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Patients inclusion and exclusion criteria | We studied patients aged between 18 and 75 years, with an American Society of Anesthesiologists (ASA) physical status of I or II and a BMI range from 18 kg m | PMC10184475 | ||
Anesthesia | Patients were routinely monitored by an electrocardiogram (ECG), heart rate (HR), invasive arterial pressure (IBP), pulse oxygen saturation (SpOThe BIS ranges from 100 (awake) to 0 (flat line EEG), and as the number decreases, the anesthetic depth increases. During general anesthesia, a BIS value of 40 to 60 was recomm... | PMC10184475 | ||
Blood samples | Flow cytometry was used to determine the number of T lymphocyte subsets (including the CD4+/CD8 + ratio, CD3 + T cells, CD4 + T cells, and CD8 + T cells) and natural killer (NK) cells. Venous blood samples were collected immediately before anesthesia induction (T | PMC10184475 | ||
Clinical measurements | Fever, postoperative pain, pain | SITE INFECTION | Before leaving the PACU (postanesthesia care unit), intraoperative awareness was evaluated using the Modified Brice Questionnaire. The level of postoperative pain at rest was assessed 1 day after surgery using a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (most pain imaginable). Postoperative 24 h analges... | PMC10184475 |
Statistical analysis | NRS, fever | SECONDARY, SURGICAL SITE INFECTION | On the principle of the intention-to-treat principle, all analyses were performed. All patients who were randomly assigned were included in the intention-to-treat group. The primary outcome was the CD4+/CD8 + ratio 24 h after surgery, while the secondary outcome measures were the number of lymphocyte subsets, intraoper... | PMC10184475 |
Results | A total of 75 Patients were enrolled between February 15 and July 31, 2022. Figure
Flow diagramBaseline patient characteristics are shown in Table
Baseline patient characteristicsASA, American Society of Anesthesiologists; BMI, body mass index; MAP, mean arterial pressure; HR, heart rate. Data are summarised by numbe... | PMC10184475 | ||
Acknowledgements | EMERGENCY | Assistance with this study: staff of Emergency Laboratory and Gastrointestinal Surgery of The Affiliated Lianyungang Hospital of Xuzhou Medical University. | PMC10184475 | |
Authors’ contributions | RECRUITMENT | Study design: Zhibin ZHAO, Hengfei LUAN, Xiaobao ZHANG. Patient recruitment: Han LI, Jiachi LI. Randomization and allocation: Han LI, Conghui HAO Data acquisition and analysis: Han LI, Jiachi LI, Conghui HAO. Drafting the manuscript: Han LI, Hengfei LUAN. Revision of the manuscript: all authors. All authors read and ap... | PMC10184475 | |
Funding | This research was supported by Lianyungang 521 project and Clinical Research Fund of The Affiliated Lianyungang Hospital of Xuzhou Medical University (LC13). | PMC10184475 | ||
Availability of data and materials | The datasets used and/or analyzed during the study are available from the corresponding author on reasonable request. | PMC10184475 | ||
Declarations | PMC10184475 | |||
Competing interests | The authors declare that they have no affiliations with or involvement in any organization or entity with any financial interest in the subject matter or material discussed in this manuscript. | PMC10184475 | ||
Ethics approval and consent to particiate | Ethical approval for this study (ethics: KY-20211130002-02) was provided by the Ethics Committee of the affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China on 29 January 2022. Written informed consent was obtained from all participants. The trial was registered in the Chinese Clinical Trial... | PMC10184475 | ||
Consent for publication | Not applicable. | PMC10184475 | ||
References | PMC10184475 | |||
Abstract | PMC10108682 | |||
Introduction | septic shock | SEPTIC SHOCK, PYOGENIC LIVER ABSCESS, UTI | This study determined the therapeutic effect of ulinastatin (UTI) on unliquefied pyogenic liver abscesses complicated by septic shock (UPLA‐SS). | PMC10108682 |
Methods | This was a randomized controlled trial involving patients with UPLA‐SS who underwent treatment at our hospital between March 2018 and March 2022. The patients were randomly divided into control ( | PMC10108682 | ||
