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1.
Joanna Ka?mierska 《Reports of Practical Oncology and Radiotherapy》2014,19(2):99-103
Background
Mycosis fungoides (MF) is a rare skin condition, effectively treated by irradiation. Since 1951, different methods of total skin irradiation have been developed. Although dose–response effect has been demonstrated in many publications, controversies about low dose treatment still exist.Aim
The analysis of results of the total skin electron irradiation (TSEI), especially low dose TSEI in comparison with standard dose treatment is the subject of this review. Also, acute and late side effects of radiotherapy in MF are discussed.Materials and methods
Medline search and analysis of studies published between 1995 and 2012, containing key words: mycosis fungoides, standard dose TSEI, low dose TSEI, total skin electron beam therapy (TSEBT).Results
Detailed analysis of relevant studies demonstrated that standard dose radiotherapy 30–36 Gy is the most effective treatment used in clinical practice. Objective response rate (ORR) is high, especially for less advanced stages of disease. Complete response rate (CR), although slightly lower, is still relatively high.For more advanced MF, TSEI serves as a very good method of palliative treatment and relief of symptoms, like pruritus, pain or desquamation.There is no consensus regarding low dose TSEI; the method is widely accepted as a palliative treatment or in case of reirradiation.Conclusions
Standard dose TSEI is an effective method of MF treatment for radical and palliative treatment, producing high rate of ORR and reasonably long time to progression (TTP). Acute and late side effect of treatment are mostly mild and easy to manage. Low dose TSEI is still in the phase of clinical studies. 相似文献2.
Lubos Tu?ek Jiri Petera Igor Sirák Milan Vo?mik Helena Dole?alová Simona Broke?ová Miroslav Hodek Linda Ka?aová Petr Paluska 《Reports of Practical Oncology and Radiotherapy》2011,16(6):243-247
Background
Low-dose rate brachytherapy is a well established treatment modality of oral cancer. Data about high-dose rate (HDR) brachytherapy are still sparse with various fractionation schedules and heterogeneous results.Aim
The aim of our retrospective study was to evaluate the results of HDR brachytherapy with doses of 3 Gy twice daily.Patients and methods
Twenty patients with squamous cell tongue cancer were treated in the years 2001–2009 by exclusive HDR BT 18 × 3 Gy twice daily. The plastic tube technique was used. Median follow up was 47 months (7.8–118) since brachytherapy.Results
The local and locoregional control was 85% and 68%, respectively. Bone necrosis developed in one case treated without mandibular shielding and soft tissue necrosis in 2 cases.Conclusion
It can be concluded that HDR brachytherapy with 18 × 3 Gy twice daily is safe with promising local control. The risk of nodal recurrences is substantial. 相似文献3.
Ercole Mazzeo Laura Rubino Michela Buglione Paolo Antognoni Stefano Maria Magrini Francesco Bertoni Manuela Parmiggiani Paola Barbieri Filippo Bertoni 《Reports of Practical Oncology and Radiotherapy》2014,19(2):77-91
Aim
To evaluate the current treatment of mycosis fungoides (MF) and Sézary syndrome (SS) focusing on the role of radiotherapy (RT), its principles and indications, and the perspectives of the novel irradiation technologies.Background
MF and SS are rare lymphoproliferative diseases whose incidence is increasing. For a long time RT has been used as a single modality or in integrated treatment programs for these diseases.Materials and methods
The latest systematic reviews, primary studies and new diagnostic and treatment guidelines on MF and SS were analyzed. Clinical outcomes together with the technical aspects and the role of RT were also evaluated.Results
New data are available on pathogenesis, diagnostic criteria, classification and staging procedures for MF and SS and several local and systemic therapies are proposed. Localized RT can cure “minimal stage” MF while total skin electron beam irradiation (TSEI) may cure initial-stage disease and may offer important symptom relief (itch, erythroderma) in a more advanced setting. Despite its efficacy, RT is not largely used, mainly because of some technical difficulties but new RT technologies may be proposed to treat large skin surfaces.Conclusions
New treatment programs offer good results, with median survival of more than 12 years in early-stage MF, but the median survival of 2.5 years or less in advanced stages is still a challenge. RT remains an option for all stages with a good cost/effectiveness ratio in a curative or palliative setting. New RT technologies can overcome some technical problems of treating large skin surfaces. 相似文献4.
