after cerebral stroke, for providing novel evidences for the treatment. Methods:Ninety-one eligible patients with Broca's aphasia after cerebral stroke were randomized into an observation group and a control group. Forty-six cases in the observation group were intervened by scalp acupuncture plus speech rehabilitation, while 45 cases in the control group were treated by speech rehabilitation alone. The aphasia battery of Chinese (ABC) and Boston diagnostic aphasia examination (BDAE) were adopted to evaluate the clinical efficacy. Results:After the treatment, the scores of oral expression, reading and writing and global score in the observation group were significantly higher than those in the control group (allP<0.05). There was a significant difference in comparing the BDAE grading between the two groups after the treatment (P<0.05). After intervention, the basically-recovered plus markedly-effective rate was 45.7% in the observation group versus 24.4% in the control group, and the between-group difference was statistically significant (P<0.05). Conclusion:Scalp acupuncture plus speech rehabilitation is effective in treating Broca's aphasia after cerebral stroke, and worth promoting.

Foot-and-mouth disease virus (FMDV) is a positive-sense RNA virus which has caused severe damage to world-wide livestock industry. The extensive genetic and antigenic diversity observed in the evolution of FMDV is generally the obstacle for controlling the disease. The homologous recombination, as a significant force driving the evolution of virus, has also effect on the epidemiological trait of FMDV. However,the role of homologous recombination in the diversification of FMDV in China has not investigated. So it is necessary to study the homologous recombination underlying the evolution of FMDV to control FMD. Based on a sound evolutionary framework, molecular evolutionary analysis was used to identify the putative recombinants. All complete FMDV genomes from China were respectively retrieved from GenBank. Homologous recombination was identified using Simplot program. Phylogenetic relations were analyzed to determine the recombination events among these FMDV isolates by using MEGA 4. The isolates O/NY00, O/China/1/99Tibet, O/Tibet/CHA/99, O/OMIII and O/ES/2001 among 16 FMDVs were identified as putative recombinants by analyzing the FMDV genomic sequences extracted from GenBank. The recombination events frequently happen between serological type Asia1 and O which are endemic FMDV circulating in China, suggesting frequent cross infection of FMDV in China. This situation further makes controlling FMDV in China more difficult. Moreover, serotypic conversion of FMDV between Asia1 and O was detected to be due to homologous recombination. These results provided clues for understanding the antigenic and genetic diversification in FMDV, and shed lights on the potential vaccination and treatment of FMD.

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.
United States ; Medical Device Legislation ; Reproducibility of Results ; United States Food and Drug Administration ; Technology ; Device Approval

Objective To explore the predictive value of systemic immune inflammatory index(SII),systemic inflammatory response index(SIRI),neutrophil to lymphocyte ratio(NLR),lymphocyte to monocyte ratio(LMR),platelet to lymphocyte radio(PLR),albumin to globulin(AGR)and heat shock protein 90α(HSP90α)in Fuhrman grade of clear cell renal cell carcinoma(ccRCC).Methods From October 2019 to August 2022,212 patients who underwent surgical treatment for ccRCC were divided into low-grade tumor group and high-grade tumor group according to Fuhrman grade.The independent influencing factors of Fuhrman grading were determined by univariate and multivariate Logistic regression analysis,and the predictive value of each inflammatory index to Fuhrman grading was evaluated by drawing Receiver operating characteristic curve(ROC).We constructed the line chart prediction model and evaluated the effectiveness of the model.Results The preoperative levels of SII,PLR,AGR,HSP90α and the maximum diameter of tumor were significantly different between high-grade group and low-grade group(P＜0.05).Logistic regression analysis showed that the maximum diameter of tumor,PLR,AGR and HSP90α were independent influencing factors of Furhman grade.By drawing the ROC curve,it was found that the area under the curve(AUC)of PLR,AGR and HSP90α to predict Furhman grade were 0.641,0.675 and 0.696.In addition,the Furhman grade line chart prediction model had good prediction ability,the AUC was 0.789(95％CI:0.717～0.862),the sensitivity was 61.80％,and the specificity was 85.40％.Conclusions There was a significant correlation between inflammation-related indexes in peripheral blood and Furhman grade of clear cell renal cell carcinoma.The Furhman grade line chart prediction model based on the maximum diameter of tumor and peripheral blood inflammation index has good predictive ability.

