滋阴养血法治疗干眼的临床观察

Clinical observation on treatment of dry eye by Ziyinyangxue method

目的观察自制中成药养血明目丸联合玻璃酸钠滴眼液治疗血虚型干眼的临床疗效。方法随机对照临床研究。采用随机数字表法将104例(208只眼)血虚型干眼患者分为治疗组和对照组,每组各52例(104只眼),治疗组患者予口服养血明目丸联合玻璃酸钠滴眼液点眼,对照组患者予局部玻璃酸钠滴眼液点眼,均治疗4周。观察两组主观症状评分、泪膜破裂时间(BUT)、泪液分泌试验(Schirmer I test,SIT)及角膜荧光素染色(FL)评分的变化,评价疗效。结果治疗4周后,治疗组52例(104只眼),治愈17只眼,好转76只眼,无效11只眼,总有效率89.4%;对照组52例(104只眼),治愈6只眼,好转74只眼,无效24只眼,总有效率76.9%。治疗组好于对照组(Mann-Whitney U检验Z=-3.154,P=0.002)。两组治疗后各项指标均较治疗前改善(P<0.001),治疗组的各项结果均好于对照组(P<0.05)。结论口服养血明目丸联合玻璃酸钠滴眼液点眼对治疗血虚证型干眼有较好的临床疗效,好于单纯人工泪液治疗,但其具体作用机制及长期疗效尚需进一步观察研究。

OBJECTIVE To observe the clinical effect of Yangxuemingmu pill combined with sodium hyaluronate eye drops on dry eye in blood deficiency syndrome. METHODS As a randomized controlled clinical study, by using the random number table method, 104 cases（208 eyes） of dry eye patients in blood deficiency syndrome were divided into treatment group and control group evenly.The treatment group were administrated with oral Yangxuemingmu pill combined with sodium hyaluronate eye drops while the control group were treated with sodium hyaluronate eye drops. Both treatment plans lasted for 4 weeks. Subjective symptom scores, tear break-up time（BUT）, score variations of Schirmer test（Schirmer I test, SIT） and corneal fluorescein staining（FL） were observed as the effect parameters. RESULTS After 4 weeks of treatment, in treatment group with 52 cases（104eyes）, 17 eyes were cured, 76 eyes were improved, 11 eyes were ineffective and the total effective rate was 89.4%;in the control group with 52 cases（104 eyes）, 6 eyes were cured, 74 eyes were improved, 24 eyes were ineffective,and the total effective rate was 76.9%. The treatment group enjoyed better result than the control group（Mann-Whitney U test, Z=-3.154, P=0.002）. After treatment, indicators of both two groups improved（P〈0.001）, moreover the treatment group received better results than the control group（P〈0.05）. CONCLUSIONS Yangxuemingmu pill combined with sodium hyaluronate eye drops had favorable clinical curative effect on dry eye in blood deficiency syndrome which was better than single use of artificial tear therapy. However, its specific mechanism and long-term efficacy need to be further studied.