1.Progress on study of factors influencing the prognosis and complications of surgery for discoid meniscus injury in children
Hai-Rui ZHANG ; Zhi-Yao ZHAO ; Bing-Zhe HUANG ; Xiao-Ning LIU
China Journal of Orthopaedics and Traumatology 2024;37(1):98-102
The discoid meniscus is a common congenital meniscal malformation that is prevalent mainly in Asians and of-ten occurs in the lateral discoid meniscus.Patients with asymptomatic discoid meniscus are usually treated by conservative methods such as observation and injury avoidance,while patients with symptoms and tears need to be treated surgically.Arthroscopic saucerization combined with partial meniscectomy and meniscus repair is the most common surgical approach.,and early to mid-term reports are good.The prognostic factors are the patient's age at surgery、follow-up time and type of surgery.Some patients experience complications such as prolonged postoperative knee pain,early osteoarthritis,retears and Osteochondritis dissecans.The incidence of prolonged postoperative knee pain was higher and the incidence of Osteochondritis dissecans was the lowest.Retears of the lateral meniscus is the main reason for reoperation.
2.Application of combined cone-beam CT and ExacTrac X-ray image-guided system in high-grade glioma radiotherapy
Jun ZHOU ; Han-Xu LI ; Zhi-Bing HUANG ; Jiu-Qing WAN ; Dong-Chun LI ; Liang-Zhi ZHONG
Chinese Medical Equipment Journal 2024;45(8):57-62
Objective To explore the optimal image-guided verification mode by using combined cone-beam CT(CBCT)and ExacTrac X-ray(ETX)image-guided system for the position verification during the first and remaining fractionated radiotherapy of high-grade glioma patients.Methods Twenty high-grade glioma patients undergoing intensity-modulated radiotherapy at some hospital from January 2018 to June 2020 were analyzed retrospectively.CBCT image-guided system was used for the patients treated for the first time to determine the corresponding position of the treatment center on the body surface and to reset and mark the treatment center,then on-line auto registration of the CBCT images with CT positioning images was carried out,and the residual setup errors were verified with ETX image-guided system;position verification of the setup errors was performed with ETX image-guided sysem during the remaining fractionated treatment.The setup errors and their interval distributionswere calculated for the patients in six directions including left-right direction(Lat),head-foot direction(Lng),anterior-posterior direction(Vrt),rotation around left-right(Pitch),rotation around head-foot(Roll)and rotation around anterior-posterior(Yaw).SPSS 22.0 statistical software was used for data analysis.Results There were 75%patients treated for the first time and 78.62%ones undergoing the remaining fractionated radiotherapy only needed one time of setup error corre-ction.Combined CBCT and ETX image-guided resetting during the first radiotherapy met clinical requirements;during the remaining fractionated radiotherapy there were significant differences between the setup errors in the six directions before and after calibration(P<0.05).The interval distribution of setup errors showed the error values in the six directions were all restricted within 0 to 1 mm and within 0° to l °during the first and remaining fractionated radiotherapy.Conclusion Involve-ment of combined CBCT and ETX image-guided system in the first and remaining fractionated radiotherapy of high-grade glioma patients after operation contributes to determining and resetting the treatment center rapidly and accurately,decreasing setup errors and enhancing the accuracy and repeatability of radiotherapy.[Chinese Medical Equipment Journal,2024,45(8):57-62].
