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1.
Parkinsonism Relat Disord ; 118: 105950, 2024 Jan.
Article En | MEDLINE | ID: mdl-38081119

INTRODUCTION: Botulinum toxin type A (BoNT/A) injections are the first-line treatment for primary hemifacial spasms (HFS), but require frequent painful injections. Although micro-hypodermic needles are commonly used for aesthetic BoNT/A injections to lessen pain and bruising, their benefits in HFS remain unclear. OBJECTIVE: To compare side effects of BoNT/A injection, specifically pain and bruising, between primary HFS patients who received injections using micro-hypodermic needles (34-G) and those using standard needles (30-G). METHODS: This cross-over, double-blind, randomised controlled trial involved HFS patients who received BoNT/A injections using either a 34-G or 30-G needle at two visits 12 weeks apart. Primary outcomes, pain and bruising were assessed immediately after injection using the Visual Analogue Scale (VAS) and Short-form McGill Pain Questionnaire (Thai version, SF-MPQ). Bruise assessment was also conducted one week after each injection. Secondary outcomes involved comparing efficacy of BoNT/A between the two types of needles and assessing other complications beyond pain and bruising. RESULTS: 65 HFS patients (47 women and 18 men; mean age 59.46 ± 11.48 years; mean disease duration 5.86 ± 4.16 years) were included in the study. Patients who received 34-G needle injections reported significantly reduced pain, as indicated by VAS, total SF-MPQ scores, and bruise scores, compared to those who received 30-G needle injections (p < 0.001, each). There were no differences in efficacy or occurrence of other complications associated with BoNT/A between the two needle types. CONCLUSION: In HFS patients, BoNT/A injections using micro-hypodermic needles resulted in reduced pain and bruising, compared to standard needles, while maintaining similar BoNT/A benefits.


Botulinum Toxins, Type A , Contusions , Hemifacial Spasm , Neuromuscular Agents , Male , Humans , Female , Middle Aged , Aged , Hemifacial Spasm/drug therapy , Hemifacial Spasm/complications , Needles/adverse effects , Pain/etiology , Contusions/chemically induced , Contusions/complications , Contusions/drug therapy , Treatment Outcome
2.
Cochrane Database Syst Rev ; 6: CD008077, 2021 06 08.
Article En | MEDLINE | ID: mdl-34101161

BACKGROUND: Heparin is an anticoagulant medication that is usually injected subcutaneously. Subcutaneous administration of heparin may result in complications such as bruising, haematoma, and pain at the injection site. One of the factors that may affect pain, haematoma, and bruising is injection speed. Several studies have been carried out to determine if speed of injection affects the amount of pain and bruising where the injection is given; however, the results of these studies have differed, and study authors have not reached a clear final conclusion. This is the second update of a review first published in 2014. OBJECTIVES: To assess the effects of duration (speed) of subcutaneous heparin injection on pain and bruising at the injection site in people admitted to hospitals or clinics who require treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). We also looked at haematoma at the injection site. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 22 June 2020. We undertook reference checking of included studies to identify additional studies. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) comparing the effects of different durations of subcutaneous injection of heparin on pain, bruising, and haematoma at the injection site. DATA COLLECTION AND ANALYSIS: For this update, two review authors independently selected studies and extracted data via Covidence software and assessed methodological quality using Cochrane's risk of bias tool. The primary outcomes of interest were pain intensity at injection site and size and incidence of bruising. The secondary outcomes of interest were size and incidence of haematoma at injection site. We calculated the odds ratio (OR), mean difference (MD), or standardised mean difference (SMD) with corresponding 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria. MAIN RESULTS: We identified one new study for this update, resulting in a total of five included studies with 503 participants who received subcutaneous injections of LMWH into the abdomen. Given the nature of the intervention, it was not possible to blind participants and caregivers (personnel) in any of the included studies. Two studies described blinding of outcome assessors. Overall, the methodological quality of included studies was moderate. The duration of the fast injection was 10 seconds, and the duration of the slow injection was 30 seconds in all included studies. Four studies reported site pain intensity after each injection at different time points. Two studies assessed site pain intensity immediately after each injection; meta-analysis showed no evidence of a difference in site pain intensity immediately after slow injection when compared to fast injection (MD -1.52, 95% CI -3.56 to 0.53; 140 participants; low-certainty evidence). Meta-analysis of three studies indicated that site pain intensity may be slightly reduced 48 hours after the slow heparin injection compared to fast injection (MD -1.60, 95% CI -2.69 to -0.51; 103 participants; low-certainty evidence). Five studies assessed bruise size at 48 hours, and two studies assessed bruise size at 60 hours. Meta-analysis showed there may be a reduction in bruise size 48 hours (SMD -0.54, 95% CI -1.05 to -0.02; 503 participants; 5 studies; very low-certainty evidence) and 60 hours (SMD -0.49, 95% CI -0.93 to -0.06; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. There was no evidence of a difference in bruise size 72 hours after slow injection compared to fast injection (SMD -0.27, 95% CI -0.61 to 0.06; 140 participants; 2 studies; low-certainty evidence). Three studies evaluated incidence of bruising and showed there may be a reduction in bruise incidence 48 hours (OR 0.39, 95% CI 0.26 to 0.60; 444 participants; low-certainty evidence) and 60 hours (OR 0.25, 95% CI 0.10 to 0.65; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. We downgraded the certainty of the evidence due to risk of bias concerns, imprecision, and inconsistency. None of the included studies measured size or incidence of haematoma. AUTHORS' CONCLUSIONS: Administering medication safely and enhancing patient comfort are the main aims of clinical nurses. In this review, we identified five RCTs that evaluated the effect of subcutaneous heparin injection duration on pain intensity, bruise size and incidence. We found that pain may be slightly reduced 48 hours after slow injection. Similarly, there may be a reduction in bruise size and incidence after slow injection compared to fast injection 48 and 60 hours postinjection. We downgraded the certainty of the evidence for all outcomes to low or very low due to risk of bias concerns, imprecision, and inconsistency. Accordingly, new trials with a more robust design, more participants, and a focus on different injection speeds will be useful in strengthening the certainty of the available evidence.


