scholarly journals The Impact of Comorbidity on Quality of Life in Chronic Myeloid Leukemia Patients with Deep Molecular Response Who Stopped Therapy By Tyrosine Kinase Inhibitors: Results of the RU-SKI Trial

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2925-2925
Author(s):  
Tatyana Ionova ◽  
Tatiana Nikitina ◽  
Natalia Porfirieva ◽  
Anna Petrova ◽  
Ekaterina Yu. Chelysheva ◽  
...  
Keyword(s):  
Social Functioning ◽  
Physical Functioning ◽  
Kinase Inhibitors ◽  
Molecular Response ◽  
Sf 36 ◽  
Before And After ◽  
Group 2 ◽  
Comorbidity Status ◽  
The Impact ◽  
Group 1

Background The data on quality of life (QoL) in chronic myeloid leukemia (CML) patients (pts) with deep molecular response (DMR) in the treatment-free remission (TFR) studies are limited. The influence of comorbidities on QoL in CML pts before and after tyrosine kinase inhibitors (TKIs) discontinuation has not been studied. Aim We aimed to study the impact of comorbidities on QoL in CML pts before and after the stop therapy by TKIs. Patients and methods The chronic phase (CP) CML pts who had received therapy by any TKI ≥3 years (yrs) with sustained DMR (BCR-ABL ≤0.01% IS) during ≥2 yrs were enrolled into the prospective TFR study RU-SKI. A regular qPCR with BCR-ABL IS evaluation was performed after TKI cessation. TKI were resumed in pts with major molecular response loss (MMR loss, BCR-ABL>0,1%). The QoL was evaluated by RAND SF-36 questionnaire at baseline before TKI stop and at 1, 3, 6, 12 mo during TFR. Eight functional scales were assessed: physical functioning, role limitations physical, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations emotional, mental health. The Integral QoL Index (IQoLI) was calculated based on the scales. Mann-Whitney test, paired Wilcoxon test χ2 were used for the statistical analysis. Molecular relapse free survival (MRFS) was evaluated by Kaplan-Meier method, log-rank test was used for comparison. Results The analysis was performed in the group of 97 CML pts. Median (Me) age was 47±14.5 (yrs), 48.5% were males. The TKI before treatment cessation were as follows: imatinib and second-generation (2G) TKIs in 67 (70%) and 30 (30%) pts accordingly; 9 (30%) pts received 2G TKIs in 1st line and 21 (70%) pts in 2nd line. Me time of observation was 25 mo (range 12-42). Comorbidities were present in 81 pts (82%) at baseline. The most frequent comorbidities were cardiovascular (38.4%), gastroenterological (29.3%) and musculoskeletal disorders (27.3%). First we compared baseline QoL in 2 pts groups: group 1 - pts with acute comorbidity status at baseline (n=42), group 2 - pts with stable comorbidity status (n=29) and with no comorbidity (n=16). QoL in group 1 was significantly worse by all functional scales, except mental health (p<0.05). The IQoLI at baseline was significantly lower in group 1 vs group 2: 0.477 vs 0.589 (p<0.001). Then we evaluated QoL at 3 mo after TKI stop in 72 available pts, as acute status comorbidity remained in 30 pts. The majority of pts exhibited QoL improvement or stabilization by all SF-36 scales. The most pronounced positive changes were observed by SF-36 scales in pts with acute comorbidity status (group 1).The proportion of pts with QoL improvement at 3 mo after TKI stop was higher in group 1 as compared to group 2 by physical functioning (57% vs 29%), role physical functioning (30% vs 5%) and social functioning (40% vs 24%), p<0.05. Increasing of social functioning was statistically significant: ∆20.2 in group 1 vs ∆12.6 in group 2 (p=0.005). The proportion of pts with QoL worsening at 3 mo after TKI stop was similar in both groups. MRFS at 24 mo was 62% (CI 46-77%) and 45% (CI 32-58%) in groups 1 and 2 respectively, with no significant differences between the groups (p=0.107). Conclusion CML pts with DMR and acute comorbidity status had a worse QoL before TKI therapy cessation compared to pts without comorbidity or with comorbidity in remission. The majority of pts exhibited QoL improvement or stabilization in early terms after TKI stop. Pts with acute comorbidity status had more pronounced positive QoL changes after treatment cessation than other pts. Possible explanation is that TKI therapy could increase the clinical symptoms manifestation by overlapping with the treatment toxicity effects. The molecular relapse rate was similar in pts with and without acute comorbidity status. Thus, comorbidity is not a factor which may have negative impact on the outcomes of stop TKI therapy in CML pts. Disclosures Ionova: Takeda, BMS: Other: Principal Investigator of IISR, Research Funding. Chelysheva:Novartis: Consultancy, Honoraria; Fusion Pharma: Consultancy. Shukhov:Novartis: Consultancy; Pfizer: Consultancy. Turkina:Novartis: Consultancy, Speakers Bureau; Pfizer: Consultancy; Bristol Myers Squibb: Consultancy; fusion pharma: Consultancy; Novartis: Consultancy, Speakers Bureau.

