天竺雾化液联合会厌逐瘀汤化裁治疗血瘀痰凝型声带小结的临床研究

Therapeutic Effects of Tianzhu Aerosol Preparation in Combination with Modified Huiyan Zhuyu Decoction on Vocal Nodules with Blood Stasis and Phlegm Stagnation Syndrome

【目的】探讨天竺雾化液雾化吸入联合会厌逐瘀汤加减治疗声带小结(血瘀痰凝型)的临床疗效。【方法】将120例声带小结(血瘀痰凝型)患者随机分为治疗组和对照组,每组各60例。对照组给予会厌逐瘀汤加减治疗,治疗组给予天竺雾化液雾化吸入联合会厌逐瘀汤加减治疗,疗程2个月,随访6个月。观察2组患者主要症状改善率和疗程结束后1/2、1、3、6个月的复发率,评价2组患者的疗效和安全性。【结果】(1)治疗2个月后,治疗组的总有效率为85.0%,对照组为65.0%,治疗组的疗效优于对照组,差异有统计学意义(P<0.01)。(2)治疗后,治疗组声音嘶哑的改善率明显高于对照组,差异有统计学意义(P<0.05);而咽喉干燥不适和咳嗽咯痰症状的改善率虽略高于对照组,但差异无统计学意义(P>0.05)。(3)疗程结束后1/2、1、3、6个月,治疗组的复发率分别为3.3%、6.6%、11.6%和16.6%,对照组分别为8.3%、13.3%、20.0%和26.6%,组间比较,治疗组各个时间段的复发率均略低于对照组,但差异均无统计学意义(P>0.05)。(4)安全性评价:治疗期间,2组患者均未出现严重的不良反应病例。【结论】天竺雾化液雾化吸入联合会厌逐瘀汤加减治疗血瘀痰凝型声带小结具有较好疗效,其疗效优于单纯会厌逐瘀汤口服治疗,且复发率更低,不良反应更少。

Objective To investigate the therapeutic effects of Tianzhu Aerosol Preparation combined with modified Huiyan Zhuyu Decoction on vocal nodules with the syndrome of blood stasis and phlegm stagnation.Methods A total of 120 vocal nodules patients with the syndrome of blood stasis and phlegm stagnation were randomly divided into treatment group and control group,60 cases in each group.The control group was treated with modified Huiyan Zhuyu Decoction orally,and the treatment group was treated with aerosol inhalation of Tianzhu Aerosol Preparation combined with oral use of modified Huiyan Zhuyu Decoction.The treatment lasted for 2 months,and the follow-up covered 6 months.The relief rate for the primary symptoms and the recurrence rate half of a month,and 1,3,6 month(s)after the completion of the therapeutic course were observed,and the clinical efficacy and safety in the two groups were compared after treatment.Results(1)After treatment for 2 months,the effective rate in the treatment group was 85.0%and that in the control group was 65.0%,and the difference was statistically significant(P<0.01),indicating that the therapeutic efficacy in the treatment group was superior to that in the control group.(2)After treatment,the relief rate for hoarseness in the treatment group was higher than that in the control group,the difference being statistically significant(P<0.05);the relief rate for dry throat,cough and expectoration in the treatment group was mildly higher than that in the control group,but the difference between the two groups was insignificant(P>0.05).(3)The recurrence rate half of a month,and 1,3,6 month(s)after the completion of the therapeutic course in the treatment group was 3.3%,6.6%,11.6%,16.6%,and in the control group was 8.3%,13.3%,20.0%,26.6%,respectively,the difference between the two groups being insignificant(P>0.05).(4)During the treatment,no severe adverse reaction was found in the two groups.Conclusion Aerosol inhalation of Tianzhu Aerosol Preparation combined with oral use of modified Huiyan Zhuyu Decoction exerts stronger efficacy than oral use of modified Huiyan Zhuyu Decoction alone for the treatment of vocal nodules with the syndrome of blood stasis and phlegm stagnation,and the therapy has lower recurrence rate and less adverse reaction.