摘要
目的:评价左金丸治疗肝胃郁热证胃食管反流病(GERD)的临床疗效。方法:采用前瞻性、随机、双盲、安慰剂平行对照设计,将66例肝胃郁热证GERD患者随机分为左金丸组和安慰剂组,每组各33例,疗程为8周。主要疗效指标为第8周时反流性疾病问卷(RDQ)症状总有效率,次要疗效指标为中医证候各项积分改善率、中医证候总有效率、胃食管反流病生存质量量表(GERD-QOL)积分和复发率等。结果:试验组完成31例,脱落2例;对照组完成30例,脱落3例。治疗8周后,左金丸组和安慰剂组的RDQ症状总有效率分别为87.1%和36.67%,2组比较差异有统计学意义(P<0.05)。左金丸组中医单项症状中主症(烧心、反酸)和次症(胸骨后灼痛、胃脘灼痛、易怒、易饥)改善率均明显高于安慰剂组(P<0.05)。左金丸组中医证候总有效率明显高于安慰剂组(87.10%vs 36.67%,P<0.05)。左金丸组中医证候治疗8周的总有效率高于治疗4周的总有效率(87.10%vs 68.75%,P<0.05)。左金丸组GERD-QOL总积分明显高于安慰剂组(P<0.05)。左金丸组治疗结束后第4周时的复发率明显低于安慰剂组(22.22%vs 63.64%,P<0.05)。结论:左金丸能有效地改善肝胃郁热证GERD患者的临床症状及中医证候,提高患者的生活质量,降低复发率。
Objective:To evaluate the clinical efficacy of the Zuojin Pill in the treatment of gastroesophageal reflux disease(GERD) with stagnating heat in liver and stomach syndrome.Methods:This is a randomized,double-blinded,and placebo parallel controlled clinical pilot study.Sixty-six subjects with GERD and Traditional Chinese Medicine(TCM) syndrome of stagnating heat in the liver and stomach were randomized into the Zuojin Pill group and the placebo group.The course of treatment was 8 weeks.The main efficacy index was the total effective rate of RDQ symptoms at the 8~(th)week.The secondary efficacy indices were the improvement rates of the single symptom of TCM syndrome,the total effective rate of TCM syndrome,GERD-QOL score,and the relapse rate at the 4~(th)week of follow-up,etc.Results:Thirty-three subjects were enrolled in each group.2 subjects dropped out in the Zuojin Pill group and 3 subjects dropped out in the placebo group.The total effective rates of RDQ symptoms of the Zuojin Pill group and the placebo group were 87.1% vs 36.67% respectively(P<0.05).The improvement rates of the primary symptoms(heartburn and acid reflux) and the secondary symptoms(substernal burning pain,epigastric burning pain,irritability,and gastric upset) of the Zuojin Pill group were significantly higher than those of the placebo group(P<0.05).The total effective rate of TCM syndrome in the Zuojin Pill group was significantly higher than that of the placebo group(87.10% vs 36.67%),and it in the Zuojin Pill group at 8 weeks of treatment was higher than that at 4 weeks(87.10% vs 68.75%)(P<0.05).The total score of GERD-QOL of the Zuojin Pill group was significantly higher than that of the placebo group(P<0.05).The relapse rate at 4~(th)week of the follow-up of the Zuojin Pill group was significantly lower than that of the placebo group(22.22% vs 63.64%,P<0.05).Conclusion:Zuojin Pill could effectively improve the clinical symptoms and TCM syndrome of GERD patients with stagnating heat in liver and stomach syndrome,improve the quality of life
作者
倪晶
许异川
火龙
温红珠
林江
NI Jing;XU Yichuan;HUO Long;WEN Hongzhu;LIN Jiang(Department of Gastroenterology,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai,200032,China)
出处
《中国中西医结合消化杂志》
CAS
2023年第12期955-960,共6页
Chinese Journal of Integrated Traditional and Western Medicine on Digestion
基金
海派中医流派传承创新团队带头人培养与流派品牌打造项目(No:2021WXGLP-007)。
关键词
左金丸
胃食管反流病
肝胃郁热证
随机对照试验
Zuojin Pill
gastroesophageal reflux disease
syndrome of stagnating heat in liver and stomach
randomized controlled clinical trial