scholarly journals A functional electric orthesis on the paretic leg improves quality of life of stroke patients

2006 ◽  
Vol 64 (1) ◽  
pp. 20-23 ◽  
Author(s):  
Mara Renata Fernandes ◽  
Luciane B.C. Carvalho ◽  
Gilmar F. Prado
Keyword(s):  
Quality Of Life ◽  
Social Functioning ◽  
Physical Functioning ◽  
Bodily Pain ◽  
Improve Quality ◽  
Stroke Patients ◽  
Normal Life ◽  
Sf 36 ◽  
Before And After

CONTEXT: Hemiparesia changes quality of life of patients with stroke making difficult a normal life. OBJECTIVE: To evaluate the effect of Functional Eletric Orthesis (FEO) applied over the paretic leg in the quality of life of stroke patients. METHOD: The quality of life of 50 stroke patients of Associacao de Assistencia a Crianca Deficiente (AACD) was evaluated with SF-36 questionnaire before and after the treatment with a FEO for rehabilitation of walking. We analyzed data according to gender and affected hemisphere. RESULTS: The average values from all domains of SF-36 improved significantly (p<0.001). Female patients improved more than male in Emotional Domain (p=0.04) and presented a trend to be better regarding Bodily Pain and Social Functioning. Patients with right hemiparesia improved more than those with left hemiparesia (p=0.02). CONCLUSION: FEO over a paretic leg is efficient to improve quality of life of stroke patients, mainly Physical Functioning.

scholarly journals The Impact of Cirrhosis and Prescription Medications on QTc Interval Before and After Liver Transplantation

2017 ◽  
Vol 32 (1) ◽  
pp. 48-53 ◽  
Author(s):  
Andrew D. Santeusanio ◽  
Kevin G. Dunsky ◽  
Stephanie Pan ◽  
Thomas D. Schiano
Keyword(s):  
Liver Transplantation ◽  
Liver Transplant ◽  
Qtc Interval ◽  
Prescription Medications ◽  
Qtc Prolongation ◽  
Before And After ◽  
Group 2 ◽  
Transplant Candidates ◽  
The Impact ◽  
Group 1

Background: Higher rates of corrected QT (QTc) prolongation have been reported in patients with cirrhosis. The impact of liver transplantation and prescription medications on the natural history of QTc prolongation has yet to be well characterized. Methods: This was a single-center review of patients receiving (group 1) or listed for (group 2) a liver transplant during 2014. Patients in group 1 were followed prospectively from the date of transplantation to assess rates of QTc normalization posttransplant. In group 2, patients were evaluated from the date of listing up until December 2015 to assess the prevalence of QTc prolongation among liver transplant candidates. Results: In group 1, 22 (75.9%) patients with QTc intervals >460 milliseconds at the time of transplant established normal baseline QTc intervals following transplantation. The median time to this QTc normalization was 17 days. In group 2, 30 (16.9%) patients had at least 1 documented QTc interval >500 milliseconds with prevalence rates of 42.9%, 19.0%, and 10.2% in patients with natural model of end-stage liver disease scores of >30, 16 to 30, and <16, respectively ( P < .01). Overall, 49.4% of patients in group 1 and 47.5% of patients in group 2 were prescribed QTc prolonging medications. Conclusion: QTc prolongation will resolve following transplantation in the majority of patients and generally occurs within the first several weeks. Among the listed liver transplant candidates, higher rates of clinically significant QTc prolongation may be observed in patients with more severe underlying cirrhosis. QTc prolonging medications are commonly prescribed in this population and warrant monitoring following initiation.

scholarly journals Quality of Life in Chronic Myeloid Leukemia Patients with Deep Molecular Response Who Stopped Therapy By Tyrosine Kinase Inhibitors: Interim Results of Russian Prospective Multicenter Trial RU-SKI

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3023-3023
Author(s):  
Anna Petrova ◽  
Ekaterina Chelysheva ◽  
Oleg Shukhov ◽  
Anastasiya Bykova ◽  
Galina Gusarova ◽  
...  
Keyword(s):  
Physical Functioning ◽  
Kinase Inhibitors ◽  
Multicenter Trial ◽  
Molecular Response ◽  
Healthy Controls ◽  
Deep Molecular Response ◽  
Before And After ◽  
Tki Treatment ◽  
Prospective Multicenter Trial

