1.Placebo Design Methodology for Clinical Trials of Pastes for Acupoint Application
Xinyan YANG ; Bingyu PU ; Meng WANG ; Jian WANG
Journal of Traditional Chinese Medicine 2025;66(10):1011-1016
Reasonable and standardised placebo setting for acupoint application pastes is a key factor for clinical trials to verify the safety and effectiveness of acupoint application. By sorting out the current design status of placebo in the allocation concealment and blind design, paste components, paste location, paste duration in the current clinical trials of acupoint application pastes, it is proposed that there are problems such as low application rate of blinding and non-standardised reporting, insufficient standardisation of placebo settings and lack of systematic research, and lack of uniform standards of the placebo evaluation method. Based on the action mechanism of acupoint application, the idea of setting placebo for acupoint application paste is proposed in terms of replacing the application material, controlling the physicochemical effect produced by transdermal absorption of drugs, and setting the permeability of placebo, in order to enrich the methodological content of the placebo setting for acupoint application, and providing more scientific and reliable clinical evidence of acupoint application.
2.The effect of Ba Duan Jin on the balance of community-dwelling older adults: a cluster randomized control trial
Leilei DUAN ; Yubin ZHAO ; Yuliang ER ; Pengpeng YE ; Wei WANG ; Xin GAO ; Xiao DENG ; Ye JIN ; Yuan WANG ; Cuirong JI ; Xinyan MA ; Cong GAO ; Yuhong ZHAO ; Suqiu ZHU ; Shuzhen SU ; Xin'e GUO ; Juanjuan PENG ; Yan YU ; Chen YANG ; Yaya SU ; Ming ZHAO ; Lihua GUO ; Yiping WU ; Yangnu LUO ; Ruilin MENG ; Haofeng XU ; Huazhang LIU ; Huihong RUAN ; Bo XIE ; Huimin ZHANG ; Yuhua LIAO ; Yan CHEN ; Linhong WANG
Chinese Journal of Epidemiology 2024;45(2):250-256
Objective:To assess the effectiveness of a 6-month Ba Duan Jin exercise program in improving the balance of community-dwelling older adults.Methods:A two arms, parallel-group, cluster randomized controlled trial was conducted in 1 028 community residents aged 60-80 years in 40 communities in 5 provinces of China. Participants in the intervention group (20 communities, 523 people) received Ba Duan Jin exercise 5 days/week, 1 hour/day for 6 months, and three times of falls prevention health education, and the control group (20 communities, 505 people) received falls prevention health education same as the intervention group. The Berg balance scale (BBS) score was the leading outcome indicator, and the secondary outcome indicators included the length of time of standing on one foot (with eyes open and closed), standing in a tandem stance (with eyes open and closed), the closed circle test, and the timed up to test.Results:A total of 1 028 participants were included in the final analysis, including 731 women (71.11%) and 297 men (28.89%), and the age was (69.87±5.67) years. After the 3-month intervention, compared with the baseline data, the BBS score of the intervention group was significantly higher than the control group by 3.05 (95% CI: 2.23-3.88) points ( P<0.001). After the 6-month intervention, compared with the baseline data, the BBS score of the intervention group was significantly higher than the control group by 4.70 (95% CI: 4.03-5.37) points ( P<0.001). Ba Duan Jin showed significant improvement ( P<0.05) in all secondary outcomes after 6 months of exercise in the intervention group compared with the control group. Conclusions:This study showed that Ba Duan Jin exercise can improve balance in community-dwelling older adults aged 60-80. The longer the exercise time, the better the improvement.
