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Methods | PMC10436133 | |||
Trial Design | anxiety | RECRUITMENT | This randomized clinical trial was approved by the institutional review board at the University of Miami. All participants provided verbal informed consent or assent. This study followed the Consolidated Standards of Reporting Trials (Participants were recruited from the University of Miami and included patients who we... | PMC10436133 |
Trial Flowchart and Survey Schedule | PMC10436133 | |||
Outcomes | Anxiety, anxiety | To quantify anxiety levels, we used the State-Trait Anxiety Inventory (STAI; range, 20-80; higher score indicates a higher level of anxiety), which is a validated and widely used survey to determine patients’ anxiety. | PMC10436133 | |
Statistical Analysis | pain | An a priori power analysis was conducted to determine the number of patients needed to detect a difference in STAI scores between the groups. To detect a clinically meaningful difference of a change of 5 points in the STAI with a power of 0.8, a significance level of 0.05, and an SD of 8.9, 51 patients were needed in e... | PMC10436133 | |
Results | psychiatric comorbidity | Of 140 eligible patients, 45 patients either declined or were excluded; therefore, 95 patients (63 [66.3%] male; mean [SD] age, 38 [16] years; range, 14-78 years) were recruited for the study and included in the final analysis, with 46 patients randomized to receive the AR intervention and 49 patients randomized to the... | PMC10436133 | |
Basic Demographics and Clinical Factors Between Groups | Anxiety, anxiety | Abbreviations: AR, augmented reality; ASA, American Society of Anesthesiologists; STAI, State-Trait Anxiety Inventory.ASA score was not available for 1 patient in the AR group. There were no patients with ASA class 4 or higher included in the study.Range, 20 to 80; higher scores indicate greater levels of anxiety.To de... | PMC10436133 | |
Changes in State-Trait Anxiety Inventory Scores Between Groups at Different Survey Points | Abbreviation: AR, augmented reality.We additionally compared the changes from the screening and preoperative surveys to postoperative surveys ( | PMC10436133 | ||
Changes in State-Trait Anxiety Inventory Scores for the Augmented Reality Group Between Survey Points by Body Part | postoperative pain, pain | Analyses were performed using analysis of variance. .To determine whether the AR intervention influenced postoperative pain or narcotic use, patients were asked their pain levels as well as narcotic use both on postoperative day 1 and at the time of the postoperative appointment (7 to 10 days after surgery). There were... | PMC10436133 | |
Augmented Reality (AR) Group Experiences With the AR Application | PMC10436133 | |||
Discussion | disorientation, postoperative pain, anxiety, pain | DISEASE, EVENTS, MOTION SICKNESS | Our randomized clinical trial focused on the effect of AR on the patient’s entire experience at our institution’s outpatient surgical center, from initial outpatient preoperative visit to completion of the scheduled surgery, and its effects on perceived anxiety and satisfaction. Our custom AR experience allowed a patie... | PMC10436133 |
Future Directions | Future directions include the inclusion of multiple centers with multiple surgeons and expansion to other languages. Our current experience focused exclusively on the day-of-surgery experience and did not provide any postoperative instructions, such as wound care or physical therapy, so adding these components might al... | PMC10436133 | ||
Limitations | anxiety | Our study has some limitations. First, this study was performed at a single institution with a single surgeon, and it was custom built to depict the exact process our patients experience. Generalizability is thus limited, since patients at other centers or with other surgeons may not experience a benefit. Additionally,... | PMC10436133 | |
Conclusions | pain, anxiety, postoperative anxiety | In this randomized clinical trial, the administration of a preoperative AR experience decreased preoperative patient anxiety, and with most patient enjoying the experience, but there was no significant effect on postoperative anxiety, pain levels, or narcotic use. These findings suggest that the use of AR may serve as ... | PMC10436133 | |
Introduction | anxiety | perioperative anxiety in children may lead to psychological and physiological side effects. Clonidine is in increasing use in the pediatric population as an anxiolytic, sedative, and analgesic because of its central alpha2-adrenergic agonist effect. Our study aimed to evaluate the effect of clonidine in the prevention ... | PMC10746874 | |
