A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk.

The current study evaluated the efficacy and safety of a denosumab biosimilar, QL1206 (60 mg), compared to placebo in postmenopausal Chinese women with osteoporosis and high fracture risk. At 31 study centers in China, a total of 455 postmenopausal women with osteoporosis and high fracture risk were randomly assigned to receive QL1206 (60 mg subcutaneously every 6 months) or placebo. From baseline to the 12-month follow-up, the participants who received QL1206 showed significantly increased bone mineral density (BMD) values (mean difference and 95% CI) in the lumbar spine: 4.780% (3.880%, 5.681%), total hip :3.930% (3.136%, 4.725%), femoral neck 2.733% (1.877%, 3.589%) and trochanter: 4.058% (2.791%, 5.325%) compared with the participants who received the placebo. In addition, QL1206 injection significantly decreased the serum levels of C-terminal crosslinked telopeptides of type 1 collagen (CTX): -77.352% (-87.080%, -66.844%), and N-terminal procollagen of type l collagen (P1NP): -50.867% (-57.184%, -45.217%) compared with the placebo over the period from baseline to 12 months. No new or unexpected adverse events were observed. We concluded that compared with placebo, QL1206 effectively increased the BMD of the lumbar spine, total hip, femoral neck and trochanter in postmenopausal Chinese women with osteoporosis and rapidly decreased bone turnover markers. This study demonstrated that QL1206 has beneficial effects on postmenopausal Chinese women with osteoporosis and high fracture risk.

The mediator role of stigma in the association of mindfulness and social engagement among breast cancer survivors in China.

PURPOSE: This study aims to explore the association between mindfulness and social engagement among Chinese breast cancer survivors (BCSs) and the mediator role of stigma in the relation of mindfulness and social engagement. METHODS: This cross-sectional study was conducted among 937 BCSs from March to April 2021 in Shanghai, China. Data were collected using the Mindful Attention Awareness Scale, the Stigma Scale for Chronic Illness 8-item version, and the index of social engagement. Descriptive statistics, independent-sample t-test, one-way ANOVA, and regression analyses were used to explore the role of stigma in the association of mindfulness and social engagement among Chinese BCSs. RESULTS: Social engagement levels differed significantly by participant's BMI, education level, employment status, personal monthly income, monthly per capita household income. Mindfulness was positively correlated with social engagement, and stigma was negatively correlated with mindfulness and social engagement among Chinese BCSs. Stigma plays a complete mediating role in the relationship between mindfulness and social engagement in BCSs. CONCLUSION: In the practice of individual mindfulness intervention on social engagement of BCSs, health care providers should identify and eliminate the constraints, which restrain the reduction of stigma level while individual mindfulness is being enhanced.

[Efficacy and adverse effects of Ningmitai Capsules combined with antibiotics in the treatment of chronic prostatitis: A meta-analysis].

OBJECTIVE: To study the effect, treatment course and adverse reactions of Ningmitai Capsules (NMT) in the treatment of chronic prostatitis (CP). METHODS: We searched the CNKI, Wanfang, COMDD and VIP databases, Cochrane Library, PubMed, EMBASE and Chinese academic conference papers for related articles before October 2019 on the treatment of CP with NMT, evaluated the quality of the literature with the Jadad Scale, and conducted a meta-analysis using the Stata14 software. RESULTS: Totally, 20 articles were included in this study, involving 3558 cases of CP, 1807 in the observation group and 1751 as controls. In the treatment of CP, NMT combined with quinolone, tetracycline or macrolide exhibited remarkably better effect than any of the above antibiotics used alone (RR ［95% CI］: 1.270 ［1.215－1.328］, 1.232 ［1.132－1.340］ and 1.239 ［1.130－1.359］, respectively) and the combination therapy also showed a higher total efficacy after 2, 4 and 8 weeks of medication (RR ［95% CI］: 1.256 ［1.185－1.330］, 1.245 ［1.165－1.330］ and 1.244 ［1.131－1.369］, respectively), though a little lower at 4 and 8 than at 2 weeks. There was no statistically significant difference in the incidence rate of adverse reactions between the NMT combination and antibiotics alone groups (P = 0.441). CONCLUSIONS: NMT combined with antibiotics, particularly with quinolone, is superior to antibiotics alone in the treatment of CP, though with no statistically significant difference in the incidence rate of adverse reactions between the two options. The length of medication does not inference the therapeutic effect.

