盐酸左西替利嗪治疗慢性特发性荨麻疹的临床研究

目的：研究盐酸左西替利嗪治疗慢性特发性荨麻疹的疗效和安全性。方法：采用随机、双盲、对照的临床研究方法，对44例慢性特发性荨麻疹患者进行随机分组，试验组予以盐酸左西替利嗪片口服，对照组采用盐酸西替利嗪片口服，每日1次。观察治疗第7、14和28天的临床疗效和不良反应：结果：服药后第7、14和28天试验组和对照组的有效率分别为77．28％和68．18％、86．37％和77．28％、90．91％和81．82％。试验组略高于对照组，但差异并无显著性。试验中没有发生严重不良反应。结论：盐酸左西替利嗪治疗慢性特发性荨麻疹安全有效。     

盐酸非索非那定治疗126例慢性特发性荨麻疹

目的:评价盐酸非索非那定片治疗慢性特发性荨麻疹的有效性和安全性。方法:多双盲、随机、平行组对照的临床试验,以盐酸西替利嗪片为对照药。结果:共完成病例126例,试验组63例,对照组63例。试验组有效率为88.89%,对照组有效率为80.95%,两组无显著性差异(P >0.05)。试验组不良反应发生率为4.76%;对照组不良反应发生率为9.52%,两组无显著性差异(P>0.05)。结论：:盐酸非索非那定片治疗慢性特发性荨麻疹的有效性与盐酸西替利嗪片相当。     

Levocetirizine in the treatment of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study

BACKGROUND: Chronic urticaria is a common skin condition. It is frequently a disabling disease because of the persistence of clinical symptoms, the unpredictable course and its negative influence on the quality of life. OBJECTIVES: To determine whether levocetirizine is efficacious in the treatment of chronic idiopathic urticaria. METHODS: A randomized, double-blind, placebo-controlled study was conducted in 106 patients with a diagnosis of chronic idiopathic urticaria. A 1-week single blind placebo run-in period (baseline) was followed by a 6-week double blind active treatment period. The patients were randomized to receive one of the following treatments once daily: (a) oral levocetirizine 5 mg, or (b) oral placebo. The study ended after another 1-week single blind placebo washout period. RESULTS: The evaluable population consisted of 100 patients. Levocetirizine administered once daily is effective and well tolerated in the treatment of the symptoms of chronic idiopathic urticaria and in improving the patient's quality of life. Levocetirizine was superior to placebo in reducing the mean total symptoms score as well as individual symptoms, the number of daily episodes and the number of weals, the overall severity of symptoms and the quality of life. The significant beneficial effects of levocetirizine lasted only during the active trial, while at follow-up there was a significant worsening of all the variables evaluated in this study, after the end of the active trial (week 7). CONCLUSIONS: A global assessment indicates that levocetirizine 5 mg once daily is an effective agent in patients with chronic idiopathic urticaria, as its action provides a rapid and satisfactory control of the symptoms and measures of subjective disease, although this is limited to the duration of treatment.     

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.     

Efficacy of H, antihistamine, corticosteroids and cyclophosphamide in the treatment of chronic dermographic urticaria

H, antihistamines relieve urticaria by blocking the action of histamine on the target tissue, while demonstration of autoantibodies in the sera of a proportion of the patients having chronic idiopathic urticaria, use of immunosuppressive drugs for the treatment of these patients has acquired the greater rationality. We evaluated the role of corticosteroids and cyclophosphamide in the treatment of chronic dermographic urticaria. Twenty-five patients, 13 males and 12 females, between 18-53 years in age, having chronic dermographic urticaria were taken up for this study. The patients were divided into three groups. Group I patients (n=9) were treated with cetirizine hydrochloride 10 mg per day orally, group II patients (n=7) were treated with betamethasone 2 mg along with cyclophosphamide 50 mg along with cetirizine 10 mg per day for a total period of 4 weeks. The patients were evaluated every week to record the therapeutic response and side effects, and then followed up without treatment for a period of 6 months to look for recurrence of the urticaria, if any. Six patients in group I and all the patients in group II and group III had complete remission while the remaining patients in group I had partial relief. The side effects included drowsiness in 4 patients. All the patients in group II had weight gain, 4 patients had acne and 2 patients developed cushingoid features. Majority of the patients relapsed within 3 days after stopping the treatment. Supplementation of the treatment with oral corticosteroids or cyclophosphamide was more effective in controlling the symptoms as compared to cetirizine alone. But a four weeks supplementation was not adequate for preventing the relapses when the drugs were withdrawn.     