Methods | agitation, anxiety | ADVERSE EFFECTS, SEPARATION | we conducted a prospective controlled randomized double-blinded clinical trial including children aged between 2 and 15 years undergoing tonsillectomy surgery. The patients were randomly allocated to receive either an intranasal dose of clonidine (4 μg/kg) (clonidine group) or an equal volume dose of saline solution (c... | PMC10746874 |
Results | anxiety | the number of patients analyzed was 78 with 39 patients in each group. There were no signification differences in demographic data and premedication acceptance between the two groups. Levels of anxiety before any premedication were similar in the two groups. However, the anxiety level 30 minutes after premedication and... | PMC10746874 | |
Conclusion | anxiety | intranasal clonidine is an interesting premedication to prevent perioperative children´s anxiety with few side effects. | PMC10746874 | |
Introduction | anxiety | Up to 60% of children undergoing anesthesia and surgery can experience significant distress and anxiety during the perioperative period [ | PMC10746874 | |
Discussion | anxiety, disorientation, hyperactivity, agitation, postoperative shivering, hypersensitivity | HYPERSENSITIVITY | We conducted a prospective randomized clinical trial to evaluate the efficacity of clonidine in reducing perioperative children´s anxiety. Our study demonstrates that intranasal clonidine is effective in preoperative anxiety, preoperative and postoperative sedation, quality of induction and intubation, quality of awake... | PMC10746874 |
Conclusion | Intranasal clonidine administration is an interesting alternative as an anxiolytic premedication before pediatric surgery. It produces effective sedation with few side effects. | PMC10746874 | ||
Competing interests | The authors declare no competing interests. | PMC10746874 | ||
Authors' contributions | Conception and design: Mariem Keskes and Nouha Amouri; acquisition of data: Mariem Keskes and Nouha Amouri; analysis and interpretation of data: Mariem Keskes, Nouha Amouri, Salma Ketata, Rahma Derbel, Imen Zouche, and Maha Charfi; drafting the article or revising it critically for important intellectual content: Marie... | PMC10746874 | ||
Background | I have read the journal’s policy and the authors of this manuscript have the following competing interests: BV has a paid role as a member of the Therapeutic Goods Administration. BV, FA and KS own shares in respective IVF companies (Monash IVF, Virtus Health and Melbourne IVF).‡ These authors are joint senior authors ... | PMC9873192 | ||
Methods and findings | Causal inference methods were used to analyse observational data in a way that emulates a target randomised clinical trial. The study cohort comprised statewide linked maternal and childhood administrative data. Participants included singleton infants conceived spontaneously or via IVF, born in Victoria, Australia betw... | PMC9873192 | ||
Conclusions | In this analysis, under the given causal assumptions, the school-age developmental and educational outcomes for children conceived by IVF are equivalent to those of spontaneously conceived children. These findings provide important reassurance for current and prospective parents and for clinicians.In a population-wide ... | PMC9873192 | ||
Author summary | PMC9873192 | |||
Why was this study done? | congenital abnormalities, intellectual disability, autism spectrum disorder | More than 8 million children have been conceived globally with the assistance of in vitro fertilisation (IVF).Some studies suggest these children have an increased risk of congenital abnormalities, autism spectrum disorder, developmental delay, and intellectual disability.Educational and school-age developmental outcom... | PMC9873192 | |
What did the researchers do and find? | Using statewide, linked population data from Victoria, Australia, we investigated the school-age developmental and educational outcomes for children born following IVF-assisted conception.The study examined 2 separate assessments of school-age development and educational outcomes among 585,659 children, including 11,05... | PMC9873192 | ||
What do these findings mean? | These findings provide reassurance for current and prospective parents, as well as clinicians who are involved in IVF.This information may be useful in providing informed consent and education to those considering IVF and those with children conceived via IVF. | PMC9873192 | ||
Data Availability | Data for this study was provided by various data custodians and linked by the Centre for Victorian Data linkage ( | PMC9873192 | ||
Introduction | COMPLICATIONS | In vitro fertilisation (IVF) is a common mode of conception worldwide [As the number of children born following IVF conception continues to rise, a deeper understanding of the long-term implications for these children is important. It is well established that there are increased risks of maternal and perinatal complica... | PMC9873192 | |
