1995中国普通外科杂志Chinese Journal of General SurgeryChinese Journal of General Surgery中国普通外科杂志1005-694743-1213/R湖南省长沙市1005-6947(2022)10-1339-0810.7659/j.issn.1005-6947.2022.10.00921-0678减重代谢专题研究R656.6MONOGRAPHIC STUDY OF BARIATRIC METABOLIC SURGERY单吻合口十二指肠回肠旁路联合袖状胃切除术对中国肥胖型2型糖尿病患者的疗效Efficacy of single-anastomosis duodenal-ileal bypass with sleeve gastrectomy in treatment of obese type 2 diabetes patients in China泽雨WANGZeyuWANGLun玉会ZHAOYuhui永恒JIAYongheng巍岐MAWeiqiJIANGTao吉林大学中日联谊医院 减重与代谢外科吉林 长春 130033Department of Bariatric and Metabolic Surgery, China-Japan Union Hospital, Jilin University, Changchun 130033, China姜晖姜涛,Email: jiangtao99@jlu.edu.cn

王泽雨,吉林大学中日联谊医院硕士研究生,主要从事减重代谢外科方面的研究。

251020223110133913461339-13462108202228092022背景与目的

在众多减重代谢手术中,单吻合口十二指肠回肠旁路联合袖状胃切除术(SADI-S)是治疗肥胖型2型糖尿病最有效的术式之一。但目前国内有关SADI-S的报道较少,本次研究探讨SADI-S对中国肥胖型2型糖尿病患者的疗效,以期为今后临床治疗的选择提供参考。

方法

回顾性分析2018年10月—2021年8月期间在吉林大学中日联谊医院接受SADI-S治疗的50例肥胖型2型糖尿病患者的临床资料。分析患者术中及术后情况(手术时间、术后住院时间及手术并发症)、术后体质量、体质量指数(BMI)、多余体质量减少率(%EWL)、总体质量减少率(%TWL)、空腹血糖、糖化血红蛋白、糖尿病完全缓解率等指标的变化。随访时间截至2022年8月。

结果

50例患者中,男24例,女26例;平均年龄34(28~43)岁。所有患者均通过腹腔镜(11例)或达芬奇机器人(39例)顺利完成SADI-S手术,无中转开腹及死亡病例。手术时间为(187.9±37.9)min,术后住院时长为6(6~7)d。手术并发症共3例(6%),其中,Clavien⁃Dindo Ⅱ级患者2例(分别为腹腔积液及吻合口瘘);Clavien⁃Dindo Ⅲ级患者1例(胃瘘)。吻合口瘘患者通过禁食、禁饮、全静脉营养及静脉应用抗生素等综合保守治疗后痊愈出院;胃瘘患者则通过胃瘘修补术治疗后痊愈出院。患者术后3、6、12、24个月体质量、BMI、空腹血糖及糖化血红蛋白均较术前明显下降(均P<0.05)。术后3、6、12、24个月%EWL分别为(57.8±17.5)%、(78.3±18.6)%、(97.3±22.1)%、(92.5±9.9)%;%TWL分别为23.2(19.9~25.9)%、31.9(29.3~33.7)%、39.3(34.7~45.2)%、43.0(39.1~47.1)%;2型糖尿病完全缓解率分别为82.0%(41/50)、95.7%(45/47)、100%(36/36)、100%(8/8)。术后3、6个月时,SADI-S对高ABCD评分患者糖尿病的治疗效果优于低ABCD评分患者,而在术后12、24个月时,SADI-S对各级ABCD评分患者的糖尿病治疗效果均显著。

结论

SADI-S对中国肥胖型2型糖尿病患者具有显著的疗效,但其长期疗效仍需进一步随访观察。

Background and Aims

Among many bariatric-metabolic procedures, the single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) is one of the most effective treatments for obese type 2 diabetes. However, there are few reports on SADI-S in China. Therefore, this study was conducted to investigate the efficacy of SADI-S in obese type 2 diabetes patients in China to provide a reference for future treatment choices.

Methods

The clinical data of 50 patients with obese type 2 diabetes undergoing SADI-S at China-Japan Union Hospital of Jilin University between October 2018 and August 2021 were retrospectively analyzed. Patients were analyzed for intraoperative and postoperative conditions (operative time, postoperative hospital stay and surgical complications), weight, body mass index (BMI), extra weight loss (%EWL), total weight loss (%TWL), fasting glucose, glycosylated hemoglobin, and complete remission rate of diabetes after surgery. Follow-up was completed as of August 2022.

