[Cost-effectiveness analysis of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in treatment of chronic rhinosinusitis].

This study aims to evaluate the effectiveness and economic efficiency of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of chronic rhinosinusitis(CRS). The randomized controlled trial(RCT) of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS was searched against EMbase, PubMed, Cochrane Library, CNKI, VIP, SinoMed, and Wanfang. The efficacy, nasal mucociliary transport time, and safety of the therapy above in the treatment of CRS were analyzed with single-group rate and Meta-analysis, and the economy and sensitivity were evaluated from the perspective of payer. A total of 9 RCTs were included, including 1 145 patients. Meta-analysis showed that compared with Triamcinolone Acetonide Nasal Spray alone, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS patients increased the effective rate(RR=1.17, 95%CI[1.11, 1.24], P<0.000 01) and shortened the nasal mucociliary transport time(MD=-3.32, 95%CI[-5.86,-0.78], P=0.01), there was no significant difference in the incidence of adverse reactions between the two groups. The incremental cost-effectiveness analysis showed that the treatment costs of the control group and the observation group were 44.15 yuan and 1 044.96 yuan, respectively. In the Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray treatment group, 75.48 yuan was spent to improve the effective rate of CRS by 1%. The one-way sensitivity analysis indicated the days of treatment, the RR of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray, the price of unit preparation of Biyuan Tongqiao Granules, and the effective rate of Triamcinolone Acetonide Nasal Spray alone had great influence on the incremental cost-effectiveness ratio. In conclusion, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray improves the therapeutic effect on CRS. The probabilistic sensitivity analysis showed that when the willingness to pay was greater than 7 920 yuan(less than 0.1 of GDP per capita 8 098 yuan), the combined therapy was economically superior to the control. Due to the limited number of articles published, it is necessary to carry out a real-world clinical trial of Biyuan Tongqiao Gra-nules and Triamcinolone Acetonide Nasal Spray in the treatment of CRS, so as to compare the cost-effectiveness of Biyuan Tongqiao Granules and Triamcinolone Acetonide Nasal Spray.

A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study.

Background: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Proliferative vitreoretinopathy is the most common cause of retinal detachment and visual loss in eyes with open globe trauma. There is evidence from experimental studies and pilot clinical trials that the use of adjunctive steroid medication triamcinolone acetonide can reduce the incidence of proliferative vitreoretinopathy and improve outcomes of surgery for open globe trauma. Objective: The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study aimed to investigate the clinical effectiveness of adjunctive triamcinolone acetonide given at the time of vitreoretinal surgery for open globe trauma. Design: A phase 3 multicentre double-masked randomised controlled trial randomising patients undergoing vitrectomy following open globe trauma to either adjunctive triamcinolone acetonide or standard care. Setting: Hospital vitreoretinal surgical services dealing with open globe trauma. Participants: Patients undergoing vitrectomy surgery who had sustained open globe trauma. Interventions: Triamcinolone acetonide 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml sub-Tenon's or standard vitreoretinal surgery and postoperative care. Main outcome measures: The primary outcome was the proportion of patients with at least 10 letters of improvement in corrected visual acuity at six months. Secondary outcomes included retinal detachment secondary to proliferative vitreoretinopathy, retinal reattachment, macula reattachment, tractional retinal detachment, number of operations, hypotony, elevated intraocular pressure and quality of life. Health-related quality of life was assessed using the EuroQol Five Domain and Visual Function Questionnaire 25 questionnaires. Results: A total of 280 patients were randomised; 129 were analysed from the control group and 130 from the treatment group. The treatment group appeared, by chance, to have more severe pathology on presentation. The primary outcome (improvement in visual acuity) and principal secondary outcome (change in visual acuity) did not demonstrate any treatment benefit for triamcinolone acetonide. The proportion of patients with improvement in visual acuity was 47% for triamcinolone acetonide and 43% for standard care (odds ratio 1.03, 95% confidence interval 0.61 to 1.75, p = 0.908); the baseline adjusted mean difference in the six-month change in visual acuity was -2.65 (95% confidence interval -9.22 to 3.92, p = 0.430) for triamcinolone acetonide relative to control. Similarly, the secondary outcome measures failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal reattachment and stable macular retinal reattachment, outcomes for the treatment group were significantly worse for triamcinolone acetonide at the 5% level (respectively, odds ratio 0.59, 95% confidence interval 0.36 to 0.99, p = 0.044 and odds ratio 0.59, 95% confidence interval 0.35 to 0.98, p = 0.041) compared with control in favour of control. The cost of the intervention was £132 per patient. Health economics outcome measures (Early Treatment Diabetic Retinopathy Study, Visual Function Questionnaire 25 and EuroQol Five Dimensions) did not demonstrate any significant difference in quality-adjusted life-years. Conclusions: The use of combined intraocular and sub-Tenon's capsule triamcinolone acetonide is not recommended as an adjunct to vitrectomy surgery for intraocular trauma. Secondary outcome measures are suggestive of a negative effect of the adjunct, although the treatment group appeared to have more severe pathology on presentation. Future work: The use of alternative adjunctive medications in cases undergoing surgery for open globe trauma should be investigated. Refinement of clinical grading and case selection will enable better trail design for future studies. Trial registration: This trial is registered as ISRCTN 30012492, EudraCT number 2014-002193-37, REC 14/LNO/1428, IRAS 156358, Local R&D registration CHAD 1031. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (12/35/64) and will be published in full in Health Technology Assessment; Vol. 27, No. 12. See the NIHR Journals Library website for further project information.

