Soft Coagulation Using Hemostatic Forceps for Prevention of Postendoscopic Papillectomy Hemorrhage

Aim: Few reports of the prophylactic use of soft coagulation with hemostatic forceps for postendoscopic papillectomy hemorrhage (PEPH) have been presented. The aim of this study was to clarify the utility of that procedure for prophylaxis. Materials and Methods: From April 2009 to March 2012, PEPH was treated in four patients after the development of the condition with a conventional procedure at our institution. Thereafter, from April 2012 to March 2016, soft coagulation using hemostatic forceps was performed as prophylactic hemostasis following an EP in five patients. For the latter procedure, the hemostatic forceps device (FD411‑QR, Olympus, Tokyo, Japan) was used in a closed position, with the coagulation wave set at 60 W (VIO 300D; ERBE, Tubingen, Germany). The primary outcome was the onset of PEPH, which was defined as a decrease in hemoglobin ≥2 g/dL after EP. Secondary endpoints were the success rate and the incidence of adverse events of soft coagulation using hemostatic forceps for emergency bleeding cases after EP. Results: The incidence of PEPH was 20% (1 of 5 cases) in the prophylactic procedure group, which was lower than that in the conventional procedures group (75%, 3 of 4 cases), though the difference was not statistically significant (P = 0.206, Fisher’s exact test). All cases of PEPH were successfully treated by soft coagulation using hemostatic forceps. Conclusion: Soft coagulation with hemostatic forceps may be suitable for use as a routine technique following EP to prevent PEPH.

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Efficacy of Omalizumab in Mastocytosis: Allusive Indication Obtained from a Prospective, Double-Blind, Multicenter Study (XOLMA Study)

Dermatology ◽

10.1159/000504842 ◽

2020 ◽

Vol 236 (6) ◽

pp. 529-539

Author(s):

Meike Distler ◽

Julia-Tatjana Maul ◽

Urs C. Steiner ◽

Peter Jandus ◽

Antonios G.A. Kolios ◽

...

Keyword(s):

Adverse Events ◽

Positive Impact ◽

Systemic Mastocytosis ◽

Group Versus ◽

Receptor Expression ◽

Double Blind ◽

Gastrointestinal Problems ◽

Significant Difference ◽

Secondary Endpoints ◽

The Difference

Background: Patients with mastocytosis often suffer from a variety of symptoms caused by mast cell mediators where treatments remain difficult, showing various success rates. Omalizumab, a monoclonal anti-IgE antibody, has been postulated to have a positive impact on mastocytosis-associated symptoms such as flush, vertigo, gastrointestinal problems, or anaphylaxis. Objective: To investigate the efficacy and safety of omalizumab in systemic mastocytosis. Methods: Patients with histologically proven mastocytosis were investigated in a multicenter prospective double-blind placebo-controlled trial to receive either omalizumab or placebo, dosed according to IgE and body weight. The primary endpoint was change in the AFIRMM activity score after 6 months of treatment. Different laboratory parameters were analyzed. Results: Sixteen patients were analyzed: 7 to omalizumab and 9 to placebo (mean age 47.7 ± 13.8 vs. 45.4 ± 8.8 years; 66.6 vs. 85.7% were female; mean disease duration 10.0 ± 5.1 vs. 4.5 ± 2.9 years, respectively). After 6 months the median AFIRMM score decreased 50% from 52.0 to 26.0 in the omalizumab group versus 104.0–102.0 in the placebo group (p = 0.286); however, the difference was not significant (p = 0.941). Secondary endpoints, including the number of allergic reactions, changes in major complaints, wheal-and-flare reaction due to mechanical irritation (Darier’s sign), and frequency of the use of mastocytosis-specific drugs improved in the omalizumab group, but not significantly. Adverse events like urticaria, bronchospasm, and anaphylactic shock showed no significant difference between the groups. No severe adverse events occurred. FcεRI (Fc-epsilon receptor) expression on basophils decreased after receiving omalizumab versus placebo. Conclusion: Omalizumab was safe and showed a tendency to improve mastocytosis-related symptoms, in particular diarrhea, dizziness, flush, and anaphylactic reactions, including the AFIRMM score and secondary endpoints; however, the difference was not significant. Due to the small study size and difference at baseline between the study groups, further studies are required to confirm our findings.