Results

Of the 50 patients, 24 cases were males and 26 cases were females, with a mean age of 34 (28-43) years. All patients completed SADI-S surgery by laparoscopic (11 cases) or robotic (39 cases) approach without conversion to laparotomy, and no death occurred. The operative time was (187.9±37.9) min and the length of postoperative hospital stay was 6 (6-7) d. Surgical complications occurred in 3 patients (6%), which included two Clavien-Dindo Grade Ⅱ complications (abdominal fluid collections and anastomotic leakage) and one Clavien⁃Dindo grade Ⅲ complication (gastric leakage). The patient with anastomotic leakage was discharged after a combination of conservative treatments, including water fasting, total intravenous nutrition, and intravenous antibiotic therapy. The patient with gastric leakage was discharged after treatment with gastric fistula repair. The patients' weight, BMI, fasting glucose and glycosylated hemoglobin decreased significantly at 3, 6, 12 and 24 months after surgery compared with their preoperative values (all P<0.05). The %EWL values were (57.8±17.5)%, (78.3±18.6)%, (97.3±22.1)%, and (92.5±9.9)%, the %TWL values were 23.2 (19.9-25.9)%, 31.9 (29.3-33.7)%, 39.3 (34.7-45.2)%, 43.0 (39.1-47.1)% and the complete remission rates of type 2 diabetes were 82.0% (41/50), 95.7% (45/47), 100% (36/36), and 100% (8/8) respectively at 3, 6, 12, and 24 months after surgery. SADI-S yielded better efficacy against diabetes in patients with high ABCD scores than those with low ABCD scores at 3 and 6 months after surgery, and yielded remarkable efficacy against diabetes in patients with ABCD scores of all levels.

Conclusion

SADI-S has an excellent effect in treating obese type 2 diabetes in the Chinese population, but its long-term impact needs to be further observed.

减肥手术肥胖症糖尿病,2型胃切除术肠旁路术Bariatric SurgeryObesityDiabetes Mellitus, Type 2GastrectomyIntestinal Bypassversion1.0.0.22299structure-time2022-10-31T17:30:26word-sourceFX

Chinese Journal of General Surgery, 2022, 31(10):1339-1346.

随着我国经济迅猛发展,人们的生活方式及饮食习惯也发生了巨大的变化,肥胖及糖尿病患者数量显著增多。据国际糖尿病联盟(International Diabetes Federation,IDF)统计[1],2021年中国成人糖尿病患者约1.4亿,预计2045年将增加至1.7亿,位居世界第一。同时[2],中国成年人中肥胖患病率平均每年增长1个百分点,2018年已增长至16.4%。另外,在肥胖和超重人群中,糖尿病患病率显著增加[3],2015—2017年体质量指数(body mass index,BMI)≥30 kg/m2肥胖患者中糖尿病患病率为20.1%[4]。肥胖和持续的高血糖不仅严重威胁着人们的身体健康,还增加了家庭和社会的经济负担[5-12]。相比于传统的“五驾马车”治疗方法,代谢手术已被证明为2型糖尿病更为有效的治疗手段[13]。在众多减重代谢手术中,单吻合口十二指肠回肠旁路联合袖状胃切除术(single-anastomosis duodeno-ileal bypass with sleeve gastrectomy,SADI-S)是治疗肥胖型2型糖尿病最有效的术式之一[14-15]

SADI-S由西班牙医生Sanchez-Pernaute等[16]于2007年首次提出,最初该术式是在54 Fr Bougie管的引导下进行的胃袖状切除,共同通道长度为200 cm。2013年美国的Mitzman等[17]对SADI-S进行改良,将Bougie管减小为42 Fr,同时将共同肠道进一步延长为300 cm。2017年我国张鹏等[18]对该术式治疗肥胖患者进行了首例报道。本中心自2018年陆续开展该术式,并对该术式治疗肥胖及糖尿病患者的临床结局进行报道[19-20],结果表明该术式安全性较好且治疗肥胖及其相关代谢病疗效显著。但目前关于该术式治疗中国肥胖型2型糖尿病文献仍极少。本研究旨在通过回顾性分析本中心收治的50例肥胖型2型糖尿病患者的临床资料,探究其疗效,以期为今后手术治疗肥胖型2型糖尿病提供参考。