Abstract Background It is reasonable to incorporate quality of life (QoL) assessment into the comprehensive evaluation of treatment outcomes in chronic myeloid leukemia (CML) patients (pts) with deep molecular response (DMR) who enter the treatment-free remission (TFR) phase and stop therapy by tyrosine kinase inhibitors (TKIs). QoL assessment was included into the design of Russian prospective multicenter trial RU-SKI along with the clinical outcomes evaluation. Aim To study QoL in chronic phase (CP) CML pts with DMR before stopping TKI treatment and during TFR observation. Materials and methods The study has been conducted within the clinical approbation supported by the Ministry of Health of RF. The CML CP pts with therapy by any TKI ≥ 3 years (yrs) and stable DMR (BCR-ABL ≤0.01% IS) during ≥2 yrs were enrolled. Pts who met these criteria and had previous resistance to any TKI were also eligible. TKIs were resumed in case of major molecular response loss (MMR, BCR-ABL>0,1%). The QoL questionnaires RAND SF-36 and EORTC QLQ C30 were filled out by the pts before stopping TKI treatment and at 1, 3, 6 and 12 months (mo) after treatment discontinuation. The comparison group consisted of healthy persons matched by age and gender to CML CP pts (n=97). The Mann-Whitney test, paired Wilcoxon test and Generalized Estimation Equations (GEE) with adjustment to age, gender, the risk group according to Sokal score and duration of TKI treatment were used for the statistical analysis. Results QoL assessment was performed in all 99 CML CP pts who were enrolled into the trial during a period from Aug 2015 till Dec 2017. The TKIs before treatment cessation were as follows: imatinib and second-generation (2G) TKIs were used in 69(70%) and 30(30%) pts accordingly. 2G TKIs were used in 9(30%) and in 21(70%) pts as 1st and 2nd line accordingly. Mean age was 47±14.5 yrs, 48.5% were males, 12.1% had high Sokal risk score. The physical functioning of CML pts before stopping TKI treatment compared to the healthy controls was significantly worse (p<0.05). Other QoL scales before stopping TKI treatment were slightly worse with no statistically significant difference compared to healthy controls (figure 1). MMR was lost in 45 pts, and was maintained in 54 pts, Me follow-up time after TKI stop was 14,9 mo (range 2,5-32). The significant improvement of role physical functioning and role emotional functioning was found (p<0.05) in pts who maintained stable MMR during 12 mo after TKI discontinuation. The Integral QoL Index increased from 0,58 to 0,72 (p<0,001) in these pts. The decreasing of nausea/vomiting, diarrhea, shortness of breath at different time points (p<0.05) during TFR was revealed (figure 2). The QoL and symptoms before TKI interruption and after reinitiating of TKIs in 45 pts who resumed treatment were similar. The Integral QoL Index before and after stopping TKI treatment was 0.62 vs 0.64 (p>0.05). Conclusion The QoL in CML CP pts with DMR on TKI treatment is slightly worse and physical functioning is significantly lower as compared to healthy controls. The positive changes of the role functioning along with TKI treatment-related symptoms decrease were revealed in pts who maintained stable MMR during 12 mo of TFR. No changes in QoL and no new symptoms were found in pts who reinitiated treatment before and after TKIs interruption. The results of QoL assessment may contribute to optimization of the treatment strategies of CML patients with DMR. Disclosures Chelysheva: Fusion Pharma: Other: provided consultations ; Bristol Myers Squibb: Other: provided consultations and performed lectures; Novartis: Other: provided consultations and performed lectures. Shukhov:Bristol Myers Squibb: Other: provided consultations and performed lectures ; Novartis: Other: provided consultations and performed lectures . Turkina:Novartis: Other: provided consultations; Bristol Myers Squibb: Other: provided consultations; Phizer: Other: provided consultations; Fusion Pharma: Other: provided consultations. Ionova:Takeda: Research Funding; BMS: Research Funding.

scholarly journals Quality of Life Scores Remained Different among the Genotypic Groups of Patients with Suspected Hemochromatosis, Even after Treatment Period

