[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.

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.

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.

Laser fluorescence assessment of the root canal using plain and conical optical fibers.

INTRODUCTION: Traditional culture-based techniques for assessing infection of the root canal system are difficult to use and prone to error. Real-time assessment of the microbial status of the root canal system using laser fluorescence would help address these limitations. METHODS: This study evaluated the performance of thin optical fibers of different diameters, with either plain or conically modified ends, connected to a KaVo KEY 3 laser with an inbuilt 655-nm laser fluorescence diagnostic system. Penetration was tested on sectioned extracted teeth. Fluorescence recordings were made ex vivo in the canals of extracted teeth with known periapical pathology. Several endodontic medicaments and irrigants were also tested for autofluorescence. RESULTS: The fibers could reach the apical third of the root canal, unless the canals had distal curvatures greater than 15 degrees . Penetration was greater for conical than for plain fibers. Fluorescence readings were significantly higher in infected canals (range, 19-99) than in noninfected canals and sound radicular dentin (range, 2-8). Of the medicaments examined, only tetracycline-based medicaments gave false-positive fluorescence signals. CONCLUSIONS: Fluorescence analysis of root canals with optical fiber probes has the potential for real-time assessment of the microbial status of the root canal system in clinical practice.

Triamcinolone-assisted internal limiting membrane peeling.

PURPOSE: To review our experience with triamcinolone-assisted pars plana vitrectomy for internal limiting membrane (ILM) peeling for various retinal diseases. METHODS: Twenty-one patients underwent surgery in which intraoperative triamcinolone acetonide (TA) was used. Indications for surgery included epiretinal membrane (3 patients), branch retinal vein occlusion associated with macular edema (2), traction retinal detachment (3), diabetic macular edema (4), vitreous hemorrhage with diabetic macular edema (4), macular hole (4), and cystoid macular edema (1). RESULTS: TA was useful in the removal of the ILM in all cases. There were no intraoperative complications or toxicity. The mean follow-up was 22 weeks (range, 9-30 weeks). Eleven patients improved by >or=2 Snellen lines, 1 lost >or=2 Snellen lines, and 9 were within 2 Snellen lines of preoperative vision at the last follow-up. CONCLUSIONS: The intraoperative use of TA improves visualization of ILMs associated with a variety of conditions. No intraoperative or postoperative complications were observed. TA-assisted removal of the ILM appears to be safe and cost effective. TA-assisted ILM peeling should be considered as an alternative to the use of intraoperative dyes.

Improved risk-benefit ratio for topical triamcinolone acetonide in Transfersome in comparison with equipotent cream and ointment: a randomized controlled trial.

BACKGROUND: Transfersome is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively. OBJECTIVES: To assess the advantages of this carrier-based formulation in humans, the efficacy and the atrophogenic potential of triamcinolone acetonide (TAC) in Transfersome was compared with commercially available TAC-containing cream and ointment. METHODS: Healthy volunteers were enrolled in double-blind, placebo-controlled clinical trials with random study medication assignment to the test areas. RESULTS: A 10-fold lower dose of TAC in Transfersome(R) (2.5 micro g cm-2) was bioequivalent to 25 micro g cm-2 TAC in conventional formulations as measured by erythema suppression (cream: P = 0.01, ointment: P < 0.001). A skin blanching assay revealed different kinetics of the formulations, with a delayed onset of action of the Transfersome and ointment preparations. Ultrasonic measurements revealed a significantly reduced atrophogenic potential. There was a 12.1% reduction in skin thickness given by TAC in Transfersome compared with a 21.1% reduction given by a bioequivalent dose in TAC cream after a 6-week treatment period (P = 0.007). CONCLUSIONS: Transfersome may significantly improve the risk-benefit ratio of topically applied glucocorticosteroids.

A risk-benefit assessment of intranasal triamcinolone acetonide in allergic rhinitis.

The efficacy of intranasal triamcinolone acetonide in seasonal and allergic rhinitis has been evaluated in clinical trials and has been compared with antihistamines and other intranasal corticosteroids. Intranasal corticosteroids are either as equally effective as or more effective than comparative drugs. Intranasal corticosteroids are particularly useful as they decrease membrane permeability and inhibit both early and late phase reactions to allergens. They minimise the nasal secretory response and reduce the sensitivity of local nasal irritant receptors. A potential benefit of topical application is the flushing action of the nasal mucosa, which may reduce allergens and secretions. In addition to seasonal and perennial rhinitis, intranasal corticosteroids have additional benefits when used to reduce inflammation in the treatment of sinusitis and may help in decreasing secondary rhinovirus infections. Furthermore, suboptimal control of asthma can be avoided by treatment of allergic rhinitis with intranasal corticosteroids. In clinical trials, common adverse effects for triamcinolone acetonide include sneezing, dry, mucosa, nasal irritation, sinus discomfort, throat discomfort, epistaxis and headache. Posterior subcapsular cataract formation has not been seen with triamcinolone acetonide. Recent literature evaluating systemic absorption of intranasal corticosteroids have shown surprising results where significant absorption has occurred with intranasal budesonide and fluticasone propionate. Growth and hypothalamic pituitary axis (HPA) function studies have been reviewed, with some intranasal corticosteroids showing changes with continual use. A retrospective study in children receiving daily triamcinolone acetonide for 12 months showed no effect on height and bodyweight. Triamcinolone acetonide at standard dosages (110 or 220microg once or twice a day) does not appear to suppress adrenal gland function and is effective in relieving most symptoms of allergic rhinitis. The International Consensus Conference Proceedings on Rhinitis now currently recommends the use of intranasal corticosteroids as first line therapy, since they have been found to be well tolerated and effective with minimal adverse effects and, specifically, no cognitive impairment. The recommended maximum dose of aqueous triamcinolone acetonide in adults and children is 220microg once a day. The aerosol form may be recommended in children between 7 and 12 years old, up to 440microg once a day or in divided doses. Duration of allergy treatment is generally for the length of each allergy season. If symptoms are perennial, then a reduction of dosage is made to the lowest effective dose with monitoring every 3 months for risk and benefit assessment. Complications to watch for include bleeding, and possible septal perforation and nasal candidiasis, although these are rare.

