Clinical trial is the most direct and the most effective way to test the performance of medical equipments.The Belmont Report is the statement of the basic moral principles and guidelines,used to help solve the moral problems produced in scientific researches involving human subjects.This apaper examines the ethical issues in clinical trials for medical equipments from the perspective of the Belmont report.It first introduces the background and basic concepts of Belmont report,background concept and the concept and the basic process of medical equipment clinical trials.Then the three principles of the Belmont Report is presented and how to apply the Report to solve ethical problems arising in medical equipment trials.Application of informed consent risk and benefits assessment,and selection of subjects participants and the distribution of research results to address the ethical issues arising in clinical trials.

Objective To compare the effects of UVA irradiation on cell morphology,quantity and expression of inducible nitric oxide synthase (iNOS) mRNA and protein in human fibroblasts versus a kerati- nocyte cell line HaCaT.Methods Human fibroblasts and HaCaT cells were cultured and irradiated by 5 J/cm~2 UVA.Then,at 24,48 and 72 h after the stimulation,the cell morphology was observed under an in- verted microscope,and iNOS mRNA and protein were measured by RT-PCR and immunohistochemistry method,respectively.Results After the irradiation,human fibroblasts showed shrinkage at the three time points,the quantities of the cells began to decrease significantly at 24 h (P

Action Potentials ; Animals ; Ear, Inner ; blood supply ; Facial Nerve ; physiopathology ; Hearing Loss, Sensorineural ; etiology ; Rabbits

This study was designed to determine the effect of backpack loading on the gait pattern and corresponding compensatory strategy, which is important to the balance control of biped robot and military training. Five healthy subjects were instructed to walk at their preferred speed on level pathway taking three different loads i.e. 6 kg, 12 kg and 25 kg, on their backs. The results showed that the gait pattern was apparently influenced, and the dominant effects were found to be the flexion of hip, knee joints and pitch angle of torso. The stride speed decreased apparently with loading on their backs, but the stride length showed less changes. Besides, the responses to taking loads might be influenced by the strength of body. An apparent multi-joints coordination motor mode was employed to compensate the influences of loading, however, their contributions are different; hip, knee joints and torso pitch made dominant contributions to the compensation while ankle joints made minor. The anterior pitch of upper torso could be employed to adjust the overall center of mass while loading on their backs, the larger the magnitude of loading on their backs, the larger the anterior pitch angle of torso. After the heel touched the ground, the flexion of hip and knee joints were effective for the shock absorption, which means that the stiffness of hip and knee joints can be used to absorb the shock and avoid the trauma of each joints.
Adult ; Ankle Joint ; physiology ; Back ; physiology ; Gait ; physiology ; Hip Joint ; physiology ; Humans ; Knee Joint ; physiology ; Male ; Weight-Bearing ; physiology

Objective To investigate the production and removal of cyclobutane pyrimidine dimer (CPD) by HaCaT cells after UVB irradiation, and the effect of baicalin in this process. Methods HaCaT cells were cultured and irradiated with given dosages of UVB, and the production and removal of CPD by HaCaT cells at given time points after UVB irradiation were assessed by immunohistochemical method. In parallel studies, HaCaT cells were preincubated with baicalin, and the effect on CPD was evaluated. Results The damage to HaCaT cells was dependent on the dosage of UVB radiation. After irradiation with 30 mJ/cm2 of UVB, CPD formation peaked at 0.5 h. CPD was removed rapidly from HaCaT cells during the first 4 h; the rate of removal decreased thereafter, and the removal was almost complete by 24 h after the irradiation. The amount of CPD decreased significantly in HaCaT cells that were preincubated with baicalin solution before UVB irradiation than that in those without the preincubation (U = 2.324, P

