Objective:To investigate the relationship between symptoms of vertigo and vestibular functions and short-term hearing outcomes in patients with flat descending sudden sensorineural hearing loss （SSNHL）. Methods:A retrospective review was conducted of the vestibular symptoms observed in 48 patients with unilateral flat-down sudden sensorineural hearing loss treated at the Department of Otolaryngology Head and Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Symptoms of vertigo and the results of cervical vestibular-evoked myogenic potentials （cVEMP）, ocular VEMP （oVEMP）, caloric test and video head-impulse test （vHIT） were collected to determine whether these factors could predict therapeutic efficacy. Results:The symptoms of vertigo was not correlated with prognosis （P>0.05） or with abnormal vestibular functions （P>0.05）. Patients with abnormal cVEMP, oVEMP, caloric test or vHIT showed significantly lower effective rates （32.0%, 44.0%, 32.0%, and 24.0%, respectively）; the greater the number of abnormal tests, the poorer the outcome. Patients with all four tests abnormal gained only （3.13±15.97） dB HL in hearing recovery, whereas those with normal cVEMP, oVEMP, caloric test or vHIT showed better chances of hearing improvements by （29.22±20.31）, （31.18±21.59）, （26.17±21.31）, and （26.38±24.05） dB HL, respectively. Conclusion:Vestibular function effectively predicts prognosis in flat descending SSNHL. Patients with abnormal vestibular tests, regardless of symptoms of vertigo, responded poorly to treatment, whereas those with normal cVEMP, oVEMP, caloric test and vHIT results achieved better hearing recovery. Abnormal vestibular function implies more extensive and severe inner-ear lesions in patients with SSNHL.
Humans ; Male ; Female ; Retrospective Studies ; Prognosis ; Adult ; Middle Aged ; Vertigo/diagnosis* ; Hearing Loss, Sensorineural/diagnosis* ; Young Adult ; Hearing Loss, Sudden/diagnosis* ; Adolescent ; Aged ; Vestibular Evoked Myogenic Potentials

Abstract This paper focuses on the regulatory strategy of drug-led drug device combination products, comparing and analyzing the definition, scope and management mode of drug device combination products in the United States, the European Union, Japan, Canada and China; summarizing and analyzing the types of combination products in the Product-specific Guidances for Generic Drug Development(PSGs) of the US FDA's scientific and technical reports in the past five years, the results show that the top three PSGs newly added to the FDA were transdermal system, nasal sprays, and single-dose prefilled syringes/pens(including auto-injectors). As of March 1, 2023, the National Medical Products Administration(NMPA) had cumulatively announced the results of 339 combination products applied for attribute definition by enterprises, of which 88 were "drug-led drug device combination products", accounting for 26%; and 78 were "device-led drug device combination products", accounting for 23%; the results of "not belonging to drug device combination products" accounted for more than half (51.0%), which indicated that there was a big difference between the industry and the regulatory understanding of the definition of drug-device combination products, and that the existing guideline and documents were unable to provide clear and predictable positioning of the combination products under research and development for the time being. This paper also puts forward suggestions for solving the problems in the development of drug-device combination products in China, in order to improve the consistency, predictability and transparency of the classification and definition of drug-device combination products in China, and to provide references for the development and scientific supervision of this kind of products.

Objective To verify whether miR-630 could inhibit MDA-MB-231 cells migration and invasion by targeting Sox4 in triple-negative breast cancer(TNBC).Methods Collection normal breast tissue and breast cancer tissue from patients undergoing breast cancer resection.RT-PCR were used to test the expression of miR-630,miR-21,miR-195,miR-134,miR-200a,miR-381 and miR-1228.Western blot were used to test the expression of COL1A1,COL1 A5,MMP-2,MMP-9 and Sox4.In vitro experiment,after miR-630 was transfected into MDA-MB-231 cells,wound healing were employed to test the migratory ability of MDA-MB-231 cells,and transwell were used to test the invasion ability of MDA-MB-231 cells.Western blot were used to investigate the expressions of COL1 Al,COL1 A5,MMP-2,MMP-9 and Sox4 in MDA-MB-231 cell.Luciferase assay was used to confirmed whether Sox43'-UTR the target gene of miR-630.Results Compared with normal breast tissue,the expression of miR-630 was decreased(P＜0.01),meanwhile the expression of COL1A1,COL1A5,MMP-2,MMP-9 and Sox4 were significantly increased in the triple-negative breast cancer tissue(P＜0.01).In the vitro experiment,compared with the control group,the expression of COL1A1,COL1A5,MMP-2,MMP-9 and Sox4 were decreased in the miR-630 group (P＜0.05);The migration activity of MDA-MB-231 cells was decreased in the miR-630 group (P＜0.01);The Luciferase activity of the Sox4-3'-UTR plasmid was significantly suppressed by miR630 (P＜0.05);Over expression of Sox4 could reverse the effect of miR-630 on MDA-MB-231(P＜0.05,P＜0.01).Conclusion In triple-negative breast cancer tissue,the expression of miR-630 decreased;miR-630 inhibits triple-negative breast cancer cells migration and invasion by targeting Sox4-3’-UTR.

Objective To investigate the effect total hip arthroplasty and hemiarthroplasty in treatment of displaced femoral neck fractures in elderly .Methods 83 cases of elderly patients with displaced femoral neck fractures were divided into two groups according the order randomly.The control group(n=53) was given hemiarthroplasty while the observation group ( n=30) took total hip arthroplasty .The clinical efficacy and occurrence of complications after surgery were compared.Results The observation group excellent rate was 90.00%(27/30), significantly higher than the 79.25%(42/53) (χ2 =11.23,P<0.05);The observation group′s operative time,blood loss and postoperative drainage were (145.33 ±6.21)min,(575.65 ±26.84)mL and (278.51 ±14.15)mL,which was more than the control group(80.12 ±5.36)min,(322.52 ±25.34)mL and (185.46 ±12.48)mL significantly(t=9.56, 8.83,10.03,all P<0.05);The observation group′s incidence of complications was 10.00%(3/30),which was sig-nificantly lower than the control group′s 22.64%(12/53) (χ2 =12.16,P <0.05).Conclusion The total hip arthroplasty has a significant effect in the treatment of femoral neck fractures in elderly ,patients have good recovery of joint function with a low incidence of complications which can be used as the preferred solution for clinical treatment .

Fourty-eight patients infected by Plasmodium vivax were randomly divided into chloroquine regimen groups A and B.Each case in group A received a total dosage of 1 200 mg(base) over a 3-day period(600 mg on the first day then 300 mg daily).Cases in group B each received total dosage of 1 500 mg(base) in 3 days(750 mg on the first day then 375 mg daily).Body temperature and blood smears were examined on days 0, 1, 2, 3, 7, 14, 21 and 28, respectively.All patients were negative for asexual parasites within 3 days.The cure rate on day 28 was 100%.Results showed that P.vivax is sensitive to chloroquine in Laza, Myanmar, and chloroquine can still be used for the imported vivax malaria cases at the China-Myanmar border.