<italic style="font-style: italic">Lianling Formula</italic> （连苓方） Combined with Topical Tacrolimus for Atopic Dermatitis in Adolescents with Heart Fire and Spleen Deficiency Syndrome：A Randomized Controlled Trial

FAN Ziyi; SUN Zhanxue; ZHANG Huili; LI Linxian; MA Shengnan; LEI Shengyi; ZHANG Lili

doi:10.13288/j.11-2166/r.2024.23.010

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Lianling Formula （连苓方） Combined with Topical Tacrolimus for Atopic Dermatitis in Adolescents with Heart Fire and Spleen Deficiency Syndrome：A Randomized Controlled Trial

更新时间：2024-11-25

- Lianling Formula （连苓方） Combined with Topical Tacrolimus for Atopic Dermatitis in Adolescents with Heart Fire and Spleen Deficiency Syndrome：A Randomized Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 65, Issue 23, Pages: 2442-2449(2024)
- 作者机构：
  
  1.北京中医药大学第三附属医院，北京市朝阳区安定门外小关街51号，100029
  2.北京中医药大学东方医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2024.23.010
  CLC：
- Received：25 May 2024，
  
  Revised：2024-09-30，
  
  Published：02 December 2024
- 稿件说明：
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范子怡,孙占学,张慧丽等.连苓方联合他克莫司软膏治疗青少年特应性皮炎发作期心火脾虚证随机对照临床观察[J].中医杂志,2024,65(23):2442-2449.

FAN Ziyi,SUN Zhanxue,ZHANG Huili,et al.Lianling Formula （连苓方） Combined with Topical Tacrolimus for Atopic Dermatitis in Adolescents with Heart Fire and Spleen Deficiency Syndrome：A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2024,65(23):2442-2449.
范子怡,孙占学,张慧丽等.连苓方联合他克莫司软膏治疗青少年特应性皮炎发作期心火脾虚证随机对照临床观察[J].中医杂志,2024,65(23):2442-2449. DOI： 10.13288/j.11-2166/r.2024.23.010.

FAN Ziyi,SUN Zhanxue,ZHANG Huili,et al.Lianling Formula （连苓方） Combined with Topical Tacrolimus for Atopic Dermatitis in Adolescents with Heart Fire and Spleen Deficiency Syndrome：A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2024,65(23):2442-2449. DOI： 10.13288/j.11-2166/r.2024.23.010.

摘要

目的

评价连苓方治疗青少年特应性皮炎（AD）发作期心火脾虚证的临床疗效及安全性。

方法

将92例AD患儿随机分为治疗组和对照组，每组46例。对照组患儿口服依巴斯汀片，治疗组口服连苓方，两组皆外用0.03%他克莫司软膏，两组疗程均为4周。评价两组治疗前后特应性皮炎积分指数改善50%（SCORAD50）和特应性皮炎积分指数改善75%（SCORAD75）达标率、特应性皮炎积分指数（SCORAD）评分、视觉模拟评分法（VAS）评分、中医证候评分、皮肤病生活质量指数（CDLQI）评分、阿森斯失眠量表（AIS）评分，记录治疗过程中两组的不良反应。