Objective:To investigate the clinicopathological and molecular genetic characteristics of tall cell variant and hobnail variant of papillary thyroid carcinoma (PTC).Methods:Twenty-one cases of tall cell variant (TCV-PTC) of PTC (TCV-PTC) and ten cases of hobnail variant of PTC (HV-PTC), as the highly aggressive group, were collected from Xuanwu Hospital from August 2009 to August 2015. Twenty-two cases of follicular variant and 21 classical PTC cases were included as control. Relevant clinical and pathologic data were obtained, and in some cases, paraffin samples were selected for gene mutation spectrum analysis using second generation sequencing.Results:There were 18 males and 56 females; 57 patients were younger than 55 years of age, and 17 patients were 55 years or older. The mean tumor size was 1.6 cm for the high-aggressive group (TCV-PTC and HV-PTC), 1.1 cm for the follicular subtype, and 1.6 cm for the classical type. There were 54 cases with thyroid capsule invasion, 24 cases with extra-thyroidal invasion, and 45 patients with lymph node metastases. Regional recurrence occurred in 7 cases, no recurrence in 54 cases, and 13 patients were lost to follow-up. The highly aggressive group was more likely to show extra-thyroidal invasion, lymph node metastases and recurrence than those with classical PTC ( P<0.05). Within this cohort, BRAF V600E mutation was detected in 53 cases and TERT promoter mutation in 6 cases. Compared with the single mutation group and no mutation group, BRAF and TERT promoter co-mutation group was more commonly detected in older age, male, larger tumor size and more prone to extra-thyroid invasion ( P<0.05). In addition, among BRAF and TERT co-mutation cases, the highly-aggressive group accounted for the highest proportion (5/6). Conclusions:TCV-PTC and HV-PTC, as highly-aggressive variants of PTC, show more aggressive biologic behavior (more lymph node metastasis, external thyroid invasion and recurrences) than the classical and follicular variants of PTC. Coexisting BRAF and TERT promoter mutations may be associated with invasive biologic behavior.

Objective:To analyze the clinicopathological and molecular features and prognostic implications of adult isocitrate dehydrogenase wild type (IDH-wt) diffuse gliomas.Methods:A total of 87 cases of adult IDH-wt diffuse gliomas from 2016 to 2020 in Xuanwu Hospital of Capital Medical University were retrospectively collected. The clinicopathological characteristics and prognosis were analyzed. Molecular characteristics were also analyzed using Sanger sequencing and next generation sequencing.Results:There were 53 males and 34 females, aged from 19 to 78 years (mean 53 years). Histopathologically, there were 63 (72.4%) glioblastomas, 16 (18.4%) anaplastic astrocytomas, six (6.9%) diffuse astrocytomas, and one (1.1%) each of anaplastic oligodendrocytoma, and anaplastic oligodendroglioma. Common molecular genetic changes in IDH-wt gliomas included TERT promoter mutation which was found in 60 cases (69.0%); MGMT promoter methylation in 43 cases (49.4%); EGFR mutation in 38 cases (43.7%); PTEN mutation in 35 cases (40.2%) and TP53 mutation in 32 cases (36.8%). In addition, PDGFRA mutation was detected in 17 cases (19.5%), CDK4 amplification in 15 cases (17.2%) and MDM2 amplification in 11 cases (12.6%). In IDH-wt diffuse gliomas, there was no significant difference in the overall survival between TERT promoter, EGFR, PTEN, TP53, PDGFRA, CDK4, MDM2 mutations and the wild-type, since these gene mutations could co-occur in any case ( P>0.05). Also there was no significant difference in the overall survival between the WHO grade Ⅱ/Ⅲ gliomas and glioblastoma patients with these gene mutations ( P>0.05). Conclusions:TERT promoter, EGFR, PTEN, TP53, PDGFRA, CDK4 and MDM2 gene mutations are common molecular genetic changes in adult IDH-wt gliomas, and are associated with poor prognosis. It is suggested that these genes are potentially useful for predicting the prognosis and should be tested in adult IDH-wt gliomas.