Levocetirizine is an effective treatment in patients suffering from chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, parallel, multicenter study

BACKGROUND: Chronic idiopathic urticaria (CIU) is defined by the almost daily presence of urticaria for at least 6 weeks without an identifiable cause. Symptoms include short-lived wheals, itching, and erythema. CIU impedes significantly a patient's quality of life (QoL). Levocetirizine is an antihistamine from the latest generation approved for CIU. AIM: To investigate the efficacy of levocetirizine, 5 mg, and placebo for the symptoms and signs of CIU, as well as for the QoL and productivity. METHODS: The primary criteria of evaluation were the pruritus severity scores over 1 week of treatment and over 4 weeks. The QoL was assessed via the Dermatology Life Quality Index (DLQI). RESULTS: Baseline pruritus severity scores were comparable in the two treatment groups (2.06+/-0.58). After 1 week, levocetirizine was superior to placebo and demonstrated a considerable efficacy (difference=0.78, P<0.001). This efficacy was maintained over the entire study period (4 weeks, P<0.001). The number and size of wheals were considerably reduced compared with placebo over 1 week and over the total treatment period (P 相似文献   

Treatment of chronic urticaria with cetirizine dihydrochloride a non-sedating antihistamine

The efficacy of cetirizine dihydrochloride, a new H₁-antagonist with minimal sedative or anticholinergic side effects was evaluated in 30 patients with chronic idiopathic urticaria. In the first part of the study, cetirizine 10 mg and placebo were compared in a double-blind cross-over trial. In the second part, patients who did not respond adequately in the first part were randomized, still double-blind, to receive 10 mg cetirizine either once daily or twice daily. In the first part, treatment was discontinued by 17 patients on placebo and two patients on cetirizine because of lack of efficacy. Cetirizine dihydrochloride was found significantly to reduce occurrence of weals, erythema and pruritus compared with placebo (P <0.001). Twenty-six of the patients improved on cetirizine and two on placebo. Mild sedation was noted by two patients on cetirizine and by one on placebo.     

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.     

Treatment of Urticaria

Urticaria is a cutaneous syndrome characterized by dermal edema (wheal) and erythema (flare) that blanches with pressure. The lesions typically last less than 24 hours and are usually pruritic. In 1983, Christensen and Maibach summarized the theory behind the use of histamine H₁ receptor antagonists (antihistamines) in clinical dermatology. These agents remain the mainstay of treatment for urticaria. This article reviews the medical literature on the effectiveness of antihistamines in urticarial syndromes, including acute, chronic idiopathic and the physical urticarias. Older antihistamines, such as chlorpheniramine and hydroxyzine, are effective in the treatment of urticarias, but they also have marked sedative and anticholinergic effects. Newer nonsedating antihistamines (second-generation antihistamines) have been developed that have reduced adverse effects because they do not cross the blood-brain barrier; these agents (acrivastine, cetirizine, loratadine, mizolastine, fexofenadine, ebastine, azelastine and epinastine) cause significantly less sedation and psychomotor impairment than their older counterparts. A review of the literature reveals that there are few studies which document the efficacy of second-generation antihistamines in the treatment of acute urticaria, a biologic entity that usually resolves within 3 weeks. We did not identify controlled studies that suggested superiority of any antihistamine in the treatment of acute urticaria. Loratadine or cetirizine, and possibly mizolastine, appear to be treatments of choice for chronic idiopathic urticaria. For symptomatic dermatographism, the combination of an antihistamine and an H₂ antagonist, e.g. chlorpheniramine and cimetidine, appears to be effective. Very few studies have been conducted on the use of antihistamines in the treatment of cold, cholinergic, and pressure urticaria. Antihistamines are the mainstay of urticarial therapy. This evidence-based review suggests that there are efficacy differences between newer, nonsedating antihistamines and older agents in some forms of the disorder. Clearly, further well-controlled clinical trials in larger numbers of patients are needed to clarify the role of these agents in the treatment of urticaria.     

