Cochlear Implantation ; methods ; Fractures, Bone ; surgery ; Humans ; Temporal Bone ; injuries ; surgery ; Temporomandibular Joint ; surgery

Objective To develop a rapid method based on ARMS, named four primers allele-specific PCR(4p-AS PCR), to detect the most common non-deletional ?-thalassemia mutation Hb Constant Spring(Hb CS) by PCR technique. Methods The 4p-ASPCR was used to detect the Hb CS mutation of ?-thalassemia in 38 DNA samples of Hb H disease patients and using PCR-RE and DNA sequencing to confirm the results. Results Among the 38 Hb H disease patients 15 cases was revealed to carry Hb CS, 16 cases were deletional Hb H, and 7 cases need to be defined.Conclusion A simple, rapid and reliable method, named 4P-ASPCR, to detect Hb CS mutation have been developed. It is also may be useful in screen other point mutations such as Hb Quong Sze.

Objective To explore the factors which are related to the reoperation and relapse hiatus hernia in children.Methods Between Jan.2002 and May 2013,64 patients who suffered from hiatus hernia in Children's Hospital of Fudan University were divided into uneventful group (U group,n =49) and reoperation group (R group,n =15).The ages at operation,barium swallow examinations,operative procedures,findings during the operation and the followup of these two groups were reviewed.Results The average ages at operation in U group and R group were (14.70 ± 0.79) months and (13.60 ± 0.59) months,respectively.The major symptoms before the second operation in R group was vomiting(6 cases),pneumonia (4 cases) and dysphagia (2 cases).Asymptomatic recurrence was found in 3 patients.Through barium swallow examination,short esophagus was found in 10 cases in U group,while 3 cases were reported in R group.However,during the operation,the length of intra-abdominal esophagus without tension could be obtained with average (3.33 ± 0.86) cm in these short esophagus patients,which was only (3.18 ± 1.14) cm in those normal esophagus patients.There was no significant difference between the U group and R group in the width of the hiatus and the ratio of stomach above the hiatus.The length of esophagus which mobilized during operation was shorter in R group than that in U group(P =0.003).The difference of operative methods and the ratio of large hernia between these two groups could not be found.The common cause of failure in R group was herniated fundoplication (9 cases),which was followed by disputed fundoplication (4 cases),twisted fundoplication (1 case) and rupture of esophagus (1 case).The average follow up time was (8.3 ± 4.2) months in R group.Vomiting was found in 3 patients,and pneumonia was found in one case in R group after the second operation.The symptoms of these four patients were relieved half year later postoperatively.Conclusions The age,symptoms,size of the hiatus,short esophagus,and the operative methods are not related to the reoperation in hiatus hernia.But if the length of intra-abdominal esophagus without tension was not obtained enough,it may contribute to the recurrence of hiatus hernia.Wrap herniation has now become the most common mechanism of failure requiring reoperation.

Objective To study the efficacy and safety of intravesical chemotherapy combined with intravenous chemotherapy for high grade T1 (T1G3) bladder cancer after transurethral resection of bladder tumor(TURBT).Methods From January 2012 to December 2015,111 patients with high grade T1 (T1 G3) bladder cancer were retrospectively reviewed.Thirty-six patients received TURBT and intravesical chemotherapy and intravenous chemotherapy (group A),75 patients received TURBT and intravesical chemotherapy(group B).In group A,there were 28 males and 8 females,with average age 66.2 years;in group B,there were 59 males and 16 females,with mean age 67.9 years.There was no statistical difference between the two groups in age,sex,smoking history,tumor diameter,tumor number.1-year recurrence-free survival (RFS),1-year progression-free survival (PFS),intravenous chemotherapy adverse reaction were analyzed.Results All the patients were followed-up for 12 months.9 patients relapsed in group A,1-year RFS rate 75％,and the median RFS of the 9 patients was 9 (3-11) months.36 patients relapsed in group B,1-year RFS rate 52％,and the median RFS of the 36 patients was 7 (3-11) months.There was statistically significant difference between the two group(P =0.02).One patient progressed in group A,1-year PFS rate 97.2％,and the PFS was 9 months.Six patients progressed in group B,1-year PFS rate 92％,and the median PFS was 9.5(6-12) months.There was no statistically significant difference (P =0.305) between the two group.Only 1 case (3％) appeared Ⅲ° or above intravenous chemotherapy adverse reaction.Conclusions Intravesical chemotherapy combined with intravenous chemotherapy offers a better RFS rate than the intravesical chemotherapy alone for patients with T1G3 bladder cancer after TURBT,and there are very low rates of serious side effects.Intravenous chemotherapy may be considered as a new therapy strategy for T1G3 bladder cancer after TURBT.

