OBJECTIVE To mine adverse drug event （ADE） signals related to the pulmonary arterial hypertension （PAH） therapeutic drug macitentan， and to provide reference for safe clinical medication. METHODS Macitentan-related ADE reports were collected from the US FDA Adverse Event Reporting System （FAERS） database from the fourth quarter of 2013 to the third quarter of 2023. Data mining was conducted by using the reporting odds ratio （ROR） method and the comprehensive standard method established by the UK Medicines and Healthcare Products Regulatory Agency （referred to as “MHRA method”） under the proportional imbalance approach. According to the systemic organ class （SOC） and preferred term （PT） stated in 26.0 edition of Medical Dictionary of Regulatory Activities， standardized coding of ADE names was performed， followed by the analysis of time to onset （TTO） and the Weibull shape parameter （WSP） test. RESULTS Overall， a total of 26 079 ADE reports were identified with macitentan as the primary suspect drug. These reports predominantly involved female patients （73.25%） and were concentrated in the age range of 18 to 65 years （42.39%）. The majority of reports originated from the US （84.42%）， with hospitalization or prolonged hospital stays （59.82%） being the most common in severe treatment outcome. A total of 269 ADE positive signals related to macitentan were identified. Among these， hypothyroidism， ADE related to renal injury such as the increase of serum creatinine and blood urea nitrogen， and ADE related to psychiatric disorders like apathy and despair were not included in the drug label. TTO analysis indicated that the majority of macitentan-related ADE signals occurred between 0-30 days after initial treatment （492 reports， 21.52%） and over 360 days （411 reports， 17.98%）. The results of WSP test showed that most of the top 20 reported ADE signals conformed to the characteristics of an early failure curve. CONCLUSIONS When clinically using macitentan in patients with PAH， attention should be given not only to the adverse reactions mentioned on the drug label but also to thyroid dysfunction， kidney dysfunction and mental disorder-related ADEs.

Objective To investigate the consistency analysis between multimodal MRI in determining vaginal involvement and parametrial infiltration in cervical cancer patients and pathological examination.Methods Ninety-two patients with cervical cancer were regressively selected and who underwent preoperative multimodal MRI examination.Using pathological results as the gold standard,the receiver operating characteristic(ROC)curve was used to analyze the diagnostic efficacy of conventional MRI,diffusion weighted imaging(DWI)and dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI)alone and in combination in predic-ting vaginal involvement and parametrial infiltration.Results(1)Vaginal involvement:the diagnostic sensitivity of conventional MRI was 65.96％,the specificity was 91.11％,and the area under the curve(AUC)was 0.775[95％confidence interval(CI)0.676-0.873].The sensitivity of DCE-MRI was 61.70％,the specificity was 95.56％,and the AUC was 0.797(95％CI 0.702-0.892).The sensitivity of DWI was 72.34％,the specificity was 88.89％,and the AUC was 0.817(95％CI 0.725-0.908).At the optimal cut-off point,the sensitivity of parallel combined detection was 97.87％,the specificity was 93.33％,and the AUC was 0.956(95％CI 0.907-0.918).(2)Parametrial infiltration:the diagnostic sensitivity of conventional MRI was 67.24％,the specificity was 91.18％,and the AUC was 0.783(95％CI 0.688-0.879).The sensitivity of DCE-MRI was 62.07％,the specificity was 94.12％,and the AUC was 0.781(95％CI 0.686-0.875).The sensitivity of DWI was 75.86％,the specificity was 97.06％,and the AUC was 0.865(95％CI 0.788-0.941).At the optimal cut-off point,the sensitivity of parallel combined detection was 98.28％,the specificity was 91.18％,and the AUC was 0.947(95％CI 0.888-1.000).Conclusion Combined multimodal MRI can improve the positive detection rate of vaginal involve-ment and parametrial infiltration in patients with cervical cancer,allowing for timely treatment adjustments,improved quality of life and longer survival.