Results | tumor necrosis | TUMOR NECROSIS | Following treatment, the white blood cell count, and lactate, C‐reactive protein, procalcitonin, tumor necrosis factor‐α, and interleukin‐6 levels were significantly decreased in all patients compared to the admission values ( | PMC10108682 |
Conclusion | infection | SEPTIC SHOCK, INFECTION, PYOGENIC LIVER ABSCESS, UTI | UTI combined with conventional treatment significantly controlled the infection symptoms, improved organ function, and shortened the treatment time in patients with UPLA‐SS.Ulinastatin combined with conventional treatment significantly controlled the infection symptoms, improved organ function, and shortened the treatm... | PMC10108682 |
INTRODUCTION | shock, bacterial endocarditis, liver abscess, intra‐abdominal malignancies, diabetes | INFLAMMATORY RESPONSE, PERIODONTAL INFECTION, SHOCK, LIVER ABSCESS, DIABETES | A liver abscess (LA) is a focal, infectious lesion of the liver caused by microorganisms, such as bacteria, fungi, or amoebas via arterial, venous, biliary tract, and direct dissemination, and is one of the more common acute critical illnesses in the intensive care unit (ICU).The direct hematogenous spread of systemic ... | PMC10108682 |
MATERIALS AND METHODS | PMC10108682 | |||
General information | This study was a single‐center, randomized, controlled trial (Register number: ChiCTR2200066693). Ninety‐nine patients (58 males and 41 females; average age, 60.18 ± 9.61 years; age range, 33−77 years) with UPLA‐SS who were admitted to the Department of Intensive Care Medicine (Huai'an First Hospital, Nanjing Medical U... | PMC10108682 | ||
Inclusion and exclusion criteria | followsThe, shock | SHOCK | The inclusion criteria for an unliquefied PLA were as followsThe inclusion criteria for infectious shock were based on the 3rd edition of the definition of infectious shock published by the Society of Critical Care Medicine (SCCM)/European Society of Intensive Care Medicine (ESICM),The exclusion criteria were as follow... | PMC10108682 |
Observation indicators | tumor necrosis, fever | LIVER, PCT, TUMOR NECROSIS | Infection‐related objective indices were monitored by comparing changes in Lac, PCT, CRP, tumor necrosis factor‐α (TNF‐α), and interleukin‐6 (IL‐6) levels, and the WBC count before and on the 1st, 2nd, and 3rd days after treatment in the two groups. Infection‐related indices were monitored by comparing the duration of ... | PMC10108682 |
Statistical analysis | The data were analyzed using SPSS 22.0 statistical software, and the count data were described by rate or composition ratio. Normally‐distributed measurement data are described by the mean ± standard deviation, and data with a skewed distribution are expressed by M (range). Comparisons between groups of count data were... | PMC10108682 | ||
RESULTS | PMC10108682 | |||
Analysis of general clinical data of patients in both groups before treatment | TNF‐α, Tumor necrosis | PCT, TUMOR NECROSIS | The statistical analysis of the baseline and treatment data of both groups did not reveal any significant differences (Analysis of general clinical data before treatment in the two groups.Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; CRP, C‐reactive protein; IL‐6, Interleukin‐6; Lac, Lactic aci... | PMC10108682 |
Indices of infection after treatment in the two groups | infection, TNF‐α, Tumor necrosis | INFECTION, PCT, TUMOR NECROSIS | Post‐treatment, the Lac, CRP, PCT, TNF‐α, and IL‐6 levels, and WBC count in both groups showed a significant reduction compared to pretreatment values (Comparison of objective indicators related to infection after treatment between two groups.Abbreviations: CRP, C‐reactive protein; IL‐6, Interleukin‐6; Lac, Lactic acid... | PMC10108682 |
Indicators of infection after treatment in the two groups | fever | The duration of ICU stay, sustained fever, and vasoactive drug use were significantly shorter in the study group compared to the control group after treatment (Comparison of infection‐related indicators between the two groups after treatment. | PMC10108682 | |
