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聚普瑞锌(L-肌肽锌复合物)口服治疗压疮:为期8周的开放标签试验。

Oral treatment of pressure ulcers with polaprezinc (zinc L-carnosine complex): 8-week open-label trial.

作者信息

Sakae Kensaku, Yanagisawa Hiroyuki

机构信息

Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, 3-25-8 Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.

出版信息

Biol Trace Elem Res. 2014 Jun;158(3):280-8. doi: 10.1007/s12011-014-9943-5. Epub 2014 Apr 3.

DOI:10.1007/s12011-014-9943-5
PMID:24691900
Abstract

Polaprezinc (zinc L-carnosine complex) is a tablet commonly prescribed for gastric ulcers in Japan. Recently, we reported the effects of polaprezinc on pressure ulcer healing at 4-week follow-up. We aimed to further evaluate the efficacy and safety of polaprezinc in 8-week treatment for chronic pressure ulcers. Patients with stage II-IV pressure ulcers for ≥ 8 weeks received 150 mg/day polaprezinc (containing 116 mg L-carnosine and 34 mg zinc) per os for a maximum of 8 weeks. We measured the severity of pressure ulcers weekly using the Pressure Ulcer Scale for Healing (PUSH) score and monitored blood biochemistry. Fourteen patients (nine men; 68.4 ± 11.8 years) were enrolled. Pressure ulcer stages were II (one patient; 7 %), III (nine; 64 %), and IV (four; 29 %). The PUSH score improved significantly from 8.1 [95 % CI, 6.0-10.3] at baseline to -1.4 [-4.0 to 1.1] after 8 weeks (P < 0.001). Differences from baseline were significant after 1 week (P < 0.05). The mean weekly improvement in PUSH score was 2.0. Eleven patients healed within 8 weeks and none dropped out. Serum zinc levels increased significantly (P < 0.001), whereas serum copper levels (P = 0.001) and copper/zinc ratios (P < 0.001) decreased significantly. In one patient, preexisting copper deficiency deteriorated. These preliminary data suggest that polaprezinc may be effective and well-tolerated in 8-week treatment of pressure ulcers and could be a candidate for their oral treatment.

摘要

聚普瑞锌(L-肌肽锌复合物)是日本常用于治疗胃溃疡的一种片剂。最近,我们报道了聚普瑞锌在4周随访时对压疮愈合的影响。我们旨在进一步评估聚普瑞锌治疗慢性压疮8周的疗效和安全性。患有II-IV期压疮≥8周的患者口服150毫克/天聚普瑞锌(含116毫克L-肌肽和34毫克锌),最长8周。我们每周使用压疮愈合量表(PUSH)评分测量压疮的严重程度,并监测血液生化指标。纳入了14名患者(9名男性;68.4±11.8岁)。压疮分期为II期(1名患者;7%)、III期(9名;64%)和IV期(4名;29%)。PUSH评分从基线时的8.1[95%CI,6.0-10.3]显著改善至8周后的-1.4[-4.0至1.1](P<0.001)。1周后与基线的差异显著(P<0.05)。PUSH评分的平均每周改善为2.0。11名患者在8周内愈合,无患者退出。血清锌水平显著升高(P<0.001),而血清铜水平(P=0.001)和铜/锌比值(P<0.001)显著降低。1名患者原有的铜缺乏症恶化。这些初步数据表明,聚普瑞锌在压疮8周治疗中可能有效且耐受性良好,可能是压疮口服治疗的一个候选药物。

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