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OBJECTIVE To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs， and to protect the legitimate rights and interests of the subjects. METHODS The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st， 2020 to July 1st， 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital. RESULTS Of the 316 clinical trials of registered anti- tumor drugs that were initially reviewed， 257 （81.3%） had problems with the contents of informed consent form， mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer （68.5%）， the incomplete notification of the test content （59.1%）， the insufficient notification of rights and interests and risks （58.4%）， the insufficient notification of personal information protection （56.0%）， and the nonstandard expression of the informed consent form （52.5%）. CONCLUSIONS There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs （GCP）. The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form， and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing， continue to strengthen the examination ability， improve the examination quality， and effectively protect the safety and interests of the subjects.
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Objective To explore the clinical expression of P53, Livin and PARP in the epithelial ovarian cancer and its correlation with the chemotherapy resistance and clinical prognosis.Methods 74 specimen of epithelial ovarian cancer confirmed from January 2009 to June 2011 in our gynecology department were selected.During the follow-up visit, the subjects were divided into chemotherapy sensitivity group and chemotherapy resistance group according to the recurrence cases, the clinical expression and survival rate for two groups were compared, the influence factors of survival time were analyzed.Results The positive rate of P53, Livin and PARP for chemotherapy sensitivity group was 47.1%, 56.9%and 52.9%;the positive rate for chemotherapy resistance group was 73.9%, 95.7% and 95.7%,the diyforences were significant(P<0.05).After 1, 3 and 5 years of treatment, the survival rate for chemotherapy sensitivity group was 100.0%, 82.4% and 66.7%,The survival rate for chemotherapy resistance group was 87.0%, 26.1% and 8.7%,the diyforences were significant(P<0.05).Based on the Cox regression model, the influence factors of the patient's age, pathological differentiation degree, clinical staging and chemotherapy sensitivity were introduced.It was known that the patient's survival time was greatly influenced by clinical staging and chemotherapy sensitivity (P<0.05).Conclusion For patients with epithelial ovarian cancer, the expression of P53, Livin and PARP is correlated with chemotherapy resistance.Therefore, the clinical effect is predictable, for patients with higher expression, the personalized therapy can improve the patient's prognosis.
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The article was aimed to study the influence of low pressure and hypoxia on rat metabolism and evaluate the intervention effect of San-Guo-Tang-San (SGTS) on high altitude polycythemia (HAPC) rats. A total of 25 rats were divided into the plain control group, high altitude model group, Hong-Jing-Tian capsule (Nuo-Di-Kang cap-sule) group, high-dose SGTS group and low-dose SGTS group, with 5 rats in each group. After one week adaptation, rats in the model group and the medication groups were put into the hyperbaric chamber for 40 days (22 h/d) to simulate high altitude environment of 5 000 m. In the end of 40th day, the hemorheology and the dry/wet weight ratio of lung of rats were measured. And plasma samples were derivatized with ECF prior to GC-MS instrumental analysis. Principal component analysis (PCA) was used to find potential biomarkers, and evaluate the intervention effects of SGTS. The results showed that the low pressure and hypoxia changed the hemorheology and dry/wet weight ratio of lung of rats markedly. Metabolomics studies showed that the high altitude model group, high-dose SGTS group, low-dose SGTS group, and Hong-Jing-Tian capsule group can be obviously differentiated. Main markers such as 9-hexylheptadecane, glycine, N-methyl-N-methoxycarbonyl-ethyl ester, 2,4-Di-tert-butylphenol, were found to be the endogenous substances of SGTS which intervening the HAPC rats. It was concluded that SGTS can intervene low pressure and hypoxia induced HAPC.
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Objective To evaluate the infection status and genotype distribution of high risk human papillomavirus (HPV) in Chongqing women with different healthy status of cervix .Methods A retrospective analysis including 3 118 cases from June 2013 to March 2014 were performed ,945 of which were carried out multiplex real time PCR ,and data of cervix healthy status and HPV positive cases were subjected to chi‐square test .Results The general positive percentage of high risk HPV was 27 .49% ,16 .35%in healthy check‐up group ,and 24 .42% in cervicitis group and 39 .87% in cervical neoplasia lesion ,there was a significant difference of HPV positive ratio between these three groups(P< 0 .05) ;and HPV positive ratio was higher in older women without significant difference .In Chongqing region ,the three most common HPV types were HPV52 (21 .97% ) ,HPV16 (20 .00% ) and HPV58 (14 .75% ) .However ,the three most common HPV types in various groups are different :HPV52 (26 .20% ) ,HPV58 (14 .3% ) and HPV51 (10 .70% ) in health check‐up group ; HPV52 (21 .10% ) ,HPV58 (20 .00% ) and HPV16 (18 .90% ) in cervicitis group while HPV16 (29 .00% ) ,HPV52 (19 .80% ) and HPV58 (11 .50% ) in cervical neoplasia lesion group .The multiple infec‐tion rate of HPV was 5 .86% ,as the cervix status gets worse ,HPV concurrent infection increases ,and concurrent HPV types vary :mostly with HPV 52 in healthy check‐up group while with HPV 16 in cervical neoplasia lesion group .Conclusion The prevalence and genotype distribution of HPV in Chongqing women with different healthy status of cervix are significant difference.
