The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cronbach's alpha coefficient and structural equation modeling were adopted to empirically analyze the results. Six variables in the hypothetical model were included: compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality control of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality control of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical institution was only influenced by capability of government regulation.

Objective To investigate neuroprotective effect of AM-36 on secondary brain injury following traumatic brain injury(TBI)in rats.Methods A total of 38 male Sprague-Dawley rats were divided into an experimental group,a control group and a sham operation group,then sustained to moder- ate TBI.AM-36(0.1 ml/100 g)was administered intraperitoneally in the experimental group and isoton- ic saline solution was administered intraperitoneally in the control and the sham operation groups at 30 mi- nutes,24 and 48 hours after TBI,respectively.The brain water content was determined at 24 hours after TBI.Rats were sacrificed by decapitation at 24 hours or one week after TBI for observing histological changes in peripheral cortex,thalamus and hippocampus by means of Hematoxylin and Eosin staining and Fluoro-Jade(F-J)staining.Results The brain water content of bilateral hemispheres 24 hours after TBI in the experimental group was significantly decreased,compared to that of the control group.Histo- logical examination revealed less degenerating neurons(F-J positive neurons)in the cortex,thalamus, CAI and CA3 of the hippocampus in AM-36 treated rats 24 hours and one week after injury(P＜0.05). Conclusion Systemic administration of AM-36 at the early stage after TBI can decrease brain water content and exert neuroprotective effect on TBI.F-J staining can be used for histopathologic quantitation of neuronal damage,for it can accurately exhibit pathologic changes following TBI induced by fluid per- cussion.

Laparoscopic Roux-en-Y gastric bypass (LRYGB) has become the gold standard operation for morbid obesity, because effects of LRYGB are quick and lasting. However, there are many potential risks due to the operative complexity and long learning curve. There are early and late complications after LRYGB. If the complications are not diagnosed and treated in time and correctly, serious results even death, may occur. Mortality after LRYGB is 0.87%. It is important for the continous and healthy development of LRYGB that postoperative complications can be diagnosed and managed in time and effectively.
Gastric Bypass ; adverse effects ; methods ; Humans ; Laparoscopy ; adverse effects ; methods ; Obesity, Morbid ; surgery ; Postoperative Complications ; diagnosis ; therapy

Animals ; Cardiomegaly ; Constriction ; Heart ; Mice

OBJECTIVETo study the role of apelin in the prevention of pulmonary hypertension induced by hypoxia in rats.

METHODSThe animal model of hypoxic pulmonary hypertension was established by exposing the rats to isobaric hypoxic chamber for 4 weeks (8 h/d, 6 d/ w). Forty male Sprague-Dawley rats were randomly divided into control group (NC), hypoxic group(HH), hypoxic with low-dose apelin (5 nmol/(kg x d) group(LA) and high-dose apelin (10 nmol/(kg x d) (HA). [pGlu]apelin-13 was administered into the rats of apelin groups by mini-osmotic pump subcutaneously. The mean pulmonary arterial pressure(mPAP) and the mean carotid arterial pressure (mCAP) were measured by either right or left cardiac catheterization, and the weight ratio of right ventricule/left ventricule plus septum (RV/(LV + S)) were calculated. The Masson's trichrome stained lung specimens were examined by light microscope to examine the vessel wall area/total area (WA/TA), vessel cavity area/total area (CA/TA) and media thickness of pulmonary arterioles (PAMT). Meanwhile, the lung homogenates were assayed for the activity of supeeroxide dismutase (SOD) and the content of malondialdehyde (MDA).

