Loratadine and cetirizine in the treatment of chronic urticaria

Aim This study was designed to compare loratadine and cetirizine in controlling the symptoms of chronic urticaria. Subjects One hundred and sixteen adult patients with chronic urticaria. Methods In this double-blind study the patients were randomly divided into three therapeutic groups: 38 received loratadine (10 mg), 40 cetirizine (10 mg) and 38 placebo tablets once daily for 28 days. Steroid-dependent subjects and patients with physical urticaria or with angioncurotic hereditary oedema as well as pregnant or breast-feeding women were excluded from the study. A suitable wash-out period was observed in case of previous treatments for the same disease. Itching, erythema, number of lesions and diameter of the largest one were evaluated according to a scale from 0 (absent) to 3 (severe). The minimum entry study score for itching plus number of lesions had to be at least equal to three. Control visits were scheduled after 3, 7 and 14 days of therapy. Symptoms, disease status, therapeutic response, side effects and compliance were evaluated at each visit. Diary cards were filled in by patients at home. Results Active drugs compared to placebo significantly reduced global clinical symptoms (p < 0.05). Loratadine was more rapid in developing its activity than the other two agents (p < 0.01 at day 3). Each single symptom showed the same trend. At the end of the study 24 (63%) patients treated with loratadine, 18 (45%) with cetirizine and 5 (13%) with placebo were free from symptoms. Four failures occurred with loratadine, six with cetirizine and seventeen with placebo. The tolerability profile was similar for all three groups. One patient receiving cetirizine dropped out due to severe gastric pain. Conclusions Loratadine is more active and safer than cetirizine in the treatment of chronic urticaria.     

In dermographic urticaria H2 receptor antagonists have a small but therapeutically irrelevant additional effect compared with H1 antagonists alone

Two studies of the additional effect of an H₂ receptor antagonist when given in combination with an H₁ antagonist were undertaken in dermographic urticaria. Using a randomized, double-blind, crossover design in 19 patients, a combination of cetirizine (10 mg at night) and ranitidine (150 mg twice daily) was compared with a combination of cetirizine (10 mg at night) and placebo. The addition of ranitidine did not produce any significant difference in linear analogue scores for weal, Itch or sleep disturbance. There was a significant depression of the frictional force/wealing response curve with an increase in wealing threshold (P<0.0001) following the addition of H₂ blockade. The wealing threshold was 54.7 ± 4.4 (mean ± SEM) g/mm² for the H₁ antagonist alone, and 73.2 ± 5.7 for the combination of H₁ and H₂ antagonists. In a second similar study involving nine different patients, comparing terfenadine (120 mg twice daily) with a combination of terfenadine and ranitidine (150 mg twice daily), the weal threshold was 59.8 ± 6.6 for the H₁ antagonist alone, and 73.0 ± 6.4 for the combination of H₁ and H₂ antagonists. Thus, in dermographic urticaria, adding an H₂ antagonist to treatment with a potent H₁ antagonist gives a small, significant reduction in wealing response, but no symptomatic benefit. We conclude that involvement of the H₂ receptor in this urticarial disease is minimal, and does not justify the use of H₂ receptor antagonists.     

Doxycycline 40 mg Capsules (30 mg Immediate-Release/10 mg Delayed-Release Beads)