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Objective To discuss the significance of region Ⅵ lymph nodes dissection in treatment of patients with clinical cervical nodes negative(cN0)papillary thyroid carcinoma(PTC).Methods Clinical data of 38 cases of cN0 PTC treated with region Ⅵ lymph nodes dissection were retrospectively analyzed.The related literature was reviewed.The cervical nodes dissection scope and the key operation points in treatment of cN0 PTC were discussed.Results No permanent recurrent laryngeal nerve injury or parathyroid damage happened.14 cases(36.84％)had occult lymph node metastasis to region Ⅵ lymph nodes.After more than 5 years of follow-up,all the cases had excellent life quality.3 cases(7.89％)were found lymph node metastasis to lateral cervical region and they were given functional neck dissection.No recurrence or metastasis occurred to the 3 cases during more than 2 years of follow-up.Conclusion Region Ⅵ lymph node dissection in treatment of cN0 PTC is safe,reliable,and with less complications.
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Objective To observe the effect of foam dressing and polyurethane gel pad in prevention of pressure ulcer for surgical patients.Methods 140 patients in neurosurgery department were randomly divided into the control group and the experimental group with 70 patients in each group.The control group received foam-rubber cushion for conventional nursing,the experimental group used foam dressing and polyurethane gel pad to prevent pressure ulcer.Instantly after the operation and 30 min later,the situation of skin pressure ulcer was recorded respectively,the maximum diameter of erythema was measured and the process was put into phases.24 hours after the operation,patients of the above two groups were visited and the situation of skin pressure ulcer was recorded.The skin pressure ulcer and the maximum diameter of erythema were compared between the two groups.Results Cases with phase Ⅰ and phase Ⅱ pressure ulcer in the experimental group were less than those of the control group at three time points,which were instantly after the operation,30 min and 24 hours later.The diameter of erythema at three time points was also less than the control group.Conclusions Foam dressing and polyurethane gel pad could effectively prevent or alleviate pressure ulcer after operation and therefore is worthy of clinical application.
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Objective To observe the ultrastructure and absorption function of colon mucosa in rat with ultra-short bowel syndrome. Methods Totally 30 SD rats were randomly divided into three groups: ultra-short bowel group (90%-95% of the intestine was surgically resected, n = 10), sham group (n = 10), and normal control group (n = 10). All animals were given with enteral nutrition. Scanning electron microscopy was performed 21 days later to observe the morphology of mucosal surface, and transmission electron microscopy was performed to observe the ultrastructural changes of intestinal epithelial cells. The absorption of colon to water, carbohydrates, and amino acid determined after 3 hours of closed perfusion of the colon with D-xylose solution and 15N-glycine on the continuous cycle of colon. Results As shown by the transmission electron microscopy, compared with the normal control group, rats in the ultra-short bowel group showed significantly decreased goblet cells on colonic mucosl surface, increased epithelial cells, longer and denser microvillus, increased area of membrane surface, increased number of cell-cell junctions, increased number of desmosome, tight junction, and gap junctions, higher development of endoplasmic reticulum and dictyosome, and increased number of mitochondria. As shown in the screening electron microscopy, compared with the normal rats, rats in the ultra-short bowl group had significantly deeper colon folds, thicker mucous membrane, increased number of bay openings, and longer and denser microvillus-like structures inside bays. The capability of water absorption was signicatnly higher in the ultra-short bowl group than in the sham group and normal control group (P = 0. 000) . The absorption rates of xylose and 15 N-glycine were also significantly higher in the ultra-short bowl group than in the control group (P ＜ 0. 01). Conclusions The absorption capability can be compensatively increased in rats with ultra-short bowel syndrome. Decreased apoptosis of colon mucosa cells, increased absorption cells, hyperplasia of microvilli, increased area of the membrane surface,and increased number of mitochondria may constitute its material and energy bases.
