摘要
目的探讨国产磁性括约肌增强器治疗胃食管反流病(GERD)的初步临床效果。方法按照上海市胸科医院-胜杰康公司磁性括约肌增强器(SS-MSA)临床试验的纳入排除标准,于2018年8月至2019年12月前瞻性入组上海交通大学附属胸科医院胸外科19例GERD患者,在腹腔镜下完成SS-MSA植入术。男性14例,女性5例;年龄(32.2±7.3)岁(范围:22~50岁),身高(170.7±6.2)cm(范围:160~179 cm),体重(65.2±10.3)kg(范围:47.5~90.0 kg)。术后主要疗效评价指标为24 h酸暴露总时间和反流总次数;次要疗效指标为受试者每天服用质子泵抑制剂的平均剂量,以及手术前后GERD-健康相关生活质量表(GERD-Q)的各项评分。患者接受外科治疗前后的各项指标比较采用配对样本t检验。结果患者GERD病史时间为19(54)个月[M(QR)]。手术时间为63(22)min,住院时间为3(2)d。未发生明显手术并发症。术后发生轻-中度吞咽困难14例,1~3个月逐步缓解;腹泻1例。1例患者术后1个月因严重吞咽困难接受磁环取出术,无腐蚀、穿孔、移位等。5例患者术后1年GERD-Q评分[11.0(4.5)分比6(1.0)分,t=4.274,P=0.013]、24 h酸暴露总时间[6.2(4.8)%比0.1(0.9)%,t=5.814,P=0.004]、DeMeester评分[23.72(16.20)分比0.96(3.10)分,t=6.678,P=0.003]均较术前明显下降。质子泵抑制剂复用率术后1、3、6、12个月时分别为6/18、5/15、3/10、1/5。结论SS-MSA植入术安全简单,住院时间短,围手术期并发症较少,1年随访结果满意,可以作为治疗GERD的方法之一。
Objective To examine the preliminary clinical efficacy of Chinese magnetic sphincter augmentation(MSA)in the treatment of gastroesophageal reflux disease(GERD).Methods According to the enrollment criteria for the MSA developed by ShengJieKang Co.and Shanghai Chest Hospital(SS-MSA)clinical trial,a total of 19 GERD patients were treated with SS-MSA from August 2018 to January 2020 at Department of Thoracic Surgery,Shanghai Chest Hospital,Shanghai Jiao Tong University.The majority of registered cases were male patients with age of(32.2±7.3)years(range:22 to 50 years),height of(170.7±6.2)cm(range:160 to 179 cm)and weight of(65.2±10.3)kg(range:47.5 to 90.0 kg).SS-MSA was implanted via laparoscopy.The major evaluation indexs of postoperative efficacy were the total time of acid exposure within 24 hours and the total number of reflux.Secondary efficacy indicators included:(1)evaluation of the average daily dose of proton pump inhibitor medications;(2)the score of GERD health related quality of life questionnaire(GERD-Q)before and after MSA implantation.Paired design t-test was used to evaluate the efficacy of the SS-MSA.Results A total of 19 patients underwent SS-MSA surgery successfully.The history of the GERD were 19(54)months(M(QR)).The operation time was 63(22)minutes and the in-hospital stay was 3(2)days.No obvious surgical complications occurred.Postoperative adverse events included 14 cases with mild to moderate dysphagia exited after surgery,gradually eased within 1 to 3 months,1 case with the removal of the device after 1 month of severe swallowing difficulties,1 case of diarrhea.No corrosion,perforation,displacement occurred.The GERD-Q score(11.0(4.5)vs.6(1.0),t=4.274,P=0.013),24-hour acid exposure time(6.2(4.8)%vs.0.1(0.9)%,t=5.814,P=0.004),and Demeester score(23.72(16.20)vs.0.96(3.10),t=6.678,P=0.003)were significantly decreased 1 year after surgery(n=5).Proton pump inhibitor reuse rates were 6/18,5/15,3/10,and 1/5 in 1,3,6 and 12 months after the operation,respectively.Conclusions SS-MSA implantation is
作者
孙益峰
姜皓耀
顾海勇
何毅
杨煜
张晓彬
杨洋
华荣
郭旭峰
叶波
茅腾
李志刚
Sun Yifeng;Jiang Haoyao;Gu Haiyong;He Yi;Yang Yu;Zhang Xiaobin;Yang Yang;Hua Rong;Guo Xufeng;Ye Bo;Mao Teng;Li Zhigang(Section of Esophageal Surgery,Department of Thoracic Surgery,Shanghai Chest Hospital,Shanghai Jiao Tong University,Shanghai 200030,China)
出处
《中华外科杂志》
CAS
CSCD
北大核心
2020年第9期691-696,共6页
Chinese Journal of Surgery
关键词
胃食管反流
胸外科手术
磁性括约肌增强器
食管括约肌
下段
Gastroesophageal reflux
Thoracic surgical procedures
Magnetic sphincter augmentation
Esophageal sphincter,lower