The impact of social capital on physical activity and nutrition in China: the mediating effect of health literacy.

BACKGROUND: Physical activity and good nutrition are important behavioral factors in promoting health and preventing disease. It is important to understand the factors affecting physical activity and nutrition. The purpose of this study was to explore whether social capital has an effect on physical activity and nutrition, and whether health literacy plays a mediating role between social capital and physical activity as well as nutrition. METHODS: This cross-sectional study was performed in a certain district of Shanghai in March and April 2017. Data was collected using a self-reported questionnaire, which included questions on sociodemographic characteristics, social capital, health literacy and health-promoting lifestyle profile-II. Health-promoting lifestyle profile-II measures the behaviours or habits of physical activity and healthy nutrition. An explore factor analysis of the principal components with varimax rotation was carried out on the social capital scale. Descriptive statistics was used to summarize the sociodemographic of participants. Mediation analysis was performed using the bootstrapping tests to examine whether health literacy mediate the relationship between social capital and physical activity as well as nutrition. RESULTS: The explore factor analysis results showed that social capital has five dimensions, namely social participation, social support, social network, control over life and feelings about the community. There is a positive correlation between social capital, health literacy, physical activity and nutrition. The correlation coefficient varied from 0.135 to 0.594. Mediation analysis demonstrated health literacy played a partial mediating effect between social capital and physical activity as well as nutrition. In the relationship between physical activity and social capital, the indirect effect of health literacy accounted for 8.20 to 12.65% of the total effect. In the relationship between nutrition and social capital, the mediation effect of health literacy accounted for 4.93 to 12.71% of the total effect. CONCLUSION: Social capital can promote physical activity and nutrition by disseminating health information. Enhancing the social capital of residents will help increase physical activity and develop healthy eating habits. Attention should also be paid to the improvement of residents' health literacy.

Potential of Gd-EOB-DTPA as an imaging biomarker for liver injury estimation after radiation therapy.

BACKGROUND: Hepatic radiation injury severely restricts irradiation treatment for liver carcinoma. The purpose of this study was to investigate the clinical application of gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Gd-EOB-DTPA)-enhanced MRI (EOB-MRI) in the assessment of liver function after external radiation therapy and to determine the relationship between focal liver reaction (FLR) and liver function. METHODS: A total of 47 patients with liver malignancies who underwent external beam radiation therapy were enrolled. EOB-MRI was performed on each patient at approximately one month post-radiotherapy. The hepatobiliary (HPB) phase images from EOB-MRI were fused with the planning CT images, and the isodose lines from the patients' treatment plans were overlaid onto the fused images. The correlation of the EOB-MR image intensity distribution with the isodose lines was studied. We also compared liver function in patients between pre-treatment and post-treatment. RESULTS: Decreased uptake of Gd-EOB-DTPA, which was manifested by well-demarcated focal hypointensity of the liver parenchyma or FLR to high-dose radiation, was observed in the irradiated areas of 38 patients. The radiotherapy isodose line of decreased uptake area of Gd-EOB-DTPA was 30-46 Gy. The median corresponding dose curve of FLR was 34.4 Gy. Nine patients showed the absence of decreased uptake area of Gd-EOB-DTPA in the irradiated areas. Compared to the 38 patients with the presence of decreased uptake area of Gd-EOB-DTPA, 9 patients with the absence of decreased uptake area of Gd-EOB-DTPA showed significant higher levels of total bile acid, total bilirubin, direct bilirubin and alpha-fetoprotein (P < 0.05). There were no significant differences in alanine transaminase, aspartate aminotransferase, gamma-glutamyl transpeptidase or albumin levels between the two groups (P > 0.05). CONCLUSIONS: Visible uptake of Gd-EOB-DTPA by the liver parenchyma was significantly associated with liver function parameters. EOB-MRI can be a valuable imaging biomarker for the assessment of liver parenchyma function outside of radiation area.

