Department of Plastic Surgery, Lahey Clinic Medical Center, Burlington, MA, USA.
Ann Surg. 2012 Mar;255(3):457-67. doi: 10.1097/SLA.0b013e3182447b5d.
To statistically evaluate published clinical efficacy data related to the use of pulsed radio frequency energy (PRFE) therapy in 3 clinical applications.
Numerous clinical studies have reported efficacy outcomes for PRFE therapy use in the palliative treatment of both postoperative and nonpostoperative pain and edema, and for its use as an adjunctive wound-healing (WH) therapeutic. Although diverse in design and endpoint, these studies are amenable to systematic review using both a vote-counting and P-value combination meta-analytic technique.
A meta-analysis of efficacy outcomes reported in clinical trials was performed using a vote-counting procedure. In addition, when possible, the sum of logs method of P-value combination was used to determine a significance level for the combined evidence within each endpoint and clinical area.
Of the 186 clinical articles identified after application of selection criteria, there were 25 controlled trials that met criteria for inclusion in vote-counting and P-value combination methods and were used for formal statistical analysis. In total, 1332 patients receiving PRFE treatment were studied. Vote-counting procedure applied to clinical outcomes from controlled studies resulted in a greater number of positive outcomes than neutral outcomes, and zero negative outcomes, for each of the clinical application groups evaluated. The sum of logs P-value method found statistically significant improvement in pain, reduction in edema, and improvement in WH outcomes.
On the basis of statistical evaluation of published clinical efficacy data, there is strong statistical evidence that PRFE therapy is effective in the treatment of postoperative and nonpostoperative pain and edema and in WH applications.
统计评估与脉冲射频能量(PRFE)治疗在 3 种临床应用中的使用相关的已发表临床疗效数据。
许多临床研究报告了 PRFE 治疗在缓解术后和非术后疼痛和水肿以及作为辅助伤口愈合(WH)治疗中的疗效结果。尽管这些研究在设计和终点方面存在差异,但它们可以通过投票计数和 P 值组合荟萃分析技术进行系统评价。
使用投票计数程序对临床试验报告的疗效结果进行荟萃分析。此外,在可能的情况下,还使用 P 值组合的对数和方法来确定每个终点和临床领域的综合证据的显著性水平。
在应用选择标准后,共确定了 186 篇临床文章,其中有 25 项符合纳入投票计数和 P 值组合方法的对照试验,并用于正式的统计分析。共有 1332 名接受 PRFE 治疗的患者接受了研究。对对照研究的临床结果进行投票计数程序分析的结果表明,对于评估的每个临床应用组,阳性结果的数量都多于中性结果的数量,并且没有阴性结果。对数 P 值法发现疼痛减轻、水肿减少和 WH 结果改善具有统计学意义。
基于对已发表临床疗效数据的统计评估,有强有力的统计证据表明 PRFE 治疗在治疗术后和非术后疼痛和水肿以及 WH 应用中是有效的。