归参止痒方治疗血虚肝旺证老年皮肤瘙痒症的临床研究

Treatment of Guishen Zhiyang Recipe for Senile Pruritus Patients with Blood Deficiency and Hyperactivity of Gan-yang Syndrome

目的观察归参止痒方治疗血虚肝旺证老年皮肤瘙痒症患者的临床疗效,并探讨其神经—内分泌—免疫发病机制。方法将90例患者按完全随机化抽签法分为治疗组与对照组,每组45例。治疗过程中治疗组完成病例41例,对照组完成38例,治疗组予口服归参止痒方汤剂,对照组予口服肤痒颗粒,两组均配合外用冰黄肤乐软膏,治疗疗程为8周。观察两组症状、皮损疗效变化,采用双抗夹心ELISA法检测两组治疗前后干细胞因子(stem cell factor,SCF)、强啡肽(dynorphin,DYN)、性激素[睾酮testosterone(T)、雌二醇estradiol(E2)]及IL-4水平变化。结果与治疗前比较,治疗8周后两组瘙痒程度、瘙痒面积、脱屑、苔癣样变、急躁易怒、烦热咽干、眩晕耳鸣症状积分降低,差异均有统计学意义(P<0.05),两组治疗4、8周后中医证候积分均降低(P<0.05),两组SCF、DYN水平均明显降低(P<0.05,P<0.01)。与对照组比较,治疗8周后治疗组在瘙痒程度、抓痕数目、脱屑、急躁易怒、眩晕耳鸣单项症状方面明显改善(P<0.05),中医证候总积分降低(P<0.05),治疗组SCF水平降低(P<0.05)。结论两组在配合外用冰黄肤乐软膏治疗基础上,归参止痒方对血虚肝旺证老年皮肤瘙痒症疗效优于对照药物,其对影响老年皮肤瘙痒症发病的神经—内分泌—免疫相关介质水平有一定的调节作用。

Objective To observe the clinical efficacy of Guishen Zhiyang Recipe（GZR）in treating senile pruritus patients with blood deficiency and hyperactivity of Gan-yang syndrome（BDHGYS）and to study the mechanism in nervous-endocrine-immune systems.Methods Ninety senile pruritus patients were assigned to the treatment group and the control group by complete randomized lot,45 in each group.Totally 41 patients in the treatment group and 38 patients in the control group completed the trial.Patients in the treatment group took GZR,while those in the control group took Fuyang Granule（FG）.External application of Binghuang Fule Soft Ointment was performed to all patients.The therapeutic course for all was 8 weeks.Symptoms and efficacy changes in skin lesion were observed in the two groups.Levels of stem cell factor（SCF）,dynorphin（DYN）,testosterone（T）,estradiol（E2）,and IL-4were detected in the two groups using double antibody sandwich ELISA.Results Compared with before treatment,pruritus degree,scratching area,scaling,lichenoid lesion,irritability and restlessness,dysphoria,dry pharynx,dizziness,and tinnitus all decreased in the two groups after 8 weeks of treatment（P〈0.05）.Scores of Chinese medical syndromes all decreased after 4 and 8 weeks of treatment（P〈0.05）.Levels of SCF and DYN obviously decreasedin the two groups after 4 and8 weeks of treatment（P〈0.05,P〈0.01）.Compared with the control group,obvious improvement was seen in pruritus degree,scratching number,scaling,irritability and restlessness,dysphoria,dizziness,and tinnitus（P〈0.05）;total scores of Chinese medical syndromes decreased（P〈0.05）;SCF also decreased（P〈0.05）in the treatment group after 8 weeks of treatment.Conclusions Based on external application of Binghuang Fule Soft Ointment,GZR showed better efficacy than that of the control.It had certain roles in regulating related mediator levels that might affect nervous-endocrine-immune systems.