Sprouty2 suppresses progression and correlates to favourable prognosis of intrahepatic cholangiocarcinoma via antagonizing FGFR2 signalling.

Fibroblast growth factor receptor 2 (FGFR2) was demonstrated to correlate to the progression and prognosis of intrahepatic cholangiocarcinoma (ICC) by numerous evidences. However, as a well-recognized suppressor of FGFR2 signalling, the clinical significance of Sprouty (SPRY) family of ICC has not been investigated. In our study, the expressions of SPRY1-4 in 20 pairs of fresh tumour tissues were detected with qPCR, and in 108 cases of paraffin-embedded tissues with immunohistochemistry. The prognostic value of SPRY family in ICC was estimated with univariate analysis and multivariate analysis. As a result, SPRY2 was identified as an independent prognostic biomarker predicting favourable prognosis of ICC. High SPRY2 expression was correlated with good differentiation of ICC. With silencing SPRY2 expression, we demonstrated that SPRY2 could suppress FGFR2-induced ERK phosphorylation, migration, invasion and epithelial-mesenchymal transition (EMT) under FGF1 stimulation. By overexpressing SPRY2-wide type or SPRY2-Y55F, the tyrosine-55 of SPRY2 was demonstrated to be essential in suppressing ERK phosphorylation, tumour invasion and EMT of ICC cells. In conclusion, SPRY2 was correlated with favourable prognosis of ICC via suppressing FGFR2-induced ERK phosphorylation, invasion and EMT. The phosphorylation of SPRY2-Y55 was required in this tumour-suppressing function of SPRY2.

The associations of comorbidities and consumption of fruit and vegetable with quality of life among stomach cancer survivors.

BACKGROUND: Stomach cancer survivors (SCS) often carry the dual burden of the cancer itself and other comorbidities; meanwhile, they are highly motivated to seek health advice about lifestyles to improve their health and quality of life (QOL). The associations of the comorbidity and the consumption of vegetable and fruit with QOL remain even less clear among the SCS. This study aimed to investigate the associations of comorbidities and consumption of fruit and vegetable with QOL among SCS. METHODS: A cross-sectional study was conducted among 969 SCS between April and July 2015 in Shanghai, People's Republic of China. Data were collected using a self-reported questionnaire, which included questions on sociodemographic characteristics, comorbidities and fruit and vegetable consumption, and a simplified Chinese version of the European Organization for Research and Treatment quality of life version 3 (EORTC QLQ-C30) questionnaire. In order to mitigate the bias caused by confounding factors, multiple linear regression models were employed to calculate the adjusted means of QOL scores. RESULTS: The proportion of participants without any comorbidity was only 23.3%, and the most common comorbidity among SCS was digestive diseases (49.8%). Participants with comorbidity generally reported lower scores for global health and functioning subscales and higher scores for symptom in EORTC QLQ-C30 compared to participants without comorbidity, indicating poorer QOL. Higher scores in most functioning subscales and lower scores in some symptoms subscales were found in participants (38.7%) who ate more than 250 g vegetables every day, compared to participants with less vegetable consumption, and in participants (58.1%) who ate fruit every day, compared to participants who didn't eat fruit every day indicating better QOL. CONCLUSIONS: The comorbidities are common health problems among SCS and have significantly negative influence on QOL, and participants with comorbidities generally reported lower QOL scores. The enough vegetables and fruit consumption are positively associated with QOL of SCS. These findings suggested that a multidisciplinary team approach and a variety of delivery systems are needed to address the medical, psychosocial, and lifestyle components for enriching patient-centered care among SCS.

The Surgical Choice of Incidental Periampullary Carcinoma Management in Emergency Laparotomy.

