Since December 2019, COVID-19 has been found in Wuhan, Hubei Province of China, which has spread in many countries and regions around the world. A large number of clinical trials have been launched in China aiming to find safe and effective drugs and treatments.The protection of subjects' legal rights, welfare and safety should be superior to the consideration of scientific and social benefits. Therefore, all parties involved in clinical trials should take corresponding measures to protect subjects' legal rights, welfare and safety. This paper discussed about the protection of subjects' legal rights, welfare and safety in clinical trials of COVID-19 from all aspects of the clinical trials, aiming to provide reference for all parties involved in clinical trials and basic ideas for the protection of subjects' legal rights, welfare and safety in clinical trials of emergencies.

Objective To research the recent efficacy of advanced cervical cancer treated with two different ways of uterine artery intervention and systemic intravenous chemotherapy respectively combined with radiotherapy.Methods Eighty-two patients with stage Ⅱ B-ⅣA cervical cancer confimed by pathology were given systemic intravenous chemotherapy combined with radiotherapy(vein group,S0 cases)and uterine artery intervention chemotherapy combined with radiotherapy(intervention group,32 cases).The therapeutic effect and remission rate of parametrium were compared.Results The total therapeutic effect rate in vein group was 90.0％(45/50),and intervention group was 93.8％(30/32),there was no significant difference between two groups(P ＞ 0.05).The remission rate of parametrium in vein group was 50.0％ (25/50),and intervention group was 75.0％(24/32),there was significant difference between two groups (P ＜ 0.05).Conclusion The effect of uterine artery intervention chemotherapy for parametrium is better than that of systemic intravenous chemotherapy.

Objective To investigate the effects of two inhibitors of arachidonic acid metabolic pathway (5-cyclooxygenase blockade MK886 and COX 2 blockade celecoxib) on growth and VEGF mRNA expression of human pancreatic cancer cell SW1990.MethodsPancreatic cancer cells SW1990 were cultured with different concentrations of MK886,celecoxib,MK886 and celecoxib,then the cell proliferation was detected by using CCK-8,BLT1 mRNA,PGE2 mRNA and VEGF mRNA expressions were determined by RTPCR.ResultsAfter 10 μmol/L MK886 or 20 mmol/L celecoxib treatment for 24 h,the growth of SW1990 was greatly suppressed ( 1.80 ±0.06 vs 1.65 ±0.10,2.04 ±0.03 vs 1.86 ±0.02,P ＜0.01 ),and the growth suppression of SW1990 cells was increased accompanying the raised concentration of MK886 or celecoxib.After both MK886 and celecoxib treatment for 12 h,the growth of SW 1990 cells was much obviously suppressed (1.72 ±0.05 vs 1.52 ±0.05,P ＜0.01 ).After celecoxib treatment for 48 h,the BLT1 mRNA,PGE2 mRNA and VEGFmRNA expressions were not significantly changed,but the expressions of PGE2 mRNA were significantly decreased ( P ＜ 0.05 ).After MK886 or MK886 + celecoxib treatment,the expressions of BLT1 mRNA,VEGF mRNA were significantly decreased ( P ＜ 0.05 ),but the expressions of PGE2 mRNA were not significantly changed when compared to control group.ConclusionsTwo metabolic pathways of arachidonic acid have a close relation with occurrence and proliferation of pancreatic cancer,when both of the pathways were blocked,the proliferation of the pancreatic cancer cell was suppressed obviously.

Objective To establish the reference range of thyroid function from the normal pregnant women in different pregnant period in Hanzhong region.Methods According to the NACB inclusion criteria,collected local resident pregnant women 4 031 cases,from July 2012 to December 2015.With the combination of random sampling,stratified sampling and cluster sampling,thyroid hormone levels were measured by a fully automated chemiluminescence analyzer and its accompanying reagents.All patients were divided into three groups:998 cases in early pregnancy (T1),1 543 cases in mid-pregnancy (T2),1 490 cases in late pregnancy (T3),and 105 cases of non-pregnant women in childbearing age (T0) were selected as control group.Results The levels of thyroid hormones were different among three periods of pregnant women.TSH were 0.25～5.32,0.42～6.26 and 0.61～7.68 mIU/L respectively in the early,middle and late stages.FT3 were 3.54～6.04,3.57～5.94 and 2.93～5.40 pmol/L,respectively.FT4 was 7.11～16.88,6.78～16.94 and 6.03～16.87 pmol/L.Thyroid hormone levels in pregnant women compared with non-pregnant women,there were significant differences (TSH:x2=233.183,P＜0.05,FT4:x2 =388.12,P＜0.05 and FT3:x2 =558.795,P＜0.05).TSH were lower in early pregnant women comparing to non-pregnancy women,and higher in middle-late pregnant women.The change of FT3 and FT4 were consistent,and reduced with the extension of pregnancy comparing to non-pregnancy women.Conclusion The level of thyroid function in pregnant women were different from non-pregnant women.and the normal reference range of local pregnant specific thyroid hormone should be established.

