【摘要】：背景:急性胰腺炎(acute pancreatitis,AP)是一個世界范圍內(nèi)高死亡率的疾病,尤其重癥急性胰腺炎的死亡率達(dá)36%-50%。急性胰腺炎發(fā)病過程中可出現(xiàn)多種并發(fā)癥,其中腹內(nèi)高壓(IAH)或腹腔間隔室綜合征(ACS)為急性胰腺炎的一種特殊并發(fā)癥,預(yù)后差、病死率高。目前認(rèn)為IAH是ACS的前奏,IAH向ACS的演變速度在不同SAP患者中差異較大,IAH期可以看成是病情演變成為ACS的重要“窗口期”和轉(zhuǎn)折點(diǎn),也是非手術(shù)治療的重要時期。而急性胰腺炎發(fā)病過程中,胰液滲出導(dǎo)致的麻痹性腸梗阻是引發(fā)腹內(nèi)壓增高的重要原因之一,所以積極治療麻痹性腸梗阻導(dǎo)致的腹內(nèi)高壓可以明顯緩解急性胰腺炎患者癥狀。新斯的明作為抗膽堿酯酶藥,通過與乙酰膽堿在膽堿能傳遞位點(diǎn)競爭性地與膽堿酯酶結(jié)合,阻遏乙酰膽堿的水解,增強(qiáng)膽堿能作用而提高興奮性副交感活性,使患者機(jī)體表現(xiàn)為毒蕈堿樣(M樣)作用,從而恢復(fù)病人的腸蠕動。當(dāng)急性胰腺炎患者胃腸道M受體興奮時能夠增強(qiáng)胃腸道蠕動,可促使患者肛門排氣、排便,所以藥物新斯的明對于改善急性胰腺炎患者麻痹性腸梗阻,降低急性胰腺炎患者腹內(nèi)壓可能具有一定效果。目前國內(nèi)尚無新斯的明治療AP合并IAH的前瞻性臨床對照研究,具有創(chuàng)新性與實(shí)用性。目的:1.探討新斯的明改善急性胰腺炎導(dǎo)致的麻痹性腸梗阻,降低患者腹腔內(nèi)壓力的治療價值。2.明確新斯的明對降低急性胰腺炎患者器官衰竭及改善預(yù)后的治療價值。方法:本臨床隨機(jī)對照試驗(yàn)于2015年8月1日至2016年2月29日在南昌大學(xué)第一附屬醫(yī)院消化內(nèi)科展開,本研究獲得醫(yī)院倫理委員會的批準(zhǔn),并在NIH注冊,注冊號為:NCT02543658�；颊邊⑴c實(shí)驗(yàn)之前均簽署知情同意書。根據(jù)亞特蘭大急性胰腺炎診斷標(biāo)準(zhǔn),即臨床符合以下3項(xiàng)中的2項(xiàng)可診斷為急性胰腺炎:與急性胰腺炎符合的腹痛;血淀粉酶和(或)脂肪酶至少3倍正常上限;增強(qiáng)CT/MRI或腹部超聲呈急性胰腺炎改變。期間共483例病人診斷為急性胰腺炎,其中輕癥急性胰腺炎患者229例,中度重癥急性胰腺炎患者187例,重癥急性胰腺炎患者67例。腹內(nèi)高壓(iah)診斷標(biāo)準(zhǔn):每4-6小時測量一次腹內(nèi)壓,連續(xù)3次平均腹內(nèi)壓≥12mmhg。符合急性胰腺炎合并腹內(nèi)高壓入組條件的患者有33例,根據(jù)隨機(jī)分組,分為實(shí)驗(yàn)組(a組)、對照組(b組)。對照組為常規(guī)治療組;實(shí)驗(yàn)組在常規(guī)治療基礎(chǔ)上給予肌肉注射新斯的明。結(jié)果:本研究的33位患者中男性24人(72.7%),女性9人(27.3%),其中重癥急性胰腺炎患者25人(75.7%),中度重癥急性胰腺炎患者8人(24.3%),無輕癥患者�；颊卟煌瑫r間點(diǎn)測得的糞便量之間統(tǒng)計學(xué)上具有差異(f=19.410,p=0.000)。實(shí)驗(yàn)組及對照組糞便量均呈上升趨勢,實(shí)驗(yàn)組高于對照組(f=8.509,p=0.007)。用藥后第1、2、3天實(shí)驗(yàn)組的糞便量高于對照組(p?0.05),其余各時間點(diǎn)實(shí)驗(yàn)組與對照組無顯著差異(p?0.05),實(shí)驗(yàn)組與對照組之間存在交互作用(f=3.756,p=0.006)�；颊卟煌瑫r間點(diǎn)所測得的腹內(nèi)壓之間統(tǒng)計學(xué)上有差異(f=35.820,p=0.000)。實(shí)驗(yàn)組及對照組腹內(nèi)壓均呈逐漸下降趨勢,實(shí)驗(yàn)組與對照組統(tǒng)計學(xué)上無明顯差異(f=2.566,p=0.119)。第3天實(shí)驗(yàn)組的腹內(nèi)壓低于對照組(p=0.036),其余各時間點(diǎn)實(shí)驗(yàn)組及對照組統(tǒng)計學(xué)上無差異(p?0.05),實(shí)驗(yàn)組與對照組之間不存在交互作用(f=1.250,p=0.282);測量實(shí)驗(yàn)組及對照組患者治療前腹內(nèi)壓及治療后24h,48h,72h腹內(nèi)壓下降百分比、72h內(nèi)達(dá)標(biāo)率(降到12mmhg以下),發(fā)現(xiàn)24h實(shí)驗(yàn)組下降率較對照組高,差異具有統(tǒng)計學(xué)意義(f=5.270,p=0.029),其余各時間點(diǎn)無統(tǒng)計學(xué)差異(p?0.05)。兩組患者達(dá)到腹內(nèi)壓ii級的患者共15例,其中實(shí)驗(yàn)組7例,對照組8例,治療后實(shí)驗(yàn)組患者24h,48h,72h腹內(nèi)壓下降百分比、72h內(nèi)達(dá)標(biāo)率及降到i級(15mmhg)的時間均優(yōu)于對照組,差異有統(tǒng)計學(xué)意義(p?0.05)。實(shí)驗(yàn)組第5天腹內(nèi)壓恢復(fù)至正�；颊邤�(shù)與對照組相比明顯增加,差異具有統(tǒng)計學(xué)意義(p=0.038),其余各時間點(diǎn)無統(tǒng)計學(xué)意義(p?0.05);兩組之間器官衰竭持續(xù)時間統(tǒng)計學(xué)上無明顯差異(p=0.465)。兩組患者在重癥監(jiān)護(hù)時間、總住院時間及預(yù)后上的差異無統(tǒng)計學(xué)意義(p?0.05)。結(jié)論:(1)新斯的明可以改善急性胰腺炎患者麻痹性腸梗阻癥狀;(2)新斯的明可以降低腹內(nèi)壓ii級以上急性胰腺炎患者的腹內(nèi)壓;(3)本研究進(jìn)行過程中未發(fā)生藥物新斯的明的安全不良事件;(4)新斯的明降低腹內(nèi)壓i級急性胰腺炎患者的腹內(nèi)壓較常規(guī)治療無明顯優(yōu)勢;(5)本研究中新斯的明對于改善急性胰腺炎患者的器官衰竭持續(xù)時間、重癥監(jiān)護(hù)時間、總住院時間及預(yù)后的作用有限;(6)由于本研究樣本量較小,實(shí)驗(yàn)結(jié)果存在一定偏差,尚需擴(kuò)大樣本量加以論證。
