养阴清热方蒸汽超声雾化对阴虚型干眼症的疗效分析

Therapeutic Effect of Yin-Nourishing and Heat-Clearing Steam Ultrasound Atomization on Dry Eye Syndrome with Yin Deficiency

摘要: 目的：评估使用自拟养阴清热方局部蒸汽超声雾化对阴虚型干眼症的疗效。方法：将门诊第一诊断为“干眼症(Dry eye syndromes, DES)”，并辨证为“阴虚证”，以阴虚症状为主的患者。将患者随机分为治疗组、对照组。① 治疗组使用自拟养阴清热方(枸杞10 g，麦冬15 g，北沙参10 g，石斛15 g，菊花15 g，金银花10 g，薄荷10 g。加入干眼治疗综合系统超声雾化器，戴眼罩后眼部雾化治疗，同时配合自行使用重组牛碱性成纤维细胞生长因子眼用凝胶(rhEGF)、玻璃酸钠滴眼液(sodium hyalurorate)。总治疗为14 ± 2天。② 对照组使用：0.9%生理盐水50 ml加入干眼治疗综合系统超声雾化器，戴眼罩后眼部雾化治疗，配合自行使用重组牛碱性成纤维细胞生长因子眼用凝胶、玻璃酸钠滴眼液，总治疗周期亦为14 ± 2天。分别于治疗前，治疗后1周、2周、1月(即治疗结束后的第二周)分别从症状、体征来评估疗效，具体评估项目包括该方剂的安全性及：患者的眼表疾病指数评分(OSDI量表，Ocular Surface Disease Index)、BUT (泪膜破裂时间，Break up Time，BUT)、Schirmer I Test (泪液分泌试验，Schirmer I Test，SIT)、角膜荧光染色(FL, Fluorescein Staining)，眼前段照相等情况。结果：治疗组共纳入79例，对照组共纳入77例。治疗组和对照组治疗结束后总有效率分别是88.7% (70/79例)、64.9% (52/77例)。治疗后1月(即治疗结束后的第二周)治疗组OSDI评分为36.72 ± 3.34，对照组评分变为45.74 ± 3.97。治疗组总有效率明显高于对照组，在统计学上差异有统计学意义(P < 0.05。且治疗后1月(即治疗结束后的第二周)治疗组BUT为11.55 ± 1.08，对照组BUT为9.79 ± 1.15；治疗组SIT为10.65 ± 0.78，对照组SIT为9.09 ± 0.75，FL评分为治疗组3.19 ± 0.28及对照组3.45 ± 0.25，在统计学上差异有统计学意义(P < 0.05)。结论：在阴虚型干眼症患者中使用该养阴清热方剂超声雾化熏眼联合重组牛碱性成纤维细胞生长因子眼用凝胶、玻璃酸钠滴眼液，临床使用安全且可以显著缓解其症状、体征。

Abstract: Objective: To evaluate the efficacy of self-formulated nourishing yin and clearing heat formula local steam ultrasonic nebulization for the treatment of xerophthalmia with yin deficiency. Methods: Patients whose outpatient first diagnosis is “Dry eye syndromes (DES)” and whose syndrome is classified as “Yin deficiency syndrome” with Yin deficiency symptoms predominating. The patients were randomly divided into treatment group and control group. ① In the treatment group, the self-formulated nourishing yin and clearing heat formula (including gouji berry 10 g, Ophiopogon 15 g, radix glehniae 10 g, dendrobe 15 g, chrysanthemum 15 g, honeysuckle flower 10 g, mint 10 g.) was used. The dry eye treatment comprehensive system ultrasonic atomizer was added, and the eye area was fogged with the formula while wearing an eye mask, and the treatment was also accompanied by the use of the rhEGF and sodium hyaluronate eye drops by the patients themselves. The total treatment period was 14 ± 2 days. ② In the control group, 0.9% sodium chloride solution 50ml was added to the dry eye treatment comprehensive system ultrasonic atomizer, and the eye area was fogged with the formula while wearing an eye mask, and the treatment was also accompanied by the use of the rhEGF and sodium hyaluronate eye drops by the patients themselves. The total treatment cycle was also 14 ± 2 days. The symptoms and signs were evaluated separately before treatment, 1 week after treatment, 2 weeks after treatment, and 1 month after treatment (i.e. the second week after treatment), evaluate the efficacy of the prescription based on symptoms and signs before treatment, 1 week, 2 weeks, and 1 month after treatment (i.e. the second week after treatment). Specific evaluation items include the safety of the prescription and the patient’s Ocular Surface Disease Index (OSDI) score, Break up Time (BUT), Schirmer I Test (SIT), Fluorescence Staining (FL), and anterior segment photography. Results: A total of 79 cases were included in the treatment group, while 77 cases were included in the control group. The total effective rates of the treatment group and the control group after treatment were 88.7% (70/79 cases) and 64.9% (52/77 cases), respectively. One month after treatment (i.e. the second week after the end of treatment), the OSDI score of the treatment group was 36.72 ± 3.34, while the control group’s score changed to 45.74 ± 3.97. The total effective rate of the treatment group was significantly higher than that of the control group, and the difference was statistically significant (P < 0.05). One month after treatment (i.e., the second week after the end of treatment), the BUT of the treatment group was 11.55 ± 1.08, while that of the control group was 9.79 ± 1.15; The SIT of the treatment group was 10.65 ± 0.78, while that of the control group was 9.09 ± 0.75. The FL score was 3.19 ± 0.28 for the treatment group and 3.45 ± 0.25 for the control group, with statistically significant differences (P < 0.05). Conclusion: In patients with dry eye of yin deficiency type, the combination of ultrasonic atomization fumigation with recombinant bovine basic fibroblast growth factor eye gel and sodium hyaluronate eye drops is safe in clinical use and can significantly alleviate its symptoms and signs.