Genes ◽  
2022 ◽  
Vol 13 (1) ◽  
pp. 118
Author(s):  
Luis Alfredo Utria Acevedo ◽  
Aline Morgan Alvarenga ◽  
Paula Fernanda Silva Fonseca ◽  
Nathália Kozikas da Silva ◽  
Rodolfo Delfini Cançado ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Iron Overload ◽  
Treatment Period ◽  
Serum Ferritin ◽  
Final Phase ◽  
Sf 36 ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background: Hemochromatosis is a genetic condition of iron overload caused by deficiency of hepcidin. In a previous stage of this study, patients with suspected hemochromatosis had their quality of life (QL) measured. We observed that QL scores differed among genotypic groups of patients. In this reported final phase of the study, the aims were to compare QL scores after a treatment period of approximately 3 years and to analyze a possible association of the serum ferritin values with QL scores. Methods: Sixty-five patients were enrolled in this final phase and divided into group 1 (patients that showed primary iron overload and homozygous genotype for the HFE p.Cys282Tyr mutation) and group 2 (other kinds of genotypes). Short Form 36 (SF-36) was performed and consisted of eight domains with a physical and also a mental component. Results: Both groups had a significant decrease in serum ferritin concentrations: group 1 had a variation from 1844 ± 1313 ng/mL to 281 ± 294 ng/mL, and group 2 had a variation from 1216 ± 631 ng/mL to 236 ± 174 ng/mL. Group 1 had a smaller mean value for these six SF-36 domains compared with group 2, indicating a worse QL. Conclusions: In this final stage, six domains demonstrated a difference among genotypic groups (role emotional and mental health, adding to the four of the initial phase), reassuring the impact of the identified genotype on the QL of hemochromatosis patients. Furthermore, despite that both patient groups demonstrated similar and significant decreases in serum ferritin values, no association was found between the decrease in this biological parameter and the SF-36 domains.

Patients (Pts) with Ph+ Chronic Myeloid Leukemia In Chronic Phase (CML-CP) with a Suboptimal Molecular Response to Imatinib (IM) Can Achieve Deeper Responses When Switched to Nilotinib

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2301-2301
Author(s):  
Carole Miller ◽  
Sikander Ailawadhi ◽  
Anand P. Jillella ◽  
Jerald P. Radich ◽  
Daniel J DeAngelo ◽  
...  
Keyword(s):  
Research Funding ◽  
Logarithmic Scale ◽  
Molecular Response ◽  
Response Dynamics ◽  
Transcript Levels ◽  
Protocol Deviation ◽  
Log Reduction ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Abstract Abstract 2301 Background: Nilotinib is a potent, highly selective Bcr-Abl kinase inhibitor approved for adult patients with Ph+ CML in chronic and accelerated phase who are resistant or intolerant to IM and for frontline CML treatment. The achievement of a complete cytogenetic response (CCyR) and a major molecular response (MMR), defined as ≥ 3 log reduction of Bcr-Abl transcript levels from a standardized baseline (equivalent to ≤ 0.1% international scale [IS]) are favorable prognostic factors. Achieving CCyR and MMR are associated with significantly lower rates of disease progression (Saglio, G. et al. N Engl J Med 2010; 362:2251). This multi-center, open-label US study was designed to assess the impact of nilotinib on Bcr-Abl molecular response dynamics in pts with CCyR but have demonstrated a suboptimal molecular response to IM. Methods: This study evaluates the change in Bcr-Abl kinetics in 2 groups of CML-CP pts (target enrollment n=50) who achieved CCyR but have a suboptimal molecular response to IM. Suboptimal molecular response was defined either as: (Group 1) pts treated ≥ 1 year with IM, but have not reached MMR; or (Group 2) pts with > 1 log increase in Bcr-Abl transcript levels from best response regardless of the IM treatment duration. Pts are treated with nilotinib 300 mg BID on study; if dose reductions are required, pts are treated with nilotinib 400 mg QD. Quantitative reverse transcriptase polymerase chain reaction (RQ-PCR) analysis is performed by a central lab at baseline and then every 3 months (mos) for Group 1. Group 2 pts are monitored by RQ-PCR at baseline, monthly for the first 3 mos and then every 3 mos on study. The primary endpoint is to measure the change on a logarithmic scale of Bcr-Abl transcript levels from a standardized baseline value by RQ-PCR after 12 mos on treatment with nilotinib. This analysis was performed on the 14 pts enrolled as of the data cut-off date of June 30, 2010. Results: Fourteen pts (Group 1:13; Group 2:1) have been treated with a median of 9.8 mos (range: 3.4–22.3 mos) on nilotinib. Thirteen pts entered the trial with a baseline CCyR. One pt (Group 1) was discontinued due to lack of evidence of CCyR at baseline (protocol deviation); however was included in the analysis since the pt had at least one post-baseline evaluation performed. Prior to enrollment, pts were treated with ≥ 400mg QD IM; the mean dose of prior IM treatment was 505 mg/day (range 377 – 786 mg/day). The median duration of prior IM treatment was 40.5 mos (range 15.3 – 115.8 mos). The median Bcr-Abl log reduction at baseline was 2.5 (0.32%IS). Overall 12/14 pts achieved MMR on study; 9 pts after 3 mos, 1 pt after 4.5 mos (measured at end of study due to a protocol deviation), and 2 pts after 9 mos. Overall, pts achieved a median 3.11 log reduction (0.078%IS) at Month (Mo) 3; median 3.33 log reduction (0.047%IS) at Mo 6, and a median 3.72 log reduction (0.019% IS) at Mo 9. Of the pts who were treated at least 12 mos, 6/7 (85.7%) reached MMR after switching to nilotinib and the median Bcr-Abl transcript log reduction at 12 mos was 3.66 (0.022% IS,1° endpoint). Nilotinib was well tolerated and brief dose interruptions were sufficient to manage most adverse events (AEs). Five of 14 pts were dose reduced for nilotinib-related AEs. The median dose intensity was 536 mg (range 300 – 600 mg/day). One of each of the following Grade 3 AEs were reported: rash, pneumonia, squamous cell carcinoma, bladder prolapse, and uterine prolapse. Only the rash was suspected to be due to nilotinib. No Grade 4 AEs were reported. One pt experienced serious AEs; pancreatitis was suspected to be related to nilotinib and pneumonia was not suspected to be related to nilotinib. Nilotinib was interrupted and the pt recovered from both events. Four pts were discontinued from the study, 3 due to abnormal labs (Grade 2–3 ALT, Grade 2 bilirubin) and 1 due to a protocol deviation. The median Bcr-Abl log reduction of these 4 pts at end of study was 3.03 logs (0.096% IS). A protocol amendment has since instated a more liberal dose reduction guideline. No pts who experienced QTcF changes had differences > 33 msec from baseline. No QTcF prolongation >500 msec was observed. Conclusions: Nilotinib treatment resulted in an improvement of molecular response in pts switched from IM and was well tolerated. Overall 12/14 (85.7%) of the pts who switched to nilotinib achieved MMR at the time of analysis, and the median Bcr-Abl log reduction for pts who reached 12 mos on study was 3.66 from the standardized baseline (0.022% IS). Disclosures: Miller: Novartis: Consultancy, Honoraria, Research Funding. Off Label Use: Nilotinib is being studied patients with suboptimal response in the context of a clinical trial. Ailawadhi: Novartis: Consultancy, Honoraria. Radich: Novartis: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria. DeAngelo: Novartis: Consultancy; BMS: Consultancy. Goldberg: Novartis: Consultancy, Honoraria, Research Funding. Williams: Novartis: Employment, Equity Ownership. Lin: Novartis: Employment. Akard: Novartis: Consultancy, Honoraria.

