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Objective:To observe any dependence of anticipatory postural adjustment (APA) on the difficulty of fine upper limb tasks and to document any effect of reticulospinal tract (RST) facilitation on APAs during such tasks.Methods:The study′s bivariate mixed design involved 4 different tasks and 3 different priming states. Thirteen healthy, male, right-handed subjects were recruited. They were asked to complete the 4 tasks of reaching, grasping a cup, pinching a card using the thumb or using the little finger, respectively for 10 times 1 in response to two different starting cues delivered through an earphone. Half of the trials with each task were initiated with 114dB white noise to startle and activate the reticulospinal tract (RST), while the others were activated with 80dB beeps as a control. Electromyographic signals were recorded from the bilateral sternocleidomastoid (SCM), lower trapezius (LT), latissimus dorsi (LD), lumbar erector spinae and right anterior deltoid muscles and also from the right flexor and extensor carpi radialis muscles (ECR/FCR). In the subsequent processing the electromyographic time domain and frequency domain indicators were converted into a pre-motor reaction time, a time to muscle peak contraction, an activation latency, and APA or compensatory postural adjustment (CPA) amplitude of the tested muscles. These were compared among the different tasks and stimuli. In addition, the 114dB test tasks were classified as two different priming status as SCM + and SCM - according to whether the sternocleidomastoid muscle (SCM) was activated in advance. Results:After RST activation the pre-motor reaction time and the time to peak contraction of all of the muscles were significantly shortened in all of the tasks. The deltoid muscle reaction times in the SCM + , SCM - and control states were (106.89±43.78)ms, (136.78±48.74)ms and (168.60±73.17)ms, respectively, and those differences are significant. The APA amplitudes of the contralateral LT and ipsilateral LD were significantly greater than normal, but the timing of muscle activation onset and the APA/CPA amplitudes of the ECR/FCR were not affected. The latency in the anticipatory muscle activation of the ECR in the little finger grip task was significantly shorter than that in reaching. Conclusions:The extensor carpi radialis show task-specific early activation in fine tasks of the upper limbs with different difficulties. RST activation can lead to early starting of expected actions, accelerate muscle contraction and increase APA amplitude of some trunk muscles, but it has no significant effect on APA/CPA amplitudes in the forearm muscles.
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Objective:To explore any differential effect of training wearing a unilateral exoskeleton on the lower-limb motor function of stroke survivors.Methods:Forty stroke survivors were randomly divided into an exoskeleton group ( n=20) and a control group ( n=20). The control group performed conventional lower extremity exercise training while the exoskeleton group received exoskeleton-assisted lower-limb physical therapy. Each participant received eighteen 40-minute training sessions over three weeks. Before and after the intervention, the walking ability, lower-limb function, balance and ability in the activities of daily living of both groups were evaluated. Integrated electromyography (iEMG) of the rectus femoris and tibialis anterior of both legs was also recorded during sit-to-stand transitions to assess the activation of the affected muscles and the symmetry of bilateral muscle activation. Results:After the three weeks, significant improvement was observed in all of the measurements in both groups, but with the exoskeleton group scoring significantly better on average in functional ambulation category grading (1.63±0.72). Both groups′ iEMGs had also improved significantly compared with before treatment, but the exoskeleton group′s average result was by that time significantly better than the control group′s average.Conclusions:A wearable exoskeleton can effectively improve the rehabilitation of walking, lower limb movement, balance and skill in the activities of daily living of persons with subacute stroke. It better activates the affected lower limb muscles and improves the symmetry of bilateral lower limb muscle activation.