3.Application of pulsed Thulium fiber laser enucleation in treatment of benign prostatic hyperplasia
Xiaoda LAN ; Xinyan CHE ; Jianing HAN ; Kunlin YANG ; Chao ZUO ; Qian ZHANG ; Kai ZHANG ; Yisen MENG
Chinese Journal of Urology 2024;45(5):372-378
Objective:To investigate the safety and efficacy of pulsed Thulium fiber laser enucleation (ThuFLEP) in the treatment of benign prostatic hyperplasia (BPH).Methods:Clinical data of 238 BPH patients who underwent ThuFLEP from November 2022 to November 2023 at Peking University First Hospital were retrospectively analyzed. Patients were divided into two groups based on different surgical techniques: 199 patients underwent traditional continuous-wave Thulium fiber laser prostatectomy (C-ThuFLEP group), and 39 patients underwent Thulium fiber laser enucleation with pulse modulation (P-ThuFLEP group). Propensity score matching was used to balance baseline characteristics between the two groups. Operative time, resected tissue weight, pre- and postoperative hemoglobin decrease, postoperative hospital stay, and postoperative catheterization time were recorded and compared between the matched groups. Intraoperative and short-term postoperative complications were also recorded and compared between the two groups. Follow-up assessments at 1 month postoperatively were conducted to compare the maximum urinary flow rate (Q max), international prostate symptom score (IPSS), international index of erectile function (IIEF-5) score, quality of life (QOL) score, and International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score between the two groups, as well as changes in Q max and IPSS, IIEF-5, and QOL before and after surgery. Results:After matching, a total of 60 patients were included, with 30 patients in each group. There were no statistically significant differences between the two groups in terms of age [(68.73±6.91) years vs. (71.07±7.34) years], American Society of Anesthesiologists (ASA) score (1-2/3-4: 23/7 vs. 23/7), comorbidity count (0-1/>1: 15/15 vs. 15/15), prostate volume [68.3 (50.0, 105.3) ml vs. 63.3 (45.7, 106.0) ml], preoperative IPSS score [24 (21, 29) vs. 23 (14, 26)], IIEF-5 score [5 (0, 15) vs. 5 (0, 13)], and QOL score [5 (4, 6) vs. 5 (5, 6)] (all P>0.05). The tissue removal rate in the P-ThuFLEP group was higher than that in the C-ThuFLEP group [0.82 (0.71, 1.18) g/min vs. 0.72 (0.46, 0.95) g/min, P=0.026], while there were no statistically significant differences between the two groups in operative time [47 (37, 79) min vs. 65 (33, 87) min], resected tissue weight [45 (31, 75) g vs. 33 (22, 65) g], postoperative hemoglobin decrease [17 (10, 23) g/L vs. 12 (7, 19) g/L], postoperative hospital stay [4 (3, 5) days vs. 4 (3, 5) days], and postoperative catheterization time [3 (3, 5) days vs. 3 (3, 6) days]. The incidence of intraoperative complications in both groups was 10% (3/30), with no statistically significant difference ( P=1.000), and no severe complications of grade Ⅲ or above occurred. There were no statistically significant differences in Q max [24 (15, 33) ml/s vs. 16 (10, 32) ml/s], IPSS score [14 (12, 15) vs. 9 (7, 12)], QOL score [2 (1, 3) vs. 2 (1, 3)], and IIEF-5 score [3 (0, 5) vs. 3 (0, 6)] between the C-ThuFLEP and P-ThuFLEP group at 1 month postoperatively (all P > 0.05), and both showed significant improvement compared to preoperative values (all P < 0.05). The ICIQ-SF score in the P-ThuFLEP group was lower than that in the C-ThuFLEP group [0 (0, 4) vs. 4 (3, 8)], with a statistically significant difference ( P=0.033). Conclusions:Compared with traditional continuous-wave Thulium fiber laser prostatectomy, pulse-modulated Thulium fiber laser enucleation demonstrates higher efficiency in tissue removal, lower early postoperative ICIQ-SF score for urinary incontinence, similar risk of intraoperative complications, and can be safely and effectively applied in the surgical treatment of BPH patients.