Background
The reasons that patients with multidrug-resistant tuberculosis (MDR TB) miss treatment are multi-factorial and complex. Identifying patterns of treatment interruption that predict poor outcomes can be used to target program activities aiming to improve treatment adherence.Objective
To characterize patterns of treatment interruption among MDR TB patients and determine the association between patterns and treatment outcomes.Methods
Retrospective analysis of MDR TB patients. A treatment interruption was defined as any time that a patient missed a prescribed dose of treatment for at least 1 day but for a period of less than 2 consecutive months. Patients were characterized by the number, length and variability of interruptions, variability of time between interruptions, and percent of missed doses. Final treatment outcome was dichotomized as a successful (cured or completed) or poor outcome (defaulted, failed, or died). Risk ratios were calculated to determine the association between characteristics of treatment interruption and treatment outcomes. All analyses were conducted in 6 month treatment intervals.Results
Only 7.0% of 583 patients completed treatment without interruption. Of the remaining 542 patients, the median time to the first interruption was 2 ½ months (70 days). In multivariate analysis, patients who had longer interruptions with sporadic variability during the 6–12 month or the 12–18 month treatment period had a significantly increased risk for poor outcomes compared to patients who had short, regular interruptions (RRadj 4.37, 95% CI 1.2–15.8; = 0.03 and RRadj 3.38, 95% CI 1.6–7.1; p = 0.001, respectively). In addition, missing 10% or more of the prescribed doses during any 6 month period in the initial 18 months of therapy significantly increased the risk for poor outcomes (RRadj range 1.55–2.35; p-value range 0.01–0.005).Conclusion
Patients that miss more consecutive days of treatment with sporadic interruption patterns or a greater proportion of treatment are at an increased risk for poor treatment outcomes. 相似文献5.
Fabio Ynoe de Moraes Heloisa de Andrade Carvalho Samir Abdallah Hanna Jo?o Luis Fernandes da Silva Gustavo Nader Marta 《Reports of Practical Oncology and Radiotherapy》2014,19(2):92-98
Background
Mycosis fungoides (MF) is an extranodal, indolent non-Hodgkin lymphoma of T cell origin. Even with the establishment of MF staging, the initial treatment strategy often remains unclear.Aim
The aim of this study was to review the clinical results of total skin electron beam therapy (TSEBT) for MF in adults published in English language scientific journals searched in Pubmed/Medline database until December 2012.Results
MF is very sensitive to radiation therapy (RT) delivered either by photons or by electrons. In limited patches and/or plaques local electron beam irradiation results in good outcomes besides the fact of not being superior to other modalities. For extensive patches and/or plaques data suggest that TSEBT shows superior response rates. The cutaneous disease presentation is favorably managed with radiotherapy due to its ability to treat the full thickness of deeply infiltrated skin. For generalized erythroderma presentation, TSEBT seems to be an appropriate initial therapy. For advanced disease, palliation, or recurrence after the first radiotherapy treatment course, TSEBT may still be beneficial, with acceptable toxicity. Recommended dose is 30–36 Gy delivered in 6–10 weeks.Conclusion
TSEBT can be used to treat any stage of MF. It also presents good tumor response with symptoms of relief and a palliative effect on MF, either after previous irradiation or failure of other treatment strategies. 相似文献6.
