Jull A, Arroll B, Parag V, Waters J
University of Auckland, Clinical Trials Research Unit, Private Bag 92019, Auckland, New Zealand.
Cochrane Database Syst Rev. 2007 Jul 18(3):CD001733. doi: 10.1002/14651858.CD001733.pub2.
Healing of venous leg ulcers is improved by the use of compression bandaging but some venous ulcers remain unhealed, and some people are unsuitable for compression therapy. Pentoxifylline, a drug which helps blood flow, has been used to treat venous leg ulcers. An earlier version of this review included 9 randomised controlled trials, but more research has been since been conducted and an updated review is required.
To assess the effects of pentoxifylline (oxpentifylline or Trental 400) for treating venous leg ulcers, compared with placebo, or other therapies, in the presence or absence of compression therapy.
For this second update we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, EMBASE and Cinahl (date of last search was February 2007), and reference lists of relevant articles.
Randomised trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression, in people with venous leg ulcers.
Details from eligible trials were extracted and summarised by one author using a coding sheet. Data extraction was independently verified by one other author.
Twelve trials involving 864 participants were included. The quality of trials was variable. Eleven trials compared pentoxifylline with placebo or no treatment; in seven of these trials patients received compression therapy. In one trial pentoxifylline was compared with defibrotide in patients who also received compression. Combining 11 trials that compared pentoxifylline with placebo or no treatment (with or without compression) demonstrated that pentoxifylline is more effective than placebo in terms of complete ulcer healing or significant improvement (RR 1.70, 95% CI 1.30 to 2.24). Significant heterogeneity was associated with differences in sample populations (hard-to-heal samples compared with "normal" healing samples). Pentoxifylline plus compression is more effective than placebo plus compression (RR 1.56, 95% CI 1.14 to 2.13). Pentoxifylline in the absence of compression appears to be more effective than placebo or no treatment (RR 2.25, 95% CI 1.49 to 3.39). A comparison between pentoxifylline and defibrotide found no statistically significant difference in healing rates. More adverse effects were reported in people receiving pentoxifylline (RR 1.56, 95% CI 1.10 to 2.22). Nearly three-quarters (72%) of the reported adverse effects were gastrointestinal.
AUTHORS' CONCLUSIONS: Pentoxifylline is an effective adjunct to compression bandaging for treating venous ulcers and may be effective in the absence of compression. The majority of adverse effects were gastrointestinal disturbances.
使用加压绷带可促进下肢静脉溃疡的愈合，但仍有一些静脉溃疡无法愈合，且有些人不适合进行加压治疗。己酮可可碱是一种有助于血液流动的药物，已被用于治疗下肢静脉溃疡。本综述的早期版本纳入了9项随机对照试验，但此后又开展了更多研究，因此需要进行更新综述。
评估己酮可可碱（氧甲唑啉或曲奥舒凡400）在有或没有加压治疗的情况下，与安慰剂或其他疗法相比，治疗下肢静脉溃疡的效果。
在本次第二次更新中，我们检索了Cochrane伤口组专业注册库、Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库和护理学与健康领域数据库（最后检索日期为2007年2月），并查阅了相关文章的参考文献列表。
在有或没有加压治疗的情况下，比较己酮可可碱与安慰剂或其他疗法治疗下肢静脉溃疡患者的随机试验。
一名作者使用编码表提取并总结了符合条件的试验的详细信息。另一名作者独立核实了数据提取情况。
纳入了12项涉及864名参与者的试验。试验质量参差不齐。11项试验比较了己酮可可碱与安慰剂或不治疗；其中7项试验的患者接受了加压治疗。在一项试验中，将己酮可可碱与去纤苷在也接受加压治疗的患者中进行了比较。综合11项比较己酮可可碱与安慰剂或不治疗（有或没有加压治疗）的试验表明，就溃疡完全愈合或显著改善而言，己酮可可碱比安慰剂更有效（相对危险度1.70，95%置信区间1.30至2.24）。显著的异质性与样本群体的差异有关（难愈合样本与“正常”愈合样本相比）。己酮可可碱加加压比安慰剂加加压更有效（相对危险度1.56，95%置信区间1.14至2.13）。在没有加压治疗的情况下，己酮可可碱似乎比安慰剂或不治疗更有效（相对危险度2.25，95%置信区间1.49至3.39）。己酮可可碱与去纤苷之间的比较发现愈合率没有统计学上的显著差异。接受己酮可可碱治疗的人报告的不良反应更多（相对危险度1.56，95%置信区间1.10至2.22）。报告的不良反应中近四分之三（72%）是胃肠道反应。
己酮可可碱是治疗静脉溃疡加压绷带的有效辅助药物，在没有加压治疗的情况下可能也有效。大多数不良反应是胃肠道不适。
