Innovation Center for Wound Repair, Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu 610041, Sichuan, People's Republic of China.
Int J Low Extrem Wounds. 2024 Jun;23(2):264-274. doi: 10.1177/15347346211050769. Epub 2021 Nov 15.
The venous leg ulcers are debilitating, painful, and often unresponsive to advanced dressing treatments, so drugs used locally and systematically are essential adjuvant therapy-pentoxifylline (PTX) whose anti-inflammatory effects may offer a promising avenue to treat venous leg ulcers. However, the current results are controversial. To further evaluate the efficacy and safety of PTX, we performed an updated meta-analysis of randomized placebo-controlled trials of PTX in the treatment of venous leg ulcers. We systematically searched multiple electronic databases PubMed, Web of Science, Embase, the Cochrane Library, the Cochrane Central Register of Controlled Trials, China Science and Technology Journal Database, WanFang Data, China National Knowledge Infrastructure, and the Chinese Biomedical Literature Database to identify eligible studies. Randomized clinical trials of pentoxifylline versus placebo treatment in patients with venous leg ulcers were considered for inclusion. The primary outcomes included ulcer healing rate and the incidence of adverse events after treatment. The secondary outcomes were the ulcer significant improvement (the ulcer size shrank by more than 60% after treatment) rate, mean duration of complete wound healing and changes in mean ulcer size. A meta-analysis and qualitative analysis were conducted to estimate endpoints. A total of 13 randomized clinical trials, including 921 individuals, were finally included. Compared with placebo, pentoxifylline significantly improved the ulcer healing rate (RR = 1.59, 95%CI 1.22 to 2.07, < .001) and significant improvement rate (RR = 2.36, 95%CI 1.31 to 4.24, = .004) while increased the incidence of gastrointestinal disturbances (RR = 2.29, 95%CI 1.04 to 5.03, = .04) at the same time. Moreover, pentoxifylline also shortened mean duration of complete wound healing ( = .007) and shrank ulcer size ( = .02). Currently available evidence suggests that pentoxifylline could help venous leg ulcers heal more quickly and effectively. However, the evidence is insufficient to prove the results due to moderate-certainty evidence. Large-scale, well-designed randomized clinical trials are warranted.
静脉性腿部溃疡使人衰弱、疼痛,且常对先进的敷料治疗无反应,因此局部和系统使用的药物是必要的辅助治疗 - 己酮可可碱(PTX),其抗炎作用可能为治疗静脉性腿部溃疡提供有希望的途径。然而,目前的结果存在争议。为了进一步评估 PTX 的疗效和安全性,我们对 PTX 治疗静脉性腿部溃疡的随机安慰剂对照试验进行了更新的荟萃分析。我们系统地检索了多个电子数据库,包括 PubMed、Web of Science、Embase、Cochrane 图书馆、Cochrane 对照试验中心注册库、中国科技期刊数据库、万方数据、中国国家知识基础设施和中国生物医学文献数据库,以确定合格的研究。将纳入己酮可可碱与安慰剂治疗静脉性腿部溃疡患者的随机临床试验。主要结局包括溃疡愈合率和治疗后不良事件的发生率。次要结局为溃疡显著改善(治疗后溃疡面积缩小超过 60%)率、平均完全愈合时间和平均溃疡大小的变化。进行荟萃分析和定性分析以估计终点。最终共纳入 13 项随机临床试验,共 921 人。与安慰剂相比,己酮可可碱显著提高了溃疡愈合率(RR=1.59,95%CI 1.22 至 2.07, < .001)和显著改善率(RR=2.36,95%CI 1.31 至 4.24, = .004),同时增加了胃肠道不适的发生率(RR=2.29,95%CI 1.04 至 5.03, = .04)。此外,己酮可可碱还缩短了完全愈合的平均时间( = .007)和缩小了溃疡面积( = .02)。目前的证据表明,己酮可可碱可以帮助静脉性腿部溃疡更快、更有效地愈合。然而,由于证据质量为中等,证据不足以证明结果。需要进行大规模、精心设计的随机临床试验。