Objective:To explore the outcome of soft tissue sarcoma (STS) on patients with soft tissue metastasis. Methods:We ana-lyzed 25 STS patients with soft tissue metastasis primarily localized on extremity and trunk. The study was conducted from June 2010 to June 2016 by retrospective analysis of the clinical and pathological characteristics of the patients. The assessed endpoints were overall survival. Results:Six patients (24%) had synchronous soft tissue metastasis, and 19 patients (76%) had metachronous metasta-sis. The average time for primary tumor recession of metastatic lesions was 45.3 months. Metastases were most common in parts of the trunk in 18 patients (72%), followed by the head and neck in 5 patients (20%). Eleven patients (44%) with lung metastasis had poor prognosis. Conclusion:STS occurred more rarely in soft tissue metastasis than in pulmonary metastasis. Neoadjuvant chemotherapy and surgical treatment were the major therapies employed. Targeted therapy as a new treatment rendered good results.

BACKGROUND:Autologous bone graft is the best method to repair bone defects after tumor curettage, but its shortcomings are as folows: increased surgical trauma, sequelae at bone graft site such as infection and pain, and a limited amount of autologous bone. OBJECTIVE:To analyze the effectiveness of xenograft and calcium sulphate artificial bone in treating bone defects after benign bone tumor removed. METHODS:Totaly 26 cases of benign bone tumor were selected, including 8 cases of giant celltumor, 5 of enchondroma, 4 of fibrous histiocytoma, 3 of bone fibrous dysplasia, 2 of non-ossifying fibroma, 2 cases of bone cysts, 1 of aneurysmal bone cyst and 1 of aneurysmal bone cyst and 1 case of chondroblastoma. Of the 26 cases, 12 cases underwent calcium sulphate pelets alone to fil bone defects after benign bone tumor removed, 6 cases were subjected to xenograft alone, and 8 cases were treated with calcium sulphate pelets combined with xenograft. The X-rays were taken at 1 week, 3 months, and 1 year after the operation in al patients to assess the bone healing process. RESULTS AND CONCLUSION:Al the patients were folowed up for 36-72 months. The absorption of calcium sulphate appeared to be absorbed earlier, the earlier absorption appearance could be observed as earlier as 1 month after the implantation, and most calcium sulphate was absolved and replaced by new bone at 3 months after the operation. The xenograft bone was degraded at 3 months post implantation and new bone formed. Osseo integration of the graft was observed at the periphery of the implant at 6 months post implantation. One year post implantation, trabecular bone was observed at the site with uniform bone density. In the combined group, thecalcium sulphate pelets were absorbed earlier and new bone formed earlier than the calcium sulphate alone group, and the xenograft absorbed later than the calcium sulphate pelets. Generaly, bony union was detectable 1 year after operation. These findings indicate that xenograft and calcium sulphate in treating benign bone tumor have acquired good results, which can be used as a substitute of autologous bone.

Objective:Cancer stem cells (CSCs) are resistant to chemotherapy. Our study aimed to investigate the stem cell-like proper-ties of doxorubicin-resistant osteosarcoma cell line 143B and its correlation with Notch signaling. Methods:We generated doxorubicin-resistant osteosarcoma cells by treating them with 2μm doxorubicin. Stem cell-like properties such as morphology change, Stro-1/CD117 double positive ratio, stem cell-related gene expression, sphere formation efficiency, and EMT character were assessed on day 5 after doxorubicin withdrawal. Notch receptor and its target genes were examined using qPCR and Western blot analysis. The stem cell-like properties of doxorubicin-resistant osteosarcoma cells were assessed when pretreated with Notch inhibitor or vehicle. The an-ti-tumor effect of Notch inhibitor was tested using a xenograft model. Results:Doxorubicin-resistant osteosarcoma cells were enriched in Stro-1+/CD117+cells, which showed obvious increased expression of stem cell-related genes, and exhibited enhanced spheroid for-mation and evident mesenchymal characteristics unlike doxorubicin-sensitive cells. qPCR and Western blot assays showed that Notch intracellular domain 1 (NICD1) and target genes Hes1 and Hey1 were upregulated in doxorubicin-resistant osteosarcoma stem cells compared with those in vehicle cells. Furthermore, pretreatment with a γ-secretase inhibitor (GSI) to prevent Notch signaling en-hanced chemo-sensitivity and inhibited doxorubicin-enriched osteosarcoma stem cell activity in vitro. Finally, the Notch inhibitor pre-vented tumor growth in mice xenograft models. Conclusion: Doxorubicin induced the enrichment of osteosarcoma stem-like cells through Notch signaling, and inactivation of Notch could be useful for overcoming drug resistance and eliminating osteosarcoma.