BACKGROUND Laparotomy patients are occasionally diagnosed as having incidental periampullary cancers, making emergency pancreaticoduodenectomy (PD) inevitable. In this situation is difficult to decide whether to perform an emergency PD or a two-stage PD. MATERIAL AND METHODS A total of 27 patients who underwent emergency abdominal laparotomy were diagnosed with periampullary or pancreatic cancer during the operation without enough preoperative preparation. Ten patients underwent emergency one-stage PD and 17 patients underwent two-stage PD. Data of 137 patients with elective PD were selected as the control group. The preoperative, operative, and postoperative parameters, including hospital stay, medical cost, blood loss, and postoperative complications between elective PD and emergency PD (one-stage and two-stage) and between one-stage PD and two-stage PD were analyzed by chi-square test, Fisher test, or t test. RESULTS Patients undergoing emergency two-stage PD had less blood loss (P=0.014), while patients with one-stage PD had shorter hospital stay (P=0.004), shorter operation time (P=0.047), and lower treatment costs (P=0.003). Additionally, the complications rates between one-stage and two-stage PD had no significant difference (P=0.365). Elective PD was the optimal method due to shorter hospital stay (P<0.001), less hemorrhage (P<0.001), shorter operative time (P<0.001), and lower cost (P<0.001) compared with emergency PD. CONCLUSIONS Based on our experience, one-stage PD had advantages of shorter hospital stay, shorter operation time, and lower treatment costs, while two-stage PD had less blood loss. The emergency two-stage PD may be more suitable for patients with unstable vital signs if emergency PD is inevitable in an emergency laparotomy.

Physical exercise, vegetable and fruit intake and health-related quality of life in Chinese breast cancer survivors: a cross-sectional study.

INTRODUCTION: Breast cancer has long-term effects on health-related quality of life (HRQOL) of cancer survivors after treatment. Few research studies have focused on the association between health behaviors and HRQOL of Chinese breast cancer survivors (BCS). The aim of this study was to examine the separate and combined influence of physical exercise, vegetable and fruit intake on health-related quality of life of BCS. METHODS: A cross-sectional study was conducted among BCS from April to July 2013, in Shanghai, China. Data were collected using a self-reported questionnaire, which included questions about basic socio-demographic characteristics, health conditions and treatments, health behaviors and HRQOL. HRQOL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) simplified Chinese V3.0 version and the Functional Assessment of Cancer Therapy-General (FACT-G) simplified Chinese 4th version. Multiple linear regression models were performed to estimate the effects of physical exercise, vegetable and fruit intake as well as the effects of health behavior patterns on HRQOL adjusting for potential confounding variables. RESULTS: Exercisers reported significantly higher scores in most HRQOL dimensions than non-exercisers. Participants who ate more than 250 g of vegetables reported significantly higher scores in most HRQOL dimensions than participants who ate equal or less than 250 g of vegetables. Participants who ate fruit every day reported significantly higher scores in all HRQOL dimensions than those who did not eat fruit every day (P Adjusted ≤ 0.032), except symptom subscales. All subscale scores and total scores of HRQOL, except symptom subscales, were positively associated with the number of adopted healthy lifestyle behaviors (P Trend ≤ 0.003). Compared to participants who adopted only one healthy behavior, participants who adopted two or three healthy behaviors both reported significantly higher HRQOL scores. CONCLUSION: Physical exercise, enough vegetable and fruit intake are positively associated with HRQOL of BCS. BCS who adopted several healthy behaviors simultaneously had better HRQOL than one healthy behavior alone. Healthy behaviors, including engagement in exercise, proper diet, especially comprehensive lifestyle behavior interventions, should be valued in improving HRQOL of BCS.

A qualitative exploration of the unmet psychosocial rehabilitation needs of cancer survivors in China.

OBJECTIVE: This study explores the unmet psychosocial rehabilitation needs of cancer survivors. METHODS: Sixty-eight cancer survivors from the Shanghai Cancer Rehabilitation Club in China participated in one of the eight focus groups. These were transcribed verbatim, coded using thematic analysis and analysed using NVivo 10. RESULTS: Five main themes were identified: the need for (1) better information: Chinese cancer survivors find it difficult to sort and evaluate the overwhelming mass of information with which they are confronted; (2) psychological support: survivors fear cancer relapse and neighbours' discrimination against them; support from other cancer survivors can relieve the stress; (3) support for survivors' families: like the survivors, family members are under great but usually unacknowledged pressure; (4) improved health and medical services: community health service centres provide little medical, informational or psychological support for cancer survivors, who seek and expect more communication with doctors; and (5) assistance with the financial burden: costs of treatment and lack of adequate medical insurance cause substantial financial pressure for survivors. CONCLUSIONS: This study shows that, in addition to their illness, Chinese cancer survivors experience a range of stresses related to their financial circumstances, lack of reliable and summarised information, poor access to support and services (including for their families) and discrimination. Support from families seems to improve survivors' ability to cope. Cancer survivors (and their families) need an integrated package of support from their families, doctors and other service providers, hospitals and communities. These findings can inform approaches to continuing care for cancer survivors. Copyright © 2015 John Wiley & Sons, Ltd.