3.The Study of Recombinant Interfering Lentiviruses and Overex-pressed Adenovirus Vectors Targeting Human c-Cbl Gene:Con-struction,Identification and Efficacy
Qi-Xin SUN ; Bing-Yi WU ; Qian-Qian YAO ; Zhi-Wei HUANG ; Zhi-Gang ZHU
Journal of Experimental Hematology 2024;32(1):274-281
Objective:To construct recombinant lentivirus and adenovirus which regulate the expression of c-Cbl gene and evaluate their efficacy.Methods:The interference lentivirus and overexpressed adenovirus targeting human c-Cbl gene were constructed by gene recombination technology.Quantitative PCR and western blotting were used to detect the expression changes in c-Cbl gene and its transcription after leukemia cells(HL60,THP1)were infected by virus.Results:Three recombinant interfering lentiviral vectors targeting human c-Cbl genes to successfully constructed and were identified by DNA sequencing,and the titers of the packaged viruses were all greater than 1 x 108 TU/ml.Among them,shRNA-2 lentivirus had the highest interference efficiency,and the expression of c-Cbl gene and CBL protein were decreased about 95%and 60%respectively after leukemia cells were infected with shRNA-2;In addition,the recombinant overexpression adenovirus targeting human c-Cbl gene was packaged successfully with the virus titer greater than 1 x 109 TU/ml.When leukemia cells were infected with adenovirus,the expression of c-Cbl gene and CBL protein were up-regulated about 10 times and 1.5 times respectively.Conclusion:Both recombinant interfering lentivirus and overexpression adenovirus can efficiently infect leukemia cells and affect the expressions of c-Cbl gene and CBL protein.It will lay a preliminary foundation for the subsequent study on the function of c-Cbl gene in tumor cells.
4.Efficacy differences between electroacupuncture and moxibustion for neurogenic bladder after spinal cord injury: a randomized controlled trial.
Hui-Lin WEI ; Ya-Feng REN ; Zhi-Lan ZHANG ; Xiao-Meng HUANG ; Bing LI
Chinese Acupuncture & Moxibustion 2023;43(9):1036-1041
OBJECTIVE:
To compare the clinical efficacy between electroacupuncture(EA) and moxibustion for neurogenic bladder (NB) after spinal cord injury (SCI).
METHODS:
One hundred and twenty patients with NB after SCI were randomly divided into an EA group, a moxibustion group, and an intermittent catheterization group, with 40 patients in each group. The patients in the intermittent catheterization group were treated with routine treatment and intermittent catheterization, while the patients in the EA group and the moxibustion group were treated with additional treatments of EA (discontinuous wave, with a frequency of 1.3-1.6 Hz, and intensity based on patient tolerance) and moxibustion, respectively. The acupoints used in both groups were Zhongji (CV 3) and Guanyuan (CV 4), bilateral Zusanli (ST 36), Yinlingquan (SP 9), and Baliao points. Each session lasted for 30 min, once daily, six times a week, for a total of six weeks.The maximum bladder capacity (MBC), residual urine vdume (RUV), detrusor pressure (Pdet) during the filling phase, bladder compliance (BC), maximum renal pelvis separation width of both kidneys, urine white blood cell count, TCM syndrome score, and World Health Organization quality of life assessment-BREF (WHOQOL-BREF) score were compared before and after treatment in the 3 groups. The number of patients in each group who achieved bladder functional balance was recorded, and the clinical efficacy was assessed after treatment.
RESULTS:
After treatment, the MBC, Pdet, BC, and WHOQOL-BREF scores in the EA group and the moxibustion group were increased (P<0.05), while the RUV, maximum renal pelvis separation width of both kidneys, urine white blood cell count, and TCM syndrome scores were decreased (P<0.05, P<0.01). In the intermittent catheterization group, MBC, RUV, maximum renal pelvis separation width of both kidneys, and urine white blood cell count were decreased (P<0.05), while BC and WHOQOL-BREF score were increased (P<0.05) after treatment. After treatment, the MBC, Pdet, BC, and WHOQOL-BREF scores in the EA group and the moxibustion group were higher than those in the intermittent catheterization group (P<0.05), while the RUV and TCM syndrome scores were lower than those in the intermittent catheterization group (P<0.05). Moreover, after treatment, the MBC and Pdet in the moxibustion group were higher than those in the EA group (P<0.05), while the RUV, maximum renal pelvis separation width of both kidneys, and TCM syndrome score in the EA group were lower than those in the moxibustion group (P<0.05). The number of patients who achieved bladder functional balance after treatment in the EA group and the moxibustion group was higher than that in the intermittent catheterization group (P<0.05). The cured and effective rate was 85.0% (34/40) in the EA group and 82.5% (33/40) in the moxibustion group, which were both higher than 65.0% (26/40) in the intermittent catheterization group (P<0.05), there was no significant difference between the EA group and the moxibustion group (P>0.05).
