内镜下抗反流黏膜切除术与热能射频治疗难治性胃食管反流病的临床疗效对比：一项单中心随机试验

doi:10.3877/cma.j.issn.2095-8765.2023.03.004

目的

比较抗反流黏膜切除术（ARMS）和热能射频消融（RF）治疗难治性胃食管反流病（RGERD）的临床疗效。

方法

本研究为单中心的随机对照研究，研究对象为2018年4月至2019年7月在南京医科大学第一附属医院消化科就诊的RGERD患者。将RGERD患者1∶1随机分为ARMS组和RF组，在术前和术后2年对患者进行GERD问卷（GERD-Q）和反流性疾病问卷（RDQ）评分，主要结局指标为术后2年GERD-Q及RDQ评分，次要结局指标为术后2年质子泵抑制剂（PPI）停用率和患者满意率。

结果

本研究共纳入分析34例患者（ARMS组18例，RF组16例），2组患者的手术操作成功率均为100%。与RF组相比，ARMS组患者住院时间更长[（7.50±1.76）比（6.06±2.24）d，P = 0.044]，术后吞咽困难发生率更高（27.78%比0%，P = 0.046）。术后2年，2组患者间GERD-Q和RDQ评分无统计学差异[（9.56±7.16）比（8.06±6.64）分，（10.00±6.00）比（9.81±4.71）分; P均>0.05]。ARMS与RF组患者间PPI停用率和患者满意率无统计学差异[（61.11%比68.75%，61.11%比62.50%; P均>0.05]。

结论

内镜下ARMS 与射频消融治疗RGERD的临床疗效相当，疗效可维持至少2年，ARMS在RGERD治疗上具有应用前景。

关键词: 射频消融术, 抗反流黏膜切除术, 难治性胃食管反流病

Objective

To compare the efficacy of Anti-reflux mucosectomy (ARMS) and radiofrequency (RF) energy delivery in gastroesophageal reflux disease(GERD).

Methods

Patients with refractory GERD (RGERD) were 1:1 randomly assigned to either ARMS group or RF group. GERD questionnaire (GERD-Q) and reflux disease questionnaire (RDQ) were performed before and 2 years after the procedures. Primary outcome was the scores of GERD-Q and RDQ at 2 years postoperatively. The Secondary outcomes were proportions of patients who completely stopped proton pump inhibitor(PPI)use and who were satisfied with the treatment postoperatively.

Results

Thirty-four patients were analyzed, with 18 in ARMS group and 16 in RF group. In both groups, the operation success rate was 100%. Compared to RF group, the length of stay in ARMS group was significantly longer [(7.50±1.76) vs (6.06±2.24) d, P=0.044], and the incidence rate of dysphagia was higher (27.78% vs 0%, P=0.046). At 2 years postoperatively, the scores of GERD-Q and RDQ did not differ between the two groups [(9.56±7.16) vs (8.06±6.64) points, (10.00±6.00) vs (9.81±4.71) points; P all >0.05]. The PPIs cessation and patient satisfaction rates did not differ between ARMS and RF group (61.11% vs 68.75%, 61.11% vs 62.50%; P all>0.05).

Conclusion

The clinical efficacy of ARMS and RF for RGERD is equivalent. ARMS, the efficacy of which could be maintained for at least 2 years, is a promising endoscopic management for RGERD.

Key words: Radiofrequency energy delivery, Anti-reflux mucosectomy, Refractory gastroesophageal reflux disease

表1 ARMS组和RF组患者的人口学数据、术前胃镜及24 h阻抗-pH监测参数比较

项目	ARMS组（18例）	RF组（16例）	统计值	P值
年龄（岁，）	59.39±14.05	54.31±13.05	t =1.087	0.285
性别（例，男性/女性）	10/8	11/5	χ² =0.624	0.429
BMI（kg/m²，）	23.97±2.97	22.22±2.48	t =1.861	0.072
GERD病程 [年，M(Q₁，Q₃)]	5.5 (2.8, 12.5)	4.0 (2.0, 9.5)	Z =-0.832	0.405
食管裂孔疝 [例（%）]	6 (33.33)	3 (18.75)	-	0.448
洛杉矶分型A或B [例（%）]	18 (100.00)	14 (87.50)	-	0.214
巴雷特食管 [例（%）]	0 (0.00)	1 (6.25)	-	0.471
萎缩性胃炎 [例（%）]	2 (11.11)	0 (0.00)	-	0.487
阻抗-pH监测 [M(Q₁，Q₃)]
DeMeester评分[分，M(Q₁，Q₃)]	31.7 (22.0, 66.7)	27.0 (19.7, 44.4)	Z =-0.898	0.369
反流事件[次，M(Q₁，Q₃)]	88.0 (77.5, 186.8)	125.0 (68.0, 160.0)	Z =-0.024	0.981
酸暴露时间[%，M(Q₁，Q₃)]	8.6 (6.4, 18.3)	6.3 (3.7, 12.7)	Z =-1.336	0.182
长反流时间[%，M(Q₁，Q₃)]	5.0 (2.8, 12.8)	2.0 (0.0, 9.5)	Z =-1.689	0.091

