{"title":"0.005% Glaumax和0.005% Xalatan的疗效和安全性比较研究","authors":"V. Erichev, V. S. Zinina, A. V. Volzhanin","doi":"10.53432/2078-4104-2022-21-3-42-48","DOIUrl":null,"url":null,"abstract":" PURPOSE. To compare hypotensive efficiency and safety of generic latanoprost 0.005 % (Glaumax, “KEVELT AS”, Estonia) and original latanoprost 0.005 % (Xalatan, “Pfizer Inc”, USA) in glaucoma patients. METHODS. The study included patients with newly diagnosed primary open-angle glaucoma or patients with primary open-angle glaucoma on carbonic anhydrase inhibitor monotherapy 4 days after cease of treatment (the “wash-out” period). Study patients were divided into 2 groups. Group 1 consisted of 25 patients (30 eyes) with initial and advanced stages of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.15 ± 1.48 mm Hg. This group of patients was prescribed instillations of 0.005 % Glaumax eye drops 1 time per day. Group 2 also included 25 patients (30 eyes) with initial stage of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.08 ± 1.42 mm Hg. Group 2 patients were prescribed instillations of 0.005 % Xalatan eye drops 1 time per day. IOPcc was measured initially after the washout period, then 1 and 2 months after the start of the new therapy. Additionally, all patients were assessed for tear film break up time (Norn’s test) at each follow-up point. RESULTS. After 1 month, IOPcc in groups 1 and 2 was 17.36 ± 1.39 and 18.09 ± 1.45 mm Hg, respectively; after 2 month, 17.87 ± 1.30 and 18.54 mm Hg, respectively. The Norn’s test results in groups 1 and 2 after 1 month were 8 (7; 9.75) and 8 (6; 9.75) seconds, after 2 months it was 8.5 (8; 9) and 8 (7; 10) seconds, respectively, which corresponded to the initial stage of the \"dry eye\" syndrome. No statistically significant intergroup differences were found in any of the cases. CONCLUSION. Xalatan 0.005 and Glaumax 0.005 have comparable efficacy and tolerability, and both help achieve persistent stabilization of IOP. The option for a single-instillation regimen is convenient for the patients.","PeriodicalId":129515,"journal":{"name":"National Journal glaucoma","volume":"56 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2022-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative study of the efficacy and safety of 0.005 % Glaumax and 0.005 % Xalatan\",\"authors\":\"V. Erichev, V. S. Zinina, A. V. Volzhanin\",\"doi\":\"10.53432/2078-4104-2022-21-3-42-48\",\"DOIUrl\":null,\"url\":null,\"abstract\":\" PURPOSE. To compare hypotensive efficiency and safety of generic latanoprost 0.005 % (Glaumax, “KEVELT AS”, Estonia) and original latanoprost 0.005 % (Xalatan, “Pfizer Inc”, USA) in glaucoma patients. METHODS. The study included patients with newly diagnosed primary open-angle glaucoma or patients with primary open-angle glaucoma on carbonic anhydrase inhibitor monotherapy 4 days after cease of treatment (the “wash-out” period). Study patients were divided into 2 groups. Group 1 consisted of 25 patients (30 eyes) with initial and advanced stages of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.15 ± 1.48 mm Hg. This group of patients was prescribed instillations of 0.005 % Glaumax eye drops 1 time per day. Group 2 also included 25 patients (30 eyes) with initial stage of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.08 ± 1.42 mm Hg. Group 2 patients were prescribed instillations of 0.005 % Xalatan eye drops 1 time per day. IOPcc was measured initially after the washout period, then 1 and 2 months after the start of the new therapy. Additionally, all patients were assessed for tear film break up time (Norn’s test) at each follow-up point. RESULTS. After 1 month, IOPcc in groups 1 and 2 was 17.36 ± 1.39 and 18.09 ± 1.45 