CONCLUSION
EA and moxibustion could effectively improve the functional state of bladder in patients with NB after SCI. EA is more effective in reducing residual urine volume and excessive activity of the urethral sphincter, and relieving TCM syndromes, while moxibustion is more effective in increasing the pressure of the detrusor during the filling period and establishing the detrusor reflex.
Humans
;
Urinary Bladder, Neurogenic/therapy*
;
Electroacupuncture
;
Moxibustion
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Quality of Life
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Spinal Cord Injuries/therapy*
;
Syndrome
5.Study on the Interventional Effects of Cornus Officinalis Before and After Wine Preparation in Liu Wei Di Huang Decoction on Postmenopausal Osteoporosis Model Rats Based on Medicinal
Zhi WEN ; Hui YU ; Qiong LONG ; Jiaying TAN ; Li HUANG ; Wangzhong XIAO ; Bing DAI
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(8):2717-2725
Objective To establish a dual wavelength HPLC method to compare the content changes of seven active components:monoglycoside,loganin,swertin,paeoniflorin,gallic acid,5-hydroxymethyl furfural and paeonol in Liuwei Dihuang Decoction(hereinafter referred to as"Liuweidihuang Decoction")before and after the preparation of Cornus wine;To explore the effect and mechanism of Liu(Shan)and Liu(Jiu)on 90 days after ovariectomy in postmenopausal osteoporosis model rats.Methods ①The contents of seven active ingredients in the Cornus wine mixed with Liuwei Dihuang Decoction were determined by dual wavelength HPLC.Chromatographic conditions:hypersil C18 chromatography(4.6 mm×250 mm,5 μm),mobile phase acetonitrile-0.3%phosphoric acid,gradient elution(0-7 min,0%-8%acetonitrile;7-15 min,8%-10%;15-20 min,10%-15%;20-30 min,15%-23%;30-50 min,23%-45%),flow rate 0.6 mL·min-1,detection wavelength:240 nm(monoglycoside,loganin,swertin,paeoniflorin),274 nm(gallic acid,5-hydroxymethyl furfural,paeonol),column temperature 30℃,injection volume 20 μL.②6-8 month old SD rats,divided into sham-operated group,model group,positive drug group,shanshuang flesh with Liuwei Dihuang Decoction group(liu(shan)group)and wine cornelian flesh withLiuwei Dihuang Decoction group(liu(wine)group),dosing started on the 5 d after ovariectomy,weighed weekly,and 5 rats from each group were taken at 90 d after surgery,weighed,anaesthetized,serum taken,bilateral femurs,and organs(uterus,spleen,liver,both kidneys and heart)were weighed.Serum calcium(Ca),phosphorus(P)and estradiol(E2)levels were measured using a fully automated biochemical instrument and chemiluminescent microparticle immunoassay,respectively;bone mineral density(BMD)values were measured using a dual-energy X-ray bone densitometer.HE staining was used to observe the morphological changes of bone tissue in rats.Results ①All the seven potent ingredients mentioned above were contained in the Liuwei Dihuang Decoction before and after the wine preparation of Cornu Cervi Pantotrichum,and the total content of the seven potent ingredients in liu(wine)was higher than that in liu(shan)(P<0.01).Among them,gallic acid and 5-hydroxymethylfurfural were higher in Liu(Jiu)than in Liu(Shan)(P<0.01),while the content of monosidine was lower than in Liu(Shan)(P<0.01).②Comparison with the sham-operated group:90 d after surgery,the serum Ca,P,E2 levels and uterine index of rats in the model group decreased(P<0.01),the BMD value decreased(P<0.01),and the degree of structural damage to bone tissue The degree of damage to the bone tissue structure was deepened,manifested by enlargement of the bone marrow cavity,gradual increase of adipocytes,dilution of the bone trabeculae arrangement,reduction of the number of bone trabeculae or even fracture.