Ozge Petek Erpolat Muge Akmansu Mehmet Dogan Huseyin Bora Ceren Kurugol Omer Uluoglu 《Reports of Practical Oncology and Radiotherapy》2010,15(6):165-171
Background
The use of HDR in the treatment of soft tissue sarcoma had been on the rise. However, there was limited study to evaluate the effect of different fractionation schemes on soft tissue and the optimal HDR scheme.Aims
We aimed to assess the histopathologic changes on soft tissue after different HDR brachytherapy doses.Methods
The subjects were divided into three groups. Each group included 10 limbs. Group A had only an applicator without radiation, group B received a total of 24 Gy at 6 Gy per fraction, twice a day, and group C received a total of 13.5 Gy in a single fraction. The histopathologic findings were grouped into soft tissue pathology-1 (edema, inflammation, endothelial proliferation, necrosis) and soft tissue pathology-2 (atrophy, calcification, vascular hyalinization, fibrosis) (STP-1–2).Results
The highest mean grade values of STP-1 and STP-2 were observed in group C (0.95 and 1.45) in comparison to group A (0.45 and 0.85) and group B (0.65 and 0.9). The difference in STP-1 was found significant only between groups A and C and the difference in STP-2 was found both between groups A and C and groups B and C.Conclusion
In our experimental study it was shown that the fractionated interstitial HDR had both lower rate and severity of toxicity in comparison to a single high dose fraction. Before using a single fractionated regimen in the clinic, the increased morbidity related to the irreversible early toxicities or progressive late toxicities should be kept in mind. 相似文献7.
Micha? Hrab Karolina Olek-Hrab Andrzej Antczak Zbigniew Kwias Tomasz Milecki 《Reports of Practical Oncology and Radiotherapy》2013,18(5):304-309
Background
Radical nephrectomy is the gold standard for treatment of renal cell carcinoma (RCC), but even for localized disease the survival rates are still unsatisfactory. Identification of prognostic factorsl is the basis for future treatment strategies for an individual patient.Aim
The aim of our study was to assess the usefulness of the concentration of IL-6 and CRP as prognostic factors in patients after nephrectomy due to localized RCC.Materials and methods
Our prospective study included 89 patients (55 men and 34 women) who had been surgically treated for RCC. The examined group included patients with localized advanced disease (from T1 to T3) with no metastases in lymph nodes (N0), and with no distant metastases (M0). All patients had blood samples drawn three times during the study (one day before surgery, six days after surgery and 6 months after surgery) to evaluate the concentration of CRP and IL-6. In each patient RCC of the kidney was removed during radical nephrectomy. Statistical analysis was conducted using statistica v.7.0.Results
Statistically significant relationships were found between the concentration of CRP before the operation and OS (p = 0.0001). CRP concentration at baseline was statistically significantly correlated with CSS (p = 0.0004). The level of IL-6 assessed before the surgery was significantly correlated with survival times such as OS (p = 0.0096) and CSS (p = 0.0002). The concentration of IL-6 and CRP measured 6 days after surgery and 6 months after surgery were not statistically significantly correlated with survival times.Conclusions
Results of our study showed that elevated levels of IL-6 and CRP in peripheral blood before surgery of RCC were correlated with worse OS and CSS. 相似文献8.
9.
10.
Objective
To compare the efficacy and safety of high dose rate (HDR) and low dose rate (LDR) brachytherapy in treating early-stage oral cancer.Data Sources
A systematic search of MEDLINE, EMBASE and Cochrane Library databases, restricted to English language up to June 1, 2012, was performed to identify potentially relevant studies.Study Selection
Only randomized controlled trials (RCT) and controlled trials that compared HDR to LDR brachytherapy in treatment of early-stage oral cancer (stages I, II and III) were of interest.Data Extraction and Synthesis
Two investigators independently extracted data from retrieved studies and controversies were solved by discussion. Meta-analysis was performed using RevMan 5.1. One RCT and five controlled trials (607 patients: 447 for LDR and 160 for HDR) met the inclusion criteria. The odds ratio showed no statistically significant difference between LDR group and HDR group in terms of local recurrence (OR = 1.12, CI 95% 0.62–2.01), overall mortality (OR = 1.01, CI 95% 0.61–1.66) and Grade 3/4 complications (OR = 0.86, CI 95% 0.52–1.42).Conclusions
This meta-analysis indicated that HDR brachytherapy was a comparable alternative to LDR brachytherapy in treatment of oral cancer. HDR brachytherapy might become a routine choice for early-stage oral cancer in the future. 相似文献11.