Anticoagulants/administration & dosage , Contusions/prevention & control , Heparin, Low-Molecular-Weight/administration & dosage , Injections, Subcutaneous/methods , Pain, Procedural/prevention & control , Anticoagulants/adverse effects , Bias , Contusions/chemically induced , Contusions/pathology , Hematoma/chemically induced , Hematoma/pathology , Heparin, Low-Molecular-Weight/adverse effects , Humans , Injections, Subcutaneous/adverse effects , Middle Aged , Pain Measurement/methods , Pain, Procedural/etiology , Randomized Controlled Trials as Topic , Time Factors
3.
J Am Soc Nephrol ; 31(7): 1628-1639, 2020 07.
Article En | MEDLINE | ID: mdl-32493693

BACKGROUND: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for dialysis-dependent CKD anemia. METHODS: This phase 3, 24-week, double-blind, double-dummy study evaluated roxadustat's noninferiority to darbepoetin alfa for hemodialysis-dependent CKD anemia. We randomly assigned Japanese patients to oral roxadustat three times weekly or to darbepoetin alfa injections once weekly, titrating doses to maintain hemoglobin between 10-12 g/dl. The primary end point was change of average hemoglobin from baseline to weeks 18-24 (∆Hb18-24). Secondary end points were average hemoglobin and proportion of patients with hemoglobin between 10-12 g/dl (maintenance rate) at weeks 18-24, and iron parameters. Safety assessments included treatment-emergent adverse events and adjudicated ophthalmologic findings. RESULTS: We randomly assigned 303 patients to roxadustat (n=151) or darbepoetin alfa (n=152). The difference between roxadustat and darbepoetin alfa in ∆Hb18-24 was -0.02 g/dl (95% confidence interval, -0.18 to 0.15), confirming roxadustat's noninferiority to darbepoetin alfa. Average hemoglobin at weeks 18-24 with roxadustat was 10.99 g/dl (95% confidence interval: 10.88 to 11.10), confirming its efficacy. Among patients with one or more hemoglobin value during weeks 18-24, the maintenance rate was 95.2% with roxadustat and 91.3% with darbepoetin alfa. Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing. Common treatment-emergent adverse events were nasopharyngitis, shunt stenosis, diarrhea, contusion, and vomiting. The proportion of patients with new or worsening retinal hemorrhage was 32.4% with roxadustat and 36.6% with darbepoetin alfa. We observed no clinically meaningful changes in retinal thickness groups. CONCLUSIONS: Roxadustat maintained hemoglobin within 10-12 g/dl in patients on hemodialysis and was noninferior to darbepoetin alfa. Treatment-emergent adverse events were consistent with previous reports. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia, NCT02952092 (ClinicalTrials.gov).