The influence of comorbid chronic diseases and physical activity on quality of life in lung cancer survivors.

PURPOSE: This study aimed to evaluate the influence of comorbid chronic diseases (CCD) and physical activity (PA) on quality of life (QOL) in lung cancer survivors (LCSs). METHODS: The study used a cross-sectional study design. A total of 701 LCSs were recruited from 17 comprehensive cancer rehabilitation clubs in Shanghai, China. Measurements used included the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy -General version 4 questionnaire (FACT-G). Independent variables were CCD and PA. Multiple linear regression models were used to control for the effect of sociodemographic characteristic. RESULTS: Subjects with CCD generally reported lower scores for most EORTC QLQ-C30 and FACT-G scales when compared to subjects without CCD, indicating poorer QOL. Subjects with PA generally reported higher scores for most EORTC QLQ-C30 and FACT-G scales when compared to subjects without PA, indicating better QOL. The influences of five times and more PA per week were larger than the influence of less than five times PA per week. Subjects without CCD and with PA generally reported similar scores for most EORTC QLQ-C30 and FACT-G scales when compared to others without CCD and PA. Subjects with CCD and PA generally reported higher scores for most EORTC QLQ-C30 and FACT-G scales when compared to other LCSs with CCD and without PA. CONCLUSIONS: CCD have significantly negative influence on QOL. PA has significantly positive influence on QOL among the LCSs with CCD, not among the other LCSs without CCD.

The experience of cancer survivors in community-based psycho-social support activities in Shanghai, China: a qualitative study.

PURPOSE: Cancer survivors are often embroiled in various physical and psycho-social issues as a consequence of cancer diagnosis and treatment. Psycho-social support activities in the phase of rehabilitation were provided to enhance their quality of life. This study seeks to explore and understand their experience of engagement in Shanghai Cancer Rehabilitation Club (SCRC). METHODS: Sixty-eight participants attended eight semi-structured focus group interviews. Data were transcribed verbatim, and thematic analysis framework was adopted for data analysis. RESULTS: The participants reported benefits such as psychological support, informational provision and tangible support in the activities. Public services were reported to have restored their dignity and enabled them to rediscover their own meaning of life. Participants also pointed out challenges on functioning and opportunity for development of SCRC. CONCLUSIONS: The psycho-social support activities of SCRC had influenced cancer survivor's life. Public health resources and supportive policies should be in place to support local self-help cancer rehabilitation groups.

Comorbid chronic diseases and their associations with quality of life among gynecological cancer survivors.

BACKGROUND: Many gynecological cancer survivors (GCS) have comorbid chronic diseases (CCD). This study was to estimate the impacts of CCD on quality of life (QOL) in GCS. METHODS: We collected cross-sectional self-reported survey data from 598 GCS between April and July 2013, in Shanghai, China. All the subjects were asked to complete a questionnaire containing the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) and questions on socio-demographic characteristics and CCD. In order to mitigate the bias caused by confounding factors, multiple linear models were employed to calculate adjusted means of QOL scores. RESULTS: Approximately three-quarters of subjects reported at least one CCD. The highest overall prevalence of all CCD was found in endometrial cancer survivors. Subjects with CCD generally reported lower scores for most EORTC QLQ-C30 scales when compared to subjects without CCD, indicating poorer QOL, particularly for cardiovascular diseases, respiratory diseases, digestive diseases, and musculoskeletal disease. CONCLUSIONS: The CCD are common health problems among GCS. CCD have significantly negative influence on QOL, and GCS with CCD generally reported lower QOL scores. These findings suggested comprehensive cares for GCS.