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Objective: To explore the surgical methods and effects of transoral endoscopic resection of benign tumors in parapharyngeal space via medial pterygomandibular raphe approach. Methods: The clinical data of 23 patients who underwent resection of benign tumors in parapharyngeal space by endoscopic medial pterygomandibular raphe approach from January 2016 to July 2020 in the Department of Otorhinolaryngology Head and Neck Surgery, the Affiliated Hospital of Qingdao University were analyzed retrospectively. There were 14 males and 9 females with a median age of 43 years. The tumors were located in the anterior space of the styloid process in 13 cases and in the posterior space in 10 cases. The smallest tumor volume was 7.3 ml and the largest was 80.2 ml. The preoperative imaging features, the characteristics and risks of this approach in the operation were analyzed, and the feasible mode of operation was explored. Results: All patients completed the operation successfully. The intraoperative blood loss was 20 to 50 ml, with an average of 28.3 ml. The operation time was 40 to 110 min, with an average of 75.4 min. The incision length was 2 to 4 cm, with an average of 3.0 cm. The postoperative pain score was 2 to 4, with an average of 3.2. The postoperative hospital stay was 4 to 9 d, with an average of 6.7 d. Postoperative pathological diagnosis included pleomorphic adenoma (n=12), neurilemmoma (n=10) and basal cell adenoma (n=1). The patients were followed up for 6 to 60 months. There was no postoperative complication such as infection or serious bleeding, and there was no tumor recurrence after operation. Conclusion: Endoscopic resection of benign tumor in parapharyngeal space via medial pterygomandibular raphe approach is a safe, effective, and minimally invasive surgical method for the treatment of tumors in parapharyngeal space.
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Adult , Female , Humans , Male , Neoplasm Recurrence, Local , Parapharyngeal Space , Pharyngeal Neoplasms/surgery , Pharynx , Retrospective StudiesABSTRACT
Objective:To observe the reliability and validity of using a head-neck relocation test (HRT) in assessing cervical position sense.Methods:A total of 62 subjects were recruited, including 32 with neck pain and 30 healthy subjects. All received two HRTs conducted by two independent assessors at a first session, and then they received another HRT 24 hours later administered by one of them. The joint position error (JPE) was measured in the four directions of cervical motion: flexion, extension, levorotation and dextrorotation. The intra- and inter-rater reliability was quantified in terms of intra-class correlation coefficients (ICCs) and the difference in JPE between the two groups was also determined for validity.Results:The intra- and inter-rater reliability for the HRT in the four directions had ICC values of 0.603-0.830 and 0.597-0.837 respectively. The corresponding standard error of measurement (SEM) values were 1.52-2.15cm and 1.69-2.09cm, while the minimal detectable change (MDC) values were 4.20-5.97cm and 4.69-5.79cm, respectively. The patients with neck pain had significantly larger JPE in cervical extension and right rotation compared to healthy individuals, on average. And their JPE for cervical extension had an area under the curve (AUC) of the receiver′s operating curve of 0.755.Conclusions:The HRT showed good intra- and inter-rater reliability in assessing cervical joint position sense. The JPE for cervical extension can be used to discriminate those with neck pain from healthy subjects.
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Objective:To analyze and summarize the application and significance of the computer-assisted surgery system in precision surgery of mediastinal tumors in children.Methods:The clinical data of 54 children that underwent mediastinal tumor resection surgery in the Affiliated Hospital of Qingdao University from August 2008 to November 2021 were collected.According to whether the Hisense CAS computer-assisted surgery system was used before the operation, the patients were divided into three-dimensional (3D) reconstruction group (29 cases, 53.70%) and two-dimensional (2D) CT group (25 cases, 46.30%). The surgical indicators, postoperative hospital stay, and the incidence of surgical complications were compared between the two groups.The t-test, Mann- Whitney U test, χ2 test or Fisher′ s exact test were carried out for statistical analysis.Simulated surgery and actual surgery were compared for both 3D reconstruction and 2D CT groups. Results:There were no significant differences in gender, age, height, weight, maximum tumor diameter and tumor location between the 3D reconstruction group and 2D CT group (all P>0.05). The operation time of the 3D reconstruction group was [(125.14±41.37) min] was shorter than that of the 2D CT group [(149.24±44.53) min] ( P=0.044). The intraoperative blood loss in the 3D reconstruction group [15.00(13.50, 25.00) mL] was less than that in the 2D CT group [36.00(30.00, 75.00) mL] ( P<0.001). In addition, the indwelling time the closed thoracic drainage tube [4.00 (3.00, 5.50) d] and postoperative hospitalization days [(8.83±3.39) d] in the 3D reconstruction group were shorter than those in the 2D CT group [7.00(5.00, 11.50) d, (11.00±4.10) d] ( P=0.001, 0.038). No significant difference in postoperative complication rates was found between the 3D reconstruction group and 2D CT group ( P>0.05). The simulated operation was consistent with the actual operation in the 3D reconstruction group. Conclusions:3D reconstruction by the computer-assisted surgery system can truly reveal the anatomical relationship between tumors and surrounding organs and blood vessels, and improve the accuracy and safety of surgical resection of mediastinal tumors in children.