Anemia/drug therapy , Darbepoetin alfa/therapeutic use , Glycine/analogs & derivatives , Hematinics/therapeutic use , Isoquinolines/therapeutic use , Renal Insufficiency, Chronic/therapy , Adult , Aged , Aged, 80 and over , Anemia/blood , Anemia/etiology , Contusions/chemically induced , Diarrhea/chemically induced , Double-Blind Method , Female , Ferritins/blood , Glycine/administration & dosage , Glycine/adverse effects , Glycine/therapeutic use , Hematinics/administration & dosage , Hematinics/adverse effects , Hemoglobins/metabolism , Hepcidins/blood , Humans , Iron/blood , Isoquinolines/administration & dosage , Isoquinolines/adverse effects , Japan , Male , Middle Aged , Nasopharyngitis/chemically induced , Renal Dialysis , Renal Insufficiency, Chronic/complications , Retinal Hemorrhage/chemically induced , Time Factors , Transferrin/metabolism , Vomiting/chemically induced , Young Adult
4.
Australas J Dermatol ; 61(3): 217-225, 2020 Aug.
Article En | MEDLINE | ID: mdl-32201935

Facial aesthetic treatment with injectable neuromodulators and hyaluronic acid fillers is well established, with favourable safety profiles and consistent outcomes. As with any medical treatment, adverse events and complications may occur. Adverse events associated with these products are typically transient and mild to moderate in severity. Serious adverse events, such as infection and intravascular occlusion, are rare. Proper patient selection, consent and counselling, preparation and impeccable injection technique are important risk reduction strategies. Both clinicians and patients must be alert to the signs and symptoms of complications so that appropriate treatment can be started promptly. In this article, the authors review the current literature and provide their consensus recommendations for minimising adverse outcomes when treating patients with botulinum toxin or hyaluronic acid fillers.


Botulinum Toxins, Type A/adverse effects , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Hyaluronic Acid/adverse effects , Neuromuscular Agents/adverse effects , Consensus , Contusions/chemically induced , Contusions/prevention & control , Directive Counseling , Edema/chemically induced , Edema/prevention & control , Erythema/chemically induced , Erythema/prevention & control , Face , Hematoma/chemically induced , Hematoma/prevention & control , Humans , Injection Site Reaction/etiology , Injection Site Reaction/prevention & control , Injections/adverse effects , Pain/chemically induced , Pain/prevention & control , Patient Education as Topic , Patient Selection
6.
Heart Lung ; 47(5): 485-488, 2018.
Article En | MEDLINE | ID: mdl-29866585

OBJECTIVES: The purpose of this qualitative study was to explore perceptions of nuisance bleeding and medication-related beliefs among adults taking dual antiplatelet drug therapy. METHODS: We conducted qualitative telephone interviews with 34 community-dwelling adults with cardiovascular disease. RESULTS: Using qualitative content analysis, we identified 4 dominant themes: nuisance bruising, nuisance bleeding, importance of medication adherence, and duration of therapy. Participants' bruising was frequently more severe than expected given the force of the bump that caused it. Concerns focused on whether increased bleeding tendencies would lead to hemorrhage in the event of a major traumatic injury, confusion about the duration of therapy, and the rationale for when and why therapy should be discontinued. CONCLUSION: Excessive bruising and medication-related concerns about hemorrhage and duration of treatment were salient issues for participants. Effective clinician-patient communication should be used to assist individuals in managing concerns to help assure positive health outcomes with antiplatelet drugs.


Health Knowledge, Attitudes, Practice , Hemorrhage/chemically induced , Medication Adherence/statistics & numerical data , Platelet Aggregation Inhibitors/adverse effects , Aged , Aged, 80 and over , Contusions/chemically induced , Culture , Female , Humans , Male , Middle Aged , Qualitative Research
7.
Cochrane Database Syst Rev ; 11: CD008077, 2017 11 01.
Article En | MEDLINE | ID: mdl-29090459