Treatment resistant depression is a common and severe mental disorder associated with significant burden of disease .Most individuals receiving conventional pharmacotheraphy fail to achieve and sustain remission.So this is still one of the difficult challenges for the psychiatrist .Much of the research pro-vided indications that the efficacy of treatment for the disease was not optimistic, but the treatment was still made great progress .The common treatments for this disease included pharmacotherapy,psychotherapy,elec-troconvulsive therapy(ECT),transcranial magnetic stimulation (TMS),magnetic resonance guided focused ultrasound surgery( MRgFUS) ,deep brain stimulation ( DBS) ,aerobic exercise,light therapy and so on.Each therapeutic strategy has its own features, and could be suitable or unsuitable in some situations.The high rates of non-remission with first-line treatment strategies make the combination of antidepressant and non-drug treatments to be the new trend of the treatments for treatment resistant depression in the future.

Objective:To evaluate the accuracy and feasibility of sentinel lymph node biopsy (SLNB) marked by 99Tcm-IT-Ritux-imab and to discuss the clinical value of the method in diagnosis and treatment of cutaneous melanoma. Methods:A total of 67 patients with cutaneous malignant melanoma received 99Tcm-IT-Rituximab-tagged SLNB from March 2008 to March 2012. Lymphoscintigra-phy was conducted 30 min to 1 h after intra-dermal injection of 99Tcm-IT-Rituximab. Subsequently, the surgery of SLNB was carried out using gamma probe. The detection and positive rates of SLNB were counted. The relationship between the status and the clinical features of the sentinel lymph node (SLN) was analyzed, such as the T stage, ulceration, age, gender, and location. The influence of SLN status on overall survival (OS) and disease-free survival (DFS) was evaluated. Results:SLNs were detected in all the 67 patients by SPECT and gamma detector, with detection rate of 100%. Fifteen patients had SLN metastasis, and the positive rate was 22.4%. Chi-square indicates that SLN metastasis is associated with age, T stage, and ulceration (P<0.05). A total of 63 patients were followed up for 24-69 months, and the median follow up time was 43 months. Kaplan-Meier survival analysis shows that both OS and DFS in the SLN-negative group are better than those in the SLN-positive group (OS:93.9%vs. 57.1%, P<0.01;DFS:79.6%versus 28.6%, P<0.01). Cox-regression multiple factors analysis suggests that both SLN status and T stage are independent factors that affect the DFS of malignant melanoma. Conclusion:SLNB assisted by 99Tcm-IT-Rituximab can well reflect the state of lymph node metastasis and is es-sential for accurate staging, prognosis judging, and treatment guiding. Its operation procedure is simple with high accuracy, and the im-aging status is stable. Therefore, it is convenient and feasible as a means of SLNB.

Objective To investigate the expression of galectin-3 in pancreatic cancer cell and its effect on the proliferation and invasion of SW1990.Methods Immunocytochemistry and semi-quantitative RT-PCR was used to detect the expression of galectin-3 protein and mRNA in SW1990,PANC1 and ASPC-1 cell lines.Galectin-3 mono-antibody of different concentrations ( 1,2,3,5 μg/ml) was used to treat SW1990 cells for 24,48,72 h,CCK-8 kits were used to detect the proliferation in SW1990 cells; Transwell chamber was used to study the invasion in SW1990.Results Expression of galectin-3 protein and mRNA was present in SW1990,PANC1,and ASPC-1.Galectin 3 mono-antibody inhibited the proliferation and number of invasive cells in a dose and time dependant manner.The inhibitory rates at 72 h were 19.8％,29.9％ and 42.7％ in 2,3,5 μg/ml galectin 3 mono-antibody groups,the difference among them and control group was statistically significant ( P ＜ 0.05 ).The inhibite rate of permeating membrane cells in 3 μg/ml galectin-3 mono antibody was 37.1％,the difference between this group and control group was statistically significant (P ＜0.05 ).ConcLusions Galectin-3 is highly expressed in pancreatic cancer cells.Galectin-3 antibody can inhibit the proliferation and migration capability of SW1990 cells.