三生通便方治疗功能性便秘肠道实热证的随机双盲安慰剂对照临床研究

目的:观察三生通便方治疗功能性便秘肠道实热证的临床疗效、对生活质量的影响和安全性。方法:选取2016年7月至2018年3月我院收治的功能性便秘肠道实热证患者70例,随机分为观察组和对照组各35例,观察组给予三生通便方颗粒剂,对照组给予安慰剂治疗,两组均治疗4周。分别于治疗前、治疗2周和治疗4周时记录评估西医症状积分和中医证候有效率,并于治疗前和治疗4周分别记录评估便秘患者西医单项症状程度和生活质量量表(PAC-QOL)。结果:经4周治疗后,观察组西医症状积分的全分析集(FAS)和符合方案集(PPS)分析均显著低于对照组(P<0.01);观察组中医证候有效率的FAS和PPS分析分别为74.29%和78.79%,均显著高于对照组的34.29%和36.36%(P<0.01);观察组西医单项症状改善的FAS和PPS分析均优于治疗前(P<0.01);观察组PAC-QOL积分的FAS和PPS分析均显著低于对照组(P<0.05)。两组不良事件发生率差异无统计学意义(P>0.05)。结论:三生通便方能有效、安全地改善功能性便秘肠道实热证患者的临床症状和生活质量,值得临床推广应用。

Randomized, Double-blind, Placebo-controlled Clinical Study of Sansheng Tongbian Decoction in the Treatment of Functional Constipation with Intestinal Excess Heat Syndrome

ABSTRACT Objective: To observe the clinical efficacy, the effect on quality of life and the safety of SanShengTongBian Decoction in the treatment of functional constipation with intestinal hyperthermia syndrome. Methods: 70 patients of functional constipation with intestinal hyperthermia syndrome in our hospital from July 2016 to March 2018 were randomly divided into observation group and control group, 35 cases in each group. The observation group was treated with Sansheng Tongbian decoction, while the control group was treated with placebo for 4 weeks respectively. The scores of symptoms and the efficiency of TCM syndromes were recorded and evaluated before treatment, 2 weeks after treatment and 4 weeks after treatment, and the western medicine individual symptom degree and quality of life scale(PAC-QOL) for constipation patients were also recorded and evaluated before treatment and 4 weeks after treatment. Results: After 4 weeks of treatment, the Full Analysis Set(FAS) and Per Protocol Set(PPS) analysis of the symptoms in the observation group were significantly lower than those in the control group (P<0.01). The FAS and PPS analysis of the effective rate of TCM syndromes in the observation group were 74.29% and 78.79%, which were significantly higher than 34.29% and 36.36% of the control group (P<0.01); the FAS and PPS analysis of the improvement of single symptom in the observation group were better than those before treatment (P<0.01). The FAS and PPS analysis of PAC-QOL score in the observation group were significantly lower than those in the control group (P<0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05). Conclusion: SanShengTongBian can effectively and safely improve the clinical symptoms and quality of life of patients with functional constipation with intestinal excess heat syndrome, which is worthy of clinical application.