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1.
A 4 week, multicentre, double-blind, double dummy, placebo controlled group comparative study was carried out during the birch pollen season to compare the efficacy and tolerability of 2% nedocromil sodium eye drops (twice daily) and 2% sodium cromoglycate eye drops (four times daily). Participants with a history of seasonal allergic conjunctivitis (SAC) were randomized to receive nedocromil sodium (60), sodium cromoglycate (61) or placebo (64). Clinical assessment of SAC showed improvement with both active treatments compared to placebo but symptomatology was low and only changes in photophobia and grittiness reached significance (P < 0.05). Patient diaries showed significant control of itching by both active treatments, compared to placebo, with no differences between the active preparations. Patients' opinions indicated a marked placebo effect: 73% of this group reported full or moderate control of symptoms, compared with 75% in sodium cromoglycate and 80% in the nedocromil sodium group. Unusual symptoms were most common (27 patients) with nedocromil sodium eye drops: P < 0.05 vs. placebo (15 patients). There were no serious adverse events. Nedocromil sodium eye drops (b.d.) and sodium cromoglycate eye drops (q.i.d.) were both considered clinically more effective than placebo in controlling symptoms of SAC due to birch pollen.  相似文献   

2.
Treating severe eye allergy   总被引:2,自引:0,他引:2  
Allergic eye conditions, particularly seasonal allergic conjunctivitis (SAC), are common. Itching, oedema and hyperaemia are relieved with topical H1-antagonists or sodium cromoglycate. The newer mast-cell stabilizing agent nedocromil sodium has a similar safety profile to sodium cromoglycate, but is more potent and has a more convenient twice-daily dosing regimen. When several placebo-controlled studies of its use in the treatment of SAC were analysed, it was found that 80% of patients reported symptom relief. In a further study, nedocromil sodium eyedrops (twice-daily dosing) had similar overall efficacy to sodium cromoglycate eyedrops (four-times-daily dosing) in subjects with SAC during the birch season, but during the period of highest pollen challenge, only the former agent was significantly more effective than placebo. Another study found that nedocromil sodium had efficacy equivalent to levocabastine over 7 days, but tended to have a more rapid onset of action. In patients with perennial allergic conjunctivitis (PAC) unresponsive to sodium cromoglycate, both clinicians and patients reported significantly better control of symptoms with nedocromil sodium eyedrops than with placebo. Recently, in a long-term study of treatment for vernal keratoconjunctivitis (VKC), it was found that nedocromil sodium 2% eyedrops produced a more rapid and marked improvement in symptoms than sodium cromoglycate 2% eyedrops and enabled lower use of steroid rescue medication. Both drugs were well tolerated and without serious side-effects.  相似文献   

3.
This was a multicentre, double-blind, randomized group comparative study in which 77 children, aged 6–16 years, received 2% nedocromil sodium eye drops and 72 received placebo, one drop into each eye twice daily. The treatment period was 4 weeks, covering the peak birch pollen season. Prior to the start or the season, patients who had mended the clinic the previous 2 years because of seasonal allergic conjunctivitis (SAC) to birch pollen, entered a one week baseline period during which symptoms were assessed, diary cards completed, and routine sampling of blood and urine earned out. The double-blind treatment period then commenced at the onset of the birch pollen season. Patients parents kept daily diary record cards of eye symptom severity and concomitant therapy. Conjunctivitis was mild in both treatment groups but nedocromil sodium was more effective than placebo in controlling symptoms. During the 2–3 weeks of peak pollen counts, this therapeutic effect was statistically significant for itching (P <0–01), watering (P <0.05) and total symptom score (P <0.01), but was not significant for grittiness (P= 0.08) or redness (P = 0.06). Global opinions of efficacy showed no difference between treatments, due to a high placebo effect (however, the diary card data indicated a significant improvement with nedocromil sodium). We therefore conclude that nedocromil sodium 2% eye drops, administered twice daily, is an effective treatment for SAC in children.  相似文献   

