改良消痔灵注射肛垫悬吊固定术治疗脱垂性痔的临床研究
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摘要
目的探讨改良消痔灵注射肛垫悬吊固定术治疗脱垂性痔的临床疗效。方法将垫江县人民医院2012年1月至2013年6月期间收治的150例符合Ⅱ、Ⅲ度内痔及混合痔诊断标准并以脱垂为主要临床表现的住院患者,前瞻性地采用随机数字表法均分为改良消痔灵注射肛垫悬吊固定术组(简称观察组)、吻合器庤上黏膜环形切除钉合术(PPH)组和经典的外切内扎术(M-M)组。观察组将消痔灵注射液(与生理盐水按1∶1混合)注射到直肠黏膜下及直肠周围间隙,进行肛垫悬吊固定治疗脱垂性痔,并与PPH组和M-M组的治疗效果、住院时间、住院费用、术后并发症及复发情况进行比较。结果 (1)观察组一次治愈49例,1例好转并经行再次改良消痔灵注射肛垫悬吊固定术治愈;PPH组一次治愈48例,2例好转且经再次M-M术治疗痊愈;M-M组一次治愈48例,2例好转且再次经M-M术治疗痊愈。3组患者的临床治疗效果比较差异无统计学意义(χ~2=0.411,P=0.814)。(2)观察组的住院时间明显短于PPH组(P<0.001)和M-M组(P<0.001),并且住院费用也明显少于PPH组(P<0.001)和M-M组(P=0.028)。(3)3组患者术后第1、2、3、7及14天时均无痔核脱出与感染发生。观察组术后不同时相的疼痛发生情况均明显轻于PPH组(除第14天外,P<0.05)和M-M组(P<0.05)。观察组术后的坠胀发生情况与PPH组相近(除第1天外,P>0.05),但其均明显轻于M-M组(P<0.05)。术后第2、3天时,观察组的出血情况与PPH组比较差异无统计学意义(P>0.05),但观察组明显轻于M-M组(P<0.05);其他时相点3组间出血情况总体比较差异均无统计学意义(P>0.05)。术后第3天时,观察组的肛缘水肿情况与PPH比较差异无统计学意义(P>0.05),但观察组明显轻于M-M组(P=0.001);其他时相点3组间总体比较差异均无统计学意义(P>0.05)。术后第1、2及3天时3组间尿潴留发生情况总体比较差异均无统计学意义(P>0.05)。(4)术后1、6及12个月时随访,肛门狭窄及肛门控便功能以及痔复发3组间总体比较差异均无统计学意义(P>0.05)。结论改良消痔灵注射肛垫悬吊固定术治疗脱垂性痔,能有效地使肛垫上提固定,消除出血、脱出等主要症状,肛门功能保存完好,其临床疗效与PPH和M-M术式接近,但住院时间更短、住院费用更少、术后并发症较轻、复发率更低。
Objective To investigate clinical effects of modified Xiaozhiling injection with anal cushion suspensory fixation in treatment of prolapsed hemorrhoids. Methods From January 2012 to June 2013, 150 hospitalized patients with Ⅱ and Ⅲ degrees internal hemorrhoids and mixed hemorrhoid, with prolapsing as the main clinical manifestations, were included prospectively, then subsequently randomly divided into a modified Xiaozhiling injection with anal cushion suspensory fixation group(observation group), a procedure for prolapse and hemorrhoids(PPH)group, and a classic Milligan-Morgan surgery(M-M) group. The Xiaozhiling injection with saline by 1:1 mixture was injected into the rectum submucosa and perirectal gap and the anal cushion suspensory fixation were performed for the treatment of prolapsed hemorrhoids in the observation group. The operations of the PPH group and M-M group were same as the convention. The treatment effect, hospitalization time, hospital expenses, postoperative complications, and recurrence were compared among these 3 groups. Results(1) Fourty-nine cases were cured and 1 case was improved in the observation group, 48 cases were cured and 2 cases were improved in the PPH group, 48 cases were cured and 2 cases were improved in the M-M group, the treatment effects had no significant differences among these 3 groups(χ~2=0.411,P=0.814).(2) The hospitalization time and hospitalization expenses of the observation group were significantly less than those of the PPH group(P<0.001) and the M-M group(P<0.001).(3) No prolapse of hemorrhoids and infection happened on day 1, 2, 3, 7, and 14 among these 3 groups. The pains of the observation group were slighter on day 1, 2, 3, 7, and 14 as compared with the PPH group(except on day 14, P<0.05) and the M-M group(P<0.05). The anus bulges had no significant difference between the observation group and the PPH group(except on day 1, P>0.05), which of the observation group were significantly slighter than those of the M-M group(P<0.05). The bleeding on day 2 and 3 and the perianal edema on day 3 had no significant difference between the observation group and the PPH group(P>0.05), which of the observation group were significantly slighter than those of the M-M group(P<0.05). The urinary retention had no significant difference on day 1–3 among these 3 groups(P>0.05).(4) The anal stenosis, anal continence, and hemorrhoids recurrence on month 1, 6, and 12 had no significant differences among these 3 groups(P>0.05).Conclusions Modified Xiaozhiling injection with anal cushion suspensory fixation in treatment of prolapsed hemorrhoids could effectively make anal cushion fixation, eliminate main symptoms of bleeding and prolapse, preserve anal function well. It's clinical efficacy is same as PPH and M-M methods, with a shorter hospitalization time, less hospitalization expenses, milder postoperative complications, and lower recurrence rate.
