scholarly journals Release Profile of Salofalk 750 mg Tablets

1995 ◽  
Vol 9 (5) ◽  
pp. 247-250
Author(s):  
Vincent Ho ◽  
Joan E Blair ◽  
Zane Cohen ◽  
Robin S McLeod

This study determined the release profile of Salofalk 750 mg tablets (Axcan Pharma), an enteric-coated 5-aminosalicylic acid (5-ASA) preparation. Twenty-one ileostomates were divided into two groups and studied. Group 1 consisted of 10 subjects (five males, five females, mean age 39 years) who had a mean length of 65 cm of small bowel resected or out of circuit. Group 2 consisted of 11 subjects (eight males, three females, mean age 59 years) whose small bowel was intact. Following an overnight fast and collection of baseline samples, one Salofalk tablet was ingested. Ileostomy effluent and urine were collected for 24 h. Plasma samples were collected hourly for 6 h, then at 8, 12 and 24 h. All subjects ate standardized meals. All samples were stored at --10 degrees C and 5-ASA and N-ac-5-ASA (a metabolite of 5-ASA) were measured by high performance liquid chromatography. The mean intestinal transit time was not statistically different between the groups but the mean ileostomy effluent output was higher in group 1 versus group 2 (10.9 versus 13.1 h, P=0.4; 918 versus 606 mL, P=0.05). The mean peak plasma concentrations of 5-ASA and N-ac-5-ASA were not significantly different (6.12 and 5.42 µ g/ mL, P=0.8, respectively, in group 1 versus 6.75 and 6.66 µ g/mL, P=0.8 in group 2). On average, 33.1% of the ingested dose was recovered in the ileostomy effluent in group 1 versus 21.2% in group 2 (P=0.06) whereas the mean recovery in urine was 40.9% in group 1 but 62.9% in group 2 (P=0.001). These results suggest that 5-ASA is released in the small bowel. There was decreased absorption of 5-ASA and increased recovery of 5-ASA in the ileostomy effluent of subjects who had a small bowel resection.

1976 ◽  
Vol 81 (3) ◽  
pp. 673-679 ◽  
Author(s):  
Hugo Scaglia ◽  
Martha Medina ◽  
Ada L. Pinto-Ferreira ◽  
Guadalupe Vazques ◽  
Carlos Gual ◽  
...  

ABSTRACT The plasma concentrations and episodic fluctuations of immunoreactive FSH and LH as well as the pituitary sensitivity to LH-RH stimulation were evaluated in post-menopausal women. The subjects were divided into 4 groups according to age. Group 1: 60–70 years old (n=11), group 2: 70–80 years old (n=22), group 3: 80–90 years old (n=31) and group 4: 90–100 years old (n=8). Standards used in gonadotrophin radioimmunoassays included the LER-907 preparation and a pooled post-menopausal serum. Since it was found that circulating gonadotrophins have an immunological pattern different from that shown by the pituitary preparation, the results were expressed in mIU/ml calculated accordingly to the immunological behaviour of pooled post-menopausal sera. The mean (± se) plasma levels of FSH (mIU/ml) were: group 1: 105.9 ± 9.5, group 2: 149.3 ± 10.5, group 3: 124.8 ± 7.1 and group 4: 149.4 ± 25.3. The mean (± se) plasma levels of LH (mIU/ml) were: group 1: 81.9 ± 12.5, group 2: 95.4 ± 9.9, group 3: 84.3 ± 7.7 and group 4: 113.5 ± 19.1. No statistically significant differences were observed among the 4 groups. One patient from each group was randomly selected in order to evaluate their LH and FSH episodic release as well as their pituitary responsiveness to exogenous stimulation. A pulsatile plasma pattern of gonadotrophin and a normal pituitary response to LH-RH injection were observed in the 4 patients studied. The results are interpreted as demonstrating that normal pituitary gonadotrophin function and pituitary reserve and responsiveness to exogenous stimulation are maintained in women of advanced age.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3360-3360
Author(s):  
Anja B Drebes ◽  
Paul Priest ◽  
Shaila Bates ◽  
Lida Moghaddam ◽  
Edward GD Tuddenham ◽  
...  