Liver function indices in the two groups after treatment | The TBil, ALT, and AST levels were significantly decreased in both groups after treatment (Recovery of liver function indices after treatment in the two groups.Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; TBil, total bilirubin. | PMC10108682 | ||
Clinical outcomes | The mortality rate in the study group (10.41%) was lower than the control group (17.65%), although the difference was not statistically significant ( | PMC10108682 | ||
DISCUSSION | deaths, ischemia‐reperfusion injury, SIRS, shock, ischemia, hypoperfusion, hypoxia, infections, hyperlactatemia, liver injury, infection, UTI, septic shock, sepsis, septic | INFECTIOUS DISEASES, PCT, INFLAMMATORY RESPONSES, SHOCK, LIVER FAILURE, ISCHEMIA, HYPOPERFUSION, HYPOXIA, INFECTIONS, DISEASE, INFECTION, UTI, SEPTIC SHOCK, SEPSIS, INFECTIOUS DISEASES | Infectious diseases affect the entire course of human development, of which there were nearly 50 million new septic patients worldwide in 2017 and 11 million deaths due to sepsis, accounting for 19.7% of global deaths.UTI is a glycoprotein purified from healthy human urineUTI suppresses neutrophil superoxide generation... | PMC10108682 |
CONCLUSION | INFLAMMATORY RESPONSE, UTI | Combined application of UTI with conventional treatment significantly reduced the inflammatory response, promoted the recovery of organ function, and shortened the treatment time in patients with UPLA‐SS, thus improving the clinical symptoms of patients, which is worth promoting in clinical practice. | PMC10108682 | |
AUTHOR CONTRIBUTIONS | PMC10108682 | |||
CONFLICT OF INTEREST STATEMENT | The authors declare no conflict of interest. | PMC10108682 | ||
ETHICS STATEMENT | All the procedures in this study were in accordance with the standards of the Ethics Review Committee of our institution (KY‐2017‐134‐01). Written informed consent from the participants and their families were obtained. | PMC10108682 | ||
DATA AVAILABILITY STATEMENT | The data generated or used during the study are available from the corresponding author by request. | PMC10108682 | ||
REFERENCES | PMC10108682 | |||
Background/aim | metabolic impairment, T2D | TYPE 2 DIABETES MELLITUS | Type 2 diabetes mellitus (T2D) is a complex metabolic impairment. Beta cell (BC) failure is the most challenging among its pathogenetic mechanisms. Recognizing reversible contributors to BC failure could guide individualized approach to early T2D treatment. The aim of this study was to compare early short-term insulin ... | PMC10387975 |
Patients and methods | STM, T2D | INS | Eighty newly diagnosed T2D patients, 30–65 years of age, presenting with HbA1c ≥ 9% were enrolled in the study. They were randomly assigned to single-month initial insulin therapy (INS) added to metformin, or to glimepiride and metformin (OAD) as only treatment. Subjects assigned to initial insulin intervention were th... | PMC10387975 |
Results | ± | INS | HbA1c was lower in INS vs OAD at 3-months: 6.26 ± 0.18% vs 6.78 ± 0.10% (p = 0.016), remaining so by 12 months (p = 0.056). BMI-adjusted ΔC-Pep was greater in INS vs. OAD at 3 months (4.60 ± 0.59 vs. 3.21 ± 0.34 m | PMC10387975 |
Conclusion | T2D improves beta cell function | Early short-term insulin intervention in newly diagnosed T2D improves beta cell function more than glimepiride, both added to metformin, resulting in a superior and longer lasting glycemic and lipid control. | PMC10387975 | |
1. Introduction | glucotoxicity, T2D | TYPE 2 DIABETES MELLITUS | Global impact of type 2 diabetes mellitus (T2D) reaches pandemic proportions [Over the course of T2D progression, increasing doses and number of glucose-lowering medications are typically required, often leading to introduction of insulin treatment, once BC capacity is apparently exhausted. Such insulin treatment repre... | PMC10387975 |
2. Patients and methods | STM, T2D, diabetes | DIABETES | This prospective, interventional randomized study, approved by Ethics Board of Zvezdara University Medical Center (Decision dated 29.01.2019), included 80 newly diagnosed T2D patients with initial HbA1c above 9.0%. They were recruited from the outpatient diabetes clinic of the Zvezdara University Medical Center in Belg... | PMC10387975 |