③Compared with the model group,90 d after surgery,the serum E2,Ca,P levels and uterine index of the rats in the liu(shan)and liu(wine)groups increased(P<0.05),the bone tissue structure of the liu(shan)and liu(wine)groups improved significantly,and the BMD value increased significantly(The liver and spleen indices of the liu(wine)groups increased(P<0.05).Conclusion The combination of the wine preparation of Cornus officinalis and its use in the formula of LiuWei Di Huang Decoction both contain monosidine,strychnine,sweretin,paeoniflorin,gallic acid,5-hydroxymethyl furfural(5-HMF)and tannin,and can effectively interfere with PMOP.Among them,the anti-osteoporotic effect of Liu Wei Di Huang Tang,which was formulated with wine and dogwood,was better than that of Liu Wei Di Huang Tang,which was formulated with Cornus officinalis,and the former contained more 5-HMF and gallic acid than the latter,which may provide some experimental basis for the selection of wine and dogwood in the 2020 edition of the Pharmacopoeia and the clinical application of Liu Wei Di Huang Tang in the prevention and treatment of PMOP.
6.Dosimetric difference between VMAT and dMLC-IMRT after breast-conserving surgery for left-sided breast cancer
Zong-Pu MAO ; Qi-Bing WU ; Cheng HUANG ; Zhi WANG
Chinese Medical Equipment Journal 2023;44(9):59-63
Objective To investigate the dosimetric difference between volume modulated arc therapy(VMAT)and dynamic multi-leaf collimator intensity modulated radiation therapy(dMLC-IMRT)after breast-conserving surgery for left-sided breast cancer so as to optimize the treatment plan for the patient.Methods The clinical data of 15 patients admitted to the radiothe-rapy department of some hospital after breast-conserving surgery for left-sided breast cancer were selected retrospectively.Three groups of plans were designed for each patient,including continue volume modulated arc therapy(cVMAT),tangent volume modulated arc therapy(tVMAT)and dMLC-IMRT plans,and then compared in terms of the dosimetric parameters of the tumor target areas and organs at risk.SPSS 25.0 software was used for statistical analysis.Results The three groups had the dose distribution of the tumor target areas meet clinical requirements,which had significant differences between the values of D2,Dmean,conformity index(CI)and homogeneity index(HI),while the difference between the numbers of monitor units were not statistically significant.The dMLC-IMRT group had higher D2 value while lowerDmeanthan the cVMAT and tVMAT groups;for CI the cVMAT behaved the best in the three groups,followed by the tVMAT group.In the low-dose region,the cVMAT and tVMAT groups had larger illuminated volumes of the affected lung than the dMLC-IMRT group;the tVMAT group had the smallest illuminated volume of heart in the three groups,and the cVMAT group had the illuminated volume of heart slightly higher than that of the dMLC-IMRT group.In the high-dose region,the cVMAT and tVMAT groups had smaller illuminated volumes of the affected lung than the dMLC-IMRT group,and the illuminated volume of the affected lung of the tVMAT group was larger than that of the cVAMT group;the dMLC-IMAT group had the largest illuminated volume of heart in the three groups,and the differences between the tVMAT and cVMAT groups were not statistically significant.Conclusion In the design of intensity-modulated radiotherapy plans after breast-conserving surgery for left-sided breast cancer,VMAT behaves better than dMLC-IMRT in conformability to the tumor target area and protection of heart and lung at risk.[Chinese Medical Equipment Journal,2023,44(9):59-63]
7.Management and prognosis of extremely preterm infants with gestational age ≤25+6 weeks.