4.
A multicenter double-blind group comparative study was carried out in 126 patients, 64 of whom received 2% nedocromil sodium eye drops, and 62 placebo eyedrops twice each day for the treatment of seasonal allergic conjunctivitis to birch pollen. The patients were evaluated at 2 week intervals for clinical signs of conjunctivitis and kept daily diary records of eye symptoms (0-4 severity scales) and concomitant therapy. Diary trends favored active treatment, and reached significance for excessive lacrimation (P less than .05) during peak pollen challenge. Clinic assessments showed the same directional trend and final opinions of treatment efficacy were significantly in favor of nedocromil sodium (P = .003, patients; P = .006, clinicians). In addition, the placebo group used significantly more topical (P less than .05) and oral (P less than .01) concomitant antihistamine therapy. Nedocromil sodium and placebo treatments were equally acceptable and well tolerated. The results show that 2% nedocromil sodium used topically twice each day is an effective therapy for seasonal allergic conjunctivitis.  相似文献   

5.
Michael Alexander  MB  ChB  FRCP 《Allergy》1995,50(S21):23-29
Comparative clinical trials which include known therapies as well as placebos are essential in constructing a solid basis from which to 'launch' any new drug. This applies especially to eye drops for treatment of seasonal allergic conjunctivitis, where the symptomatology, already dependent on the vagaries of the natural pollen challenge season, is further influenced by a positive washing action of the placebo eye drops. Tilavist (2% nedocromil sodium ophthalmic solution) has therefore been compared with sodium cromoglycate eye drops and non-sedating antihistamine tablets, both mainstays in the treatment of seasonal allergy, in a series of double-masked, placebo-controlled, mainly multicentre studies. Nedocromil sodium, twice or four times daily, proved as effective overall as sodium cromoglycate (2% or 4% four times daily) in three seasonal trials, and was the more effective treatment in a study of patients with vernal keratoconjunctivitis. Its efficacy was most evident during peak periods of pollen challenge, when neither placebo nor sodium cromoglycate eye drops controlled breakthrough symptoms. Three further seasonal studies showed nedocromil sodium eye drops to be as effective as standard oral doses of astemizole and terfenadine, whilst a faster onset of action than terfenadine was reported in one multicentre study.  相似文献   

6.
BACKGROUND: Vernal keratoconjunctivitis (VKC) is a severe though transient form of ocular allergy, predominant in young males, which requires careful management. Corticosteroids are effective but also cause serious topical side-effects in the eye, such as glaucoma and cataracts. The safer, mast cell stabilizing anti-inflammatories (commonly sodium cromoglycate) therefore have an important role. This parallel group study compared efficacy, tolerability and safety of sodium cromoglycate 2% with nedocromil sodium 2%, administered as one drop per eye four times daily for a period of 5 months. METHODS: Children aged 4-17 years, with a diagnosis of mostly limbal VKC in the last 12 months, entered a 2-week baseline during which they used only artificial tears, and were then randomized to treatment, in groups of 18, on an investigator single-masked basis. Daily symptom diary cards were kept by patients/guardians, and VKC was assessed by the clinician at approximately monthly intervals. Dexamethasone was provided for rescue control of severe symptoms, if needed. RESULTS: A total of 34 patients completed the study. Both trial treatments produced rapid improvements and many ocular signs and symptoms, including Trantas' dots, chemosis, itching, soreness and sticky discharge, were fully controlled by the end of the study. However, nedocromil sodium took effect more quickly, with a significant reduction compared to sodium cromoglycate for itching, grittiness, hyperaemia and keratitis within 6 weeks. In addition, nedocromil sodium was the more efficacious overall (significant vs sodium cromoglycate for hyperaemia, keratitis, papillae and pannus at 22 weeks). Both treatments were well tolerated and without serious adverse effects. Final opinions favoured nedocromil sodium, with full control of VKC recorded for 94% (patient opinion) and 100% (clinician opinion) of this treatment group, compared with 29% and 0%, respectively, in the sodium cromoglycate group. CONCLUSIONS: Nedocromil sodium 2% eye drops is significantly more effective than sodium cromoglycate for treatment of VKC.  相似文献   