2.1. Calculations and statistical analysis | Serum C-Peptide (C-Pep) from all samples was analyzed by ECLIA assay (Cobas Elecsys C-Peptide assay, Roche Diagnostics GmbH, Mannheim, Germany) in Beo-Lab laboratory, Belgrade (baseline normal C-Pep reference range: 1.10–4.40 ng/mL). Absolute increase in serum C-Pep (ΔC-Pep) was calculated as difference between postpra... | PMC10387975 | ||
3. Results | STM, T2D, overweight | OBESE | A total of 80 newly diagnosed T2D patients were included in the analysis, 58.8% male and 41.3% female. All subjects completed the 12-month follow-up period with no dropouts. Their average age at baseline was 54.04 ± 9.41 years, and the average BMI was 29.74 ± 4.91 kg/mBaseline C-Pep did not differ between sexes (female... | PMC10387975 |
3.1. Metabolic changes in newly diagnosed T2D patients on short-term insulin treatment or glimepiride, during the 12 months of follow-up | INS | Forty-two patients were randomly assigned to receive early short-term insulin treatment added on metformin (INS). They did not differ in age, sex, nor BMI from 38 patients assigned to treatment with glimepiride and metformin (OAD). The two groups did not differ in baseline FPG, HbA1c, or serum lipid levels (In both INS... | PMC10387975 | |
3.2. Beta cell function in newly diagnosed T2D on early short-term insulin treatment or on glimepiride added to metformin, over 12 months of follow-up | T2D | INS | ΔC-Pep in INS group increased after 3 and 12 months, compared to the pretreatment values. The INS group improved STM-derived relative C-Pep (ΔC-Pep%) by 3 months (p = 0.000) and preserved this by 12 months (p = 0.000). The postprandial C-Pep to glucose ratio (PCPG) was also increased in the INS group at 3 months (p = 0... | PMC10387975 |
4. Discussion | T2D, STM, weight gain, diabetes, hypoglycemic, glucotoxicity, lipotoxicity | OBESE, INSULIN RESISTANCE, DYSFUNCTION, DIABETES | Results of our study support early 1-month insulin and metformin treatment’s superiority over glimepiride and metformin in newly diagnosed T2D, on beta cell (BC) functional recovery, glycemic and lipid control, enduring beyond the short span of treatment itself. The concept of early short-term insulin treatment in newl... | PMC10387975 |
5. Conclusion | T2D | Early short-term insulin treatment in newly diagnosed treatment-naïve T2D patients improves beta cell function more than long-term therapy with glimepiride, as reflected in C-peptide response to standardized test meal. Limited insulin intervention added to metformin is superior to glimepiride and metformin treatment re... | PMC10387975 | |
References | STM | INS | Correlation of baseline C-Pep with BMI (Pearson correlation coefficient r = 0.32; p = 0.004).Correlation of Δ C-Pep in STM with BMI (Pearson correlation coefficient r = 0.23; p =0.043).HbA1c changes on early insulin treatment (INS) vs. oral antidiabetics-only (OAD) groups during 12 months of follow-up.Differences in BM... | PMC10387975 |
Background | Atelectasis | ATELECTASIS, PERIOPERATIVE COMPLICATION | Atelectasis during general anesthesia is a risk for perioperative complications. EIT measurements were performed in mechanically ventilated healthy children during elective surgery to demonstrate the changes in ventilation distribution during general anesthesia. The ventilation distribution was quantified by calculatin... | PMC10091533 |
Methods | lung disease | LUNG DISEASE | EIT measurements were performed in 23 children (9 weeks—10 years) without lung disease to detect changes in regional ventilation during elective surgery. Three previously defined time points were marked during the measurement: after intubation and start of pressure-controlled ventilation (PCV), change to pressure suppo... | PMC10091533 |
Results | atelectasis | RECRUITMENT, ATELECTASIS | With increasing spontaneous breathing, dorsal recruitment of atelectasis occurred. The dorsal ventilation fraction increased over the time of general anesthesia with increasing spontaneous breathing, whereas the ventral fraction decreased relatively (Difference ± 5.5 percentage points respectively; 95% CI; 3.5—7.4; | PMC10091533 |
