P555 Outcomes of multiswitching from original infliximab to biosimilars in patients with inflammatory bowel disease

Abstract Background Since 2013 multiple Infliximab (IFX) biosimilars became available in the market. While there is evidence that switching from original IFX (RemicadeÒ) to an approved biosimilar product is safe and effective, little is known about outcomes of reverse switching and multiple switching among biosimilars in IBD patients. As the access to biosimilars at competitive prices increases, it is necessary to evaluate multiple switches to provide data on their interchangeability. Our aim was to evaluate the efficacy, safety and pharmacokinetic profile in a cohort of IBD patients who experienced multiple switches. Methods This is a cohort retrospective observational study, enrolling patients with IBD who were successively switched from original IFX to one or more biosimilars (multiswitching). We compared clinical disease activity, assessed using the Harvey-Bradshaw index (HBI) and partial Mayo Score (pMS), biochemical markers (hemoglobin, C-reactive protein (CRP) and albumin), IFX trough levels (ITL) and anti-IFX antibodies (ADA) immediately before and after multiswitching. Adverse and infusion-related events leading to drug discontinuation were registered. Results We included 26 patients (59% male, mean age 35±12 years), 85% (n=22) with Crohn’s Disease (CD) and 15% (n=4) with ulcerative colitis (UC) or indeterminate colitis. The mean disease duration from diagnosis was 9±6 years. According to Montreal classification, most patients were A2 (68%), had ileocolonic disease (L1 51%; L2 9%; L3 50%) and an inflammatory phenotype (B1 41%; B2 23% and B3 36%). Perianal disease was present in 44%. Half of patients had pancolitis (E3). About 51% of the patients had a prior resection surgery and 27% was on combination therapy when the first switch occurred. In 35% (n=9) of the patients three switches were observed. The mean follow-up from the first switch was 15±18 months. There was no significant difference in the proportion of patients in clinical remission (HBI < 5; Mayo score < 3) (91% vs 96%, p=NS). We found no differences in laboratory markers such as CRP (0,79 vs 0,67 mg/dl, p=NS), hemoglobin (13,83 vs 13,75g/dl, p=NS) and albumin (3,98 vs 4,37mg/dl, p=NS) before and after the multiswitching. No significant difference was observed in mean ITL (4,9 vs 4,05 μg/mL, p=NS) or in the proportion of patients with ITL>3ug/ml (p=0.205). None of patients developed ADA, infusion-related events or loss of response leading to drug discontinuation. During our follow-up none of patients was operated. Drug persistence was 100%. Conclusion In our cohort, no significant changes in efficacy, safety or immunogenicity were observed when IBD patients experienced multiple switches between the original IFX and its biosimilars.

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Functional outcome of platelet rich plasma on lateral epicondylitis of elbow

International Journal of Research in Orthopaedics ◽

10.18203/issn.2455-4510.intjresorthop20171577 ◽

2017 ◽

Vol 3 (3) ◽

pp. 408

Author(s):

Narayanan V. L. ◽

Preetha P. ◽

Maria Joshna J. ◽

Mishal Dhivya P. J. ◽

Anbu Selvan

Keyword(s):

Plasma Treatment ◽

Conservative Management ◽

Platelet Rich Plasma ◽

Lateral Epicondylitis ◽

Mayo Score ◽

Plasma Injection ◽

Before And After ◽

Elbow Function ◽

The Mean

Background: The study was conducted with the aim to explore the efficacy of platelet rich plasma in sixty patients who presented to us with lateral epicondylitis of elbow where conservative management has failed.Methods: Between 2013 and 2015, 60 patients (M: F- 20: 40) with lateral epicondylitis of elbow were included. All patients presented to us with lateral epicondylitis of elbow where conservative management has failed. All patients are treated with platelet rich plasma injection. Serial follow-up were done at 1, 6 and 12 month.Results: All sixty patients had significant improvement before and after platelet rich plasma injection. The mean VAS score and the Mayo score suggests significant improvement in pain and elbow function following platelet rich plasma treatment. Conclusions: Platelet rich plasma improves pain and elbow function in patients suffering from lateral epicondylitis where conservative management has failed. Platelet rich plasma treatment may decrease the overall time for healing, and thereby decreasing the overall need for surgical intervention.