Despite advances in surgical techniques, eye trauma remains a leading cause of blindness and visual impairment. The main cause of trauma is a scarring process within the eye ­ proliferative vitreoretinopathy. There is good evidence from laboratory work and small-scale clinical studies that the addition of a steroid medication, triamcinolone acetonide, given in and around the eye at the time of surgery for eye trauma, can reduce the incidence of proliferative vitreoretinopathy scarring and improve the outcomes of surgery. The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study was a multicentre clinical trial designed to test the use of triamcinolone acetonide as an addition to surgery to improve outcomes in eyes with 'open globe' penetrating injuries. A total of 280 patients were recruited and randomised to receive standard surgery or surgery with the additional steroid (triamcinolone acetonide). No benefit was found from the addition of the steroid medication. The addition of steroid medication was not good value for money. Secondary outcome measures suggested that triamcinolone acetonide may have had a negative effect on outcomes, although this may have been due to the presence of more severe cases amongst the patients allocated to receive the additional steroid (triamcinolone acetonide). The use of adjunctive triamcinolone acetonide in eye trauma cases undergoing surgery is therefore not recommended. Future studies with different additional medications and/or more targeted case selection are indicated to improve outcomes for eyes experiencing penetrating trauma.

Clinical and biochemical assessment of the effect of topical use of coenzyme Q10 versus topical corticosteroid in management of symptomatic oral lichen planus: randomized controlled clinical trial.

BACKGROUND: Oral lichen planus (OLP) is a chronic mucocutaneous immunologically mediated condition that has a great adverse effect on oral functions. Corticosteroids are still the first drugs of choice used in the treatment of OLP; however, they have extensive medical side effects. The present study was carried out to assess the clinical therapeutic effect of the topical use of coenzyme Q10 (coQ10 or ubiquinol) versus topical corticosteroids in the management of symptomatic OLP and to determine whether the effect, if any, was due to the powerful antioxidant activity of coQ10. SUBJECTS AND METHODS: We performed a randomized, double blinded controlled trial at the Faculty of Dentistry, Cairo University, Egypt. The study was conducted on 34 patients suffering from symptomatic OLP. Patients were randomly divided into two groups: intervention group (I),who received topical CoQ10 in the form of mucoadhesive tablets (40% CoQ10) 3 times daily for one month and control group (II),who received topical corticosteroid (kenacort in Orabase: triamcinolone acetonide 0.1% 5-g adhesive paste - dermapharm), 4 times daily for one month. Patients were evaluated at one-week intervals using the clinical parameters (score) of pain (VAS) and lesion size. Additionally, salivary levels of malondialdehyde (MDA) were detected in both groups before and after treatment using ELISA. All recorded data were analysed using independent t test, ANOVA followed by Bonferroni post hoc test for lesion size and salivary level of MDA data and Mann-Whitney U test and Friedman test for VAS data. RESULTS: Both groups showed a significant reduction in pain and the size of the lesions (p ≤ 0.05) with no statistically significant difference between them (p > 0.05), and this clinical improvement was associated with a reduction in the salivary levels of MDA in both groups. CONCLUSIONS: The topical use of CoQ10 mucoadhesive tablets was as effective as the topical use of triamcinolone acetonide, and its clinical effect was associated with a reduction in the salivary level of MDA. TRIAL REGISTRATION: The study protocol was registered at www. CLINICALTRIAL: gov (NCT04091698) and registration date: 17/9/2019.

An ultralow-cost portable centrifuge from discarded materials for medical applications.

Reliable centrifugation for medical applications has historically required access to expensive, bulky, and electricity-dependent commercial devices, which are generally unavailable in resource-poor settings. Although several portable, low-cost, non-electric centrifuges have been described, these solutions have predominately been designed for diagnostic applications requiring sedimentation of relatively small volumes. Moreover, construction of these devices frequently requires access to specialized materials and tools that are often unavailable in underserved areas. Herein, we describe the design, assembly, and experimental validation of the CentREUSE-an ultralow-cost, portable, discarded material-based, human-powered centrifuge for use in therapeutic applications. The CentREUSE demonstrated a mean centrifugal force of 10.5 relative centrifugal force (RCF) ± 1.3. Sedimentation of 1.0 mL triamcinolone acetonide suspension for intravitreal use after 3 min of CentREUSE centrifugation was comparable to that achieved after 12 h of gravity-mediated sedimentation (0.41 mL ± 0.04 vs. 0.38 mL ± 0.03, p = 0.14). Sediment compactness after 5 min and 10 min of CentREUSE centrifugation was similar to that observed after centrifugation with a commercial device for 5 min at 10 RCF (0.31 mL ± 0.02 vs. 0.32 mL ± 0.03, p = 0.20) and 50 RCF (0.20 mL ± 0.02 vs. 0.19 mL ± 0.01, p = 0.15), respectively. Templates and instructions for construction of the CentREUSE are included as part of this open-source publication.