scholarly journals To compare the effects of intra vaginal prostaglandin E1 and intra-cervical prostaglandin E2 for prelabour ripening of unfavorable uterine cervix in nulliparous women

2017 ◽  
Vol 6 (8) ◽  
pp. 3381 ◽  
Author(s):  
Shikha A. Jain ◽  
Nisha C. Chakravarti
Keyword(s):  
Prostaglandin E2 ◽  
Uterine Cervix ◽  
Prostaglandin E1 ◽  
Neonatal Outcome ◽  
Induction Of Labour ◽  
Nulliparous Women ◽  
Before And After ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background: Induction of labour by use of prostaglandins improves the obstetric outcome in complicated cases such as prolonged deliveries. The aim of the present study was to compare the effect of prostaglandin E1 (PGE1) and prostaglandin E2 (PGE2) for prelabour ripening of unfavourable uterine cervix in nulliparous women, to study the effect of PGE1 and PGE2 on duration of labor and to evaluate the obstetrical and neonatal outcome of induction of labour using prostaglandins E1 and E2.Methods: This was a prospective study conducted on 50 nulliparous women with singleton pregnancy with gestational age ≥37 weeks during the period from August 2008 to October 2010 in the Department of Obstetrics and Gynaecology of Bombay Hospital Institute of Medical Sciences and Allied Hospitals, Mumbai. All the 50 patients were divided into two groups. Group-1 containing 25 patients received intravaginal PGE1, (Tablet Misoprostol 25 mcg) inserted in the posterior vaginal fornix under all aseptic precautions. Group-2 containing 25 patients received intracervical PGE2, (Dinoprostone gel, 0.5 mg). Analysis and comparison of various parameters like induction- delivery interval, Bishops score before and after administration of drug, mode of delivery, neonatal outcome, foeto-maternal complications between the two groups were noted and analysed the data statistically by using Chi-square, continuity correction, Fisher's exact test and Mann-Whitney tests.Results: Majority of the patients in both the groups were under the age of 23-27 years. Post-datism was the common indication noticed in 18 (72%) and 13 (52%) patients of both the groups respectively. Maximum patients had a Bishop’s score of 3 in PGE1 (56%) and PGE2 groups (48%) respectively. The improvement in Bishop’s score in both the groups before and after drug administration was 6.20 and 6.76 respectively. Maximum patients in both the groups went into active labour within six hours of induction of labour. The most common side effects seen in our study was nausea and vomiting in both groups. Majority (23) were born with Apgar score 8-10 in group 1 and 21 for group 2 patients.Conclusions: Both the drugs had similar efficacy and safety in induction of labour. Prospective research is required to fully evaluate the impact of AMOR-IPAT on nulliparous birth outcomes.