BACKGROUND: Heparin is an anticoagulant medication that is usually injected subcutaneously. Subcutaneous administration of heparin may result in complications such as bruising, haematoma, and pain at the injection site. One of the factors that may affect pain, haematoma, and bruising is injection speed. For patients and healthcare providers, strategies that can reduce pain and bruising are considered important. Reducing patients' discomfort and concerns whenever and wherever possible is an important aim of nursing. Several studies have been carried out to see if speed of injection affects the amount of pain and bruising where the injection is given, but results of these studies have differed and study authors have not reached a clear final conclusion. This is the first update of the review first published in 2014. OBJECTIVES: To assess the effects of duration (speed) of subcutaneous heparin injection on pain, haematoma, and bruising at the injection site in people admitted to hospitals or clinics who require treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched March 2017) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2). The CIS also searched trials registries for details of ongoing or unpublished studies. Review authors searched two Persian databases - Iranmedex and Scientific Information Database (SID) - as well as Google Scholar. SELECTION CRITERIA: We sought randomised controlled trials (RCTs) comparing the effects of different durations of subcutaneous injection of heparin on pain, bruising, and haematoma at the injection site. DATA COLLECTION AND ANALYSIS: Two review authors (MM, LJ), working independently, extracted data onto a structured form and assessed study quality. We used the criteria recommended by Cochrane to assess the risk of bias of included studies. For the outcomes, we calculated the mean difference (MD) or the standardised MD (SMD) with corresponding 95% confidence intervals (CIs). We pooled data using fixed-effect and random-effects models. We used GRADE to assess the overall quality of evidence supporting outcomes assessed in this review. MAIN RESULTS: For this update, we identified three new studies and therefore included in the Review four studies with a total of 459 participants who received subcutaneous injections of LMWH into the abdomen. Only one trial reported the injected drug volume (0.4 mL). Owing to the nature of the intervention, it was not possible to blind participants and care givers (personnel) in any included study. Two studies described blinding of outcome assessors; therefore overall, the methodological quality of included studies was moderate. The duration of the fast injection was 10 seconds and the duration of the slow injection was 30 seconds in all included studies.Three studies reported site pain intensity after each injection at different time points. Two studies assessed site pain intensity immediately after each injection, and meta-analysis on 140 participants showed no clear difference in site pain intensity immediately post slow injection when compared to fast injection (low-quality evidence; P = 0.15). In contrast, meta-analysis of two studies with 59 participants showed that 48 hours after the heparin injection, slow injection was associated with less pain intensity compared to fast injection (low-quality evidence; P = 0.007). One study (40 participants) reported pain intensity at 60 and 72 hours after injection. This study described no clear difference in site pain intensity at 60 and 72 hours post slow injection compared to fast injection.All four included studies assessed bruise size at 48 hours after each injection. Meta-analysis on 459 participants showed no difference in bruise size after slow injection compared to fast injection (low-quality evidence; P = 0.07). None of the included studies measured the incidence of haematoma as an outcome. AUTHORS' CONCLUSIONS: We found four RCTs that evaluated the effect of subcutaneous heparin injection duration on pain intensity and bruise size. Owing to the small numbers of participants, we found insufficient evidence to determine any effect on pain intensity immediately after injection or at 60 and 72 hours post injection. However, slow injection may reduce site pain intensity 48 hours after injection (low-quality evidence). We observed no clear difference in bruise size after slow injection compared to fast injection (low-quality evidence). We judged this evidence to be of low quality owing to imprecision and inconsistency.


Anticoagulants/administration & dosage , Contusions/prevention & control , Heparin, Low-Molecular-Weight/administration & dosage , Injections, Subcutaneous/methods , Pain, Procedural/prevention & control , Anticoagulants/adverse effects , Contusions/chemically induced , Heparin, Low-Molecular-Weight/adverse effects , Humans , Injections, Subcutaneous/adverse effects , Middle Aged , Pain Measurement/methods , Pain, Procedural/etiology , Randomized Controlled Trials as Topic , Time Factors
8.
Cochrane Database Syst Rev ; 10: CD008077, 2017 10 01.
Article En | MEDLINE | ID: mdl-28965359

BACKGROUND: Heparin is an anticoagulant medication that is usually injected subcutaneously. Subcutaneous administration of heparin may result in complications such as bruising, haematoma, and pain at the injection site. One of the factors that may affect pain, haematoma, and bruising is injection speed. For patients and healthcare providers, strategies that can reduce pain and bruising are considered important. Reducing patients' discomfort and concerns whenever and wherever possible is an important aim of nursing. Several studies have been carried out to see if speed of injection affects the amount of pain and bruising where the injection is given, but results of these studies have differed and study authors have not reached a clear final conclusion. This is the first update of the review first published in 2014. OBJECTIVES: To assess the effects of duration (speed) of subcutaneous heparin injection on pain, haematoma, and bruising at the injection site in people admitted to hospitals or clinics who require treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched March 2017) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2). The CIS also searched trials registries for details of ongoing or unpublished studies. Review authors searched two Persian databases - Iranmedex and Scientific Information Database (SID) - as well as Google Scholar. SELECTION CRITERIA: We sought randomised controlled trials (RCTs) comparing the effects of different durations of subcutaneous injection of heparin on pain, bruising, and haematoma at the injection site. DATA COLLECTION AND ANALYSIS: Two review authors (MM, LJ), working independently, extracted data onto a structured form and assessed study quality. We used the criteria recommended by Cochrane to assess the risk of bias of included studies. For the outcomes, we calculated the mean difference (MD) or the standardised MD (SMD) with corresponding 95% confidence intervals (CIs). We pooled data using fixed-effect and random-effects models. We used GRADE to assess the overall quality of evidence supporting outcomes assessed in this review. MAIN RESULTS: For this update, we identified three new studies and therefore included in the Review four studies with a total of 459 participants who received subcutaneous injections of LMWH into the abdomen. Only one trial reported the injected drug volume (0.4 mL). Owing to the nature of the intervention, it was not possible to blind participants and care givers (personnel) in any included study. Two studies described blinding of outcome assessors; therefore overall, the methodological quality of included studies was moderate. The duration of the fast injection was 10 seconds and the duration of the slow injection was 30 seconds in all included studies.Three studies reported site pain intensity after each injection at different time points. Two studies assessed site pain intensity immediately after each injection, and meta-analysis on 140 participants showed no clear difference in site pain intensity immediately post slow injection when compared to fast injection (low-quality evidence; P = 0.15). In contrast, meta-analysis of two studies with 59 participants showed that 48 hours after the heparin injection, slow injection was associated with less pain intensity compared to fast injection (low-quality evidence; P = 0.007). One study (40 participants) reported pain intensity at 60 and 72 hours after injection. This study described no clear difference in site pain intensity at 60 and 72 hours post slow injection compared to fast injection.All four included studies assessed bruise size at 48 hours after each injection. Meta-analysis on 459 participants showed no difference in bruise size after slow injection compared to fast injection (low-quality evidence; P = 0.07). None of the included studies measured the incidence of haematoma as an outcome. AUTHORS' CONCLUSIONS: We found four RCTs that evaluated the effect of subcutaneous heparin injection duration on pain intensity and bruise size. Owing to the small numbers of participants, we found insufficient evidence to determine any effect on pain intensity immediately after injection or at 60 and 72 hours post injection. However, slow injection may reduce site pain intensity 48 hours after injection (low-quality evidence). We observed no clear difference in bruise size after slow injection compared to fast injection (low-quality evidence). We judged this evidence to be of low quality owing to imprecision and inconsistency.