左西替利嗪、曲尼司特联合卡介苗素治疗慢性荨麻疹的临床观察

目的观察左西替利嗪、曲尼司特联合免疫调节剂卡介苗素治疗慢性荨麻疹的疗效。方法将入选的患者随机分为3组:治疗组56例,予口服左西替利嗪5mg1次/d、曲尼司特0.1g3次/d联合卡介苗素2mL肌肉注射隔日1次治疗;对照A组45例予口服左西替利嗪和曲尼司特治疗,对照B组45例单纯口服左西替利嗪治疗,方法均同治疗组。三组均用药8周后评价疗效,停药1月后观察复发情况。结果治疗组有效率91.1%,明显优于两个对照组((75.6%,42.2%)(P均0.05),差异有显著性;治疗组复发率(6/42例)低于两个对照组(9/26例,9/12例)。结论左西替利嗪、曲尼司特联合卡介苗素治疗慢性荨麻疹疗效好,复发率低。     

Chronic urticaria: a role for newer immunomodulatory drugs?

Chronic urticaria is now recognized as an autoreactive disorder in a substantial fraction of patients. A serologic mediator of whealing has been demonstrated in 50-60% of patients with chronic urticaria, and autoantibodies against the high affinity IgE receptor or IgE have been detected in about half of these patients. The demonstration that chronic urticaria is frequently autoimmune has encouraged a more aggressive therapeutic approach, with the use of immunomodulatory drugs.A step-by-step approach to the management of chronic urticaria is proposed, based on our personal experience and review of current medical literature, identified through Medline research and hand searching in medical journals. The non- or low-sedating H(1) receptor antagonists (antihistamines), such as cetirizine, fexofenadine, loratadine, mizolastine and, more recently, levocetirizine, desloratadine and ebastine, represent the basic therapy for all chronic urticaria patients. Older sedating antihistamines, such as hydroxyzine and diphenhydramine, may be indicated if symptoms are severe, are associated with angioedema, and if the patient is anxious and disturbed at night.Corticosteroid therapy with prednisone or methylprednisolone can be administered for a few days (7-14) if urticarial symptoms are not controlled by antihistamines and a rapid clinical response is needed. In cases of relapse after corticosteroid suspension, leukotriene receptor antagonists, such as montelukast and zafirlukast, should be tried. In our experience, remission of urticarial symptoms can be achieved in 20-50% of chronic urticaria patients unresponsive to antihistamines alone. When urticaria is unremitting and is not controlled by combined therapy with antihistamines and leukotriene receptor antagonists, prolonged corticosteroid therapy may be needed. Long-term corticosteroid therapy should be administered at the lowest dose able to control urticarial symptoms, in order to minimize adverse effects. In a few patients, however, high-dose corticosteroid therapy may have to be administered for long periods. In these patients, immunosuppressive treatment with low-dose cyclosporine can be started. This type of treatment has a corticosteroid-sparing effect and is also generally effective in patients with severe, unremitting urticaria, but requires careful monitoring of cyclosporine plasma concentration and possible adverse effects. Other immunomodulating drugs that have been tried in chronic urticaria patients include hydroxychloroquine, dapsone, sulfasalazine and methotrexate, but their efficacy has not been proven in large controlled studies. Warfarin therapy may also be considered in some patients with chronic urticaria and angioedema unresponsive to antihistamines.     

