安神香囊改善肠易激综合征患者睡眠质量的临床观察

目的 观察安神香囊对肠易激综合征（irritable bowel syndrome，IBS）患者睡眠质量的影响。方法 将符合标准的160例患者按照1∶1的比例随机分为对照组和观察组，各80例，两组患者均予中医辨证治疗，观察组在此基础上加用安神香囊，疗程均为4周；观察两组患者主要症状（腹痛腹胀、大便频率、大便性状）积分、中医证侯积分、匹兹堡睡眠质量量表（Pittsburgh sleep quality index，PSQI）评分及不良反应。结果 观察组脱落2例，对照组脱落5例；观察组腹痛腹胀、大便频率、大便性状的改善率分别为85.9%、89.7%、83.3%，对照组为72.0%、82.7%、78.7%，两组腹痛腹胀的改善率比较差异具有统计学意义（P<0.05）；观察组中医治疗总有效率为91.0%，对照组为77.3%，两组比较差异具有统计学意义（P<0.05）；两组患者PSQI评分均降低（P<0.05），且观察组低于对照组，两组比较差异具有统计学意义（P<0.05）。结论 安神香囊能有效降低IBS患者PSQI评分，改善患者睡眠质量，对缓解IBS的主要症状也有辅助作用，并且能提高中医治疗IBS的疗效，未见明显不良反应。

Effect of Anshen Sachet on the Sleep Quality of Patients with Irritable Bowel Syndrome

Objective To observe the effect of Anshen Sachet on the sleep quality of patients with irritable bowel syndrome (IBS). Methods A total of 160 patients were randomized into observation group and control group, with 80 patients in each group. Both groups were given syndrome differentiation-based traditional Chinese medicine (TCM) treatment for 4 weeks, and Anshen Sachet was additionally administered for the observation group. The scores of major symptoms (abdominal pain/distension, defecation frequency, and stool appearance), TCM syndrome score, Pittsburgh Sleep Quality Index (PSQI) score, and side effects were evaluated for the patients in the two groups. Results There were 2 drop-outs in the observation group and 5 in the control group. The rates of improvements in abdominal pain/distension, defecation frequency, and stool appearance were 85.9%, 89.7%, and 83.3%, respectively, for the observation group, versus 72.0%, 82.7%, 78.7%, respectively, for the control group, with a significant difference observed in the improvement rate of abdominal pain/distension between the two groups (P<0.05). Compared with the control group, the observation group had a significantly higher overall response rate to TCM treatment (91.0% vs 77.3%, P<0.05). After treatment, both groups showed a significant reduction in PSQI score (P<0.05), and the observation group had a significantly lower PSQI score than the control group (P<0.05). Conclusion Anshen Sachet can effectively reduce the PSQI score, improve the sleep quality, help alleviate the major symptoms of IBS, and enhance the therapeutic effect of TCM in patients with IBS, with no remarkable side effects observed.