scholarly journals Effects of nintedanib by inclusion criteria for progression of interstitial lung disease

2021 ◽  
pp. 2004587
Author(s):  
Toby M. Maher ◽  
Kevin K. Brown ◽  
Michael Kreuter ◽  
Anand Devaraj ◽  
Simon L. F. Walsh ◽  
...  

The INBUILD trial investigated nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression.Subjects had a fibrosing ILD other than idiopathic pulmonary fibrosis and met these criteria for ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice: Group A, relative decline in FVC ≥10% predicted; Group B, relative decline in FVC ≥5–<10% predicted with worsened respiratory symptoms and/or increased extent of fibrosis on HRCT; Group C, worsened respiratory symptoms and increased extent of fibrosis on HRCT only.In the placebo group, the rates of FVC decline over 52 weeks in Groups A, B and C, respectively, were −241.9, −133.1 and −115.3 mL·year−1 in the overall population (p=0.0002 for subgroup-by-time interaction) and −288.9, −156.2 and −100.1 mL·year−1 among subjects with a usual interstitial pneumonia [UIP]-like fibrotic pattern on HRCT (p=0.0005 for subgroup-by-time interaction). Nintedanib had a greater absolute effect on reducing the rate of FVC decline in Group A than Group B or C. However, the relative effect of nintedanib versus placebo was consistent across the subgroups (p>0.05 for heterogeneity).In conclusion, the inclusion criteria used in the INBUILD trial, based on FVC decline or worsening of symptoms and extent of fibrosis on HRCT, were effective at identifying patients with progressive fibrosing ILDs. Nintedanib reduced the rate of decline in FVC across the subgroups based on the inclusion criteria related to ILD progression.

2020 ◽  
Vol 21 (2) ◽  
pp. 105-110
Author(s):  
Md Shawkat Alam ◽  
Sudip Das Gupta ◽  
Hadi Zia Uddin Ahmed ◽  
Md Saruar Alam ◽  
Sharif Muhammod Wasimuddin

Objective: To compare the clean intermittent self-catheterization (CISC) with continuous indwelling catheterization (CIDC) in relieving acute urinary retention (AUR) due to benign enlargement of prostate (BEP). Materials and Methods :A total 60 patients attending in urology department of Dhaka Medical college hospital were included according to inclusion criteria ,Patients were randomized by lottery into two groups namely group –A and group –B for CISC and IDC drainage respectively . Thus total 60 patients 30 in each group completed study. Results : Most men can safely be managed as out-patients after AUR due to BPH. The degree of mucosal congestion and inflammation within the bladder was found to be lower in those using CISC and the bladder capacity in these patients was also found higher.Patients with an IDC had a high incidence of UTIs then that of patients with CISC. During the period of catheterization the incidence of UTI was 43.3% in group B in comparison to 40% in group A; before TURP 36% in group B in comparison to 10% incidence in group A.According to patient’s opinion CISC is better than IDC in the management of AUR. Experiencing bladder spasm, reporting blood in urine, management difficulties, incidence and severity of pain were less in CISC group, and the method of CISC was well accepted by patients as well as their family members. Conclusion: From the current study it may be suggested that CISC is better technique for management of AUR patient due to BPH than IDC. It can also be very helpful when surgery must be delayed or avoided due to any reasons in this group of patients. Bangladesh Journal of Urology, Vol. 21, No. 2, July 2018 p.105-110


2010 ◽  
Vol 113 (Special_Supplement) ◽  
pp. 48-52 ◽  
Author(s):  
Toru Serizawa ◽  
Masaaki Yamamoto ◽  
Yasunori Sato ◽  
Yoshinori Higuchi ◽  
Osamu Nagano ◽  
...  