Target trial emulation. | SE | AEDC, Australian Early Development Census; ATE, average treatment effect; DAG, directed acyclic graph; IPW, inverse probability weight; IVF, in vitro fertilisation; NAPLAN, National Assessment Program for Literacy and Numeracy; RD, risk difference; RR, relative risk; SE, standard error. | PMC9873192 | |
Methods | PMC9873192 | |||
Study design | This study is reported as per the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline (Checklist in | PMC9873192 | ||
Population | The study population included all singleton livebirths in Victoria between 2005 and 2014. Twins and higher order multiple births were excluded. Perinatal information was collected from audited birth outcome data through the Victorian Perinatal Data Collection (VPDC) [ | PMC9873192 | ||
Exposure | The exposure was conception via IVF compared with spontaneous conception. The term “IVF” is used collectively to include both conventional IVF, IVF with ICSI, and associated laboratory techniques. IVF cases were identified through the IVF database. Victorian births not identified in the IVF database were allocated to t... | PMC9873192 | ||
Main outcome measures | Childhood educational and developmental outcomes were assessed using 2 standardised, national assessments. The Australian Early Development Census (AEDC) [ | PMC9873192 | ||
Australian Early Developmental Census (AEDC) | SECONDARY | The AEDC assesses broad childhood functional development at school entry (age 4 to 6) across 5 domains: physical health and wellbeing, social competence, emotional maturity, language and cognitive skills (school-based) and communication skills, and general knowledge. The primary AEDC outcome for this study was a global... | PMC9873192 | |
The National Assessment Program–Literacy and Numeracy (NAPLAN) | NAPLAN is a school-based psychometric assessment, assessing 5 educational domains: grammar and punctuation, reading, writing, spelling, and numeracy [ | PMC9873192 | ||
Covariates | Covariates to be considered for inclusion in the statistical analysis models were decided a priori by the authorship team whose expertise included epidemiology, perinatology, reproductive endocrinology, and education. These covariates included child’s sex (as assigned at birth), child’s age in years at assessment, lang... | PMC9873192 | ||
Linkage | Administrative record linkage techniques were employed to match cases with the exposure (conception via IVF) through to childhood outcome data. Data linkage was performed by the Centre for Victorian Data Linkage (CVDL), a third-party government-funded data linkage unit [Two separate, linked study populations were ident... | PMC9873192 | ||
Causal assumptions | The ATE (average treatment effect) estimand used in this study is based upon the Potential Outcomes Framework. If a set of assumptions is met, then causal interpretation can be made. The causal assumptions are counterfactual consistency, ignorability (conditional exchangeability), and positivity. Counterfactual consist... | PMC9873192 | ||
Handling of missing data | The proportions of missing data are described in | PMC9873192 | ||
Statistical analysis | Descriptive statistics were calculated and are reported for each cohort by IVF exposure status, according to type and distribution of data. | PMC9873192 | ||
Treatment effect size modelling | REGRESSION | All multivariate models were adjusted for the listed covariates identified in the prespecified SAP, except for (1) maternal BMI; and (2) second parent education level, for AEDC outcome models only.For each of the imputed datasets, the predicted probability of exposure or PS and associated inverse probability weight (IP... | PMC9873192 | |
Clustering | Clustering of data within mothers due to more than 1 singleton birth during the study period was accounted for in the imputation models, the calculation of inverse probability weights and estimation of the treatment effect by using robust SEs. | PMC9873192 | ||
Sensitivity analyses | MP | SENSITIVITY | Sensitivity analyses were also performed to address identified sources of potential bias. For both AEDC (special needs status) and NAPLAN (exempt status) cohorts, sensitivity analyses were performed: (1) by excluding these cases completely; and (2) by imputing their outcomes (Fig A in The analysis for this study was pe... | PMC9873192 |
Ethics/Governance | Ethical approval for the project was obtained from Mercy, Monash Health and Melbourne IVF Health Human Research Ethics Committees. Each data custodian provided contractual approval for data access and data linkage. The CVDL approved the project and performed the linkage. | PMC9873192 | ||