Silicone gel sheeting for treating keloid scars.

BACKGROUND: Keloid scarring is one of the most common types of pathological scarring. Keloid scars that fail to heal can affect a person's physical and psychological function by causing pain, pruritus, contractures, and cosmetic disfigurement. Silicone gel sheeting (SGS) is made from medical-grade silicone reinforced with a silicone membrane backing and is one of the most commonly used treatments for keloid scars. However, there is no up-to-date systematic review assessing the effectiveness of SGS for keloid scars. A clear and rigorous review of current evidence is required to guide clinicians, healthcare managers and people with keloid scarring. OBJECTIVES: To assess the effectiveness of silicone gel sheeting for the treatment of keloid scars compared with standard care or other therapies. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was December 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that recruited people with any keloid scars and assessed the effectiveness of SGS. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment, data extraction and GRADE assessment of the certainty of evidence. We resolved initial disagreements by discussion, or by consulting a third review author when necessary. MAIN RESULTS: Two studies met the inclusion criteria. Study sample sizes were 16 and 20 participants. The trials were clinically heterogeneous with differences in causes for scarring (e.g. surgery, infected wounds, and trauma), site (e.g. chest and back), and ages of scars. The duration of follow-up was three and four and a half months. The included studies reported three comparisons; SGS compared with no treatment, SGS compared with non-silicone gel sheeting (a dressing similar to SGS but which does not contain silicone), and SGS compared with intralesional injections of triamcinolone acetonide. One trial had a split-body design and one trial had an unclear design (resulting in a mix of paired and clustered data). The included studies reported limited outcome data for the primary review outcome of scar severity measured by health professionals and no data were reported for severity of scar measured by patients or adverse events. For secondary outcomes some data on pain were reported, but health-related quality of life and cost-effectiveness were not reported. Both trials had suboptimal outcome reporting, thus many domains in the risk of bias were assessed as unclear. All evidence was rated as being very low-certainty, mainly due to risk of bias, indirectness, and imprecision.  SGS compared with no treatment Two studies with 33 participants (76 scars) reported the severity of scar assessed by health professionals, and we are uncertain about the effect of SGS on scar severity compared with no treatment (very low-certainty evidence, downgraded once for risk of bias, once for inconsistency, once for indirectness, and once for imprecision). We are uncertain about the effect of SGS on pain compared with no treatment (21 participants with 40 scars; very low-certainty evidence, downgraded once for risk of bias, once for inconsistency, once for indirectness, and once for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness. SGS compared with non-SGS One study with 16 participants (25 scars) was included in this comparison. We are uncertain about the effect of SGS on scar severity assessed by health professionals compared with non-SGS (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). We are also uncertain about the effect of SGS on pain compared with non-SGS (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness. SGS compared with intralesional injections of triamcinolone acetonide One study with 17 participants (51 scars) reported scar severity assessed by health professionals, and we are uncertain about the effect of SGS on scar severity compared with intralesional injections of triamcinolone acetonide (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). This study also reported pain assessed by health professionals among 5 participants (15 scars) and we are uncertain about the effect of SGS on pain compared with intralesional injections of triamcinolone acetonide (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and twice for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness. AUTHORS' CONCLUSIONS: There is currently a lack of RCT evidence about the clinical effectiveness of SGS in the treatment of keloid scars. From the two studies identified, there is insufficient evidence to demonstrate whether the use of SGS compared with no treatment, non-SGS, or intralesional injections of triamcinolone acetonide makes any difference in the treatment of keloid scars. Evidence from the included studies is of very low certainty, mainly driven by the risk of bias, indirectness, and imprecision due to small sample size. Further well-designed studies that have good reporting methodologies and address important clinical, quality of life and economic outcomes are required to reduce uncertainty around decision-making in the use of SGS to treat keloid scars.

Suprachoroidal Injection of Triamcinolone Acetonide Injectable Suspension for the Treatment of Macular Edema Associated With Uveitis in the United States: A Cost-Effectiveness Analysis.