Omega-3 polyunsaturated fatty acids (PUFAs) have been broadly investigated and shown to exert many preventive and therapeutic actions besides their important role in maintenances human health and normal development. In mammals, the level of omega-3 PUFAs is relatively too low compared with omega-6 PUFAs, which metabolically and functionally distinct from omega-3 PUFAs and often have important opposing physiological functions. Either the inefficiency of omega-3 PUFAs or the excess of omega-6 PUFAs will cause many healthy problems. So methods have been sought to increase the amount of omega-3 PUFAs and to improve the omega-6/omega-3 ratio in body. In this study, the sFat-1 gene, which putatively encodes a omega-3 fatty acid desaturase, was chemically synthesized according to the sequence from Caenorhabditis briggssae (with codon usage modified), and constructed into a mammal expression vector pcDNA3. 1-sFat1-EGFP. This vector was introduced into CHO cells by lipid-mediated transfection, and it's expression quickly and effectively elevated the cellular omega-3 PUFAs (from 18-carbon to 22-carbon) contents and dramatically improved the ratio of omega-6/omega-3 PUFAs. Cellular lipids extracts from stably selected cells were analyzed with GC-MS and the results showed that amount of total omega-6 PUFAs dropped from 48.97% (in GFP cells)to 35.29% (in sFat-1 cells), whereas the amount of total omega-3 PUFAs increased from 7.86% to 24.02%, respectively. The omega-6/omega-3 ratio also dropped from 6.23 to 1.47. These data demonstrates the Caenorhabditis briggssae omega-3 Fatty Acid Desaturase gene, sFat-1, was synthesized successfully and can produce omega-3 PUFAs by using the corresponding omega-6 PUFAs as substrates, which shows its potential for use in the production of omega-3 PUFAs in transgenic animals.
Animals ; CHO Cells ; Caenorhabditis ; enzymology ; genetics ; Cricetinae ; Cricetulus ; Fatty Acid Desaturases ; genetics ; physiology ; Fatty Acids ; analysis ; Plasmids ; Polymerase Chain Reaction

OBJECTIVE: To study the effect of basic fibroblast growth factor(b-FGF) on revascularization and bone remodeling of allogeneic mandible transplantation in repair of mandible defects in rabbits. METHODS: The mandible defects of 20 adult rabbits were created in both sides. The defects on the left side were implanted with allogeneic bone and local administration of b-FGF; the defects on the right side were only repaired with allogeneic bone as control group. At 1, 3 months after operation, the revascularization and bone remodeling were observed by ink-gelation vascular perfusion-transparency and histological examination. RESULTS: The allogeneic bone and b-FGF group had more marked vascularization and more quick and complete bone formation than control group. CONCLUSION: b-FGF can improve revascularization and bone formation after allogeneic mandible transplantation; allogeneic bone combined with b-FGF is a promising bone substitute in clinical uses.

AIMTo assess the psychometric properties of the Chinese Index of Premature Ejaculation (CIPE).

METHODSThe sexual function of 167 patients with and 114 normal controls without premature ejaculation (PE) were evaluated with CIPE. All subjects were married and had regular sexual activity. The CIPE has 10 questions, focusing on libido, erectile function, ejaculatory latency, sexual satisfaction and difficulty in delaying ejaculation, self-confidence and depression. Each question was responded to on a 5 point Likert-type scale. The individual question score and the total scale score were analyzed between the two groups.

RESULTSThere were no significant differences between the age, duration of marriage and educational level (P> 0.05) of patients with and without PE and normal controls. The mean latency of patients with PE and normal controls were 1.6 +/- 1.2 and 10.2 +/- 9.5 minutes, respectively. Significant differences between patients with (26.7 +/- 4.6) PE and normal controls (41.9 +/- 4.0) were observed on the total score of CIPE (P< 0.01). Using binary logistic regression analysis, PE was significantly related to five questions of the original measure. They are the so-called the CIPE-5 and include: ejaculatory latency, sexual satisfaction of patients and sexual partner, difficulty in delaying ejaculation, anxiety and depression. Receiver Operating Characteristic (ROC) curve analysis of CIPE-5 questionnaire indicated that the sensitivity and specificity of CIPE were 97.60 % and 94.74 %, respectively. Employing the total score of CIPE-5, patients with PE could be divided into three groups: mild (>15 point) 19.8 %, moderate (10-14 point) 62.8 % and severe (< 9 point) 16.7 %.