Object The authors retrospectively reviewed the results of Gamma Knife surgery (GKS) used as the sole treatment for brain metastases in patients who met the eligibility criteria for the ongoing JLGK0901 multi-institutional prospective trial. They also discuss the anticipated results of the JLGK0901 study. Methods Data from 1508 consecutive cases were analyzed. All of the patients were treated at the Gamma Knife House of Chiba Cardiovascular Center or the Mito Gamma House of Katsuta Hospital between 1998 and 2007 and met the following JLGK0901 inclusion criteria: 1) newly diagnosed brain metastases, 2) 1–10 brain lesions, 3) less than 10 cm3 volume of the largest tumor, 4) no more than 15 cm3 total tumor volume, 5) no findings of CSF dissemination, and 6) no impairment of activities of daily living (Karnofsky Performance Scale score < 70) due to extracranial disease. At the initial treatment, all visible lesions were irradiated with GKS without upfront whole-brain radiation therapy. Thereafter, gadolinium-enhanced MR imaging was performed every 2–3 months, and new distant lesions were appropriately retreated with GKS. Patients were divided into groups according to numbers of tumors: Group A, single lesions (565 cases); Group B, 2–4 tumors (577 cases); and Group C, 5–10 tumors (366 cases). The differences in overall survival (OS) were compared between groups. Results The median age of the patients was 66 years (range 19–96 years). There were 963 men and 545 women. The primary tumors were in the lung in 1114 patients, gastrointestinal tract in 179, breast in 105, urinary tract in 66, and other sites in 44. The overall mean survival time was 0.78 years (0.99 years for Group A, 0.68 years for Group B, and 0.62 years for Group C). The differences between Groups A and B (p < 0.0001) and between Groups B and C (p = 0.0312) were statistically significant. Multivariate analysis revealed significant prognostic factors for OS to be sex (poor prognostic factor: male, p < 0.0001), recursive partitioning analysis class (Class I vs Class II and Class II vs III, both p < 0.0001), primary site (lung vs breast, p = 0.0047), and number of tumors (Group A vs Group B, p < 0.0001). However, no statistically difference was detected between Groups B and C (p = 0.1027, hazard ratio 1.124, 95% CI 0.999–1.265). Conclusions The results of this retrospective analysis revealed an upper CI of 1.265 for the hazard ratio, which was lower than the 1.3 initially set by the JLGK0901 study. The JLGK0901 study is anticipated to show noninferiority of GKS as sole treatment for patients with 5–10 brain metastases compared with those with 2–4 in terms of OS.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 846.3-846
Author(s):  
N. Madeira ◽  
M. Alvarenga Santos ◽  
L. Cunha Miranda ◽  
S. Clemente ◽  
S. Furtado

Background:Interstitial Lung Diseases (ILD) may present features suggesting an underlying autoimmune process, which seem to differentiate them from idiopathic interstitial pneumonias, although without fully meeting the classification criteria (CC) for a specific connective tissue disease. Different terms had been used to describe these conditions and, to reach a consensus, the European Respiratory Society/American Thoracic Society proposed the CC for an entity named Interstitial Pneumonia with Autoimmune Features (IPAF). Clinical evolution and prognosis of this entity are still poorly understood.Objectives:To evaluate clinical evolution and prognosis of a population of patients with IPAF.Methods:Retrospective analysis of clinical files of patients followed by the Pulmonology Department since 02/2012 until 06/2019, who met the CC for IPAF, regarding clinical, functional and radiological evolution. Patients were considered to have a progressive phenotype in 24±3 months from their 1stevaluation if they fulfil 1 of the 4 criteria: relative decline in FVC ≥10% predicted; relative decline in FVC ≥5–<10% predicted and worsened respiratory symptoms; relative decline in FVC ≥5–<10% predicted and increased extent of fibrosis on High-resolution Computed Tomography (HRCT); worsened respiratory symptoms and increased extent of fibrosis on HRCT.Results:22 (7.4%) of 296 ILD patients met IPAF CC. 59.0% were female with an age at the 1stevaluation of 66.7±12.4 years. They were all non-smokers (63.6%) or ex-smokers (36.4%). Serologic and morphologic criteria were both present in 21 (95.4%) and clinical criteria in 5 patients (22.7%). Antinuclear antibodies (ANA) were identified in 19, rheumatoid factor in 4, SSA in 3 and anti-Jo-1 in 1 patient. HRCT patterns were identified in 21 patients: 15 nonspecific interstitial pneumonia (NSIP), 5 organizing pneumonia (OP) and 2 lymphocytic interstitial pneumonia (LIP). One NSIP and 1 LIP identified on HRCT were confirmed by histopathology. Three patients had inflammatory arthritis and 2 had Raynaud’s phenomenon. Immunosuppressive therapy was introduced in most cases (18 patients, including systemic corticotherapy in 17, azathioprine in 4, mycophenolate mofetil in 1), azithromycin was prescribed in 2 patients and 3 remained without therapy. Regarding the follow up at 24±3 months from the 1stevaluation (3 patients were excluded due to too recent follow-up), 4 patients (18.2%) had progressive phenotype, 7 (31.8%) had a favourable evolution and 3 (13.6%) patients had died. During a follow-up of 31.1±19.8 months, this number rose to 6 patients (27.3%), all of them died by respiratory cause and had NSIP pattern. No differences were found in age, last FVC, therapy and time of disease evolution between those who died and the others.Conclusion:Our study showed that a small proportion of IPAF patients had a progressive phenotype and the NSIP pattern seemed to be a poor prognosis factor for survival.References:[1]Ito Y, Arita M, Kumagai S, et al. Serological and morphological prognostic factors in patients with interstitial pneumonia with autoimmune features. BMC Pulm Med 2017; 17:111 10.1186/s12890-017-0453-zDisclosure of Interests:None declared