7.
Atopic keratoconjunctivitis   总被引:2,自引:0,他引:2  
S. Bonini 《Allergy》2004,59(S78):71-73
Atopic keratoconjunctivitis (AKC) represents a disease usually classified under the term of allergic conjunctivitis together with seasonal allergic conjunctivitis (SAC), perennial allergic conjunctivitis (PAC) and vernal keratoconjunctivitis (VKC). However, AKC and VKC have clinical and pathophysiological features quite different from SAC and PAC, in spite of some common markers of allergy. This article aims to review personal studies suggesting that allergic conjunctivitis (similarly to asthma, rhinitis and atopic dermatitis) is a heterogeneous disease entity with different preferential pathogenetic mechanisms and a spectrum of clinical expression which varies according to individual cases. AKC and VKC may thus represent a model of atopy quite distinct from the classical type-1 hypersensitivity mechanism.  相似文献   

8.
Nedocromil sodium is a non-steroidal prophylactic agent developed for the management of asthma. We have assessed the steroid sparing potential of inhaled nedocromil sodium 4 mg four limes daily in a randomized, double blind, placebo controlled study in 69 asthmatic subjects controlled on inhaled beclomethasone dipropionate in the dose range 1000 2000 μg daily. Following a 4 week run-in period subjects added nedocromil sodium or placebo by metered dose inhaler to their usual medication for a further 4 weeks. The dose of inhaled steroid was then reduced at fortnightly intervals according to a predetermined schedule, with monitoring of asthma severity, symptom scores, bronchodilator use and peak flow recordings. Sixty subjects entered the steroid reduction phase and achieved median (range) % decreases in steroid dose of 80 (17-100)% with nedocromil sodium compared to 65 (0-100)% with placebo (P = 0.34) with 14 patients in the nedocromil sodium group and 10 in the placebo group being withdrawn completely from inhaled steroids. Subjective global assessment scores were significantly better with nedocromil sodium (mean 2.14) than with placebo (2.93; P<0.02) though there was no difference between individual daily symptom scores. In this study therefore in asthmatic patients controlled on high doses of inhaled steroids, nedocromil sodium was well tolerated but the smalt differences in steroid sparing effect between nedocromil and placebo were not statistically significant.  相似文献   

9.
Currently, six basic allergic eye diseases are recognized. In seasonal (SAC) and perennial allergic conjunctivitis (PAC), the allergic response is mediated predominantly by mast cells, whereas the more severe conditions, vernal (VKC) and atopic keratoconjunctivitis (AKC) and giant papillary conjunctivitis (GPC), are associated with a preponderance of T cells. Acute allergic conjunctivitis (AAC) occurs when a large quantity of allergen inoculates the eye and is usually self-limiting. SAC, the most common ocular allergy, is the ocular component of hayfever. PAC in the UK is most commonly caused by the house-dust mite (HDM); diagnosis is confirmed by skin-prick tests, eosinophils in the conjunctival smear, and raised tear or serum total IgE. SAC and PAC can usually be managed with chromone eyedrops and antihistamines. VKC usually presents in children under 10 years of age and mainly affects boys. Sufferers frequently have a personal or family history of atopy. Corneal involvement can occur in VKC, making it potentially sight-threatening. AKC occurs in atopic adults, and like VKC it affects the cornea. VKC and AKC require steroid treatment under specialist supervision; minimization of the steroid dose can often be achieved with use of a chromone. GPC occurs due to repeated contact of the conjunctival surface with a foreign surface, such as contact lenses. Attention to lens hygiene or switching to different lenses and treatment with a chromone are frequently effective. In all allergic eye diseases contact with the precipitating allergen should be avoided as far as possible.  相似文献   

10.
M. Leino  P. Montan  F. Njå 《Allergy》1994,49(3):147-151
In a multicenter, double-blind, single-dummy, group-comparative study, 169 patients received ophthalmic sodium cromoglycate 2% four times daily, and 170 patients received 4% ophthalmic sodium cromoglycate twice daily, together with placebo eye-drops twice daily, for the treatment of seasonal allergic conjunctivitis (SAC) to birch pollen. The treatment period was 4 weeks during the birch pollen season. Daily pollen counts were used to identify the peak 14-d period. Clinical examinations were made before the start of treatment, after 1 week of treatment, and at the end of the treatment period. Patients kept daily diary record cards of eye symptom severity and concomitant therapy. Symptoms were generally mild and, except for chemosis (week 4) and soreness (weeks 2 and 3), which were less in the 4% group (P0.05), no significant treatment differences were seen for symptoms or for antihistamine rescue therapy. Both treatments were considered to be very or moderately effective by more than 90% of patients, and no treatment differences occurred in either clinicians' or patients' opinions of efficacy. The results indicate that the use of 4% sodium cromoglycate eye-drops twice daily is as effective and well tolerated as 2% sodium cromoglycate four times daily in the treatment of birch-pollen conjunctivitis.  相似文献   