A qualitative study of smoking behavior among the floating population in Shanghai, China.

BACKGROUND: China has become the world's largest producer and consumer of tobacco and lung cancer is China's leading cause of cancer deaths. The large majority of Chinese smokers are men. Tobacco consumption is of particular concern among China's internal floating (or migrant) population, which has become a permanent feature of Chinese society, because this population is very large (over 100 million persons) and it has a high prevalence of smoking. Considering additionally that like the general population of China, the smoking prevalence rate of women from this group is quite low, we therefore aimed to explore smoking-related knowledge, attitudes and behaviours among male smokers in the floating population to help inform the development of effective smoking cessation interventions in this important target group in China. METHODS: We interviewed 39 floating population male smokers in six focus groups and performed a qualitative content analysis of the interviews. RESULTS: Most participants knew that smoking is risky to health but they knew little about why. Habit and social participation were key drivers of smoking. Smoking was regarded as a core component of their identity by the urban residents. Some participants had tried to stop smoking but none reported having ever been educated about smoking. CONCLUSIONS: Smoking cessation interventions for China's male floating population would need to incorporate comprehensive education and information about why smoking is dangerous and the benefits of stopping.

Systematic analysis of gene expression and molecular interactions in cardiac and non-cardiac gastric carcinomas.

BACKGROUND/AIMS: : This study aims to comparing the gene expression profiles and molecular interactions among gastric cardiac adenocarcinomas (GCA), gastric noncardiac adenocarcinomas (GNCA) and their adjacent normal tissues. METHODOLOGY: Gene expression profile of GSE29272 was downloaded from Gene expression omnibus. Differentially expressed genes (DEGs) were identified at the cut-off of p-value ≤ 0.01. Gene ontology (GO) enrichment analysis was further performed for the DEGs, and then the binding sites of the transcriptional factors and the specific protein-protein interactions were analyzed. RESULTS: Total 1024 DEGs were screened, including 741 up-regulated genes and 283 down-regulated genes. VSNL1 (visinin-like protein-1) is expressed relatively higher in the GNCA and could be its molecular biomarker, as KRT14 (cytokeratin 14) in the GCA. GO analysis showed that the analogous cancer-relevant factors network appears in these two cancer subgroups. The DEGs in the GCA tend to be bound by SPIB and ZNF354C. FN1 lies in the center of the protein-protein interaction networks of the two cancer subgroups. CONCLUSIONS: We found out the RNA expression level of the two gastric cancers varied greatly from the normal tissues while gene expression profile of them were very similar, however, the different biomarker and transcriptional factors indicate the differences of two mechanisms.

Effect of celecoxib on inhibiting tumor repopulation during radiotherapy in human FaDu squamous cell carcinoma.

AIM OF THE STUDY: FaDu human squamous cell carcinoma (FaDu-hSCC) demonstrated accelerated tumor repopulation during fractionated irradiation with pathological validation in a xenograft model system. Previous studies showed that the selective cyclooxygenase (COX)-2 inhibitor celecoxib can enhance the tumor response to radiotherapy. So we aimed to explore the effect of celecoxib in inducing apoptosis and inhibiting repopulation of FaDu tumors in nude mice during fractionated radiotherapy. MATERIAL AND METHODS: FaDu-hSCC was transplanted into the right hind leg of BALB/C nude mice. Mice were treated with celecoxib and/or fractionated irradiation. Celecoxib (100 mg/kg/day) was administered by daily gavage. Irradiation was delivered with 12 to 18 fractions of 3.0 Gy daily or every second day based on Petersen's repopulation model. At different time points, tumors were excised for immunohistochemistry staining. RESULTS: Significant tumor repopulation occurred after about 18 days of radiotherapy. On average, Ki-67 and bromodeoxyuridine (BrdUrd) labeling indices (LI) decreased with daily irradiation (both p < 0.05) and increased with every-second-day irradiation (both p > 0.05), suggesting accelerated repopulation. Ki-67 LI decreased in celecoxib concurrent with radiotherapy for 12 fractions in 24 days and 18 fractions in 36 days compared with irradiated alone (p = 0.004 and 0.042, respectively). BrdUrd LI values were lower in the concurrent groups than irradiated alone (p = 0.001 and 0.006, respectively). Epithelial growth factor receptor (EGFR) expression score decreased in the concurrent groups than irradiated alone (p = 0.037 and 0.031, respectively). Caspase-3 expression scores were higher in the concurrent groups than irradiated alone (p = 0.05 and 0.006, respectively). CONCLUSIONS: Celecoxib concurrent radiotherapy could inhibit tumor repopulation and increase tumor apoptosis during the treatment in FaDu squamous cell carcinoma.