Comparison of intranasal triamcinolone acetonide with oral loratadine in the treatment of seasonal ragweed-induced allergic rhinitis.

A double-blind, randomized, multicenter, parallel-group controlled study compared the efficacy and safety of intranasal triamcinolone acetonide (220 micrograms/day) and oral loratadine (10 mg/day) in patients with at least two seasons of ragweed-induced seasonal allergic rhinitis. A 28-day screening period, including a 5-day baseline period, preceded a 4-week treatment period. Reduction in rhinitis symptom scores was evident in both groups as early as day 1, with no significant between-group differences during week 1. At weeks 2, 3, and 4, patients treated with triamcinolone acetonide were significantly (P < 0.05) more improved in total nasal score, nasal itch, nasal stuffiness, and sneezing than were patients treated with loratadine. At weeks 3 and 4, rhinorrhea and ocular symptoms were significantly (P < 0.05) more improved from baseline among triamcinolone acetonide patients compared with loratadine patients. There was no significant between-group difference in relief from postnasal drip at any time point. Physicians' global evaluations significantly (P = 0.002) favored triamcinolone acetonide at the final visit, with moderate to complete relief of symptoms attained by 68% of triamcinolone acetonide patients and 59% of loratadine patients. Over the 4-week treatment period, triamcinolone acetonide patients had significantly greater improvement in total nasal score, nasal itch, nasal stuffiness, sneezing, and ocular symptoms. Both treatments were well tolerated, with headache being the most frequently reported drug-related adverse effect in both the triamcinolone acetonide (15%) and loratadine (11%) groups. These results indicate that triamcinolone acetonide is more effective than oral loratadine in relieving the symptoms of ragweed-induced seasonal allergic rhinitis.

Quantitative ultrasound of the heel and serum and urinary cortisol values in assessment of long-term corticotherapy side effects in female bronchial asthma patients.

Female asthma patients (26) with and without corticotherapy were studied. The control group included 19 healthy women. Skeletal status was assessed by ultrasound measurement of the heel (Achilles, Lunar, Madison, WI, USA) and serum and urinary corisol expressed adrenal function. Ultrasound and hormonal values were significantly lower in patients treated with glucocorticosteroids (GC) than in controls. In patients without GC, cortisol parameters were normal and ultrasound measurements were moderately diminished. 57% of women with and 33% of women without GC-therapy had an ultrasound T-score less than -2.5. Decrease of ultrasound values estimated by linear regression in relationship to time of asthma duration was highest in women with GC therapy. Several significant coefficients of correlation between ultrasound and adrenal function parameters were noted only in patients treated with GC. These data suggest that bone and endocrinological side effects due to steroid therapy in asthma patients show similar trends. Results obtained in present study require further longitudinal investigations.

Ultrasonic assessment of cutaneous atrophy caused by intradermal corticosteroids.

A noninvasive technique of pulsed ultrasound was used to determine the long-term changes in skin thickness resulting from intradermal injections of triamcinolone acetonide (TA). Injections of 0.1 ml of either saline or a suspension containing 5 mg/ml or 10 mg/ml of TA were made at selected sites on the forearms of two human volunteers. The corticosteroid-treated sites showed a maximal decrease of 30% to 40% of the original skin thickness at 4 to 8 weeks after a single injection. A transient thinning was observed at control sites injected with saline. A greater degree of thinning was seen at the site injected with 10 mg/ml of TA as compared to the site injected with 5 mg/ml of TA. The thinning at the corticosteroid injection sites persisted at least 18 weeks after the single corticosteroid injection but had approached normal thickness values by 44 weeks following treatment. Pulsed ultrasound may be useful as a noninvasive technique for monitoring the effects of intradermally injected corticosteroids on human skin thickness and may also be useful in assessing intrinsic atrophogenic potentials of different corticosteroid molecules in human skin and the duration of action of various injectable formulations of a corticosteroid.