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目的:评价加减旋覆夏麻芍草汤治疗小儿咳嗽变异性哮喘(cough variant asthma,CVA)的临床疗效。方法:采用随机、阳性药平行对照的前瞻性研究方法,选择符合纳入标准的CVA患儿60例,随机分为治疗组与对照组,每组30例。治疗组采用加减旋覆夏麻芍草汤治疗,对照组采用布地奈德粉吸入剂+孟鲁司特钠咀嚼片治疗,疗程均为3个月。评价两组患儿的临床疗效与中医证候疗效,比较两组的临床症状、体征改善情况;采用荧光酶免疫分析法(FEIA)检测患儿的血清嗜酸性粒细胞阳离子蛋白(ECP)水平,采用酶联免疫吸附试验(ELISA)检测患儿的尿白三烯(LTE4)水平。治疗期间,记录两组患儿的合并用药情况及不良反应发生情况;治疗结束后随访6个月,比较两组有效病例的复发情况。结果:1临床疗效:治疗后,治疗组的总有效率为89.3%,对照组为85.2%,两组临床疗效比较,差异无统计学意义(P>0.05)。2中医证候疗效:治疗后,治疗组的总有效率为85.7%,对照组为81.5%,两组中医证候疗效比较,差异无统计学意义(P>0.05)。3主要临床症状、体征:治疗组在改善患儿咯痰、咳呕、多汗、舌象异常、下眼睑发青等症状或体征方面,其疗效明显优于对照组(P<0.01)。4实验室指标:治疗后,两组患儿的尿LTE4、血ECP水平均显著降低(P<0.01),且治疗组患儿的血ECP水平明显低于对照组(P<0.01)。5合并用药与不良反应发生情况:治疗组的合并用药患儿例数少于对照组(P≤0.05);治疗期间,两组均未发生严重不良反应事件。6复发情况:治疗组的复发率为8.0%,对照组为30.4%,但两组复发情况比较,差异无统计学意义(P>0.05)。结论:加减旋覆夏麻芍草汤是治疗小儿CVA的有效方剂,且有一定的疗效持续性,能有效改善患儿的临床症状与体征,无不良反应。其下调CVA患儿异常的LTE4和ECP水平可能是起效的机制之一。
OBJECTIVE: To evaluate the clinical effect of Xuanfu Xiamaoshao Cao Tang in the treatment of pediatric cough variant asthma (CVA). Methods: A prospective study of randomized, positive drug parallel control, 60 children with CVA who met the inclusion criteria were randomly divided into treatment group and control group, with 30 cases in each group. The treatment group was treated with plus and minus swale Xiamao Shao Cao Tang, the control group budesonide powder inhaler + montelukast sodium chewable tablets were treated, the course of treatment were 3 months. The clinical curative effect and TCM syndrome curative effect of two groups of children were evaluated. The clinical symptoms and signs of the two groups were compared. The level of serum eosinophil cationic protein (ECP) in children was detected by fluorescent enzyme immunoassay (FEIA) Enzyme-linked immunosorbent assay (ELISA) was used to detect urinary leukotriene (LTE4) in children. During the treatment, the combination of medication and adverse reactions were recorded in both groups. After 6 months of follow-up, the recurrence of effective cases in both groups were compared. Results: 1 Clinical efficacy: After treatment, the total effective rate was 89.3% in the treatment group and 85.2% in the control group. There was no significant difference between the two groups in clinical curative effect (P> 0.05). 2 TCM Syndrome Efficacy: After treatment, the total effective rate was 85.7% in the treatment group and 81.5% in the control group. There was no significant difference in the curative effect between the two groups (P> 0.05). 3 The main clinical symptoms and signs: The treatment group was significantly better than the control group (P <0.01) in improving the symptoms and signs such as expectoration, vomiting, hyperhidrosis, tongue abnormality and lower eyelid development in children. 4 laboratory indicators: After treatment, urinary LTE4, ECP levels in both groups were significantly decreased (P <0.01), and the level of ECP in the treatment group was significantly lower than that in the control group (P <0.01). 5 combination of medication and adverse reactions: the treatment group of patients with combined medication less than the control group (P≤0.05); during treatment, no serious adverse reactions occurred in both groups. Recurrence: The recurrence rate was 8.0% in the treatment group and 30.4% in the control group, but there was no significant difference between the two groups (P> 0.05). Conclusion: The addition and subtraction convulsion Xiamao Shao Cao Tang is an effective prescription for the treatment of children with CVA, and has a certain effect of sustained, can effectively improve the clinical symptoms and signs of children without adverse reactions. Its downregulation of abnormal levels of LTE4 and ECP in children with CVA may be one of the mechanisms of action.