内镜射频治疗胃食管反流病的对照和前瞻性队列疗效研究的系统评价和荟萃分析。

Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease.

机构信息

The Esophageal and Swallowing Center, Division of Gastroenterology and Hepatology, Department of Medicine, The MetroHealth Medical Center and Case Western Reserve University, 2500 MetroHealth Drive, Cleveland, OH, 44109, USA.

BioMedical Strategies, La Jolla, CA, USA.

出版信息

Surg Endosc. 2017 Dec;31(12):4865-4882. doi: 10.1007/s00464-017-5431-2. Epub 2017 Feb 23.

Abstract

BACKGROUND

The endoscopic radiofrequency procedure (Stretta) has been used for more than a decade to treat patients with gastroesophageal reflux disease (GERD). However, the efficacy of the procedure in improving objective and subjective clinical endpoints needs to be further established.

AIM

To determine the efficacy of the Stretta procedure in treating patients with GERD, using a systematic review and meta-analysis of controlled and cohort studies.

METHODS

We conducted a systematic search of the PubMed and Cochrane databases for English language clinical studies of the Stretta procedure, published from inception until May 2016. Randomized controlled trials (RCTs) and cohort studies that included the use of the Stretta procedure in GERD patients were included. A generalized inverse weighting was used for all outcomes. Results were calculated by both fixed effects and random effects model.

RESULTS

Twenty-eight studies (4 RCTs, 23 cohort studies, and 1 registry) representing 2468 unique Stretta patients were included in the meta-analysis. The (unweighted) mean follow-up time for the 28 studies was 25.4 [14.0, 36.7] months. The pooled results showed that the Stretta reduced (improved) the health-related quality of life score by -14.6 [-16.48, -12.73] (P < 0.001). Stretta also reduced (improved) the pooled heartburn standardized score by -1.53 [-1.97, -1.09] (P < 0.001). After Stretta treatment, only 49% of the patients using proton pump inhibitors (PPIs) at baseline required PPIs at follow-up (P < 0.001). The Stretta treatment reduced the incidence of erosive esophagitis by 24% (P < 0.001) and reduced esophageal acid exposure by a mean of -3.01 [-3.72, -2.30] (P < 0.001). Lower esophageal sphincter (LES) basal pressure was increased post Stretta therapy by a mean of 1.73 [-0.29, 3.74] mmHg (P = NS).

CONCLUSIONS

The Stretta procedure significantly improves subjective and objective clinical endpoints, except LES basal pressure, and therefore should be considered as a viable alternative in managing GERD.

摘要

背景

内镜射频治疗(Stretta)技术已被应用于治疗胃食管反流病(GERD)患者十余年。然而,该技术在改善客观和主观临床终点方面的疗效仍需进一步确定。

目的

通过对 Stretta 技术治疗 GERD 的对照研究和队列研究进行系统评价和荟萃分析,确定其疗效。

方法

我们对PubMed 和 Cochrane 数据库进行了系统检索,检索自成立以来至 2016 年 5 月发表的关于 Stretta 技术治疗 GERD 患者的英文临床研究。纳入了使用 Stretta 技术治疗 GERD 患者的随机对照试验(RCT)和队列研究。所有结局均采用广义逆方差加权法进行计算,计算结果分别采用固定效应模型和随机效应模型。

结果

28 项研究(4 项 RCT 和 23 项队列研究及 1 项注册研究)共 2468 例独特的 Stretta 患者纳入荟萃分析。28 项研究的(未加权)平均随访时间为 25.4 [14.0,36.7] 个月。汇总结果显示,Stretta 可降低(改善)健康相关生活质量评分 14.6 分[-16.48,-12.73](P<0.001)。Stretta 还可降低(改善)烧心标准化评分 1.53 分[-1.97,-1.09](P<0.001)。治疗后,仅有 49%基线时使用质子泵抑制剂(PPI)的患者在随访时需要使用 PPI(P<0.001)。Stretta 治疗可使糜烂性食管炎的发生率降低 24%(P<0.001),食管酸暴露平均降低-3.01[-3.72,-2.30](P<0.001)。治疗后下食管括约肌(LES)基础压平均升高 1.73[-0.29,3.74]mmHg(P=NS)。

结论

Stretta 技术可显著改善主观和客观临床终点,除 LES 基础压外,因此可作为 GERD 治疗的一种可行替代方案。

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