Objective
Extremely low-frequency magnetic field (ELF-MF) has been reported to be of potential pathogenetic relevance to Alzheimer''s disease (AD) for years. However, evidence confirming this function remains inconclusive. Chronic Al treatment has been identified as a contributing factor to cognitive function impairment in AD. This study aims to examine whether or not ELF-MF and Al have synergistic effects toward AD pathogenesis by investigating the effects of ELF-MF with or without chronic Al treatment on SD rats.Methods
Sprague-Dawley (SD) rats were subjected one of the following treatments: sham (control group), oral Al (Al group), ELF-MF (100 µT at 50 Hz) with oral Al (MF+Al group), or ELF-MF (100 µT at 50 Hz) without oral Al (MF group).Results
After 12 wk of treatment, oral Al treatment groups (Al and MF+Al groups) showed learning and memory impairment as well as morphological hallmarks, including neuronal cell loss and high density of amyloid-β (Aβ) in the hippocampus and cerebral cortex. ELF-MF without Al treatment showed no significant effect on AD pathogenesis. ELF-MF+Al treatment induced no more damage than Al treatment did.Conclusions
Our results showed no evidence of any association between ELF-MF exposure (100 µT at 50 Hz) and AD, and ELF-MF exposure does not influence the pathogenesis of AD induced by Al overload. 相似文献12.
Michael J. J. Chu Anthony R. J. Phillips Alexander W. G. Hosking Julia R. MacDonald Adam S. J. R. Bartlett Anthony J. R. Hickey 《PloS one》2013,8(10)
Backgrounds and Aim
Current assessment of pre-operative liver function relies upon biochemical blood tests and histology but these only indirectly measure liver function. Mitochondrial function (MF) analysis allows direct measurement of cellular metabolic function and may provide an additional index of hepatic health. Conventional MF analysis requires substantial tissue samples (>100 mg) obtained at open surgery. Here we report a method to assess MF using <3 mg of tissue obtained by a Tru-cut® biopsy needle making it suitable for percutaneous application.Methods
An 18G Bard® Max-core® biopsy instrument was used to collect samples. The optimal Tru-cut® sample weight, stability in ice-cold University of Wisconsin solution, reproducibility and protocol utility was initially evaluated in Wistar rat livers then confirmed in human samples. MF was measured in saponin-permeabilized samples using high-resolution respirometry.Results
The average mass of a single rat and human liver Tru-cut® biopsy was 5.60±0.30 and 5.16±0.15 mg, respectively (mean; standard error of mean). Two milligram of sample was found the lowest feasible mass for the MF assay. Tissue MF declined after 1 hour of cold storage. Six replicate measurements within rats and humans (n = 6 each) showed low coefficient of variation (<10%) in measurements of State-III respiration, electron transport chain (ETC) capacity and respiratory control ratio (RCR). Ischemic rat and human liver samples consistently showed lower State-III respiration, ETC capacity and RCR, compared to normal perfused liver samples.Conclusion
Consistent measurement of liver MF and detection of derangement in a disease state was successfully demonstrated using less than half the tissue from a single Tru-cut® biopsy. Using this technique outpatient assessment of liver MF is now feasible, providing a new assay for the evaluation of hepatic function. 相似文献13.