scholarly journals 1520. Respiratory Syncytial Virus Hospitalizations (RSVH) and All-Cause Bronchiolitis Hospitalizations (BH) Among Children Aged ≤ 24 Months at the Start of RSV Season With Bronchopulmonary Dysplasia/Chronic Lung Disease of Prematurity (BPD/CLDP) Before and After the 2014 American Academy of Pediatrics (AAP) Policy

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S762-S762
Author(s):  
Jaime Fergie ◽  
Tara Gonzales ◽  
Mina Suh ◽  
Xiaohui Jiang ◽  
Jon Fryzek ◽  
...  
Keyword(s):  
Health Information System ◽  
International Health ◽  
International Classification Of Diseases ◽  
Data Set ◽  
Before And After ◽  
Classification Of Diseases ◽  
Group 2 ◽  
Syncytial Virus ◽  
The Impact ◽  
Group 1

Abstract Background The AAP, in 2014, stopped endorsing palivizumab for use in children with BPD/CLDP born at &lt; 32 weeks’ gestational age (wGA) between the ages of 12 to 24 months not requiring medical support during the 6 months before the start of RSV season and all children with BPD/CLDP born at &gt; 32 wGA. We sought to understand the impact of the guidance change on RSVH and BH in children no longer advised for RSV immunoprophylaxis with palivizumab. Methods Children with BPD/CLDP aged ≤ 24 months at the RSV season start and hospitalized for RSV or bronchiolitis during the 2010-2017 RSV seasons (November-March) were studied. RSVH, BH, and BPD/CLDP were defined by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and ICD-10-CM codes. ICD-9 codes for wGA combine 31 and 32 wGA into one code. Therefore, for BPD/CLDP, we classified group 1 as children aged 12 to 24 months who were born at &lt; 31 wGA and group 2 as those born at ≥ 31 wGA. The Children’s Hospital Association’s Pediatric Health Information System® (PHIS) data set was used to describe frequency and characteristics of RSVH and BH and disease severity (including intensive care unit [ICU] admission and mechanical ventilation [MV]) before and after the 2014 AAP policy. Statistical analyses were done using z-tests; SAS version 9.4. Results Among children with BPD/CLDP, RSVH rates were 1.7% (1035/59,217) before 2014 and 2.1% (973/45,470) after 2014 (P&lt; 0.0001). RSVH rose after the policy change vs before among children with BPD/CLDP in both group 1 (0.40% vs 0.26%; P&lt; 0.0001) and group 2 (0.22% vs 0.14%; P=0.002). Similarly, BH also increased for both group 1 (P&lt; 0.0001) and group 2 (P=0.002) after the guidance change vs before. Although ICU admissions increased significantly for children with BPD/CLDP in both group 1 (P&lt; 0.0001) and group 2 (P=0.0004), use of MV (P=0.002) increased after 2014 for children with BPD/CLDP in group 1 only. Similar results were observed for BH. Conclusion This analysis highlights the increase in RSVH, BH, and associated severity among BPD/CLDP subgroups within the PHIS health system after 2014. Further study of long-term complications associated with RSVH in these children is warranted. Disclosures Jaime Fergie, MD, AstraZeneca (Speaker’s Bureau)Sobi, Inc. (Speaker’s Bureau) Tara Gonzales, MD, Sobi, Inc. (Employee) Mina Suh, MPH, International Health, EpidStrategies (Employee) Xiaohui Jiang, MS, EpidStrategies (Employee) Jon Fryzek, PhD, MPH, EpidStrategies (Employee) Adam Bloomfield, MD, FAAP, Sobi, Inc. (Employee)

scholarly journals Does balneotherapy provide additive effects to physical therapy in patients with subacute supraspinatus tendinopathy? A randomized, controlled, single-blind study