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CENTRAL MACULAR THICKNESS AFTER CATARACT SURGERY IN NON-DIABETICS AND DIABETICS WITHOUT RETINOPATHY

Pakistan Armed Forces Medical Journal ◽

10.51253/pafmj.v6i6.6840 ◽

2021 ◽

Vol 71 (6) ◽

pp. 1993-96

Author(s):

Marrium Shafi ◽

Muhammad Akmal Khan ◽

Yaseen Lodhi ◽

Asma Aftab ◽

Muhammad Haroon Sarfraz

Keyword(s):

Cataract Surgery ◽

Thickness Measurement ◽

Case Control ◽

Macular Thickness ◽

P Value ◽

Central Macular Thickness ◽

Significant Difference ◽

Before And After ◽

The Mean

Objective: To determine the mean change in central macular thickness after cataract surgery and to compare the mean change in central macular thickness after cataract surgery in non-diabetics and diabetics without diabetic retinopathy Study design: Case control Study settings and duration: A case control study was carried out at Ophthalmology department, POF hospital, Wah Cantt. Study duration was 6 months (April 2019-September 2019) Material and methods: A sample size of 60 patients was calculated by using Open Epi Software. We used non probability consecutive sampling. Patients were divided into two groups; Cases (Diabetic) and controls (non-Diabetic). All patients underwent phacoemulsification and observed after 4 weeks for macular thickness measurement using optical coherence tomography before and after surgery. Data analysis was done with SPSS version 20. Post stratification t test was applied. P value ≤0.05 was considered significant. Results: Total 60 patients were included. Mean age of patients was 65.31 ±7. 63SD.There were 35 (58.3%) males and 25 (41.7%) female patients in the study. We found a significant increase in central macular thickness in cases and controls [(223.100±15.86SD vs 227.2667±17.9SD, p=0.000) and (221.200±12.16SD vs 226.289±16.7861SD, p =0.001)] before and after phacoemulsification in cases and controls respectively. However, no significant difference was found between the groups (p=0.486). Conclusion: Central macular thickness was increased after uncomplicated phacoemulsification in both diabetics and non-diabetics without retinopathy for up to a follow-up period of 4 weeks but the thickness did not differ between the two groups.

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Effect of Syndesmotic Implant Removal on Dorsiflexion

Foot & Ankle International ◽

10.1177/1071100718818572 ◽

2019 ◽

Vol 40 (5) ◽

pp. 499-505 ◽

Cited By ~ 6

Author(s):

Jorge Briceno ◽

Timilien Wusu ◽

Philip Kaiser ◽

Patrick Cronin ◽

Alyssa Leblanc ◽

...

Keyword(s):

Final Analysis ◽

Ankle Dorsiflexion ◽

Implant Removal ◽

Inclusion Criteria ◽

Level Of Evidence ◽

Level Ii ◽

Significant Difference ◽

Before And After ◽

The Mean

Background: There is limited evidence that syndesmotic implant removal (SIR) is beneficial. However, many surgeons advocate removal based on studies suggesting improved motion. Methodologic difficulties make the validity and applicability of previous works questionable. The purpose of this study was to examine the effect of ankle dorsiflexion after SIR using radiographically measured motion before and after screw removal utilizing a standardized load. Methods: All patients undergoing isolated SIR were candidates for inclusion. Dorsiflexion was measured radiographically: (1) immediately before implant removal intraoperatively, (2) immediately after removal intraoperatively, and (3) 3 months after removal. A standardized torque force was applied to the ankle and a perfect lateral radiograph of the ankle was obtained. Four reviewers independently measured dorsiflexion on randomized, deidentified images. A total of 29 patients met inclusion criteria. All syndesmotic injuries were associated with rotational ankle fractures. There were 11 men (38%) and 18 women (62%). The mean, and standard deviation, age was 50.3 ± 16.9 years (range 19-80). Results: The mean ankle dorsiflexion pre-operatively, post-operatively, and at a 3-month follow-up was 13.7 ± 6.6 degrees, 13.3 ± 7.3 degrees and 11.8 ± 11.3 degrees, respectively ( P = .466). For subsequent analysis, 5 patients were excluded because of the potential confounding effect of retained suture button devices. Analysis of the remaining 24 patients (and final analysis of 21 patients who had complete 3-month follow-up) demonstrated similar results with no statistically significant difference in ankle dorsiflexion at all 3 time points. Conclusion: Removal of syndesmotic screws may not improve ankle dorsiflexion motion and should not be used as the sole indication for screw removal. Level of Evidence: Level II, prospective cohort study.