4.Predictive value of preoperative pelvic floor electrophysiological parameters on early urinary incontinence following radical prostatectomy
Shuhui YU ; Jianing HAN ; Lijun ZHONG ; Congyu CHEN ; Yunxiang XIAO ; Yanbo HUANG ; Yang YANG ; Xinyan CHE
Journal of Peking University(Health Sciences) 2024;56(4):594-599
Objective:To explore the predictive value of preoperative pelvic floor electromyography(EMG)parameters for the risk of urinary incontinence after prostate cancer surgery.Methods:This study retrospectively analyzed the medical records of 271 patients who underwent radical prostatectomy in the urology department of Peking University First Hospital from January 2020 to October 2022.The data included patient age,body mass index(BMI),international prostate symptom score(IPSS),prostate-specific antigen(PSA)levels,Gleason score,type of surgery,urethral reconstruction,lymph node dis-section,nerve preservation,catheterization duration,D'Amico risk classification,American Society of Anesthesiologists(ASA)score,Charlson comorbidity index,postoperative duration,prostate volume,and pelvic floor EMG parameters(pre-resting mean,fast muscle mean,and slow muscle mean scores).Independent risk factors affecting early postoperative urinary incontinence were identified through multiva-riate Logistic regression analysis.The predictive efficacy of pelvic floor EMG results was evaluated by cal-culating the area under the receiver operating characteristic(ROC)curve,and the optimal threshold for early postoperative urinary incontinence was determined based on the Youden index and clinical signifi-cance.Results:The study included 271 prostate cancer patients,with an 81.9%rate of voluntary urinary control post-surgery.The median score for fast pelvic floor muscles was 23.5(18.2,31.6),and for slow muscles,it was 12.5(9.6,17.3).Among the patients,179(66.1%)did not preserve nerves,and 110(40.6%)underwent urethral reconstruction.Advanced age and low fast muscle scores were identified as independent risk factors for urinary incontinence.Patients aged ≤60 had 5.482 times the voluntary urinary control rate compared with those aged ≥70(95%CI:1.532-19.617,P<0.05).There was a significant correlation between fast muscle scores and urinary incontinence recovery(OR=1.209,95%CI:1.132-1.291,P<0.05).When the optimal threshold for preoperative fast muscle score was set at 18.5,the ROC sensitivity and specificity were 80.6%and 61.2%,respectively.Con-clusion:Preoperative pelvic floor EMG parameters show good predictive accuracy and clinical applicabili-ty for the risk of urinary incontinence after prostate cancer surgery.These parameters can be used for ear-ly identification of urinary incontinence risk,with age and fast muscle scores being important predictors.
5.Imaging features and differential diagnosis of arrested pneumatisation of the sphenoid sinus
Zhongyu YAN ; Chengyao LIU ; Xinyan WANG ; Zheng LI ; Bentao YANG ; Junfang XIAN
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(7):451-455
OBJECTIVE To Analysis of CT and MRI imaging features of arrested pneumatisation of the sphenoid sinus and differentiate from osteogenic and chondrogenic tumours of the region.METHODS Retrospective analysis of CT and MRI findings was performed of 13 patients with sphenoid sinus arrested pneumatisation and 20 patients with osteogenic and chondrogenic tumours and tumor like lesions in the same period.Evaluation indicators included location,size,density,presence of expansive changes,calcification,cortical bone changes,MRI signal characteristics,signal changes after fat suppression,degree of enhancement,and statistical analysis was conducted.RESULTS Finally,the location includes the sphenoid body(4 cases),pterygoid process(3 cases)and multiple involved areas(6 cases).The arrested pneumatisation area is mainly characterized by fat density or mixed density of adipose and soft tissue.The longest diameter of the arrested pneumatisation zone is 0.8-4.1 cm.There is internal calcification(7 cases)and without bone expansive changes(13 cases).Cases with intact bone cortex(13 cases);On MRI T1WI,high signal(11 cases),equal signal(2 cases),on T2WI,high signal(10 cases),equal signal(3 cases).Decreased signal after fat suppression(13 cases),no significant enhancement(10 cases),and slight enhancement(3 cases).CONCLUSION The arrested pneumatisation of sphenoid sinus is a rare anatomical variation characterized by a mixed density of fat or soft tissue,intact bone cortex,without bone expansive changes,decreased signal of MRI fat suppression,and no obvious enhancement,which will help to differentiate from osteogenic and chondrogenic tumours of the region.