依巴斯汀雷尼替丁联合治疗慢性荨麻疹疗效观察

目的观察依巴斯汀、雷尼替丁联合治疗慢性荨麻疹的疗效。方法62例患者随机分成两组,治疗组口服依巴斯汀与雷尼替丁,对照组口服西替利嗪与雷尼替丁,疗程4周,评估疗效,记录不良反应。结果治疗组和对照组有效率分别为84.26%和71.43%,差异无显著性(P>0.05)。结论依巴斯汀、雷尼替丁联合治疗慢性荨麻疹疗效好,安全可靠。     

Cellular adhesion molecules in chronic urticaria: modulation of serum levels occurs during levocetirizine treatment

BACKGROUND: Some antihistamines are capable of reducing levels of adhesion molecules in wealing tissues of patients with chronic urticaria (CU). OBJECTIVES: To determine if 6 weeks of therapy with levocetirizine 5 mg once daily would also induce any decrease in serum levels of intercellular adhesion molecule-1, vascular cell adhesion molecule-1, endothelial leucocyte adhesion molecule-1 (ELAM-1) or P-selectin in subjects with CU and chronic autoimmune urticaria. METHODS: Thirty-six patients with CU (18 with positive and 18 with negative autologous serum skin test) were studied, together with 10 control healthy subjects. All patients received levocetirizine 5 mg daily. Serum soluble cellular adhesion molecule (CAM) levels were determined by immunoenzymatic assay before and after the end of the study period. Disease activity was recorded according to the EAACI/GA(2)LEN/EDF scoring system. RESULTS: After levocetirizine therapy CAM levels decreased in patients with CU, significantly in the cases of ELAM-1 and P-selectin. Patients' clinical scores improved during regular antihistamine therapy. CONCLUSIONS: Levocetirizine 5 mg daily demonstrated a broad anti-inflammatory effect in patients with CU. The significant decrease in serum levels of ELAM-1 and P-selectin might reflect the inhibitory activity on neutrophil rolling and extravasation towards inflamed skin.     

祛风止痒保健茶辅助治疗慢性荨麻疹临床疗效观察

目的评价一种祛风止痒保健茶组方对慢性荨麻疹的辅助治疗效果与安全性。方法 80例临床确诊的慢性荨麻疹患者随机分为2组,治疗组应用含有黄芪、白术、防风、五味子、乌龙茶的保健茶和左西替利嗪治疗;对照组使用黄芪、白术、防风、五味子配合左西替利嗪治疗。分别于治疗后4周和8周总结荨麻疹活动性评分(Urticaria activity score,UAS)和临床疗效等;并于24周后随访痊愈患者的复发率。结果4周、8周后治疗组和对照组UAS评分均比治疗前有明显下降(P0.05),但2组之间没有明显的差别。治疗8周后治疗组瘙痒程度较对照组减轻(t=2.402,P0.05)。治疗组有效率为95.2%,明显高于对照组88.9%,其结果差异有统计学意义(χ~2=5.011,P0.05)。24周后随访,治愈患者中治疗组2例复发,对照组8例复发。结论包含乌龙茶成分的祛风止痒保健茶能提高慢性荨麻疹的临床治疗效果,有一定的止痒和减少复发的作用。     

甘草祛风汤治疗慢性特发性荨麻疹临床观察及对血清IFN-γ和IL-4水平的影响

目的研究甘草祛风汤治疗慢性特发性荨麻疹(CIU)的临床疗效及其对血清IFN-γ和IL-4水平的影响。方法将60例CIU患者随机分为两组,分别予甘草祛风汤和盐酸西替利嗪片进行治疗,观察疗效和复发率。采用ELISA法测定IFN-γ和IL-4水平,并与40例健康对照组进行比较。结果甘草祛风汤组经治疗后第4周,第12周疗效评价均优于西替利嗪组,治疗后第12周复发率两组相比差异有统计学意义(P0.01)。CIU患者血清IFN-γ和IL-4水平与健康对照组差异有统计学意义(P0.01),甘草祛风汤组经治疗后第4周、第12周血清IFN-γ和IL-4水平与治疗前及西替利嗪组相比均有统计学意义(P均0.01)。结论甘草祛风汤可有效治疗CIU,且疗效持久,复发率较低。通过检测并比较两种反映Th1/Th2平衡的细胞因子水平,发现甘草祛风汤可有效提高血清IFN-γ水平,降低IL-4水平,对恢复机体自身免疫平衡有积极的作用。     

