止敏方口服联合雾化治疗过敏性结膜炎湿热夹风证的临床研究

The Clinical Study of the Treatment of Allergic Conjunctivitis with Damp-Heat Com⁃plex Wind Syndrome Using Zhimin Formula Orally Combined with Nebulization

目的观察止敏方口服联合雾化治疗湿热夹风证过敏性结膜炎(AC)的临床疗效。方法纳入2021年1月—2021年12月苏州市中医医院诊治的湿热夹风证AC患者90例(180只眼),随机分成联合组、雾化组和对照组,每组30例(60只眼)。联合组予止敏方口服及雾化,雾化组单予止敏方雾化,对照组予盐酸氮卓斯汀滴眼液滴眼,均治疗14 d。观察3组患者治疗前后的症状积分、体征积分、泪液免疫球蛋白E(Ig E)抗体值,评价临床疗效。结果3组治疗前症状、体征积分和泪液Ig E抗体比较,差异均无统计学意义(P>0.05)。(1)症状积分:治疗后3组症状积分均较治疗前降低,差异均有统计学意义(t_(联合组)=-18.199、t_(雾化组)=-15.715、t对照组=-13.739,均P=0.000)。治疗后3组间比较,差异有统计学意义(F=8.594,P=0.000)。与对照组比较,联合组和雾化组症状积分均较低,差异均有统计学意义(t_(联合组)=-3.640,P=0.000;t_(雾化组)=-3.156,P=0.002),联合组与雾化组比较,差异无统计学意义(P>0.05)。(2)体征积分:治疗后3组体征积分均较治疗前降低,差异均有统计学意义(t_(联合组)=-18.887、t_(雾化组)=-17.742、t对照组=-15.556,均P=0.000)。治疗后3组间比较,差异有统计学意义(F=16.959,P=0.000)。与对照组比较,联合组和雾化组体征积分均较低,差异均有统计学意义(t_(联合组)=-5.157,P=0.000;t_(雾化组)=-4.409,P=0.000),联合组与雾化组比较,差异无统计学意义(P>0.05)。(3)泪液Ig E抗体:治疗后3组Ig E抗体指标均较治疗前降低,差异均有统计学意义(t_(联合组)=-48.276、t_(雾化组)=-38.164、t对照组=-34.129,均P=0.000)。治疗后3组间比较,差异有统计学意义(F=1937.535,P=0.000)。与对照组比较,联合组和雾化组均较低(t_(联合组)=-56.682、t_(雾化组)=-21.667,均P=0.000)。联合组低于雾化组(t=-49.470,P=0.000),差异均有统计学意义。(4)临床疗效:3组临床疗效比较,差异有统计学意义(Z=14.887,P=0.001)。与联合组比较,雾化组和对照组均较低(Z_(雾化组)=-16.483,P=0.024;Z对照组=-23.267,P=0.001),差异均有统计学意义,雾化组和对照组比较,差异无统计学差异(P>0.05)。(5)复发率:3组复发率比较,差异有统计学意义(χ^(2)=22.816,P=0.000)。与对照组比较,联合组和雾化组均较低(χ^(2)_(联合组)=22.500,P=0.000;χ^(2)_(雾化组)=6.696,P=0.010),联合组低于雾化组(χ^(2)=5.963,P=0.015),差异均有统计学意义。结论止敏方口服加雾化的联合疗法治疗湿热夹风证AC有效,且较单一疗法优势显著。

OBJECTIVE To observe the clinical efficacy of oral administration of Zhimin Formula combined with nebulization in the treatment of allergic conjunctivitis(AC)with damp-heat complex wind syndrome.METHODS A total of 90 cases(180 eyes)of AC patients with damp-heat complex wind syndrome treated at Suzhou Hospital of Traditional Chinese Medicine from January 2021 to December 2021 were randomly divided into combined group(CMG),nebulization group(NG),and control group(CG),with 30 cases in each group(60 eyes).The combined group received oral Zhimin Formula and nebulization,the nebulization group received Zhimin Formula nebulization alone,and the control group received eye drops of levocabastine hydrochloride.All groups were treated for 14 days.Symptom scores,sign scores,and tear immunoglobulin E(IgE)antibody level before and after treatment were observed to evaluate clinical efficacy.RESULTS There were no statistically significant differences in symptom scores,sign scores,and tear IgE antibody levels among the three groups before treatment(P>0.05).(1)Symptom scores:After treatment,the symptom scores of all three groups decreased compared to before treatment,and the differences were statistically significant(t_(CMG)=-18.199,t_(NG)=-15.715,t_(CG)=-13.739,all P=0.000).There were significant differences among the three groups after treatment(F=8.594,P=0.000).Compared with the control group,both the combined group and nebulization group had lower symptom scores,with statistically significant differences(t_(CMG)=-3.640,P=0.000;t_(NG)=-3.156,P=0.002).There was no significant difference between the combined group and nebulization group(P>0.05).(2)Sign scores:After treatment,the sign scores of all three groups decreased compared to before treatment,and the differences were statistically significant(t_(CMG)=-18.887,t_(NG)=-17.742,t_(CG)=-15.556,all P=0.000).There were significant differences among the three groups after treatment(F=16.959,P=0.000).Compared with the control group,both the combined group and nebulization group had lower sign scores,with statistically significant differences(t_(CMG)=-5.157,P=0.000;t_(NG)=-4.409,P=0.000).There was no significant difference between the combined group and the nebulization group(P>0.05).(3)Tear IgE antibody:After treatment,the IgE antibody levels of all three groups decreased compared to before treatment,and the differences were statistically significant(t_(CMG)=-48.276,t_(NG)=-38.164,t_(CG)=-34.129,all P=0.000).There were significant differences among the three groups after treatment(F=1937.535,P=0.000).Compared with the control group,both the combined group and nebulization group had lower levels of IgE antibodies(t_(CMG)=-56.682,t_(NG)=-21.667,both P=0.000).The combined group was lower than the nebulization group(t=-49.470,P=0.000),and the differences were statistically significant.(4)Clinical efficacy:There were significant differences in clinical efficacy among the three groups(Z=14.887,P=0.001).Compared with the combined group,both the nebulization group and the control group had lower efficacy(Z_(NG)=-16.483,P=0.024;Z_(CG)=-23.267,P=0.001),and the differences were statistically significant.There was no significant difference between the nebulization group and the control group(P>0.05).(5)Recurrence rate:There were significant differences in recurrence rates among the three groups(χ^(2)=22.816,P=0.000).Compared with the control group,both the combined group and nebulization group had lower recurrence rates(χ^(2)CG=22.500,P=0.000;χ^(2)NG=6.696,P=0.010),and the combined group was lower than the nebulization group(χ^(2)=5.963,P=0.015),with statistically significant differences.CONCLUSIONS The combination of oral administration of Zhimin Formula and nebulization is effective in treating AC with damp-heat complex wind syndrome,and it has a significant advantage over single therapy.