Results | The total cohort included 585,659 singleton births in Victoria between 2005 and 2014. Among this cohort, 173,200 children, including 4,697 IVF births, were linked to AEDC outcome data. Additionally, 342,331 children, including 8,976 IVF births, were linked to NAPLAN data ( | PMC9873192 | ||
Participant flow chart. | intrauterine insemination, Death | IVF, in vitro fertilisation; IVF cases, pregnancies and children identified with conception assisted by IVF; Controls, pregnancies and children not identified as IVF assisted conception; ART, assisted reproductive technology; non-IVF ART, ovulation induction and intrauterine insemination; VPDC, Victorian Perinatal Data... | PMC9873192 | |
Global developmental vulnerability at school entry (The Australian Early Development Census, AEDC) | PMC9873192 | |||
Primary outcome | Our findings suggest no causal effect of IVF conception on developmental vulnerability, with 13.6% of IVF-conceived children predicted to be developmentally vulnerable (<10th percentile in 2 or more domains of the 5 AEDC domains) compared with 13.9% of spontaneously conceived children. The adjusted RD was at −0.3%, ind... | PMC9873192 | ||
Secondary outcomes | SECONDARY | For secondary outcomes, we examined each of the 5 AEDC domains individually. The unadjusted observed results and causal model results for each individual domain are reported in | PMC9873192 | |
Missing data | Outcome data were missing for 5.6% of the AEDC-linked cohort. The vast majority (92%) of these missing cases were children with special needs (5.2% of overall cohort). There was no evidence of an association between the presence of missing outcome and exposure status (Chi | PMC9873192 | ||
Psychometric assessment of 5 educational domains at primary school (The National Assessment Program–Literacy and Numeracy, NAPLAN) | PMC9873192 | |||
Primary outcome | SE | Our findings indicate the causal effect of IVF conception on overall NAPLAN z-score was indistinguishable from zero. The predicted outcome mean z-score and was 0.013 (SE 0.024) for IVF-conceived children and −0.016 (SE 0.002) for spontaneously conceived controls, with an adjusted mean difference of 0.030 (95% CI −0.018... | PMC9873192 | |
Secondary outcomes | SECONDARY | For secondary outcomes, we examined individual NAPLAN domain z-scores (Additionally, for each domain, a binary outcome (domain scores above or below the national minimum standard) was examined. In 4 of 5 domains (numeracy, reading, spelling, and writing), IVF-conceived children were less likely to be below the national... | PMC9873192 | |
Missing data | Spontaneously conceived children were more likely to have missing NAPLAN data (7.6%) than IVF-conceived children (5.9%, Chi | PMC9873192 | ||
Sensitivity analyses | To validate our analysis model, we re-examined our AEDC primary outcome and the NAPLAN binary domain outcomes using TMLE modelling. Results from the TMLE model did not meaningfully differ from the findings of the primary analysis (Table A in An E-value was estimated for both primary outcomes and was found to be 1.90 an... | PMC9873192 | ||
Discussion | subfertility | REGRESSION | Using a causal inference approach, we found no effect of IVF conception on developmental vulnerability at school entry in Victorian children born between 2005 and 2014. Additionally, IVF-conceived children performed as well as their spontaneously conceived peers in school-based psychometric testing at age 7 to 9 years.... | PMC9873192 |
Supporting information | PMC9873192 | |||
Direct acyclic graph. | (DOCX)Click here for additional data file. | PMC9873192 | ||
Methods: Description of outcome metrics. | (DOCX)Click here for additional data file. | PMC9873192 | ||
Study protocol. | (DOCX)Click here for additional data file.Tables A and B. Table A. Successful linkages by birth year. Table B. Annual cycle summaries from major Victorian IVF providers 2010–2014.(DOCX)Click here for additional data file.Fig A. Analysis flow chart (NAPLAN).(DOCX)Click here for additional data file. | PMC9873192 | ||
Methods: Multiple imputation model summary and model diagnostics. | REGRESSION, SENSITIVITY | Table A. Missing data summary (NAPLAN). Fig A. NAPLAN convergence. Fig B. NAPLAN density plots of observed and imputed data. Fig C. NAPLAN distribution of outcome and covariates after imputation in m = 1 dataset.(DOCX)Click here for additional data file.Figs A–D: Distribution and overlap of manually calculated stabilis... | PMC9873192 | |
STROBE guideline checklist. | (DOCX)Click here for additional data file.This paper uses data from the Australian Early Development Census (AEDC). The AEDC is funded by the Australian Government Department of Education, Skills and Employment. The findings and views reported are those of the author(s) and should not be attributed to the Department or... | PMC9873192 | ||