Anticoagulants/administration & dosage , Contusions/prevention & control , Heparin/administration & dosage , Injections, Subcutaneous/adverse effects , Pain, Procedural/prevention & control , Anticoagulants/adverse effects , Contusions/chemically induced , Heparin/adverse effects , Humans , Injections, Subcutaneous/methods , Middle Aged , Pain Measurement , Pain, Procedural/etiology , Randomized Controlled Trials as Topic , Time Factors
9.
BMC Musculoskelet Disord ; 18(1): 374, 2017 Aug 30.
Article En | MEDLINE | ID: mdl-28854973

BACKGROUND: To determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules. METHODS: In this 8-week, double-blind trial, palpable palmar nodules on one hand of adults with Dupuytren disease were selected for treatment. Patients were randomly assigned using an interactive web response system to receive a dose of 0.25 mg, 0.40 mg, or 0.60 mg (1:1:1 ratio) and then allocated to active treatment (CCH) or placebo (4:1 ratio). All patients and investigators were blinded to treatment. One injection was made in the selected nodule on Day 1. Caliper measurements of nodule length and width were performed at screening and at Weeks 4 and 8. Investigator-reported nodular consistency and hardness were evaluated at baseline and Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction were assessed at study end. RESULTS: In the efficacy population (n = 74), percentage changes in area were significantly greater with CCH 0.40 mg (-80.1%, P = 0.0002) and CCH 0.60 mg (-78.2%, P = 0.0003), but not CCH 0.25 mg (-58.3%, P = 0.079), versus placebo (-42.2%) at post-treatment Week 8. Mean change in nodular consistency and hardness were significantly improved with CCH versus placebo at Weeks 4 and 8 (P ≤ 0.0139 for all). At Week 8, investigator global assessment of improvement was significantly greater with CCH 0.40 mg and 0.60 mg (P ≤ 0.0014) but not statistically significant with CCH 0.25 mg versus placebo (P = 0.13). Most patients were "very satisfied" or "quite satisfied" with CCH 0.40 mg and 0.60 mg. Contusion/bruising (50.0% to 59.1%) was the most common adverse event with CCH treatment. CONCLUSION: In patients with Dupuytren disease, a single CCH injection significantly improved palmar nodule size and hardness. The safety of CCH was similar to that observed previously in patients with Dupuytren contracture. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02193828 . Date of trial registration: July 2, 2014 to December 5, 2014.


Clostridium histolyticum , Dupuytren Contracture/diagnosis , Dupuytren Contracture/drug therapy , Microbial Collagenase/administration & dosage , Aged , Contusions/chemically induced , Double-Blind Method , Female , Humans , Injections, Intralesional , Male , Microbial Collagenase/adverse effects , Middle Aged , Treatment Outcome
10.
Clin Exp Rheumatol ; 35(3): 471-476, 2017.
Article En | MEDLINE | ID: mdl-28094753

