| Objective:To observe the clinical efficacy and safety of Sheti Zhiqiu Prescription combined with intradermal needling in treatment of patients with allergic rhinitis(AR)of deficient cold of lung Qi syndrome,and to explore the action mechanism of Sheti Zhiqiu Prescription combined with intradermal needling based on the expression of high mobility group protein B1(HMGB1)and immune balance of T helper 1 cell(Th1)/T helper 2 cell(Th2).Methods:The method of randomized controlled trial was used in this study.According to the inclusion and exclusion criteria,60 patients with moderate-to-severe persistent AR of deficient cold of lung Qi syndrome were selected and randomly divided into Sheti Zhiqiu Prescription combined with intradermal needling group(combination group),Sheti Zhiqiu Prescription group[traditional Chinese medicine(TCM)group]and intradermal needling group,with 20 cases in each group.The TCM group was treated with Sheti Zhiqiu Prescription granules with water,3 times a day.The intradermal needling group was treated with intradermal needling,and Yintang,bilateral Yingxiang,Feishu,Lieque,Hegu and Zusanli were selected as the acupoints for acupuncture.The needles were retained for 2 days before being replaced.The combination group was treated with oral Sheti Zhiqiu Prescription granules combined with intradermal needling,and the methods were the same as the TCM group and the intradermal needling group.The three groups were all treated for 4 weeks.Nasal and ocular symptom scores,including 6 symptoms of nasal congestion,rhinorrhea,nasal itching,sneezing,ocular itching/foreign body sensation/redness and tearing,and rhinitis control assessment test(RCAT)scores,including 6 items of nasal congestion frequency,sneezing frequency,tearing frequency,sleep disruption,activity limitation and self-rating of rhinitis symptom control,before and after treatment in the three groups were observed and recorded.Nasal secretion of the subjects before and after treatment were also collected,and the enzyme linked immunosorbent assay method was used to test the levels of HMGB1,Th1 cytokines interferon-γ(IFN-γ)and interleukin-2(IL-2)and Th2 cytokines interleukin-4(IL-4)and interleukin-5(IL-5)in nasal secretion.The clinical efficacy of each treatment was evaluated according to the change of the total nasal and ocular symptom score before and after treatment,and the safety of each treatment was evaluated according to the occurrence of treatment-related adverse events(TRAEs)in the study.Results:1.Study completionIn this study,4 subjects were excluded from the intradermal needling group,and no subjects were excluded from the combination group and the TCM group.In the combination group,17 cases completed the study and 3 cases dropped out;in the TCM group,18 cases completed the study and 2 cases dropped out;in the intradermal needling group,13 cases completed the study and 3 cases dropped out.Intention-to-treat analysis of the outcome indicators in each group was performed.2.Comparison of nasal and ocular symptom scoresCompared with before treatment,symptom scores and total score of the combination group and the TCM group decreased after treatment(P<0.05);in the intradermal needling group,there was no significant change in sneezing score after treatment(P>0.05),while the other symptom scores and total score decreased(P<0.05).The changes of symptom scores in the three groups after treatment were compared,and in terms of nasal congestion score,decrease of the combination group after treatment was greater than that of the TCM group and the intradermal needling group(P<0.05),and there was no significant difference in decrease between the latter two groups(P>0.05);in terms of rhinorrhea score,nasal itching score,ocular itching/foreign body sensation/redness score and total score,decrease of the combination group after treatment was greater than that of the TCM group and the intradermal needling group(P<0.05),and decrease of the TCM group was greater than that of the intradermal needling group(P<0.05);in terms of sneezing score,decrease of the combination group and the TCM group after treatment was greater than that of the intradermal needling group(P<0.05),and there was no significant difference in decrease between the first two groups(P>0.05);in terms of tearing score,there was no significant difference in decrease among the three groups after treatment(P>0.05).3.Comparison of RCAT scoresCompared with before treatment,RCAT scores and total score of combination group and the TCM group decreased after treatment(P<0.05);in the intradermal needling group,there was no significant change in sneezing frequency score after treatment(P>0.05),while the other item scores and total score decreased(P<0.05).The changes of RCAT scores in the three groups after treatment were compared,and in terms of nasal congestion frequency score,decrease of the combination group after treatment was greater than that of the TCM group and the intradermal needling group(P<0.05),and there was