Division of Gastroenterology, University of Calgary, Calgary, Canada.
BMC Gastroenterol. 2012 May 31;12:58. doi: 10.1186/1471-230X-12-58.
Wireless capsule pH-metry (WC) is better tolerated than standard nasal pH catheter (SC), but endoscopic placement is expensive.
to confirm that non-endoscopic peroral manometric placement of WC is as effective and better tolerated than SC and to perform a cost analysis of the available esophageal pH-metry methods.
Randomized trial at 2 centers. Patients referred for esophageal pH testing were randomly assigned to WC with unsedated peroral placement or SC after esophageal manometry (ESM). Primary outcome was overall discomfort with pH-metry. Costs of 3 different pH-metry strategies were analyzed: 1) ESM + SC, 2) ESM + WC and 3) endoscopically placed WC (EGD + WC) using publicly funded health care system perspective.
86 patients (mean age 51 ± 2 years, 71% female) were enrolled. Overall discomfort score was less in WC than in SC patients (26 ± 4 mm vs 39 ± 4 mm VAS, respectively, p = 0.012) but there were no significant group differences in throat, chest, or overall discomfort during placement. Overall failure rate was 7% in the SC group vs 12% in the WC group (p = 0.71). Per patient costs ($Canadian) were $1475 for EGD + WC, $1014 for ESM + WC, and $906 for ESM + SC. Decreasing the failure rate of ESM + WC from 12% to 5% decreased the cost of ESM + WC to $991. The ESM + SC and ESM + WC strategies became equivalent when the cost of the WC device was dropped from $292 to $193.
Unsedated peroral WC insertion is better tolerated than SC pH-metry both overall and during placement. Although WC is more costly, the extra expense is partially offset when the higher patient and caregiver time costs of SC are considered.
Clinicaltrials.gov Identifier NCT01364610.
无线胶囊 pH 测量（WC）比标准鼻 pH 导管（SC）更能被患者接受，但内镜放置的费用较高。
确认非内镜经口测压放置 WC 与 SC 一样有效且更能被患者接受，并对现有的食管 pH 测量方法进行成本分析。
在 2 个中心进行的随机试验。将因食管 pH 测试而转介的患者随机分为未镇静的经口 WC 放置或食管测压（ESM）后的 SC。主要结果是 pH 测量的总体不适。从公共资助的医疗保健系统角度分析了 3 种不同 pH 测量策略的成本：1）ESM+SC，2）ESM+WC 和 3）内镜放置的 WC（EGD+WC）。
共纳入 86 名患者（平均年龄 51 ± 2 岁，71%为女性）。与 SC 组相比，WC 组的总体不适评分较低（分别为 26 ± 4mm 和 39 ± 4mm VAS，p=0.012），但在放置过程中喉咙、胸部或总体不适无显著差异。SC 组的总体失败率为 7%，WC 组为 12%（p=0.71）。每个患者的成本（加元）为 EGD+WC 为 1475 美元，ESM+WC 为 1014 美元，ESM+SC 为 906 美元。将 ESM+WC 的失败率从 12%降低到 5%，将 ESM+WC 的成本降低到 991 美元。当 WC 设备的成本从 292 美元降至 193 美元时，ESM+SC 和 ESM+WC 策略变得等效。
未镇静的经口 WC 插入比 SC pH 测量更能被患者接受，无论是总体上还是在放置过程中。虽然 WC 的成本较高，但考虑到 SC 对患者和护理人员时间成本的影响，其额外费用会部分抵消。
Clinicaltrials.gov 标识符 NCT01364610。