Anti-inflammatory dose doxycycline 40 mg capsules (30 mg immediate-release and 10 mg delayed-release beads) provide a sub-antimicrobial dose that reduces the inflammatory response in patients with rosacea without producing drug concentrations required to treat bacterial diseases. The efficacy of oral, anti-inflammatory dose doxycycline 40 mg capsules once daily in the treatment of adults with rosacea was demonstrated in two pivotal large, randomized, double-blind, placebo-controlled, multicenter trials. After 16 weeks’ therapy, anti-inflammatory dose doxycycline 40 mg was significantly more effective in improving rosacea than placebo, providing a greater reduction in the total inflammatory lesion count (primary endpoint) than placebo. Anti-inflammatory dose doxycycline 40 mg was associated with a rapid onset of action, achieving a significantly greater decrease in total inflammatory lesion count than placebo by the first follow-up visit at week 3 in both studies. Maximum anti-inflammatory efficacy appears to be achieved with doxycycline 40 mg capsules once daily, as no additional improvement in rosacea symptoms was achieved with oral doxycycline 100 mg once daily (usual antibacterial dosage) in a small, randomized, double-blind trial. Anti-inflammatory dose doxycycline 40 mg was generally well tolerated in clinical trials, with most adverse events being of mild to moderate intensity.     

A multicentric trial of loratadine and cetirizine in urticaria

Two hundred and ten patients with chronic urticaria were divided into two groups; one group was treated with Loratadine 10mg daily while the other with cetirizine 10mg daily. The total duration of treatment was four weeks. Pretreatment and post-treatment evaluations were made. It was noticed that loratadine was superior to cetirizine in terms of a rapid onset of actions, overall clinical efficacy and minimal side effects.     

Itraconazole in the treatment of superficial mycoses—a double-blind study vs. placebo

Ninety-four patients with dermatophytosis and 16 patients with pityriasis versicolor were assigned under double-blind conditions to oral itraconazole (100 mg once daily) or placebo. The medication consisted of two capsules, each containing 50 mg of active substance, or placebo and was given for 15 or 30 days in patients with dermatophytosis and for 15 days in patients with pityriasis versicolor. Patients with pityriasis versicolor who had not responded at the end of the double-blind period were treated on an open basis with itraconazole (100 mg once daily) for 15 days. In the treatment of dermatophyte infections for 30 days, both clinical response and mycological cure were significantly superior in the itraconazole group compared with placebo. Oral administration of itraconazole (100 mg once daily) was also highly efficacious in the treatment of pityriasis versicolor. None of the placebo patients was clinically or mycologically cured at the end of the double-blind phase compared to seven out of eight itraconazole patients. All placebo patients who entered the open phase responded to itraconazole treatment. Three itraconazole-treated patients and nine placebo-treated patients reported side-effects.     

Effects of bepotastine, cetirizine, fexofenadine, and olopatadine on histamine-induced wheal-and flare-response, sedation, and psychomotor performance

Although many antihistamines are now in clinical use, few studies directly compare their pharmacodynamic and sedative activities in humans in vivo. We designed a double-blind, placebo-controlled, crossover study to compare the inhibitory effects of bepotastine, cetirizine, fexofenadine, and olopatadine on histamine-induced flare-and-wheal response. Systemic sedative effects and impaired psychomotor activities by these drugs were also evaluated. Bepotastine (10 mg twice a day), cetirizine (10 mg once a day), fexofenadine (60 mg twice a day), and olopatadine (5 mg twice a day) or placebo was given in a double-blind manner to seven healthy volunteers before histamine challenge by iontophoresis. At 0, 1, 2, 4, 8, 12, and 24 h following the oral administration of these drugs, histamine iontophoresis-induced wheal-and-flare response was measured. Sedative effects by the drugs were also evaluated by a visual analogue scale for subjective sedation, and by word processor test for psychomotor activity. Each volunteer was tested with all of the drugs (including placebo), administered in a random order with a washout period of at least 1 week. Histamine iontophoresis induced marked wheal-and-flare response in all participants. Bepotastine, cetirizine, fexofenadine, and olopatadine yielded significant reduction of histamine-induced wheal-and-flare response compared to placebo (P < 0.01). Among the drugs, olopatadine and cetirizine suppressed most markedly and persistently histamine-induced wheal-and-flare response, while bepotastine and fexofenadine produced a significant, but less persistent suppression. Olopatadine, fexofenadine, and cetirizine showed a significant systemic sedative effect in this order with bepotastine showing the least sedative effect. Moreover, olopatadine affected psychomotor performance most markedly, which was followed by fexofenadine and cetirizine. These results indicate that bepotastine, cetirizine, fexofenadine, and olopatadine inhibit histamine-induced wheal-and-flare response of humans in vivo and induce a variable systemic sedative effect and impaired psychomotor activity. Although olopatadine and cetirizine showed the strongest and most persistent suppression of histamine-induced wheal-and-flare response, olopatadine showed a considerable sedative effect with impaired psychomotor performance.     