[Abstract]:BACKGROUND: Acute pancreatitis (AP) is a worldwide disease with high mortality, especially severe acute pancreatitis (SAP) with a mortality rate of 36% - 50%. Several complications may occur during the onset of acute pancreatitis, of which intraabdominal hypertension (IAH) or abdominal compartment syndrome (ACS) is a special complication of acute pancreatitis. At present, IAH is considered to be the prelude of ACS. The rate of evolution of IAH to ACS varies greatly among different SAP patients. IAH can be regarded as an important "window" and turning point for the development of ACS, and also an important period for non-surgical treatment. Neostigmine, as an anti-cholinesterase drug, is enhanced by competitive binding with acetylcholine at the cholinergic transmission site to inhibit the hydrolysis of acetylcholine. Cholinergic enhances excitatory parasympathetic activity and restores the intestinal peristalsis of patients with acute pancreatitis. When M receptors in the gastrointestinal tract are excited, the gastrointestinal peristalsis of patients with acute pancreatitis can be enhanced, and the anal exhaust and defecation of patients can be promoted. Therefore, neostigmine can improve the patients with acute pancreatitis. There is no prospective clinical controlled study of neostigmine in the treatment of AP complicated with IAH in China, which is innovative and practical. Objective: 1. To explore the effect of neostigmine on the improvement of paralytic intestinal obstruction caused by acute pancreatitis and the reduction of intraperitoneal pressure in patients with acute pancreatitis. Methods: A randomized controlled trial was conducted in the Department of Gastroenterology, First Affiliated Hospital of Nanchang University from August 1, 2015 to February 29, 2016. The study was approved by the Hospital Ethics Committee and registered in NIH with the registration number N:N. According to the diagnostic criteria of Atlanta acute pancreatitis, two of the following three items can be diagnosed as acute pancreatitis: abdominal pain consistent with acute pancreatitis; blood amylase and/or lipase at least three times the normal upper limit; enhanced CT/MRI or abdominal ultrasound showing acute pancreatitis A total of 483 patients were diagnosed as acute pancreatitis, including 229 patients with mild acute pancreatitis, 187 patients with moderate severe acute pancreatitis and 67 patients with severe acute pancreatitis. 33 patients were randomly divided into experimental group (group a) and control group (group b). The control group was treated with routine therapy, and the experimental group was given neostigmine intramuscularly on the basis of routine therapy. Results: Among the 33 patients in this study, 24 (72.7%) were male and 9 (27.3%) were female, including 25 (75.3%) with severe acute pancreatitis. There were statistically significant differences (f = 19.410, P = 0.000) in the amount of feces measured at different time points. The amount of feces in the experimental group and the control group showed an upward trend. The amount of feces in the experimental group was higher than that in the control group (f = 8.509, P = 0.007). The amount of feces in the experimental group was higher than that in the control group on the first, second and third days after treatment. There was