聚卡波非钙片治疗糖尿病合并慢性便秘的有效性和安全性研究

Efficacy and safety of calcium polycarbofil tablets in the treatment of diabetes patients with chronic constipation

目的评价聚卡波非钙片治疗糖尿病合并慢性便秘患者的疗效和安全性。方法选取昆山市第一人民医院2022年1月至2023年6月内分泌科门诊部招募的48例糖尿病合并慢性便秘患者,接受聚卡波非钙片(1.0 g,tid,po)治疗2周,记录自发排便(SBM)次数、完全自主排便(CSBM)次数、首剂24 h或48 h内SBM发生率、每周首次服用聚卡波非钙片出现SBM的平均时长;采用Bristol大便形态量表(BSFS)评估大便性状,中文版《便秘患者生活质量评估》(PAC-QOL)评估患者生活质量;主要疗效指标:试验2周的SBM次数变化;次要疗效指标:患者CSBM、大便形态、生活质量、血糖变化。结果符合条件的入组患者48例,46例完成研究。每周SBM的中位次数从基线时的5.0(3.0,7.0)次增加到2周治疗结束后的6.0(4.0,7.0)次,聚卡波非钙片治疗2周后SBM次数显著增加,差异具有统计学意义(P<0.05);每周服用聚卡波非钙片后首次出现SBM的平均时间为14 h;服用聚卡波非钙片首剂后24 h和48 h内出现SBM的患者比例分别为80.2%和95.8%;服药2周后和停药2周后,与基线相比,BSFS和PAC-QOL评分均显著增加(P<0.05),空腹血糖显著降低(P<0.05);分层分析显示,基线SBM较低的患者经过治疗后,SBM和CSBM次数显著增加,特别是在女性、老年人、BMI≤25 kg/m^(2)、长期便秘和未合并其他泻药的患者中,未发生超药品说明书不良反应事件。结论聚卡波非钙片治疗糖尿病合并慢性便秘是有效安全的,尤其是在基线SBM次数较低的患者中,聚卡波非钙片治疗2周还可降低空腹血糖,可能成为糖尿病合并慢性便秘患者的新的治疗方案。

Objective To evaluate the efficacy and safety of calcium polycarbofil tablets in the treatment of diabetes patients with chronic constipation.Methods From January 2022 to June 2023,48 patients with diabetes complicated with constipation,who were recruited from the outpatient department of the Department of Endocrinology in Kunshan First People's Hospital,were treated with calcium polycarbofil tablets(1.0 g,tid,po)for 2 weeks.The number of spontaneous bowel movement(SBM),the number of completely spontaneous bowel movement(CSBM),the incidence of SBM within 24 hours or 48 hours of the first dose,and the average duration of SBM after taking calcium polycarbofil tablets for the first time every week were recorded.The Bristol Stool Form Scale(BSFS)was used to assess stool characteristics.The Chinese version of PAC-QOL was used to evaluate the quality of life of the patients.The major efficacy indexes were the changes in SBM during the two weeks of experiment,and the minor efficacy indexes included CSBM,stool morphology,life quality and glucose change.Results Among the 48 eligible patients,46 completed the study.Calcium polycarbofil tablets significantly increased the median frequency of SBM per week,from 5.0(3.0,7.0)times at baseline to 6.0(4.0,7.0)times after 2 weeks of treatment(P<0.05).The average time for SBM to appear for the first time after taking calcium polycarbofil tablets per week was 14 hours.The proportion of patients who had SBM within 24 hours and 48 hours after taking the first dose of calcium polycarbofil tablets was 80.2%and 95.8%,respectively.After two weeks of treatment and at two weeks after cessation of medication,both BSFS and PAC-QOL scores significantly increased compared with the baseline(P<0.05),while the level of fasting blood glucose significantly decreased(P<0.05).Layered analysis showed that patients with lower baseline SBM had a significant increase in SBM and CSBM after treatment,especially in the female patients,elderly patients,patients with BMI≤25 kg/m^(2),patients with long-term constipation,and the patients without concomitant laxatives.There was no incidence of off-labeladversereactions.Conclusion Calcium polycarbofil tablets are effective and safe in the treatment of diabetes patients with chronic constipation,especially in patients with lower SBM at baseline.Two weeks of treatment with cal‐cium polycarbofil tablets can also decrease fasting blood glucose,which may be a new treatment for diabetes patients with chronic constipation.