Volume 100 ·  Issue 30 ·  2020

To evaluate the clinical efficacy and safety of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer.

Patients were randomized 2∶1 to test group and control group. Patients in test group received Cipterbin (4 mg/kg loading dose and 2 mg/kg maintenance dose each week, IV) combined with vinorelbine (25 mg/m² on days 1,8 and 15 of each 28 days, IV). Patients in control group received vinorelbine (25 mg/m² on days 1,8 and 15 of each 28 days, IV).The primary end point was progression free survival (PFS).

A total of 315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group). The median PFS of test group was significantly longer than that of control group, 39.1 weeks vs 14.0 weeks (HR=0.24; 95%CI, 0.16-0.36; P<0.000 1). The objective response rate (ORR) and disease control rate (DCR) in test group were significantly higher than those in control group, ORR was 46.7% vs 18.45% (P<0.000 1) and DCR was 79.72% vs 45.63% (P<0.000 1). The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.The most common adverse events associated with Cipterbin were infusion reactions. Left ventricular ejection fraction reduced to less than 50% in 5 patients, which were recovered. No serious cardiotoxicity.

The recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine has significant efficacy and good safety. It is the optimized therapy regime for patients with taxane-pretreated HER2 positive metastatic breast cancer, which provides more targeted therapy opportunities for HER2 positive breast cancer patients in China.

To investigate the clinical significance of the expression of integrin β2 (ITGB2) and tumor infiltrating dendritic cells CD80 and CD86 in triple negative breast cancer (TNBC).

The expression levels of ITGB2 and MHC-1 in MDA-MB-231 cells and TNBC tissues were detected by Western bolt and RT-PCR, and the expressions of ITGB2, CD80 and CD86 in TNBC tissues were detected by immunohistochemistry.

1.The expression level of ITGB2 in TNBC cell line (1.67±0.38) was higher than that in MCF-10A cell line (1.06±0.38), and the expression level of MHC-1 molecules in TNBC cell line (0.64±0.20) was lower than that in MCF-10A cell line (1.02±0.21). The difference was statistically significant (P=0.036 and 0.020, respectively). 2.The expression level of ITGB2 in TNBC tissues (1.55±0.47) was significantly higher than that in normal breast tissues (1.04±0.31). 3. Immunohistochemistry showed that the expression level of ITGB2 in TNBC tissues (3.31±2.29) was significantly higher than that in paracancerous tissues (1.20±1.19). Combined with clinicopathological data, it was suggested that the expression of ITGB2 was correlated with tumor stage (P=0.038), histological grade (P=0.022), lymph node metastasis (P=0.019), ki67 expression (P=0.000) and total survival (P=0.003). 4. Immunohistochemistry showed that the expression of CD80 and CD86 in TNBC tissues (3.07±1.57, 3.93±1.64) was significantly lower than those in paracancerous tissues (4.63±2.92 vs 5.23±2.85) (P=0.032 and 0.027).

The high expression of ITGB2 in triple negative breast cancer affects the prognosis of patients.

To explore the application of axillary reverse mapping (ARM) in breast cancer sentinel lymph node biopsy (SLNB), and to collect and record patient′s data during operation. Through the specific experimental data, the anatomical location and morphology of the intercostal brachial nerve (ICBN) and the anatomic relationship of the axillary lymph nodes were analyzed to accurately locate the anatomical division of the axillary fossa of sentinel lymph node (SLN) and ARM lymph nodes.

The technique of methylene blue staining for SLN combined with indocyanine green fluorescent staining for axillary reverse mapping was used to analyze the patients of Tianjin Central Hospital of Gynecology Obstetrics from June 2017 to June 2018. The clinical data of 35 patients with T1-2N0M0 breast cancer were analyzed.

Of the 35 patients, two cases were excluded from metastatic carcinoma of the SLN. Thirty-three cases were included in the data analysis. Three cases of ICBN were located 0-2.0 cm (9.09%) from the lower edge of the iliac vein, 27 cases were located at 2.0-4.0 cm (81.82%), and 3 cases of ICBN were located greater than 4.0 cm (9.09%). In the region of 0-2.0 cm from the lower edge of the iliac vein, 1-2 ARM lymph nodes were found in 5 cases; in the 2.0-4.0 cm area, SLN was found in 33 cases, 4 of which found 1 coincident lymph node; at>4.0 cm ARM lymph nodes and overlapping lymph nodes were not found in the cm region, and 1-2 SLNs were found in 3 cases.

Individual ICBNs vary greatly, with different shapes and distances from the lower edge of the axillary vein. The axillary region below the iliac vein can be divided into three regions: ARM region (0-2.0 cm); SLN region (2.0-4.0 cm); and sentinel gate region (>4.0 cm). The position 2.0 cm from the lower edge of the iliac vein can be used as the boundary between the ARM lymph node and the SLN. 4. There is a certain proportion of coincidence rate between SLN and ARM lymph nodes.