Abbreviations | REGRESSION | Australian Early Development Censusaverage treatment effectAboriginal and Torres Strait Islanderbody mass indexconfidence intervalCentre for Victorian Data Linkagedirected acyclic graphintracytoplasmic sperm injectioninverse probability weightinverse-probability-weighted regression adjustmentin vitro fertilisationmean ... | PMC9873192 | |
References | birth defects, congenital abnormalities, Sarah Stock, congenital anomalies, primary schoolage, EPS, ALL, PhDSenior | PRETERM BIRTH, MINOR, SENSITIVITY, ADVERSE EFFECT, BEST, SAID, REGRESSION, EVENTS |
Dear Dr Lindquist, Thank you for submitting your manuscript entitled "School-age outcomes among IVF-conceived children: a causal inference analysis using linked population-wide data" for consideration by PLOS Medicine.Your manuscript has now been evaluated by the PLOS Medicine editorial staff as well as by an academic... | PMC9873192 |
Background | INFECTIOUS DISEASES, VIRUS, SEVERE ACUTE RESPIRATORY SYNDROME, CORONAVIRUS | Edited by: Ahmed Mostafa, National Research Centre, EgyptReviewed by: Abdullah Salah Alanazi, Al Jouf University, Saudi Arabia; Benjamin Florian Koch, Goethe University Frankfurt, GermanyThis article was submitted to Infectious Diseases: Epidemiology and Prevention, a section of the journal Frontiers in Public Health†T... | PMC10053493 | |
Materials and methods | COVID-19 patients were recruited and randomly divided into two group, i.e., the experimental group and the control group. The experimental group received regular care plus nasal irrigation and oral rinse with 5% sodium bicarbonate solution, while the control group only received regular care. Nasopharyngeal and orophary... | PMC10053493 | ||
Results | A total of 55 COVID-19 patients with mild or moderate symptoms were included in our study. There was no significant difference in gender, age and health status between the two groups. The average negative conversion time was 1.63 days after treatment with sodium bicarbonate, and the average hospitalization time of the ... | PMC10053493 | ||
Conclusions | VIRUS | Nasal irrigation and oral rinse with 5% sodium bicarbonate solution is effective in virus clearance for COVID-19 patients. | PMC10053493 | |
1. Introduction | coronavirus disease 2019 | CORONAVIRUS, CORONAVIRUS DISEASE 2019, SEVERE ACUTE RESPIRATORY SYNDROME, ACUTE INFECTION | The emergence and spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to the global pandemic of coronavirus disease 2019 (COVID-19) (It has been demonstrated that nasal irrigation and oral rinse with physiological saline solution is a simple and effective way to reduce acute infection of the ... | PMC10053493 |
2. Materials and methods | COVID-19 patients were recruited according to the following criteria. | PMC10053493 | ||
2.1. Inclusion criteria | POSITIVE | All admitted patients with age more than 18 years.COVID-19 patients with mild or moderate symptoms.Positive RT-PCR result at the time of admission. | PMC10053493 | |
2.2. Exclusion criteria | AIDS, immune deficiency | AIDS, IMMUNE DEFICIENCY, MALIGNANT TUMORS, CAVITY, CHRONIC SINUSITIS | Refusal to participate.Any severe cases of COVID-19.Patients with a history of nasal surgery, chronic sinusitis or drug intervention through nasal cavity.Women in the period of pregnancy or lactation.Patients with immune deficiency (such as patients with malignant tumors, organ or bone marrow transplants, AIDS, and tho... | PMC10053493 |
2.3. Study design | ≥24-h | This was a randomized, open-label, single-center pilot study. Patients were observed for 4–5 days after hospitalization to exclude any severe cases of COVID-19, and then randomly divided into two group, i.e., the experimental group and the control group. The experimental group received regular care plus nasal irrigatio... | PMC10053493 | |
2.4. Data analysis | Statistical analysis was performed using the IBM SPSS Statistics (version 19). Categorical data were used for expressing frequency and percentage, and χ | PMC10053493 | ||
3. Results and discussion | infection, nose and mouth | CORONAVIRUS, INFECTION, DISEASES, INFLUENZA | A total of 55 patients (26 males and 29 females) were included in our study. These patients were hospitalized because of positive RT-PCR results. The patients were randomly divided into two groups, 32 cases in the control group and 23 cases in the experimental group. The minimum and maximum ages were 35 and 100 years o... | PMC10053493 |
4. Conclusions | The results of this pilot study demonstrated that nasal irrigation and oral rinse with 5% sodium bicarbonate solution was effective in reducing the viral load for COVID-19 patients. The sample size of this study was small. Some patients may already have symptoms before hospitalization, which might affect the total hosp... | PMC10053493 | ||