Abstract Abstract 3360 Background: Point-of-care testing (POCT) is widely used for monitoring of the international normalized ratio (INR) in patients on oral anticoagulation with a vitamin-K antagonist (VKA) and numerous clinical studies have assessed the accuracy of this method in comparison with INR results from venous blood samples analysed in the laboratory. There is however a paucity of clinical data to support the use of POCT in patients on dual anticoagulation with low molecular weight heparin (LMWH) and a VKA during initiation of anticoagulation or bridging after a surgical procedure. Aim: To test the hypothesis whether therapeutic doses of LMWH interfere with INR measurements when using a POCT system during times of dual anticoagulation with LMWH and a VKA. To further investigate whether the effect is most pronounced once LMWH has reached peak plasma levels and less evident 10 hours and more after administration of LMWH. Methods: We prospectively collected 160 consecutive venous blood samples from patients on therapeutic doses of LMWH - Tinzaparin (175 IU/kg once daily) and a VKA commonly warfarin for INR testing in our laboratory. At the same time all patients had their INR determined on capillary blood collected by finger prick using a CoaguChek XS Pro and INR test strips with the same lot number (Roche Diagnostics Ltd, UK). 60 blood samples were collected within 3–6 hours after administration of LMWH (group 1) and 100 samples were collected 10 hours or more after the last injection of LMWH (group 2). For each sample the dose and time of the last injection of LMWH was recorded along with the time of the venepuncture and the result of the capillary INR. To ensure that we had a wide variation in the plasma concentrations of LMWH we carried out anti-Xa testing on a cross-section of venous samples The dosing advice for Warfarin was based on the INR result of the venous blood sample processed in the laboratory. Results: The correlation coefficient between the POCT INR and the laboratory INR was 0.98 in group 1 and 0.97 in group 2. In the Bland Altman analysis for group 1 the mean 95% confidence interval (CI) was 0.03 (range+/− 1.96 SD: −0.26 to +0.32) and for group 2 the mean 95% CI was 0.00 (range −0.28 to +0.29). These results are comparable to results of our internal quality control between POCT INR and laboratory INR in patients on VKA alone with a mean 95% CI of −0.02 (range −0.26 to +0.29). The mean INR was 1.8 by both methods in group 1 and 1.7 by both methods in group 2 and anti-Xa levels ranged from 0 to1.19 U/mL. A variation in the result of the POCT INR and laboratory INR of 0.5 or greater is thought to affect dosing decisions for Warfarin. Such a variation was observed in 3% (2/60) in group 1 and 2% (2/100) in group 2. Conclusion: There was good accuracy of the INR obtained with the POCT system used and this was not affected by the timing of the administration of LMWH in relation to testing. Disclosures: No relevant conflicts of interest to declare.


1980 ◽  
Vol 94 (1) ◽  
pp. 117-125 ◽  
Author(s):  
Zvi Dickerman ◽  
Ruth Prager-Lewin ◽  
Osnat Lahmy ◽  
Zvi Laron