OBJECTIVES: EULAR guidelines state that adverse effects (AEs) of glucocorticoid (GC) therapy should be considered and discussed with the patient before treatment is initiated. However, reliable quantitative data, especially on cutaneous AEs of low-to-medium dose GCs are lacking. We performed a study assessing the occurrence of cutaneous AEs of GCs and its association with current and cumulative GC doses in patients with rheumatoid arthritis (RA). METHODS: In a cross-sectional study performed in 2 outpatient rheumatology centres, 381 RA patients were enrolled. They were classed into 4 groups, according their mean daily dose during the past 12 months: 0 mg (n=87), <5mg (n=108), 5-7.5 mg (n=130), and >7.5 mg (n=56) of prednisone equivalent. AEs of GC on the skin were assessed by physical examination using a predefined scoring system, and by patients' self-assessments. Data were analysed according GC dose categories and cumulative doses. RESULTS: Cushingoid habitus, easy bruising, skin atrophy, and impaired wound healing as reported by patients occurred significantly more frequently in those using a GC the past 12 months, compared to those not using a GC. At physicians' assessments, only Cushingoid habitus and ecchymosis were more prevalent in GC users. The prevalence of these AEs was statistically significantly positively associated with current and cumulative GC dose. There was low occurrence of abnormal stretch marks, acne, perioral dermatitis, alopecia and hirsutism, which were not correlated with GC use. CONCLUSIONS: Certain GC-associated cutaneous AEs are common in RA, but other AEs of GC occur infrequently at the low-to-medium GC doses used in RA.


Arthritis, Rheumatoid/drug therapy , Glucocorticoids/adverse effects , Skin Diseases/chemically induced , Skin/drug effects , Aged , Arthritis, Rheumatoid/diagnosis , Atrophy , Contusions/chemically induced , Contusions/epidemiology , Cross-Sectional Studies , Cushing Syndrome/chemically induced , Cushing Syndrome/epidemiology , Dose-Response Relationship, Drug , Ecchymosis/chemically induced , Ecchymosis/epidemiology , Female , Germany/epidemiology , Glucocorticoids/administration & dosage , Humans , Male , Middle Aged , Prevalence , Risk Assessment , Risk Factors , Self-Assessment , Skin/pathology , Skin Diseases/diagnosis , Skin Diseases/epidemiology , Time Factors , Treatment Outcome , Wound Healing/drug effects
13.
BMJ Case Rep ; 20162016 Sep 08.
Article En | MEDLINE | ID: mdl-27609590

A 72-year-old man, on treatment for prostate cancer, attended the emergency department with his 2nd episode of spontaneous extensive bruising and haematomas. His first presentation was 2 months prior but this was thought to be because of his aspirin and he improved when aspirin was discontinued. On this occasion aspirin had been restarted 7 days before he developed his symptoms. His blood investigation was significant for a much raised activated partial thromboplastin time (aPTT). On his 3rd day of admission he deteriorated clinically with a drastic drop in his haemoglobin and worsening tense haematomas. Blood investigations confirmed the diagnosis of acquired factor VIII deficiency and he subsequently received treatment with factor VIII inhibitor bypassing activity, steroids and immunosuppresants.


Aspirin/adverse effects , Hemophilia A/diagnosis , Platelet Aggregation Inhibitors/adverse effects , Prostatic Neoplasms/drug therapy , Aged , Contusions/chemically induced , Hematoma/chemically induced , Hemophilia A/chemically induced , Humans , Male , Partial Thromboplastin Time
14.
NPJ Prim Care Respir Med ; 25: 15026, 2015 Jul 09.
Article En | MEDLINE | ID: mdl-26158805

BACKGROUND: Non-adherence to corticosteroid treatment has been shown to reduce treatment efficacy, thus compromising asthma control. AIMS: To examine the experiences of treatment side effects, treatment concerns and adherence to inhaled (ICS) and oral corticosteroids (OCS) among people with asthma and to identify the degree of concordance between clinician estimates of side effects and the prevalence reported by patients. METHODS: Asthma UK members were sent validated questionnaires assessing treatment concerns, experiences of side effects and adherence. Questionnaires measuring clinicians' estimates of the prevalence of corticosteroid side effects were completed online. RESULTS: Completed questionnaires were returned by 1,524 people taking ICS, 233 taking OCS and 244 clinicians (67% of clinicians were primary care nurses). Among people with asthma, 64% of those taking ICS and 88% of those taking OCS reported ⩾ 1 side effect. People reporting high adherence to ICS (t = -3.09, P<0.005) and those reporting low adherence to OCS (t = 1.86, P < 0.05; one-tailed test) reported more side effects. There was a disparity between clinicians' estimates of the frequency of side effects and the frequency reported by people with asthma: e.g., although 46% of people taking ICS reported sore throat, clinicians estimated that this figure would be 10%. Patients who reported side effects had stronger concerns about both ICS (r = 0.46, P < 0.0001) and OCS (r = 0.50, P < 0.0001). Concerns about corticosteroids were associated with low adherence to ICS (t = 6.90, P < 0.0001) and OCS (t = 1.71; P < 0.05; one-tailed test). CONCLUSIONS: An unexpectedly large proportion of people with asthma experienced side effects and had strong concerns about their treatment, which compromised adherence. These findings have implications for the design of interventions to optimise asthma control through improved adherence.