结果

治疗组脱落4例，对照组脱落5例，采用意向性分析，最终两组各46例纳入统计。两组治疗后SCORAD评分均低于本组治疗前，且治疗组低于对照组（

＜0.01）；治疗组治疗后SCORAD50和SCORAD75的达标率分别为80.43%、47.83%，显著高于对照组治疗后的63.04%、26.09%（

＜0.05）；两组治疗后VAS评分、中医证候评分、CDLQI评分、AIS评分均低于本组治疗前（

＜0.01），且治疗后治疗组VAS评分、中医证候评分、CDLQI评分均低于对照组（

＜0.05或

＜0.01），而AIS评分高于对照组（

＜0.05）。治疗后治疗组SCORAD评分中的红斑、丘疹/水肿、渗出/结痂、表皮剥脱、干燥均低于治疗前（

＜0.05或

＜0.01），对照组患儿红斑、丘疹/水肿、渗出/结痂、干燥情况均低于治疗前（

＜0.05或

＜0.01），治疗后治疗组红斑、渗出/结痂、表皮剥脱评分均低于对照组（

＜0.05）。治疗后治疗组中医证候评分中的心烦、瘙痒、口干、纳差、大便不调评分均低于治疗前（

＜0.01），对照组瘙痒、心烦、小便赤均低于治疗前（

＜0.05或

＜0.01），治疗后治疗组瘙痒、口干、纳差、大便不调、小便赤评分均低于对照组（

＜0.05或

＜0.01）。治疗过程中两组患儿均未发生不良反应。

结论

连苓方联合他克莫司软膏可有效改善青少年AD发作期心火脾虚证的临床症状，在减轻患儿皮损、瘙痒、缓解伴随的中医证候、提高生活质量方面具有良好疗效，且安全性好。

Abstract

Objective

To evaluate the clinical effectiveness and safety of

Lianling Formula

（连苓方） in the treatment of adolescent atopic dermatitis （AD） exacerbation stage with heart fire and spleen deficiency syndrome.

Methods

Ninety-two patients were randomly divided into a treatment group and a control group， with 46 cases in each group. Patients in the control group took oral ebastine tablets， and patients in the treatment group took

Lianling Formula

orally， and both groups used 0.03% topical tacrolimus for 4 weeks. Before and after treatment， the improvement of scoring atopic derma

titis index by 50% （SCORAD50） and 75% （SCORAD75）， scoring atopic dermatitis index （SCORAD）， visual analog scale （VAS）， traditional Chinese medicine （TCM） symptom score， the children's dermatology life quality index （CDLQI）， Athens insomnia scale （AIS） score of both groups were evaluated， and the adverse reactions in both groups were recorded.

Results

Four cases in the treatment group and five cases in the control group were dropped， and intention-to-treat analysis was used. Finally 46 cases in each group were included in the statistics. The SCORAD scores after treatment were lower than those before treatment， and the scores in treatment group were lower than those of the control group （

＜0.01）； the attainment rates of SCORAD50 and SCORAD75 after treatment in the treatment group were 80.43% and 47.83%， which were significantly higher than those in the control group of 63.04% and 26.09%， respectively （

＜0.05）. VAS scores， TCM symptom scores， CDLQI scores， and AIS scores were lower than those before treatment （

＜0.01）， and VAS scores， TCM symptom scores， and CDLQI scores of the treatment group were lower than those of the control group after treatment （

＜0.05 or

＜0.01）， while AIS scores were higher than those of the control group （

＜0.05）. The erythema， papule/edema， oozing/crusting， epidermal peeling， and dryness in the SCORAD scores of the treatment group after treatment were lower than those before treatment （

＜0.05 or

＜0.01）， and the erythema， papule/edema， oozing/crusting， and dryness of children in the control group were lower than those before treatment （

＜0.05 or

＜0.01）. The scores of erythema， oozing/crusting， and epidermal peeling in the treatment group after treatment were all lower than those in the control group （

＜0.05）. The scores of vexation， itching， dry mouth， poor appetite and irr

egular bowel movements in terms of TCM symptoms in the treatment group after treatment were lower than those before treatment （

＜0.01）， and the scores of itching， vexation， dark urine in the control group were lower than those before treatment （

＜0.05 or

＜0.01）. The scores of itching， dry mouth， poor appetite， irregular bowel movements， and dark urine in the treatment group after treatment were all lower than that in the control group （

＜0.05 or

＜0.01）. No adverse reactions occurred in both groups of children during treatment.

Conclusion

Lianling Formula

combined with topical tacrolimus can effectively improve the clinical symptoms of adolescent AD exacerbation with heart fire and spleen deficiency syndrome， and the formula is effective and safe in improving the children's skin lesions， reducing itching， relieving the accompanied TCM symptoms， and improving the quality of life.

关键词

Keywords

references

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⁰

Lianling Formula （连苓方） Combined with Topical Tacrolimus for Atopic Dermatitis in Adolescents with Heart Fire and Spleen Deficiency Syndrome：A Randomized Controlled Trial

DOI：10.13288/j.11-2166/r.2024.23.010

摘要

Abstract

关键词

Keywords

references