Efficacy and safety of mizolastine 10 mg in a placebo-controlled comparison with loratadine in chronic idiopathic urticaria: results of the MILOR Study.

BACKGROUND: Mizolastine is a novel histamine H1-antagonist registered in Europe for the management of allergic rhinitis and urticaria. OBJECTIVES: To compare the clinical efficacy and safety of mizolastine with loratadine and placebo in patients with chronic idiopathic urticaria (CIU). METHODS: A multicentre, double-blind, parallel group study was designed in which 247 patients with CIU were randomised after a 1-week placebo run-in period to 10 mg daily mizolastine (n = 88), 10 mg daily loratadine (n = 79), or placebo (n = 80) for a 4-week treatment period. RESULTS: Mizolastine and loratadine both relieved symptoms of CIU. After 2 weeks' treatment, the severity of pruritus (visual analogue score (VAS) assessed by patients) decreased significantly in both the mizolastine and loratadine groups compared with placebo (mizolastine: -36.7 mm, P = 0.0001; loratadine: -29.8, P = 0.0071; placebo: -16.3); this improvement with both active treatments was maintained throughout the treatment period, the difference being significant only for the mizolastine group (P = 0.0090). Both active treatments were also associated with reduced weekly episodes of urticaria compared with placebo, which was significant after 2 weeks' treatment (mizolastine: 7.9 episodes, P = 0.0061; loratadine: 8.3, P = 0.0221; placebo: 13.3). Angioedema was improved to a clinically significant extent with mizolastine, and loratadine compared with placebo in those patients who had this symptom before treatment. Overall tolerability of both treatments was similar to placebo, and there were no clinically relevant effects on cardiac repolarisation with either mizolastine or loratadine. CONCLUSION: Mizolastine (10 mg daily) is confirmed as an effective and well tolerated agent, comparable to loratadine and superior to placebo, for the management of CIU. Mizolastine acted as rapidly as loratadine in improving urticarial symptoms from the first day of treatment.     

Addition of fexofenadine to a topical corticosteroid reduces the pruritus associated with atopic dermatitis in a 1-week randomized,multicentre, double-blind,placebo-controlled,parallel-group study

BACKGROUND: Fexofenadine, a nonsedating, H1-receptor selective antihistamine, exhibits consistent efficacy and safety in the treatment of allergic rhinitis and urticaria. The pruritus associated with atopic dermatitis is considered to be induced, in part, by histamine. Therefore, we thought that fexofenadine may be useful in the relief of pruritus associated with atopic dermatitis. OBJECTIVE: To compare the efficacy of twice-daily fexofenadine hydrochloride (HCl) 60 mg vs. placebo in reducing the pruritus associated with atopic dermatitis. METHODS: In this randomized, multicentre, double-blind, placebo-controlled study, patients (aged >or= 16 years) with atopic dermatitis underwent a 1-week placebo lead-in period, followed by randomization to fexofenadine HCl 60 mg twice daily or placebo for 1 week. All patients also received topical treatment with 0.1% hydrocortisone butyrate twice daily throughout the study. The primary efficacy endpoint was mean change in pruritus score from baseline. Patients reflectively recorded pruritus scores twice daily (day and night) using a five-point scale (0 = none; 4 = very severe). RESULTS: Fexofenadine (n = 201) significantly decreased the severity of pruritus compared with placebo (n = 199) (mean change in score -0.75 (unadjusted 95% confidence interval [-0.88, -0.62]) vs. -0.5 [-0.62, -0.38], respectively; P = 0.0005). This improvement was seen after just 1 day of treatment (P = 0.039) and was maintained throughout the treatment period (P = 0.019). Compared with placebo, fexofenadine significantly improved both diurnal (P = 0.0001) and nocturnal pruritus (P = 0.013). In addition, significantly more patients in the fexofenadine group experienced a reduction in the ratio of pruritus area to body surface area compared with those in the placebo group (P = 0.007). The incidence of adverse events was low and similar across all treatment groups. CONCLUSIONS: Fexofenadine HCl 60 mg twice daily demonstrated a rapid, significant improvement in the pruritus associated with atopic dermatitis, with a safety profile equivalent to that of placebo.     