Abstract. Clomiphene citrate was administered at a dose of 50 mg/day for 3 months to 29 boys with delayed puberty, 15 in a stage of early puberty (group 1) and 14 in stages of mid puberty (group 2). In both groups a significant acceleration in the advancement of pubertal signs was noted in the 6-month period following initiation of therapy as compared to a non-treated control group. A significant rise in the mean (± sd) basal plasma LH levels, from 1.0 ± 0.4 to 2.7 ± 2.2 mU/ml in group 1 (P < 0.05) and from 1.0 ± 0.6 to 2.2 ± 1.7 mU/ml in group 2 (P < 0.05) was observed following the treatment period with clomiphene. Concomitantly there was a rise of the mean basal plasma FSH level from 1.1 ± 0.4 to 2.0 ± 1.5 mU/ml in group 1 (P ± 0.05) and from 1.9 ± 1.6 to 3.4 ± 3.0 mU/ml in group 2 (P < 0.02). The mean LH peak response to an iv bolus of LRH (50 μg/m2 iv) rose from 8.3 ± 4.2 to 13.0 ± 5.3 mU/ml in group 1 (P < 0.05) and from 9.2 ± 5.8 to 12.6 ± 6.8 mU/ml in group 2 (NS). The mean peak plasma FSH response to LRH rose from 2.0 ± 0.6 to 5.9 ± 4.2 mU/ml in group 1 (P < 0.05) and from 4.3 ± 4.0 to 7.0 ± 6.8 mU/ml in group 2 (NS). Clomiphene therapy caused a rise of the basal plasma testosterone level from 68 ± 53 to 313 ± 270 ng/100 ml in group 1 (P < 0.01) and from 103 ± 67 to 392 ± 248 ng/100 ml in group 2 (P < 0.01). The plasma testosterone response to one hCG stimulation (5000 U im), tested in 4 boys immediately before and after the 3-month period of clomiphene administration revealed an increase in both the basal and the peak testosterone levels (P < 0.05 and P < 0.001, respectively). A standard clomiphene test consisting of the administration of 100–200 mg/day clomiphene citrate for 8 days was performed in 8 boys before initiation of clomiphene treatment for the 3-month period. In 4, including 2 boys in an early stage of puberty, there was a suppression of the basal level of gonadotrophins and their response to synthetic LRH. The other 4 boys, all of them in stages of mid-puberty, showed an increase in the basal and peak plasma gonadotrophin levels following LRH stimulation. In all 8 boys there was a significant rise of the basal plasma testosterone level. Despite the varying response to the short clomiphene test in these 8 boys, all gave a good response to the prolonged administration of clomiphene citrate. It was concluded that treatment with small doses of clomiphene citrate for a period of 3 months induces an acceleration of puberty in boys with delayed or slowlyprogressing puberty, once the stage of initiation of puberty has been passed.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG


Angiology ◽  
2021 ◽  
pp. 000331972199141
Author(s):  
Arafat Yildirim ◽  
Mehmet Kucukosmanoglu ◽  
Fethi Yavuz ◽  
Nermin Yildiz Koyunsever ◽  
Yusuf Cekici ◽  
...  

Many parameters included in the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke, vascular disease, age 65-74 years, sex category) scores also predict coronary artery disease (CAD). We modified the ATRIA score (ATRIA-HSV) by adding hyperlipidemia, smoking, and vascular disease and also male sex instead of female. We evaluated whether the CHA2DS2-VASc, CHA2DS2-VASc-HS, ATRIA, and ATRIA-HSV scores predict severe CAD. Consecutive patients with coronary angiography were prospectively included. A ≥50% stenosis in ≥1epicardial coronary artery (CA) was defined as severe CAD. Patient with normal CA (n = 210) were defined as group 1, with <50% CA stenosis (n = 178) as group 2, and with ≥50% stenosis (n = 297) as group 3. The mean ATRIA, ATRIA-HSV, CHA2DS2-VASc, and CHA2DS2VASc-HS scores increased from group 1 to group 3. A correlation was found between the Synergy between PCI with Taxus and Cardiac Surgery score and ATRIA ( r = 0.570), ATRIA-HSV ( r = 0.614), CHA2DS2-VASc ( r = 0.428), and CHA2DS2-VASc-HS ( r = 0.500) scores ( Ps < .005). Pairwise comparisons of receiver operating characteristics curves showed that ATRIA-HSV (>3 area under curve [AUC]: 0.874) and ATRIA (>3, AUC: 0.854) have a better performance than CHA2DS2-VASc (>1, AUC: 0.746) and CHA2DS2-VASc-HS (>2, AUC: 0.769). In conclusion, the ATRIA and ATRIA-HSV scores are simple and may be useful to predict severe CAD.


