低容量聚乙二醇电解质散联合首荟通便胶囊在慢性功能性便秘患者结肠镜检查肠道准备中的应用研究

Application of low volume polyethylene glycol-electrolyte solution combined with Shouhui Laxative Capsule in bowel preparation before colonoscopy examination for patients with chronic functional constipation

摘要:

目的 探讨与标准大容量聚乙二醇电解质散（4L PEG-ELS）方案相比，低容量PEG-ELS联合首荟通便胶囊（SHLC）方案对慢性功能性便秘（CFC）患者结肠镜检查前肠道准备的有效性和安全性。方法 采用单中心、观察者盲法、随机对照试验方法，招募2021年1月－2021年12月在山东大学齐鲁医院（青岛）接受结肠镜检查的CFC患者282例，随机分配到SHLC+2 L PEG-ELS组、SHLC+3 L PEG-ELS组和4 L PEG-ELS组。观察患者波士顿肠道准备评分（BBPS）和肠道准备耐受性。结果 最终纳入240例患者。SHLC+2 L PEG-ELS、SHLC+3 L PEG-ELS和4 L PEG-ELS组的BBPS分别为（6.22±1.09）、（6.26±0.97）和（7.06±0.63）分，差异无统计学意义（P > 0.05）。节段性BBPS显示，3组患者在左半结肠［（2.32±0.72）、（2.41±0.64）和（2.58±0.59）分］、中段结肠［（2.18±0.83）、（2.26±0.76）和（2.44±0.81）分］和右半结肠［（1.67±0.71）、（1.72±0.67）和（2.23±0.66）分］方面比较，差异均无统计学意义（P > 0.05）。梅奥耐受性问卷显示4 L PEG-ELS组患者耐受性和再次肠道准备意愿均差于SHLC+3 L PEG-ELS组和SHLC+2 L PEG-ELS组（P = 0.007和P = 0.021）。与4 L PEG-ELS组相比，SHLC+2 L PEG-ELS组和SHLC+3 L PEG-ELS组服药后首次排便间隔时间提前（P = 0.036），睡前排便次数增加（P = 0.035），但在总排便次数方面比较，差异无统计学意义（P > 0.05）。3组患者肠道准备后不良反应发生率无明显差异（P > 0.05）。结论 对于CFC患者的肠道准备，低容量PEG-ELS联合SHLC可能是一种新颖的策略，它提高了患者耐受性和依从性，肠道准备效果和安全性与4 L PEG-ELS标准方案相当。

Abstract:

Objective To investigate the efficacy and safety of a low-volume polyethylene glycol-electrolyte solution (PEG-ELS) in combination with Shouhui Laxative Capsule (SHLC) compared to a standard high-volume regimen (4L PEG-ELS) for bowel preparation before colonoscopy in patients with chronic functional constipation (CFC).Methods This was a single-center, observer-blind, randomized controlled study that recruited 282 patients with CFC who underwent colonoscopy from January 2021 to December 2021 and were randomly assigned to the SHLC + 2 L PEG-ELS group, SHLC+3 L PEG-ELS group and 4 L PEG-ELS group. The primary outcomes were the Boston bowel preparation scale (BBPS) and patient bowel preparation tolerance.Results 240 patients were eventually included. The BBPS scale of SHLC + 2 L PEG-ELS, SHLC + 3 L PEG-ELS, and 4 L PEG-ELS groups were (6.22 ± 1.09), (6.26 ± 0.97), and (7.06 ± 0.63), respectively, and the difference was not statistically significant (P > 0.05). The differences in segmental BBPS among the three groups in the left colon [(2.32 ± 0.72), (2.41 ± 0.64) and (2.58 ± 0.59)], middle colon [(2.18 ± 0.83), (2.26 ± 0.76) and (2.44 ± 0.81)] or right colon [(1.67 ± 0.71), (1.72 ± 0.67) and (2.23 ± 0.66)] were not statistically significant (P > 0.05). The Mayo Tolerance Questionnaire showed that the patient tolerance and willingness to repeat bowel preparation in the 4 L PEG-ELS group were inferior to those in the SHLC + 3 L PEG-ELS group and SHLC+2L PEG-ELS group (P = 0.007 and P = 0.021). Compared with the 4 L PEG-ELS group, the SHLC + 2 L PEG-ELS group and SHLC+3 L PEG-ELS groups had an earlier time between first bowel movements (P = 0.036) and an increased number of bedtime bowel movements (P = 0.035) after taking the drug, but there was no significant difference in the total number of bowel movements (P > 0.05). There was no significant difference in the incidence of adverse events after bowel preparation among the three groups (P > 0.05).Conclusion For bowel preparation in patients with CFC, low-volume PEG-ELS combined with SHLC may be a novel strategy, which greatly improves patient tolerance and compliance, and its bowel preparation efficacy and safety are comparable to 4 L PEG-ELS standard scheme equivalent.