1 资料与方法1.1 一般资料

采用回顾性描述性研究方法。收集2018年10月—2021年8月期间50例接受SADI-S治疗的肥胖型2型糖尿病的临床资料,男24例,女26例;年龄34(28~43)岁。术前体质量、BMI、空腹血糖、糖化血红蛋白分别为(120.4±27.6)kg、(41.0±6.9)kg/m2、9.6(7.8~13.2)mmol/L、8.5(7.2~9.3)%。糖尿病病程1(0~4)年,ABCD评分7(5~10)分。所有患者及家属术前均已充分了解手术相关知识及风险,签署知情同意书。本研究已通过医院伦理委员会审批[批件号:20211130019]。

1.2 纳入标准与排除标准

纳入标准:⑴ BMI≥37.5 kg/m2且同时患有2型糖尿病或BMI>27.5~<37.5 kg/m2且糖尿病病情严重;⑵ 2018年10月—2021年8月期间于本中心行SADI-S手术。排除标准:⑴ 修正手术;⑵ 年龄<16岁或>65岁。

1.3 手术方式

SADI-S手术通过腹腔镜或达芬奇机器人进行。全麻生效后,患者取“头高脚低大字位”。常规腹腔镜操作,通过阑尾确定回盲部,从回盲部逆行测量共同通道,距回盲部300 cm处进行标记。游离胃结肠韧带,在34 Fr Bougie管的引导下行胃袖状切除。游离十二指肠球部后切断十二指肠球部,将近端十二指肠残端与回肠标记处行端-侧吻合(图1)。大网膜复位,胃切缘与网膜加固缝合,术毕。

10.7659/j.issn.1005-6947.2022.10.009.F001<bold>SADI-S</bold>手术示意图Surgical diagram for SADI-S
1.4 观察指标与评价标准

观察指标:⑴ 术中及术后情况:手术时间、术后住院时间及手术并发症;⑵ 减重效果:术后3、6、12、24个月体质量、BMI、多余体质量减少率(excess weight loss,%EWL)及总体质量减少率(total weight loss,%TWL);⑶ 糖尿病疗效:术后3、6、12、24个月糖化血红蛋白、空腹血糖及糖尿病完全缓解率。

评价标准:⑴ 肥胖型2型糖尿病诊断标准:BMI≥27.5 kg/m2且伴有空腹血糖≥7.0 mmol/L,或口服糖耐量实验2 h血糖(OGTT 2 h)≥11.1 mmol/L,或糖化血红蛋白≥6.5%;⑵ 糖尿病完全缓解:在不使用降糖药物的情况下糖化血红蛋白<6%;⑶ ABCD评分采用Lee等[21]提出的ABCD糖尿病评价体系;⑷ 术后并发症采用Clavien⁃Dindo分级评估[22]

1.5 随访

随访指标为术后3、6、12、24个月的体质量、BMI、%EWL、%TWL、空腹血糖、糖化血红蛋白等指标的变化情况。随访时间截至2022年8月。

1.6 统计学处理

应用SPSS 22.0统计软件进行分析。正态分布的计量资料以均数±标准差(x¯±s)表示,组间比较采用两独立样本t检验;偏态分布的计量资料以中位数(四分间距)[MIQR)]表示,组间比较采用Mann-Whitney U检验;计数资料以绝对数或百分比[n(%)]表示,组间比较采用χ2检验或Fisher确切概率法。P<0.05表示差异具有统计学意义。

2 结 果2.1 手术相关情况

50例肥胖型2型糖尿病患者均顺利完成SADI-S(腹腔镜11例,机器人39例),无中转开腹及围术期死亡。手术时间为(187.9±37.9)min,术后住院时间为6(6~7)d。手术并发症共3例,发生率为6%(3/50)。其中,Clavien⁃Dindo Ⅱ级患者2例,分别为:腹腔积液及吻合口瘘;Clavien⁃Dindo Ⅲ级患者1例,为胃瘘。吻合口瘘患者通过禁食、禁饮、全静脉营养及静脉应用抗生素等综合保守治疗后痊愈出院;胃瘘患者则通过胃瘘修补术治疗后痊愈出院。

2.2 随访情况

采用门诊或电话的方式进行随访,术后3个月随访例数为50,随访率为100%(50/50);术后6个月随访例数为47,随访率为94%(47/50);术后12个月随访例数为36,随访率为72%(36/50);术后24个月随访例数为8,随访率为36.4%(8/22)。