Joerg Wendler Gerd R Burmester Helmut S?rensen Andreas Krause Constanze Richter Hans-Peter Tony Andrea Rubbert-Roth Peter Bartz-Bazzanella Siegfried Wassenberg Iris Haug-Rost Thomas D?rner 《Arthritis research & therapy》2014,16(2):R80
Introduction
The aim of this study was to evaluate the safety and efficacy of rituximab (RTX) in a large cohort of patients with rheumatoid arthritis in routine care, and to monitor changes in daily practice since the introduction of RTX therapy.Methods
This was a multicentre, prospective, non-interventional study conducted under routine practice conditions in Germany. Efficacy was evaluated using Disease Activity Score in 28 joints (DAS28) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Safety was assessed by recording adverse drug reactions (ADRs). Physician and patient global efficacy and tolerability assessments were also evaluated.Results
Overall, 2,484 patients (76.7% female, mean age 56.4 years, mean disease duration 11.7 years) received RTX treatment (22.7% monotherapy). The total observation period was approximately six-years (median follow-up 14.7 months). RTX treatment led to improvements in DAS28 and HAQ-DI that were sustained over multiple courses. DAS28 improvements positively correlated with higher rheumatoid factor levels up to 50 IU/ml. Response and tolerability were rated good/very good by the majority of physicians and patients. Mean treatment intervals were 10.5 and 6.8 months for the first and last 400 enrolled patients, respectively. Infections were the most frequently reported ADRs (9.1%; 11.39/100 patient-years); approximately 1% of patients per course discontinued therapy due to ADRs.Conclusions
Prolonged RTX treatment in routine care is associated with good efficacy and tolerability, as measured by conventional parameters and by physicians’ and patients’ global assessments. Rheumatoid factor status served as a distinct and quantitative biomarker of RTX responsiveness. With growing experience, physicians repeated treatments earlier in patients with less severe disease activity. 相似文献14.
Helen Anne Snooks Ben Carter Jeremy Dale Theresa Foster Ioan Humphreys Philippa Anne Logan Ronan Anthony Lyons Suzanne Margaret Mason Ceri James Phillips Antonio Sanchez Mushtaq Wani Alan Watkins Bridget Elizabeth Wells Richard Whitfield Ian Trevor Russell 《PloS one》2014,9(9)
Objective
To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall.Design
Cluster trial randomised by paramedic; modelling.Setting
13 ambulance stations in two UK emergency ambulance services.Participants
42 of 409 eligible paramedics, who attended 779 older patients for a reported fall.Interventions
Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture.Main Outcome Measures
Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care.Safety
Further emergency contacts or death within one month.Cost-Effectiveness
Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness.Results
17 intervention paramedics used CCDS for 54 (12.4%) of 436 participants. They referred 42 (9.6%) to falls services, compared with 17 (5.0%) of 343 participants seen by 19 control paramedics [Odds ratio (OR) 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72); quality of life (mean SF12 differences: MCS −0.74, 95% CI −2.83 to +1.28; PCS −0.13, 95% CI −1.65 to +1.39) and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52). However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3). Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without.Conclusions
Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture.Trial Registration
ISRCTN Register ISRCTN10538608 相似文献15.
Marcelo dos Santos Ana Maria da Cunha Mercante Iúri Drumond Louro Ant?nio José Gon?alves Marcos Brasilino de Carvalho Eloiza Helena Tajara da Silva Adriana Madeira álvares da Silva 《PloS one》2012,7(9)
Background
Oral squamous cell carcinoma is an important cause of death and morbidity wordwide and effective prognostic markers are still to be discovered. HIF1α protein is associated with hypoxia response and neovascularization, essential conditions for solid tumors survival. The relationship between HIF1α expression, tumor progression and treatment response in head and neck cancer is still poorly understood.Patients and Methods
In this study, we investigated HIF1α expression by immunohistochemistry in tissue microarrays and its relationship with clinical findings, histopathological results and survival of 66 patients with squamous cell carcinoma of the lower mouth.Results
Our results demonstrated that high HIF1α expression is associated with local disease-free survival, independently from the choice of treatment. Furthermore, high expression of HIF1α in patients treated with postoperative radiotherapy was associated with survival, therefore being a novel prognostic marker in squamous cell carcinoma of the mouth. Additionally, our results showed that MVD was associated with HIF1α expression and local disease relapse.Conclusion
These findings suggest that HIF1α expression can be used as a prognostic marker and predictor of postoperative radiotherapy response, helping the oncologist choose the best treatment for each patient. 相似文献16.
