活血通腑方防治术后腹腔粘连多中心随机双盲对照临床研究
A Multicenter, Randomized, Double-Blind Clinical Study of Huoxue Tongfu Formula in Postoperative Peritoneal Adhesions
-
摘要: 目的 观察活血通腑方防治术后腹腔粘连(PPA)的临床疗效,探讨其可能作用机制。方法 采用多中心随机双盲对照的研究方法,将119例粘连性肠梗阻手术患者分为对照组(58例)和治疗组(61例)。对照组常规治疗,治疗组在对照组基础上予活血通腑方治疗,干预4周,观察2组患者术后第1次排气时间、第1次排便时间;术后腹痛VAS评分;术后血清转化生长因子-β(TGF-β),纤连蛋白(FN)水平;术后B超粘连评价;术后1年随访观察粘连性肠梗阻复发率及复发手术率。结果 治疗后与对照组比,治疗组能减少术后第1次排气及第1次排便时间(P<0.01),降低术后7 d及14 d 的VAS疼痛评分(P<0.01),减少术后腹腔粘连形成(P<0.05),减少术后粘连性肠梗阻复发及复发手术率(P<0.05)。组内比较VAS 疼痛评分,对照组术后7、14 d与术后3 d比较差异有统计学意义(P<0.05~0.01);治疗组术后7、14 d与术后3 d比较有显著性差异(P<0.01)。2组术后血清TGF-β、FN含量3 d显著升高(P<0.01),治疗组14 d无显著差异(P>0.05),2组比较,术后7、14 d,治疗组明显修复(P<0.01)。结论 活血通腑方对术后腹腔粘连疗效显著,值得临床推广运用。Abstract: OBJECTIVE To observe the clinical effect of Huoxue Tongfu formula on prevention and treatment of postoperative peritoneal adhesions (PPA) and to explore its possible mechanism. METHODS 119 patients with adhesive intestinal obstruction were divided into two groups: control group (n=58) and treatment group (n=61). The control group was treated with routine therapy and the treatment group was treated with Huoxue Tongfu formula on the basis of the control group. After 4 weeks of intervention, the first time of exhaust and defecation were observed in the two groups, and the VAS score of postoperative abdominal pain was also observed. Serum transforming growth factor -β (TGF-β), the level of fibronectin (FN) and the B-ultrasound adhesion after operation were evaluated, and the recurrence rate of the adhesive ileus and rate of its recurrent operation were observed at 1-year follow-up. RESULTS Compared with the control group, the treatment group reduced the first time of exhaust and defecation after operation (P<0.01), lower the VAS pain score of 7 d and 14 d (P<0.01), reduce the postoperative peritoneal adhesion formation (P<0.05), and reduce recurrence rate of postoperative adhesive intestinal obstruction and the rate of its recurrent operation (P<0.05). Comparing with postoperative 3th day, there was statistically significant on postoperative 7th day and 14th day(P<0.05, P<0.01) in control group, and there was significant difference on postoperative 7th day and 14th day(P<0.01) in treatment group. The serum level of TGF-β and FN were significantly increased on postoperative 3th day(P<0.01) both in treatment group and control group. And there was no significant difference on postoperative 14th day(P>0.05) in treatment group. Comparing the two groups, there was a significant reduction in treatment group on postoperative 7th and 14th day(P<0.01). CONCLUSION The effect of Huoxue Tongfu formula on postoperative peritoneal adhesion is significant, and it is worthy of clinical popularization and application.