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Objective:To investigate the application value of Hisense computer-assisted surgery system (CAS) three-dimensional reconstruction in the precision treatment of pediatric liver tumors.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 82 children with liver tumors who were admitted to Affiliated Hospital of Qingdao University from January 2013 to September 2021 were collected. There were 39 males and 43 females, aged 13(19)months. Children underwent upper abdominal dynamic enhanced computed tomography (CT) examination, and three-dimensional reconstruction was performed on CT images of arterial, equili-brium and venous phases with Hisense CAS. Surgical feasibility and scheme were evaluated and conducted based on the results of upper abdominal dynamic enhanced CT examination, and then revised according to three-dimensional reconstruction results of Hisense CAS. Observation indicators: (1) comparison of surgical scheme between two-dimensional enhanced CT images and three-dimensional reconstruction results of Hisense CAS; (2) intraoperative and postoperative situations; (3) follow-up. Follow-up was conducted by outpatient examination to detect postoperative compli-cations and residual liver compensation up to November 2021. Measurement data with normal distribution were represented as Mean± SD. Measurement data with skewed distribution were represented as M(IQR) or M(range). Count data were described as absolute numbers or percentages. Results:(1) Comparison of surgical scheme between two-dimensional CT images and three-dimensional reconstruction results of Hisense CAS. ① Based on the two-dimensional CT images, 42 cases of 82 children could undergo one-stage resection and 40 children could not. However, based on the three-dimensional reconstruction results of Hisense CAS, 48 cases of 82 children could undergo one-stage resection and 34 children could not. There were 6 children with one-stage resection feasibility based on the three-dimensional reconstruction results of Hisense CAS rather than the two-dimensional CT images. For the 34 children undergoing chemotherapy firstly, 31 cases had surgical feasibility after chemotherapy based on the two-dimensional CT images and 3 cases could not undergo surgery because of unapparent tumor regression or tumor surrounding impor-tant vessels. However, the 34 children had surgical feasibility after chemotherapy based on the three-dimensional reconstruction results of Hisense CAS. The revision rate of surgical feasibility was 11.0%(9/82) for the 82 children. ② Based on the two-dimensional CT images, 15 cases of 82 children underwent liver left lobectomy, 21 cases underwent liver right lobectomy, 7 cases underwent mesohepatectomy, 13 cases underwent extended left hemihepatectomy, 23 cases underwent extended right hemihepatectomy, 3 cases underwent segmental hepatectomy. However, based on the three-dimensional reconstruction results of Hisense CAS, 20 cases of 82 children underwent liver left lobectomy, 29 cases underwent liver right lobectomy, 7 cases underwent mesohepatectomy, 7 cases underwent extended left hemihepatectomy, 14 cases underwent extended right hemihepatectomy, 5 cases underwent segmental hepatectomy. The revision rate of surgical scheme was 36.6%(30/82) for the 82 children. (2) Intraoperative and postoperative situations. The operation time, volume of intraoperative blood loss, duration of postoperative hospital stay of the 82 children were (182±18)minutes, 20(10)mL, (10.2±1.9)days, respectively. (3) Follow-up. All the 82 children were followed up for 10 (range, 2?18)months. There was no obvious complication occurred to the 82 children after surgery, and the residual liver can satisfy the liver compensation of body. All the children survived well.Conclusion:Three-dimensional reconstruction of Hisense CAS is conducive to judging the surgical feasibility and formulation of accurate surgical plan of children with liver tumors.