Conclusion | COLLAPSE | Controlled ventilation of healthy children resulted in increased ventilation of the ventral and collapse of the dorsal lung areas. Restart of spontaneous breathing after cessation of surgery resulted in an increase in ventilation in the dorsal with decrease in the ventral lung areas. By calculating the GI, representing... | PMC10091533 | |
Trial registration | ClinicalTrials.gov Registration ID: NCT04873999. First registration: 05/05/2021. | PMC10091533 | ||
Keywords | PMC10091533 | |||
Background | ventilation-induced lung injury, atelectasis | ATELECTASIS | Ensuring optimal ventilation during invasive ventilation contributes to lung protection. High ventilation pressures, high tidal volumes and regional atelectasis formation contribute significantly to ventilation-induced lung injury [There are already numerous publications for the use of EIT measurements in adults. Data ... | PMC10091533 |
Methods | PMC10091533 | |||
Subjects | hernias | DERMOID CYSTS, MINOR, CNS INFECTIONS | The study protocol was approved by the ethics committee of the Ludwig-Maximilians University Munich. This sample size was chosen in order to additionally perform a correlation analysis of the impedance and volume curves. A sample size of 19 participants was calculated. Taking into account 15% possible dropouts, 23 pati... | PMC10091533 |
Setting | LUDWIG | Elective pediatric surgical operations at the Traunstein Hospital, Academic Teaching Hospital of the Ludwig Maximilian University of Munich, Germany. | PMC10091533 | |
Cardiopulmonary monitoring | Vital signs, transcutaneous oxygen saturation (SpO | PMC10091533 | ||
Electrical impedance tomography | EIT measurements were performed with the Dräger PulmoVista 500 (Dräger Medical Deutschland GmbH, Lübeck, Germany). The 16-electrode belt was placed between the 3rd and 5th intercostal spaces. Ventilation data were continuously recorded by the EIT device via a serial interface (Medibus, Dräger Medical Deutschland GmbH, ... | PMC10091533 | ||
Experimental protocol | EVENT | Pediatric patients were screened for inclusion and exclusion criteria during the anesthesiology or pediatric surgery informed consent interview. Written informed consent was obtained from the parents/legal guardians after they were informed of the planned study. Demographic data, vital signs and medical history were ob... | PMC10091533 | |
Global and regional tidal variation | Global ventilation was divided among the four horizontal regions and the percentage of ventilation was shown for each region. ROI were designated from ventral (ROI 1) to dorsal (ROI 4). The mean values of a one-minute time interval of the regional tidal variations at the previously defined time points (PCV, PSV, SB) we... | PMC10091533 | ||
End-expiratory lung impedance (EELI) | The difference between two end-expiratory images at two freely selectable cursor positions C1 and C2 quantifies the global and regional changes in end-expiratory lung impedance (∆EELI). This impedance change is shown on the one hand by colors and on the other hand by numerical parameters. The global numerical value rep... | PMC10091533 | ||
Global Inhomogeneity index | EVENT | One-minute sequences of each EIT data were selected to calculate the GI. The minute containing the event marker "PCV" was selected. The GI was calculated as described by Zhao [The increasing inhomogeneous distribution of ventilation during controlled ventilation can be visualized with the GI. It quantifies the gas dist... | PMC10091533 | |
Statistical analysis | atelectasis | RECRUITMENT, ATELECTASIS | The results of this publication are based on an exploratory analysis of the results of the data from ventilated children.The change in regional ventilation fraction during general anesthesia was examined in an exploratory analysis. The changes were analyzed graphically (see Figs. Ventilation distribution based on horiz... | PMC10091533 |
Results | PMC10091533 | |||
