Leung P C, Wong Margaret W N, Wong W C
Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.
Hong Kong Med J. 2008 Feb;14(1):29-33.
To further study the clinical value of a herbal supplement in the treatment of chronic foot ulcers in diabetic patients.
Double-blind randomised, placebo-control trial.
Two general hospitals in Hong Kong.
Eighty patients were recruited according to strict selection criteria.
Clinical measures included standard antidiabetic treatment, daily wound care including antiseptic bath, debridement, toe removal for gangrene when necessary, and the daily consumption of a herbal drink or placebo.
The primary outcome was limb salvage. Secondary outcomes included: granulation maturation, local temperature and circulatory changes, tumour necrosis factor-alpha levels, and adverse events.
Limb salvage was achieved in 85% of the patients. Among the early failures, three each came from the treatment and placebo groups. After shifting to herbal treatment (without unblinding of the original treatment), all were rescued in those initially assigned to herbal concoction (6 out of 6) while only 50% (6 out of 12) were rescued from among those initially assigned to placebo. The speed of granulation maturation, and decline in tumour necrosis factor-alpha levels indicating control of inflammation, were also more favourable with the herbal group. No serious adverse events were observed.
The herbal adjuvant therapy was effective in helping the healing of chronic diabetic ulcers.
进一步研究一种草药补充剂用于治疗糖尿病患者慢性足部溃疡的临床价值。
双盲随机、安慰剂对照试验。
香港的两家综合医院。
根据严格的入选标准招募了80名患者。
临床措施包括标准的抗糖尿病治疗、每日伤口护理，包括抗菌浴、清创，必要时切除坏疽趾，以及每日饮用草药饮品或安慰剂。
主要观察指标为肢体保全。次要观察指标包括：肉芽成熟、局部温度和循环变化、肿瘤坏死因子-α水平以及不良事件。
85%的患者实现了肢体保全。在早期治疗失败的患者中，治疗组和安慰剂组各有3例。转为草药治疗（不揭开原治疗的盲法）后，最初分配到草药配方组的所有患者（6例中的6例）均获救，而最初分配到安慰剂组的患者中只有50%（12例中的6例）获救。草药组的肉芽成熟速度以及表明炎症得到控制的肿瘤坏死因子-α水平下降情况也更有利。未观察到严重不良事件。
草药辅助治疗有助于慢性糖尿病溃疡的愈合。