2020 ◽  
Vol 5 (05) ◽  
pp. 96-103
Author(s):  
Deepa S. Patil ◽  
Prashanth A.S

Rajonivrutti condition manifests in the end phase of Jarawastha; but its Samprapti begins from the Sandhikala of Madhyamawastha and Jarawastha due to Vatavruddi in womens reaching Rajonivrutti. Postmenopausal Asthikshaya is a disabling disease, which renders women a bedridden life. Here 40 subjects diagnosed with postmenopausal Asthikshaya fulfilling the inclusion criteria were selected for the study and randomly categorized intp two groups as group A and group B each consisting of 20 subjects. Group A received Amapachana with Hinguvachadivati, Yastimadhu Siddha Ksheerabasti administered in Yoga Basti schedule followed by Tritiyatriphala Rasayana. Group B received Amapachana with Hinguvachadivati, Sadhyosnehapana with Amrita Ghrita, Sarvanga Abyanga with Murchita Tilataila followed by Sarvanga Swedana and Sneha Virechana was admistered with Eranda Taila followed by Tritiyatriphala Rasayana was given. Tritiya Triphala Rasayana selected for the present study by adapting all the general principles of prevention and management of Asthikshaya and as it is a well known Rasayana.


2021 ◽  
pp. e20210156
Author(s):  
Maria Montes de Oca1 ◽  
Maria Victorina Lopez Varela2 ◽  
Ana Maria B. Menezes3 ◽  
Fernando C. Wehrmeister3 ◽  
Larissa Ramirez4 ◽  
...  

Objective: To assess the frequency and severity of 24-hour respiratory symptoms according to COPD GOLD-ABCD classification (2017-version), the distribution of the patients with COPD into GOLD categories using mMRC (=2) or CAT (=10) scores, and agreement between these cut-off points. Methods: In this cross-sectional study (LASSYC study), 24-hour day respiratory symptoms were assessed by the Evaluating Respiratory Symptoms in COPD (E-RS) questionnaire, Nighttime Symptoms of COPD Instrument (NiSCI), Early Morning Symptoms of COPD Instrument (EMSCI), CAT and mMRC scores. Results: Among the 734 patients with COPD, 61% were male, age 69.6±8.7 years, FEV1% post-BD 49.1±17.5%, mMRC 1.8±1.0 and CAT 15.3±.8.1. By mMRC 33.7% were group-A, 29.2% group-B, 10.2% group-C and 26.9% group-D. By CAT 22.3% were group-A, 41% group-B, 4.8% group-C and 31.9% group-D. Using the mMRC the severity of E-RS, NiSCI and EMSCI scores increased from group A to D. Using the CAT, the groups B and D had the higher scores. Agreement between mMRC and CAT was 89.5% (Kappa statistics=75.7%). For mMRC score of 2, CAT score of =11 showed the maximum Youden's index (1.34). For mMRC score of 1, CAT score of =9 and =10 showed the maximum Youden's index (1.48). Conclusion: GOLD COPD classification by CAT seems to better discriminate 24-hour symptoms. Results do not support the equivalent use of CAT=10 and mMRC=2 for assessing symptoms.


2020 ◽  
Vol 5 (05) ◽  
pp. 89-95
Author(s):  
Pooja Abhrange ◽  
S. G. Chavan ◽  
Prashanth A.S.