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Switching to an Infliximab Biosimilar Was Safe and Effective in Dutch Sarcoidosis Patients

Cells ◽

10.3390/cells10020441 ◽

2021 ◽

Vol 10 (2) ◽

pp. 441

Author(s):

Bas J. M. Peters ◽

Anish Bhatoe ◽

Adriane D. M. Vorselaars ◽

Marcel Veltkamp

Keyword(s):

Adverse Event ◽

Cohort Study ◽

Adverse Events ◽

Inflammatory Response ◽

Retrospective Cohort Study ◽

Retrospective Cohort ◽

Primary Outcome ◽

Single Center ◽

Secondary Endpoints ◽

Trough Levels

The effect of switching from originator infliximab to biosimilar infliximab in patients with sarcoidosis is unknown. The objective of this study is to investigate the effect of switching from Remicade® or Inflectra® to Flixabi® in patients with severe refractory sarcoidosis. This single center retrospective cohort study was performed at St Antonius Hospital Nieuwegein, The Netherlands. All patients diagnosed with severe refractory sarcoidosis receiving Remicade® or Inflectra® switched to Flixabi®. The primary outcome was infliximab discontinuation within 6 months of switching. Secondary endpoints included adverse events and loss of clinical, functional, or inflammatory response. Out of 86 patients who switched to Flixabi®, 79 patients had complete data. None of the 79 patients discontinued infliximab during the first 6 months after switching. Five patients reported an adverse event related to Flixabi® treatment. We found no change from baseline in FVC, FEV1, DLCOc, 6MWT, and infliximab trough levels 26 weeks after switching. An improvement in physical functioning of 7.3 ± 13.4 points (p = 0.002) with RAND/SF36 and in biomarker sIL-2R (−475.58 ± 1452.39; p = 0.005) was observed. Switching from originator infliximab Remicade® or biosimilar infliximab Inflectra® to biosimilar infliximab Flixabi® did not result in treatment discontinuation or loss of clinical/functional/inflammatory remission.

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A randomized, double-blind, phase III study comparing SB3 (trastuzumab biosimilar) with originator trastuzumab in patients treated by neoadjuvant therapy for HER2-positive early breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.509 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 509-509 ◽

Cited By ~ 6

Author(s):

Xavier B. Pivot ◽

Igor Bondarenko ◽

Mikhail Dvorkin ◽

Ekaterina Trishkina ◽

Jin-Hee Ahn ◽

...

Keyword(s):