no significant difference in decrease between the latter two groups;in terms of sneezing frequency score,decrease of the combination group and the TCM group after treatment was greater than that of the intradermal needling group(P<0.05),and there was no significant difference in decrease between the first two groups(P>0.05);in terms of tearing frequency score,there was no significant difference in decrease among the three groups after treatment(P>0.05);in terms of sleep disturbance score,activity limitation score,symptom control score and total score,decrease of the combination group after treatment was greater than that of the TCM group and the intradermal needling group(P<0.05),and decrease of the TCM group was greater than that of the intradermal needling group(P<0.05).4.Comparison of laboratory indicatorsCompared with before treatment,levels of HMGB1,IL-4 and IL-5 of the combination group and the TCM group after treatment decreased(P<0.05),while levels of IFN-γand IL-2 of the two groups increased(P<0.05);in the intradermal needling group,levels of HMGB1 and IL-5 after treatment decreased(P<0.05),and levels of IFN-γand IL-2 increased(P<0.05),while there was no significant change in level of IL-4(P>0.05).The changes of laboratory indicators in the three groups after treatment were compared,and decrease of HMGB1,IL-4 and IL-5 and increase of IFN-γand IL-2 of the combination group after treatment were higher than those of the TCM group and the intradermal needling group(P<0.05).Decrease of HMGB1,IL-4 and IL-5 and increase of IL-2 of the TCM group were higher than those of the intradermal needling group(P<0.05).No statistical significance(P>0.05).There was no significant difference in increase of IFN-γbetween the TCM group and the intradermal needling group(P>0.05).5.Correlation analysis of outcome indicatorsIn the combination group,the change of HMGB1 was strongly negatively correlated with the changes of IFN-γand IL-2(r=-0.773,r=-0.686,P<0.05),and was moderately positively correlated with the change of IL-4(r=0.536,P<0.05),and was strongly positively correlated with the change of IL-5(r=0.692,P<0.05);the change of total nasal and ocular symptom score was strongly positively correlated with the change of HMGB1(r=0.711,P<0.001),and was moderately negatively correlated with the changes of IFN-γand IL-2(r=-0.447,r=-0.540,P<0.05),and was moderately positively correlated with the changes of IL-4 and IL-5(r=0.517,r=0.562,P<0.05).6.Evaluation of clinical efficacyThe clinical efficacy of the combination group was better than that of the TCM group and the intradermal needling group(Z=-1.976,Z=-2.670,P<0.05),and there was no significant difference in the clinical efficacy between the TCM group and the intradermal needling group(Z=-0.969,P>0.05).7.Evaluation of safetyA total of 15 TRAEs occurred in the three groups,including 7 cases in the combination group,mainly dry mouth and local skin pruritus;5 cases in the TCM group,mainly dry mouth;3 cases in the intradermal needling group,all local skin pruritus.The symptoms of all TRAEs were mild and resolved spontaneously without special treatment.There were 12 subjects with at least one TRAE in the three groups,5 in the combination group,4 in the TCM group and 3 in the intradermal needling group;the incidence of TRAEs was 25.00%(5/20)in the combination group,20.00%(4/20)in the TCM group and 16.67%(3/18)in the intradermal needling group.There was no significant difference in the incidence of TRAEs among the three groups(χ~2=0.410,P>0.05).Conclusion:(1)Sheti Zhiqiu Prescription combined with intradermal needling can effectively relieve the nasal symptoms of nasal congestion,rhinorrhea,nasal itching and sneezing and the ocular symptoms of ocular itching/foreign body sensation/redness and tearing in patients with AR of deficient cold of lung Qi syndrome.(2)Sheti Zhiqiu Prescription combined with intradermal needling can reduce the occurrence frequency of nasal congestion,sneezing and tearing in patients with AR of deficient cold of lung Qi syndrome,and reduce their sleep disruption and activity limitation caused by AR symptoms.It can significantly improve the disease control situation of patients.(3)Sheti Zhiqiu Prescription combined with intradermal needling can inhibit the expression and secretion of HMGB1 and Th2 cytokines IL-4 and IL-5 in patients with AR of deficient cold of lung Qi syndrome,and promote the expression and secretion of Th1 cytokines IFN-γand IL-2.It can effectively regulate the expression of HMGB1 and the immune balance of Th1/Th2 in patients.(4)Sheti Zhiqiu Prescription combined with intradermal needling is an effective and safe treatment for patients with AR of deficient cold of lung Qi syndrome.This treatment may play a role in treat AR by inhibiting the expression and release of HMGB1 in patients,thereby inhibiting their Th2 immune response and promoting their Th1 immune response,and improving the Th1/Th2 immune imbalance. |
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