CONCLUSIONThe CIPE-5 is a useful method for the evaluation of sexual function of patients with PE and can be used as a clinical endpoint for clinical trials studying the efficacy of pharmacological intervention.

Adult ; Aged ; Algorithms ; China ; Coitus ; Ejaculation ; Humans ; Logistic Models ; Male ; Middle Aged ; Orgasm ; physiology ; Penile Erection ; physiology ; Psychometrics ; ROC Curve ; Sexual Dysfunction, Physiological ; classification ; diagnosis ; psychology ; Surveys and Questionnaires ; Time Factors

OBJECTIVETo summarize the clinical experience and to evaluate the safety and technical characters of laparoscopy-assisted total/subtotal colectomy(LAC).

METHODSFrom June 2005 to May 2008, a total of 150 cases underwent LAC in Jinling Hospital. There were 126 cases of severe functional constipation (SFC) treated by LAC combined with modified Duhamel procedure. There were 11 cases of familial adenomatous polyposis, 8 cases of ulcer colitis and 5 cases of multiple colorectal tumors treated with LAC combined with ileum-rectum anastomosis.

RESULTSOf the 150 cases, LAC was successfully performed in 147 cases. The mean operation time of LAC was (76.0+/-23.5) min. The estimated operative blood loss was (35.4+/-10.9) ml. The length of assisted incision was (5.2+/-1.1) cm. The time to resume intestinal function was (42.5+/-12.6) h. There was no postoperative wound infection, anastomotic stoma and other complications. Within 1 week after operation, severe diarrhea occurred in 2 cases and incomplete small bowl obstruction in 2 cases, who were relieved by conservative treatment. The mean postoperative hospital stay in patients without complication was(7.2+/-1.5) d. One year later, the score of gastrointestinal index quality of life in 116 patients was (110.3+/-20.7), which was significantly elevated as compared with the pre-operation score (90.1+/-23.8) and was not significantly different with the healthy score. The constipation symptoms were released in all the 105 SFC patients with different degree diarrhea in 7 cases and recurrence of mild constipation in 4 cases. There was no sign of recurrence and metastasis in 3 cases of multiple colorectal tumors.

CONCLUSIONSLAC embodies the advantages of less invasiveness of laparoscopy. It is a reasonable choice of operation method in treating various diseases related to total colon.

Adolescent ; Adult ; Aged ; Colectomy ; methods ; Colonic Diseases ; surgery ; Constipation ; surgery ; Female ; Humans ; Laparoscopy ; Male ; Middle Aged ; Minimally Invasive Surgical Procedures ; Young Adult

The complex field cure instrument is a new medical instrument with which an experiment was carried out. Rats were continuously irradiated by the complex field for 90 days, with a day's total dose of 285.9 M.T.G. while other rats weren't irradiated for control group. The animals were respectively killed at 7d, 14d, 30d, 60d and 90d, and their blood samples were taken for cell and humoral immune analysis. The results show that values of lymphocyte transform rate, soluble receptor (SIL-2R), total hemolytic complement levels (CH50) and immunoglobulin (A.G.) after irradiation are more than those of the control group having proved that the instrument may improve immune function of rats.
Animals ; Female ; Immunoglobulin A ; blood ; Immunoglobulin G ; blood ; Immunoglobulins ; blood ; Lymphocyte Activation ; Lymphocyte Count ; Male ; Physical Therapy Modalities ; instrumentation ; Rats ; Rats, Sprague-Dawley ; Receptors, Interleukin-2 ; blood ; Time Factors