Efficacy and safety of antihistamines in allergic skin disorders

Background For patients with urticaria, H₁-antihistamines remain the gold standard medical treatment of choice. They act by blocking H₁ receptors on the vascular endothelial cell surface. Newer, non-sedating antihistamines such as loratadine also act to some extent by blocking the release of histamine from mast cells, basophils and human skin tissue. Efficacy All of the newer antihistamines (loratadine, terfenadine, astemizole and cetirizine) have been shown to have comparable efficacy to the classic sedating antihistamines and to be significantly superior to placebo in terms of symptom improvement. Loratadine has been shown to be at least as effective as the other non-sedating agents and cetirizine. Antihistamines also have a potential benefit in the management of patients with atopic dermatitis. In two studies, loratadine was found to be significantly superior to placebo in the reduction of pruritus. Safety In terms of safety, the newer antihistamines have important differences. Cetirizine, for example, causes dose-related sedation and functional impairment compared to placebo. In contrast, loratadine has no such sedative effects. Terfenadine and astemizole have also been shown to be free of sedative effects, but exceeding the recommended dose of either may increase the risk of a serious cardiac arrhythmia, torsades de pointes. Plasma levels of both terfenadine and astemizole may also be increased as a result of interaction with various drugs. In contrast, loratadine has not been shown to induce ECG changes, even at doses of 40 mg o.d. for 90 days.     

Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind,placebo-controlled studies

The oral antiviral valacyclovir, which is 3 to 5 times more bioavailable than its parent compound acyclovir, is a good candidate for effective therapy to suppress recurrent herpes labialis lesions. The efficacy of oral valacyclovir in the suppression of herpes labialis has not previously been reported. Two identical, randomized, double-blind, parallel-group studies were conducted to evaluate the efficacy of oral valacyclovir 500 mg (n=49) versus placebo (n=49) once daily for 16 weeks in the suppression of herpes labialis among patients with a history of 4 or more recurrent lesions in the previous year. Data from the studies were pooled for analysis. Twenty-eight patients (60%) in the valacyclovir group compared with only 18 patients (38%) in the placebo group were recurrence-free throughout the 4-month treatment period (P=.041). The mean time to first recurrence was significantly longer with valacyclovir (13.1 weeks) compared with placebo (9.6 weeks) (P=.016). The total number of recurrences in patients using valacyclovir was 24 compared with 41 in patients using placebo. The incidence of adverse events during the 4-month treatment period was slightly lower in the valacyclovir group (22 events, 33% of patients) compared with the placebo group (29 events, 39% of patients). The results of these small double-blind, placebo-controlled studies suggest that oral valacyclovir 500 mg once daily for 4 months is effective and well tolerated for the prevention of recurrent herpes labialis. More research with larger patient numbers is warranted to corroborate and extend these findings.     