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BACKGROUND: The study about the multiple differentiation potentials of the mesenchymal stem cells is still on the stage of the animal experimentation. Can mesenchymal stem cells have the ability to differentiate into certain tissues and develop the corresponding functions after they are transplanted into certain tissues?OBJECTIVE: To observe the differentiation of the bone marrow mesenchymal stem cells into the nerve and its effect on the nerve functional recovery after they are transplanted into the peripheral zone of the ischemic infarction focus of the cerebral cortex.DESIGN: A randomized controlled study.SETTING: The Department of Anatomy of the School of Basic Medical College of Sun Yat-sen University; the Department of Neurology of the First Hospital of Sun Yat-sen University; Department of Pathology of the Medical College of Jinan University.MATERIALS: The experiment was conducted at the Medical College of Sun Yat-sen University from November 2002 to November 2003. Forty-eight male SD rats were chosen and randomly divided into two groups, with 32 rats in cerebral infarction model group and 16 in the non-model control group. In the cerebral infarction group, the rats were randomly divided again into two groups: 16 rats in the transplantation group and 16 in the phosphate buffered fluid group. The anterior fontanel taken as the reference point, 5 μL(5 × 104 L-1) of the bone marrow mesenchymal stem cells or the phosphate buffered fluid was respectively transplanted at the site 3 mm away on the caudal side and 1.5 mm aside at the depth of 2. 0 - 3. 0 mm.METHODS: The bone marrow mesenchymal stem cells were obtained through the separation and purification of the bone marrow of the ribs taken away in the thoracic surgery from the patients without the hematological diseases, and then the cells underwent in vitro culture, the amplification and the identification. At the 2nd and 6t1 weekend after the transplantation,the rats of every group were anesthetized, and the samples were taken from the transplantation site and made into the 25 μm of continuous frozen section. Then, the immunohistochemical method was used for the detection of the expressions of neuron specific enolase, neurofibril protein, glial fibrillary acidic protein, and nidogen to evaluate the ability of the bone marrow mesenchymal stem cells to differentiate into neurons and glial cells. Eight rats of the transplantation group and 8 rats of the phosphate buffered fluid group were randomly taken out, and 2 and 6 weeks before and after the transplantation the bar walking test evaluation method was used to identify the general status and reaction ability of the rats. Sixteen rats of the control group were assessed at the same time.enolase, neurofibril protein, glial fibrillary acidic protein and nidogen in the bar walking test.2nd weekend after the transplantation, there were positive expressions of glial fibrillary acidic protein and nidogen at the transplantation site of the bone marrow mesenchymal stem cells. At the 6th weekend there were positive expressions of neuron specific enolase and neurofibril protein at the transplantation site of the bone marrow mesenchymal stem cells. While in the phosphate buffered fluid group, there were negative expressions of neuron specific enolase, neurofibril protein, glial fibrillary acidic protein and nidosymptoms in the control group and the evaluation scores were all 9. 2 weeks after the transplantation, and the evaluation scores of the motor function in the transplantation group were higher than the ones in the phosphate buffered fluid group, [(6.7±0.9), (5.3-±1.0), (P ＜0.05)]. Six weeks after the transplantation, the evaluation scores of the motor function in the transplantation group were also higher than those in the phosphate buffered fluid group[(8.9±1. 1),(7.2±0.8),(P ＜0.05)].CONCLUSION: After their transplantation into the central nervous system,the bone marrow mesenchymal stem cells showed the ability to differentiate into neurons and glial cells, in which the characteristics of some neurons and glial cells were found. Bar walking test found that the evaluation scores of the motor function in the transplantation group were higher than those in the phosphate buffered fluid group, which suggests that the bone marrow mesenchymal stem cells have a significant effect on restoration of the functions of the nerves.
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Aim To investigate whether SC58125 synergized with TNF-? to induce HT-29 cell apoptosis and study the possible molecular mechanism. Methods By using MTT, agarose gel electrophoresis and flow cytometry, we examined the effect of SC58125/TNF-? on cell proliferation and apoptosis in HT-29 cells. The activity of caspase-3 and the changes of I?B? and NF-?B were also measured after treatment with SC58125 by Electrophoretic mobility shift assay and Western blot. Results Both SC58125 and TNF-? exhibited cytotoxicity, the combination of the two agents significantly reduced HT-29 cell viability in a dose-dependent manner. TNF-?-treated cells showed oligonucleosomal cleavage of genomic DNA. SC58125 significantly enhanced the inhibition of cell proliferation and inducement of cell apoptosis of TNF-?,the apoptotic index was increased from 11.2%?1.1% to 53.9%?2.1%. SC58125/TNF-?-induced apoptosis of HT-29 cells was accompanied by the induction of caspases-3. I?B? levels were substantially decreased after treatment with TNF-? and the degradation of I?B? was almost completely inhibited when SC58125 was added in NF-?B was activated in HT-29 cells after treatment with TNF-?, whereas pretreatment of HT-29 cells with SC58125 for 2 h, TNF-?-induced NF-?B DNA binding was profoundly inhibited. Conclusion SC58125 synergizes with TNF-? to inhibit cell growth and induce apoptosis in HT-29 cells, which may be mediated by activating caspases and preventing degradation of I?B?.