[Efficacy and safety of Kuntai capsule and estrogen for menopausal syndrome: a meta-analysis].

OBJECTIVE: To evaluate the efficacy and safety of Kuntai Capsule and Estrogen for Menopausal Syndrome. METHODS: Related randomized controlled trials about Kuntai capsule and estrogen in recent 10 years were collected by various kinds of database according to strict inclusion and exclusion criteria. Valid data were extracted to conduct meta-analysis by RevMan5.0. RESULTS: A total of 196 articles were retrieved, but only 6 were finally included. Meta-analysis showed that no significant differences were observed in Kupperman score between Kuntai group and estrogen [WMD = 0.22, 95%CI (-1.14, 1.58), P > 0.05]. While E(2) level was significantly higher in estrogen group than that in Kuntai [WMD = -59.59, 95%CI(-87.35, -31.83), P < 0.01]. The incidence of adverse effects was significantly lower in Kuntai group compared to the estrogen group [RR = 0.61, 95%CI(0.45,0.83), P < 0.01]. CONCLUSION: Kuntai can improve symptoms of menopausal syndrome effectively as the same as estrogen and tends to have lower incidence of adverse effects.

[The effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension].

OBJECTIVE: To evaluate the effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension. METHOD: A total of 1051 mild to moderate essential hypertensives were recruited from 22 centers and randomized into three groups and were given low-dose L-amlodipine besylate (2.5 mg/d), high-dose L-amlodipine besylate (5.0 mg/d), and amlodipine maleate (5.0 mg/d) on the principle of open-label and parallel control. The study drugs were administered for 8 weeks. RESULTS: After 8 weeks treatments, the response rate of the three groups were 72.4%, 85.6%, and 76.2%, respectively. The rate difference between high-dose L-amlodipine besylate group and the other two groups were statistically significant (P < 0.01), while the rate difference between low-dose L-amlodipine besylate group and amlodipine maleate group was similar (P = 0.28). The event rates of the three groups were similar (4.3%, 4.6%, and 5.1%, respectively, P = 0.84). CONCLUSION: High-dose L-amlodipine besylate is superior to the other 2 groups on blood pressure control. The efficacy profiles of amlodipine maleate and low-dose L-amlodipine besylate are equivalent. Safety profiles of these three groups are comparable.

Real-world evidence of osimertinib in Chinese patients with EGFR T790M-positive non-small cell lung cancer: a subgroup analysis from ASTRIS study.

PURPOSE: ASTRIS study aimed the largest to evaluate the effectiveness and safety of second- or higher-line osimertinib in patients with advanced/metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) in the real-world setting. Here we report the results of Chinese patients in ASTRIS study. METHODS: Adults with EGFR T790M-positive advanced NSCLC pretreated with EGFR-tyrosine kinase inhibitor (EGFR-TKI), having a WHO performance status score of 0-2 and asymptomatic, stable central nervous system (CNS) metastases were included. All patients received once-daily osimertinib 80 mg orally. The outcomes included investigator-assessed clinical response, progression-free survival (PFS), time-to-treatment discontinuation (TTD), and safety. RESULTS: A total of 1350 patients were included. Response rate was 55.7% (95% confidence interval [CI] 0.53-0.58). The median PFS and the median TTD were 11.7 months (95% CI 11.1-12.5) and 13.9 months (95% CI 13.1-15.2), respectively. Overall, 389 patients (28.8%) had at least one protocol-specified adverse event (AE); AEs of interstitial lung diseases/pneumonitis-like events and QT prolongation were reported in 3 (0.2%) and 59 (4.4%) patients, respectively. CONCLUSION: Osimertinib was effective in Chinese patients with T790M-positive NSCLC who had progressed after first- or second-generation EGFR-TKI in real-word setting and the results were consistent with ASTRIS study overall population and AURA studies. No new safety signals or events were identified. CLINICAL TRIAL NUMBER: NCT02474355.