RESULTS(1) mPAP and RV/(LV + S) of HH group were significantly higher than those of NC group. mPAP of LA and HA groups were lower than those of HH group. The RV/(LV + S) of HA group was significantly lower than that of HH group, but there was no significant difference between HH group and LA group. (2) Masson's trichrome staining revealed that WA/TA and PAMT of HH group were higher than those of NC group. Administration of apelin significantly eliminated WA/TA and PAMT in LA and HA groups. (3) CA/TA of HH group was lower than that of NC group. Administration of apelin significantly elevated CA/TA in LA and HA groups. (4) The activity of SOD and content of MDA in HH group was, respectively, lower and higher than those in NC group. Apelin treatment increased the activity of SOD in LA and HA groups while decreased the content of MDA.

CONCLUSIONSApelin could play an important role in treatment of hypoxic pulmonary hypertension of rats and the mechanisms of protection were associated with vasodilation of pulmonary artery and inhibition of oxidative stress.

Animals ; Cardiotonic Agents ; pharmacology ; therapeutic use ; Hypertension, Pulmonary ; etiology ; physiopathology ; prevention & control ; Hypoxia ; complications ; physiopathology ; Intercellular Signaling Peptides and Proteins ; pharmacology ; therapeutic use ; Male ; Oxidative Stress ; drug effects ; Pulmonary Artery ; physiopathology ; Rats ; Rats, Sprague-Dawley ; Vasodilation ; drug effects

OBJECTIVETo evaluate the efficacy of laparoscopic Roux-en-Y gastric bypass (LRYGB) in the treatment of type 2 diabetes mellitus(T2DM).

METHODSClinical data of 62 cases undergoing LRYGB from May 2010 to October 2011 were analyzed retrospectively.

RESULTSLRYGB was completed in 58 patients successfully. The mean operative time was(144.5±59.0) min and the mean intraoperative blood loss was(57.8±135.5) ml. Postoperatively two patients developed anastomotic bleeding, one gastric paralysis, one anastomotic leak, and one malnutrition, which were all healed by conservation treatment. One patient developed anastomotic stricture which was alleviated by balloon dilatation. Forty-nine cases were followed up for six months, in whom 34 patients required no further medical treatment, 9 received less medicines, and 6 were inactive. Body mass index, fasting C-peptide, and HbA1c were improved postoperatively. Compared to other patients, the 34 patients with clinical complete remission had higher BMI and shorter disease course(both P<0.05).

CONCLUSIONSLRYGB can safely and efficiently be applied in T2DM patients. Short-term efficacy is satisfactory and the long-term outcomes require further evaluation.

Adult ; Diabetes Mellitus, Type 2 ; surgery ; Female ; Gastric Bypass ; Humans ; Laparoscopy ; Male ; Middle Aged ; Retrospective Studies ; Treatment Outcome

OBJECTIVETo discuss the characteristics and operative selection of far lateral lumbar disc herniation (FLLDH).

METHODSTwenty-three cases of FLLDH, 14 were foraminal, and 9 were extraforaminal lumbar disc herniation. Of the 23 cases, low back pain was observed in 8 cases (31%), severe lower leg pain in 21 cases (91%) and Lasegue sign in 10 cases (43%). CT and MRI showed the protruded disc in and outside of the foramen clearly. Three surgical procedures were performed, including hemilaminotomy with medial facetectomy, facetectomy with pedicle screw fixation and fusion with posteolateral bone grafting, and the transmuscular approaches.

RESULTSTwenty-two cases were followed up for an average of 3.6 years. According to the Macnab criteria, 15 patients achieved excellent results, good 4, fair 3 and poor 0. Excellent and good rate was 86%.

CONCLUSIONSThe symptoms and signs of FLLDH mainly result from injury of upper nerve segments with the dominant symptom of severe lower leg pain. CT and MRI appearance are not only sensitive but also specific for the diagnosis of FLLDH. In foraminal lumbar disc herniation, the hemilaminotomy with medial facetectomy is recommended. While in extraforaminal lumbar disc herniation, either facetectomy with pedicle screw fixation and fusion with posterolateral bone grafting or transmuscular approaches for removal of nucleus pulposus can be chosen. Microendoscopic discectomy is a new, safe and efficient method for the disease, however, a skillful microendoscopic technique should be mastered prior.