OBJECTIVES: Suprachoroidal injection of triamcinolone acetonide is the first Food and Drug Administration-approved treatment for macular edema associated with uveitis. A cost-effectiveness analysis was performed comparing this treatment with best supportive care (BSC) for the management of this indication from US Medicare and commercial payer perspectives. METHODS: A patient-level simulation was developed per the patient characteristics and changes in best-corrected visual acuity letter scores observed in a phase III study of triamcinolone acetonide (PEACHTREE). The wholesale acquisition cost of triamcinolone acetonide was $1650/injection; suprachoroidal injection cost was assumed at $200/injection. Healthcare costs were informed by a US claims-based analysis. Mortality risk associated with severe vision loss and blindness was modeled by applying a hazard ratio to all-cause mortality rates of the US general population. Health-related quality of life weights, obtained from a regression model fitted to the Visual Function Questionnaire-25 data from PEACHTREE, were applied based on the best-corrected visual acuity scores of both eyes. Costs (2020 US dollar) and benefits were discounted at 3% annually. Incremental cost-effectiveness ratios were estimated over a 10-year horizon. RESULTS: In the base-case, the incremental cost-effectiveness ratio comparing triamcinolone acetonide with BSC was $28 479 per quality-adjusted life-year gained. The wholesale acquisition cost for triamcinolone acetonide for suprachoroidal use was ∼68%, ∼56%, and ∼27% below the willingness-to-pay thresholds of $150 000, $100 000, and $50 000 per quality-adjusted life-year gained, respectively. Results were robust in sensitivity and scenario analyses. CONCLUSIONS: Triamcinolone acetonide for suprachoroidal use is cost-effective compared with BSC for patients with macular edema associated with uveitis.

Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6.

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema after cataract surgery in diabetic patients. SETTING: 7 ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial. METHODS: Diabetic patients (n = 163) undergoing uneventful cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n = 36), perioperative intravitreal bevacizumab (n = 36), combination treatment (n = 45), or no additional treatment (control group, n = 46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY). RESULTS: The mean total healthcare costs and QALYs were as follows: triamcinolone group €1827 (U.S. dollars [$] 2295)/0.166; bevacizumab group €2050 ($2575)/0.144; combination group €2027 ($2546)/0.166; and control group €2041 ($2564)/0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was €321 984 ($404 503) per QALY for the combination group compared with that of the triamcinolone group. Assuming the willingness-to-pay as €20 000 ($25 126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient who received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone. CONCLUSIONS: In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed that triamcinolone is also cost-effective.

Assessment of various intralesional injections in keloid: comparative analysis.

 : In reaction to skin injury in genetically predisposed persons, the keloid is formed and marked by benignant overgrowth of dermic collagen. Intralesional triamcinolone was used in the treatment of keloids with varying results. AIM: Intralesional triamcinolone is a gold standard in treating the keloids in comparison with its effectiveness versus intralesional 5-fluorouracil intralesional verapamil and intralesional platelet-rich plasma. PATIENTS AND METHODS: Several 160 cases were categorized into four groups of each group-containing 40 cases. Group-A (control) treated with intralesional triamcinolone and Group-B intralesional verapamil, Group-C intralesional 5-fluorouracil, and Group-D intralesional platelet-rich plasma. Patients were assessed for clinical response based on a decrease in the patient and observer scar assessment scale (POSAS) at baseline and the end of treatment. RESULTS: The mean base-line POSAS score was 91 ± 10.98 SD check-in Group-A, 90 ± 10.85 in Group-B, 89 ± 10.06 in Group-C, and 92 ± 10.84 in Group-D. POSAS score after 24 weeks 36 ± 12.74 in Group-A, 29 ± 10.91 in Group-B, 39 ± 13.74 in Group-C, 36 ± 12.74 in Group-D. Statistically, a significant difference was observed between groups. CONCLUSION: Intralesional verapamil reported to be the most effective therapy and platelet-rich plasma was effective as intralesional triamcinolone acetonide with no serious side effects and 5-fluorouracil was less effective in treating the keloids.

TRENDS IN INTRAVITREAL CORTICOSTEROID AGENT USE BY US OPHTHALMOLOGISTS IN MEDICARE BENEFICIARIES AND ASSOCIATION WITH PHYSICIAN-INDUSTRY INTERACTIONS.

PURPOSE: To report trends of intravitreal corticosteroid use and explore the relationship between career experience, reported industry payments, and prescribing habits. METHODS: A retrospective review of ophthalmologists who administered intravitreal dexamethasone implants (DEX) and triamcinolone acetonide (TA) injections between August 2013 and December 2017. RESULTS: A total of 1,070 US ophthalmologists were reimbursed by Medicare for 522,804 DEX injections and 2.6 million TA injections. There was a significant positive trend in the number of DEX (P = 0.01), but not TA, injections per year. Mid-career and late-career physicians performed significantly greater total injections on average compared with early-career physicians (both P < 0.001). Early-career physicians performed a greater proportion of DEX injections than late-career physicians (P = 0.006). Industry payments were positively associated with the proportion of DEX used and inversely correlated with the proportion of TA administered (P < 0.001). On multivariate analysis, years in practice, number of payments, and total value of payments were significantly associated with the number of DEX injections administered (all P < 0.001). CONCLUSION: From 2013 to 2017, the use of DEX increased, whereas TA use remained stable. There was a positive association between DEX use and physician-industry interactions, which may be explained by seniority and experience. This study does not define a causal relationship.

Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial.

BACKGROUND: Whether they are injected peri- or intraocularly, corticosteroids are still essential tools in the therapeutic arsenal for treating inflammatory macular oedema. A few years ago, however, only triamcinolone acetonide was available to ophthalmologists. While this compound was initially developed for rheumatological or dermatological use, it has been increasingly deployed in ophthalmology, despite still being off-label. In 2011, the system for delivery of dexamethasone from a biodegradable, injectable implant into the vitreous cavity obtained approval for use in inflammatory macular oedema. While the efficacy and safety of triamcinolone in macular oedema, including inflammatory oedema, have already been studied, there are currently no publications on subconjunctival triamcinolone injections, which are simple, effective and well tolerated. To date, the dexamethasone 700 µg implant has been authorized for the treatment of noninfectious intermediate and posterior uveitis, but there have been no studies to evaluate the efficacy and safety of the different peri- and intraocular strategies, including the treatment of inflammatory macular oedema. METHODS: This protocol is therefore designed to compare the efficacy and safety of peri- and intraocular corticosteroid injections in the treatment of inflammatory macular oedema. In this ongoing study, 142 patients will be included, and the oedematous eye will be randomised to treatment with either subconjunctival triamcinolone injection or an intravitreal implant containing 700 µg dexamethasone. Follow-up is planned for 6 months with monthly visits. Each visit will include visual acuity measurement, a slit lamp examination, fundoscopy, intraocular pressure measurement, laser flare measurement (if available) and spectral domain optical coherence tomography. DISCUSSION: The results of this trial will have a real impact on public health if it is shown that a Kenacort retard® (i.e. triamcinolone) injection costing just €2.84 and performed in the physician's office (with no additional overhead costs) is at least as effective as the dexamethasone 700 µg implant (Ozurdex®; costing approximately €960 with the injection performed in a dedicated room), with no increased side effects. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02556424. Registered on 22 September 2015.

A randomised controlled trial of the clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injections: the hip injection trial (HIT) protocol.

BACKGROUND: Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection. METHODS: The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants' 'average' follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial. DISCUSSION: To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections. TRIAL REGISTRATION: ISRCTN: 50550256 , 28th July 2015.

Post-cataract eye drops can be avoided by depot steroid injections.

There are over 400 000 cataract operations now being performed annually in the UK. With the majority of those patients being older people, comorbidities such as dementia or arthritis can prevent patients putting in their own post-operative eye drops. Where there is a lack of family or other support, district nursing services are often called upon to administer these eye drops, which are typically prescribed four times a day for 4 weeks, thus potentially totalling 112 visits for drop instillation per patient. To reduce the burden of these post-operative eye drops on district nursing services, administration of an intra-operative sub-Tenon's depot steroid injection is possible for cataract patients who then do not require any post-operative drop instillation. As a trial of this practice, 16 such patients were injected in one year, thus providing a reduction of 1792 in the number of visits requested. Taking an estimated cost of each district nurse visit of £38, this shift in practice potentially saved more than £68 000; the additional cost of the injection over the cost of eye drops was just £8.80 for the year. This practice presents an opportunity to protect valuable community nursing resources, but advocacy for change in practice would be needed with secondary care, or via commissioners.

Intra-articular injection with triamcinolone hexacetonide in patients with rheumatoid arthritis: prospective assessment of goniometry and joint inflammation parameters / Injeção intra-articular de hexacetonido de triancinolona em pacientes com artrite reumatoide: avaliação prospectiva da goniometria e parâmetros de inflamação articular

Abstract Objectives: To evaluate local joint variables after intra-articular injection with triamcinolone hexacetonide in rheumatoid arthritis patients. Methods: We blindly and prospectively (baseline, 1, 4, 12 and 24 weeks) evaluated metacarpophalangeal, wrist, elbow, shoulder, knee and ankle joints after triamcinolone hexacetonide intra-articular injection by the following outcome measures: visual analogue scale 0–10 cm (VAS) for rest pain (VASR); VAS for movement pain (VASM); VAS for joint swelling (VASSw); flexion (FlexG) and extension (ExtG). Results: 289 patients (635 joints) were studied. VASSw (p < 0.001) and VASR (0.001 < p < 0.016) improved from T0 to T4, T12 and T24 for all joints. VASM improved from T0 to T4 (p < 0.021) for all joints; T0 to T12 (p < 0.023) for MCF and knee; T0 to T24 (p < 0.019) only for MCF and knee. FlexG improved from T0 to T4 (p < 0.001) for all joints; T0 to T12 (p < 0.001) and T0 to T24 (p < 0.02) only for MCF and knee. ExtG improved from T0 to T4 (p < 0.001) for all joints except for elbow; T0 to T12 (p = 0.003) for wrist, metacarpophalangeal and knee; and T0 to T24 (p = 0.014) for MCF and knee. Conclusion: VASSw responded better at short and medium term after IAI with triamcinolone hexacetonide in our sample of RA patients.

