小承气汤合增液汤治疗阿片类药物所致便秘临床观察

目的：评价小承气汤合增液汤治疗阿片类药物所致便秘的有效性和安全性。方法：2011年1月—2012年3月对80例符合入选标准的患者进行随机分组、平行对照研究。治疗组（小承气汤合增液汤治疗）40例,对照组（果导片治疗）40例,观察期4周,治疗期2周,随访2周。观察治疗患者首次排便时间、排便间隔时间、每次排便时间、排便形状、排便难度、停药复发时间、生活质量评分。严密观察和记录治疗过程中的不良事件,进行安全性评价。结果：治疗后第7天、第14天评估,治疗组便秘评分水平较对照组明显降低。治疗后随访2周,治疗组治愈率和显效率较对照组明显升高。两组不良事件发生率分别为10%和7.5%,组间差异无统计学意义。结论：小承气汤合增液汤治疗阿片类药物所致便秘较果导片治疗疗效增加,安全性相当。

Clinical Study of Constipation Caused by Opioids Analgesics Treated with Xiaochengqi Decoction plus Fluid-increasing Decoction

Objective ： To evaluate the efficacy and safety of Xiaoehengqi Decoction plus Fluid- increasing Decoction in the treatment of constipation caused by opioids analgesics. Methods ： From January 2011 to March 2012, eighty patients with constipation caused by opioids analgesics were randomized parallel-controlled into two groups. The treatment group （ 40 patients） received Xiaochengqi Deeoetion plus Fluid-lncreasing Decoction, while the control group （ 40 patients） received Phenolphthalein, observing for 4 weeks including medication 2 weeks, follow-up visit 2 weeks. The first defecate time, the time between two defecate, defecate duration, properties, difficulty, recurrence time after drug discontinuance and the score of KPS of two groups were compared. The occurrences of adverse events were evaluated as well. Results ： Seven days and fourteen days after treatment, the level of constipation score was decreased significantly in treatment group than that in the control group. After follow-up visit 2 weeks, the cure rate and significant efficiency in treatment group was increased significantly. The adverse events incidence in two groups was 10% and 7.5% respectively, and no differences were found. Conclusions：Xiaochengqi Decoction plus Fluid-increasing Decoction is more effect than Maren soft capsule, and is comparable to Phenolphthalein in the safety for the treatment of constipation caused by opioids analgesics.