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.
Citation： MIN Xiaoling,ZHENG Yan,LIU Shixi,LIANG Chuanyu,HU Chunhong. Randomized Controlled Trial of Compound Loratadine Capsule in the Treatment of Allergic Rhinitis. Chinese Journal of Evidence-Based Medicine, 2004, 04(10): 673-676. doi: Copy