Objective:To explore the mediating effect of social support on social avoidance and distress and reproductive concerns in young breast cancer patients undergoing chemotherapy.Methods:This is a cross-sectional study. From February 2020 to December 2021, a total of 180 young breast cancer patients undergoing chemotherapy in Shandong Cancer Hospital were selected as the research objects using the convenient sampling method. General Data questionnaire, Social Support Rating Scale, Reproductive Concerns After Cancer Scale (RCAC) and Social Avoidance and Distress Scale (SADS) were used to investigate patients. Pearson correlation analysis was used to investigate the correlation among social support, social avoidance, distress and reproductive concerns in young breast cancer patients undergoing chemotherapy. Structural equation models was used to explore the mediating effect of social support between social avoidance and distress and reproductive concerns. A total of 180 questionnaires were distributed in this study, and 172 were effectively received, with an effective recovery of 95.56% (172/180) .Results:The total score of SADS of young breast cancer patients undergoing chemotherapy was (18.98±3.15), the total score of RCAC was (59.85±5.03), and total score of Social Support Rating Scale was (33.53±4.25). Pearson correlation analysis results showed that social avoidance, distress was positively correlated with reproductive concerns ( r=0.810, P<0.01), and social support was negatively correlated with reproductive concerns and social avoidance and distress ( r=-0.570, -0.612; P<0.01). Structural equation model results showed that social support played a partial mediating role between social avoidance and distress and reproductive concerns. Conclusions:Social support plays a mediating effect between social avoidance and distress and reproductive concerns in young breast cancer patients undergoing chemotherapy. Medical and nursing staff should provide more social support for young breast cancer patients undergoing chemotherapy, reduce reproductive concerns and improve quality of life.

Objective:To identify the risk factors of non-sentinel lymph node (nSLN) metastasis in breast cancer patients with 1~2 positive axillary sentinel lymph node (SLN) and construct an accurate prediction model.Methods:Retrospective chart review was performed in 917 breast cancer patients who underwent surgery treatment between 2002 and 2017 and pathologically confirmed 1-2 positive SLNs. According to the date of surgery, patients were divided into training group (497 cases) and validation group (420 cases). A nomogram was built to predict nSLN metastasis and the accuracy of the model was validated.Results:Among the 917 patients, 251 (27.4%) had nSLN metastasis. Univariate analysis showed tumor grade, lymphovascular invasion (LVI), extra-capsular extension (ECE), the number of positive and negative SLN and macro-metastasis of SLN were associated with nSLN metastasis (all P<0.05). Multivariate Logistic regression analysis showed the numbers of positive SLN, negative SLN and macro-metastasis of SLN were independent predictors of nSLN metastasis (all P<0.05). A nomogram was constructed based on the 6 factors. The area under the receiver operating characteristic curve was 0.718 for the training group and 0.742 for the validation group. Conclusion:We have developed a nomogram that uses 6 risk factors commonly available to accurately estimate the likelihood of nSLN metastasis for individual patient, which might be helpful for radiation oncologists to make a decision on regional nodal irradiation.

Objective:To identify the risk factors of non-sentinel lymph node (nSLN) metastasis in breast cancer patients with 1~2 positive axillary sentinel lymph node (SLN) and construct an accurate prediction model.Methods:Retrospective chart review was performed in 917 breast cancer patients who underwent surgery treatment between 2002 and 2017 and pathologically confirmed 1-2 positive SLNs. According to the date of surgery, patients were divided into training group (497 cases) and validation group (420 cases). A nomogram was built to predict nSLN metastasis and the accuracy of the model was validated.Results:Among the 917 patients, 251 (27.4%) had nSLN metastasis. Univariate analysis showed tumor grade, lymphovascular invasion (LVI), extra-capsular extension (ECE), the number of positive and negative SLN and macro-metastasis of SLN were associated with nSLN metastasis (all P<0.05). Multivariate Logistic regression analysis showed the numbers of positive SLN, negative SLN and macro-metastasis of SLN were independent predictors of nSLN metastasis (all P<0.05). A nomogram was constructed based on the 6 factors. The area under the receiver operating characteristic curve was 0.718 for the training group and 0.742 for the validation group. Conclusion:We have developed a nomogram that uses 6 risk factors commonly available to accurately estimate the likelihood of nSLN metastasis for individual patient, which might be helpful for radiation oncologists to make a decision on regional nodal irradiation.

Objective: To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis. Methods: An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs. Results: A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal. Conclusion Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.

