2% 多佐胺/0.5%噻吗洛尔固定组合:品牌药与普通药在疗效和副作用方面的比较

Nada M.Y. El Adawy, Yasser S. Mohamed, Noha M. Khalil, Yasmine M. Elsayed, Mohamed B. Kenawy
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引用次数: 0

摘要

本研究的目的是比较 2% 多佐胺/0.5% 噻吗洛尔固定组合品牌药(Cosopt)与普通药(Twinzol)的疗效和副作用。 该研究包括 92 名被诊断为原发性开角型青光眼的患者的 92 只眼睛,这些患者适用于 20 毫克/毫升多佐胺/5 毫克/毫升噻吗洛尔的抗青光眼固定组合药物。)患者被随机分为两组:第一组接受 Cosopt,第二组接受 Twinzol。在就诊时,测量眼压并记录任何一种眼药水的局部副作用。在 3 个月的随访期间,每月监测并记录眼压下降的百分比。 一个月后,Cosopt 和 Twinzol 的眼压下降百分比显示出显著的 P 值 0.032,Cosopt 组的平均眼压下降百分比为 28.55%,中位数为 26.92%,最小值为 3.82%,最大值为 62.96%,而 Twinzol 组的平均眼压下降百分比分别为 23.14%、21.29%、4.17% 和 57.14%。另一方面,两组患者 3 个月后的眼压下降百分比的 P 值(0.646)不显著。两组在 1 个月(0.462)和 3 个月(0.639)时的眼压测量结果在统计学上差异不显著。在副作用方面,两种眼药水的副作用相当,P 值均为 0.49。 这项研究表明,与同类产品 Cosopt 相比,使用普通疗法 Twinzol 具有可靠的疗效和安全性。
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A comparison between 2% dorzolamide/0.5% timolol fixed combination: brand name drug to its generic counterpart regarding efficacy and side effects
The aim of this study was to compare 2% dorzolamide/0.5% timolol fixed combination brand name drug (Cosopt) to its generic counterpart (Twinzol) regarding efficacy and side effects. The study included 92 eyes of 92 patients diagnosed with primary open-angle glaucoma and are indicated for antiglaucoma fixed combination of 20 mg/ml dorzolamide/5 mg/ml timolol). Patients were randomly divided into two groups: the first group received Cosopt, whereas the second received Twinzol. In visit, intraocular pressure (IOP) was measured and any local side effects by either eye drops was recorded. Monitoring and recording the percentage of IOP drop each month and all over the 3 months duration of follow up visits were done. The percentage of IOP drop for Cosopt and Twinzol after 1 month showed a significant P value of 0.032, with a mean percent reduction in IOP of 28.55%, median percent reduction of 26.92%, the minimum is 3.82% while the maximum is 62.96% for the Cosopt group, while that for Twinzol was 23.14, 21.29, 4.17, and 57.14%, respectively. On the other hand, the percentage of drop of IOP between the two groups after 3 months showed insignificant P value (0.646). IOP measurement was statistically insignificant between the two groups at 1 (0.462) and 3 months (0.639). As regards side effects; both eye drops were comparable with an insignificant P value of 0.49. The study demonstrated a reliable efficacy and safety on using generic therapy Twinzol compared with band counterpart Cosopt.
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审稿时长
19 weeks
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