11.
BACKGROUND: Evidence for the effectiveness of topical treatments, in providing symptomatic relief from ocular allergy, remains uncertain. AIMS: To assess the effectiveness and relative efficacy of topical treatments for the management of seasonal allergic conjunctivitis. DESIGN OF STUDY: A systematic review and meta-analysis. SETTING: A literature search of the Cochrane Library, Medline, and EMBASE bibliographic databases. METHOD: Double-masked randomised controlled trials were identified, that compared the use of topical mast cell stabilisers (sodium cromoglycate, nedocromil, lodoxamide) with placebo, topical antihistamines with placebo, and topical mast cell stabilisers with topical antihistamines. RESULTS: A meta-analysis of six trials showed that patients using sodium cromoglycate were 17 times (95% confidence interval [CI] = 4 to 78) more likely to perceive benefit compared with those using a placebo, although this estimate may be partially influenced by publication bias. Five trials indicated that those patients using nedocromil were 1.8 times (95% CI = 1.3 to 2.6) more likely to perceive their allergy to be moderately or totally controlled than those using a placebo. Four trials showed that those using antihistamines were 1.3 times (95% CI = 0.8 to 2.2) more likely to perceive a 'good' treatment effect than those using mast cell stabilisers, although this beneficial effect was not statistically significant. Limited evidence suggests that antihistamines might have a faster therapeutic effect compared to mast cell stabilisers. CONCLUSION: Overall, these findings confirm the benefit of topical mast cell stabilisers and antihistamines over placebo for the treatment of allergic conjunctivitis. There is, however, insufficient evidence to recommend the use of one type of medication over another. Treatment preferences should therefore be based on convenience of use (with reduced frequency of instillation for some preparations), patient preference, and costs, especially as important side effects were not reported with any medication.  相似文献   

12.
Abstract. In a double-blind group comparative trial nedocromil sodium (Tilade®) at a dose of 4 mg four times daily was compared with placebo in the management of out-patients with bronchial asthma. Treatments were delivered by pressurized aerosol over a period of 28 days following a 2-week base-line during which patients continued on their usual therapy. Twenty-one patients entered the nedocromil sodium group and twenty entered the placebo group. All were using beclomethasone dipropionate aerosol as maintenance steroid therapy plus intermittent use of a bronchodilator taken by inhalation. The dose of steroid was reduced for all patients after 2 weeks of treatment and again for approximately half the patients after 3 weeks trial treatment. Patients in the nedocromil sodium treatment group improved in respect of Diary Card symptom scores and peak expiratory flow rate (PEFR), and in their requirements for inhaled bronchodilators. Patients in the placebo group were worse, particularly in respect of daytime asthma symptoms ( P < 0·01), bronchodilator use ( P < 0·05) and morning PEFR during the third week of trial treatment ( P < 0·05). More patients in the nedocromil sodium group than in the placebo group thought their treatment had been effective ( P < 0·05). Nedocromil was well tolerated. Despite the short duration of treatment imposed at this stage in the clinical evaluation of a new compound, our results were sufficiently encouraging to prompt further evaluation of nedocromil sodium over the longer period required (3–12 months) for the clinical assessment of a new treatment for chronic asthma.  相似文献   