Objective: To evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily combined with dasabuvir 250mg, twice daily in non-cirrhotic Chinese adult patients with newly diagnosed and treated chronic HCV genotype 1b infection. Methods: A randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial was conducted in mainland China, Korea, and Taiwan.Safety and efficacy of OBV/PTV/r plus DSV administered for 12 weeks were evaluated in a newly diagnosed and treated (interferon alpha /pegylated interferon alpha) and ribavirin non-cirrhotic adults with chronic HCVgenotype 1b infection. Patients randomly received OBV/PTV/r plus DSV for 12 weeks (Group A), or placebo for 12 weeks (Group B) followed by an open-label phase of OBV/PTV/r plus DSV for 12 weeks. Sustained response (SVR12) rate obtained at 12 weeks and (SVR24) 24 weeks after discontinuation of treatment, and the incidence of adverse events and laboratory abnormalities after double-blind and open-label phase treatment were assessed. Results: A total of 410 cases of Chinese patients were included and randomly assigned to group A and B (with 205 cases in each group) in a 1:1 ratio. The rates of SVR12 and SVR24 were 99% (95% CI: 94.8% - 99.8%) in the newly diagnosed patients in group A (205 patients) and the rates of SVR12 and SVR24 were 100% in treated patients (95% CI: 96.3% - 100%). Different baseline characteristics had no effect on SVR12 and SVR24 rates. Most of the adverse events occurred were mild, asymptomatic, and≥ 3 laboratory abnormalities during treatment were rare, including elevation of alanine aminotransferase (2 cases in double-blind stage A group), aspartate aminotransferase (Double-blind stage A (3 cases) and total bilirubin (1 case in open-label phase B group); however, those mild adverse events could be recovered after drug withdrawal or discontinuation. only1 person discontinued drugs due to adverse events (Group B, open-label phase). Conclusion The 12 weeks treatment course of OBV/PTV/r combined with DSV produced 99% ~ 100% rates of SVR12 and SVR24 in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection, and the tolerance and safety were good.

Objective To explore the surgical feasibility and clinical efficacy of one-stage anterior-posterior approaches in treatment of severe fracture and dislocation of lower cervical spine in "beach chair position".Methods Sixteen male cases of severe fracture and dislocation of lower cervical spine and with a mean age of 49.8 years (range,36-78 years) treated surgically from May 2012 to May 2016 were analyzed retrospectively by using case series study.The segment of injury was C4-5 in 4 cases,C5-6 in 7 and C6-7 in 5.The degree of spinal cord injury according to the American Spine injury Association (ASIA) score was Grade A in 4 cases,Grade B in 7 and Grade C in 5.Sub-axial injury classification (SLIC) score was 8 points in 9 cases and 9 points in 7.After a general anesthesia,a ring with a hole was hanged on patient's head before the operation.Then,under the protection of hole traction,the upper of operating bed was swung up slowly,so that the patient was restricted in vertical "beach chair position" with traction on the halo in order to immobilize the head and partially reduce the kyphotic deformity.Routine cervical anterior-posterior approach was done with the exposure of damaged section of the front and rear structure.Pedicle screw system or lateral mass screw displacement was conducted.Anterior intervertebral discectomy or fracture vertebral was performed,using collaborative reset prying method before and after the road.In the front of intervertebral cage or titanium net support bone graft,rear pedicle screws or lateral mass screws fixation and bone graft fusion were implemented.The operation time and blood loss were recorded.The healing of the wound was observed.The recovery of neurological function was evaluated according to the ASIA grade.Postoperative review X-ray,CT and MRI were done to evaluate the reset and bone graft in position and fusion.Results All the surgeries were done well without aeroembolism and other related complications.The mean operative time was 153 minutes (range,150-180 minutes),and the mean amount of blood loss was 543 ml (range,400-800 ml).Sixteen cases were followed-up from 6 to 24 months (mean 13.7 months).All the incision were healed at Ⅰ stage.Spinal cord function did not aggravate.The ASIA grade was improved with an average of one to two Grades 6 months after surgery.Postoperative X-ray and CT confirmed that graft object position was favorable and cervical sequence was recovered well.The Cobb angle decreased from (23.6 ± 5.3) ° preoperatively to (4.0 ± 0.4)°postoperatively,and the translational displacement of vertebral body was restored into (2.7 ±0.4) mm (P ＜ 0.01) from (10.9 ± 1.6) mm before operation.The cervical spinal canal was not obstructed and the cervical spinal cord was relieved,showed by MRI.Conclusions One-stage anterior-posterior approaches for severe fracture and dislocation of lower cervical spine circumferential reconstruction in "beach chair position" is a beneficial and effective method,without the need of changing positions in a collaborative reduction and fixation.The method can reduce the interference of spinal cord,shorten the operation time and save anterior extra fixation.

Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.

Humans ; Liver Cirrhosis ; Portal Vein ; Venous Thrombosis

Objective To study the inhibitory effects of δ-opioid receptor activation in serumdeprivation induced apoptosis of human liver cells and the proposed protein kinase C(PKC)pathway mechanism.Methods MTT assay was used to detect the survival rate of human liver cells in vitro and Annexin V-FITC/PI double staining was used to detect the cell apoptosis rate.Flow cytometry was used to analyze cell cycle,RT PCR used to analyze the PKC mRNA and Western Blot analysis was used for detecting the protein expression of PKC and Caspase-3.Results After serum-deprivation for 48h of cultured human liver cells in vitro,significant liver cell apoptosis occurred.The apoptosis was suppressed by δ-opioid receptor activation,which manifested as a slower rate of apoptosis,decreased expression of Caspase-3and increased expression of PKC.After GF109203X was added,the inhibitory effects of DADLE decreased markedly.Conclusion Activation of δ-opioid receptor on the membrane of human liver cells has inhibitory effects on serum-deprivation induced apoptosis of liver cells.The underlying mechanism may be associated with PKC pathway activation.