Yan Liang YU ; Hui Feng ZHONG ; Chun CHEN ; Wen Tao GONG ; Yi Chu HUANG ; Bing Chun LIN ; Zhi Feng HUANG ; Chuan Zhong YANG
Chinese Journal of Pediatrics 2023;61(1):36-42
Objective: To investigate the outcomes including major complications and prognosis of extremely preterm infants with gestational age ≤25+6 weeks. Methods: The cross-sectional study enrolled 233 extremely preterm infants with gestational age ≤25+6 weeks who were admitted to the Department of Neonatology of Shenzhen Maternity and Child Healthcare Hospital from January 2015 to December 2021. The clinical data including perinatal factors, treatments, complications, and prognosis were extracted and analyzed. These extremely preterm infants were also grouped according to gestational age and year of admission to further analyze their survival rate, major complications, causes of death, and long-term outcomes. The comparisons between the groups were performed with Chi-square test and Kruskal-Wallis. Results: Among these 233 extremely preterm infants, 134 (57.5%) were males and 99 (42.5%) females. The gestational age was (24.6±0.9) weeks, the birth weight was 710.0 (605.0,784.5) g, and the overall survival rate was 61.8% (144/233). Among the surviving extremely preterm infants, the earliest gestational age was 22+2 weeks and the lowest birth weight was 390 g. There were 17.6% (41/233) of extremely preterm infants had treatment withdrawn and were discharged in line with the will of guardians. Among the rest 192 extremely preterm infants managed with aggressive treatments, 14 (7.3%) died in hospital and 34 (17.7%) had treatment withdrawn later due to severe complications. Of the 192 extremely preterm infants, 144 (75.0%) survived, and the survival rate increased year by year (χ2=26.28, P<0.001) while the mortality decreased year by year (χ2=14.09, P=0.027). Among the survivors, 20.8%(30/144) had no major complications, and the incidence of complications was also negatively related with the gestational age (χ2=7.24, P=0.044), and the length of invasive ventilation was negatively related to the gestational age (χ2=29.14, P<0.001). In the group of less than 23+6 weeks, all extremely preterm infants had one or more major complications. The follow-up were completed in 122 infants and revealed that delayed motor development, language retardation, and hearing and vision impairment accounted for 17.2% (21/122), 8.2% (10/122) and 17.2% (21/122), respectively. Conclusions: Extremely preterm infants with gestational age ≤25+6 weeks are difficult to treat, but the survival rate of infants undergoing aggressive treatments increases year by year. Although the prevalence of major complications is still high, most extremely preterm infants have acceptable prognosis during follow-up.
Female
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Humans
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Infant
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Infant, Newborn
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Male
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Pregnancy
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Birth Weight
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Cross-Sectional Studies
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Gestational Age
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Infant, Extremely Premature
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Prognosis
;
Retrospective Studies
8.Epidemiological characteristics of cardio-metabolic risk factors among children and adolescents aged 7-17 years in 4 provinces of China.
