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针刺蝶腭神经节治疗变应性鼻炎的临床随机对照试验

A Randomized Controlled Clinical Trial of Acupuncture at the Sphenopalatine Ganglion for the Treatment of Allergic Rhinitis

  • 摘要:
    目的 评价针刺蝶腭神经节(sphenopalatine ganglion, SPG)治疗变应性鼻炎(allergic rhinitis, AR)的临床疗效及安全性。
    方法  采用随机对照试验设计,将120例AR患者按1∶1比例分为试验组(针刺SPG,每周2次,疗程2周)和对照组(口服富马酸卢帕他定片,每日10 mg,疗程2周)。主要结局指标为治疗后1周及2周的鼻炎症状与体征积分;次要结局指标为鼻炎伴随症状评分(total non-nasal symptom score, TNNSS)及鼻结膜炎生活质量问卷(rhinoconjunctivitis quality of life questionnaire, RQLQ)评分。
    结果  试验组和对照组各排除4例,最终每组各56例完成研究。治疗2周后,试验组与对照组总有效率分别为82.1%与87.5%,差异无统计学意义。两组治疗后各时点症状、体征积分、TNNSS及RQLQ评分均较治疗前下降,差异有统计学意义(P<0.001)。广义估计方程(GEE)分析显示,两组在多数指标上改善趋势一致,但存在“组别×时间”交互作用,提示试验组在治疗第1周对鼻塞症状的改善优于对照组〔试验组:2.0(1.0, 2.0) vs. 对照组:2.0(1.0, 2.0),交互项P=0.023〕。森林图分析进一步表明,治疗1周时鼻塞症状的标准化均数差(SMD)为-0.420(95%置信区间:-0.795, -0.046),至第2周时所有指标SMD的95%置信区间均跨越0点。安全性方面,试验组不良事件发生率与对照组比较差异无统计学意义。
    结论  针刺SPG与口服富马酸卢帕他定均可有效改善AR患者的症状与生活质量,短期总体疗效相当。但针刺SPG在缓解鼻塞症状方面起效更快,且安全性良好。

     

    Abstract:
    Objective To evaluate the clinical efficacy and safety of acupuncture at the sphenopalatine ganglion (SPG) for the treatment of allergic rhinitis (AR).
    Methods A randomized controlled trial design was used. A total of 120 patients with AR were randomly assigned in a 1∶1 ratio to either the experimental group (acupuncture on the SPG, twice a week for 2 weeks) or the control group (oral lupatadine fumarate tablets, 10 mg daily for 2 weeks). The primary outcome measures were nasal symptom and sign scores at 1 and 2 weeks after treatment. Secondary outcome measures included the total non-nasal symptom score (TNNSS) and the rhinoconjunctivitis quality of life questionnaire (RQLQ) score.
    Results Four cases were excluded from both the experimental group and the control group. Ultimately, 56 cases in each group completed the study. After two weeks of treatment, the total effective rates were 82.1% for the experimental group and 87.5% for the control group, with no statistically significant difference. At each time point after treatment, the symptom scores, sign scores, TNNSS, and RQLQ scores in both groups decreased compared to baseline, and these differences were statistically significant (P < 0.001). Generalized estimating equation (GEE) analysis showed that the improvement trends for most indicators were consistent between the two groups, but there was a "group × time" interaction, indicating that improvement in nasal congestion symptoms in the experimental group was greater than in the control group during the first week of treatment (experimental group: 2.0 1.0, 2.0 vs. control group: 2.0 1.0, 2.0, interaction P = 0.023). Forest plot analysis further showed that the standardized mean difference (SMD) for nasal congestion symptoms at one week of treatment was -0.420 (95% confidence interval: -0.795, -0.046), and the 95% confidence intervals for all indicators' SMD at two weeks crossed zero. Regarding safety, there was no statistically significant difference in the incidence of adverse events between the experimental and control groups.
    Conclusion Acupuncture on the SPG and oral administration of lupatadine fumarate can both effectively alleviate symptoms and improve the quality of life for patients with AR. The overall short-term efficacy is comparable. However, acupuncture on the SPG is more effective in relieving nasal congestion and has a good safety profile.

     

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