美国FDA近日要求在凝胶剂Regranex（becaplermin）的标签上增加新的黑框警示，声明该药在用于糖尿病患者手足溃疡的治疗时，如果使用3管或以上的用量，可能会增加用药者患癌死亡的风险。一项对1 622名暴露于Regranex的患者及未暴露于该凝胶剂的2 809名类似患者的回顾性研究比较了两组人群的癌症发生率及病死率。结果发现，应用Regranex的患者癌症发生率总体并未增加，但应用3管或以上Regranex患者的癌症病死率却增加了5倍。FDA皮肤及牙科用药产品部门负责人称，在做出这项标签警示决定时，FDA仍谨慎提醒临床医生要仔细评价Regranex的治疗益处和风险。对于已知患有恶性肿瘤的患者，并不推荐使用该药。
Regranex属于重组人源化血小板生长因子，可以直接用于无法治愈的糖尿病患者的手足溃疡。重组血小板生长因子与内源性物质有类似的生物活性，能够促进细胞快速分化，因此在该产品1997年批准上市以前，生产商就一直在关注该药相关不良反应如增加癌细胞的一些研究。在2001年结束的一项长期安全性研究中，与未用药组相比，使用Regranex治疗的患者出现了更多的死亡病例。此后，又一项研究对于1998年1月至2003年6月之间的医疗保险数据进行了回顾分析，此项研究对于使用Regranex和未用药的两组有类似诊断结果，用药情况及医保情况的人群进行了分析。结果显示，接受了3管或更多处方的Regranex患者，与未使用Regranex组相比，患癌死亡的比率更高，但并未显示出是何种特定的癌症，只是综合所有类型的癌症得出的结论。
| REGRANEX |
| Manufacturer |
| Ortho-McNeil Pharmaceuticals, Inc. |
| Legal Classification |
| Rx |
| Pharmacological Class |
| Growth factor. |
| Generic Name |
| Becaplermin 0.01%; gel; contains parabens, m-cresol. |
| Indications |
| Adjunct in the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. |
| Children |
| <16 yrs: not recommended. |
| Adults |
| ≥16 yrs: Apply once daily until complete healing has occurred. Measure size of ulcer and adjust at 1–2 week intervals. Calculate amount of gel needed based on ulcer size and product tube size. Squeeze calculated length of gel from tube onto clean measuring surface (e.g., wax paper). Spread gel over entire ulcer to thickness of about 1/16 inch. Cover with saline dressing for about 12 hrs. Remove dressing and rinse. Replace with clean saline dressing (no gel). Reevaluate if ulcer does not decrease in size by about 30% after 10 weeks, or if complete healing has not occurred after 20 weeks. To calculate amount of gel in centimeters: If using the 15g tube: Length of gel (in cm) to be applied daily = wound area (length x width in cm2) ÷ 4. If using the 2g tube: Length of gel (in cm) to be applied daily = wound area (length x width in cm2) ÷ 2. |
| Contraindications |
| Neoplasm(s) at application site. |
| Precautions |
| Systemic malignancies (increased death rate with ≥3 tubes of becaplermin gel treatment). Not for use in wounds that close by primary intention. Pregnancy (Cat.C). Nursing mothers. |
| Adverse Reactions |
| Erythematous rash. |
| How Supplied |
| Gel—2g, 15g |