地氯雷他定治疗慢性荨麻疹疗效观察

目的 :观察地氯雷他定治疗慢性荨麻疹的疗效和安全性。方法 :采取随机对照临床试验 ,试验组每日口服一片地氯雷他定 (每片 5mg) ,疗程 1 4d;对照组每日口服一片西替利嗪 (每片 1 0mg) ,疗程 1 4d。结果 :共治疗 85例 ,试验组 4 3例 ,对照组 4 2例。总有效率试验组为 88 37% ,对照组为80 95 % ,两组比较差异无显著性 (P >0 0 5 )。不良反应发生率试验组为 9 30 % ,对照组为 1 9 0 5 % ,两组比较差异无显著性 (P >0 0 5 )。结论 :地氯雷他定是一种治疗慢性荨麻疹有效安全的药物。     

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。     

A comparison of cetirizine and terfenadine in the management of solar urticaria.

Many solar urticaria patients may benefit from the use of antihistamines. Historically, the value of such therapy was limited by sedation. Newer agents such as terfenadine and cetirizine that are relatively non-sedating appear to be better tolerated by patients. The latter drug, in addition to its antihistamine effect, also appears to inhibit eosinophil migration, which terfenadine and other potent H1 antagonists do not significantly affect. Eosinophils have been reported as early migrating cells in induced solar urticaria, raising the possibility that the dual action of cetirizine may provide a greater potential benefit in the management of solar urticaria. Six patients with idiopathic solar urticaria were entered into a double-blind, phototest study to compare cetirizine and terfenadine. Using the minimal urticarial dose as a phototest end-point, both drugs were equally effective in raising the threshold of sensitivity in 4 patients. Two patients failed to respond to either therapy, which is in keeping with the known variable response to histamine blockade in solar urticaria. At the dosage used, cetirizine therapy appears to be no more effective than terfenadine.     

依匹斯汀与左西替利嗪治疗慢性荨麻疹多中心随机双盲对照研究

目的：研究和比较依匹斯汀和左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、双模拟和对照临床研究。试验组依匹斯汀胶囊每日1次,每次10mg,对照组盐酸左西替利嗪胶囊每日1次,每次5mg,均连续服用28天。于用药后随访,观察疗效和不良反应。结果：入选病例131例,可评价疗效和安全性病例120例。经28天治疗后依匹斯汀组及左西替利嗪组总有效率分别为70.05％、67.79％,两组比较差异无显著性（P=0.2564）。依匹斯汀组和左西替利嗪组不良反应发生率分别为11.48％和23.33％。结论：依匹斯汀治疗慢性荨麻疹安全有效。     

西替利嗪联合曲尼司特治疗慢性荨麻疹疗效观察

目的观察西替利嗪联合曲尼司特治疗慢性荨麻疹的疗效。方法将入选的80例患者按就诊时间顺序随机分为两组,治疗组48例,对照组32例。治疗组口服西替利嗪10mg,1次/d,曲尼司特0.1g3次/d;对照组仅口服西替利嗪10mg,1次/d;两组均连用4周后评价疗效,停药4周后观察复发情况。结果治疗4周后,治疗组有效率(75.00%)明显高于对照组(50.00%),差异有显著性意义(χ2=5.27,Р<0.05);对照组复发率(55.56%)明显高于治疗组(22.73%)。结论西替利嗪联合曲尼司特治疗慢性荨麻疹疗效满意,能明显降低复发率,疗效优于单用西替利嗪组。