Some unhealthy life habits, such as long-term smoking, heavy drinking, sexual overstrain and frequent stay-up could induce the Yin deficiency symptoms of zygomatic red and dysphoria. Stems of Dendrobii officinalis flos (DOF) showed the efficacy of nourishing Yin. In this study, the hyperthyroidism Yin deficiency model was set up to study the yin nourishing effect and action mechanism of DOF, in order to provide the pharmacological basis for developing DOF resources and decreasing resource wastes. ICR mice were divided into five groups: the normal control group, the model control group, the positive control group and DOF extract groups (6.4 g · kg(-1)). Except for the normal group, the other groups were administrated with thyroxine for 30 d to set up the hyperthyroidism yin deficiency model. At the same time, the other groups were administrated with the corresponding drugs for 30 d. After administration for 4 weeks, the signs (facial temperature, pain domain, heart rate and autonomic activity) in mice were measured, and the facial and ear micro-circulation blood flow were detected by laser Doppler technology. After the last administration, all mice were fasted for 12 hours, blood were collected from their orbits, and serum were separated to detect AST, ALT, TG and TP by the automatic biochemistry analyzer and test T3, T4 and TSH levels by ELISA. (1) Compared with the normal control group, the model control group showed significant increases in facial and ear micro-circulation blood flow, facial temperature and heart rate (P < 0.05, P < 0.01), serum AST, ALT (P < 0.01), T3 level (P < 0.05), TSH level (P < 0.05) and notable deceases in pain domain (P < 0.01), TG level (P < 0.01). (2) Compared with the model control group, extracts from DOF (6 g · kg(-1)) could notably reduce facial and ear micro-circulation blood flow, facial temperature and heart rate (P < 0.05, P < 0.01) and AST (P < 0.05) and enhance pain domain (P < 0.01) and TG (P < 0.01). Extracts from DOF (4 g · kg(-1)) could remarkably reduce AST and ALT levels (P < 0.01, 0.05). Extracts from DOF (6 g · kg(-1) 4 g · kg(-1)) could significantly reduce T3 and increase serum TSH level (P < 0.05). DOF could improve Yin deficiency symptoms of zygomatic red and dysphoria in mice as well as liver function injury caused by overactive thyroid axis. According to its action mechanism, DOF may show yin nourishing and hepatic protective effects by impacting thyroxin substance metabolism, improving micro-circulation and reducing heart rate.
Animals ; Dendrobium ; chemistry ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Flowers ; chemistry ; Humans ; Hyperthyroidism ; drug therapy ; metabolism ; Male ; Mice ; Mice, Inbred ICR ; Phytotherapy ; Thyroxine ; metabolism ; Yin Deficiency ; drug therapy ; metabolism

OBJECTIVETo investigate the relation between sinus-straddling hematoma (SSH) and venous sinus injury and explore the approaches for surgical management.

METHODSThirty-six cases of stride sinus hematoma were reviewed to observe the incidence rate of sinus injury complicated with (SSH) and explore its surgical management.

RESULTSThe incidence rate of venous sinus injury following (SSH) was 80.56% (29/36), and appropriate surgical management yielded good therapeutic effect in these patients.

CONCLUSIONIntracranial stride sinus hematoma is often accompanied by venous sinus injury, and adequate preoperative risk evaluation may improve the success rate of the operation.

Adolescent ; Adult ; Brain Injuries ; complications ; China ; epidemiology ; Cranial Sinuses ; injuries ; Female ; Hematoma ; epidemiology ; etiology ; Humans ; Incidence ; Intracranial Hemorrhage, Traumatic ; epidemiology ; etiology ; Male ; Middle Aged

Objective To investigate the value of neutrophil CD64 combined with monocyte chemotactic protein 1 (MCP-1),interleukin-8 (IL-8) and interferon-inducible protein-10 (IP-10) in the clinical diagnosis of neonatal sepsis.Method Cases of neonatal sepsis from March 2015 to June 2016 in the department were chosen as sepsis group.35 neonates with non-infection diseases were selected as noninfection group and 40 healthy newborn infants were assigned as control group.The level of CD64 in blood were detected by flow cytometry,while the level of MCP-1,IL-8 and IP-10 of the serum in the three groups were detected by automatic biochemical analyzer.The differences between groups were compared by single factor ANOVA.The ROC curves of sepsis diagnosed by whole blood CD64,serum MCP-1,IL-8 and IP-10 were drew.Result The level of CD64,IL-8 and IP-10 of the neonatal blood in the sepsis group were significantly higher than that in the non-infection group (P ＜ 0.05) and control group (P ＜ 0.05).There were no significant difference between the sepsis group and non-infection group in MCP-1 (P ＞ 0.05),but significantly higher than that in the control group (P ＜ 0.05).The levels of serum MCP-1 and IP-10 in the non-infection group were significantly higher than those in the control group (P ＜ 0.05),but there was no significant difference between the non-infection group and control group in CD64 and IL-8 (P ＞0.05).The optimal thresholds of blood CD64,MCP-1,IL-8 and IP-10 in the diagnosis of sepsis were 35.0 MFI,58.6 ng/L,60.3 ng/L,0.46 μg/L.The sensitivity and specificity of the diagnosis of sepsis were 92.8％ and 90.6％ in CD64,70.0％ and 42.6％ in MCP-1,78.5％ and 68.0％ in IL-8,72.8％ and 54.6％ in IP-10,97.1％ and 94.6％ when combined.Conclusion The combination test of CD64,MCP-1,IL-8 and IP-10 can improve the sensitivity and specificity of the diagnosis of sepsis.

Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
Clinical Trials, Phase III as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Medical Informatics

Due to a great amount of data in clinical trials, the data cleansing needs to adopt a variety of measures, including the latest developed visual check approach. According to the different types of clinical data and the different stages in the course of clinical data management, this study reviews 8 types of visual graphics that show the relevance and trend among the data. The series of graphics can rapidly detect abnormal data, monitor clinical research in real-time, make the data management process much easier and improve the clinical trial efficiency and data quality.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; methods

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.
Clinical Trials as Topic ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards ; Software Validation