6.Relationship between the expression levels of circPIP5K1A and miR-124-3p in serum and the severity of disease and infertility in patients with endometriosis
Ruiping XIE ; Xinyan LI ; Caixia YANG ; Junmei FAN
Chinese Journal of Endocrine Surgery 2024;18(3):423-428
Objective:To investigate the correlation between the expression of cyclic RNA PIP5K1A (circPIP5K1A) and microRNA-124-3p (miR-124-3p) in the serum and the severity of the disease and infertility in patients with endometriosis (EM) .Methods:A total of 110 cases of EM patients admitted to Shanxi Provincial Children's Hospital (Shanxi Maternal and Child Health Hospital) from Jan. 2020 to Jan. 2022 were regarded as the research objects, and were diveded into infertility group (44 cases) and successful pregnancy group (66 cases) according to the pregnancy outcome. General data were collected and the levels of serum miR-124-3p and circPIP5K1A were compared between the two groups; Pearson correlation was applied to analyze the correlation between serum miR-124-3p and circPIP5K1A. The diagnostic value of miR-124-3p and circPIP5K1A levels in patients with stage III-V EM was evaluated by ROC curve; Logistic regression analysis was applied to analyze the factors influencing the occurrence of infertility.Results:The expression level of serum miR-124-3p in stage Ⅰ EM patients (1.06±0.21) was higher than that in stage Ⅱ (0.83±0.19), stage Ⅲ (0.65±0.12) and stage Ⅴ (0.44±0.08), and the serum miR-124-3p level decreased with the increase of r-AFS stage. The differences were statistically significant ( t=54.29, P<0.05). The expression level of circPIP5K1A (0.77±0.12) was lower than that of stage Ⅱ (0.90±0.15), stage Ⅲ (1.20±0.20) and stage Ⅴ (1.53±0.26), and increased with the increase of r-AFS stage, and the differences were statistically significant ( t=90.45, P<0.05). Pearson correlation analysis showed that the expression of circPIP5K1A and miR-124-3p in serum of EM patients was negatively correlated ( r=-0.424, P<0.05) ; the serum miR-124-3p level in infertility group was lower than that in successful pregnancy group, and the serum circPIP5K1A level in infertility group was higher than that in successful pregnancy group ( P<0.05). ROC curve results showed that the area under the curve (AUC) of serum miR-124-3p and circPIP5K1A levels in the diagnosis of stage III-V EM patients was 0.900 and 0.887 respectively. The corresponding sensitivity was 88.24%, 85.29%, and the specificity was 78.95%, 88.16%, respectively. The AUC of combined diagnosis was 0.937, the sensitivity was 82.35%, and the specificity was 90.79%. Multivariate Logistic regression analysis showed that miR-124-3p and circPIP5K1A were related factors affecting infertility ( P<0.05) . Conclusions:The expression of miR-124-3p in the serum of EM patients decreases, and the expression of circPIP5K1A increases. The combined detection of miR-124-3p and circPIP5K1A has certain diagnostic value for the patients with stage III-V EM, and they are closely related to the occurrence of infertility.
7.The efficiency and safety of "U-shape" en bloc enucleation technique in Thulium fiber laser enucleation and resection of prostate
Chao ZUO ; Kunlin YANG ; Xinyan CHE ; Yaming GU ; Yingzhi DIAO ; Xuebing MENG ; Yisen MENG ; Kai ZHANG
Chinese Journal of Urology 2024;45(7):515-520
Objective:To investigate the therapeutic effectiveness and safety of "U shape" en bloc Thulium fiber laser enucleation and resection of the prostate (ThuLERP) technique.Methods:The clinical data of 105 benign prostatic hyperplasia (BPH) patients treated by a single surgeon in Peking University First Hospital from January to October 2022 were retrospectively reviewed. Among them, 50 patients underwent "U-shaped" en bloc technique prostate enucleation (UEBT), and 55 patients underwent prostate lobe removal using the lobe technique (LT). There were no significant differences between UEBT and LT groups ( P>0.05) in term of the age[(69.1±6.9)years old vs.( 68.8±9.1)years old], international prostate symptom score(IPSS)[(22.7±1.9)vs.(22.8±2.7)] and maximum flow rate(Q max ) [(9.0±3.7)ml/s vs.(9.3±4.3)ml/s]. The prostate-specific antigen(PSA) of UEBT group was higher than that of LT group[7.52(3.05, 8.76)ng/ml vs.6.78(1.61, 7.45)ng/ml], and the prostate volume of the UEBT group was larger than that of LT group [(103.49±46.19)ml vs.(75.73±30.69) ml, all P<0.05]. In the UEBT group, the apical of prostate was bluntly enucleated with pre-transection urethral mucosa at the apex of prostate technique. Secondly, glands formed grooves at 12 o'clock after vaporization, which served as anatomical marker. At last, the whole lobe which was like "U shape" were resected using laser. In the LT group, glands was divided to three lobe, the middle, the left and the right lobe was bluntly enucleated respectively. Perioperative data, postoperative complications and clinical outcomes were compared between the two groups. Correlation between enucleation efficiency and enucleation weight was analysed using linear regression. Results:There were no significant differences between the UEBT and LT group ( P>0.05) in term of morcellation time[18(9, 34)min vs.16(8, 28)min], resection rate[(0.5±0.1)g/ml vs.