Objectives: To observe the clinical effect and safety of auricular point sticking combined with periocular needle-embedding therapy for pseudomyopia and prevention of true myopia.
Methods: A total of 269 children with pseudomyopia were randomized into an observation group (134 cases, 2 cases dropped out) and a control group (135 cases, 5 cases dropped out). In the control group, the healthy education was provided. In the observation group, besides the intervention as the control group, the auricular point sticking was delivered at gan (CO12), pi (CO13), xin (CO15) and yan (LO5) on one ear in each treatment, combined with periocular needle-embedding technique at bilateral Cuanzhu (BL 2), Yuyao (EX-HN 4) and Sibai (ST 2). There were 2 weeks of interval after 4 weeks of treatment. One course of treatment was composed of 6 weeks and 2 courses were required. Separately, before treatment, after 6 and 12 weeks of treatment, and after 12 weeks (the 1st follow-up visit) and 24 weeks (the 2nd follow-up visit) of treatment completion, the spherical equivalent (SE), SE progression, axial length (AL) progression, accommodative amplitude (AMP), the score of the TCM symptom and the general symptom were observed in the two groups. The safety and compliance were evaluated in the two groups.
Results: After 6 and 12 weeks of treatment, and in the 1st and 2nd follow-up visits, SE increased when compared with that before treatment in the two groups (P<0.05), and AMP was larger than that before treatment in the observation group (P<0.05). After 12 weeks of treatment, and in the 1st and 2nd follow-up visits, the progression of SE was slower in the observation group compared with that in the control group (P<0.01, P<0.001). After 6 and 12 weeks of treatment, and in the 1st and 2nd follow-up visits, the progression of AL in the observation group was lower than that of the control group (P<0.05, P<0.01, P<0.001); and in the 1st and 2nd follow-up visits, AMP of the observation group was larger when compared with that in the control group (P<0.05, P<0.001). After 6 and 12 weeks of treatment, and in the 1st and 2nd follow-up visits, the total scores of TCM symptom and general symptom were reduced in comparison with those before treatment in the observation group (P<0.05); after 6 and 12 weeks of treatment, the total scores of TCM symptom and general symptom were lower than those before treatment in the control group (P<0.05). In the 1st and 2nd follow-up visits, the difference of the total score of TCM symptom and general symptom in the observation group was larger than that of the control group (P<0.05). In the observation group, compared with the control group, the scores for pale/dark complexion in the 1st and 2nd follow-up visits and that for lassitude in the 2nd follow-up visit were lower (P<0.05), the score for poor concentration after 12 weeks of treatment and that for poor sleep and memory in the 2nd follow-up visit were lower (P<0.05). There were no adverse reactions in the two groups. The compliance was 98.5% in the observation group and was 96.3% in the control group, without statistical difference (P>0.05).
Conclusions: On the basis of health education, auricular point sticking combined with periocular needle-embedding therapy can effectively prevent from true myopia, control the increase of SE, delay the growth of AL and improve AMP in children with pseudomyopia. This compound therapeutic regimen can relieve the general symptom and comprehensively prevent from myopia through multiple approaches, with high safety and satisfactory compliance.
目的: 观察耳穴贴压联合眼周揿针技术预防假性近视发展成为真性近视的临床疗效及安全性。方法: 将269例假性近视患儿随机分为观察组（134例，脱落2例）与对照组（135例，脱落5例）。对照组予健康宣教；观察组在对照组基础上予耳穴贴压（肝、脾、心、眼，每次取单侧耳穴）联合眼周揿针（双侧攒竹、鱼腰、四白）干预，治疗4周后休息2周，6周为一疗程，共治疗2个疗程。分别于治疗前、治疗6周、治疗12周及治疗结束后12周（第1次随访）、24周（第2次随访）观察两组患儿等效球镜（SE）及SE进展量、眼轴（AL）进展量、调节幅度（AMP）、中医症状和全身症状评分，并评价安全性及依从性。结果: 治疗6、12周及第1、2次随访，两组患儿SE较治疗前增长（P<0.05），观察组患儿AMP较治疗前升高（P<0.05）。治疗12周及第1、2次随访，观察组患儿SE进展量低于对照组（P<0.01，P<0.001）；治疗6、12周及第1、2次随访，观察组患儿AL进展量低于对照组（P<0.05，P<0.01，P<0.001）；第1、2次随访，观察组患儿AMP高于对照组（P<0.05，P<0.001）。治疗6、12周及第1、2次随访，观察组患儿中医症状和全身症状总分较治疗前降低（P<0.05）；治疗6、12周，对照组患儿中医症状和全身症状总分较治疗前降低（P<0.05）。观察组患儿第1、2次随访中医症状和全身症状总分差值大于对照组（P<0.05）；第1、2次随访面色淡白/晦暗评分及第2次随访神疲乏力评分低于对照组（P<0.05）；治疗12周注意力下降评分及第2次随访睡眠不佳、记忆力下降评分低于对照组（P<0.05）。两组均无不良反应发生，观察组依从性为98.5%，对照组为96.3%，两组依从性比较差异无统计学意义（P>0.05）。结论: 在健康宣教基础上，耳穴贴压联合眼周揿针技术可有效预防假性近视向真性近视进展，控制SE增加、延缓AL增长、增加AMP，且能改善全身症状，从多途径综合预防近视，安全性高，依从性好。.
Keywords: advantageous technology of TCM; auricular point sticking; embedding needle; myopia; prevention; public health disease.