PURPOSE: The characteristic expression of DNA damage response proteins in familial breast cancers with BRCA1, BRCA2, or non-BRCA1/2 mutations has not been analyzed in Chinese patients. Our study aimed to assess the differential expression of microcephalin 1 (BRIT1), ATM serine/threonine kinase (ATM), checkpoint kinase 2 (CHEK2), BRCA1, RAD51 recombinase (RAD51), and poly (ADP-ribose) polymerase 1 (PARP-1) and establish the profile of Chinese familial breast cancers with different mutation status. METHODS: We constructed five tissue microarrays from 183 familial breast cancer patients (31 with BRCA1 mutations; 14 with BRCA2 mutations, and 138 with non-BRCA1/2 mutations). The DNA response and repair markers used for immunohistochemistry analysis included BRIT1, ATM, CHEK2, BRCA1, RAD51, and PARP-1. The expressions of these proteins were analyzed in BRCA1/2 mutated tumors. The association between pathologic characteristics with BRCA1/2 mutation status was also analyzed. RESULTS: In familial breast cancer patients, BRCA1 mutated tumors were more frequent with high nuclear grade, estrogen receptor/progesterone receptor/human epidermal growth factor receptor 2 negative, low Ki-67, and positive CK5/6. BRCA1 mutated tumors had lower CHEK2 and higher cytoplasmic BRIT1 expression than BRCA2 and non-BRCA1/2 mutation tumors. BRCA2-associated tumors showed higher CHEK2 and cytoplasmic RAD51 expression than those in other groups. Nuclear PARP-1 expression in BRCA1/2-associated tumors was significantly higher than in non-BRCA1/2 mutation tumors. Moreover, we found quite a few of negative PARP-1 expression cases in BRCA1/2 mutated groups. CONCLUSION: The clinicopathologic findings of BRCA1-associated Chinese familial breast cancers were similar to the results of other studies. Chinese familial breast cancer patients with BRCA1/2 mutations might have distinctive expression of different DNA damage response proteins. The reduced expression of PARP-1 in Chinese BRCA1/2 mutated breast cancer patients could influence the therapeutic outcome of PARP-1 inhibitors.
Asian Continental Ancestry Group* ; Breast Neoplasms* ; Breast* ; Checkpoint Kinase 2 ; Cytoplasm ; DNA Damage* ; DNA Repair ; DNA* ; Estrogens ; Genes, BRCA1 ; Genes, BRCA2 ; Humans ; Immunohistochemistry ; Phosphotransferases ; Rad51 Recombinase ; Receptor, Epidermal Growth Factor

The clinical electroencephalogram (EEG) monitoring systems based on personal computer system can not meet the requirements of portability and home usage. The epilepsy patients have to be monitored in hospital for an extended period of time, which imposes a heavy burden on hospitals. In the present study, we designed a portable 16-lead networked monitoring system based on the Android smart phone. The system uses some technologies including the active electrode, the WiFi wireless transmission, the multi-scale permutation entropy (MPE) algorithm, the back-propagation (BP) neural network algorithm, etc. Moreover, the software of Android mobile application can realize the processing and analysis of EEG data, the display of EEG waveform and the alarm of epileptic seizure. The system has been tested on the mobile phones with Android 2. 3 operating system or higher version and the results showed that this software ran accurately and steadily in the detection of epileptic seizure. In conclusion, this paper provides a portable and reliable solution for epileptic seizure monitoring in clinical and home applications.
Algorithms ; Cell Phone ; Electrocardiography ; Electroencephalography ; instrumentation ; Entropy ; Epilepsy ; diagnosis ; Humans ; Monitoring, Physiologic ; instrumentation ; Neural Networks (Computer) ; Software

Objective To compare the reliability and effectiveness of anterolateral thigh flap with double vein anastomosis or one vein anastomosis for reconstruction of head and neck defects.Methods Two hundred and sixty four cases of anterolateral thigh flap transfers for head and neck reconstruction from January,2013 to September,2013 in the Second Xiangya Hospital of Central South University were reviewed.260 patients were randomly divided into 2 groups.In the experimental group,there were 138 patients 140 cases of anterolateral thigh flap with one vein one artery anastomosis.In the control group,there were 122 patients 124 cases of anterolateral thigh flap with double vein one artery anastomosis.Results Among 264 anterolateral thigh flaps,the overall success rate of free flap was 98.1％ (259/264),5 free flaps were lost.In the experimental group,there were 6 free flaps occurred venous thrombosis,two of them were lost.In the control group,there were 5 cases occurred venous thrombosis,three of them were lost.No arterial thrombosis occurred in both groups.The time of micromanipulation was 18 to 101 min,with the average of 47 min in the experimental group.In the control group,the time was 45 to 133 min,with the average of 71 min.(P =0.0003).Conclusion Anterolateral thigh flap with one vein one artery anastomosis for head and neck reconstruction did not affect the survival rate but it can absolutely reduce the operation time.

Objective To summarize the application of 909 anterolateral thigh myocutaneous flaps in the repair of oral and maxillofacial defects and to examine their benefits in maxillofacial reconstruction of these defects.Methods Patients were recruited from January 2004 to December 2012 in the Department of Oral and Maxillofacial Surgery of the Second Xiangya Hospital of Central South University.All patients underwent reconstructive surgery with anterolateral thigh myocutaneous flaps,and patient age ranged from 19 to 81 years with a mean of 51.2 years.There were 761 flaps showing single lobe and 148 flaps showing a multi-island pedicle.The largest area among the single flaps was 28 cm× 12 cm,and the smallest was 4 cm× 2 cm.Results Among the 909 transferred flaps,882 survived and 27 showed necrosis,with a survival rate of about 97.0％.The common complications at flap donor site were poor wound healing 9.6％(87/909),localized paresthesia 61.0％(500/820),and altered quadriceps force 15.0％(123/820).No case was presented with local serious complications,and 90％ of the patients achieved good functional recovery and aesthetically acceptable results after the reconstruction by anterolateral thigh myocutaneous flaps.Conclusions The anterolateral thigh myocutaneous free flaps are more suitable for oral and maxillofacial defects than other flaps and should be preferred.