(0.5±0.1)g/ml], catheter indwelling duration[(3.8±1.4)d vs.(3.6±1.1)d] and hospitalization stay[(4.1±0.3)d vs.(3.9±0.8)d].The difference between the UEBT group and LT group in operation time[54(42, 100)min vs.80(60, 150)min], enucleated time[37(26, 75)min vs.47(31, 69)min], hemostasis time[4(3, 6)min vs.9(7, 15)min], enucleation efficiency[(1.8±0.5)g/min vs.(1.1±0.4)g/min] and hemoglobin decline[13(9, 22)g/L vs.17(10, 22)g/L]were statistically significant ( P<0.05). In both groups, postoperative IPSS were (6.6±1.7) and (6.2±1.4) respectively, and Q max were(18.9±3.1)ml/s and (16.8±3.8)ml/s respectively, which were significantly different from that before the operation ( P<0.05). However, there was no significant difference between the two groups ( P>0.05). The enucleation efficiency increased with the increase of prostate volume( r=0.791, 0.880 respectively, P<0.05).After 2 weeks of follow up the postoperative immediate urinary continence rate of UEBT group and LT group were 10.0%(5/50)and 27.3%(15/55), respectively, and the two groups had statistical differences ( P<0.05). But after 3 months of follow up, there was no urinary continence in the two groups, and incidence of postoperative urethral stricture were 2.0%(1/50) and 5.5%(3/55) respectively in UEBT and LT group, whose difference was not significant( P>0.05). Conclusions:ThuLERP can relieve lower urinary tract symptoms in a comparable way with high efficacy and safety. ThuLERP with the "U-shaped" en bloc technique was statistically superior to the lobe technique in operation time, enucleation time, enucleation efficiency, hemoglobin decline and also avoided stress urinary incontinence at early stage after operation.
8.Fuling Zexie Decoction Combined with Lifestyle for the Intervention of Metabolic Syndrome of Dampness Syndrome:A Clinical Randomized Trial
Shaoqin LIN ; Chengcheng WANG ; Qing XU ; Fei TAN ; Zhimin YANG ; Xinyan CHEN
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(10):1453-1461
Objective To explore the clinical efficacy of Fuling Zexie Decoction combined with lifestyle intervention in patients with metabolic syndrome (MetS) of dampness syndrome. Methods A total of 40 patients with MetS of dampness syndrome were randomly divided into experimental group (n=20) and control group (n=20) according to a randomized double-blind placebo-controlled design. The experimental group was given oral administration of Fuling Zexie Decoction,the control group was given placebo,150 mL each time,twice a day. Both groups were given healthy lifestyle(healthy eating habits and exercise mode) education. The intervention period was 16 weeks. Traditional Chinese medicine dampness syndrome scale score and the diagnostic indexes of MetS,including waist circumference (WC),systolic blood pressure (SBP),diastolic blood pressure (DBP),triglyceride (TG),high density lipoprotein cholesterol (HDL-C) and fasting blood glucose (FBG),were evaluated before and after treatment. Other metabolic indexes such as body mass index(BMI),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),homeostasis model assessment of insulin resistance(HOMA-IR),uric acid(UC),as well as inflammation related indexes including C-reactive protein (CRP),interleukin-6 (IL-6) and tumor necrosis factor(TNF-α) were also evaluated. Results A total of 33 people completed the trial,including 17 people in the experimental group and 16 people in the control group. Compared to the baseline period,FBG,BMI,LDL-C and dampness syndrome scale score in the experimental group were significantly decreased at the 8th and 16th week of intervention(P<0.05). WC was significantly decreased at the 8th week of intervention(P<0.05). CRP showed a downward trend at the 16th week of intervention(P<0.05). Moreover,SBP and IL-6 in control group decreased significantly at the 8th and 16th week of intervention(P<0.05). WC,DBP and HOMA-IR decreased significantly at the 8th week of intervention (P<0.05). There was no significant difference in other outcome indexes between the two groups at the 8th and 16th week of intervention (P>0.05). The safety indexes of all patients before and after intervention were not significantly abnormal,and no serious adverse events occurred. Conclusion This study initially shows the positive regulatory effect of Fuling Zexie Decoction combined with lifestyle on metabolism and inflammation-related indexes in people with MetS of dampness syndrome,which helps to improve the level of dampness syndrome and provides a basis for further research.
