ZINC THERAPY FOR SCLERODERMA--PHASE I STUDY

目前还没有已被证实可以改变其病程的治疗方法 硬皮病，一种平均预期寿命不到10年的疾病。 实验证据表明，缺血再灌流引起的损伤， 金属催化的自身抗原结构修饰和过量 成纤维细胞胶原蛋白的产生在本病的发病机制中起重要作用。锌 在体外已经被证明可以抑制这些过程中的每一个。锌一直是 安全地用于其他疾病的治疗，特别是威尔逊病 疾病，但锌疗法在硬皮病患者中的安全性仍有待于 被建立起来。 本研究的目的是评价口服的安全性和生物利用度。 硬皮病患者中的硫酸锌。使用一种常见的给药方案 肝豆状核变性治疗后，弥漫性硬皮病患者将 临床监测不良事件，作为主要研究结果结束 为期6周的审判。 到目前为止，还没有发生严重的不良反应，也没有协议 辍学生。硬皮病患者血清锌水平的平均升高 已经观察到，与在其他种群中看到的一致。其中两个 四名完成研究方案的患者已选择继续 由于主观原因，在研究方案结束时服用锌 实惠的感觉。患者和医生全球视力的平均改善 模拟量表分数、健康评估问卷分数，以及 观察改良的Rodnan皮肤评分。皮肤的量度 成纤维细胞锌水平在锌治疗前后尚未确定。如果是锌 对硬皮病患者是安全的和生物可用的，它 作为一种有希望的药物，可能会有利地改变 硬皮病。

No treatments exist which have been proven to modify the course of scleroderma, a disease with median life expectancy of less than 10 years. Experimental evidence has implicated ischemia-reperfusion-induced injury, metal-catalyzed modifications of autoantigen structure, and excess fibroblast collagen production in the pathogenesis of this disease. Zinc has been shown in vitro to inhibit each of these processes. Zinc has been used safely for the treatment of other conditions, notably Wilson's Disease, but the safety of zinc therapy in scleroderma patients remains to be established. The aim of this study is to assess the safety and bioavailability of oral zinc sulfate in scleroderma patients. Using a dosing regimen common to Wilson's Disease therapy, patients with diffuse scleroderma will be monitored clinically for adverse events as the primary study outcome over a 6-week trial. To date, there have been no significant adverse events, and no prptocol dropouts. Mean increases in serum zinc levels in scleroderma patients have been observed, consistent with those seen in other populations. Two of four patients to complete the study protocol have elected to continue taking zinc at the conclusion of the study protocol due to a subjective sense of benefit. Mean improvements in patient and physician global visual analogue scale scores, health assessment questionnaire scores, and modified Rodnan skin scores have been observed. Measures of cutaneous fibroblast zinc levels before and after zinc therapy are pending. If zinc is safe and bioavailable when administered to scleroderma pateints, it holds promise as an agent which may favorably alter the clinical course of scleroderma.