Adult ; Aged ; Diskectomy ; methods ; Female ; Follow-Up Studies ; Humans ; Intervertebral Disc Displacement ; diagnosis ; surgery ; Lumbar Vertebrae ; surgery ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Spinal Fusion ; methods ; Tomography, X-Ray Computed

OBJECTIVETo investigate the clinicopathological features of multiple mucosal neuromas without multiple endocrine neoplasia type IIB (non-MEN-IIB MMN).

METHODSThree cases of non-MEN-IIB MMNs were analyzed for the clinical manifestations and histopathological characteristics.

RESULTSAll the 3 cases were females, age ranging from 30 to 45 years. Two cases of them involved in the laryngopharyngeal mucosa and another one located in the left margin of the tongue. Clinically, non-MEN-IIB MMNs presented with uncertain foreign body sensation, itching, vomiting and causalgia in the laryngopharyngeal areas. Mucosal papular lesions were treated by laser ablation or local surgical excision. The cases were respectively followed up for 6 to 20 months and found nothing. Histological examination showed the lesions were not encapsulated and contained irregular tortuous nerve bundles with undefined perineurium in the lamina propria. There were no nuclear palisade. Immunophenotype showed tumor cells strongly positive for vimentin, S-100, myelin specific enolase, CD56, neurofilament and neuron specific enolase, uniformly negative to CD34, CD117 and epithelial membrane antigen.

CONCLUSIONSNon-MEN-IIB MMN is a very rare disease and the possibility of MEN-IIB should be excluded before making diagnosis. The lesions located in the mucosal tissue with polyp-like or papular appearance, so they should be differentiated from other neoplasms or non-neoplastic lesions.

Adult ; Female ; Humans ; Middle Aged ; Multiple Endocrine Neoplasia Type 2b ; pathology ; Neuroma ; pathology

OBJECTIVETo explore the inhibitory effect of migration-inducing gene 7 (Mig-7) gene silencing induced by retroviral-mediated small hairpin RNA (shRNA) on vasculogenic mimicry (VM), invasion and metastasis of human hepatocellular carcinoma (HCC) cells in vitro.

METHODSTwo target sequences (Mig-7 shRNA-1 and Mig-7 shRNA-2) and one negative control sequence (Mig-7 shRNA-N) were synthesized. The recombinant retroviral vectors carrying Mig-7 shRNA were constructed, and HCC cell line MHCC-97H were transfected with Mig-7 shRNA-1, Mig-7 shRNA-2, Mig-7 shRNA-N, or the empty vector, or treated with 125 µg/mL recombinant human endostatin (ES). Mig-7 expression in the treated cells was detected using semi-quantitative PCR and Western blotting. The inhibitory effect of Mig-7 silencing on VM formation was investigated in a 3-dimensional cell culture system; the changes in cell adhesion, invasion and migration were assessed with intercellular adhesion assay, Transwell invasion assay and Transwell migration assay, respectively.

RESULTSThe expression of Mig-7 at both mRNA and protein levels decreased significantly, VM formation, invasion and metastasis were suppressed, while intercellular adhesion increased significantly in MHCC-97H cells in Mig-7 shRNA-1 and Mig-7 shRNA-2 groups (P<0.05); such changes were not observed in cells transfected with Mig-7 shRNA-N or the empty vector, nor in cells treated with ES.

CONCLUSIONSMig-7 silencing by retroviral-mediated shRNA significantly inhibits VM formation, invasion and metastasis and increases the intercellular adhesion of the HCC cells, while ES does not have such inhibitory effects.

The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cronbach's alpha coefficient and structural equation modeling were adopted to empirically analyze the results. Six variables in the hypothetical model were included: compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality control of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality control of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical institution was only influenced by capability of government regulation.
China ; Clinical Trials as Topic ; Humans ; Quality Control ; Research Personnel ; Surveys and Questionnaires