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羟乙基淀粉A(天然药物)对年龄相关性黄斑变性患者视力的影响:一项随机双盲对照临床试验。

The EFFEct of HESA-A (natural drug) on visual acuity in age related macular degeneration: a randomized double blind controlled clinical trial.

作者信息

Ahmadi Amrollah, Ghanbari Heshmatollah, Soheilian Masoud, Naseri Mohsen

机构信息

Institute of Cancer Research Center, Medical Sciences/University of Tehran, Tehran, Iran.

出版信息

Afr J Tradit Complement Altern Med. 2009 Jul 3;6(4):549-53. doi: 10.4314/ajtcam.v6i4.57199.

Abstract

We investigated the clinical efficacy and safety of HESA-A (a drug of herbal-marine origin) in the treatment of age related macular degeneration (AMD). In a randomized double blind clinical trial 280 eyes of 280 (157 F, 123 M) patients with wet and dry AMD were randomly assigned in treatment or placebo groups. Patients in treatment group received HESA-A tablet 25 mg/Kg twice a day orally and controls received placebo with the same method for 4 weeks. Visual acuity at baseline and after one month of treatment was measured and compared between two groups. All patients were followed up for 5 months after treatment. Mean patients' age was 69.06+/-8.49 years. At the end of study visual acuity improved significantly from 1.69+/-0.65 LogMar to 1.03+/- 0.40 LogMar in treatment group but not in controls (P: 0.000 and P: 0.67 in treatment and control groups respectively). No drug reaction or recurrence was reported during the study and 5-month post treatment follow up period in HESA-A treated group. This study showed significant efficacy and safety of HESA-A in improvement of visual acuity in AMD patients in short term.

摘要

我们研究了海萨 - A(一种草药 - 海洋来源的药物)治疗年龄相关性黄斑变性(AMD)的临床疗效和安全性。在一项随机双盲临床试验中,将280例(157例女性,123例男性)湿性和干性AMD患者的280只眼睛随机分为治疗组或安慰剂组。治疗组患者口服海萨 - A片剂,剂量为25mg/kg,每日两次,对照组采用相同方法服用安慰剂,持续4周。测量并比较两组患者基线时和治疗1个月后的视力。治疗后对所有患者进行了5个月的随访。患者平均年龄为69.06±8.49岁。研究结束时,治疗组视力从1.69±0.65 LogMar显著提高到1.03±0.40 LogMar,而对照组未提高(治疗组和对照组的P值分别为0.000和0.67)。在研究期间以及海萨 - A治疗组治疗后5个月的随访期内,未报告药物反应或复发情况。这项研究表明,海萨 - A在短期内改善AMD患者视力方面具有显著的疗效和安全性。

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