便通胶囊防治神经外科术后便秘的随机对照研究.docx

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1、便通胶囊防治神经外科术后便秘的随机对照研究李瑞春徐高峰鱼潇Summary目的：比较便通胶囊与麻仁润肠丸治疗神经外科术后便秘的临床疗效及安全性。方法：选取2014年1月至2016年12月西安交通大学第一附属医院由治的神经外科术后患者192例作为研究对象，采用随机对照设计，随机分为观察组和对照组，每组96例。观察组服用便通胶囊，3粒/次，2次/d；对照组服用麻仁润肠丸，12丸/次，2次/d。2组疗程均为2周。记录2组患者术后72 h便秘发生率，术后3 d引流量，住院时间与首次排便时间，术后第1、3、7天免疫功能水平变化，术后并发症及不良反应等。结果：观察组术后72 h便秘发生率为2. 01%,显著

2、低于对照组的9. 38%, 2组间比较差异有统计学意义(P0.05),但术后第2、3天观察组引流量均低于对照组，差异有统计学意义(P0.05) o观察组住院时间、置管时间与首次排便时间均短于对照组，各项指标组间差异有统计学意义(P0.05) ；2组免疫功能变化情况、术后并发症和不良反应情况，观察组疗效均优于对照组，组间差异有统计学意义（P0.05） o结论：便通胶囊对神经外科术后便秘有显著治疗作用，对免疫功能有一定调节作用，疗效优于麻仁润肠丸，临床使用安全性高。Key便通胶囊；麻仁润肠丸；神经外科手术;便秘；免疫功能；随机对照A Randomized Controlled Trial of B

3、iantong Capsule in the Treatment ofConstipation after NeurosurgeryLi Ruichunl, Xu Gaofeng2, Yu Xiao3(Department of Neurosurgery, the First Affiliated Hospital of Xi anJiaotong University, Xi an 710061, China)Abstract Objective： To compare the efficacy and safety of BianTongCapsule and Maren Runchang

4、 Pill in treating constipation afterneurosurgery. Methods： A total of 192 patients undergoingneurosurgery in the First Affiliated Hospital of Xiz an JiaotongUniversity from January 2014 to December 2016 were enrolled in therandomized controlled trial. They were randomly divided into theobservation g

5、roup and the control group, with 96 in each group. Theobservation group took Biantong capsule, 3 capsules a day, 2 times aday for 2 weeks, and the control group took Maren Runchang Pills, 1to 2 pills a day, 2 times a day, for 2 weeks. The incidence ofconstipation at 72 hours after operation, the dra

6、inage volume at 3days postoperatively, the length of hospital stay and the firstdefecation time, the changes of immune function at the 1st, 3rd, and7th postoperative days, and postoperative complications wererecorded. Results： The incidence of constipation at the 72 hpostoperatively was 2. 01% in th

7、e observation group, which wassignificantly lower than 9. 38% in the control group 9. 38%, Thedifference between the two groups was statistically significant(P0. 05) , but the drainagevolume of the observation group was lower than that of the controlgroup on the second and third day after operation

8、(P0.05) . Thehospitalization time, drainage tube indwelling time and the firstdefecation time were shorter in the observation group than in thecontrol group. The difference between the groups was statisticallysignificant (P0. 05) ； the change of immune function level andpostoperative complications a

9、nd the adverse reactions of the 2 groupswere better than the control group. There were statisticallysignificant differences between the groups (P0.05）,具有可比性。1.2 诊断标准开放性脑外伤和闭合性脑外伤的诊断标准参照现代颅脑损伤学4；颅内肿瘤的诊断标准参照神经外科学5；脑出血的诊断标准参照中国脑出血诊治指南（2014）6oL3纳入标准1）无肠道器官病变。2）无意识障碍及偏瘫，语言表达、理解能力正常，可以独自完成量表的填写。3）知情同意并愿意配

10、合参与本研究。L4排除标准1）合并有其他严重疾病。2）术后认知功能异常。3）中途退出者。4）术前1周内自行服用过任任一润肠通便或胃肠动力类药者。5）对试验药物过敏者7-8。L5脱落与剔除标准脱落标准：经知情同意并且筛选合格的受试者，因故未完成本研究所规定的疗程及观察周期。剔除标准：不符合纳入标准，符合排除标准的受试者;研究期间未能按照规定用药（用药量未超过1/3者）或者中途退出者（研究时间未超过1/3者）；入组后没有任何数据者。1.6 治疗方法基础治疗：术后注射头抱曲松钠（广州白云山医药集团股份有限公司白云山制药总厂，国药准字H44021532） , 2 g/次静脉滴注，2次/d,连用注射3

11、d,预防术后感染。其他均采取对症支持治疗，同时监测生命体征。1.6. 1对照组于禁食期结束之后，在基础治疗的同时给予麻仁润肠丸（北京同仁堂股份有限公司同仁堂制药厂，国药准字Z11020159） , 口服，12丸/次，2次/d,连续用药2周。1.6. 2观察组于禁食期结束之后，在基础治疗的同时给予便通胶囊（健民药业团股份有限公司，国药准字Z19990071） , 口服，3粒/次，2次/d,连续用药2周。L7观察指标L7.1术后72 h便秘发生率在便秘药物的治疗下，根据改良的便秘症状评分表，分别由2位医师根据症状标准对术后72 h便秘症状进行评分，评价术后72 h便秘发生率，即总分达到或超过3分的百分比。症状评分见表1。1.7.2术后引流量为减轻脑膜刺激症状，预防脑膜粘连及蛛网膜颗粒闭塞，避免或减少术后脑水肿的发生，术后患者需放置引流管，并对引流量进行监测，本研究记录