Maruyama Masaki, Miida Suguru, Sato Toshihiro, Kimura Takazumi, Watanabe Azuma, Watanabe Hideo, Nishizawa Masafumi, Horikawa Kyohei, Kajiwara Takahiro, Karasawa Yusuke, Hasebe Yuko, Nozawa Kazutaka, Terai Shuji
Department of Internal Medicine Kashiwazaki General Hospital and Medical Center Kashiwazaki Niigata Japan.
Sato Clinic Kashiwazaki Niigata Japan.
JGH Open. 2023 Aug 11;7(9):610-617. doi: 10.1002/jgh3.12956. eCollection 2023 Sep.
Stimulant laxatives may cause electrolyte abnormalities, dehydration, and abdominal pain; their long-term use can lead to tolerance and subsequent refractory constipation. We investigated the effectiveness, safety, and quality of life after switching from stimulant laxatives to lubiprostone in elderly patients with chronic constipation (CC).
This multicenter, interventional, open-label, single-arm, before-and-after comparison study enrolled 99 Japanese patients aged 65-90 years with CC who took stimulant laxatives for ≥2 weeks prior to switching to lubiprostone monotherapy.
The mean ± SD spontaneous defecations at Week 1 of 7.8 ± 6.2 times/week was not significantly different from that at baseline (8.3 ± 4.7). Spontaneous defecations were significantly reduced at Weeks 2 (-1.5 ± 4.0, < 0.001) and 4 (-1.5 ± 3.7, < 0.001). The Bristol Stool Form Scale score did not change from baseline (4.7 ± 0.9) at Weeks 1 (4.5 ± 1.3) or 4 (4.3 ± 1.3), but it did at Week 2 (4.3 ± 1.5, < 0.05). The Patient Assessment of Constipation Quality of Life questionnaire score increased (0.36 ± 0.07, < 0.001) after 28 days. Nausea was the only symptom that worsened from baseline and was the most frequently reported adverse drug reaction (15.2%).
Switching to lubiprostone monotherapy for CC was not associated with significant concerns in short-term spontaneous defecation frequency and safety, but it might affect the efficacy and patient quality of life over 2 weeks. Careful treatment strategies facilitating gradual switching to lubiprostone monotherapy may be needed in patients using stimulant laxatives.
刺激性泻药可能导致电解质异常、脱水和腹痛；长期使用会导致耐受性及随后的难治性便秘。我们研究了老年慢性便秘（CC）患者从刺激性泻药改用鲁比前列酮后的有效性、安全性及生活质量。
本多中心、干预性、开放标签、单臂、前后对照研究纳入了99名65 - 90岁的日本CC患者，这些患者在改用鲁比前列酮单药治疗前服用刺激性泻药≥2周。
第1周时平均±标准差的自发排便次数为7.8±6.2次/周，与基线时（8.3±4.7）无显著差异。第2周（-1.5±4.0，<0.001）和第4周（-1.5±3.7，<0.001）时自发排便次数显著减少。布里斯托大便形态量表评分在第1周（4.5±1.3）或第4周（4.3±1.3）时与基线（4.7±0.9）无变化，但在第2周时发生变化（4.3±1.5，<0.05）。便秘生活质量患者评估问卷评分在28天后升高（0.36±0.07，<0.001）。恶心是唯一较基线恶化的症状，也是最常报告的药物不良反应（15.2%）。
CC患者改用鲁比前列酮单药治疗在短期自发排便频率和安全性方面无重大问题，但可能在2周后影响疗效和患者生活质量。对于使用刺激性泻药的患者，可能需要谨慎的治疗策略以促进逐渐改用鲁比前列酮单药治疗。