2020 ◽  
Author(s):  
Cihan Koç ◽  
Emine Eda Kurt ◽  
Fatmanur Aybala Koçak ◽  
Hatice Rana Erdem ◽  
Naime Meriç Konar
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Physical Therapy ◽  
Handgrip Strength ◽  
Additional Contribution ◽  
Sf 36 ◽  
Before And After ◽  
Group 2 ◽  
Group 1

Abstract This study assessed the additional contribution of balneotherapy on physical therapy in subacute supraspinatus tendinopathy. Ninety patients with subacute supraspinatus tendinopathy were included. They were randomized into two equal groups. In group 1 (n = 45), transcutaneous electrical nerve stimulation (TENS), hot pack, ultrasound treatments, and Codman’s and range of motion (ROM) exercises were performed. In group 2 (n = 45), balneotherapy was added to the treatment program. In both groups, shoulder active ROM and handgrip strength were measured. Pain was evaluated using a Visual Analogue Scale (VAS) (rest, sleep, movement); functional assessment and quality of life were measured respectively with the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), and the Short Form-36 health survey (SF 36) form. All measurements were repeated before and after 15 treatment sessions. There were statistically significant differences between the before and after assessment parameters in group 1 (all p < 0.05), but not for SF-36 General Health Perceptions, SF-36 Mental Health sub-parameters, and handgrip strengths. However, there were statistically significant differences between all the evaluation before and after the treatment in group 2 (all p < 0.05). When the two groups were compared in terms of alpha gains, statistically significant differences were observed in favor of group 2 in all measurements (all p < 0.05) except for SF-36 Emotional Role Difficulty and SF-36 Mental Health sub-parameters. This study shows that the addition of balneotherapy to physical therapy for subacute supraspinatus tendinopathy can make additional contributions to shoulder ROM, pain, handgrip strength, functional status, and quality of life.

Nilotinib-Associated Molecular Responses Achieved in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients with a Suboptimal Molecular Response to Imatinib.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2206-2206
Author(s):  
Allen S. Yang ◽  
Anand Jillella ◽  
Carole B. Miller ◽  
Luke P. Akard ◽  
Daniel J. DeAngelo ◽  
...  
Keyword(s):  
Research Funding ◽  
Molecular Response ◽  
Imatinib Treatment ◽  
Molecular Responses ◽  
Transcript Levels ◽  
Log Reduction ◽  
Group 2 ◽  
Grade 3 ◽  
The Impact ◽  
Group 1