Breast Cancer ◽

Adverse Events ◽

Pathologic Complete Response ◽

Complete Response ◽

Phase Iii ◽

Her2 Positive ◽

Double Blind ◽

Secondary Endpoints ◽

The Difference ◽

Equivalence Margin

509 Background: SB3, a proposed biosimilar to the originator trastuzumab (TRZ), demonstrated similarity to its originator in terms of biological activities and pharmacokinetic (PK) equivalence. This study compared SB3 to TRZ in terms of efficacy, safety, PK, and immunogenicity in patients treated by neoadjuvant therapy for HER2 positive early breast cancer (NCT02149524). Methods: Phase III, randomized, double blind, multicenter study compared neoadjuvant SB3 or TRZ for 8 cycles concurrently given with chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide). Then patients underwent surgery followed by 10 cycles of SB3 or TRZ. The primary endpoint was breast pathologic complete response (bpCR) rate. Equivalence was declared if the 90% confidence interval (CI) of the ratio or the 95% CI of the difference of the bpCR rates in the per-protocol set (PPS) were contained within the pre-defined equivalence margins (0.785, 1.546) and (-13%, 13%), respectively. Secondary endpoints were total pathologic complete response (tpCR), overall response rate (ORR), event-free survival, PK, immunogenicity, and safety. Results: 800 patients were included in PPS. The bpCR rates were 51.7% for SB3 and 42.0% for TRZ. The ratio of bpCR rate was 1.259 and its 90% CI was 1.112-1.426, within the pre-defined equivalence margin. The difference of bpCR rate was 10.70% and its 95% CI was 4.13-17.26; the lower margin was contained within, the upper margin was outside the pre-defined equivalence margin. Secondary endpoints were comparable between SB3 vs TRZ: tpCR rate (45.8% vs 35.8%); ORR (96.3% vs 91.2%). Safety was comparable between SB3 vs TRZ during neoadjuvant period: incidence of treatment-emergent adverse events (96.6% vs 95.2%), most commonly neutropenia, alopecia, and nausea; incidence of serious adverse events (10.5% vs 10.7%). PK equivalence was demonstrated and immunogenicity between SB3 vs TRZ was comparable (0.7% vs 0.0%). Conclusions: Equivalence was demonstrated between SB3 and TRZ based on the ratio of bpCR rates. Safety, PK, and immunogenicity were similar. Complete safety and survival data will follow. Clinical trial information: NCT02149524.

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Safety and tolerability of topical polyhexamethylene biguanide: a randomised clinical trial in healthy adult volunteers

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2020-317848 ◽

2020 ◽

pp. bjophthalmol-2020-317848

Author(s):

Vincenzo Papa ◽

Ivanka van der Meulen ◽

Sylvie Rottey ◽

Guy Sallet ◽

Jolanda Overweel ◽

...

Keyword(s):

Adverse Events ◽

Primary Outcome ◽

Controlled Trial ◽

Randomised Clinical Trial ◽

Treatment Groups ◽

Formal Safety Assessment ◽

Registration Number ◽

Potential Benefits ◽

The Difference ◽

Adult Volunteers

Background and AimsPolyhexamethyl biguanide (PHMB), a widely used topical treatment for Acanthamoeba keratitis (AK), is unlicensed with no formal safety assessment. This study evaluated its safety and tolerability.MethodsA prospective, randomised, double-masked controlled trial in 90 healthy volunteers. Subjects were treated with topical 0.04%, 0.06%, 0.08% PHMB or placebo (vehicle) 12× daily for 7 days, then 6× daily for 7 days. The rates of dose-limiting adverse events (DLAEs) leading to interruption of dosing, mild adverse events (AEs) (not dose limiting) and incidental AEs (unrelated to treatment) were compared. The primary outcome was the difference between treatments for DLAE rates.Results5/90 subjects developed DLAE within <1–4 days of starting treatment; 2/5 using PHMB 0.06% and 3/5 PHMB 0.08%. These resolved within 1–15 days. There were no significant differences in DLAE between treatment groups. Mild AEs occurred in 48/90 subjects (including placebo). There was no trend for an increased incidence of any AE with increasing concentrations of PHMB, except for corneal punctate keratopathy with PHMB 0.08%, which fully resolved within 7–14 days.ConclusionThese findings are reassuring for PHMB 0.02% users. They also suggest that higher PHMB concentrations may show acceptable levels of tolerance and toxicity in AK subjects, whose susceptibility to AE may be greater than for the normal eyes in this study. Given the potential benefits of higher PHMB concentrations for treating deep stromal invasion in AK, we think that the use of PHMB 0.08% is justified in treatment trials.Trial registration numberNCT02506257.

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Efficacy and Safety of Yukgunja-Tang for Patients with Cancer-related Anorexia: A Randomized, Controlled Trial, Pilot Study

Integrative Cancer Therapies ◽

10.1177/15347354211019107 ◽

2021 ◽

Vol 20 ◽

pp. 153473542110191

Author(s):

Myung-Hyun Ko ◽

Si-Yeon Song ◽

Su-Jeong Ha ◽

Jee Young Lee ◽

Seong Woo Yoon ◽

...