To analyze the screening results of breast cancer in rural women in Fujian Province from 2015 to 2018, and to explore the screening mode of breast cancer.

Breast cancer screening was provided for 35-64 years old rural women in Fujian province. Color Doppler ultrasound was used as the primary screening method. Suspected patients were referred to mammography. Color Doppler ultrasound and breast X -ray 4-5 grade were diagnosed by pathology.

The incidence of breast cancer from 2015 to 2018 was 56.96/10 million, 94.41/10 million, 71.61/10 million, and 73.05/10 million, respectively. And the peak age of breast cancer was (46-55) years. From 2015 to 2018, the proportion of cancer in situ showed an overall upward trend. The sensitivity of color Doppler ultrasound was 79.06%, and the sensitivity of mammography for those diagnosed abnormally by ultrasound was 91.88%.

Breast cancer screening for women of the right age is an important measure to raise the rate of early diagnosis and early treatment and reduce the mortality of breast cancer. Screening mode based on breast ultrasound is the most suitable technology. We need to further expand the coverage of screening, improve the screening system and process, and ensure the health of women.

To investigate the effects of serum immunoglobulin A/complement factor 3 (IgA/C3) ratio and glomerular C3 staining on clinical prognosis in patients with IgA nephropathy.

From January 1st, 2007 to December 30th, 2016, a total of 519 patients with biopsy-proven IgA nephropathy (IgAN) in West China Hospital were retrospectively reviewed and divided into four groups based on serum IgA/C3 ratio and glomerular C3 staining: group A with IgA/C3 ratio ≥3.046 (median) and glomerular C3 staining ≥2 (n=151), group B with IgA/C3 ratio ≥3.046 and glomerular C3 staining<2 (n=109), group C with IgA/C3 ratio<3.046 and glomerular C3 staining ≥2 (n=119), and group D with IgA/C3 ratio<3.046 and glomerular C3 staining<2 (n=140). Clinical data, pathological characteristics and the primary endpoint [≥ 50% decline in estimated glomerular filtration rate (eGFR) and/or end-stage renal disease (ESRD)]were collected. Clinical prognosis and relevant risk factors were analyzed among the four groups.

Totally, 519 patients (298 males, 57.4%) with an average age of (33.6±10.9) years were recruited and followed up for (43.4±21.6) months. The rate of complete remission plus partial remission was 74.2% (112/151), 74.3% (81/109), 72.3% (86/119), 81.4% (114/140) in group A, B, C, D, respectively. Meanwhile, The rate of ESRD was highest in group A (14.6% vs 9.2%, 13.4%, 8.6%). Renal outcome (patients reached the endpoint) was worse in group A and C compared with group B and D (15.2%, 16.0 vs 8.3%, 7.9%). Moreover, 80-month renal survival rate was significantly worse in group A (84.8%) than that in group B and D (91.7% and 92.1%), but no statistical significant difference was found between group A and B (P_AB=0.085; P_AD=0.028). There was no significant difference of renal survival rate between group A and C (84.8% vs 84.0%, P=0.896). Multivariate Cox model showed that hypertension (HR=2.753, 95%CI: 1.452-5.217, P=0.002), serum creatinine (HR=1.011, 95%CI: 1.008-1.014, P<0.001), and tubular atrophy/interstitial fibrosis (T1/T2) (HR=6.595, 95%CI: 3.107-13.999, P<0.001) were independent predictors of poor renal survival.

Serum IgA/C3 ratio and glomerular C3 staining are predictors of renal clinical prognosis in patients with IgA nephropathy.

To observe the clinical effect of tonsillectomy on IgA nephropathy (IgAN) after renal transplantation.

From March 2011 to July 2018, 201 kidney transplantation recipients who were diagnosed of IgAN by transplant renal biopsy in the Department of Organ Transplantation of the First Affiliated Hospital of Sun Yat-sen University were retrospectively reviewed, of which 18 patients underwent tonsillectomy after renal biopsy. The clinical data of the 18 patients were collected, patient and kidney survival time and function of the transplanted kidney were analyzed.

Of the 18 recipients, 13 were male and 5 were female, with an average age of (36.0±10.9) years. All 18 patients survived during follow-up. Two patients returned to dialysis treatment 10 months and 14 months after tonsillectomy, respectively. The creatinine was 94 (78, 133) μmol/L, 95 (74, 139) μmol/L, 106 (87, 158) μmol/L and 95(81, 147) μmol/L before tonsillectomy, 3 months, 1 year and 2 years after tonsillectomy, respectively ( P=0.206). Urinary protein quantification was 0.31 (0.16, 1.38) g/24 h, 0.34 (0.10, 1.42) g/24 h, 0.33 (0.11, 0.56) g/24 h and 0.25 (0.10, 0.50) g/24 h at the same time points, respectively (P=0.104). The two patients who returned to dialysis were diagnosed of IgAN by transplant renal biopsy because of elevated creatinine, proteinuria and hematuria, 9 years and 4 years after kidney transplant respectively. Renal biopsy suggested that glomerular and segmental sclerosis were 7/24, 5/24 and 1/6, 2/6, respectively. Additionally, interstitial fibrosis and tubular atrophy (IF/TA) were both occupied 30% in the biopsies, and tonsillectomy was performed 461 days and 1 077 days after diagnosis of IgAN, respectively.