Resumo Objetivos: Avaliar variáveis articulares locais após a injeção intra-articular (IIA) de hexacetonido de triancinolona (HT) em pacientes com artrite reumatoide (AR). Métodos: Avaliaram-se de modo cego e prospectivo (inicial, 1, 4, 12 e 24 semanas) as articulações metacarpofalângica (MCF), punho, cotovelo, ombro, joelho e tornozelo após a IIA de HT à procura das seguintes medidas de desfecho: escala visual analógica (EVA) de 0 a 10 cm para dor em repouso (EVAr); EVA para dor ao movimento (EVAm); EVA para inchaço das articulações (EVAi); flexão (FlexG) e extensão (ExtG). Resultados; Estudaram-se 289 pacientes (635 articulações). A EVAi (p < 0,001) e a EVAr (0,001 < p < 0,016) melhoraram de T0 a T4, T12 e T24 em todas as articulações. A EVAm melhorou de T0-T4 (p < 0,021) em todas as articulações; T0-T12 (p < 0,023) na MCF e no joelho; T0-T24 (p < 0,019) apenas na MCF e no joelho. A FlexG melhorou de T0-T4 (p < 0,001) em todas as articulações; T0-T12 (p < 0,001) e T0-T24 (p < 0,02) apenas na MCF e no joelho. A ExtG melhorou de T0-T4 (p < 0,001) em todas as articulações, exceto no cotovelo; T0-T12 (p = 0,003) no punho, na MCF e no joelho; e T0-T24 (p = 0,014) na MCF e no joelho. Conclusão: A EVAi respondeu melhor em curto e médio prazos após a IIA de HT na presente amostra de pacientes com AR.

Intra-articular injection with triamcinolone hexacetonide in patients with rheumatoid arthritis: prospective assessment of goniometry and joint inflammation parameters.

OBJECTIVES: To evaluate local joint variables after intra-articular injection with triamcinolone hexacetonide in rheumatoid arthritis patients. METHODS: We blindly and prospectively (baseline, 1, 4, 12 and 24 weeks) evaluated metacarpophalangeal, wrist, elbow, shoulder, knee and ankle joints after triamcinolone hexacetonide intra-articular injection by the following outcome measures: visual analogue scale 0-10cm (VAS) for rest pain (VASR); VAS for movement pain (VASM); VAS for joint swelling (VASSw); flexion (FlexG) and extension (ExtG). RESULTS: 289 patients (635 joints) were studied. VASSw (p<0.001) and VASR (0.001

Eficacia y seguridad de triamcinolona acetónido intralesional como tratamiento de cicatrices hipertroficas o queloides post quemadura / Efficacy and safety of triamcinolone acetonide intralesional as treatment of hypertrophic scars or post-burn keloids

