角膜炎,疱疹性%更昔洛韦%胶囊
角膜炎,皰疹性%更昔洛韋%膠囊
각막염,포진성%경석락위%효낭
Keratitis,herpetic%Ganciclovir%Capsules
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.
目的 探討更昔洛韋膠囊治療單純皰疹病毒性角膜炎的臨床療效.方法 採用前瞻性、隨機、對照、單盲的研究方法.選取2008年5月至2009年6月在複旦大學附屬眼耳鼻喉科醫院眼科門診確診的60例(60隻眼)單純皰疹病毒性角膜炎患者,分型為角膜基質炎與角膜內皮炎,使用隨機數字錶法分成兩組.對照組使用0.15%更昔洛韋凝膠,每日4次,以及0.1%氟米龍滴眼液,每日 3次;試驗組使用更昔洛韋凝膠與氟米龍滴眼液滴眼,用藥方法與對照組相同,聯閤更昔洛韋膠囊,每日3次,每次1000 mg,用藥時間為8週.治療前與治療後1、2、4、6及8週隨訪,評估眼痛、視物模糊、畏光、異物感、流淚等癥狀與結膜充血、結膜水腫、睫狀充血、角膜炎癥反應、角膜後彈力層皺褶、角膜後沉著物等體徵,評價治療有效率與治愈率,併觀察用藥後不適感與副作用.兩組間癥狀與體徵評分值的比較採用秩和檢驗,角膜知覺變化的比較採用卡方檢驗.結果 兩組患者的治療前癥狀(對照組10.70±3.61,試驗組11.87±3.47)與體徵(對照組13.83±3.74,試驗組15.27±3.83)評分均無統計學意義(Z=-1.269、-1.419,P＞0.05).對照組在治療後各隨訪時間點的總評分值分彆為13.63±7.64、10.53±7.18、7.83±6.49、5.37±5.33及4.37±5.11,試驗組分彆為8.37±4.31、2.70±2.65、0.70±1.44、0.33±0.92及0.17±0.65,均顯著低于對照組(Z=-2.801、-4.895、-5.260、-4.758、-4.292,P＜0.05).對照組在治療後各隨訪時間點的有效率分彆為50.0%、73.3%、86.7%、93.3%及96.6%,治愈率分彆為0.0%、3.3%、16.7%、30.0%及43.3%,而試驗組在治療後各隨訪時間的有效率均為100.0%,治愈率分彆0.0%、36.7%、76.7%、90.0%及93.3%,均顯著高于對照組,治療有效率的差異有統計學意義(x2=20.00、16.433、22.571、22.636、17.330,P＜0.001).對照組與試驗組的複髮率分彆為16.7%與10.0%,差異無統計學意義(x2=0.557,P=0.448).試驗組末見明顯的用藥後不適感與肝腎功能損傷等副作用.結論 更昔洛韋膠囊能夠有效輔助治療單純皰疹病毒性角膜基質炎與內皮炎,緩解癥狀與體徵較快,縮短病程明顯,安全性較好.
목적 탐토경석락위효낭치료단순포진병독성각막염적림상료효.방법 채용전첨성、수궤、대조、단맹적연구방법.선취2008년5월지2009년6월재복단대학부속안이비후과의원안과문진학진적60례(60지안)단순포진병독성각막염환자,분형위각막기질염여각막내피염,사용수궤수자표법분성량조.대조조사용0.15%경석락위응효,매일4차,이급0.1%불미룡적안액,매일 3차;시험조사용경석락위응효여불미룡적안액적안,용약방법여대조조상동,연합경석락위효낭,매일3차,매차1000 mg,용약시간위8주.치료전여치료후1、2、4、6급8주수방,평고안통、시물모호、외광、이물감、류루등증상여결막충혈、결막수종、첩상충혈、각막염증반응、각막후탄력층추습、각막후침착물등체정,평개치료유효솔여치유솔,병관찰용약후불괄감여부작용.량조간증상여체정평분치적비교채용질화검험,각막지각변화적비교채용잡방검험.결과 량조환자적치료전증상(대조조10.70±3.61,시험조11.87±3.47)여체정(대조조13.83±3.74,시험조15.27±3.83)평분균무통계학의의(Z=-1.269、-1.419,P＞0.05).대조조재치료후각수방시간점적총평분치분별위13.63±7.64、10.53±7.18、7.83±6.49、5.37±5.33급4.37±5.11,시험조분별위8.37±4.31、2.70±2.65、0.70±1.44、0.33±0.92급0.17±0.65,균현저저우대조조(Z=-2.801、-4.895、-5.260、-4.758、-4.292,P＜0.05).대조조재치료후각수방시간점적유효솔분별위50.0%、73.3%、86.7%、93.3%급96.6%,치유솔분별위0.0%、3.3%、16.7%、30.0%급43.3%,이시험조재치료후각수방시간적유효솔균위100.0%,치유솔분별0.0%、36.7%、76.7%、90.0%급93.3%,균현저고우대조조,치료유효솔적차이유통계학의의(x2=20.00、16.433、22.571、22.636、17.330,P＜0.001).대조조여시험조적복발솔분별위16.7%여10.0%,차이무통계학의의(x2=0.557,P=0.448).시험조말견명현적용약후불괄감여간신공능손상등부작용.결론 경석락위효낭능구유효보조치료단순포진병독성각막기질염여내피염,완해증상여체정교쾌,축단병정명현,안전성교호.
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.