-
[1] 专家组预防腹部外科手术后腹腔粘连的中国专家共识. 预防腹部外科手术后腹腔粘连的中国专家共识[J]. 中华普通外科杂志, 2017,32(11):984-988. [2] TEN BR, ISSA Y, VAN SANTBRINK EJ, et al. Burden of adhesions in abdominal and pelvic surgery: systematic review and met-analysis[J]. BMJ, 2013,347:f5588. [3] BRUGGMANN D, TCHARTCHIAN G, WALLWIENER M, et al. Intra-abdominal adhesions: definition, origin, significance in surgical practice, and treatment options[J]. Dtsch Arztebl Int, 2010,107(44):769-775. [4] VERCELLINI P, SOMIGLIANA E, VIGANO P, et al. Chronic pelvic pain in women: etiology, pathogenesis and diagnostic approach[J]. Gynecol Endocrinol, 2009,25(3):149-158. [5] RAY NF, DENTON WG, THAMER M, et al. Abdominal adhesiolysis: inpatient care and expenditures in the United States in 1994[J]. J Am Coll Surg, 1998,186(1):1-9. [6] MAVROS M N, VELMAHOS GC, LEE J, et al. Morbidity related to concomitant adhesions in abdominal surgery[J]. J Surg Res, 2014,192(2):286-292. [7] TEN BR, STOMMEL MW, STRIK C, et al. Benefits and harms of adhesion barriers for abdominal surgery: A systematic review and meta-analysis[J]. Lancet, 2014,383(9911):48-59. [8] 杨丽丽, 卞尧尧, 赵敏, 等. 防治手术后腹腔粘连屏障材料:生物特性及优势与不足[J]. 中国组织工程研究, 2019,23(2):272-277. [9] 王广成, 邵明亮. 丹参厚朴合剂治疗小儿肠粘连临床观察[J]. 中国实用医药, 2010,5(14):42-43. [10] 刘春香. 理气活血法在妇科术后防粘连的临床应用分析[J]. 中国医药指南, 2013,11(35):199-200. [11] 朱建光, 王永福, 卞尧尧. 通腑方治疗粘连性肠梗阻60例回顾性疗效评价[J]. 时珍国医国药, 2016,27(6):1409-1410. [12] 曾莉, 张亚大. 大承气汤加减治疗术后粘连性肠梗阻22例[J]. 国医论坛, 2003,18(1):8. [13] 曾莉, 钱海华, 赵群男, 等. 活血通腑方治疗术后粘连性肠梗阻56例临床观察[J]. 南京中医药大学学报, 2010,26(3):178-180. [14] HOLMDAHL L, RISBERG B. Adhesions: Prevention and complications in general surgery[J]. Eur J Surg, 1997,163(3):169-174. [15] 中药新药临床研究指导原则(试行)[M]. 北京: 中国医药科技出版社,2002:3-6. [16] 尚晓滨, 吴咸中. 术后早期炎症性肠梗阻的诊断和治疗[J]. 中国中西医结合外科杂志, 2003,9(6):56-58. [17] 文谦, 赵雨, 刘劼, 等. 电针治疗功能性消化不良上腹痛综合征的临床疗效观察[J]. 四川大学学报(医学版), 2018,49(5):817-820. [18] HAHN RG. Fluid absorption in endoscopic surgery[J]. Br J Anaesth, 2006,96(1):8-20. [19] METTLER L, HUCKE J, BOJAHR B, et al. A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy[J]. Hum Reprod, 2008,23(5):1093-1100. [20] KONINCKX PR, GOMEL V, USSIA A, et al. Role of the peritoneal cavity in the prevention of postoperative adhesions, pain, and fatigue[J]. Fertil Steril, 2016,106(5):998-1010. [21] 曾莉, 徐庆, 陈卫平, 等. 活血通腑方优选方对TNF-α诱导下腹膜间皮细胞TGF-β1、FN、CTGF蛋白含量的影响[J]. 南京中医药大学学报, 2008,24(5):324-326. [22] 苗立英, 薛恒, 张明群, 等. 超声诊断腹膜粘连的临床评价——20年文献分析[J]. 中国微创外科杂志, 2013,13(12):1061-1064. [23] HA US, KOH JS, CHO KJ, et al. Hyaluronic acid-carboxymethylcellulose reduced postoperative bowel adhesions following laparoscopic urologic pelvic surgery: a prospective, randomized, controlled, single-blind study[J]. BMC Urol, 2016,16(1):28.
点击查看大图
计量
- 文章访问数: 740
- HTML全文浏览量: 11
- PDF下载量: 556
- 被引次数: 0