世界科学技术-中医药现代化2025，Vol.27Issue(12)：3691-3700,10.DOI:10.11842/wst.20250805001
中医阵列微针治疗干眼症的临床随机对照研究
A Clinical Randomized Controlled Study of Traditional Chinese Medicine Arrayed Microneedle in the Treatment of Dry Eye Disease
摘要
Abstract
Objective To investigate the clinical efficacy of traditional Chinese medicine(TCM)arrayed microneedle combined with 0.1%sodium hyaluronate artificial tears in the treatment of dry eye disease,and compare the effect with sham arrayed microneedle combined with artificial tears and simple artificial tears treatment.Methods A prospective,single-center,randomized controlled trial design was used to randomly divide 129 patients with dry eye disease into TCM arrayed microneedle group,sham arrayed microneedle group and simple artificial tear group according to the ratio of 1:1:1.On the basis of artificial tear eye drops on demand,the TCM arrayed microneedle group and the sham arrayed microneedle group were stimulated with micro-needles or sham needles at specific acupoints around the eyes and the body according to the principle of syndrome differentiation and treatment of Traditional Chinese Medicine.And BL-2,TE-23,EX-HN5,ST-2 and SI-6 were selected as the main points,and BL-13,SP-6,LR-3 and LU-5 were the matching points for different syndromes.The treatment was performed once every other day for 4 weeks,and the patients were followed up to the 10th week.The main outcome measure was Subjective Symptom Scale scores(SSSS).Secondary outcomes included the Ocular Surface Disease Index(OSDI),Chinese Dry Eye Questionnaire(CDEQ),Non-contact Tear Film Break-up Time(NIBUT),Schirmer I Test(SIT)and so on.Results Compared with before treatment,SSSS,OSDI and CDEQ scores of the TCM arrayed microneedle group and sham arrayed microneedle group decreased significantly at week 2,week 4 of the treatment and,week 6 and week 10 of follow-up after treatment(all P<0.0001).There was no significant difference in the artificial tear group at each time point after treatment(P>0.05).After treatment,the SSSS,OSDI and CDEQ scores of the TCM arrayed microneedle group were significantly lower than those of the simple artificial tear group,and the differences were statistically significant(all P<0.0001).The SSSS,OSDI and CDEQ scores of the sham arrayed microneedle group were significantly lower than those of the simple artificial tear group,and the difference was statistically significant(P<0.05).After treatment,compared with the sham arrayed microneedle group,the SSSS,OSDI and CDEQ scores of the traditional Chinese medicine arrayed microneedle group decreased significantly at week 4,week 6 and week 10,and the differences were statistically significant(P<0.0001).Conclusion TCM arrayed microneedle combined with artificial tears in the treatment of dry eye disease can effectively relieve subjective symptoms and reduce the frequency of artificial tears,which has good clinical application prospects and safety.关键词
中医阵列微针/干眼/0.1%玻璃酸钠滴眼液/临床研究Key words
Traditional Chinese medicine arrayed microneedle/Dry eye/0.1%sodium hyaluronate eye drops/Clinical research分类
医药卫生引用本文复制引用
SUN Zhengzheng,ZHANG Yao,LI Xiang,LI Shanshan,YIN Xuan,XU Shifen,LIU Baojun..中医阵列微针治疗干眼症的临床随机对照研究[J].世界科学技术-中医药现代化,2025,27(12):3691-3700,10.基金项目
国家中医优势专科建设单位项目:神志病科(国中医药医政函[2024]90号) （国中医药医政函[2024]90号）
上海市中医药管理局(临床类)重点学科建设项目(交叉创新类)(shzyyzdxk-2024108):数智针灸学,负责人:徐世芬. （临床类）