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Objective To investigate the effectiveness of Xingding injection on glomeruloscerosis in rats treated with adriblastine.Methods Twenty-four rats were randomly divided into three groups.The rats in three groups were injected with normal saline(NS),NS associated with adriblastine,adriblastine associated with Xingding injection respectively.The content of protein in urine of 24 hours and total cholesterol(Chol),total protein(TP),albumin(Alb),creatinine(Cr) in serum were detected.Results In Xingding group,the contents of protein in urine of 24 hours and Cr in serum were significantly lower,and that of serum Alb was significantly higher compared with those of the control group(P
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AIM: To investigate the expression of TNF-?, TGF-? in patients with oral lichen planus (OLP) and normal oral mucosa (NOM). METHODS: An immunohistochemical technique was performed to detect TNF-?, TGF-?_1 and TGF-?_2 expression in 22 cases with OLP and 10 normal controls. RESULTS: In lamina propria of OLP, the expression of TNF-? and TGF-?_1 were increased, whereas TGF-?_2 did changed significantly compared with control group. TNF-? positive signal were mostly found in macrophages, lymphocytes. TGF-?_1 positive cell was present in macrophages, endothelial cells and fibrocytes. CONCLUSION: TNF-? and TGF-?_1 play an important role in the development and maintenance of OLP local inflammation.
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AIM: To investigate whether protein kinase C (PKC) is involved in the proliferation and the telomerase expression in human hepatocellular carcinoma cells. METHODS: Human hepatocellular carcinoma cells (BEL-7402) were treated with exogenous phorbol-12-myristate-13-acetate (PMA, PKC activator) and staurosporine (SP, PKC inhibitor) for 48 hours. The techniques of cell culture and the telomeric repeat amplification protocol silver staining in combination with computer image scanning system in vitro were used to observe the variations of the growth and the telomerase expression. RESULTS: The proliferative potential of BEL-7402 cells was decreased by the action of PMA as well as SP, and the telomerase expression was also inhibited by PMA and SP. CONCLUSION: Our findings suggest that the proliferation of human hepatocellular carcinoma cells and the telomerase expression may be related to PKC. [
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AIM: To explore the effects of PMA(phorbol-12-myristate-13-acetate,a tumor promoter, mimicking the action of diacylglycerol on PKC)and laminin on the adhesion and the proliferation of human hepatocellular carcinoma cells, and provide a new clue to liver cancer treatment. METHODS: Human hepatocellular carcinoma cell line(BEL-7402)was used to identify the endogenous laminin and protein kinase C-?(PKC-?) expression, and the effects of laminin and PMA on the adhesion and the proliferation were also investigated in vitro. RESULTS: By the effect of exogenous laminin, human hepatocellular carcinoma cell (BEL-7402) possessed endogenous laminin expression and increased the adhesion and the proliferation, which was showed the synergistic action by the effect of PMA in combination. By the action of PMA alone,the proliferation and the PKC-? expression increased by exogenous laminin were decreased, and the adhesion and the endogenous laminin expression were increased. CONCLUSIONS: The finding suggested that the adhesion and the proliferation of human hepatocellular carcinoma cell were closely related to the effects of endogenous or exogenous laminin ,which were associated with cPKC-? activity. Therefore,the application of anti-laminin antibody in combination with PKC antagonist might be a new clue to find out the therapy for liver cancer.
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AIM: To explore the effect and the mechanism of sulphated heparin on the proliferation and the apoptosis of human hepatocellular carcinoma cells. METHODS: The human hepatocellular carcinoma cell line (HepG-2) was used to identify the expression of ras gene protein and to study the effect of sulphated heparin on proliferation and the apoptosis in vitro . RESULTS: The sulphated heparin downregulated the ras protein expression and inhibited the cell growth in HepG2 cells. In the presence of sulphated heparin, the apoptosis rate of HepG2 increased. CONCLUSION:The data suggest that the effects of sulphated heparin on the proliferation and the apoptosis of the human hepatocellular carcinoma cell are correlated with the signaling transduction mediated by ras gene protein.