Adam Chiche? Janusz Skowronek Marek Kanikowski 《Reports of Practical Oncology and Radiotherapy》2011,16(3):87-94
Background
Hyperthermia (HT) causes a direct damage to cancerous cells and/or sensitize them to radiotherapy with usually minimal injury to normal tissues. Adjuvant HT is probably one of the most effective radiation sensitizers known and works best when delivered simultaneously with radiation. In breast conserving therapy, irradiation has to minimize the risk of local relapse within the treated breast, especially in an area of a tumor bed. Brachytherapy boost reduces 5-year local recurrence rate to mean 5,5%, so there still some place for further improvement. The investigated therapeutic option is an adjuvant single session of local HT (thermal boost) preceding standard CT-based multicatheter interstitial HDR brachytherapy boost in order to increase the probability of local cure.Aim
To report the short-term results in regard to early toxicity of high-dose-rate (HDR) brachytherapy (BT) boost with or without interstitial microwave hyperthermia (MV HT) for early breast cancer patients treated with breast conserving therapy (BCT).Materials and methods
Between February 2006 and December 2007, 57 stage IA–IIIA breast cancer patients received a 10 Gy HDR BT boost after conservative surgery and 42.5–50 Gy whole breast irradiation (WBI) ± adjuvant chemotherapy. 32 patients (56.1%) were treated with additional pre-BT single session of interstitial MW HT to a tumor bed (multi-catheter technique). Reference temperature was 43 °C and therapeutic time (TT) was 1 h. Incidence, severity and duration of radiodermatitis, skin oedema and skin erythema in groups with (I) or without HT (II) were assessed, significant p-value ≤ 0.05.Results
Median follow-up was 40 months. Local control was 100% and distant metastasis free survival was 91.1%. HT sessions (median): reference temperature 42.2 °C, therapeutic time (TT) 61.4 min, total thermal dose 42 min and a gap between HT and BT 30 min. Radiodermatitis grades I and II occurred in 24 and 6 patients, respectively, differences between groups I and II were not significant. Skin oedema and erythema occurred in 48 (85.7%) and 36 (64.3%) cases, respectively, and were equally distributed between the groups. The incidence and duration of skin oedema differed between the subgroups treated with different fractionation protocols of WBI, p = 0.006. Skin oedema was present up to 12 months. No difference in pattern of oedema regression between groups I and II was observed, p = 0.933.Conclusion
Additional thermal boost preceding standard HDR BT boost has a potential of further improvement in breast cancer local control in BCT. Pre-BT hyperthermia did not increase early toxicity in patients treated with BCT and was well tolerated. All side effects of combined treatment were transient and were present for up to 12 months. The increase in incidence of skin oedema was related to hypofractionated protocols of WBI. The study has to be randomized and continued on a larger group of breast cancer patients to verify the potential of local control improvement and to assess the profile of late toxicity. 相似文献17.
Alejandro Floriano Icíar Santa-Olalla Alberto Sanchez-Reyes 《Reports of Practical Oncology and Radiotherapy》2013,18(3):173-178
Aim
To analyze intrafraction movement in patients undergoing frameless robotic radiosurgery and evaluate the influence of image acquisition frequency on global accuracy.Background
Stereotactic radiosurgery requires high spatial accuracy in dose delivery. In conventional radiosurgery, a rigid frame is used to guarantee a correct target alignment and no subsequent movement. Frameless radiosurgery with thermoplastic mask for immobilization cannot completely eliminate intrafraction patient movement. In such cases, it is necessary to evaluate its influence on global treatment accuracy.Materials and methods
We analyzed the intrafraction motion of the first 15 patients undergoing intracranial radiosurgery (39 fractions) with the CyberKnife VSI system at our institution. Patient position was measured at a 15–90-s interval and was used to estimate intrafraction patient movement.Results
With our acquisition image protocol and immobilization device, the 99% displacement error was lower than 0.85 mm. The systematic movement components were lower than 0.05 mm and the random component was lower than 0.3 mm in the 3 translational axes. Clear linear time dependence was found in the random component.Conclusions
Selection of the X-ray image acquisition time is necessary to meet the accuracy required for radiosurgery procedures with the CyberKnife VSI system. We verified that our image acquisition protocol met the 1-mm criterion. 相似文献18.
