清热补益煎剂治疗急性放射性直肠炎的临床研究

Study on effect of QingreBuyi decoction on acute radiation proctitis

目的:探讨清热补益煎剂治疗放射性直肠炎(ARP)的安全性和有效性。方法:60例ARP患者随机分为2组:治疗组(清热补益煎剂联合常规方案)和对照组(常规方案)各30例,2周为1疗程。观察血D-乳酸、二胺氧化酶和肝肾功能变化,各症状积分、治愈率、总有效率和不良事件。结果:治疗后,治疗组D-乳酸和二胺氧化酶低于对照组(P<0.05或P<0.01),改善腹痛或不适、排便异常与黏液血便优于对照组(P<0.05或P<0.01),总有效率高于对照组(P<0.05);两组无不良事件。结论:清热补益煎剂联合常规方案治疗ARP安全、有效,可促进受损肠屏障功能恢复,总体疗效优于单纯常规疗法。

Objective： To investigate the effect and safety of QingreBuyi decoction（QBD） in treating acute radiation proctitis（ARP）. Methods： Sixty patients were randomized into the treatment group （QBD plus conventional therapy, n=30） and the control group （conventional therapy, n=30）. The changes of syndromes and signs score, D- lactic-acid and diamine oxidase, total effective rate, hepatic/renal function and adverse event were observed. Results ： The levels of D- lactic-acid and diamine oxidase in the treatment group were decreased than those in the control group after treatment （P〈0.05 or P〈0.01）.The effect of treating stomachache, diarrhea, defecation dysfunction and bloody stools were significantly better in the treatment group（P〈0.05 or P〈0.01）. The total curative effect in the treatment group was significantly higer（P〈0.05）. No adverse event was found in either group. Conclusions： The QBD plus conventional therapy, shows effects of repairing the damage of intestinal mucosal barrier function and is effective and safe for ARP.