13.
The effect of inhaled nedocromil sodium (4 mg by pressurized aerosol) on the dual asthmatic reaction to bronchial antigen challenge was studied in eight patients with asthma. The following prechallenge/postchallenge treatment combinations were administered: nedocromil sodium/placebo, nedocromil sodium/nedocromil sodium, placebo/nedocromil sodium, and placebo/placebo. Each patient received three treatment combinations assigned with a balanced incomplete block design. Nedocromil sodium administered before antigen challenge was significantly more effective than placebo in blocking both the early (p less than 0.001) and late (p less than 0.01) fall in FEV1. Postchallenge administration of nedocromil sodium tended to delay the onset of late asthmatic reaction but did not provide significant protection compared to placebo. These results demonstrated that nedocromil sodium prevents both phases of the dual asthmatic reaction to bronchial antigen provocation when it is inhaled before challenge. Further investigation is necessary to elicit a definite answer to whether nedocromil sodium administered after bronchial challenge has an effect on late asthmatic reaction.  相似文献   

14.
J. M. Henriksen 《Allergy》1988,43(6):449-453
A double-blind, placebo-controlled, crossover study investigated the efficacy of nedocromil sodium in reducing bronchoconstriction subsequent to exercise challenge in asthmatic children. Twelve children aged 7-14 years (mean 10.8 years) were pretreated with nedocromil sodium aerosol (2 inhalations; 2 mg/inhalation) or matching placebo, 30 min prior to treadmill running. Lung function was measured at regular intervals postexercise and the mean maximum percentage decrease in PEF and FEV1 compared following nedocromil sodium or placebo pretreatment. Nedocromil sodium significantly reduced the fall in PEF (P less than 0.001) and FEV1 (P less than 0.001) and provided significantly greater protection (P less than 0.001) than placebo. No adverse reactions or unusual symptoms were observed.  相似文献   

15.
Levels of an interleukin 10 (IL-10) are reduced in asthmatic patients in comparison to healthy subjects. Fact, that IL-10 is produced by Th1 and that inhibits cytokine production by Th2 lymphocytes has led to the concept that IL-10 might be beneficial in mitigating allergic inflammation. The purpose of this study was to define the effect of 4 week monotherapy with triamcinolone acetonide or nedocromil sodium on the serum level of IL-10, bronchial hyperresponsiveness and clinical parameters in atopic asthma children. It was an 8 week, randomised, double-blind trial of 37 children with moderate asthma allergic to house dust mite. Patients were randomly allocated to receive 200 mcg triamcinolone twice daily (n = 18), or 0.004 g nedocromil four times daily (n = 19). Thirty children completed the study. After treatment with triamcinolone the level of IL-10 in blood serum significantly increased, bronchial hyperreactivity significantly decreased, and all clinical parameters improved. Mean IL-10 levels in serum before and after treatment with triamcinolone were 7.5 pg/ml with 95%CI 6.79%-8.22% and 14.21 pg/ml with 95%CI 11.33%-17.09% respectively (p < 0.001). After treatment with nedocromil, clinical symptoms improved significantly, IL-10 serum levels and bronchial hyperreactivity did not change significantly (p = 0.094 and p = 0.09 respectively). This study demonstrates that one possible way by which triamcinolone contribute to inhibition of inflammation is by effect on IL-10.  相似文献   

16.
Nedocromil sodium is a new chemical entity which shows similar properties to sodium cromoglycate (SCG) and in addition exhibits a preferential activity in stabilizing mucosal mast cells. We have compared the effect of inhalation of nebulized placebo, SCG and nedocromil sodium on the bronchoconstrictor response to inhaled adenosine monophosphate (AMP) in eight atopic asthmatic subjects aged 25 yr (range 21-32 yr). The geometric mean provocation doses of AMP required to produce a 20% decrease in FEV1 (PD20FEV1) and a 40% decrease in Vmax30 (PD40 Vmax30) following placebo were 4.9 (0.3-14.2) and 1.8 (0.1-8.4) mumol respectively. Prior inhalation of both SCG and nedocromil sodium significantly inhibited the bronchoconstrictor response to AMP with PD20FEV1s of 36.6 (4.0-132.7) and 134 (12.4-560), and PD40 Vmax30 values of 20.5 (1.4-110) and 101.6 (5-560) mumol respectively (P less than 0.001). Nedocromil sodium was 3.9 (FEV1) and 8.0 (Vmax30) times more potent than SCG (P less than 0.001). In conclusion, both drugs inhibit the bronchoconstrictor response to inhaled AMP, and nedocromil is at least 4-8 times more potent than SCG.  相似文献   