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Pyrocardan Scaphotrapeziotrapezoid Joint Arthroplasty for Isolated Osteoarthritis: Results after a Mean Follow-Up of 5 Years

Journal of Wrist Surgery ◽

10.1055/s-0041-1733877 ◽

2021 ◽

Author(s):

Martin Cholley-Roulleau ◽

Yves Bouju ◽

Flore-Anne Lecoq ◽

Alexandre Fournier ◽

Philippe Bellemère

Keyword(s):

Case Series ◽

Preoperative Assessment ◽

Contralateral Side ◽

High Rate ◽

Significant Difference ◽

Flexion Extension ◽

Functional Scores ◽

Before And After ◽

The Mean

Abstract Background Isolated scaphotrapeziotrapezoid (STT) osteoarthritis (OA) mainly develops in women over 50 years of age in a bilateral manner. Many surgical treatments are available, including distal scaphoid resection with or without interposition, trapeziectomy, and STT arthrodesis. However, there is a controversy about which procedure is the most effective. Purposes The purpose of this study was to report the outcomes of the Pyrocardan implant for treating STT isolated OA at a mean follow-up of 5 years. Patients and Methods Consecutive patients who underwent STT arthroplasty using the Pyrocardan were reviewed retrospectively by an independent examiner who performed a clinical and radiological evaluation. Results The mean follow-up time was 5 years (range 3–8 years). Thirteen patients (76%) were followed for more than 5 years. Between the preoperative assessment and the last follow-up, pain levels decreased significantly. There was no significant difference in the mean Kapandji opposition score. Grip and pinch strengths were 88 and 91% of the contralateral side. The active range of motion in flexion–extension and radioulnar deviation was not significantly different to the contralateral side (119° vs. 121° and 58° vs. 52°, p > 0.1). Functional scores were improved significantly. No identifiable differences were found in the radioscaphoid, capitolunate, and scapholunate angles before and after surgery. In three cases, the preoperative dorsal intercalated scapholunate instability (DISI) failed to be corrected. In one case, DISI appeared after the procedure. There was one asymptomatic dislocation of the implant. Calcification around the trapezium and/or distal scaphoid was found in four cases. The survival rate of the implant without reoperation was 95%. Conclusions In the medium term, Pyrocardan implant is an effective treatment for STT OA as it reduces pain, increases grip strength, and maintains wrist mobility. This is consistent with the results of other published case series using pyrocarbon implants. It provides a high rate of patient satisfaction. Nevertheless, the surgical procedure must be done carefully to avoid STT ligament damage, periarticular calcifications, or dislocation.

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Safety of Radiotherapy in Patients with Cardiac Implantable Electronic Devices

10.21203/rs.3.rs-200190/v1 ◽

2021 ◽

Author(s):

Donghoon Han ◽

Ji Hyun Lee ◽

Youngjin Cho ◽

Il-Young Oh

Keyword(s):

Cumulative Dose ◽

Medical Records ◽

Beam Energy ◽

Electronic Devices ◽

Cardiac Implantable Electronic Devices ◽

Significant Difference ◽

Before And After ◽

The Mean ◽

The Relationship

Abstract Background: Patients with cardiac implantable electronic devices (CIEDs) usually have multiple comorbidities, and some require radiotherapy (RTx) for cancer treatment. However, the effect of RTx in patients with CIEDs is unclear. We aimed to examine the effectiveness of RTx in patients with CIEDs, and share our real-world clinical experience in this population.Methods: We recruited patients with a pacemaker or implantable cardioverter-defibrillator who underwent RTx between April 2009 and August 2019. RTx and CIED interrogation data were collected from electronic medical records. Patients who received an RTx cardiology consultation and CIED interrogation before and after RTx were assigned to the proper consultation (PC) group. All others were enrolled in the no-consultation (NC) group. Results: Out of 23 patients, 3 (13.0%) and 20 (87.0%) patients were assigned to the PC and NC groups, respectively. The most common RTx sites were the abdomen and pelvis (34.8%). The mean cumulative dose was 50.1 ± 11.7 Gy, and the mean beam energy was 10.3 ± 4.01 mV. The PC and NC groups showed no significant difference in cumulative dose (51.5 ± 12.1 vs. 45.3 ± 3.9, p=0.19) or beam energy (10.4 ± 4.03 vs. 7.0 ± 1.41, p=0.08). There was no significant between-group difference in any pre-RTx CIED parameter. Two patients died during the study period; both were in the NC group. The relationship between death and device malfunction was not clear in either case.Conclusions: Patients with CIEDs frequently do not receive a cardiology consultation before RTx. Although radiotherapy-related CIED complications occur stochastically and are difficult to predict, cooperation between the cardiology and radiation therapy departments, and regular device follow-up are necessary for the safety of these patients.