表1 ARMS组和RF组患者的人口学数据、术前胃镜及24 h阻抗-pH监测参数比较

项目	ARMS组（18例）	RF组（16例）	统计值	P值
年龄（岁，）	59.39±14.05	54.31±13.05	t =1.087	0.285
性别（例，男性/女性）	10/8	11/5	χ² =0.624	0.429
BMI（kg/m²，）	23.97±2.97	22.22±2.48	t =1.861	0.072
GERD病程 [年，M(Q₁，Q₃)]	5.5 (2.8, 12.5)	4.0 (2.0, 9.5)	Z =-0.832	0.405
食管裂孔疝 [例（%）]	6 (33.33)	3 (18.75)	-	0.448
洛杉矶分型A或B [例（%）]	18 (100.00)	14 (87.50)	-	0.214
巴雷特食管 [例（%）]	0 (0.00)	1 (6.25)	-	0.471
萎缩性胃炎 [例（%）]	2 (11.11)	0 (0.00)	-	0.487
阻抗-pH监测 [M(Q₁，Q₃)]
DeMeester评分[分，M(Q₁，Q₃)]	31.7 (22.0, 66.7)	27.0 (19.7, 44.4)	Z =-0.898	0.369
反流事件[次，M(Q₁，Q₃)]	88.0 (77.5, 186.8)	125.0 (68.0, 160.0)	Z =-0.024	0.981
酸暴露时间[%，M(Q₁，Q₃)]	8.6 (6.4, 18.3)	6.3 (3.7, 12.7)	Z =-1.336	0.182
长反流时间[%，M(Q₁，Q₃)]	5.0 (2.8, 12.8)	2.0 (0.0, 9.5)	Z =-1.689	0.091

表2 ARMS组和RF组患者围手术期指标比较

组别	例数	住院时间（d，）	术后腹痛 [例（%）]	术后腹胀 [例（%）]	术后吞咽困难 [例（%）]	严重不良事件 [例（%）]	术后需食管扩张 [例（%）]	术后需外科手术 [例（%）]
ARMS组	18	7.50±1.76	9 (50.00)	2 (11.11)	5 (27.78)	0 (0.00)	0 (0.00)	0 (0.00)
RF组	16	6.06±2.24	5 (31.25)	1 (6.25)	0 (0.00)	0 (0.00)	0 (0.00)	0 (0.00)
统计值		t =2.096	χ² =1.229	χ²=0.249	-	-	-	-
P值		0.044	0.315	0.999	0.046	-	-	-

表2 ARMS组和RF组患者围手术期指标比较

组别	例数	住院时间（d，）	术后腹痛 [例（%）]	术后腹胀 [例（%）]	术后吞咽困难 [例（%）]	严重不良事件 [例（%）]	术后需食管扩张 [例（%）]	术后需外科手术 [例（%）]
ARMS组	18	7.50±1.76	9 (50.00)	2 (11.11)	5 (27.78)	0 (0.00)	0 (0.00)	0 (0.00)
RF组	16	6.06±2.24	5 (31.25)	1 (6.25)	0 (0.00)	0 (0.00)	0 (0.00)	0 (0.00)
统计值		t =2.096	χ² =1.229	χ²=0.249	-	-	-	-
P值		0.044	0.315	0.999	0.046	-	-	-

表3 ARMS组和RF组患者术后症状评分比较

组别	例数	RDQ（分，）		GERDQ（分，）
组别	例数	术前	术后	术前	术后
ARMS	18	18.44±5.53	9.56±7.16^a	13.44±2.15	10.00±6.00^a
RF	16	18.88±3.91	8.06±6.64 ^a	12.75±1.98	9.81±4.71 ^a
t值		0.628		0.100
P值		0.535		0.921

表3 ARMS组和RF组患者术后症状评分比较

组别	例数	RDQ（分，）		GERDQ（分，）
组别	例数	术前	术后	术前	术后
ARMS	18	18.44±5.53	9.56±7.16^a	13.44±2.15	10.00±6.00^a
RF	16	18.88±3.91	8.06±6.64 ^a	12.75±1.98	9.81±4.71 ^a
t值		0.628		0.100
P值		0.535		0.921

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Anti-reflux mucosectomy versus radiofrequency energy delivery for refractory gastroesophageal reflux disease: a single-center randomized controlled trial

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Anti-reflux mucosectomy versus radiofrequency energy delivery for refractory gastroesophageal reflux disease: a single-center randomized controlled trial