2.3 减重效果与糖尿病疗效

体质量、BMI在术后不同随访时间的变化如表1所示。术后3、6、12、24个月的体质量、BMI、空腹血糖、糖化血红蛋白较术前均明显下降,差异均有统计学意义(均P<0.05)。糖尿病完全缓解率在术后3、6、12、24个月分别为82.0%(41/50)、95.7%(45/47)、100%(36/36)、100%(8/8)。术后3、6、12、24个月%EWL分别为(57.8±17.5)%、(78.3±18.6)%、(97.3±22.1)%、(92.5±9.9)%,%TWL分别为23.2(19.9~25.9)%、31.9(29.3~33.7)%、39.3(34.7~45.2)%、43.0(39.1~47.1)%(图2)。

10.7659/j.issn.1005-6947.2022.10.009.T001

SADI-S术后减重及糖尿病疗效

Weight loss and diabetes status after SADI-S
指标术前(n=50)术后
3个月(n=50)6个月(n=47)12个月(n=36)24个月(n=8)
体质量(kg,x¯±s120.4±27.692.4±21.01)80.8±16.11)71.4±14.91)74.2±13.21)
BMI(kg/m2x¯±s41.0±6.931.5±5.41)27.7±3.851)24.5±3.51)24.8±2.41)
糖化血红蛋白[%,MIQR)]8.5(7.2~9.3)5.3(5.0~5.7)1)5.0(4.8~5.3)1)5.1(4.6~5.2)1)4.8(4.5~5.1)1)
空腹血糖[mmol/L,MIQR)]9.6(7.8~13.2)5.4(5.0~6.0)1)5.2(4.8~5.6)1)4.9(4.8~5.5)1)4.7(4.5~5.1)1)
糖尿病完全缓解率(%)8295.7100100

注:1)与术前比较,P<0.05

Notes: 1) P<0.05 vs. preoperative value

10.7659/j.issn.1005-6947.2022.10.009.F002<bold>SADI-S</bold>术后减重指标的变化趋势  A:%EWL;B:%TWL<bold>The changing trends of weight-loss variables after SADI-S</bold>  A: %EWL; B: %TWL
2.4 SADI-S对不同ABCD评分患者糖尿病疗效

不同ABCD评分患者在各随访时间点的糖尿病完全缓解率如图3所示,术后3、6个月时,SADI-S对高ABCD评分患者疗效优于低ABCD评分患者,而在术后12、24个月时,SADI-S对各级ABCD评分患者均疗效显著。

10.7659/j.issn.1005-6947.2022.10.009.F003不同<bold>ABCD</bold>评分患者在各随访时间点的糖尿病完全缓解率Complete remission rates in patients with different ABCD scores at each follow-up time
3 讨 论

大中华减重与代谢手术数据库2021年度报告[23]显示:SADI-S仅占减重与代谢总手术量的0.3%,可见目前国内SADI-S应用仍较少,同时亦缺乏SADI-S相关报道。故笔者基于本次研究结果,进一步探讨SADI-S手术的优势及现阶段不足。

SADI-S又被称为单吻合口十二指肠转位术(one anastomosis duodenal switch,OADS)或保留幽门的胃肠减重手术(stomach intestinal pylorus sparing surgery,SIPS)[24]。单吻合口及不打开肠系膜的特点明显降低了手术难度,提高了手术安全性[25-28]:单吻合口使吻合口相关并发症明显降低,不打开肠系膜则降低了疝的发生。在Cottam团队[29]的研究中发现SADI-S术后并发症发生率明显低于胆胰转流十二指肠转位术(biliopancreatic diversion with duodenal switch,BPD/DS)(1.6% vs. 20.9%,P<0.05),其中BPD/DS术后共发生2例吻合口瘘,而SADI-S则未发生;Finno等[30]研究也发现SADI-S的远期并发症发生率显著小于BPD/DS(13.1% vs. 4.4%,P<0.05),并且术后疝的发生更少(4例vs. 17例)。同时,一项匹配队列研究[31]发现SADI-S的远期并发症发生率显著小于Roux-en-Y胃转流术(Roux-en-Y gastric bypass,RYGB),因不良事件的再干预率也远低于RYGB(14.7% vs. 39.3%,P=0.001)。并且RYGB术后残胃癌的发生一直是人们所担心的问题[32],而SADI-S手术保留了幽门,有效地降低了胃癌的发生几率。在本次研究中,SADI-S手术并发症发生率为6%,这与Zaveri等[33]研究中报道的7.7%及Surve等[34]报道的4.3%结果相似。并且3例手术并发症均在达芬奇机器人手术系统下完成,其中腹腔积液及吻合口瘘发生在学习曲线之前,通过我们对学习曲线的研究,当术者达到熟练阶段后,手术的安全性会明显提高[35]。所以SADI-S手术并发症发生率较低,且术者度过学习曲线后,手术安全性会进一步提高。