Anne Louise Bischoff Nilofar Vahman F?lsgaard Charlotte Giwercman Carson Jakob Stokholm Louise Pedersen Maria Holmberg Amalie Bisgaard Sune Birch Theodore F. Tsai Hans Bisgaard 《PloS one》2013,8(4)
Background
Pregnant women were suspected to be at particular risk when H1N1pnd09 influenza became pandemic in 2009. Our primary objective was to compare the immune responses conferred by MF59®-adjuvanted vaccine (Focetria®) in H1N1pnd09-naïve pregnant and non-pregnant women. The secondary aims were to compare influences of dose and adjuvant on the immune response.Methods
The study was nested in the Copenhagen Prospective Studies on Asthma in Childhood (COPSAC2010) pregnancy cohort in 2009-2010 and conducted as a single-blinded block-randomised [1∶1∶1] controlled clinical trial in pregnant women after gestational week 20: (1) 7.5 µg H1N1pnd09 antigen with MF59-adjuvant (Pa7.5 µg); (2) 3.75 µg antigen half MF59-adjuvanted (Pa3.75 µg); (3) 15 µg antigen unadjuvanted (P15 µg); and in non-pregnant women receiving (4) 7.5 µg antigen full adjuvanted (NPa7.5 µg). Blood samples were collected at baseline, 3 weeks, 3 and 10 months after vaccination, adverse events were recorded prospectively.Results
58 pregnant women were allocated to Pa7.5 µg and 149 non-pregnant women were recruited to NPa7.5 µg. The sero-conversion rate was significantly increased in non-pregnant (NPa7.5 µg) compared with pregnant (Pa7.5 µg) women (OR = 2.48 [1.03–5.95], p = 0.04) and geometric mean titers trended towards being higher, but this difference was not statistically significant (ratio 1.27 [0.85–1.93], p = 0.23). The significant titer increase rate showed no difference between pregnant (Pa7.5 µg) and non-pregnant (NPa7.5 µg) groups (OR = 0.49 [0.13–1.85], p = 0.29).Conclusion
Our study suggests the immune response to the 7.5 µg MF59-adjuvanted Focetria® H1N1pnd09 vaccine in pregnant women may be diminished compared with non-pregnant women.Trial Registration
ClinicalTrials.gov . NCT01012557相似文献19.
Ma?gorzata Skórska Tomasz Piotrowski 《Reports of Practical Oncology and Radiotherapy》2013,18(4):201-208
Background and aim
This study proposed a method to estimate the beam-on time for prostate cancer patients treated on Tomotherapy when FW (field width), PF (pitch factor), modulation factor (MF) and treatment length (TL) were given.Material and methods
The study was divided into two parts: building and verifying the model. To build a model, 160 treatment plans were created for 10 patients. The plans differed in combination of FW, PF and MF. For all plans a graph of beam-on time as a function of TL was created and a linear trend function was fitted. Equation for each trend line was determined and used in a correlation model. Finally, 62 plans verified the treatment time computation model – the real execution time was compared with our estimation and irradiation time calculated based on the equation provided by the manufacturer.Results
A linear trend function was drawn and the coefficient of determination R2 and the Pearson correlation coefficient r were calculated for each of the 8 trend lines corresponding to the adequate treatment plan. An equation to correct the model was determined to estimate more accurately the beam-on time for different MFs. From 62 verification treatment plans, only 5 disagreed by more than 60 s with the real time from the HT software. Whereas, for the equation provided by the manufacturer the discrepancy was observed in 16 cases.Conclusions
Our study showed that the model can well predict the treatment time for a given TL, MF, FW and it can be used in clinical practice. 相似文献20.
Rachael Maree Hunter Mark Isaac Alessandra Frigiola David Blundell Kate Brown Kate Bull 《PloS one》2013,8(3)