Objective: To evaluate the efficacy and safety of testa triticum tricum purif for the treatment of functional constipation(FC) in the late middle-aged and elderly patients. Methods: This study was designed as a multicenter randomized controlled trial. Patients who met Rome Ⅲ diagnostic criteria of FC were enrolled, with age between 55-85 years old. Those with organic diseases were excluded. The patients were randomly allocated to receive testa triticum tricum purif (3.5 g bid) or polyethylene glycol 4000 powder (PEG4000, 10g bid) for 8 weeks, followed by single dose of maintenance therapy for 4 weeks. Follow-up visits were at 4 and 12 weeks after treatment discontinuation. The independent investigators in each center evaluated the constipation symptoms scores. The primary endpoints included rates of significant improvement, improvement and overall improvement at the end of 2, 4 and 8 weeks of therapy, which were calculated by the reduction of symptom scores ≥75%, 50%-74%, ≥25% respectively. Results: A total of 127 FC subjects were enrolled from 3 centers, and 122 cases valid for final analysis. The mean age was (69.4±6.9) years old, including 62 cases in testa triticum tricum purif group and 60 cases in PEG4000 group. The demographic data, constipated symptoms scores and proportion of FC subtypes at baseline were comparable. The rates of significant improvement, improvement and overall improvement in testa triticum tricum purif and PEG4000 groups at the end of 2, 4 and 8 weeks were 37.70% (23/61) vs 59.32% (35/59) (P=0.018), 57.38% (35/61) vs 74.14% (43/58) (P=0.054), and 64.41% (38/59) vs 79.31% (46/58) (P=0.073) respectively. Testa triticum tricum purif therapy significantly improved the proportion of spontaneous bowel movement(SBM) ≥3 times/week from 43.55% (27/62) to 80.33% (49/61), 83.61% (51/61) and 93.22% (55/59) at 2, 4, and 8 weeks respectively (all P<0.01), which were comparable with PEG4000 group (all P>0.05). The proportion of normalized stool forms in study group was significant higher than that of control group at the end of 8 weeks [86.44% (51/59) vs 67.24% (39/58), P=0.014]. Only one patient complained mild abdominal distension during testa triticum tricum purif therapy. Conclusions: The efficacy of testa triticum tricum purif for the treatment of FC in late middle-aged and older patients is comparable with osmotic laxatives PEG4000, which has significant effect on normalization of fecal forms and reliable safety.
目的： 评价小麦纤维素治疗中老年人功能性便秘的疗效和安全性。 方法： 采用多中心随机对照设计。纳入符合罗马Ⅲ功能性便秘诊断标准且排除了器质性疾病的患者，年龄55～85岁。采用随机数字表法随机分为两组，分别服用小麦纤维素颗粒(3.5 g/次，2次/d)和聚乙二醇4000散剂(10 g/次，2次/d)，治疗期8周，减量维持治疗期4周，停药后4周末、12周末随访。由独立问卷员对症状进行评分。主要疗效指标是治疗2周、4周和8周时的显著有效率、有效率和总有效率，分别按治疗后症状计分减少≥75%、50%～74%、≥25%的例数计算。 结果： 3个临床中心共纳入受试者127例，有效例数122例，年龄(69.4±6.9)岁。小麦纤维素组62例，聚乙二醇组60例，两组受试者人口学资料、基线期症状评分和各亚型便秘所占比例有可比性。小麦纤维素和聚乙二醇治疗2周、4周和8周时的总有效率分别为37.70%(23/61)比59.32%(35/59)(P＝0.018)、57.38%(35/61)比74.14%(43/58)(P＝0.054)、64.41%(38/59)比79.31%(46/58)(P＝0.073)。小麦纤维素治疗2周、4周和8周后自发排便次数≥3次/周的患者比例由治疗前的43.55%(27/62)提升至80.33%(49/61)、83.61%(51/61)和93.22%(55/59)(P<0.01)，与各时间点的聚乙二醇组相比，差异均无统计学意义(P均>0.05)。小麦纤维素治疗后粪便性状正常的患者比例明显提升，治疗8周时明显高于聚乙二醇组[86.44%(51/59)比67.24%(39/58)，P＝0.014]。小麦纤维素组仅1例出现轻度腹胀。 结论： 小麦纤维素对中老年人功能性便秘的疗效与渗透性泻剂聚乙二醇4000相当，其在有效改善粪便性状的同时较少引起稀粪，安全性好。.
Keywords: Aged; Functional constipation; Testa triticum tricum purif; Treatment.