Metabolism is the natural process of the body, which is necessary to maintenance of the homeostasis of an individual person. Everybody constitutions are always in the process of metabolism, which is a combination of Anabolism (Construction) and Catabolism (Deterioration). As Agni is prime factor for all the Chayapachayakriya. Medoroga, is one of the Metabolic disease, in which contributing factors are Agni, Ama along with Kaphapradhana Tridosha, Medodhathu. Due to various types of etiological factors, the Agni in the body gets vitiated and Jatharagnimandya occurs. By this Jatharagnimandya, Dhathuparinama will not occur properly. This will lead to Medoroga and further many other Upadravas. To correct these conditions, Ayurveda has many modes of therapies like Samshodhana, Samshamana. By these we can correct the metabolism from the root cause. Here 40 Subjects diagnosed with Medoroga w.s.r. to Hyperlipidemia fulfilling the Inclusion criteria were selected for study and randomly categorized into two groups as Group A and Group B each consisting of 20 subjects. For both groups Amapachana with Chitrakadi Vati, Sadhyosnehapana with Murchita Sarshapa Taila, Sarvanga Abhyanga with Murchita Tila Taila followed by Swedana. And Virechana was administered with Virechana Gulika. Than each group received two different Shamanoushadhi. So, the objective of the study is to establish the efficacy of Virechana along with Dashanga Guggulu and Virechana along with Shadushana Guggulu in the management of Medoroga.


QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
N A Fahmy ◽  
S M Alfawal ◽  
H S Abdelsamie ◽  
A M Hassan

Abstract Background Atrial fibrillation (AF) is the most common sustained arrhythmia affecting humans. It is an electrical disturbance that leads to rapid, disorganized, and asynchronous contraction of the atrial muscle. In clinical practice, it accounts for approximately one-third of hospitalizations for cardiac rhythm disturbances. The incidence of AF increases from less than 0.1% per year in those under 40 years old to exceed 1.5% per year in women and 2% per year in men older than 80 years. Aim of the Work: to discuss the effect of variation in amiodarone use (including dosage and duration) on dysrhythmia recurrence in patients with new-onset AF in ICU. Patients and Methods This was a prospective observational study conducted over 6 months, 60 patients who fulfilled inclusion criteria were included in the study divided in two groups according to amiodarone dosage, each group is 30 patients: Group (A): received a loading dose of amiodarone followed by an infusion (1200mg amiodarone). Group (B): received a loading dose of amiodarone not followed by an infusion (300mg amiodarone). Results a significant positive correlation was observed between level of C-reactive protein (CRP) and the rate of AF recurrence. As regard effect of CRP on AF recurrence; in AF recurrent patients, mean is (191±77.3) with range from 15 to 352 which significantly differed from Non-recurrent AF patients, mean is (89±63) with range from 20 to 223 (p value &lt;0.001). AF recurrence was higher in group (B) than group (A),. In group (A) 8 patients had recurrent AF representing 26.7 % and in group (B) 19 patients had AF recurrence representing 63.3% (p value =0.004). Conclusion Patients with new-onset AF in (ICU) who are treated with amiodarone should receive a loading dose, immediately followed by an infusion.


2020 ◽  
Vol 31 (1) ◽  
pp. 71-77
Author(s):  
Beatrice Trabalza Marinucci ◽  
Giulio Maurizi ◽  
Camilla Vanni ◽  
Giuseppe Cardillo ◽  
Camilla Poggi ◽  
...  

Abstract OBJECTIVES Few experiences comparing paediatric and adult patients treated for pulmonary sequestration (PS) have been reported. Surgical treatment is considered the best choice, but the time of surgery is still controversial. We present our experience in this setting, comparing characteristics, histological results and outcome of paediatric and adult patients undergoing PS resection. METHODS Between 1998 and 2017, a total of 74 patients underwent lobectomy or sublobar resection for PS. Sixty patients were children (group A: ≤16 years old) and 14 were adults (group B: &gt;16 years old). Preoperative diagnosis was radiological. PS was intralobar (42 cases) and extralobar (32 cases). The operation was a muscle-sparing lateral thoracotomy or video-assisted thoracoscopic surgery. Preoperative characteristics, histological results and short-/long-term results of the 2 groups were retrospectively analysed and compared. RESULTS Thirty-seven percent of the patients in group A presented with respiratory symptoms and 79% in group B (P = 0.44). Most symptomatic patients were treated with a lobectomy. In group A, 2 patients (3%) had a malignant transformation of the lesion. Patients with a prenatal diagnosis treated after the age of 1 year became more symptomatic than those operated on before the age of 1 year (57% vs 23%; P = 0.08). No differences were found in postoperative complications. Long-term stable remission of respiratory symptoms was obtained in 91% of patients in group A and 100% in group B. Adulthood (P = 0.03) and the association with congenital cystic adenomatoid malformation (P = 0.03) were negative prognostic factors for the development of respiratory symptoms. CONCLUSIONS Surgical treatment of PS is safe and feasible. Despite the small number of patients included, study results indicated that an early operation during childhood may prevent the subsequent development of respiratory symptoms. Surgical treatment is also recommended to prevent the rare transformation into malignancy.