Keyword(s):

Adverse Events ◽

Functional Assessment ◽

Laboratory Tests ◽

Primary Outcome ◽

Secondary Outcome ◽

Nutrition Counseling ◽

Treatment Groups ◽

Patients With Cancer ◽

Tnf Α ◽

The Difference

Objective: The purpose of this study is both to estimate the efficacy and the safety of Yukgunja-tang (YGJT) and to establish evidence for the use of herbal medicines in the management of patients with cancer-related anorexia. Methods: We enrolled 40 patients with cancer-related anorexia. The enrolled participants were randomly allocated to 2 groups: the control group (n = 20), which received nutrition counseling, and the treatment group (n = 20), which received nutrition counseling and was administered YGJT at twice a day for 4 weeks (a total of 56 times @ 3.0 g each time). The primary outcome of this study was the score on the anorexia/cachexia subscale (ACS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes were the FAACT score with the ACS score excluded, the score on the Visual Analog Scale (VAS) for appetite, and the results on laboratory tests regarding appetite, such as leptin, tumor necrosis factors (TNF-α), interleukin-6 (IL-6), and ghrelin. All variables related to the safety assessment, such as vital signs, electrocardiography results, laboratory test results (complete blood cell count, chemistry, urine test), and adverse events, were documented on the case report form (CRF) at every visit. Result: The difference in the primary outcome, that is, the score on the anorexia/cachexia subscale (ACS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), between the control and the treatment groups was statistically significant ( P = .023) as was the difference in the FAACT scores with the ACS score excluded, a secondary outcome, between the 2 groups; however, no statistically significant differences were noted in the scores on the VAS or the levels of leptin, TNF-α, IL-6, and ghrelin. In addition, no significant differences in the numbers and the types of adverse events or in the results on the laboratory tests between the control and the treatment groups were recorded. Conclusion: These results obtained in this research confirmed the efficacy and the safety of using YGJT as a herb-medicine treatment option for patients with cancer-related anorexia.

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A Meta-Analysis Comparing the Efficacy and Safety of Peramivir with Other Neuraminidase Inhibitors for Influenza Treatment

Medicina ◽

10.3390/medicina56020063 ◽

2020 ◽

Vol 56 (2) ◽

pp. 63

Author(s):

Jui-Yi Chen ◽

Shih-Kai Wei ◽

Chih-Cheng Lai ◽

Teng-Song Weng ◽

Hsin-Hua Wang

Keyword(s):

Adverse Events ◽

Primary Outcome ◽

Meta Analysis ◽

Random Effect ◽

Random Effect Model ◽

Neuraminidase Inhibitors ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Effect Model ◽

The Difference

Background and Objectives: This meta-analysis compared the efficacy and safety of peramivir compared to other neuraminidase inhibitors (NAIs). Materials and Methods: Data from PubMed, Embase, and Cochrane databases and ClinicalTrials.gov were searched until January 2019. Randomized controlled trials (RCTs) and observational studies (OSs) comparing peramivir with other NAIs for treating influenza were included. The Grading of Recommendations, Assessments, Development, and Evaluations (GRADE) system was used to judge the overall certainty of evidence; the result was moderate. The primary outcome was time to alleviation of symptoms. Twelve articles involving 2681 patients were included in this meta-analysis. We used a random-effect model to pool the effect size, which is expressed as the difference in means (MD), risk ratio (RR), and 95% confidence interval (CI). Results: Overall, peramivir was superior to other NAIs (MD = −11.214 hours, 95% CI: −19.119 to −3.310). The incidence of adverse events (RR = 1.023, 95% CI: 0.717 to 1.460) and serious adverse events (RR = 1.068, 95% CI: 0.702 to 1.625) in the peramivir group was similar to those in the oseltamivir group. In addition, peramivir had higher efficacy than each NAI alone. Conclusion: In conclusion, the efficacy of peramivir might be higher than that of other NAIs, and this agent is tolerated as well as other NAIs.

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Safety and adequacy of endoscopic ultrasound-guided random liver biopsy in comparison with transjugular and percutaneous approaches

Endoscopy International Open ◽

10.1055/a-1274-9763 ◽

2020 ◽

Vol 08 (12) ◽

pp. E1850-E1854

Author(s):

Neil Bhogal ◽

Bernadette Lamb ◽

Benjamin Arbeiter ◽

Sarah Malik ◽

Harlan Sayles ◽

...