2020 ◽  
pp. 105566562098023
Author(s):  
Ashwina S. Banari ◽  
Sanjeev Datana ◽  
Shiv Shankar Agarwal ◽  
Sujit Kumar Bhandari

Objectives: To compare nasal and upper airway dimensions in patients with cleft lip and palate (CLP) who underwent nasoalveolar molding (NAM) with those without NAM during infancy using acoustic pharyngometry and rhinometry. Materials and Methods: Eccovision acoustic pharyngometry and rhinometry (Sleep Group Solutions) was used for assessment of mean area and volume of nasal and upper airway in patients with complete unilateral CLP (age range 16-21 years) treated with NAM (group 1, n = 19) versus without NAM (group 2, n = 22). Results: The mean nasal cross-sectional areas and volume were higher in group 1 compared to group 2 on both cleft ( P value <.001) and noncleft side ( P value >.05). The mean area and volume of upper airway were also significantly higher in group 1 compared to group 2 ( P value <.05). Conclusions: Nasoalveolar molding being one of the first interventions in chronology of treatment of patients with CLP, its long-term outcome on nasal and upper airway patency needs to be ascertained. The results of the present study show that the patients with CLP who have undergone NAM during infancy have better improvement in nasal and upper airway patency compared with those who had not undergone NAM procedure. The basic advantages of being noninvasive, nonionizing and providing dynamic assessment of nasal and upper airway patency make acoustic pharyngometry and rhinometry a diagnostic tool of choice to be used in patients with CLP.


2019 ◽  
Vol 1 (1) ◽  
pp. 7-10
Author(s):  
Gaurav Singh ◽  
Madan Mishra ◽  
Amit Gaur ◽  
Dhritiman Pathak

Background: Fractures of the mandible can be studied and described in anatomic terms, functional considerations, treatment strategies, and outcome measures. The performance of any fixation system depends on multiple factors including plate adaptation, screw placement, bone quality, drilling conditions, and postoperative patient compliance. Bite force assesses masticatory muscle function under clinical and experimental conditions. Method: 30 patients with isolated, noncomminuted mandibular fractures were randomly divided into two equal groups. Group 1 patients were treated using 3-dimensional locking miniplates and group 2 patients were treated with standard miniplates. The bite forces were recorded at definite time intervals: preoperatively, and second week, sixth week, third month, and sixth month postoperatively. Result: At 6 weeks postoperative, 3 month postoperative, and 6 month postoperative, the mean bite force was found to be significantly higher among group 1 patients as compared to those in group 2 in all the sites. While at 2 week postoperative, the mean bite force was found to be significantly higher in Group 2 as compared to Group 1 at incisor region. Conclusion: The overall results of the present study show better performance in bite force for the 3-dimensional locking miniplate when compared with standard miniplates.


2000 ◽  
Vol 93 (3) ◽  
pp. 662-669 ◽  
Author(s):  
Tomiei Kazama ◽  
Ken Takeuchi ◽  
Kazuyuki Ikeda ◽  
Takehiko Ikeda ◽  
Mutsuhito Kikura ◽  
...  

Background Suitable propofol plasma concentrations during gastroscopy have not been determined for suppressing somatic and hemodynamic responses in different age groups. Methods Propofol sedation at target plasma concentrations from 0.5 to 4.0 microgram/ml were performed randomly in three groups of patients (23 per group) who were undergoing elective outpatient gastroscopy: ages 17-49 yr (group 1), 50-69 yr (group 2), and 70-89 yr (group 3). Plasma propofol concentration in which 50% of patients do not respond to these different stimuli were determined by logistic regression: verbal command (Cp50ls), somatic response to gastroscopy (Cp50endo), and gag response to gastroscopy (Cp50gag). Hemodynamic responses were also investigated in the different age groups. Results Cp50ls concentrations were 2.23 microgram/ml (group 1), 1.75 microgram/ml (group 2), and 1.40 microgram/ml (group 3). The Cp50endo values in groups 1 and 2 were 2.87 and 2.34 microgram/ml, respectively, which were significantly higher than their respective Cp50ls values. Cp50endo value in group 3 was 1.64 microgram/ml, which was close to its Cp50ls value. Because of a high degree of interpatient variability, Cp50gag could not be defined. Systolic blood pressure response decreased with increasing propofol concentrations. Conclusions The authors determined the propofol concentration necessary for gastroscopy and showed that increasing age reduces it. Propofol concentration that suppresses somatic response induces loss of consciousness in almost all young patients.