Objective To investigate clinical effects of modified Xiaozhiling injection with anal cushion suspensory fixation in treatment of prolapsed hemorrhoids. Methods From January 2012 to June 2013, 150 hospitalized patients with Ⅱ and Ⅲ degrees internal hemorrhoids and mixed hemorrhoid, with prolapsing as the main clinical manifestations, were included prospectively, then subsequently randomly divided into a modified Xiaozhiling injection with anal cushion suspensory fixation group(observation group), a procedure for prolapse and hemorrhoids(PPH)group, and a classic Milligan-Morgan surgery(M-M) group. The Xiaozhiling injection with saline by 1:1 mixture was injected into the rectum submucosa and perirectal gap and the anal cushion suspensory fixation were performed for the treatment of prolapsed hemorrhoids in the observation group. The operations of the PPH group and M-M group were same as the convention. The treatment effect, hospitalization time, hospital expenses, postoperative complications, and recurrence were compared among these 3 groups. Results(1) Fourty-nine cases were cured and 1 case was improved in the observation group, 48 cases were cured and 2 cases were improved in the PPH group, 48 cases were cured and 2 cases were improved in the M-M group, the treatment effects had no significant differences among these 3 groups(χ~2=0.411,P=0.814).(2) The hospitalization time and hospitalization expenses of the observation group were significantly less than those of the PPH group(P<0.001) and the M-M group(P<0.001).(3) No prolapse of hemorrhoids and infection happened on day 1, 2, 3, 7, and 14 among these 3 groups. The pains of the observation group were slighter on day 1, 2, 3, 7, and 14 as compared with the PPH group(except on day 14, P<0.05) and the M-M group(P<0.05). The anus bulges had no significant difference between the observation group and the PPH group(except on day 1, P>0.05), which of the observation group were significantly slighter than those of the M-M group(P<0.05). The bleeding on day 2 and 3 and the perianal edema on day 3 had no significant difference between the observation group and the PPH group(P>0.05), which of the observation group were significantly slighter than those of the M-M group(P<0.05). The urinary retention had no significant difference on day 1–3 among these 3 groups(P>0.05).(4) The anal stenosis, anal continence, and hemorrhoids recurrence on month 1, 6, and 12 had no significant differences among these 3 groups(P>0.05).Conclusions Modified Xiaozhiling injection with anal cushion suspensory fixation in treatment of prolapsed hemorrhoids could effectively make anal cushion fixation, eliminate main symptoms of bleeding and prolapse, preserve anal function well. It's clinical efficacy is same as PPH and M-M methods, with a shorter hospitalization time, less hospitalization expenses, milder postoperative complications, and lower recurrence rate.
引文
1陆杰.痔病的治疗与微创概念.长春中医药大学学报,2009,25(5):803-804.
2Zacharakis E,Kanellos D,Pramateftakis MG,et al.Long-term results after stapled haemorrhoidopexy for fourth-degree haemorrhoids:a prospective study with median follow-up of 6years.Tech Coloproctol,2007,11(2):144-148.
3Shao WJ,Li GC,Zhang ZH,et al.Systematic review and metaanalysis of randomized controlled trials comparing stapled haemorrhoidopexy with conventional haemorrhoidectomy.Br JSurg,2008,95(2):147-160.
4Burch J,Epstein D,Baba-Akbari A,et al.Stapled haemorrhoidectomy(haemorrhoidopexy)for the treatment of haemorrhoids:a systematic review and economic evaluation.Health Technol Assess,2008,12(8):iii-iv,ix-x,1-193.