INTRODUCCIÓN: Antecedentes: El Instituto de Evaluación de Tecnologías en Salud e Investigación ha recibido la solicitud de evaluar el uso de triamcinolona inyectable para su uso en pacientes con cicatrices post quemadura dentro del sistema de EsSalud, indicación actualmente no contemplada en el petitorio de medicamentos. Aspectos Generales: Los queloides y las cicatrices hipertróficas representan una respuesta exagerada del tejido hacia un daño dérmico y caracterizado por proliferación local de fibroblastos con sobreproducción de colágeno. En el caso de queloides el crecimiento del tejido fibroso se extiende más allá del área original de la lesión, comprometiendo también a la piel normal adyacente. En cambio, las cicatrices hipertróficas pueden tener una apariencia clínica similar, pero en contraste a los queloides, permancen confinados a los limites del área de la herida y tienden a regresionar espontáneamente. Ambos tipos de lesiones cicatricilaes pueden causar afectación de la funcionalidad y deformidad cosmética y están frecuentemente asociados con disminución de la calidad de vida de los pacientes afectados. Tecnología Sanitaria de Interés: Acetónido de triamcinolona es un glucocorticoide con marcada acción antiinflamatoria. La presentación en suspensión estéril para inyectable se usa para la administración intra-articular. Cada ml de la solución acuosa provee 10 mg de acetónido de triamcinolona. Contienen a benzil alcohol como preservante. La administración intralesional de la inyección de acetónido de triamcinolona está indicada para la alopecia areata, lupus eritematoso discoide, queloides y placas de psoriasis. METODOLOGÍA: Estratégia de Búsqueda: Se realizó una búsqueda de la literatura con respecto a la eficacia y seguridad de triamcinoloma intralesional para el tratamiento de las cicatrices hipertróficas y queloides en las bases de datos de MEDLINE, EMBASE, CENTRAL, DARE y TRIPDATASE. Adicionalmente, se hizo una búsqueda dentro de la información generada por las principales agencias de tecnologías sanitarias que realizan revisiones sistemáticas (RS), evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC). RESULTADOS: Sinopsis de la Evidencia: Se realizó la búsqueda bibliográfica y de evidencia científica que sustente el uso de acetónido de triamcinolona intralesional en el tratamiento de las cicatrices hipertróficas o queloides según la pregunta PICO establecida. Para el presente documento se seleccionó el siguiente cuerpo de evidencia: Guías Clínicas: Se identificó una única guía consensuada de recomendaciones en el manejo de las cicatrices. No se identifcó evidencias sobre el uso de acetónido de triamcinolona intralesional en el tratamiento de las cicatrices hipertróficas o queloides para Evaluaciones de tecnologías sanitaria, Revisiones sistemáticas y Ensayos clínicos. Revisiones narraticas: Se indentificaron tres revisiones que incluyeron la descripción de estudios de series de casos y un estudo prospectivo del uso de triamcinolona. CONCLUSIONES: Los hallazgos de las mejoras del volumen de las cicatrices hipertróficas y queloides proviene de estudios de baja calidad. Se trataron principalmente de reportes de casos con dismiles dosis y regimenes de adminstración de triamcinolona y con mediciones poco claras, insuficientes e consistentes de desenlaces de respuesta al tratamiento. Actualmente, el tratamiento de las cicatrices presenta varios retos derivados de la complejidad de los mecanismos patofisiológicos, la dificuldad para cuantificar los cambios de la cicatriz y estudios de baja calidad metodológica. Como resultado, el manejo ha diso dirigido por la experiencia del clínico. El uso de corticoesteroides intralesionales como la triamcinolona, está recomendado generalmente como segunda línea de tratamiento después del uso de estrategias dirigidas a contener o prevenir el desarrollo de cicatrices.La población objetivo de esta evaluación sufren de cicatrices que tienen un impacto importante a nivel funcional y sociológico, por lo que requieren que se los ofrezca opciones con potencial benefício como los corticoesteroides intralesionales. El tratamiento con triamcinolona no supone una complejidade importante en su aplicación y de bajo costo. Además, los efectos adversos observados con su uso son generalmente locales y de baja gravedad. El Instituto de Evaluación de Tecnologías Sanitarias-IETSI, aprueba por el período de 2 años a partir de la fecha de publicación del presente dictamen preliminar, el uso de triamcinolona acetónido intralesional para el tratamiento de pacientes con cicatrices hipertróficas o queloides post quemadura.

Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial.

BACKGROUND: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss involves posterior segment (vitreoretinal) surgery. Despite improvements in vitreoretinal surgical techniques, outcomes in these patients remain unsatisfactory, and development of the intraocular scarring response proliferative vitreoretinopathy is the leading cause. Proliferative vitreoretinopathy is the most common cause of recurrent retinal detachment in these eyes; it is reported to occur in up to 45 % of cases. METHODS/DESIGN: The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a multi-centre, double-masked, parallel-arm randomised controlled trial with an internal pilot designed to investigate the effectiveness and cost-effectiveness of using intravitreal and sub-Tenon's triamcinolone acetonide peri-operatively in patients undergoing vitrectomy following open globe trauma. In total, 300 eyes of 300 patients will be recruited and randomly allocated to one of two treatment groups. Both groups will receive standard surgical treatment and routine pre-operative and post-operative treatment and care. The treatment group will receive an adjunctive peri-operative steroid combination (triamcinolone acetonide) consisting of 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml into the sub-Tenon's space. The trial incorporates a two-stage internal pilot to examine projected recruitment and retention rates. Progression criteria from the internal pilot study will enable us to determine whether to undertake the main trial. Patients and primary outcome assessors will be masked to treatment allocation. The primary outcome will be an improvement from baseline to 6 months of at least 10 on the corrected visual acuity as measured by ETDRS letter score. Secondary outcomes will be development of scarring, retinal detachment, intraocular pressure abnormalities, quality of life and public sector service use. DISCUSSION: This is the first powered, controlled clinical trial to investigate the use of adjunctive triamcinolone in patients undergoing vitrectomy following open globe trauma. TRIAL REGISTRATION: EudraCT2014-002193-37 . Registered on 5 September 2014. ISRCTN30012492 . Registered on 5 September 2014.

Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in combination with process capability index.

An ultra high performance liquid chromatography method was developed and validated for the quantitation of triamcinolone acetonide in an injectable ophthalmic hydrogel to determine the contribution of analytical method error in the content uniformity measurement. During the development phase, the design of experiments/design space strategy was used. For this, the free R-program was used as a commercial software alternative, a fast efficient tool for data analysis. The process capability index was used to find the permitted level of variation for each factor and to define the design space. All these aspects were analyzed and discussed under different experimental conditions by the Monte Carlo simulation method. Second, a pre-study validation procedure was performed in accordance with the International Conference on Harmonization guidelines. The validated method was applied for the determination of uniformity of dosage units and the reasons for variability (inhomogeneity and the analytical method error) were analyzed based on the overall uncertainty.