Tonsillectomy can maintain the stability of renal function and prevent the aggravation of proteinuria in IgAN patients after renal transplantation. However, if pathology suggests obvious glomerulosclerosis or IF/TA, tonsillectomy may not be effective.

To investigate the risk factors associated with mortality and the prognostic value of Charlson comorbidity index (CCI) for mortality in patients with non-high-risk pulmonary embolism complicated by caner.

Patients diagnosed with non-high-risk pulmonary embolism and caner from the medical departments of West China Hospital of Sichuan University from May, 2015 to April, 2018 were included in this study. The patients were classified into death group and survival group according to whether they died during hospitalization. Clinical information was collected and univariate along with multivariate analysis were performed in order to identify the independent risk factor related to short-term mortality in these patients. Besides, all the patients were assessed the comorbidity burden using CCI score and thereby to evaluate the prognostic value of CCI for short-time mortality.

A total of 195 patients were included in this study, including 115 males and 80 females. In all, 32 patients died during hospitalization and the mortality rate was 16.4%. Univariate analysis showed that male (P=0.044), age ≥65y (P=0.008), staying in bed (P=0.001), chronic pulmonary diseases (P=0.030), central venous catheterization (P=0.015), stroke history within 1 month (P=0.015), pneumonia (P=0.017), respiratory failure (P=0.017), diabetes mellitus (P=0.005) and anemia (P=0.035) were related to short term mortality of these patients. As for laboratory examination results, levels of hemoglobin and sodium in death group were significantly lower than survival group (P<0.05). Multivariate logistic regression showed that age ≥65y (OR=3.01, 95%CI: 1.05-8.68, P=0.041), staying in bed (OR=4.15, 95%CI: 1.37-12.54, P=0.012), central venous catheterization (OR=16.10, 95%CI: 2.09-124.08, P=0.008), stroke history within 1 month (OR=6.56, 95%CI: 1.05-40.95, P=0.044) and hyponatremia (OR=2.75, 95%CI: 1.06-7.15, P=0.038) were independent risk factors of short term mortality in these patients. Besides, CCI score in death group was significantly higher than that in survival group (5.66±2.96 vs 4.13±2.74, P=0.005). Pulmonary embolism patients with CCI≥4 were associated with 4.25-fold increased risk of mortality compared with patients with CCI<4 (OR=4.25, 95%CI: 1.83-9.89, P=0.001), and the per additional 1-score increase of CCI after 4 was associated with 4.89-fold increased risk of mortality (OR=4.89, 95%CI: 2.07-11.55, P<0.001). Survival analysis showed that patients with CCI≥4 had lower survival rate than the patients with CCI<4 during hospitalization (P<0.001).

Age ≥65y, staying in bed, central venous catheterization, stroke history within 1 month and hyponatremia are independent risk factor of short-term mortality in patients with non-high-risk pulmonary embolism and caner. CCI score has prognostic value of short term mortality in these patients, and the risk increases with the increase of comorbidities patients have.

Helicobacter pylori (H. pylori) Infection is an important risk factor for gastric cancer, and eradicationH. pyloriCan effectively prevent the occurrence of gastric cancer. The latest major guidelines and consensus at home and abroad clearly state that:H. pyloriInfection is an infectious disease, and all infected people should be given eradication treatment. However, due to the irregular use of antimicrobial drugs,H. pyloriThe rate of resistance to commonly used antimicrobial drugs increased year by year, and the success rate of eradication decreased year by year. In almost all member countries of the six regions of the World Health Organization (WHO),H. pyloriResistance rates to clarithromycin, metronidazole and levofloxacin have all exceeded 15 percent, resulting in the "standard triple regimen" based on the above three antimicrobials no longer being suitable for eradicationH. pyloriEmpirical treatment protocols of. Therefore, there is an urgent need to develop new and safe and effectiveH. pyloriTherapeutic options for eradication.

Increasing Helicobacter pylori (H. pylori) Drug resistance severely affects its eradication effect. A dual therapy consisting of proton pump inhibitors (PPIs) and amoxicillin can overcomeH. pyloriResistant to clarithromycin, used forH. pyloriOf remedial treatment. Vonolaxen is a novel potassium-ion competitive acid blocker (P-CAB) that has a stronger and longer-lasting inhibition of gastric acid compared to PPI. There is no comparison between the combination therapy of vornoraxan and amoxicillin and otherH. pyloriRandomized controlled study of the efficacy of standard treatment regimens.