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Role of daily anal stimulation for intractable functional constipation in infants

World Journal of Pediatric Surgery ◽

10.1136/wjps-2020-000135 ◽

2020 ◽

Vol 3 (2) ◽

pp. e000135

Author(s):

Tianqi Zhu ◽

Xiaoyi Sun ◽

Dan Zhu ◽

Qian You ◽

Xiaoting Wan ◽

...

Keyword(s):

Anorectal Manometry ◽

Intervention Program ◽

Functional Constipation ◽

Mean Amplitude ◽

Significant Difference ◽

Before And After ◽

Stool Form ◽

The Mean

ObjectiveFunctional constipation is one of the most common problems in pediatric gastroenterology. The aim of the present study was to evaluate the effectiveness of daily anal stimulation in infants with intractable functional constipation (IFC). Our evaluation was based on clinical improvement and on changes in manometric parameters through time.MethodsInfants with IFC treated between January 2018 and December 2019 were included in this retrospective study. Treatment processing included daily anal stimulation for infants and psychological counseling for parents. All cases underwent a complete intervention program and were evaluated for improvement in symptoms and for changes in anorectal manometry within 1 year of follow-up.ResultsA total of 161 patients were included in this study. Positive response was achieved in all patients. Frequency of defecation, change in stool form and decrease in the defecatory pain were significantly relieved in all infants after intervention. On anorectal manometry, no significant difference was found in the peristaltic frequency of distal rectum before and after treatment. There was a significant increase in the mean amplitude of peristalsis and improvement in the rhythm after intervention. In the 1 year of follow-up, three patients had recurrence of constipation requiring colectomy.ConclusionIn terms of the high clinical efficacy and limited side effects, daily anal stimulation may be included in the initial part of an intervention program for IFC in infants.

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Psychological Complications in Women Undergoing Voluntary Sterilization by Salpingectomy

The British Journal of Psychiatry ◽

10.1192/bjp.127.1.67 ◽

1975 ◽

Vol 127 (1) ◽

pp. 67-70 ◽

Cited By ~ 11

Author(s):

Anand Bhushan Khorana ◽

Anirudh A. Vyas

Keyword(s):

Sexual Functioning ◽

Psychiatric Symptoms ◽

Emotional Adjustment ◽

Structured Interviews ◽

Significant Difference ◽

Before And After ◽

The Mean ◽

Psychological Origin ◽

Behaviour Changes

SummaryFive-hundred women electing salpingectomy for contraception and their husbands were studied by means of structured interviews and questionnaires over periods of three months to two years, beginning before surgery. The post-operative follow-up was completed for 374 couples. The subject's condition was compared before and after operation for emergence of any symptoms, and whether there was any significant difference in frequency of intercourse or other sexual behaviour, changes in sexual functioning, emotional adjustment and marital satisfaction. There was evidence of adverse psychological and sexual changes but these were apparently of a mild nature. Eighty-three per cent of the subjects complained of various symptoms, presumably of psychological origin; in 65 per cent sexual desire had declined, and 29 per cent had not resumed intercourse. The mean score of psychiatric symptoms based on clinical ratings rose from 0.38 before to 4.35 after operation, which is statistically highly significant. Paradoxically satisfaction with the operation was expressed by 92 per cent of the subjects.

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Melatih Kepemimpinan Perangkat Desa Kebonharjo Kulonprogo: Membangun Sikap Anti Korupsi

Proceeding of Community Development ◽

10.30874/comdev.2017.16 ◽

2018 ◽

Vol 1 ◽

pp. 107

Author(s):

Adi Heryadi ◽

Evianawati Evianawati

Keyword(s):