Management of Stenosing Flexor Tenosynovitis: Maximizing Nonoperative Success without Increasing Morbidity.

BACKGROUND: Traditional nonoperative management of stenosing tenosynovitis is limited to one corticosteroid injection, followed by surgery in the case of failure. Recently, nonoperative strategies have been extended to include two or three injections despite the absence of large prospective studies supporting this practice. METHODS: A prospective study was performed of all patients presenting with stenosing tenosynovitis to a single surgeon (R.S.R.) over a 22-year period. Patients with potentially confounding comorbidities were excluded. All digits received one to three injections of triamcinolone acetonide plus local anesthetic into the tendon sheath. Data were analyzed by digit. RESULTS: Five hundred seventy-one digits (401 patients) were included. Digits that were symptomatic for 3 months or less were more likely to resolve after one injection than those that were symptomatic for more than 3 months (OR, 2.6; 95 percent CI, 1.67 to 4.0; p < 0.01). For the digits that failed to resolve after the first injection, those that were symptomatic for 5 months or less before one injection were more likely to respond to a second injection than those that were symptomatic for more than 5 months (OR, 9.4; 95 percent CI, 3.0 to 29.7; p < 0.01). Eight digits received three injections, after which six (75 percent) achieved remission. There were no instances of tendon/pulley rupture, infection, or soft-tissue atrophy. CONCLUSIONS: Stenosing tenosynovitis is more likely to respond to nonoperative therapy when treated before 3 months. It is safe and effective to administer more than one corticosteroid injection, as second and third doses increase the overall remission rate without increasing morbidity. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Different Entry Site Efficacy of Knee Intra-articular Injections.

BACKGROUND: Complaints of knee pain secondary to early osteoarthritis may account for up to 30% of visits to primary care physicians. Due to the proposed inflammatory changes in early osteoarthritis, intra-articular injections of corticosteroids (IACS) have been considered as an option for disease progression modification, pain control, and improvement of function. However, some studies have suggested poor accuracy rates of IA injections depending on the entry site chosen. It is therefore the aim of this study to evaluate the efficacy of IA knee corticosteroid injection in reducing pain and improving function in patients with early osteoarthritis and whether the low accuracy rates reported with the Anterolateral joint line injection site translate to worse functional and pain outcome measures as compared to Suprapatellar lateral injections. MATERIALS AND METHODS: The study was carried out as an open-label, randomized controlled trial with 60 sequential patients recruited. Simple randomization separated groups into anterolateral joint line or suprapatellar lateral injection sites. Improvements were measured with WOMAC and VAS scores after injection of Lidocaine and steroid solution. RESULTS: Patients receiving IACS injections had a measurable improvement in self-reported outcomes as evidenced by standard deviation change in WOMAC and VAS scores. The majority of patients had a clinically significant improvement in VAS scores as compared to their initial measures with a notable amount of patients improving significantly as well on their WOMAC scores, irrespective of the injection site chosen. CONCLUSIONS: We have therefore continued the use of palpation-guided intra-articular knee injections in an effort to reduce costs as compared to other injection modalities with positive results in our osteoarthritis patients.

THE OMAR STUDY: Comparison of Ozurdex and Triamcinolone Acetonide for Refractory Cystoid Macular Edema in Retinal Vein Occlusion.

PURPOSE: To compare the risks and benefits of adding either intravitreal dexamethasone implant (DEX) or preservative-free triamcinolone acetonide (TA) to bevacizumab monotherapy in refractory cystoid macular edema due to retinal vein occlusion. METHODS: This is a multicenter, comparative, interventional, retrospective study that included 74 patients who were initially treated with intravitreal bevacizumab and later received either DEX or TA for the treatment of recalcitrant cystoid macular edema due to retinal vein occlusion. Main outcomes were best-corrected visual acuity, central macular thickness, cost of therapy, frequency of intravitreal injections, and side effects. RESULTS: Thirty-nine patients received TA and 35 patients received DEX injections. Groups were similar in age and gender distribution. Although the mean central macular thickness improved significantly for all groups (P < 0.0001), logMAR best-corrected visual acuity did not change significantly after steroid introduction (P = 0.06). Frequency of any intravitreal injection decreased significantly from 0.66 ± 0.18 to 0.26 ± 0.08 injections per month after initiation of steroids (P < 0.0001). This effect was greater in the DEX groups (P < 0.0001). Monthly cost decreased with TA but increased with DEX. CONCLUSION: Adding steroids improved anatomical outcome but did not affect final vision. Injection frequency decreased significantly after adding steroids, more so with DEX. There was no difference between TA and DEX regarding anatomical or functional outcomes or the incidence of side effects.