目的 分析双歧杆菌四联活菌片在2型糖尿病患者便秘患者中治疗的有效性及安全性.方法 选择2019年2月～2020年2月的127例2型糖尿病患者便秘患者进行本次研究,按照抽签法分为研究组(n=65)和对照组(n=62),对照组采用莫沙必利片治疗,每次5 mg,于餐前口服,每天服用3 次.观察组在对照组的基础上,采用双歧杆菌四联活菌片治疗,每次1.5g,于餐后口服.两组治疗疗程均为2周.比较两组治疗效果,治疗前后临床症状和便秘严重程度评分变化,治疗前后生长抑素(SS)、血管活性肠肽(VIP)及胃动素水平变化,治疗前后一氧化氮(NO)水平变化,治疗前后便秘患者生活质量量表(PAC-QOL)评分,治疗后不良反应发生率.结果 治疗后,研究组总有效率显著高于对照组[96.92(63/65)vs83.87％(52/62)](P ＜ 0.05);两组治疗前排便频率、粪便性状、排便不尽、下坠、坠感、排便困难、腹胀及便秘严重程度评分均无差异(P ＞ 0.05),治疗后研究组排便频率、粪便性状、排便不尽、下坠、坠感、排便困难、腹胀及便秘严重程度评分显著低于对照组[(0.75±0.15)分vs(1.26±0.19)分,(1.19±0.12)分vs(1.40±0.16)分,(0.80±0.12)分vs(1.30±0.18)分,(0.67±0.11)分vs(1.05±0.12)分,(0.97±0.11)分vs(1.21±0.25)分,(4.56±0.61)分vs(5.69±0.65)分](P ＜ 0.05);两组治疗前生长抑素、血管活性肠肽及胃动素水平均无差异(P ＞ 0.05),治疗后研究组生长抑素、血管活性肠肽水平均显著低于对照组[(12.38±2.65)pg/mL vs(17.85±3.59)pg/mL,(30.28±3.71)pg/mL vs(36.23±3.98)pg/mL](P＜ 0.05);胃动素显著高于对照组[(236.01±32.50)pg/mL vs(197.63±30.15)pg/mL](P ＜ 0.05);两组治疗前NO 水平均无差异(P ＞ 0.05),治疗后研究组NO 水平显著低于对照组[(49.03±8.19)mmol/L vs(63.27±10.38)mmol/L] (P ＜ 0.05);两组治疗前生理评分、社会心理评分、担忧评分、满意度评分及总均分均无差异(P ＞ 0.05),治疗后研究组生理评分、社会心理评分、担忧评分、满意度评分及总均分均显著低于对照组[(8.50±0.81)分vs(9.32±0.91)分,(11.65±2.09)分vs(14.02±1.63)分,(19.17±2.51)分vs(22.31±2.42)分,(8.69±1.05)分vs(12.51±1.52)分,(47.27±5.36)分vs(58.93±6.02)分](P ＜ 0.05);两组腹泻、腹胀、腹痛、呕吐及总发生率均无显著差异(P ＞ 0.05).结论 双歧杆菌四联活菌片可有效调节胃肠道功能,改善2型糖尿病患者便秘症状,促进粪便排出,不良反应少,安全可靠.“,”Objective To study the efficacy and safety of Bifidobacterium Tetravaccine tablets in the treatment of constipation in patients with type2 diabetes mellitus. Methods 127 patients with constipation in patients with type 2 diabetes who received treatment in our hospital from February 2019 to February 2020 were selected for this study, according to the method of drawing lots, they were divided into study group(n=65) and control group(n=62), the control group treated with mosapride tablets, 5mg each time, Take orally before meals, 3 times a day. On the basis of the control group, the study group was treated with bifidobacterium Tetravaccine tablets, 1.5g each time, take orally after meals. Both groups were treated for 2 weeks. The treatment effect, clinical symptoms and constipation severity score before and after treatment, somatostatin (SS), vasoactive intestinal peptide (VIP) and motilin levels before and after treatment, nitric oxide (no) level before and after treatment, pac-qol score before and after treatment, incidence of adverse reactions after treatment were compared between the two groups. Results After treatment, The total effective rate of the study group was significantly higher than that of the control group [96.92(63/65)vs83.87％(52/62)] (P＜0.05). Before treatment, there was no difference in defecation frequency, stool characteristics, incomplete defecation, falling, falling feeling, defecation difficulty, abdominal distension and constipation severity scores between the two groups (P＞0.05). After treatment, the defecation frequency, stool characteristics, incomplete defecation, falling, falling feeling, defecation difficulty, abdominal distension and constipation severity scores of the study group were significantly lower than those of the control group [(0.75±0.15)scores vs(1.26±0.19)scores, (1.19±0.12) scores vs(1.40±0.16)scores,(0.80±0.12)scores vs(1.30±0.18)scores,(0.67±0.11)scores vs(1.05±0.12)scores,(0.97±0.11)scores vs(1.21±0.25)scores,(4.56±0.61)scores vs(5.69±0.65)scores] (P＜0.05). There was no difference in the levels of somatostatin, vasoactive intestinal peptide and motilin between the two groups before treatment (P＞0.05). After treatment, the levels of somatostatin and vasoactive intestinal peptide in the study group were significantly lower than those in the control group [(12.38±2.65)pg/mL vs(17.85±3.59)pg/mL,(30.28±3.71)pg/mL vs(36.23±3.98)pg/mL] (P＜0.05). Motilin was significantly higher than that in the control group [(236.01±32.50)pg/mL vs9197.63±30.15] pg/mL] (P＜0.05). There was no difference in the levels of no between the two groups before treatment (P＞0.05). After treatment, the levels of no, in the study group were significantly lower than those in the control group [(49.03±8.19)mmol/L vs(63.27±10.38)mmol/L] (P＜0.05).There was no difference in physiological score, social psychological score, worry score, satisfaction score and total average score between the two groups before treatment (P＞0.05). After treatment, the physiological score, social psychological score, worry score, satisfaction score and total average score of the study group were significantly lower than those of the control group [(8.50±0.81)scores vs(9.32±0.91)scores,(11.65±2.09)scores vs(14.02±1.63)scores,(19.17±2.51)scores vs(22.31±2.42)scores,(8.69±1.05) scores vs(12.51±1.52)scores,(47.27±5.36)scores vs(58.93±6.02)scores] (P＜0.05). There was no significant difference in diarrhea, abdominal distension, abdominal pain, vomiting and total incidence between the two groups (P＞0.05). Conclusion Bifidobacterium quadruple viable tablets can effectively regulate gastrointestinal function, improve constipation symptoms of patients with type 2 diabetes, promote fecal excretion, with less adverse reactions, and is safe and reliable.