Demographic data | Twenty-three patients were included in the study. All underwent EIT measurements during general anesthesia in the course of elective surgery. Demographic data of all study participants are shown in Table Demographic data of healthy children | PMC10091533 | ||
Changes in regional ventilation during general anesthesia | RECRUITMENT | Analysis of the changes in regional ventilation during general anesthesia in healthy children showed that with increasing efforts of spontaneous breathing, from PCV over PSV to SB, the proportion of ventilation in ventral areas decreased by 5.5 percentage points, whereas regional proportion recruitment occurred in dors... | PMC10091533 | |
Changes in the ∆EELI/∆EELV | At all ventilation mode transitions a reduction in the end-expiratory volume was measured. With increasing spontaneous breathing the dorsal regions showed an increase, while the ventral regions decrease. Changing the mode of ventilation showed a very small EELV reduction, while the onset of spontaneous breathing showed... | PMC10091533 | ||
Ventilation distribution of healthy children based on Global Inhomogeneity index | SD | The GI was calculated and showed a nearly homogeneous ventilation distribution with a GI of 47% (SD ± 4%, Range: 40, 53, Fig. Global Inhomogeneity index (GI). The GI suggests that healthy children have a very homogeneous distribution of ventilation | PMC10091533 | |
Discussion | pulmonary disease, atelectasis, diaphragmatic contraction | COLLAPSE, PULMONARY DISEASE, ATELECTASIS, POSITIVE | The main findings of this study were: 1.) Dorsal proportion of ventilation occurring during general anesthesia was recruited with increasing spontaneous breathing, whereas the proportion of ventilation decreased in ventral regions. Changing the mode of ventilation from controlled to pressure-supported resulted in a sig... | PMC10091533 |
Limitations | The sample size of this study is very small with 23 participants. In addition, there were large differences in age, height and weight of the patients. Therefore, the scatter of the data of the individual patients is sometimes very large and the difference of the mean values is small. The trend of changes of all patient... | PMC10091533 | ||
Conclusions | atelectasis | ATELECTASIS | This study shows that dorsal atelectasis with decrease in ventilation also occurs in infants, small and older children due to the influence of general anesthesia. At the same time, ventral lung areas are increasingly ventilated. With increasing spontaneous breathing, dorsal lung areas are recruited again. The Global In... | PMC10091533 |
Acknowledgements | ROTH | We would like to thank all staff members of the pediatric surgery practice, the department of anesthesia, the surgical team and the pediatric clinic of Traunstein Hospital for their help and support during the performance of this study. Special thanks go to the anesthesiologists Dr. Winfried Roth and Ulf van Schwartzen... | PMC10091533 | |
Authors’ contributions | DC performed the clinical trial, interpreted the data, and was a major contributor in writing the manuscript. IW helped to interpreted the data and authored parts of the article. SR performed the statistical analysis. GW interpreted the data and wrote parts of the article. All authors read and approved the final manusc... | PMC10091533 | ||
Funding | This study was funded by departmental funds and supported by Dräger Medical, Lübeck, Germany. | PMC10091533 | ||
Availability of data and materials | MINOR | The data sets generated and analysed in this study are not publicly available due to protection of minor patients and required consent by Dräger. They can be obtained from the corresponding author upon reasonable request. | PMC10091533 | |
Declarations | PMC10091533 | |||
Ethics approval and consent to participate | W. Eisenmenger | This observational study was approved by the Ethics Committee of Ludwig-Maximilians-University Munich (Chairperson Prof. Dr. W. Eisenmenger, No.: 20–1048 dated 14.04.2021). All methods were performed in accordance with the relevant guidelines and regulations. The written informed consent of the parents or guardians was... | PMC10091533 | |
Consent for publication | Not applicable. | PMC10091533 | ||