mm Hg, respectively; after 2 month, 17.87 ± 1.30 and 18.54 mm Hg, respectively. The Norn’s test results in groups 1 and 2 after 1 month were 8 (7; 9.75) and 8 (6; 9.75) seconds, after 2 months it was 8.5 (8; 9) and 8 (7; 10) seconds, respectively, which corresponded to the initial stage of the \\\"dry eye\\\" syndrome. No statistically significant intergroup differences were found in any of the cases. CONCLUSION. Xalatan 0.005 and Glaumax 0.005 have comparable efficacy and tolerability, and both help achieve persistent stabilization of IOP. The option for a single-instillation regimen is convenient for the patients.\",\"PeriodicalId\":129515,\"journal\":{\"name\":\"National Journal glaucoma\",\"volume\":\"56 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"National Journal glaucoma\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.53432/2078-4104-2022-21-3-42-48\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"National Journal glaucoma","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.53432/2078-4104-2022-21-3-42-48","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
目的。比较0.005%仿制药拉坦前列素(Glaumax,“KEVELT AS”,爱沙尼亚)和0.005%原药拉坦前列素(Xalatan,“辉瑞公司”,美国)在青光眼患者中的降压效果和安全性。方法。该研究纳入了新诊断的原发性开角型青光眼患者或停止治疗4天后接受碳酸酐酶抑制剂单药治疗的原发性开角型青光眼患者(“洗脱期”)。研究患者分为两组。第一组25例(30只眼)初、晚期新诊断POAG,初始角膜代偿IOP (IOPcc)为25.15±1.48 mm Hg,给予0.005% Glaumax滴眼液,每日1次。2组25例(30眼)为初诊POAG,初始角膜代偿IOP (IOPcc)为25.08±1.42 mm Hg,给予0.005% Xalatan滴眼液,每日1次。IOPcc最初在洗脱期后测量,然后在新疗法开始后1个月和2个月测量。此外,在每个随访点评估所有患者的泪膜破裂时间(Norn试验)。结果。1个月后,1组和2组的IOPcc分别为17.36±1.39和18.09±1.45 mm Hg;2个月后分别为17.87±1.30 mm Hg和18.54 mm Hg。1、2组患者1个月后Norn 's试验结果为8 (7;9.75)和8 (6);9.75)秒,2个月后为8.5 (8;9)和8 (7);10)秒,这与“干眼”综合征的初始阶段相对应。在任何病例中均未发现统计学上显著的组间差异。结论。Xalatan 0.005和Glaumax 0.005的疗效和耐受性相当,都有助于实现IOP的持续稳定。单次注射方案的选择对患者来说是方便的。
Comparative study of the efficacy and safety of 0.005 % Glaumax and 0.005 % Xalatan
PURPOSE. To compare hypotensive efficiency and safety of generic latanoprost 0.005 % (Glaumax, “KEVELT AS”, Estonia) and original latanoprost 0.005 % (Xalatan, “Pfizer Inc”, USA) in glaucoma patients. METHODS. The study included patients with newly diagnosed primary open-angle glaucoma or patients with primary open-angle glaucoma on carbonic anhydrase inhibitor monotherapy 4 days after cease of treatment (the “wash-out” period). Study patients were divided into 2 groups. Group 1 consisted of 25 patients (30 eyes) with initial and advanced stages of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.15 ± 1.48 mm Hg. This group of patients was prescribed instillations of 0.005 % Glaumax eye drops 1 time per day. Group 2 also included 25 patients (30 eyes) with initial stage of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.08 ± 1.42 mm Hg. Group 2 patients were prescribed instillations of 0.005 % Xalatan eye drops 1 time per day. IOPcc was measured initially after the washout period, then 1 and 2 months after the start of the new therapy. Additionally, all patients were assessed for tear film break up time (Norn’s test) at each follow-up point. RESULTS. After 1 month, IOPcc in groups 1 and 2 was 17.36 ± 1.39 and 18.09 ± 1.45 mm Hg, respectively; after 2 month, 17.87 ± 1.30 and 18.54 mm Hg, respectively. The Norn’s test results in groups 1 and 2 after 1 month were 8 (7; 9.75) and 8 (6; 9.75) seconds, after 2 months it was 8.5 (8; 9) and 8 (7; 10) seconds, respectively, which corresponded to the initial stage of the "dry eye" syndrome. No statistically significant intergroup differences were found in any of the cases. CONCLUSION. Xalatan 0.005 and Glaumax 0.005 have comparable efficacy and tolerability, and both help achieve persistent stabilization of IOP. The option for a single-instillation regimen is convenient for the patients.