5杨向东,龚文敬.PPH手术并发症的回顾性调查.结直肠肛门外科,2008,14(1):58-61.
6李东冰,谭竟范,李华山,等.痔切除吻合器痔上黏膜环切术在脱垂性痔中的应用.中国普外基础与临床杂志,2007,14(1):91-92.
7黄德铨,陈敏,甘昌芝,等.PPH术与外剥内扎硬注术治疗重度脱垂性痔的疗效对比研究.西部医学,2013,25(9):1326-1328.
8Tripathi RK,Bolegave SS,Shetty PA,et al.Efficacy and safety of a polyherbal formulation in hemorrhoids.J Ayurveda Integr Med,2015,6(4):225-232.
9张远,廖松林,马述仕,等.“消痔灵注射液”的实验研究.中医杂志,1980,21(7):69-71,81.
10史兆岐.消痔灵四步注射法治疗Ⅲ、Ⅳ期痔-闭塞直肠上动脉分支和痔硬化消失法.中国中西医结合杂志,1998,18(4):201-203.
11中华医学会外科学分会结直肠肛门外科学组,中华中医药学会肛肠病专业委员会,中国中西医结合学会结直肠肛门病专业委员会.痔临床诊治指南(2006版).中华胃肠外科杂志,2006,9(5):461-463.
12郑芳,杨超,吴毅,等.肛垫悬吊固定联合消痔灵注射治疗混合痔的临床疗效.新医学,2011,42(12):817-819.
13郑芳,吴毅,杨超,等.肛垫悬吊固定术与外剥内扎术治疗混合痔的疗效研究.结直肠肛门外科,2012,18(1):34-37.
14国家中医药管理局.中华人民共和国中医药行业标准·中医病证诊断疗效标准(2012版).北京:中国医药科技出版社,2012:53-54.
15倪家骧,孙海燕译.疼痛治疗技术·上卷.北京:北京大学医学出版社,2011:203-217.
16王振军,汤秀英,王东,等.内痔的病理形态改变特征及其意义.中华外科杂志,2006,64(3):177-180.
17肖团友,孙锋,黄丹丹,等.脱垂性痔形成机制研究进展.中华实用诊断与治疗杂志,2016,30(7):637-638.
18秦新裕,姚礼庆.外科手术并发症的预防和处理.上海:复旦大学出版社,2005:249.
19Milligan ETC,Morgan CN,Jones LE,et al.Surgical anatomy of the anal canal and the operative treatment of hemorrhoids.Lancet,1937,230(5959):1119-1124.
20曾四清.肛垫高位悬吊术治疗环状混合痔56例.中国中西医结合外科杂志,2012,18(1):96-97.
21Ho YH,Cheong WK,Tsang C,et al.Stapled hemorrhoidectomy-cost and effectiveness.Randomized,controlled trial including incontinence scoring,anorectal manometry,and endoanal ultrasound assessments at up to three months.Dis Colon Rectum,2000,43(12):1666-1675.
22Rowsell M,Bello M,Hemingway DM.Circumferential mucosectomy(stapled haemorrhoidectomy)versus conventional haemorrhoidectomy:randomised controlled trial.Lancet,2000,355(9206):779-781.
23Loder PB,Kamm MA,Nicholls RJ,et al.Haemorrhoids:pathology,pathophysiology and aetiology.Br J Surg,1994,81(7):946-954.
24Longo A.Treatment of hemorrihoids disease by reduction of mucosa and hemorrhoids prolapse with a circular suturing device:a new procedure.Rome:Italy.Proceedings of the 6th World Congress of Endoscopic Surgery,1998:777-784.
25贺平,陈鸿亮.吻合器痔上黏膜环切钉合术与Milligan-Morgan术治疗脱垂性痔的Meta分析.中华胃肠外科杂志,2015,18(12):1224-1230.
26蔡砚豪.消痔灵肛垫悬吊固化作用的动物实验研究.新中医,2015,47(2):233-234.
27李淼,赵泽华.消痔灵注射液的临床应用进展.现代诊断与治疗,2009,24(2):85-87.
2Zacharakis E,Kanellos D,Pramateftakis MG,et al.Long-term results after stapled haemorrhoidopexy for fourth-degree haemorrhoids:a prospective study with median follow-up of 6years.Tech Coloproctol,2007,11(2):144-148.
