Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, 200127, China.
Department of Clinical Laboratory, Shanghai East Hospital, School of Medicine, Tong Ji University, Shanghai, 200120, China.
Chin J Integr Med. 2020 Nov;26(11):845-852. doi: 10.1007/s11655-020-3099-2. Epub 2020 Sep 1.
To evaluate the efficacy of Chinese medicine acupoint application (CMAA) combined with Western medicine for perennial allergic rhinitis (PAR) in children.
In this prospective, parallel, randomized, placebo-controlled and single-blind trial from August to September, 2017, 180 children with PAR were randomly assigned to an integrative group (CMAA and Montelukast), CMAA group (CMAA and placebo tablet), or Montelukast group (placebo CMAA and Montelukast). Participants were applied with CMAA for 6 sessions over 2 weeks, and/or Montelukast Chewable Tablet orally once daily for 12 weeks. The changes in severity of symptoms were measured by Visual Analog Scale (VAS) and rhinitis control assessment test (RCAT) at 0, 2, 4 and 12 weeks of treatment. Blood samples were collected for serum interleukin-4, interferon gamma γ and T helper type 1 (Th1)/Th2 flow cytometric analysis at the time points of 0, 4 and 12 weeks.
Eight cases dropped out from the trial, 3 in the integrative group, 2 in the CMAA group and 3 in the Montelukast group. The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline (P<0.01 or P<0.05). The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks (P<0.01 or P<0.05). At 2, 4 and 12 weeks, the scores of nasal congestion, sneezing, sleep problem, and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline (P<0.01 or P<0.05). The least percentages of Th2 and the most alleviated Th2 shift (highest Th1/Th2) were observed in the integrative group at 12 weeks compared with the other two groups (P<0.05).
The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR. (Registered at Chinese Clinical Trial Register, registration No. ChiCTR-IOR-17012434).
评价中药穴位贴敷（CMAA）联合西药治疗儿童常年性变应性鼻炎（PAR）的疗效。
采用前瞻性、平行、随机、安慰剂对照、单盲试验，于 2017 年 8 月至 9 月，纳入 180 例 PAR 患儿，按 1∶1∶1 比例随机分配至整合组（CMAA+孟鲁司特）、CMAA 组（CMAA+安慰剂片）和孟鲁司特组（CMAA+安慰剂+孟鲁司特）。患儿接受 CMAA 治疗 6 次，共 2 周，或孟鲁司特咀嚼片口服，每日 1 次，共 12 周。治疗 0、2、4 和 12 周时，采用视觉模拟量表（VAS）和鼻炎控制评估测试（RCAT）评估症状严重程度的变化。在 0、4 和 12 周时采集血清样本，采用流式细胞术检测白细胞介素-4（IL-4）、γ干扰素（IFN-γ）和 T 辅助细胞 1/2（Th1/Th2）比值。
试验中共有 8 例患儿脱落，整合组 3 例，CMAA 组 2 例，孟鲁司特组 3 例。与基线相比，3 组患儿在治疗后第 4 周和第 12 周 VAS 评分显著降低，RCAT 评分显著升高（均 P<0.01 或 P<0.05）。在第 2 周和第 4 周，整合组和 CMAA 组的 VAS 评分显著低于孟鲁司特组，RCAT 评分显著高于孟鲁司特组（均 P<0.01 或 P<0.05）。与基线相比，在第 2、4 和 12 周时，整合组和 CMAA 组的鼻塞、打喷嚏、睡眠问题和鼻炎症状控制评分均显著升高（均 P<0.01 或 P<0.05）。与其他 2 组相比，在第 12 周时，整合组 Th2 的比例最低，Th2 偏移得到最大缓解（Th1/Th2 比值最高）（P<0.05）。
与单独使用孟鲁司特或 CMAA 相比，CMAA 联合孟鲁司特治疗儿童 PAR 可能更有效、更合适。（临床试验注册号：ChiCTR-IOR-17012434）