2021 ◽  
Vol 9 (4) ◽  
pp. 232596712110024
Author(s):  
Koray Şahin ◽  
Fatih Şentürk ◽  
Mehmet Ersin ◽  
Ufuk Arzu ◽  
Mechmet Chodza ◽  
...  

Background: Knot-tying suture-bridge (SB) rotator cuff repair may compromise the vascularity of the repaired tendon, causing tendon strangulation and medial repair failure. The knotless SB repair technique has been proposed to overcome this possibility and decrease retear rates. Purpose: To compare clinical and structural outcomes and retear patterns between the knot-tying and knotless SB techniques. We hypothesized that the knotless technique would result in lower retear rates owing to the preservation of intratendinous vascularity. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 104 patients with full-thickness rotator cuff tears were randomly and prospectively allocated to undergo knot-tying (group 1) or knotless (group 2) SB repair. Clinical outcome measures included range of motion, the visual analog scale (VAS) for pain, and the Constant score for function. Repair integrity was evaluated on magnetic resonance imaging scans using the Sugaya classification. Retears were also classified according to their pattern as type 1 (lateral) or type 2 (medial). Results: Overall, 88 patients (group 1: n = 42 [mean ± SD age, 54.3 ± 9.8 years]; group 2: n = 46 [mean ± SD age, 55.8 ± 8.2 years]) were included in the final analysis. The mean ± SD follow-up period was 25.4 ± 8.3 and 23.3 ± 7.2 months for groups 1 and 2, respectively. From preoperatively to postoperatively, the mean VAS pain score improved significantly in both groups (group 1: from 7.4 ± 1.7 to 1.0 ± 1.7; group 2: from 7.1 ± 1.9 to 1.3 ± 2.0; P < .0001 for both), as did the mean ± SD Constant score (group 1: from 51.7 ± 13.4 to 86.0 ± 11.5; group 2: from 49.4 ± 18.4 to 87.2 ± 14.8; P < .0001 for both). There was no significant difference between the groups for the postoperative VAS or Constant score. The retear rate was not significantly different between the groups (19.0% [8/42] in group 1 and 28.3% [13/46] in group 2; P > .05). There was a significant difference in the type 2 failure rate (75.0% [6/8] in group 1 and 23.1% [3/13] in group 2; P = .03). Conclusion: Both techniques showed excellent improvement and comparable clinical outcomes, and there was no significant difference in retear rates. Consistent with previously published data, the type 2 failure rate was significantly higher with the knot-tying technique. Registration: NCT03982108 ( ClinicalTrials.gov identifier).


Author(s):  
Nilgün Gültiken ◽  
Murat Yarim ◽  
Gül Fatma Yarim ◽  
Mahmut Sözmen ◽  
Elvan Anadol ◽  
...  

AbstractThe objective of this study was to investigate the plasma concentrations of insulin-like growth factor-2 (IGF-2) as well as its expression in the uterus and ovary of healthy dogs and those with cystic endometrial hyperplasia (CEH)–pyometra complex. Group 1 (n = 10) included bitches with open cervix pyometra, while Group 2 (n = 7) consisted of clinically healthy bitches in dioestrus. The number of IGF-2 immunopositive interstitial cells was significantly higher in Group 1, whereas in Group 2 there were only two cases in which a few cells were IGF-2 immunopositive. IGF-2 immunopositivity was observed in the endometrial glandular epithelium in both groups. Additionally, interstitial fibroblasts and macrophages in the endometrium were also positive in Group 1. The concentration of plasma IGF-2 was higher in Group 1 than in Group 2 (P < 0.05). The concentration was positively correlated with IGF-2 expression in the endometrial glands (r = 0.926; P < 0.001) in Group 1. However, a negative correlation was present between plasma IGF-2 concentration and IGF-2 expression in the interstitial endocrine cells of the ovary in Group 1 (r = −0.652; P < 0.05). The results suggest that IGF-2 plays an important role during the inflammatory process occurring in bitches with CEH–pyometra complex as well as in the endometrium of healthy bitches in dioestrus.


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