直肠粘膜保护剂治疗痔急性发作的临床研究

目的研究含直肠粘膜保护剂的肛门栓剂治疗痔急性发作的有效性及安全性。方法对123例患者采用随机、双盲对照的方法进行研究。研究组使用含直肠粘膜保护剂的肛门栓剂，对照组使用无粘膜保护成分的栓剂。结果（1）开盲后研究组60例，对照组63例。2组均未出现全身不良反应。（2）在治疗48h后，研究组疼痛、出血及瘙痒的减轻程度已明显优于对照组(P＜0.05)。（3）治疗7d后，研究组的疼痛、出血、水肿、糜烂和瘙痒的减轻程度也优于对照组(P＜0.05）。结论含直肠粘膜保护剂的肛门栓剂对痔发作有明显的疗效，未见到明显副作用。

Double-blind randomized clinical trial in evaluating the efficacy and safety of rectum mucosa protector in the treatment of acute hemorrhoids

Objective　To evaluate the clinical efficacy and safety of Titanoreine suppository containing rectum mucosa protector in the treatment of acute hemorrhoids.　Methods　Double blind, placebo controlled randomized study was made in patients with acute hemorrhoids (within 4 days). The duration of study was seven days, during which Titanoreine suppositories and suppositories without mucosa protector were used twice daily in the study group and control group respectively.　Results　123 patients completed the 7-day treatment (60 patients in the study group and 63 in the control group). Patients in the two groups were comparable in age, sex, diagnosis, history of hemorrhoids, symptoms and signs before the enrollment. No major adverse event was observed in both groups. Score reduction on pain, bleeding, and itchiness was significantly different between the two groups after 2-day treatment (P＜0.05). After 7-day treatment, score reduction on pain, bleeding, edema, erosion, and itchiness was significantly higher in the study group than in the control group (P＜0.05).　Conclusions　Data from the study showed that Titanoreine suppository containing rectum protector is safe and effective in the treatment of acute hemorrhoids.