摘要
目的 探讨更昔洛韦胶囊治疗单纯疱疹病毒性角膜炎的临床疗效.方法 采用前瞻性、随机、对照、单盲的研究方法.选取2008年5月至2009年6月在复旦大学附属眼耳鼻喉科医院眼科门诊确诊的60例（60只眼）单纯疱疹病毒性角膜炎患者,分型为角膜基质炎与角膜内皮炎,使用随机数字表法分成两组.对照组使用0.15%更昔洛韦凝胶,每日4次,以及0.1%氟米龙滴眼液,每日 3次;试验组使用更昔洛韦凝胶与氟米龙滴眼液滴眼,用药方法与对照组相同,联合更昔洛韦胶囊,每日3次,每次1000 mg,用药时间为8周.治疗前与治疗后1、2、4、6及8周随访,评估眼痛、视物模糊、畏光、异物感、流泪等症状与结膜充血、结膜水肿、睫状充血、角膜炎症反应、角膜后弹力层皱褶、角膜后沉着物等体征,评价治疗有效率与治愈率,并观察用药后不适感与副作用.两组间症状与体征评分值的比较采用秩和检验,角膜知觉变化的比较采用卡方检验.结果 两组患者的治疗前症状（对照组10.70±3.61,试验组11.87±3.47）与体征（对照组13.83±3.74,试验组15.27±3.83）评分均无统计学意义（Z=-1.269、-1.419,P＞0.05）.对照组在治疗后各随访时间点的总评分值分别为13.63±7.64、10.53±7.18、7.83±6.49、5.37±5.33及4.37±5.11,试验组分别为8.37±4.31、2.70±2.65、0.70±1.44、0.33±0.92及0.17±0.65,均显著低于对照组（Z=-2.801、-4.895、-5.260、-4.758、-4.292,P＜0.05）.对照组在治疗后各随访时间点的有效率分别为50.0%、73.3%、86.7%、93.3%及96.6%,治愈率分别为0.0%、3.3%、16.7%、30.0%及43.3%,而试验组在治疗后各随访时间的有效率均为100.0%,治愈率分别0.0%、36.7%、76.7%、90.0%及93.3%,均显著高于对照组,治疗有效率的差异有统计学意义（x2=20.00、16.433、22.571、22.636、17.330,P＜0.001）.对照组与试验组的复发率分别为16.7%与10.0%,差异无统计学意义（x2=0.557,P=0.448）.试验组末见明显的用药后不适感与肝肾功能损伤等副作用.结论 更昔洛韦胶囊能够有效辅助治疗单纯疱疹病毒性角膜基质炎与内皮炎,缓解症状与体征较快,缩短病程明显,安全性较好.
Objective To evaluate the clinical values of oral ganciclovir on the treatment of herpes simplex keratitis （HSK）. Methods A randomized, controlled, single-blind and prospective study was carried out from May in 2008 to June in 2009 at Department of Ophthalmology, Eye Ear Nose and Throat Hospital of Fudan University. 60 patients （60 eyes） with HSK, including stromal keralitis and corneal endotheliitis, were enrolled in the study and were randomly arranged into two groups in average. Oral ganciclovir was orally administered 1000 mg 3 times per day for 8 weeks, 0. 15% ganciclovir ophthalmic gel,4 times per day, and 0. 1% fluorometholone eye drops, 3 times per day, in the test group, meanwhile, the control group was adopted the same ophthalmic gel and eye drops without the oral capsules. The symptoms and signs were evaluated before and after the therapy 1st week, 2nd week, 4th week, 6th week and 8th day respectively with the side effects observed. Results There was no significant difference between the control and test group in the mean scores of symptoms （control 10.70 ±3.61, test 11.87 ±3.47） and signs （control 13. 83 ± 3. 74, test 15.27 ± 3.83 ） respectively before the treatment （ Z = - 1. 269 and - 1. 419;P 〉 0. 05 ）. After the administration, the total scores of symptoms and signs in the test group were 8. 37 ±4. 31,2. 70 ±2. 65, 0. 70 ± 1.44, 0. 33 ±0. 92 and 0. 17 ±0. 65 respectively at each follow-up time point,which were obviously lower than those in the control group, 13.63 ±7.64, 10.53 ±7. 18, 7. 83 ±6.49,5.37 ± 5.33 and 4. 37 ± 5.11 respectively （ Z = - 2. 801, - 4. 895, - 5. 260, - 4. 758, and - 4. 292;P 〈0. 05）. The efficacy rates in the test group were all 100. 0% after the administration, but those in the control group were 50. 0%, 73.3%, 86. 7%, 93. 3% and 96. 6%. Furthermore, the cure rates in the test group were 0. 0%, 36. 7%, 76. 7%, 90. 0% and 93. 3% respectively at each follow-up time point, which were significantly higher than those in the control group with 0. 0%, 3.3%, 16. 7%, 30. 0% and 43. 3% respectively （ x2 =20.00, 16.433, 22.571, 22.636 and 17.330; P〈0. 001）. There was no obvious discomfortableness and adverse reaction observed in the test group. Unfortunately, 5 patients in the control group and 3 patients in the test group underwent the recurrence of HSK after the course of treatment, but there was no significant difference between the groups in the recurrence rate. Conclusions Oral ganciclovir can effectively assist to relieve the symptoms and signs and shorten the pathogenesis of herpes simplex stromal keratitis and corneal endotheliitis. And short-term oral ganciclovir has comfirmed good safety.
出处
《中华眼科杂志》
CAS
CSCD
北大核心
2010年第11期994-999,共6页
Chinese Journal of Ophthalmology