The effect of cetirizine on symptoms and wealing in dermographic urticaria

The effect of cetirizine, 10 mg at night, on dermographic urticaria, was studied in 19 patients. The study design was a randomized, double-blind, crossover comparison with placebo, each treatment being given for 7 days. Patients kept a daily diary of itch and weal severity (100-mm linear analogue scale), and recorded sleep disturbance. The dermographic weal response was measured objectively with a spring-loaded stylus, and the weal threshold calculated from the force/response curve. There was a small, insignificant subjective response to placebo, but no objective response. On cetirizine, the subjective assessment of wealing was reduced from 34.3±6.7 (mean ± SEM, 0–100 scale) to 16.8±4.1 (P= 0.02), itch was reduced from 43.2±6.6 to 19.4±4.1 (P=0.001), and nights disturbed from 46.2 to 8.8% (P=0.03). There was a shift to the right in the position of the force/response curve, and the wealing threshold increased from 24.6±3.2 to 54.7±4.4 g/mm² (P=0.00001), but there was no correlation between change in itch scores and wealing threshold. Cetirizine 10 mg daily is an effective treatment in dermographic urticaria, and its usefulness will depend on the prevalence of unwanted effects.     

地氯雷他定治疗慢性荨麻疹临床研究

目的评价地氯雷他定治疗慢性荨麻疹的疗效与安全性。方法采用随机开放平行对照的方法,对78例慢性荨麻疹患者随机分组,分别给予地氯雷他定5mg、西替利嗪10mg,均每日一次口服,观察治疗第14d、第28d的临床疗效及停药1w后的复发率。结果两者第14d、第28d的有效率分别为:地氯雷他定组68.89%和91.11%,西替利嗪组60.67%和84.85%,两者间无显著性差异(P>0.05)。停药1w后复发率,地氯雷他定组28.89%,西替利嗪组36.36%。两者试验过程中均无明显不良反应。结论地氯雷他定、西替利嗪治疗慢性荨麻疹疗效好,安全性高。     

Efficacy of interferon and placebo in the treatment of recurrent genital herpes: a double-blind trial

One hundred patients experiencing recurrence of genital herpes were randomly assigned to treatment with either recombinant DNA-derived human leukocyte interferon (interferon alfa-2a, Roferon-A, Hoffmann-LaRoche & Co., Ltd.) or placebo in a double-blind study. All patients were given a three-day course of treatment by subcutaneous injection within 24 hr after the first signs of recurrence. Interferon alfa-2a was given according to one of two daily regimens (6 X 10(6) or 18 X 10(6) units), either as a single dose followed by two doses of placebo or as three consecutive doses. In comparison with placebo, interferon alfa-2a reduced the duration of a single recurrent episode of genital herpes by approximately 50% (P less than .05) compared with placebo. As compared with pretreatment episodes, a reduction of greater than 50% in healing time was observed in 81% of those receiving interferon alfa-2a in comparison with only 10% of placebo recipients. Response was not related to size of dose, and treatment did not significantly prolong the interval between the first and second recurrences. No serious adverse reactions were observed, but most patients developed flu-like symptoms after the subcutaneous injection. Leukopenia and thrombocytopenia were minimal and transient. On the basis of overall efficacy and adverse effects, the single dose of 6 X 10(6) units of interferon alfa-2a was considered optimal, and this regimen may be of value in the routine treatment of recurrent herpes.     

Alitretinoin in chronic hand eczema: summary of clinical trials

After an open preliminary study, two double-blind placebo-controlled randomized studies have confirmed the value of per os alitretinoin in the management of severe chronic hand eczema (CHE). The first showed dose-dependent efficacy and a response defined as "clear" or "almost clear" by 53% of the patients receiving 10-40 mg of alitretinoin per day for 12 weeks. In the second multicenter study (the Bach study), comparing the efficacy of a 12-week alitretinoin treatment (10 mg, 30 mg) to placebo for CHE, a "clear or almost clear" result was observed in 17% (placebo group), 28% (group alitretinoin 10 mg), and 48% (group alitretinoin 30 mg). The onset of action was also significantly shorter in the group treated with 30 mg of alitretinoin compared to the group treated with 10 mg. In a study of randomized retreatment versus placebo, 80% of the patients who were initially responders to alitretinoin and whose CHE had relapsed found "clear" or "almost clear" with alitretinoin 30 mg administered for 12-24 weeks compared to 48% with alitretinoin 10 mg. In all the studies, clinical tolerance was comparable and satisfactory, with the most frequent negative side effects being headache, flushing, and mucocutaneous signs identical to those compared with other retinoids. An increase in cholesterol and/or triglycerides was the most frequent biological side effect. Central hypothyroidism, with no clinical expression, was observed more rarely. These studies confirm that alitretinoin treatment can be envisaged as second-line therapy in adults with CHE that does not respond to well-observed treatment with class potent or very potent dermocorticoids.     