Data availability statement | The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author. | PMC10053493 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Institutional Review Board of RuiJin Hospital LuWan Branch. The patients/participants provided their written informed consent to participate in this study. | PMC10053493 | ||
Author contributions | DISEASES | TW, YZ, RZ, YM, JY, YL, QC, XL, HW, SH, CZ, and BT: methodology, investigation, and data curation. XW: writing—original draft, review and editing, conceptualization, supervision, and funding acquisition. All authors contributed to the article and approved the submitted version.We thank Shanghai Frontiers Science Center... | PMC10053493 | |
Conflict of interest | XW is employed by company Nanning Jiuzhouyuan Biotechnology Co Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10053493 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10053493 | ||
References | PMC10053493 | |||
ABSTRACT | co-first author Tan et al. Apatinib plus exemestane for ER+/HER2- MBC. | PMC10578185 | ||
Purpose | MBC | METASTATIC BREAST CANCER | Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR)-2. This study was conducted to assess the efficacy and safety of apatinib combined with exemestane in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic ... | PMC10578185 |
Methods | toxicity | DISEASE, METASTATIC DISEASE | This single-center, single-arm phase II study enrolled patients with ER+/HER2- MBC progressed on previous letrozole or anastrozole. Stratified analysis was performed according to the number of chemotherapy regimens for metastatic disease. The primary endpoint was progression free survival (PFS). Secondary endpoints inc... | PMC10578185 |
Results | METASTATIC DISEASE | Thirty patients were enrolled with median four prior anticancer therapies. Eighty percent of patients received chemotherapy for metastatic disease. The median PFS (mPFS) and OS were 5.6 (95%CI: 4.3–6.9) months and 15.7 (95% CI: 9.7–21.7) months, respectively. The ORR, DCR, and CBR were 21.4%, 71.4%, and 46.4%, respecti... | PMC10578185 | |
Conclusions | Apatinib plus exemestane exhibited objective efficacy in patients with ER+/HER2- MBC who have failed multiple lines of treatment. The AEs of apatinib required close monitoring and most of patients were well tolerated. | PMC10578185 | ||
KEYWORDS | PMC10578185 | |||
Introduction | gastric adenocarcinoma, breast cancer | GASTRIC ADENOCARCINOMA, BREAST CANCER | Nearly 70% of breast cancer is estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-).Much evidence supports a close interaction of the ER signaling with angiogenesis and its vascular endothelial growth factor receptor (VEGFR) signaling pathway.Apatinib, a small-molecule VEGFR-tyros... | PMC10578185 |
Methods | PMC10578185 | |||
Patients | hematologic, hepatic, and renal function, cardiovascular disease, Cancer | UNCONTROLLED HYPERTENSION, RECURRENCE, METASTASIS, LIVER METASTASES, CARDIOVASCULAR DISEASE, BRAIN METASTASES, DISEASE, HER2 GENE AMPLIFICATION, ONCOLOGY, CANCER | The included patients aged 18–70 years and were pathologically diagnosed as MBC, with ER+ (+, >10%) and HER2–. HER2- was defined as no staining or scores of 1+ by immunohistochemistry (IHC), and cases with 2+ by IHC were confirmed absence of HER2 gene amplification by fluorescence in situ hybridization (FISH). Patients... | PMC10578185 |
Intervention measures | toxicity, proteinuria, hand and foot syndrome | ADVERSE EVENTS, DISEASE, HYPERTENSION | Eligible patients received apatinib at a starting dose of 500 mg/d and exemestane 25 mg/d on days 1–28 of each 4-week cycle. Apatinib could also be started with 250 mg/d, and then gradually increased to 500 mg/d in one week, as to improve tolerance for the old and infirm patients. A dose reduction of apatinib will be a... | PMC10578185 |
Baseline and follow-up assessment | death | DISEASE PROGRESSION, ADVERSE EVENT | The pretreatment evaluation included detailed medical history, physical examination, routine laboratory tests, and computed tomography (CT) of measurable lesions at baseline. Laboratory tests included blood routine, liver function, renal function, electrolytes, and urinalysis. CT was conducted for efficacy evaluation e... | PMC10578185 |
Clinical efficacy | Tumors | TUMORS | Efficacy was evaluated according to the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), | PMC10578185 |
Statistical analysis | DISEASE | In sample size estimate, 24 months of accrual period and 6 months of follow-up period were assumed. The study was designed with two-sided, α = 0.05, 85% power to detect a null median PFS of 2.8 months and experimental median PFS of 5.6 months (All statistical analyses were conducted by using SPSS version 18 (SPSS Inc.,... | PMC10578185 |
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