Adrenal Cortex Hormones/adverse effects , Asthma/drug therapy , Drug-Related Side Effects and Adverse Reactions/epidemiology , Primary Health Care , Administration, Inhalation , Administration, Oral , Adult , Aged , Candidiasis, Oral/chemically induced , Candidiasis, Oral/epidemiology , Contusions/chemically induced , Contusions/epidemiology , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Humans , Male , Medication Adherence , Mental Disorders/chemically induced , Mental Disorders/epidemiology , Middle Aged , Pharyngitis/chemically induced , Pharyngitis/epidemiology , Physicians, Primary Care , Prevalence , Primary Care Nursing , Self Report , Stomatognathic Diseases/chemically induced , Stomatognathic Diseases/epidemiology , Surveys and Questionnaires , United Kingdom , Weight Gain
15.
World J Gastroenterol ; 21(19): 6082-7, 2015 May 21.
Article En | MEDLINE | ID: mdl-26019477

Infliximab (IFX) is an anti-tumor necrosis factor chimeric antibody that is effective for treatment of autoimmune disorders such as Crohn's disease and ulcerative colitis (UC). IFX is well tolerated with a low incidence of adverse effects such as infections, skin reactions, autoimmunity, and malignancy. Dermatological manifestations can appear as infusion reaction, vasculitis, cutaneous infections, psoriasis, eczema, and skin cancer. Here, we present an unusual case of extensive and sporadic subcutaneous ecchymosis in a 69-year-old woman with severe UC, partial colectomy and cecostomy, following her initial dose of IFX. The reaction occurred during infliximab infusion, and withdrawal of IFX led to gradual alleviation of her symptoms. We concluded that Henoch-Schönlein purpura, a kind of leukocytoclastic vasculitis, might have contributed to the development of the bruising. Although the precise mechanisms of the vasculitis are still controversial, such a case highlights the importance of subcutaneous adverse effects in the management of UC with IFX.


Colitis, Ulcerative/drug therapy , IgA Vasculitis/chemically induced , Immunosuppressive Agents/adverse effects , Infliximab/adverse effects , Aged , Biopsy , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/immunology , Colonoscopy , Contusions/chemically induced , Ecchymosis/chemically induced , Female , Humans , IgA Vasculitis/diagnosis , IgA Vasculitis/drug therapy , Promethazine/therapeutic use , Risk Factors , Severity of Illness Index , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors
16.
Dermatol Surg ; 41 Suppl 1: S127-36, 2015 Apr.
Article En | MEDLINE | ID: mdl-25828037

OBJECTIVE: To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine (SPHAL) versus no treatment for lip augmentation and perioral rhytides. METHODS AND MATERIALS: Adults scoring 1 (very thin) to 2 (thin) on the Medicis Lip Fullness Scale (MLFS) for upper and lower lips were randomized (3:1) to SPHAL or no treatment. Treatment success was an MLFS increase ≥1 point at Week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale, Wrinkle Assessment Scale for Upper Lip Lines) and safety were assessed throughout. RESULTS: Statistically significantly more patients were treatment successes with SPHAL (upper lip [80.2% vs 11.9%], lower lip [84.2% vs 18.4%], and upper and lower lips combined [76.1% vs 11.6%]), compared with no treatment (p <.001, all outcomes). Patients treated for both lip augmentation and perioral rhytides were rated as having an aesthetically meaningful improvement in perioral rhytides (p <.001). Most common treatment-emergent adverse events (AEs) included lip bruising, swelling, and pain and were mostly mild and transient in nature, without anticipated device AEs. CONCLUSION: Small particle hyaluronic acid plus lidocaine was effective and well tolerated and significantly more effective when both lips and perioral rhytides were treated, with improvement evident up to 6 months after treatment.


Anesthetics, Local/administration & dosage , Cosmetic Techniques , Hyaluronic Acid/administration & dosage , Lidocaine/administration & dosage , Lip , Skin Aging , Adolescent , Aged , Anesthetics, Local/adverse effects , Contusions/chemically induced , Edema/chemically induced , Female , Gels , Humans , Hyaluronic Acid/adverse effects , Injections, Intradermal , Lidocaine/adverse effects , Male , Middle Aged , Pain/chemically induced , Particle Size , Rejuvenation , Young Adult
18.
Facial Plast Surg ; 30(6): 647-55, 2014 Dec.
Article En | MEDLINE | ID: mdl-25536132

Fillers are frequently used in beautifying procedures. Despite major advancements of the chemical and biological features of injected materials, filler-related adverse events may occur, and can substantially impact the clinical outcome. Filler granulomas become manifest as visible grains, nodules, or papules around the site of the primary injection. Early recognition and proper treatment of filler-related complications is important because effective treatment options are available. In this report, we provide a comprehensive overview of the differential diagnosis and diagnostics and develop an algorithm of successful therapy regimens.


