摘要目的:探讨猪小肠黏膜下层（SIS）生物补片应用于开放Lichtenstein无张力疝修补术的远期疗效。方法:采用前瞻性随机对照研究方法。选取2013年8月至2014年3月2家医疗中心收治的76例（天津市人民医院52例、北京中日友好医院24例）单侧腹股沟疝行开放Lichtenstein无张力疝修补术病人的临床资料。按随机数字表法分为2组，使用Biodesign Surgisis补片为对照组，使用SIS生物补片为试验组。观察指标：（1）入组病人分组情况。（2）术后远期疗效。通过电话、短信或邮寄信件方式进行随访，病人因其他原因死亡或出现疝复发视为随访终点事件。随访时间截至2019年12月。正态分布的计量资料以 x±s表示，组间比较采用 t检验。偏态分布的计量资料以 M（范围）表示，组间比较采用Mann-Whitney U检验。计数资料以绝对数表示，组间比较采用 χ2检验和Fisher确切概率法。 结果:（1）入组病人分组情况：筛选出符合条件的病人76例。76例病人中，对照组和试验组各38例。对照组病人性别（男、女），年龄，体质量指数，麻醉方式（椎管内麻醉、局部麻醉），手术部位（腹股沟左侧、腹股沟右侧），Gilbert分型（Gilbert Ⅰ型、Gilbert Ⅱ型、Gilbert Ⅲ型、Gilbert Ⅳ型、Gilbert Ⅴ型），手术时间分别为35、3例，（56±15）岁，（23.0±2.0）kg/m 2，22、16例，16、22例，9、16、0、11、2例，（49±15）min；试验组病人上述指标分别为34、4例，（54±13岁），（22.9±2.2）kg/m 2，17、21例，14、24例，9、21、1、7、0例，（53±21）min。两组病人上述指标比较，差异均无统计学意义（ χ2 =0.157， t=0.532、0.367， χ2 =1.317、0.220， Z=-0.315， t=-0.765， P>0.05）。（2）术后远期疗效：对照组35例病人获得随访，其中4例因其他疾病死亡，随访时间为（68.8±2.7）个月，疝复发、慢性疼痛各1例，无异物感、术后感染发生。试验组31例病人获得随访，无因其他疾病死亡病例，随访时间为（68.8±2.7）个月，无上述并发症发生。两组病人疝复发、术后慢性疼痛比较，差异均无统计学意义（ P>0.05）。 结论:生物补片应用于开放Lichtenstein无张力疝修补术的远期疗效较好。国产SIS生物补片的远期疗效与Biodesign Surgisis补片比较，差异无统计学意义。

abstractsObjective:To investigate the long-term effects of porcine small intestinal submucosa (SIS) biologic mesh in open Lichtenstein tension-free hernia repair.Methods:The prospective randomized controlled study was conducted. The clinical data of 76 patients with unilateral inguinal hernia who underwent open Lichtenstein tension-free hernia repair in 2 medical centers (52 cases in Tianjin People′s Hospital and 24 cases in China-Japan Friendship Hospital) from August 2013 to March 2014 were selected. Based on random number method, patients were allocated into two groups. Patients undergoing Lichtenstein tension-free hernia repair using Biodesign Surgisis mesh were allocated into control group, and patients undergoing Lichtenstein tension-free hernia repair using SIS biologic mesh were allocated into experiment group. Observa-tion indicators: (1) grouping situations of the enrolled patients; (2) postoperative long-term effects. Follow-up was conducted using telephone interview, text message or mail to detect hernia recurrence or death due to other reasons as the end-point event of patients up to December 2019. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented by M (range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Results:(1) Grouping situations of the enrolled patients: a total of 76 patients were selected for eligibility. There were 38 cases in the control group and the experiment group, respectively. The number of males and females, age, body mass index, cases with intraspinal anesthesia or local anesthesia (anesthesia method), cases with inguinal hernia on the left side or on the right side, cases classified as type Ⅰ, Ⅱ, Ⅲ, Ⅳ or Ⅴ of Gilbert classification, operation time of the control group were 35, 3, (56±15)years, (23.0±2.0)kg/m 2, 22, 16, 16, 22, 9, 16, 0, 11, 2 and (49±15)minutes, respectively. The above indicators of the experiment group were 34, 4, (54±13)years, (22.9±2.2)kg/m 2, 17, 21, 14, 24, 9, 21, 1, 7, 0, and (53±21)minutes, respectively. There was no significant difference in the above indicators between the two groups ( χ2=0.157, t=0.532, 0.367, χ2=1.317, 0.220, Z=-0.315, t=-0.765, P>0.05). (2) Post-operative long-term effects: 35 patients of the control group were followed up for (68.8±2.7)months, 4 cases of which died due to other reasons, 1 case had hernia recurrence, 1 case had chronic pain and no foreign body sensation and postoperative infection occurred. Thirty-one patients of the experiment group were followed up for (68.8±2.7)months, with no death or above complications. There was no significant difference in hernia recurrence or chronic pain between the two groups ( P>0.05). Conclusion:The long-term effects of biological mesh in open Lichtenstein tension-free hernia repair is satisfactory and there is no difference in the long-term effects between the domestic SIS biological mesh and Biodesign Surgisis mesh.