Zhi Ru WANG ; Wei Yi LI ; Hong Ru JIANG ; Xiao Fang JIA ; Fei Fei HUANG ; Xiao HU ; Hui Jun WANG ; Bing ZHANG ; Zhi Hong WANG
Chinese Journal of Epidemiology 2023;44(4):592-597
Objective: This study aimed to investigate the epidemiological characteristics of cardio-metabolic risk factors among children and adolescents aged 7-17 years in (Hebei, Zhejiang, Shaanxi, Hunan) 4 provinces of China and the influence of demographic and economic characteristics on them. Methods: A total of 1 747 children and adolescents aged 7-17 from a Community-based Cohort Study on Nervous System Disease in 2018 were selected. High waist circumference, central obesity, elevated TG, elevated TC, elevated LDL-C, decreased HDL-C, elevated blood pressure, elevated blood glucose, and clustering of risk factors was analyzed. χ2 test was used for univariate analysis, multivariate logistic regression was used to analyze the correlation between demographic and economic factors and risk factors, and the Cochran-Armitage trend test was used for trend analysis. Results: The detection rates of high waist circumference, decreased HDL-C, elevated blood pressure, elevated TG, elevated blood glucose, central obesity, elevated TC, and elevated LDL-C were 29.08%, 15.28%, 13.17%, 13.05%, 11.79%, 7.33%, 6.53%, and 5.15%, respectively. The rate of clustering of risk factors was 18.37%. Multivariate logistic regression analysis showed that the risk of high waist circumference in girls was higher than that in boys (OR=1.67, 95%CI: 1.26-2.22), and the risk of elevated blood glucose and clustering of risk factors was lower than that in boys (OR=0.69, 95%CI: 0.49-0.99; OR=0.72, 95%CI: 0.53-0.99). The risk of high waist circumference, decreased HDL-C, and clustering of risk factors in 13-17 years old group was higher than that in the 7-year-olds group (OR=2.24, 95%CI: 1.65-3.04; OR=1.59, 95%CI: 1.20-2.11; OR=1.75, 95%CI: 1.26-2.44), but the risk of central obesity was lower (OR=0.54, 95%CI: 0.37-0.78). The risk of elevated TC, elevated TG, and decreased HDL-C in children and adolescents in southern was higher than that in northern parts of China (OR=1.88, 95%CI: 1.25-2.83; OR=1.61, 95%CI: 1.17-2.22; OR=1.55, 95%CI: 1.19-2.04), but the risk of high waist circumference and central obesity was lower than that in northern China (OR=0.57, 95%CI: 0.43-0.75; OR=0.62, 95%CI: 0.42-0.90). The risk of decreased HDL-C in rural children and adolescents was higher than in urban children and adolescents (OR=1.36, 95%CI: 1.02-1.83). The risk of multiple risk factors increased with the increase in average monthly household income per capita and BMI level. Conclusions: High waist circumference, decreased HDL-C and elevated blood pressure were prominent cardio-metabolic risk factors among children and adolescents aged 7-17 years in 4 provinces of China in 2018. The region, average monthly household income per capita, and BMI were the main influencing factors of cardio-metabolic risk factors.
Male
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Female
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Humans
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Child
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Adolescent
;
Obesity, Abdominal/epidemiology*
;
Cholesterol, LDL
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Blood Glucose
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Cohort Studies
;
Body Mass Index
;
Risk Factors
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Obesity
;
Hypertension
;
China/epidemiology*
;
Waist Circumference
9.Evaluation of chemosensory function in patients with upper respiratory tract post-viral olfactory dysfunction.
Yi Chen GUO ; Lin Yin YAO ; Zhi Fu SUN ; Jia LIU ; Xiao Bing HUANG ; Yong Xiang WEI
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2022;57(1):29-35
Objective: To observe the changes of olfactory function, intranasal trigeminal nerve function and taste function in patients with upper respiratory tract post-viral olfactory dysfunction (PVOD), and to explore the correlation of chemosensory function. Methods: The clinical data of 42 patients with PVOD who visited to the Olfactory and Taste Center of Otorhinolaryngology Head and Neck Surgery Department of Beijing Anzhen Hospital from January to December of 2019 were analyzed retrospectively, including 20 males and 22 females, aging (48.86±11.47) years (x¯). Twenty subjects in normal control group were selected according to the sex ratio of PVOD patients. Sniffin' Sticks olfactory tests were performed on the subjects, including threshold test (T), discrimination test (D) and identification test (I), and the sum of the above three test scores was the TDI value. At the same time, olfactory event-related potentials (oERPs), trigeminal event-related potentials (tERPs) and taste function test were performed. According to the taste function test, the patients were divided into normal gustation (NG) group and gustatory dysfunction (GD) group. The results of olfaction, taste and intranasal trigeminal nerve function tests were compared among different groups, and the correlation analysis was carried out. SPSS statistical software was used for statistical analysis. Results: GD was present in 14 (33.3%) of 42 PVOD patients with a course of PVOD of 5 (3, 6) months (M (Q1, Q3)). The gustatory function of patients with PVOD was related to gender (r=0.565, P<0.001), smoking status (r=-0.512, P=0.001), duration (r=-0.357, P=0.020) and olfactory function (all P<0.05). The olfactory function of GD group was worse than that of NG group, and the differences of TDI value and T value between the two groups were statistically significant (10.25±4.58 vs 13.35±3.61, 1.54±0.66 vs 2.10±0.88, t value was 2.40 and 2.10 respectively, both P<0.05). The amplitudes of oERPs and tERPs were significantly lower in GD group than those in NG group (all P<0.05). Conclusion: In patients with PVOD, the subjective and objective olfactory function, intranasal trigeminal nerve function and taste function were decreased, and there was a correlation, suggesting that there was a synergistic effect between the chemosensory functions of PVOD patients.