Objective:To analyze the clinicopathological features of chordoid glioma.Methods:A total of 12 cases of chordoid gliomas from 2009 to 2020 in Xuanwu Hospital of Capital Medical University and General Hospital of Chinese People′s Liberation Army were retrospectively analyzed. The clinical and imaging characteristics, pathologic and molecular characteristics were analyzed, and the relevant literature was reviewed.Results:All 12 patients (4 males and 8 females) aged from 25 to 67 years (mean 39 years) and mainly had a history of headache or/and vision loss. MRI showed that the lesions located in the third ventricle, and they showed abnormal enhancement. Pathologically, these 12 cases displayed the morphologic characteristics of chordoid gliomas, including papillary structures in two cases. Immunohistochemically, GFAP and vimentin were expressed in all 12 cases (12/12). TTF1 was also expressed in all cases (10/10). CD34 and CKpan were seen in 11 cases (11/12). EMA with dot-and/or-ring like positivity was seen in 9 cases (9/10). Tissues were available in nine chordoid gliomas for Sanger sequencing to detect PRKCA and IDH gene mutation, and eight cases (8/9) showed PRKCA gene D463H mutation. None of these cases showed IDH1 R132 and IDH2 R172 mutation. All 12 patients underwent surgery, and four were lost to follow up. The remaining eight patients were progression or recurrence free at last follow-up in January 2021.Conclusions:Chordoid gliomas have relatively distinguishing clinical and histopathological features. PRKCA gene mutation in chordoid gliomas can be considered as a biomarker for the diagnosis and differential diagnosis of chordoid gliomas, and may provide a direction for future targeted therapy.

Background::The potential impact of β cell function and insulin sensitivity on adverse pregnancy outcomes in women with gestational diabetes mellitus (GDM) remains uncertain. We aimed to investigate the association between β cell dysfunction, insulin resistance, and the composite adverse pregnancy outcomes.Methods::This observational study included 482 women diagnosed with GDM during pregnancy. Quantitative metrics on β cell function and insulin sensitivity during pregnancy were calculated using traditional equations. The association of β cell dysfunction and insulin resistance with the risk of the composite adverse pregnancy outcomes was investigated using multivariable-adjusted logistic regression models.Results::Multivariable-adjusted odds ratios (ORs) of adverse pregnancy outcomes across quartiles of homeostatic model assessment for insulin resistance (HOMA-IR) were 1.00, 0.95, 1.34, and 2.25, respectively ( P for trend = 0.011). When HOMA-IR was considered as a continuous variable, the multivariable-adjusted OR of adverse pregnancy outcomes was 1.34 (95% confidence interval 1.16-1.56) for each 1-unit increase in HOMA-IR. Multivariable-adjusted ORs of adverse pregnancy outcomes across quartiles of homeostatic model assessment for β cell function (HOMA-β) were 1.00, 0.51, 0.60, and 0.53, respectively ( P for trend = 0.068). When HOMA-β was considered as a continuous variable, the multivariable-adjusted OR of adverse pregnancy outcomes was 0.57 (95% CI 0.24-0.90) for each 1-unit increase in HOMA-β. However, other quantitative metrics were not associated with the composite adverse pregnancy outcomes. Conclusions::We demonstrated a significant association of β cell function and insulin sensitivity with the risk of adverse pregnancy outcomes. We have provided additional evidence on the early identification of adverse pregnancy outcomes besides the glycemic values.

OBJECTIVE: To explore the feasibility of remote monitoring of neonatal jaundice in newborns with ABO hemolytic disease. METHODS: Forty six neonates of gestational age >35 weeks with ABO hemolytic disease admitted to Women's Hospital, Zhejiang University School of Medicine from January 20th, 2020 to February 29th, 2020 were enrolled in the study (study group). The newborns were followed up at home after discharge, the transcutaneous bilirubin (TCB) levels were measured by parents using the provided device and the results were sent to the doctor by smart phone using the installed APP. Fifty six newborns with ABO hemolytic disease admitted in 2018 who received conventional outpatient follow-up after discharge served as the control group. The demographic characteristics, total serum bilirubin (TSB) level during hospitalization, number of outpatient visit and rate of re-admission due to rebound hyperbilirubinemia were compared between the two groups. RESULTS: There were no significant differences between the two groups in gestational age, birth weight, delivery mode, gender, length of the first hospitalization, TSB level before phototherapy and before discharge, and the managements during the first hospitalization (all CONCLUSIONS The remote follow-up for neonatal jaundice at home can effectively reduce the number of outpatient visits without increasing the risk of readmission and severe neonatal hyperbilirubinemia for newborns with ABO hemolytic disease.
Bilirubin ; Erythroblastosis, Fetal/diagnosis* ; Female ; Humans ; Hyperbilirubinemia, Neonatal/diagnosis* ; Infant, Newborn ; Jaundice, Neonatal/diagnosis* ; Monitoring, Physiologic/methods* ; Phototherapy