便通胶囊防治胸腰椎骨折术后便秘的随机对照研究

目的:比较便通胶囊与滋阴润肠口服液治疗胸腰椎骨折术后便秘的疗效、安全性与依从性。方法:采用随机对照设计,共纳入144例胸腰椎骨折术后患者,随机分为2组,每组72例,分别口服便通胶囊与滋阴润肠口服液。记录2组患者首次排便时间、住院时间及不良反应,随访停药后第4周、12周及24周便秘的复发率。结果:对照组有5例患者因治疗3天无效提前退出试验,治疗组70.83%的患者在术后24 h首次排便,治疗组首次排便时间较对照组提前了0.5 d(1.4±0.6 d Vs 1.9±1.1,P0.05),治疗组住院时间较对照组缩短了5.8 d(15.8±12.5 d Vs 21.6±15.9,P0.05),且术后第8周、16周及28周治疗组便秘复发率也显著低于对照组(P0.05),远期疗效稳定。2组不良反应发生率均较低,并且组间比较无统计学意义。结论:便通胶囊治疗胸腰椎骨折术后便秘患者,起效迅速,缩短患者住院时间且复发率低,安全性佳,值得临床推广应用。

A Randomized Controlled Trial of Biantong Capsule in the Treatment of Constipation after Thoracolumbar Fracture Surgery

To compare the efficacy, safety and compliance of Bian Tong Capsule and Ziyin Runchang oral solution in treating constipation after thoracolumbar vertebral fracture surgery.Methods:A total of 144 patients were randomized into Biantong capsule (treatment group) and Ziyin Runchang oral solution (control group) to treat constipation with 72 in each. The first defecation time, length of stay in hospital, the adverse reaction of drugs were recorded as well as the recurrence rate of constipation after drug discontinuance at the 4th ,12th ,24th week. Results:Five patients in control group drop out of the trials for ineffective treatment after 3 days. Patients who had the first defecation within 24 h after operation were 70.83% in the treatment group. The first defecation time in the treatment group were 0.5 day earlier than that of the control group (1.4±0.6 vs 1.9±1.1, P<0.05), and length of stay in hospital was 5.8 days shorter than that of the control group (15.8±12.5 Vs 21.6±15.9, P<0.05). Besides, recurrence rate of constipation after operation at the 8th, 16th, 28th week was significantly lower than that of the control group (P<0.05). The occurrence rate of ADR in both groups remained low and had no significant difference. Conclusion:Biantong capsule is effective in the treatment of constipation after thoracolumbar vertebral fracture surgery with low recurrence rate. It is safe and worthy of clinical promotion.