Female
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Humans
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Male
;
Nose
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Olfaction Disorders/etiology*
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Retrospective Studies
;
Smell
;
Taste
10.Progress on clinical trials of common gastrointestinal cancer drugs in China from 2012 to 2021.
Hui Yao HUANG ; Da Wei WU ; Qi ZHU ; Yue YU ; Hai Xue WANG ; Jun WANG ; Man GA ; Xin Yu MENG ; Jing Ting DU ; Shuang Man MIAO ; Zhi Xia ZHAO ; Xin WANG ; Pu SHANG ; Min Jiang GUO ; Li Hong LIU ; Yu TANG ; Ning LI ; Cai CAO ; Bing He XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2022;44(3):276-281
Objective: Systematically summarize the research progress of clinical trials of gastric cancer oncology drugs and the overview of marketed drugs in China from 2012 to 2021, providing data and decision-making evidence for relevant departments. Methods: Based on the registration database of the drug clinical trial registration and information disclosure platform of Food and Drug Administration of China and the data query system of domestic and imported drugs, the information on gastric cancer drug clinical trials, investigational drugs and marketed drugs from January 1, 2012 to December 31, 2021 was analyzed, and the differences between Chinese and foreign enterprises in terms of trial scope, trial phase, treatment lines and drug type, effect and mechanism studies were compared. Results: A total of 114 drug clinical trials related to gastric tumor were registered in China from 2012 to 2021, accounting for 3.7% (114/3 041) of all anticancer drug clinical trials in the same period, the registration number showed a significant growth rate after 2016 and reached its peak with 32 trials in 2020. Among them, 85 (74.6%, 85/114) trials were initiated by Chinese pharmaceutical enterprise. Compared with foreign pharmaceutical enterprise, Chinese pharmaceutical enterprise had higher rates of phase I trials (35.3% vs 6.9%, P=0.001), but the rate of international multicenter trials (11.9% vs 67.9%, P<0.001) was relatively low. There were 76 different drugs involved in relevant clinical trials, of which 65 (85.5%) were targeted drugs. For targeted drugs, HER2 is the most common one (14 types), followed by PD-1 and multi-target VEGER. In the past ten years, 3 of 4 marketed drugs for gastric cancer treatment were domestic and included in the national medical insurance directory. Conclusions: From 2012 to 2021, China has made some progress in drug research and development for gastric carcinoma. However, compared with the serious disease burden, it is still insufficient. Targeted strengthening of research and development of investment in many aspects of gastric cancer drugs, such as new target discovery, matured target excavating, combination drug development and early line therapy promotion, is the key work in the future, especially for domestic companies.
China
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Gastrointestinal Agents/therapeutic use*
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Gastrointestinal Neoplasms
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Humans
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Pharmaceutical Preparations
;
United States
;
United States Food and Drug Administration

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