Smiell J M
The R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869, USA.
Am J Surg. 1998 Aug;176(2A Suppl):68S-73S. doi: 10.1016/s0002-9610(98)00174-3.
This overview of the safety of becaplermin gel is based on six well-controlled clinical studies that included patients with lower extremity diabetic neuropathic ulcers. Patients receiving becaplermin gel (n = 538), placebo gel (n = 278), or good ulcer care alone (n = 190) had a similar incidence of ulcer-related adverse events, such as infection, cellulitis, or osteomyelitis. Erythematous rash occurred in 2% of patients with suspected wound infections treated with becaplermin gel and 1% of patients treated with placebo gel. No rashes were observed in patients treated with good ulcer care alone. The incidence of cardiovascular, respiratory, musculoskeletal, and central and peripheral nervous system disorders were similar across all treatment groups. Mortality rates were also similar across all treatment groups. Patients treated with becaplermin gel did not develop neutralizing antibodies against becaplermin. Therefore, becaplermin gel appears to be a safe therapy for the treatment of lower extremity diabetic ulcers.
本关于贝卡普勒明凝胶安全性的概述基于六项严格对照的临床研究，这些研究纳入了患有下肢糖尿病神经性溃疡的患者。接受贝卡普勒明凝胶治疗的患者（n = 538）、接受安慰剂凝胶治疗的患者（n = 278）或仅接受良好溃疡护理的患者（n = 190）发生溃疡相关不良事件的发生率相似，如感染、蜂窝织炎或骨髓炎。在接受贝卡普勒明凝胶治疗的疑似伤口感染患者中，2%出现红斑疹，接受安慰剂凝胶治疗的患者中这一比例为1%。仅接受良好溃疡护理的患者未观察到皮疹。所有治疗组中心血管、呼吸、肌肉骨骼以及中枢和周围神经系统疾病的发生率相似。所有治疗组的死亡率也相似。接受贝卡普勒明凝胶治疗的患者未产生针对贝卡普勒明的中和抗体。因此，贝卡普勒明凝胶似乎是治疗下肢糖尿病溃疡的一种安全疗法。