Keyword(s):

Liver Biopsy ◽

Adverse Events ◽

Success Rate ◽

Endoscopic Ultrasound ◽

Safety Profile ◽

Primary Outcome ◽

Technical Success ◽

Ultrasound Guided ◽

Technical Success Rate ◽

Tissue Acquisition

Abstract Background and study aims Endoscopic ultrasound-guided liver biopsy (EUS-LB) is an accepted technique for tissue acquisition. Traditionally, random LB has been performed with percutaneous (PC-LB) and transjugular (TJ-LB) approaches. The purpose of this study was to compare the safety profile and efficacy of EUS-LB, PC-LB, and TJ-LB. Patients and methods A retrospective analysis was performed at a tertiary academic medical center. Inclusion criteria for analysis were all adult patients who underwent EUS-LB since inception and TJ-LB/PC-LB over a 3-year span (June 2016 to June 2019). The primary outcome assessed was any adverse events. Secondary outcomes included technical success resulting in tissue acquisition and diagnostic adequacy of the sample for histologic analysis. Results A total of 513 patients were included for analysis. There were 135 EUS-LB, 287 PC-LB, and 91 TJ-LB. The most common indication for LB was abnormal liver function tests. For the primary outcome, the rate of adverse events was low with five reported (< 1 %). There were two in the EUS-LB group, two in the PC-LB group, and one in TJ-LB group, and this difference was not statistically significant (P = 0.585). The technical success rate was 100 % in each group. The rate of diagnostic adequacy was 100 % in TJ-LB group and 99 % in both EUS-LB and PC-LB groups. This difference was not statistically significant (P = 1.000). The most common histologic finding was non-specific changes (33.7 %) followed by non-alcoholic steatohepatitis (15.60 %). Conclusion In comparison with PC-LB and TJ-LB, EUS-LB has comparable safety profile, technical success rate, and diagnostic adequacy. EUS-LB should be considered as an option for random liver biopsy.

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Success Rate of Obturation of Root Canals by Different Techniques in Primary Molars: A Comparative Clinical Study

Current Dentistry ◽

10.2174/2542579x02999200503032916 ◽

2020 ◽

Vol 2 (1) ◽

pp. 36-44

Author(s):

Satyawan G. Damle ◽

Ritika Bansal ◽

Dhanashree D. Sakhare

Keyword(s):

Success Rate ◽

Study Groups ◽

Primary Molars ◽

Control Group ◽

Second Primary ◽

Chi Square ◽

Exact Test ◽

Root Canals ◽

Significant Difference ◽

Comparative Clinical Study

Objective: To compare the success rate of different obturation procedures in primary mandibular second molars clinically and also by digital radiovisiography. Methods: A total of 40 children aged between 4-8 years with deeply carious mandibular second primary molars indicated for single session pulpectomy were selected. Canals were obturated with Metapex. The 3 study groups (Endodontic plugger, Handheld lentulospiral, Navi Tip syringe) were compared with the control group (reamer) both clinically and radiovisiographically. The data collected were statistically analyzed using Pearson’s Chi-square and Fisher’s exact test. Results: The use of Navi tip syringe led to the least number of voids followed by Endodontic plugger and Reamer and the highest number of voids was reported with Lentulospiral. Navitip presented maximum number of optimally filled cases followed by Endodontic plugger and Lentulospiral and least number of optimally filled cases with reamer. However, there was no statistically significant difference (p>0.05) in any of the groups with clinical (pain and tenderness to percussion) and radiographic parameters (presence or absence of voids and length of obturation). Conclusion: Within the limitations of the present study, though the clinical outcome was statistically insignificant, Navitip syringe exhibited encouraging results and is a promising option for obturation in primary teeth.

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Macular buckling versus vitrectomy on macular hole associated macular detachment in eyes with high myopia: a randomised trial

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2020-317800 ◽

2021 ◽

pp. bjophthalmol-2020-317800

Author(s):

Xiujuan Zhao ◽

Yonghao Li ◽

Wei Ma ◽

Ping Lian ◽

Xiling Yu ◽

...

