Objectives To evaluate the efficacy and safety of desloratadine in the patients with chronic urticaria(cu). Methods We searched PubMed, Blackwell, BIOSIS Preview, The Cochrane Library, VIP and CNKI electronically from January 1, 2000 to April, 2008. Relevant journals and conference proceedings were also handsearched. Randomized controlled trials (RCTs) and quasi-RCTs comparing desloratadine with other medicines in the patients with CIU were considered eligible. The quality of the included trials was assessed by the Jadad scale, and meta-analysis was conducted using RevMan 5.0 software. Results Nineteen trials involving 3,448 participants contributed to the meta-analysis. The results of the meta-analysis indicated that desloratadine showed similar effect on the improvement of signs and symptoms compared with loratadine RR 1.04 and 95%CI 0.99 to 1.09, mizolastine in RR 0.99 and 95%CI 0.92 to 1.07, cetirizine RR 1.05 and 95%CI 0.97 to 1.13 and terfenadine RR 1.10 and 95%CI 0.84 to 1.44. And desloratadine had similar safety to mizolastine RR 0.84 and 95%CI 0.45 to 1.58, ceririzine RR 0.67 and 95%CI 0.67 and 0.39 to 1.15 and terfenadine RR 0.44 and 95%CI 0.17 to 1.10. Desloratadine was safer than loratadine RR 0.74 and 95%CI 0.55 to 1.00. Conclusions Desloratadine, the active metabolite of loratadine, is an oral, once-daily, non-sedating antihistamine that is effective in the treatment of CIU. Desloratadine provides rapid and sustained relief of CIU symptoms.
Objective To evaluate the clinical effectiveness and safety of compound loratadine capsule in the treatment of allergic rhinitis. Methods A multi-center randomized single blind controlled trial (by using a random number table generated random sequence and the sequence was concealed by sealed envelopes) was designed. Two hundred and forty outpatients with allergic rhinitis who met the inclusion and exclusion criteria were randomized to the treatment group (n=120 with compound loratadine capsule, 1 capsule q 24 h) or the control group (n=120 with loratadine tablet, 1 tablet q 12 h). All patients were given standard therapy. Results ① At the end of the treatment, in the compound loratadine group, 101 patients completed the study, and 19 patients withdrew. In the loratadine group, 103 patients completed the study, 17 patients withdrew. According to intention-to-treat analysis (ITT), the improvement rates of the treatment and control groups were 89.17% (107/120) and 88.33% (106/120) respectively. No significant difference was seen between the two groups (rank sum test, u=-1.8348, P＞0.05). According to per-protocol analysis (PP), the improvement rates of the treatment and control groups were 96.04% (97/101) and 91.26% (94/103) respectively. No significant difference was seen between the two groups (rank sum test, u=-1.625 7, P＞0.05). ② Adverse events were slight to moderate.The adverse event rates were 22.5% (27/120) and 21.67% (26/120) in the treatment and control groups respectively. No significant difference was seen between the two groups ( χ2 test, P＞0.05). Conclusion Compound loratadine capsule is effective and safe for allergic rhinitis.
Objective This review compared clinical effectiveness, cardiac safety and economics of astemizole, loratadine, cetirizine and terfenadine to provide evidence for adjustment of Essential Drug List in China. Search strategy We searched Medline, Cochrane Library, Embase and Chinese Biomedical Database. Fourteen databases for drug safety and pharmaceutical economics were additionally searched. Selection Criteria Randomized controlled trials and systematic reviews, published in English and Chinese and comparing two or more of these four antihistamines for allergic rhinitis and urticaria were included for study of effectiveness. Non-randomized clinical trials were additionally included for economic evaluation. Cardiac safety studies of antihistamines for allergic diseases of any type were included. Quality Appraisal Jadad scale was primarily applied to randomized controlled trials. Allocation concealment and intention-to-treat analysis were also appraised. The QUOROM statement was applied to systematic reviews and meta-analysis. Data extraction and analyses For the study of effectiveness, composite data were primarily extracted and analyzed by fixed effect model. Sensitivity analysis was done to explore the heterogeneity. For the study of cardiac safety, cases of adverse drug reactions and death were summarized. Difference of occurrence rate in sex and age were analyzed if possible.Electrocardiography and clinical symptoms were summarized. Results No studies on economic evaluation were identified. 27 and 6 randomized controlled trials, including 3 227 participants, for allergic rhinitis and urticaria were identified. Cetirizine was superior to loratadine (n=709) in symptom score and onset of action, superior to terfenadine (n=645) in Quality of Life and superior to astemizole (n=498) in patient satisfaction and onset of action. 73 h-ADR cases were identified in astemizole, 27 cases in terfenadine, 1 case in loratadine and none in cetirizine. No deaths were identified. Combination of terfenadine plus grapefruit juice (n=l8), itraconazole (n=6), nefazodone (n=67), and loratadine administration concomitant with cemitidine (n=30) significantly prolonged QTc interval. Conclusions Cetirizine was superior to other three antihistamines in terms of clinical effectiveness and drug safety. Astemizole and terfenadine could cause significantly more cardiac-related adverse reactions than cetirizine and loratadine.