17.
Two studies involving double-blind group comparative trials in human volunteers compared the effects of intranasal nedocromil sodium (2.6 mg active drug per nostril, q.i.d.) with placebo on clinical symptoms and performance impairment associated with the common cold. In the first study volunteers were challenged with rhinoviruses (RV9 and RV14), and in the second study with respiratory coronavirus. In both studies, active and placebo groups of volunteers were demographically similar. Infection rates in both groups were also similar. There were no withdrawals resulting from unusual symptoms related to either treatment. In the rhinovirus study (19, placebo; 20, nedocromil sodium) daily symptom scores and daily mean nasal secretion weights were significantly lower in the nedocromil sodium-treated group. In the coronavirus study (26, placebo; 27, nedocromil sodium) there was little difference in the severity of colds between the active and placebo-treated groups, but trends favoured nedocromil sodium. In both studies the impairment of performance in volunteers who developed a cold was significantly less in those treated with nedocromil sodium than in those treated with placebo.  相似文献   

18.
19.
Nedocromil sodium is a pyranoquinoline dicarboxylic acid derivative, formulated in a metered-dose inhaler. Because nedocromil sodium has in vitro and in vivo anti-inflammatory properties, it was evaluated in a group of steroid-dependent patients with asthma to observe how well it might be tolerated and for evidence of any beneficial effects. In a double-blind, group-comparative study, 127 patients received nedocromil sodium and 61 received placebo, administered as two puffs of 2 mg, four times per day, for 12 weeks. Ten patients developed adverse reactions, seven receiving active drug and three patients receiving placebo. Two patients of each group withdrew because of worsening asthma. Despite selecting patients whose asthma was stable, when they were receiving established therapeutic regimens that included steroids and bronchodilators, it was found that diary-card symptom scores, morning and evening peak expiratory flow rate values, and inhaled beta-agonist usage all demonstrated slight but significant benefit with addition of nedocromil sodium. It is concluded that the inhaled, anti-inflammatory agent, nedocromil sodium, may be added to asthma-treatment regimens with the reasonable expectation of further modest symptomatic benefit.  相似文献   

20.
A prospective, cross-sectional and randomized cross-over study was conducted to study the clinical features and treatment outcome among Thai patients with vernal keratoconjunctivitis (VKC). History-taking and eye examinations were performed. Mild cases of VKC were given topical antihistamine four times daily. Moderate and severe cases of VKC were treated with topical lodoxamide four times a day. Severe cases of VKC were given topical corticosteroids. Moderate and severe cases of VKC, which were refractory to treatment with either corticosteroids or a mast cell stabilizer had topical cyclosporine 0.5% instilled four times daily. Five patients were exposed to two different treatment regimens in sequence. As main outcome measures, itching, foreign body sensation, photophobia, conjunctival injection, papillae and chemosis were evaluated weekly. The patients with the palpebral type of VKC had daily symptoms, which were more severe and triggered by house-dust with a significant difference among the groups. Limbal VKC was associated with allergic rhinitis more commonly than palpebral VKC. Positive results of skin prick testing to acacia, careless weed, mold, Johnson grass and cow's milk were significantly more common in patients with palpebral VKC. The most common symptoms and signs were found in the mixed type of VKC. Purulent discharge, pannus and lid erythema were found in the palpebral type. Levocabastine hydrochloride was sufficient for mild cases of limbal VKC; lodoxamide for the limbal and mixed types. Prednisolone acetate was the drug of choice in severe cases of any type but only for a short period of time. The success rate of topical cyclosporine in the palpebral type was lower than in the limbal type due to an intolerable burning sensation. Topical cyclosporine used in 4 patients with limbal and palpebral type had a success rate of 100% which was greater than in the lodoxamide group (66.7%, 0%). Compared with topical corticosteroid-treated eyes in one patient, the success rate in topical cyclosporine-treated eyes was not success. Grading the severity of each type of VKC is crucial to obtain good response of any medication and compliance. Topical cyclosporine 0.5% can be an alternative drug to relieve symptoms and signs of VKC in order to avoid steroid-induced glaucoma.  相似文献   

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