Objective To identify the factors that were predictive of outcome and to determine the effect of age on perioperative complications.Methods Reviewed the records of 1 100 consecutive patients who underwent anterolateral thigh flap free flap transfers for oral and maxillofacial cancer surgery defects between February 2002 and March 2013.All patients were divided into two groups:A group (＜60 years old) and B group (≥60 years old).Postoperative complications were analyzed from all patients.Results There were 781 cases in A group and 319 in B group.The overall success rate was 97.2％(1 100/l 132)[97.3％ (781/803) in A group,97.0％ (319/329) in B group,P＞0.05].The overall complication rate was 27.5％ (302/1 100)[25.9％ (202/781) in A group,31.3％ (100/319) in B group,P=0.064].Multivariate Cox regression analyses revealed that American Society of Anesthesiologists (ASA) status (P＜0.001),operation time (P=0.021) and comorbidity (P=0.002) were the independent factor for the complication of patients.However,age (P＞0.05) was not an independent factor for the complication of patients.Conclusions Oral and maxillofacial reconstruction using anterolateral thigh flap free flaps in elderly patients can achieve similar outcomes as in younger patients.Controlling operative time is very important in reducing postoperative complications and improving the results of surgery.

To better evaluate neuromuscular function of patients with stroke related motor dysfunction, we proposed an effective corticomuscular coherence analysis and coherent significant judgment method. Firstly, the related functional frequency bands in the electroencephalogram (EEG) were extracted via wavelet decomposition. Secondly, coherence were analysed between surface electromyography (sEMG) and sub-bands extracted from EEG. Further more, a coherent significant indicator was defined to quantitatively describe the similarity in certain frequency domain and phase lock activity between EEG and sEMG. Through the analysis of corticomuscular coherence during knee flexion-extension of stroke patients and healthy controls, we found that the stroke patients exhibited significantly lower gamma-band corticomuscular coherence in performing the task with their affected leg, and there was no statistically significant difference between their unaffected lag and the healthy controls, but with the rehabilitation training, the bilateral difference of corticomuscular coherence in patients decreased gradually.
Case-Control Studies ; Electroencephalography ; Electromyography ; Exercise Therapy ; Humans ; Knee ; physiology ; Muscle, Skeletal ; physiology ; Range of Motion, Articular ; Stroke Rehabilitation

Objective:To study the direction of cervical node extracapsular spread(ECS)of oral squamous cell carcinoma(OSCC). Methods:57 cases of OSCC were treated by combined radical operation.The relationship between ECS and T stage,tumor thick-ness,differentiation degree of OSCC,lymph node size and the ECS direction in each lymph node level were statistically analysed. Results:ECS was found in 30 of the 57 cases,and in 78 of the 174 metastasis positive lymph nodes.29 ECS nodes in levelⅠ,the frequency of the shallow side was 26,the deep side 13(P=0.000 3).But the difference in other levels was not statistically signifi-cant(P>0.05).It was not statistically significant between the incidence of ECS and T stage;it was statistically significant between the incidence of ECS and tumor thickness(P<0.05),tumor differentiation degree(P<0.05)and the lymph node size(P<0.01). Conclusion:ECS of OSCC on the shallow side is more than that in the deep side of lymph nodes in levelⅠ.ECS is positively corre-lated with the tumor thickness of OSCC,metastasied lymph node size;negatively related to the differentiation degree of OSCC.

OBJECTIVETo seek a new method for reconstructing bilateral intemrnal jugular vein invaded by metastasis lymph node in advanced oral cancer patients.

METHODSA combination of microvascular anastomosis and longitudinal constriction suture venoplasty was performed to reconstruct internal jugular vein. We resected the part of the bilateral internal jugular vein of advanced oral cancer patients invaded by metastasis lymph node and used the external carotid vein to reconstruct the internal jugular vein. A part of the vessel wall of the internal jugular vein could also be resected to reconstruct the vein. Longitudinal constriction suture venoplasty could slowly narrow the lumen diameter of the internal jugular vein. Thus, difference in anastomosis diameter should be avoided because it generates eddy currents and subsequently causes blood clots. A total of five advanced cases of oral squamous cell carcinoma were involved in this study. We performed bilateral radical neck dissection on all patients to reconstruct the internal jugular vein and observed their postoperative conditions.

RESULTSPostopera-tive follow-up of 5 months to 19 months was performed on all patients. Doppler or CT angiography and related tests showed no internal jugular vein thrombosis. No patient with facial edema, throat swelling, cerebral edema, and high intracranial pressure or other serious complications caused by blocked venous blood was observed. The one-year survival rate of five patients was 60% (3/5).

CONCLUSIONMicrovascular anastomosis combined with longitudinal constriction suture venoplasty is a new method for reconstructing internal jugular vein. This method was proved successful and clinically feasible.

Carcinoma, Squamous Cell ; Constriction ; Humans ; Jugular Veins ; Lymphatic Metastasis ; Mouth Neoplasms ; Neck Dissection ; Postoperative Period ; Reconstructive Surgical Procedures ; Sutures