[Inhibitory effect of compound cantharides capsule on the proliferation of xenografts of human hepatocellular carcinoma HepG(2)215 in mice].

OBJECTIVE: To investigate the inhibitory effect of compound cantharides capsules on the proliferation of xenografts of human hepatocellular carcinoma HepG(2215) in mice and their mechanism of action. METHODS: One hundred healthy Balb/c mice (5-week old, male:female 1:1) were used in this study. Mouse models of human HepG(2215) hepatocarcinoma were established. The tumor-bearing mice were divided into five groups randomly. The control group A received daily intragastric administration of physiologic saline. The intervention groups B1, B2 and B3 were treated with compound cantharides capsule in a dose of 12.5 mg×kg(-1)×d(-1), 25 mg×kg(-1)×d(-1) and 37.5 mg×kg(-1)×d(-1), respectively, for 10 consecutive days. The group C had intraperitoneal injection of cyclophosphamide (25 mg×kg(-1)×d(-1)) for 10 consecutive days. The mice were sacrificed after the completion of administration. The tumors were taken out, the tumor volume was measured, the inhibitory rate of body weight was calculated, and the serum AFP concentration and the level of HBV DNA were determined. The survival of each group mice was analyzed. The levels of mRNA expression of apoptosis-related genes were assayed by quantitative RT-PCR. Apoptosis in the tumor cells was assayed with TUNEL staining. Flow cytometry was used to detect the levels of CD3(+), CD19(+), CD4(+) and CD8(+), and microvessel density (MVD) of the tumors was assessed by immunohistochemistry. RESULTS: After completion of the treatment, the inhibition rate of tumor growth of the groups B1, B2 and B3 was 29.8%, 38.7% and 48.1%, respectively, and that of the group C was 52.4%, with a significant difference among the groups (P < 0.05). The median survival time of the groups A, B1, B2, B3 and C was (30.0 ± 3.2) days, (49.0 ± 5.1) days, (50.0 ± 5.2) days, (57.5 ± 6.5) days and (49.0 ± 4.7) days, respectively. The median survival time of the group B3 was significantly longer than that of other groups (P < 0.05). The serum AFP level in the groups A, B1, B2, B3 and C was (492.7 ± 48.5) ng/ml, (281.2 ± 25.6) ng/ml, (194.3 ± 18.7) ng/ml, (170.1 ± 15.8) ng/ml and (138.7 ± 12.5) ng/ml, respectively, indicating that it was significantly inhibited in the group C. The inhibition rate of HBV DNA replication of the groups B1, B2, B3 and C was (46.0 ± 5.1)%, (65.5 ± 6.9)%, (81.3 ± 7.8)% and (19.5 ± 2.1)%, respectively, showing that compound cantharides capsules inhibited HBV DNA replication in a dose-dependent manner. The apoptosis rate of the groups A, B1, B2, B3 and C was (0.27 ± 0.03)%, (7.18 ± 2.12)%, (9.17 ± 2.42)%, (11.27 ± 3.03)% and (5.44 ± 2.45)%, respectively, and that of the group B3 was significantly higher than that of the groups A, B1, B2 and C (P < 0.05). The expression level of bax mRNA was significantly higher than that of the group C (P < 0.05). The drug could significantly decrease the bcl-2 mRNA expression level, more remarkably along with the increasing dose of cantharides, and it was significantly lower than that in the group C (P < 0.05). The levels of CD4(+), CD8(+), CD3(+) and CD19(+) were significantly higher than that in the groups A and C (P < 0.05). The value of MVD of the group B3 was significantly lower that that of groups A and C (P < 0.05). CONCLUSION: Compound cantharides capsules may inhibit the replication of HBV DNA in HepG(2215) cells, inducing apoptosis in the tumor cells, enhancing the immune function to inhibit the growth of liver cancer cells in mice, and significantly prolong the median survival time of tumor-bearing mice.