no significant difference between the experimental group and the control group at the other time points (p? 0.05). there was interaction between the experimental group and the control group (f = 3.756, P = 0.006). the intraabdominal pressure of the patients at different time points was statistically different (f = 35.820, P = 0.000). the intraabdominal pressure of the experimental group and the control group showed a gradual downward trend, and the experimental group and the control group showed a gradual downward trend. The intraabdominal pressure of the experimental group was lower than that of the control group on the third day (p = 0.036), and there was no significant difference between the experimental group and the control group at other time points (p? 0.05). There was no interaction between the experimental group and the control group (f = 1.250, P = 0.282). 24 hours, 48 hours, 72 hours of intra-abdominal pressure decreased percentage, within 72 hours of the standard rate (down to 12 mmHg below), found that 24 hours of the experimental group than the control group, the decline rate was statistically significant (f = 5.270, P = 0.029), the rest of the time point no statistical difference (p? 0.05). Two groups of patients reached intra-abdominal pressure level II patients in 15 cases, including 7 cases in the experimental group, 8 cases in the control group, after treatment. The decrease percentage of intra-abdominal pressure at 24, 48 and 72 hours, the time of reaching the standard within 72 hours and the time of lowering to grade I (15mmhg) in the experimental group were all better than those in the control group (p?0.05). The number of patients whose intra-abdominal pressure returned to normal on the fifth day in the experimental group was significantly higher than that in the control group (p=0.038), and there was no statistical significance at the other time points. There was no significant difference in the duration of organ failure between the two groups (p = 0.465). there was no significant difference in the duration of intensive care, total hospitalization and prognosis between the two groups (p? 0.05). conclusion: (1) neostigmine can improve the symptoms of paralytic intestinal obstruction in patients with acute pancreatitis; (2) neostigmine can reduce intraabdominal pressure I Intra-abdominal pressure in patients with grade I or above acute pancreatitis; (3) Neostigmine did not occur during the study; (4) Neostigmine had no significant advantage in reducing intra-abdominal pressure in patients with grade I acute pancreatitis as compared with conventional treatment; (5) Neostigmine was shown to improve the persistence of organ failure in patients with acute pancreatitis. Time, intensive care time, total hospitalization time and prognosis are limited. (6) Because the sample size of this study is small, there are some deviations in the experimental results, it is necessary to expand the sample size to demonstrate.
【學(xué)位授予單位】：南昌大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：R576

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