2020 ◽  
Vol 32 (1) ◽  
pp. 42-44
Author(s):  
Mahmuda Sultana ◽  
Md Tazul Islam ◽  
Pran Krishna Basak ◽  
Md Samir Uddin ◽  
Zakia Sultana

Introduction: Heart valves serve the important function of preventing backflow, or regurgitation, in the healthy heart. It is well known that cardiac valves can suffer from congenital and acquired disease. Most frequent acquired valvular abnormalities are stenoses of the aortic and mitral valves, which account for approximately 2/3rd of all valve disease. For the management of valvular disease morphology of right atrioventricular valve is essential. Materials and Methods: Study design was descriptive type of study. Place and period of study was Department of Anatomy, Sylhet MAG Osmani Medical College, Sylhet from July 2015 to June 2016. Results: Present study was performed on 70 post mortem human hearts of age ranging from 9 to 70 years. Human heart was collected from the unclaimed dead bodies autopsied in the department of Forensic medicine in Sylhet MAG Osmani Medical College during the study period fulfilling the inclusion criteria. Conclusion: The collected samples were divided into 3 groups depending on age. Group – A: (9 - 21 Years), Group - B: (22 - 41 Years), Group - C: ( 42 -70) Years. Each group was subdivided into two groups depending on their sex. Medicine Today 2020 Vol.32(1): 42-44


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12589-e12589 ◽  
Author(s):  
Kristina A. Novoselova ◽  
Liubov Yu Vladimirova ◽  
Natalia A Abramova ◽  
Anna E Storozhakova ◽  
Irina L. Popova ◽  
...  

e12589 Background: Better efficiency and safety of Nab-P is known to be due to the advantages of pharmacokinetics and pharmacodynamics of the drug. The fraction of unbound paclitaxel in plasma is 2.6-fold higher with Nab-P than with P. The purpose of the study was to assess efficacy and safety of Nab-P in ≥2nd lines of chemotherapy (CT) in patients (pts) with mBC with VC. Methods: Inclusion criteria: mBC with VC, ≥ 2 line of CT, HR+, HER2neu+ or triple negative type (TN), normal liver and renal function. Pts received Nab-P 260 mg/m2 q 21 days. Pts with Her2/Neu + received trastuzumab 6 mg/kg q 21 days. Results: 32 mBC pts, mean age 51.34 years (CI 35-76) were included. Among 32 pts Her2/Neu + had 5 (15.6%), TN – 9 (28.1%), HR+ 18(56.3%). 13(40.6%) pts received Nab-P as 2 line of CT, 13 (40.6%) pts, as 3-4 lines, 7(21.9%) as ≥5 lines. Pts were divided into 2 groups: group A - pts with VC 17(53.1%), group B - without VC 15(46.9%). Groups were comparable by age, number of previous CT lines, immunohistochemical types of BC. Group A had 2.47±0.32 CT lines (CV51.83%), including 8(47%) pts, who had received paclitaxel (P) in previous CT lines. Group B had on average 2±0.27 CT lines (CV53.03%). The objective response rate (ORR) was 37.5%(12 pts). In the group A ORR was 35.3% (6 pts). Out of 8 pts with VC, who had received P in previous lines, ORR was achieved in 3 pts (37.5%). In the group B ORR was 33.34%(5 pts). TTP was 6.8 mos (95% CI 6.1-13.7) for all pts, in the group A – 5.7 mos (95% CI 5.9-10.2), in the group B 6 mos (95% CI 6.5-13.7) (p = 0.046). Median 3-year OS of pts in group A was 18.9 mos (95% CI 4.3-22.4), in group B - 22.5 mos (95% CI 8.2-26.7) (p = 0.038). Toxicity did not differ significantly in pts in groups A and B and was manageable. Pts, who previously received P, had no new or severe toxicity. Conclusions: The data obtained confirms the possibility of Nab-P application in pts with VC. The use of Nab-P in pts treated with taxanes in previous lines is supposed for further study.


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