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AIM: To examine the effect of insulin on the proliferation of human hepatocellular carcinoma cell and its possible mechanisms. METHODS: The human hepatocellular carcinoma cell line(HepG-2) was used to study the changes in calcium ion across plasma membrane (Ca 2+ APM)under the action of insulin by the assay of atomic absorption spectrum, and in the proliferation under the action of insulin and calcium ion antagonist (isoptin). RESULTS: The influx of Ca 2+ APM and the proliferation was increased after insulin administration, but the proliferation was inhibited by isoptin. CONCLUSION: Changes in the homeostasis of calcium ion across plasma membrane was involved in the effect of insulin on the proliferation of human hepatocellular carcinoma.
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AIM: To explore the molecular mechanisms of SC58125 on apoptosis in HepG2 cells. METHODS: Cell culture, ELISA, flow cytometry, RT-PCR, Western blot and electrophoretic mobility shift assay (EMSA) analysis were employed to clarify the effect of SC58125 on apoptosis in HepG2 cells and related molecular mechanisms. RESULTS: SC58125 induced apoptosis in HepG2 cells in a concentration-dependent manner, which was accompanied by inhibition of NF-?B, activation of caspase-3, decrease of bcl-2 mRNA and increase of p53 mRNA. However, no significant changes were found in the DNA binding of AP-1. CONCLUSION: SC58125 induces apoptosis in HepG2 cells, which may be related to the inhibition of NF-?B, activation of caspase-3, decrease of bcl-2 mRNA and increase of p53 mRNA.
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Therapeutic efficiency of advanced stage liver cancer is insufficiency,which has become the hot spot of research.Clinical observation found that prognosis of liver cancer with integrity amicula was better.It is generally accepted that silicon dioxiode(SiO2) can induce pulmonary fibrosis,resulting in the formation of pneumosilicosis.Use of SiO2 as embolism material induces hepatic fibrosis and forms the fibrosis amicula around the liver carcinoma,and then restrains the recurrence and metabasis of liver cancer,which has been turned into one of the aspect of liver carcinoma therapy.The possible mechanisms of inducing hepatic fibrosis by SiO2 are peroxidative damage by free radical,releasing of active cytokines,or inducing cell apoptosis and the activation of HSC etc.
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AIM: To investigate the changes of expression of Nogo-A at different time points in brain ischemic infarct rats.METHODS: The model of 80 cases of middle cerebral artery occlusion(MCAO) in rats was established.The expression of Nogo-A mRNA and protein were determined by Western blotting and hybridization,and the relationship between functional scoring and Nogo-A was also evaluated.RESULTS: In the brain of MCAO rats,Nogo-A mRNA expression was decreased on day 3 and increased significantly on day 7.The highest level was observed at the 21th d,keeping the same level at the 28th d.Nogo-A protein expression showed the same results.These results were correlated with the brain function scoring.CONCLUSION: Expression of Nogo-A does not increase in the early stage,but increases significantly in the late stage of MCAO,suggesting that Nogo-A expression may play an important role in the nerve regeneration of brain ischemic injury.
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AIM: To explore the differentiation and the functional behavior of marrow mesenchymal stem cells (MSC) transplanted into the cerebral infarction area after cerebral middle artery ischemia in rats. METHODS: MSC were isolated from human rib marrow and cultured in L DMEM medium in vitro. The model of rat cerebral infarction by cerebra middle artery occlusion was established, and the identified MSC were transplanted intracerebrally 10 days later. Immunohistochemistry technique was used to identify the cell survivor and its differentiation to the neurogenesis in the transplantation site, and at 2 weeks and 6 weeks after transplantation, the functional tests were comparatively studied. RESULTS: The results showed that the survivor of transplanted MSC was differentiated to neural phenotype cells, and the functional behavior of the injury rats was recovered significantly after MSC transplantation (P
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AIM: To investigate the dynamic changes of Nogo-A expression in ischemic infarct brain in rats. METHODS: The model of middle cerebral artery occlusion (MCAO) in 80 rats was established and expression of Nogo-A mRNA was measured by immunohistochemistry and hybridization. RESULTS: In the brain of MCAO rats, Nogo-A mRNA expression was decreased at the third day and increased significantly at the 7th day, and reached high level at the 21th day, then remained the high level to the 28th day. Nogo-A protein expression showed the same results. CONCLUSION: Expression of Nogo-A did not change in the early stage of MCAO, but increased significantly in the late stage of MCAO, suggesting that Nogo-A expression may play an important role in the nerve regeneration of brain ischemic injury. [