Keyword(s):

Success Rate ◽

Macular Hole ◽

High Myopia ◽

Randomised Trial ◽

Case Series ◽

Primary Treatment ◽

Closure Rate ◽

Macular Detachment ◽

The Difference ◽

Myopic Maculopathy

AimTo compare the efficacy of macular buckling (MB) and pars plana vitrectomy (PPV) for full-thickness macular holes (FTMH) and associated macular detachment (MD) in highly myopic eyes.MethodsProspective interventional case series of eyes undergoing PPV or MB for FTMH and MD.Main outcome measuresBest-corrected visual acuity (BCVA) at postoperative month 24. Other measured outcomes include the initial surgical success rate, macular hole closure rate and the progression of myopic maculopathy.ResultsA total of 53 eyes from 53 participants were included in this study (26 participants receiving MB and 27 participants receiving PPV), and finally 49 eyes from 49 participants (25 participants in the MB group and 24 participants in the PPV group) were analysed. At postoperative month 24, the BCVA had improved significantly in those that underwent either MB (p<0.001) or PPV (p=0.04). The difference between the groups was not significant (p=0.653). The surgical failure rate after the primary treatment was significantly higher in the PPV group than the MB group (25.00% vs 4.00%, respectively; p=0.04). The macular closure rate was higher in the MB group compared with the PPV group, but the difference was not statistically significant (64.00% vs 58.33%, respectively; p=0.45). Myopic maculopathy development may be more severe following PPV than following MB surgery.ConclusionPatients with high myopia obtained anatomical and functional improvements from either MB or PPV. However, MB achieved a significantly higher success rate in retinal reattachment compared with PPV.Trial registration numberNCT03433547.

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Using supraglottic airways by paramedics for airway management in analogue microgravity increases speed and success of ventilation

Scientific Reports ◽

10.1038/s41598-021-88008-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Jochen Hinkelbein ◽

Anton Ahlbäck ◽

Christine Antwerber ◽

Lisa Dauth ◽

James DuCanto ◽

...

Keyword(s):

Airway Management ◽

Success Rate ◽

Simulated Microgravity ◽

Laryngeal Tube ◽

Space Missions ◽

Airway Device ◽

Future Space ◽

Secondary Endpoints ◽

Present Trial

AbstractIn the next few years, the number of long-term space missions will significantly increase. Providing safe concepts for emergencies including airway management will be a highly challenging task. The aim of the present trial is to compare different airway management devices in simulated microgravity using a free-floating underwater scenario. Five different devices for airway management [laryngeal mask (LM), laryngeal tube (LT), I-GEL, direct laryngoscopy (DL), and video laryngoscopy (VL)] were compared by n = 20 paramedics holding a diving certificate in a randomized cross-over setting both under free-floating conditions in a submerged setting (pool, microgravity) and on ground (normogravity). The primary endpoint was the successful placement of the airway device. The secondary endpoints were the number of attempts and the time to ventilation. A total of 20 paramedics (3 female, 17 male) participated in this study. Success rate was highest for LM and LT and was 100% both during simulated microgravity and normogravity followed by the I-GEL (90% during microgravity and 95% during normogravity). However, the success rate was less for both DL (60% vs. 95%) and VL (20% vs. 60%). Fastest ventilation was performed with the LT both in normogravity (13.7 ± 5.3 s; n = 20) and microgravity (19.5 ± 6.1 s; n = 20). For the comparison of normogravity and microgravity, time to ventilation was shorter for all devices on the ground (normogravity) as compared underwater (microgravity). In the present study, airway management with supraglottic airways and laryngoscopy was shown to be feasible. Concerning the success rate and time to ventilation, the optimum were supraglottic airways (LT, LM, I-GEL) as their placement was faster and associated with a higher success rate. For future space missions, the use of supraglottic airways for airway management seems to be more promising as compared to tracheal intubation by DL or VL.

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