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Objective:To explore the appropriate use of a self-developed scoliosis rehabilitation robot in treating adolescent idiopathic scoliosis (AIS), and also its safety and effectiveness.Methods:The scoliosis rehabilitation robot consists of a closed-loop pneumatic control system and multi-segment torso, pelvis and upper extremity fixation devices. It provides three-dimensional synchronous correction. Eighteen AIS subjects first received 30min of robot-assisted treatment using the maximum tolerable orthotic force. The angles of their spinal processes were evaluated using ultrasound before the treatment and after 30 seconds, 5 minutes and 30 minutes of treatment, then 5min later. In a second 30sec course of treatment the transverse orthotic force was 10%, 15%, 20%, 25%, and 30% of the patient′s body weight. Any adverse effects were observed and recorded.Results:The robot ran smoothly and could apply intelligent and precise correction. No severe adverse effects were reported. The mean correction of the spinal process angles showed a significant cumulative effect with treatment time, reaching 104% at 30min. The mean process angle correction increased with the applied force. Force at 25% of the patient′s weight produced an average correction of 104% in patients with mild AIS and 65% in those whose AIS was moderate.Conclusion:The scoliosis rehabilitation robot is safe and immediately effective. Setting the transverse force at 25% of a patient′s weight gives the best corrective effect with mild AIS. Moderate AIS requires more force.
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The causes for male sexual orientation are complicated, which have not yet been clarified. Recent years have witnessed fruitful progress in the field of biology, while the impact of environment has received little attention. Adverse childhood experiences (ACEs), identified as a special environment in the early stage of development, can affect the individual phenotype by DNA methylation. Given the relationships among male sexual orientation, ACEs, and DNA methylation, as well as based on the existing theory, this article proposes the model "ACEs-DNA methylation-male sexual orientation"from the perspective of environment and epigenetics, aiming to provide a theoretical basis for future research.
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Child , Female , Humans , Male , Adverse Childhood Experiences , DNA Methylation , Sexual BehaviorABSTRACT
Background@#Hong Kong's construction industry currently faces a manpower crisis. Blue-collar workers are a disadvantaged group and suffer higher levels of chronic diseases, for example, cancer, than the wider population. Cancer risk factors are likely to cluster together. We documented prevalence of cancer-associated lifestyle risk behaviors and their correlates among Hong Kong construction workers. @*Methods@#Data were collected from workers at 37 railway-related construction worksites throughout Hong Kong during May 2014. Tobacco use, alcohol consumption, unbalanced nutrition intake, and physical inactivity were included in the analysis. Latent class analysis and multivariable logistic regression were performed to identify the patterns of risk behaviors related to cancer, as well as their impact factors among construction workers in Hong Kong. @*Results@#Overall, 1,443 workers participated. Latent class analysis identified four different behavioral classes in the sample. Fully adjusted multiple logistic regression identified age, gender, years of Hong Kong residency, ethnicity, educational level, and living status differentiated behavioral classes. @*Conclusion@#High levels of lifestyle-related cancer-risk behaviors were found in most of the Hong Kong construction workers studied. The present study contributes to understanding how cancer-related lifestyle risk behaviors cluster among construction workers and relative impact factors of risk behaviors. It is essential to tailor health behavior interventions focused on multiple risk behaviors among different groups for further enlarging the effects on cancer prevention.
