G-Q Yin1, W-H Jiang, P-Q Wu, C-H He, R-S Chen, L Deng. 1. Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China. shao_xicai1@163.com.
Abstract
OBJECTIVE: This study focuses on evaluating the clinical effects of sublingual dust mite drops for the treatment of allergic asthma in children. PATIENTS AND METHODS: 156 pediatric patients with allergic rhinitis and asthma were randomly divided into control and observation groups (78 cases each). For the control group the standard global initiative for asthma (GINA) asthma control scheme was adopted; meanwhile, the observation group patients received the standard GINA combined with sublingual administration of dust mite drops, once per day, gradually increasing the dose to reach a high maintenance level. After six months the sublingual drops were stopped and then the effects of the treatments on both groups of patients were compared. RESULTS: The symptoms of asthma and rhinitis in the daytime and nighttime for both groups decreased gradually with time. However, the observation group's outcome at the 6th, 12th and 24th month were significantly better than those of the control group (p < 0.05). Moreover, the FVC, FEV1 and PEF values of the two groups increased gradually, but those of the observation group improved more obviously (p < 0.05). The total effective rate of the observation group at the 6th and 24th months was significantly higher than that of the control group (p < 0.05). The contrast of complete and good control at 6 months had no statistical significance (p > 0.05). But at the 24th month, the observation group had significantly higher rates of complete and good control (p < 0.05). During the median time of sublingual administration of 20.3 months (ranging from 6 to 36 months), there were no evident adverse reactions. Finally, after the intervention, there were no significant differences between the IgE levels of the two groups (p > 0.05); however, the levels of IL-2 increased gradually and improved more in the observation group (p < 0.05). CONCLUSIONS: The results of our study support the notion that sublingual administration of dust mite drops to treat allergic rhinitis and asthma can improve clinical symptoms, increase the efficiency rate and increase the serum IL-2 level, and does not cause an increase in adverse reactions or IgE levels in treated children.
RCT Entities:
OBJECTIVE: This study focuses on evaluating the clinical effects of sublingual dust mite drops for the treatment of allergic asthma in children. PATIENTS AND METHODS: 156 pediatric patients with allergic rhinitis and asthma were randomly divided into control and observation groups (78 cases each). For the control group the standard global initiative for asthma (GINA) asthma control scheme was adopted; meanwhile, the observation group patients received the standard GINA combined with sublingual administration of dust mite drops, once per day, gradually increasing the dose to reach a high maintenance level. After six months the sublingual drops were stopped and then the effects of the treatments on both groups of patients were compared. RESULTS: The symptoms of asthma and rhinitis in the daytime and nighttime for both groups decreased gradually with time. However, the observation group's outcome at the 6th, 12th and 24th month were significantly better than those of the control group (p < 0.05). Moreover, the FVC, FEV1 and PEF values of the two groups increased gradually, but those of the observation group improved more obviously (p < 0.05). The total effective rate of the observation group at the 6th and 24th months was significantly higher than that of the control group (p < 0.05). The contrast of complete and good control at 6 months had no statistical significance (p > 0.05). But at the 24th month, the observation group had significantly higher rates of complete and good control (p < 0.05). During the median time of sublingual administration of 20.3 months (ranging from 6 to 36 months), there were no evident adverse reactions. Finally, after the intervention, there were no significant differences between the IgE levels of the two groups (p > 0.05); however, the levels of IL-2 increased gradually and improved more in the observation group (p < 0.05). CONCLUSIONS: The results of our study support the notion that sublingual administration of dust mite drops to treat allergic rhinitis and asthma can improve clinical symptoms, increase the efficiency rate and increase the serum IL-2 level, and does not cause an increase in adverse reactions or IgE levels in treated children.