Abstract Abstract 2206 Poster Board II-183 Background Nilotinib is a potent, highly selective Bcr-Abl kinase inhibitor approved for adult patients with Ph+ CML in chronic and accelerated phase who are resistant or intolerant to imatinib. The achievement of a major molecular response (MMR), defined as a 3 log reduction of the Bcr-Abl transcript level from the baseline mean, is a favorable prognostic factor for the disease at any time point. This multi-center, open-label study was designed to assess the impact of nilotinib on Bcr-Abl molecular response dynamics in patients who have achieved complete cytogenetic response but have demonstrated a suboptimal molecular response to imatinib. Methods This study evaluates the change in Bcr-Abl kinetics in 2 groups of CML-CP patients (n=160) who achieve CCyR but have a suboptimal molecular response to imatinib defined either as: (Group 1) treated > 1 year with imatinib, but Bcr-Abl transcript levels did not reach ≤ 0.1% on the international scale (IS) (MMR); or (Group 2) > 1 log increase in Bcr-Abl transcript levels regardless of the imatinib treatment duration. At study entry, patients are treated with nilotinib 300 mg b.i.d. The primary endpoint is to measure the change on a logarithmic scale of Bcr-Abl transcript levels from a standardized baseline value by RQ-PCR after 12 months on treatment with nilotinib. Since there is a paucity of efficacy data published for suboptimal responders to imatinib, this preliminary analysis was performed on a small cohort of patients enrolled as of the data cut-off date of July 21, 2009. Results 11 CML-CP suboptimal molecular responding patients have been treated with a median of 2.6 months on nilotinib. One patient entered the study as a Group 2 patient and ten entered into Group 1. 1 patient was deemed ineligible due to lack of evidence of CCyR at baseline. The remaining 10 entered the trial with a baseline CCyR. Prior to enrollment, patients were treated with at least 400mg QD imatinib; the mean dose of prior imatinib treatment was 463 mg/day (range 377 – 573 mg/day). The median duration of prior imatinib treatment was 39.5 months (range 14.0-106.4 mo). 1 patient was previously treated with interferon. 8 patients have been treated for >3 months. Out of these 8 patients, 2 have been treated for > 6 months and 1 patient has been treated for > 9 months. Aside from these 8 patients, another 3 did not yet reach end of Month 3 at the time of analysis. Six out of 8 evaluable patients (75%) achieved MMR; 4 patients after three months on nilotinib, 1 patient after 4.5 months on nilotinib (measured at end of study), and 1 patient after 9 months on nilotinib. Overall, patients achieved a median log reduction of PCR transcript levels of 3.1 (range 2.1-4.5) from the standardized baseline (based on the IS) at the end of Month 3. 4 out of 11 patients were dose reduced for nilotinib related adverse events (AEs). No grade 4 AEs were reported. 1 patient experienced a grade 3 headache and two cases of grade 3 elevated ALT were reported. Brief dose interruptions were sufficient to manage most AEs. The median dose intensity was 600 (range 400-600 mg/day). No patients discontinued from the study due to an AE as of the data cut-off date. No patients who experienced QTcF changes had differences >34 msec from baseline. No QTcF prolongation >500 msec was observed. Conclusions Nilotinib treatment results in high rates of molecular response in CML-CP patients with suboptimal molecular responses to imatinib. 75% of the evaluable patients who switched to nilotinib achieved MMR at the time of analysis, and all evaluable patients achieved a median > 3 log reduction of PCR transcripts from the standardized baseline within 3 months of starting therapy. No patients were discontinued due to AEs. Outcomes for additional patients enrolled and longer term follow-up will become available. Disclosures: Yang: Bristol Myers Squibb: Speakers Bureau; Celgene: Research Funding, Speakers Bureau; Esai: Speakers Bureau; Therepi: Equity Ownership. Off Label Use: Nilotinib for suboptimal responders to imatinib therapy. Miller:Novartis Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau. Akard:Novartis: Consultancy, Research Funding. DeAngelo:Bristol-Myers Squibb: Speakers Bureau; Celgene: Speakers Bureau; Enzon Pharmaceuticals: Speakers Bureau; Novartis Pharmaceuticals: Speakers Bureau. Goldberg:Novartis Pharmaceuticals: Research Funding, Speakers Bureau. Williams:Novartis Pharmaceuticals: Employment. Radich:Novartis Pharmaceuticals: Consultancy, Honoraria, Research Funding.

Comparison of 24-Hour Electrocardiogram Parameters in Patients with Graves Disease Before and After Anti-Thyroid Therapy

2020 ◽  
Vol 20 ◽  
Author(s):  
Gamze Akkuş ◽  
Yeliz Sökmen ◽  
Mehmet Yılmaz ◽  
Özkan Bekler ◽  
Oğuz Akkuş
Keyword(s):  
Treatment Group ◽  
Medical Treatment ◽  
Surgical Therapy ◽  
Graves Disease ◽  
Before And After ◽  
Euthyroid Status ◽  
Ectopic Beats ◽  
Group 2 ◽  
Electrocardiographic Parameters ◽  
Group 1

Background: We aimed prospectively investigate the laboratory and electrocardiographic parameters (hearth rate, QRS, QT, QTc, Tpe, Tpe/QTc, arrhythmia prevalance) in patients with graves disease before and after antithyroid therapy. Methods: 71 patients (48 female, 23 male), age between 18-50 (mean±SD: 36.48±12.20 ) with GD were included into the study. Patients treated with antithyroid therapy (thionamids and/or surgical therapy) to maintain euthyroid status. Patients were examined in terms of electrocardiographic parameters before and after the treatment. Results: Mean TSH, free thyroxin (fT4) and tri-iodothyrionine (fT3) levels of all patients were 0.005±0.21, 3.27± 1.81, 11.42±7.44, respectively. While 9 patients (group 2) underwent surgical therapy, had suspicious of malignant nodule or large goiter and unresponsiveness to medical treatment; the other patients (n=62, group 1) were treated with medical therapy. Patients with surgical therapy had more increased serum fT4 (p=0.045), anti-thyroglobulin value (p=0.018) and more severe graves orbitopathy (n=0.051) before treatment when compared to medical therapy group. Baseline Tpe duration and baseline Tpe/QTc ratio and frequency of supraventricular ectopic beats were found to be significantly higher in group 2 when compared to group 1 (p=0.00, p=0.005). Otherwise baseline mean heart rate, QRS duration, QTc values of both groups were similar. Although the patients became their euthyroid status, group 2 patients had still suffered from more sustained supraventricular ectopics beats than group 1. Conclusion: Distinct from medical treatment group, surgical treatment group with euthyroidism at least 3 months had still suffered from an arrhythmia (Tpe, Tpe/QTc, supraventricular and ventricular ectopic beats).

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