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Methyl-CpG binding protein 2 (MeCP2) is a basic nuclear protein involved in the regulation of gene expression and microRNA processing. Duplication of MECP2-containing genomic segments causes MECP2 duplication syndrome, a severe neurodevelopmental disorder characterized by intellectual disability, motor dysfunction, heightened anxiety, epilepsy, autistic phenotypes, and early death. Reversal of the abnormal phenotypes in adult mice with MECP2 duplication (MECP2-TG) by normalizing the MeCP2 levels across the whole brain has been demonstrated. However, whether different brain areas or neural circuits contribute to different aspects of the behavioral deficits is still unknown. Here, we found that MECP2-TG mice showed a significant social recognition deficit, and were prone to display aversive-like behaviors, including heightened anxiety-like behaviors and a fear generalization phenotype. In addition, reduced locomotor activity was observed in MECP2-TG mice. However, appetitive behaviors and learning and memory were comparable in MECP2-TG and wild-type mice. Functional magnetic resonance imaging illustrated that the differences between MECP2-TG and wild-type mice were mainly concentrated in brain areas regulating emotion and social behaviors. We used the CRISPR-Cas9 method to restore normal MeCP2 levels in the medial prefrontal cortex (mPFC) and bed nuclei of the stria terminalis (BST) of adult MECP2-TG mice, and found that normalization of MeCP2 levels in the mPFC but not in the BST reversed the social recognition deficit. These data indicate that the mPFC is responsible for the social recognition deficit in the transgenic mice, and provide new insight into potential therapies for MECP2 duplication syndrome.
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Objective To explore the effect of pattern-specific physical therapy based on functional impair-ment on chronic neck pain ( CNP ) . Methods Ninety-three CNP patients treated in the outpatient department of our hospital between March 2016 and November 2017 were randomly divided into a study group ( n=46) and a control group ( n=47) . The control group received routine physical treatment, while the study group was treated with pattern-specific physical therapy involving local pain management, traction, soft tissue relaxation, mobilization, strength training, posture control training and active exercise as well as health education. Each was based on a physical exami-nation and pattern classification by doctors and therapists. The subjects in both groups were required to complete 3 to 6 ninety-minute sessions of outpatient treatment and 6 thirty-minute sessions of self-training at home over 2 weeks. Pain intensity and cervical dysfunction were rated using a visual analogue scale ( VAS) and a neck disability index ( NDI) before and after the two-week intervention and one month later. Before the intervention and during the follow-up, postural analyses for the head and neck in a standing position were performed. The cranial vertebral angle ( CVA) , protracted shoulder angle ( PSA) and sagittal head elevation were measured. Results Eighty-seven par-ticipants completed the treatments and follow-up. After the 2-week intervention, the average VAS rating at the end of cervical anteflection in the study group was significantly lower than that in the control group ( P≤0.05) . Significantly greater improvement in the NDI scores was observed in the study group than the control group ( P≤0.05) . During the follow-up, it was found that the average CVA score had improved more significantly in the study group than with the control group ( P≤0.01) , but there were no significant differences in the other measurements between the two groups.Conclusion This pattern-specific physical therapy process is more effective for relieving the end pain during cervical anteflection quickly. It can improve functioning and ability in daily activities to some degree, as well as correct head and neck posture in the long term. It may be helpful in regulating physical therapy for neck pain and for developing a standardized treatment protocol for CNP .
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Objective@#To study the segment of liver according to the large amount of three-dimensional(3D) reconstructive images of normal human livers and the vascular system, and to recognize the basic functional liver unit based on the anatomic features of the intrahepatic portal veins.@*Methods@#The enhanced CT primitive DICOM files of 1 260 normal human livers from different age groups who treated from October 2013 to February 2017 provided by 16 hospitals were analyzed using the computer-aided surgery system.The 3D liver and liver vascular system were reconstructed, and the digital liver 3D model was established.The vascular morphology, anatomical features, and anatomical distributions of intrahepatic portal veins were statistically analyzed.@*Results@#The digital liver model obtained from the 3D reconstruction of CAS displayed clear intrahepatic portal vein vessels of level four.Perform a digital liver segments study based on the analysis of level four vascular distribution areas.As the less anatomical variation of left hepatic portal vein, the liver was classified into four types of liver segmentation mainly based on right hepatic portal vein.Type A was similar to Couinaud or Cho′s segmentation, containing 8 segments(537 cases, 42.62%). Type B contained 9 segments as there are three ramifications of right-anterior portal vein(464 cases, 36.82%). The main difference for Type C was the variation of right-posterior portal vein which was sector shape(102 cases, 8.10%). Type D contained the cases with special portal vein variations, which needs three-dimensional simulation to design individualized liver resection plan(157 cases, 12.46%). These results showed that there was no significant difference in liver segmental typing between genders(χ2=2.179, P=0.536) and did not reveal any significant difference in liver segmental typing among the different age groups(χ2=0.357, P=0.949).@*Conclusions@#The 3D digital liver model can demonstrate the true 3D anatomical structures, and its spatial vascular variations.The observation of anatomic features, distribution areas of intrahepatic portal veins and individualized liver segmentation achieved via digital medical 3D visualization technology is of great value for understand the complexity of liver anatomy and to guide the precise hepatectomy.