Algorithms , Biocompatible Materials/adverse effects , Dermatologic Agents/adverse effects , Facial Dermatoses/diagnosis , Granuloma/diagnosis , Skin/pathology , Contusions/chemically induced , Contusions/diagnosis , Cosmetic Techniques , Diagnosis, Differential , Edema/chemically induced , Edema/diagnosis , Edema/therapy , Facial Dermatoses/chemically induced , Facial Dermatoses/therapy , Granuloma/chemically induced , Granuloma/therapy , Humans , Necrosis/chemically induced , Necrosis/diagnosis , Skin Ulcer/chemically induced , Skin Ulcer/diagnosis
19.
Soud Lek ; 59(3): 26-7, 2014 Jul.
Article En | MEDLINE | ID: mdl-25186774

It is occasionally difficult to distinguish between a self-inflicted bruise and true bruise. The important point of diagnosis is a good, thorough history taking and detailed examination of the affected area.


Contusions/etiology , Violence , Contusions/chemically induced , Heparin/administration & dosage , Heparin/adverse effects , Humans , Male , Middle Aged , Myocardial Infarction/drug therapy , Wounds and Injuries/etiology
20.
Cochrane Database Syst Rev ; (7): CD008077, 2014 Jul 18.
Article En | MEDLINE | ID: mdl-25036897

BACKGROUND: Heparin is an anticoagulant medication that is normally injected subcutaneously. Subcutaneous administration of heparin may result in complications such as bruising, haematoma and pain at the injection site. One of the factors that may affect pain, haematoma and bruising is injection speed. OBJECTIVES: To assess the effects of the duration (speed) of subcutaneous heparin injection on pain, haematoma and bruising at the injection site in people admitted to hospitals or clinics who require treatment with unfractionated heparin or low molecular weight heparin. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched August 2013) and CENTRAL (2013, Issue 7). We searched MEDLINE, EMBASE, CINAHL and two Persian databases Iranmedex and SID (August 2013). SELECTION CRITERIA: We sought randomised controlled trials (RCTs) comparing the effects of different durations of subcutaneous injections of heparin on pain, bruising and haematoma at the injection site. DATA COLLECTION AND ANALYSIS: Two review authors, working independently, extracted data onto a structured form and assessed study quality. We used the criteria recommended by the Cochrane Handbook to assess the quality of included studies. The study outcomes were summarised using quantitative and qualitative methods. MAIN RESULTS: One RCT was identified which met the inclusion criteria, involving 50 participants with a mean age of 55.25 (± 12.37) years. In this trial it was not possible to blind the participants and care givers. The method of sequence generation and allocation concealment was not described. The overall quality of the evidence was moderate due to the single small included study. Each participant had two injections, one in the left side and one in right side of the abdomen. One of these was injected slowly (intervention) and the other was injected fast (control). The second injection was 12 hours after the first injection. The duration of fast injection was 10 seconds and the duration of slow injection was 30 seconds. The study reported a significantly lower pain intensity for slow versus fast injection. The mean pain intensity was 13.9 ± 17.1 mm with the slow injection and 20.6 ± 22.3 mm with the fast injection (P < 0.001). In addition the bruising sizes were smaller with slow injections compared to fast injections at 48 hours follow-up (mean bruising size 18.76 ± 9.32 mm(2) with the slow injection and 109.2 ± 468.66 mm(2) with the fast injection, P = 0.033) and 72 hours follow-up (mean bruising size 21.72 ± 76.16 mm(2) with the slow injection and 110.12 ± 472.86 mm(2) with the fast injection, P = 0.025). The incidence of haematoma was not measured as an outcome. AUTHORS' CONCLUSIONS: There is only limited evidence of any difference in pain intensity and bruising sizes following slow versus fast injections due to the inclusion of only one small unblinded trial. The single included study suggests that slow injection might have slightly lower pain intensity and bruising size at the heparin injection site, but the results should be considered with caution. Until more reliable evidence emerges, slow injection might be the preferred approach.


Anticoagulants/administration & dosage , Contusions/prevention & control , Heparin/administration & dosage , Injections, Subcutaneous/methods , Pain/prevention & control , Anticoagulants/adverse effects , Contusions/chemically induced , Heparin/adverse effects , Humans , Injections, Subcutaneous/adverse effects , Middle Aged , Pain/etiology , Randomized Controlled Trials as Topic , Time Factors
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