Comparative efficacy of cetirizine and levocetirizine in chronic idiopathic urticaria

H1 receptor antagonists are the mainstay of treatment for chronic idiopathic urticaria. Newer hydroxyzine derivatives such as cetirizine and levocetirizine have been found to be equally efficacious in preclinical studies in patients with chronic idiopathic urticaria. In this study, the clinical efficacy of cetirizine and levocetirizine has been studied sequentially in individual patients. Fifty chronic idiopathic urticaria patients received 10 mg of levocetirizine daily for 6 weeks. Some 45 patients out of these showed reasonably good clinical efficacy on a visual analog scale to qualify for comparison with levocetirizine. A total of 30 patients completed the study period of 6 weeks each of cetirizine and levocetirizine sequentially. Thus, the clinical efficacy of cetirizine and levocetirizine was comparable with a marginal advantage of better antipruritic effect with levocetirizine, probably at the cost of increased sedation.     

The effect of addition of calcipotriol ointment (50 μg/g) to acitretin therapy in psoriasis

Our purpose was to find out whether the addition of calcipotriol ointment (50 μg/g) to systemic treatment with acitretin produces additional therapeutic effects and thereby an acitretin-sparing effect, and further to investigate the safety and tolerability of this combination. A multicentre, randomized, double-blind placebo-controlled study was designed. Patients were randomized to receive calcipotriol or placebo. All patients were treated with a starting dose of 20 mg acitretin per day and doses were adjusted at 2-weekly intervals with increments of 10 mg per day up to a maximum of 70 mg per day. The dose requirement for acitretin, clinical signs and adverse events were recorded. Seventy-six patients were randomized to treatment with calcipotriol 50 μg/g ointment twice daily and 59 patients to treatment with the vehicle only twice daily. Clearance or marked improvement was achieved by 67% of the patients in the calcipotriol group and by 41% of the patients in the placebo group ( P  = 0.006). Calcipotriol treatment proved to have a statistically significant additional effect to acitretin on the Psoriasis Area and Severity Index, redness, thickness and scaliness as compared with placebo. Clearance or marked improvement was achieved with a statistically significantly lower cumulative dose of acitretin by the patients in the calcipotriol group as compared with the placebo group. The number of patients reporting adverse events was pronounced and largely related to acitretin. No significant differences were observed between the two treatment groups with respect to adverse events. Laboratory assessments were essentially normal. The addition of calcipotriol ointment to acitretin treatment contributes to the efficacy, reduces the cumulative dose of acitretin to reach marked improvement or clearance, and is well-tolerated and safe.     

Short term treatment of pityrosporum folliculitis with itraconazole

We compared the efficacy and safely of short-term itraconazole with that of placebo in 26 patients of pityrosporum folliculitis. Twenty-six patients of mycologically proven pityrosporum folliculitis entered a double-blind placebo-controlled trial. Patients were randomly assigned to 7 days of treatment with either itraconazole, 200 mg once daily, or placebo. A global clinical assessment and mycological examination (KOH and smear examination) were performed at baseline and at 4 weeks after treatment. In this study, itraconazole in a dose of 200 mg for 7 days produced a distinct and statistically significant improvement over placebo (p<0.01). 84.6% of itraconazole treated patients were considered to be healed or markedly improved at the study's end point compared with 8.3% of placebo treated group (p<0.01). Eighty-four percent of patients receiving active treatment showed negative mycological examination as compared to 8.3% of placebo-treated group (p<0.01). Short-term treatment with itraconazole is effective and well tolerated in the management of pityrosporum folliculitis.     