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Objective To investigate the neuroprotective effect and its mechanism of therapeutic hypothermia induced by dihydrocapsaicin (DHC) on cerebral ischemia reperfusion injury in mice.Methods Twenty adult wild type (WT) mice were randomly divided into WT group and WT + DHC group,ten mice in each group.Twenty transient receptor potential receptor 1 (TRPV1) knockout mice were randomly divided into TRPV1 KO group and TRPV1 KO + DHC group,ten mice in each group.The model of focal cerebral ischemia reperfusion injury was established in all mice.The mice in the WT group and TRPV1 KO group were subcutaneously injected with physiological saline 1.25 mg · kg-1 · h-1 after reperfusion.The mice in the WT + DHC group and TRPV1 KO + DHC group were subcutaneously injected with DHC 1.25 mg · kg-1 · h-1 after reperfusion.All the mice were moved into the cage at 22 degrees centigrade after 90 minutes of reperfusion.The core body temperature during the reperfusion period was recorded in every 5 minutes to 24 hours after reperfusion.The neurobehavioral score was performed before anesthesia and 24 hours after anesthesia.After the neurobehavioral test,the brain tissue sections of mice were stained with 2,3,5-triphenyltetrazolium chloride;and the infarction rate of the brain tissue was calculated.Results There was no significant difference in the core body temperature among the four groups at 0,30 and 60 minutes after reperfusion (P > 0.05).There was no significant difference in the core body temperature between 90 minutes and 0,30 and 60 minutes after reperfusion (P > 0.05);but the core body temperature at 2,3,4,6,12 and 24 hours after reperfusion was significantly lower than that at 0,30,60 and 90 minutes after reperfusion in WT group,TRPV1 KO group and TRPV1 KO + DHC group(P < 0.05).There was no significant difference in the core body temperature among the WT group,TRPV1 KO group and TRPV1 KO + DHC group at 2,3,4,6,12 and 24 hours after reperfusion (P > 0.05).The core body temperature at 90 minutes and 2,3,4,6,12,24 hours after reperfusion was significantly lower than that at 0,30 and 60 minutes after reperfusion in WT + DHC group(P < 0.05);and the core body temperature in WT + DHC group was significantly lower than that in WT group,TRPV1 KO group and TRPV1 KO + DHC group at the same time point(P < 0.05).There was no significant difference in the total neurobehavioral score among the four groups before anesthesia (P > 0.05).The total neurobehavioral score at 24 hours after reperfusion was significantly lower than that before anesthesia in the four groups (P < 0.05).The total neurobehavioral score in WT + DHC group was significantly higher than that in WT group,TRPV1 KO group and TRPV1 KO + DHC group at 24 hours after reperfusion(P <0.05).There was no significant difference in the total neurobehavioral score among WT group,TRPV1 KO group and TRPV1 KO + DHC group at 24 hours after reperfusion (P > 0.05).There was no significant difference in the score of spontaneous activity,climbing test,body proprioception and response to vibrissae touch among the four groups at 24 hours after reperfusion (P > 0.05).The score of symmetry test of limbs movement and forepaw stretching test in WT + DHC group was significantly higher than that in WT group,TRPV1 KO group and TRPV1 KO + DHC group at 24 hours after reperfusion(P < 0.05).There was no significant difference in the score of symmetry test of limbs movement and forepaw stretching test among the WT group,TRPV1 KO group and TRPV1 KO + DHC group at 24 hours after reperfusion (P > 0.05).The infarction rate of brain tissue in WT + DHC group was significantly lower than that in the other three groups at 24 hours after reperfusion (P < 0.05);but there was no significant difference in the infarction rate of brain tissue among the WT group,TRPV1 KO group and TRPV1 KO + DHC group (P > 0.05).Conclusion Subcutaneous injection of DHC after focal cerebral ischemia and repeffusion of mice can induce therapeutic hypothermia by activating TRPV1 receptor,and reduce brain tissue damage and improve neurological function.