作为BPD/DS的简化术式,SADI-S治疗肥胖型糖尿病具有极佳的疗效[36]。在减重效果方面,Enochs等[14]对SADI-S、RYGB、袖状胃切除术(sleeve gastrectomy,SG)三种术式的疗效进行了比较,研究结果表明SADI-S的减重疗效远高于RYGB和SG(%EWL:88.4% vs. 78.3% vs. 64.1%,P<0.001)。同样一项基于倾向性评分的研究[37]结果显示SADI-S术后2年%TWL显著高于RYGB(P=0.017)。在本次研究中,SADI-S术后12个月%EWL为97.3%,术后24个月仍保持为92.5%,这与 Sánchez-Pernaute[38]研究结果相似(%EWL=95%)。另外,在Lee等[39]的报道中SG术前BMI与本次研究中(分别为:40.7 kg/m2,41.0 kg/m2)相近,但其术后12个月%TWL仅为26.2%,明显低于SADI-S术后12个月的39.3%。在糖尿病疗效方面,本次研究中SADI-S术后12个月糖尿病完全缓解率为100%,这与Sánchez-Pernaute等[38]及Surve等[34]的研究结果相似(分别为92%,94.4%)。Shen等[40]比较了不同减重手术治疗不同ABCD评分糖尿病患者的疗效,虽然RYGB与SG在治疗高ABCD评分(10~9)患者时均具有较好的疗效,术后12个月糖尿病完全率分别为:100%,81.8%,但两者在低ABCD(2~0)患者中的表现却不理想,糖尿病完全缓解率分别为:12%,21.4%。同样Lee等[39]报道了SG术后1年ABCD评分<4的患者糖尿病完全缓解率为0。而在本次研究中,虽然术后3个月ABCD评分小于4分的患者糖尿病完全缓解率为37.5%,但在术后12个月时糖尿病完全缓解率达到100%。所以,SADI-S在治疗肥胖型糖尿病时,疗效优势明显。

Wang等[41]曾报道过SADI-S术后24个月,1例低体质量糖尿病患者体质量减轻过多,BMI为17.96 kg/m2,相似的结果也出现在本次研究中,有2例患者在术后12个月时BMI<20 kg/m2,分别为19.1 kg/m2及18.9 kg/m2,他们的术前BMI分别为30.1 kg/m2及31.6 kg/m2,ABCD评分分别为2和4。故SADI-S治疗低体质量肥胖型糖尿病患者时,如何预防体质量减少过多是值得讨论与关注的。另外,SADI-S主要包括胃袖状切除和十二指肠回肠吻合两个操作,前者的作用机制是以限制摄入为主,后者的作用机制是以减少吸收为主,其术后营养情况一直是人们所关注的。既往研究中[34, 42]曾多次报道SADI-S术后营养不良的现象,其主要的治疗方案为延长共同通道、管饲营养支持治疗或口服药物补充等。故患者行SADI-S治疗时,如何有效地预防术后营养不良的发生仍需要更多临床证据。同时,由于SADI-S手术保留了幽门,持续的胃内高压会增加胃食管反流的发生或使现有胃食管反流加重,虽然RYGB是有效的解决方法[43],但系统化的治疗方案仍是人们未来研究的重要方向之一。

综上,SADI-S对中国肥胖型2型糖尿病患者具有十分可观的疗效,其长期疗效有待进一步随访观察。

所有作者均声明不存在利益冲突。

王泽雨, 王伦, 赵玉会, 等.单吻合口十二指肠回肠旁路联合袖状胃切除术对中国肥胖型2型糖尿病患者的疗效[J]. 中国普通外科杂志, 2022, 31(10):1339-1346. doi:10.7659/j.issn.1005-6947.2022.10.009

Wang ZY, Wang L, Zhao YH, et al. Efficacy of single-anastomosis duodenal-ileal bypass with sleeve gastrectomy in treatment of obese type 2 diabetes patients in China[J]. Chin J Gen Surg, 2022, 31(10):1339-1346. doi:10.7659/j.issn.1005-6947.2022.10.009

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