Treatment of severe psoriasis with etretin (RO 10-1670)

Eighty patients with severe psoriasis were treated in a double-blind fashion with either an initial dose of 10 mg, 25 mg or 50 mg of etretin daily or with placebo. Follow-up examinations were carried out monthly and the efficacy of treatment was evaluated by using the PASI score. Adverse effects of the treatment were recorded monthly; liver enzymes, cholesterol and triglycerides were measured. After 2 months of treatment the maintenance dose was reduced in some of the patients either because of complete remission or adverse effects. After 2 months treatment, groups receiving 25 mg/day and 50 mg/day showed significantly lower PASI scores than the placebo group. The 10 mg/day group showed a response intermediate between the 25 mg and 50 mg groups and the placebo group. Thus, the optimal initial dose seems to be approximately 25 mg/day and the maintenance dose somewhat lower. Six months after the start of treatment there were no significant differences between the four groups; the last follow-up examination took place during the summer and some of the patients probably experienced spontaneous improvement. Although clinical adverse effects were frequent in all groups, severe side effects, namely hair loss and paronychia, occurred frequently only among patients treated with an initial dose of 50 mg of etretin daily. The effect of treatment on liver enzymes, cholesterol and triglycerides was minimal.     

左西替利嗪与西替利嗪治疗慢性荨麻疹多中心随机双盲对照研究

目的 研究和比较左西替利嗪和西替利嗪治疗慢性荨麻疹的疗效和安全性.方法 选择慢性荨麻疹患者为研究对象,采用多中心、随机、双盲、对照临床研究.试验组盐酸左西替利嗪片每日1次,每次5mg,对照组盐酸西替利嗪片每日1次,每次10mg,均连续服用28d.分别于用药后第7、14、28天随访,观察疗效和不良反应.结果 入选病例132例,可评价疗效和安全性病例均为130例.ITT分析左西替利嗪组治疗后第7、14、28天有效率分别为73.44%、82.81%、89.06%,西替利嗪组有效率分别为77.27%、81.82%、81.82%,两组比较差异无显著性.左西替利嗪组和西替利嗪组不良反应发生率分别为14.06%和18.18%,主要有口干、嗜睡.结论 左西替利嗪治疗慢性荨麻疹安全有效.     

Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study

This randomised, double-blind, placebo-controlled, parallel-group, international, dose-ranging study investigated the effect of treatment with rupatadine 5, 10 and 20 mg once daily for 4 weeks on symptoms and interference with daily activities and sleep in 12-65 years-old patients with moderate-to-severe chronic idiopathic urticaria (CIU). Rupatadine 10 and 20 mg significantly reduced pruritus severity by 62.05% and 71.87% respectively, from baseline, over a period of 4 weeks compared to reduction with placebo by 46.59% (p < 0.05). Linear trends were noted for reductions in mean number of wheals and interference with daily activities and sleep with rupatadine 10 and 20 mg over the 4-week treatment period. The two most frequently reported AEs were somnolence (2.90% for placebo, 4.29% for 5 mg-, 5.41% for 10 mg- and 21.43% for 20 mg-rupatadine-treated group) and headache (4.35% for placebo, 2.86% for 5 mg-, 4.05% for 10 mg- and 4.29% for 20 mg-rupatadine-treated group). These findings suggest that rupatadine 10 and 20 mg is a fast-acting, efficacious and safe treatment for the management of patients with moderate-to-severe CIU. Rupatadine decreased pruritus severity, in a dose- and time-dependent manner.