9.Estrogen upregulates DNA2 expression through the PI3K-AKT pathway in endometrial carcinoma.
Xinyan WANG ; Xiuling XU ; Ting ZHANG ; Yang JIN ; Sheng XU ; Lifeng CHEN ; Yucheng LAI ; Ling ZHANG ; Ruolang PAN ; Yan YU
Journal of Zhejiang University. Science. B 2023;24(3):262-268
Endometrial cancer is the most common gynecological malignancy, affecting up to 3% of women at some point during their lifetime (Morice et al., 2016; Li and Wang, 2021). Based on the pathogenesis and biological behavioral characteristics, endometrial cancer can be divided into estrogen-dependent (I) and non-estrogen-dependent (II) types (Ulrich, 2011). Type I accounts for approximately 80% of cases, of which the majority are endometrioid carcinomas, and the remaining are mucinous adenocarcinomas (Setiawan et al., 2013). It is generally recognized that long-term stimulation by high estrogen levels with the lack of progesterone antagonism is the most important risk factor; meanwhile, there is no definite conclusion on the specific pathogenesis. The incidence of endometrial cancer has been on the rise during the past two decades (Constantine et al., 2019; Gao et al., 2022; Luo et al., 2022). Moreover, the development of assisted reproductive technology and antiprogestin therapy following breast cancer surgery has elevated the risk of developing type I endometrial cancer to a certain extent (Vassard et al., 2019). Therefore, investigating the influence of estrogen in type I endometrial cancer may provide novel concepts for risk assessment and adjuvant therapy, and at the same time, provide a basis for research on new drugs to treat endometrial cancer.
Female
;
Humans
;
Proto-Oncogene Proteins c-akt
;
Phosphatidylinositol 3-Kinases
;
Endometrial Neoplasms
;
Estrogens
;
Breast Neoplasms
;
DNA Helicases
10.Mutation-associated transcripts reconstruct the prognostic features of oral tongue squamous cell carcinoma.
Libo LIANG ; Yi LI ; Binwu YING ; Xinyan HUANG ; Shenling LIAO ; Jiajin YANG ; Ga LIAO
International Journal of Oral Science 2023;15(1):1-1
Tongue squamous cell carcinoma is highly malignant and has a poor prognosis. In this study, we aimed to combine whole-genome sequencing, whole-genome methylation, and whole-transcriptome analyses to understand the molecular mechanisms of tongue squamous cell carcinoma better. Oral tongue squamous cell carcinoma and adjacent normal tissues from five patients with tongue squamous cell carcinoma were included as five paired samples. After multi-omics sequencing, differentially methylated intervals, methylated loop sites, methylated promoters, and transcripts were screened for variation in all paired samples. Correlations were analyzed to determine biological processes in tongue squamous cell carcinoma. We found five mutated methylation promoters that were significantly associated with mRNA and lncRNA expression levels. Functional annotation of these transcripts revealed their involvement in triggering the mitogen-activated protein kinase cascade, which is associated with cancer progression and the development of drug resistance during treatment. The prognostic signature models constructed based on WDR81 and HNRNPH1 and combined clinical phenotype-gene prognostic signature models showed high predictive efficacy and can be applied to predict patient prognostic risk in clinical settings. We identified biological processes in tongue squamous cell carcinoma that are initiated by mutations in the methylation promoter and are associated with the expression levels of specific mRNAs and lncRNAs. Collectively, changes in transcript levels affect the prognosis of tongue squamous cell carcinoma patients.
Humans
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Biomarkers, Tumor
;
Nerve Tissue Proteins
;
Prognosis
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Squamous Cell Carcinoma of Head and Neck/pathology*
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Tongue Neoplasms/pathology*

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