Competing interests | The authors declare no competing interests. | PMC10091533 | ||
References | PMC10091533 | |||
Background | ACUTE RADIATION DERMATITIS | Randomized controlled study was conducted to evaluate the efficacy of Sanyrene® vs. control intervention (DaBao®, a complex of hyaluronic acid and Vitamin E) for acute radiation dermatitis in patients receiving radiotherapy. | PMC10604398 | |
Methods | head and neck cancer, dermatitis, breast cancer | HEAD AND NECK CANCER, DERMATITIS, BREAST CANCER | Patients with breast cancer or head and neck cancer undergoing radiotherapy (≥ 50 Gy) were eligible. Participants were randomly assigned to either Sanyrene arm or control intervention arm in a ratio of 1:1. The primary endpoint was incidence rate of ≥ grade 2 radiation induced dermatitis. (Trial Registration: ChiCTR210... | PMC10604398 |
Results | dermatitis | DERMATITIS | A total of 102 eligible patients were randomly assigned into the study. The rate of ≥ grade 2 radiation dermatitis was 22% in Sanyrene group, as compared with 67.3% in the control intervention group ( | PMC10604398 |
Conclusions | head and neck cancer, dermatitis, breast cancer | HEAD AND NECK CANCER, DERMATITIS, BREAST CANCER | This trial suggests that Sanyrene is effective on preventing serious radiation dermatitis and improving skin related quality of life in patients with breast cancer or head and neck cancer receiving radiotherapy. | PMC10604398 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13014-023-02363-9. | PMC10604398 | ||
Keywords | PMC10604398 | |||
Introduction | head and neck cancer, HNC, breast cancer | HEAD AND NECK CANCER, SKIN TOXICITY, BREAST CANCER | Radiation therapy (RT) is the standard treatment for most patients with head and neck cancer (HNC) or breast cancer (BC). The routine radiation dose of RT for these patients is often more than 50 Gy either as a primary or postoperative treatment. Many studies have confirmed RT-induced skin toxicity is closely associate... | PMC10604398 |
Materials and methods | PMC10604398 | |||
Patient selection | cellulitis, allergic reaction, HNC | CELLULITIS, AUTOIMMUNE SKIN DISEASE, SKIN TOXICITY, ALLERGIC REACTION | The design of this study was a randomized controlled trial comparing Sanyrene with control intervention in 102 HNC and BC patients receiving radiation therapy. Patients were consecutively enrolled from June 2020 to July 2021 at department of radiation oncology in Xi’an, China. This study (Trial Registration: ChiCTR2100... | PMC10604398 |
Randomization | cancer | CANCER | After completion of informed consent, participants were randomized to either the intervention arm (Sanyrene) or the control intervention arm in a ratio of 1:1. The randomization procedures were carried out by sealed enveloping from the central office of the Clinical Trials Centre. Blocked randomization was performed us... | PMC10604398 |
Treatment | HNC | LYMPH NODE METASTASIS | RT dose for patients with BC was 50 Gy/25 fractions delivered over 5 weeks. Most patients (88.2%) received 3-dimensional conformal radiation therapy (3D-CRT), and 6 patients (11.8%) received volumetric modulated arc radiation therapy (VMAT). To elevate skin dose, all patients were treated with 5 mm bolus over chest wal... | PMC10604398 |
Endpoint evaluation | toxicities, erythema, edema | EDEMA, SECONDARY, ERYTHEMA, SKIN TOXICITY | All patients completed a range of questionnaires by interview every week from the start of radiotherapy treatment until four weeks after the completion of radiotherapy. The acute radiation morbidity scoring criteria of radiation therapy oncology group (RTOG) was used to grade provider-assessed toxicities. The primary e... | PMC10604398 |
Statistical analysis | According to our preliminary research results, the incidence rate of ≥ 2 grade RD in the control group is 65.6%. We estimated that approximately 102 patients would need to be randomized in a 1:1 ratio, with 51 patients in each group. This is to detect a difference in the incidence rate of ≥ grade 2: 65.6% in the contro... | PMC10604398 | ||
Results | PMC10604398 |
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