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Objective To determine the effectiveness and medical cost-effectiveness of clinical rehabilitation for promoting the functional recovery of sub-acute cerebral infarction patients.Methods Totally 247 sub-acute patients with cerebral infarction were randomly divided into a clinical rehabilitation group of 129 and a routine rehabilitation group of 118.The clinical group received a standardized rehabilitation intervention and drug treatment,while the routine rehabilitation group received routine rehabilitation therapy and drug treatment.The Fugl-Meyer assessment (FMA) and the modified Barthel index (MBI) were used to compare the two groups after the treatment and 3 and 6 weeks later.The hospital cost for six weeks was also compared between the 2 groups.Results At 3 and 6 weeks,improvement in the average FMA and MBI scores was observed in both groups but the inter-group differences were not significant.The total hospital cost of the clinical group was,however,significantly less than that of the others.Conclusion Clinical rehabilitation can improve the motor function and ability in the activities of daily living of stroke patients.It also has economic benefits.
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Worldwide sales of biologic drugs exceeded 100 billion USD in 2011. About 32% is from therapeutic monoclonal antibody (mAb). With many blockbuster biopharmaceutical patents expiring over the next decade, there is a great opportunity for biosimilar to enter the worldwide especially emerging market. Both European Medicines Agency (EMA) and Food and Drug Administration (FDA) have introduced regulatory frameworks for the potential approval of biosimilar mAb therapeutics. Rather than providing a highly abbreviated path, as in the case for small molecule chemical drug, approval for biosimilar mAb will require clinical trial and the details will be very much on a case-by-case basis. Since mAb is the dominant category of biologic drugs, mAb will be the focus of this review. First, the United States (US) and European Union (EU) approved mAb and those in phase 3 trials will be reviewed, then strategies on how to win biosimilar competition will be reviewed.
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Animals , Humans , Antibodies, Bispecific , Therapeutic Uses , Antibodies, Monoclonal , Therapeutic Uses , Antibodies, Monoclonal, Humanized , Therapeutic Uses , Biosimilar Pharmaceuticals , Reference Standards , Clinical Trials, Phase III as Topic , Drug Approval , European Union , United States , United States Food and Drug AdministrationABSTRACT
Objective To compare contrast-enhanced ultrasound and conventional ultrasound in determining artery stenosis of varying degrees of accuracy. Methods Using conventional ultrasound and contrast-enhanced ultrasound renal artery stenosis was diagnosed.And the renal artery diameter stenosis were measured the extent to which digital subtraction angiography (DSA) as the standard diagnostic accuracy of two methods to determine the rate. Results 50 patients were diagnosed as renal artery stenosis with DSA,21 patients stenosis rate 30%-49%,23 patients stenosis rate 50%-75%,6 patients stenosis rate >75%.diagnose accordance rate 78%(38/50)with conventional color doppler and 92% (46/50) with contrast-enchanced ultrasound.The difference was statistically significant (P<0.05=. ConclusionUsing ultrasound imaging of the renal artery stenosis to determine the degree had higher accuracy than the conventional ultrasonic testing method,was suitable for clinical application.