3Shao WJ,Li GC,Zhang ZH,et al.Systematic review and metaanalysis of randomized controlled trials comparing stapled haemorrhoidopexy with conventional haemorrhoidectomy.Br JSurg,2008,95(2):147-160.
4Burch J,Epstein D,Baba-Akbari A,et al.Stapled haemorrhoidectomy(haemorrhoidopexy)for the treatment of haemorrhoids:a systematic review and economic evaluation.Health Technol Assess,2008,12(8):iii-iv,ix-x,1-193.
5杨向东,龚文敬.PPH手术并发症的回顾性调查.结直肠肛门外科,2008,14(1):58-61.
6李东冰,谭竟范,李华山,等.痔切除吻合器痔上黏膜环切术在脱垂性痔中的应用.中国普外基础与临床杂志,2007,14(1):91-92.
7黄德铨,陈敏,甘昌芝,等.PPH术与外剥内扎硬注术治疗重度脱垂性痔的疗效对比研究.西部医学,2013,25(9):1326-1328.
8Tripathi RK,Bolegave SS,Shetty PA,et al.Efficacy and safety of a polyherbal formulation in hemorrhoids.J Ayurveda Integr Med,2015,6(4):225-232.
9张远,廖松林,马述仕,等.“消痔灵注射液”的实验研究.中医杂志,1980,21(7):69-71,81.
10史兆岐.消痔灵四步注射法治疗Ⅲ、Ⅳ期痔-闭塞直肠上动脉分支和痔硬化消失法.中国中西医结合杂志,1998,18(4):201-203.
11中华医学会外科学分会结直肠肛门外科学组,中华中医药学会肛肠病专业委员会,中国中西医结合学会结直肠肛门病专业委员会.痔临床诊治指南(2006版).中华胃肠外科杂志,2006,9(5):461-463.
12郑芳,杨超,吴毅,等.肛垫悬吊固定联合消痔灵注射治疗混合痔的临床疗效.新医学,2011,42(12):817-819.
13郑芳,吴毅,杨超,等.肛垫悬吊固定术与外剥内扎术治疗混合痔的疗效研究.结直肠肛门外科,2012,18(1):34-37.
14国家中医药管理局.中华人民共和国中医药行业标准·中医病证诊断疗效标准(2012版).北京:中国医药科技出版社,2012:53-54.
15倪家骧,孙海燕译.疼痛治疗技术·上卷.北京:北京大学医学出版社,2011:203-217.
16王振军,汤秀英,王东,等.内痔的病理形态改变特征及其意义.中华外科杂志,2006,64(3):177-180.
17肖团友,孙锋,黄丹丹,等.脱垂性痔形成机制研究进展.中华实用诊断与治疗杂志,2016,30(7):637-638.
18秦新裕,姚礼庆.外科手术并发症的预防和处理.上海:复旦大学出版社,2005:249.
19Milligan ETC,Morgan CN,Jones LE,et al.Surgical anatomy of the anal canal and the operative treatment of hemorrhoids.Lancet,1937,230(5959):1119-1124.
20曾四清.肛垫高位悬吊术治疗环状混合痔56例.中国中西医结合外科杂志,2012,18(1):96-97.
21Ho YH,Cheong WK,Tsang C,et al.Stapled hemorrhoidectomy-cost and effectiveness.Randomized,controlled trial including incontinence scoring,anorectal manometry,and endoanal ultrasound assessments at up to three months.Dis Colon Rectum,2000,43(12):1666-1675.
22Rowsell M,Bello M,Hemingway DM.Circumferential mucosectomy(stapled haemorrhoidectomy)versus conventional haemorrhoidectomy:randomised controlled trial.Lancet,2000,355(9206):779-781.
23Loder PB,Kamm MA,Nicholls RJ,et al.Haemorrhoids:pathology,pathophysiology and aetiology.Br J Surg,1994,81(7):946-954.
24Longo A.Treatment of hemorrihoids disease by reduction of mucosa and hemorrhoids prolapse with a circular suturing device:a new procedure.Rome:Italy.Proceedings of the 6th World Congress of Endoscopic Surgery,1998:777-784.
25贺平,陈鸿亮.吻合器痔上黏膜环切钉合术与Milligan-Morgan术治疗脱垂性痔的Meta分析.中华胃肠外科杂志,2015,18(12):1224-1230.
26蔡砚豪.消痔灵肛垫悬吊固化作用的动物实验研究.新中医,2015,47(2):233-234.
27李淼,赵泽华.消痔灵注射液的临床应用进展.现代诊断与治疗,2009,24(2):85-87.