Transformational Leadership ◽

Data Collection ◽

Paired Samples ◽

Significant Difference ◽

Before And After ◽

Post Test ◽

Sample Test ◽

Corruption Perception ◽

Measuring Tool

This study aims to prove whether transformational leadership training is effective for building anti-corruption attitudes of villages in Kebonharjo village, subdistrict Samigaluh Kulonprogo. This research is an experimental research with one group pre and posttest design.Subject design is 17 people from village of 21 candidates registered. Measuring tool used in this research is the scale of anti-corruption perception made by the researcher referring to the 9 anti-corruption values with the value of reliability coefficient of 0.871. The module used as an intervention made by the researcher refers to the transformational leadership dimension (Bass, 1990). The data collected is analyzed by statistical analysis of different test Paired Sample Test. Initial data collection results obtained sign value of 0.770 which means> 0.05 or no significant difference between anti-corruption perception score between before and after training. After a period of less than 1 (one) month then conducted again the measurement of follow-up of the study subjects in the measurement again using the scale of anti-corruption perception. The results of the second data collection were analysed with Paired Samples Test and obtained the value of 0.623 sign meaning p> 0.05 or no significant difference between post test data with follow-up data so that the hypothesis of this study was rejected.

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SUBLINGUAL VITAMIN D3 DRUG THERAPY IN VITAMIN D DEFICIENCY PATIENTS AT PRAVARA RURAL HOSPITAL

International Journal of Clinical and Biomedical Research ◽

10.31878/ijcbr.2019.54.05 ◽

2019 ◽

pp. 18-20

Author(s):

Sanjeeva Kumar Goud T ◽

Rahul Kunkulol

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Vitamin D3 ◽

Serum Vitamin ◽

Cross Sectional ◽

Serum Vitamin D ◽

Significant Difference ◽

Before And After

The present study was aimed to study the effect of Sublingual Vitamin D3 on Serum Vitamin D level in Vitamin D deficiency patients. This was a cross-sectional and interventional study. All the Vitamin D deficiency patients of age 18-60years and either gender, willing to participate in the study were included. Patients who had greater than 20 ng/ml were excluded from the study. The total number of participants in our study was 200, out of these 111 males and 89 females, the mean age in our study was 51.07 ± 7.39Yrs. All volunteers were given sublingual vitamin D3 (60,000IU) in six doses every fifteen days of follow up for 3 months. The subject’s serum 25(OH)D levels were estimated before and after the treatment of sublingual vitamin D3. There was a statistically significant difference in serum vitamin D3 level before 16.61±6.71 ng/ml and after 35.80±7.80 ng/ml after treatment with Sublingual Vitamin D3. Six doses of 60,000IU of Vitamin D3 sublingual route having improved the role of serum 25(OH)D levels in the treatment of Vitamin D3 deficiency patients.Keywords: Vitamin D3; Sublingual route

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Unilateral lateral rectus recession is an effective surgery for intermittent exotropia in young children

BMC Ophthalmology ◽

10.1186/s12886-020-01778-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Oriel Spierer ◽

Abraham Spierer

Keyword(s):

Young Children ◽

Success Rate ◽

Lateral Rectus ◽

Intermittent Exotropia ◽

Age At Surgery ◽

Surgical Methods ◽

Before And After ◽

The Mean ◽

Consecutive Esotropia

Abstract Background Different surgical methods have been suggested for the correction of intermittent exotropia. Unilateral lateral rectus recession has been described as a surgical alternative for small and moderate-angle exotropia. In general, previous studies did not focus on the outcomes of unilateral lateral rectus recession in young children with intermittent exotropia. The purpose of this study is to evaluate the surgical outcomes of unilateral lateral rectus recession in the treatment of moderate-angle exotropia (≤ 25 PD (prism diopters)) in children. Methods The charts of all patients younger than 12 years of age with moderate-angle exotropia (up to 25 PD) who were operated during the years 2006–2018 were retrospectively reviewed. Fifty-eight patients underwent unilateral lateral rectus recession and had a minimum follow up of 6 months. The angle of exotropia (PD) before and after surgery and the success rate were documented. Results Mean age at surgery was 6.4 ± 1.9 (range 3.5–11.0) years. Exotropia improved from a preoperative angle of 21.4 ± 4.0 PD to 3.5 ± 5.9 PD postoperatively (p < 0.001). Success rate, defined as deviation of ≤ 10 PD, was achieved in 86.2%. There were 2 (3.4%) cases of overcorrection (consecutive esotropia). There were no intra- or postoperative complications. The mean follow-up duration after surgery was 2.3 ± 1.7 years. Conclusions In children with moderate angle exotropia, good postoperative success rate was achieved by performing unilateral lateral rectus recession.

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