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红藤棱莪煎治疗反流性食管炎的效果评价:基于双重差分模型的临床随机对照试验
作者:王洪蓓1  燕莉2  张林3 
单位:1. 北京市西城区展览路医院, 北京 100044;
2. 北京市西城区展览路社区卫生中心, 北京 100037;
3. 北京中医药大学 基础医学院, 北京 100020
关键词:红藤棱莪煎 反流性食管炎 随机临床试验 疗效评价 双重差分 
分类号:R571
出版年·卷·期(页码):2021·40·第五期(697-703)
摘要:

目的:通过观察应用红藤棱莪煎治疗反流性食管炎湿热血瘀证的临床疗效,评价红藤棱莪煎在反流性食管炎中的作用。方法:对北京市西城区展览路医院2012年8月至2015年2月55例反流性食管炎患者采用随机数字表法进行随机分组,即治疗组(30例)和对照组(25例)。治疗组开展为期1个疗程8周的红藤棱莪煎治疗,对照组采用口服奥美拉唑肠溶胶囊8周。基线收集研究对象的年龄、性别、病程、症状及胃镜检查等资料,8周后随访收集研究对象的症状及胃镜检查资料。运用双重差分(DID)模型对干预前后的治疗效果进行评价。结果:红藤棱莪煎干预前后反流性食管炎主要症状总积分(DID=-2.19,P<0.001)、证候总积分(DID=-9.54,P<0.001)及胃镜积分(DID=-0.31,P=0.02)均较奥美拉唑有较大的改善。双重差分全模型结果显示,红藤棱莪煎对主要症状总积分(β3=-2.19,P<0.001)和证候积分(β3=-9.54,P<0.001)的改善明显好于奥美拉唑,但对胃镜积分的改善与奥美拉唑间差异无统计学意义(β3=-0.313,P=0.072)。结论:红藤棱莪煎较奥美拉唑能显著改善反流性食管炎主要症状和中医证候,但对胃镜积分的改善与奥美拉唑相比并未见显著差异。

Objective: To observe the clinical effect of Hongteng Lenge Decoction in the treatment of reflux esophagitis with damp heat and blood stasis syndrome, and to evaluate the effect of Hongteng Lenge Decoction in reflux esophagitis. Methods: This study is a randomized clinical controlled trial. Patients with reflux esophagitis who came to Zhanlan Road Hospital from August 2012 to February 2015 were randomly divided into treatment group (30 cases) and control group (25 cases). The treatment group was treated with Hongteng Lenge Decoction for 8 weeks, and the control group was treated with omeprazole enteric coated capsules for 8 weeks. Age, gender, course of disease, symptoms and gastroscopic results were collected at baseline as well as duing a 8-week follow-up. Statistical analysis used Difference in Difference (DID) to evaluate the treatment effect before and after the intervention. Results: The major symptom score of reflux esophagitis(DID=-2.19, P<0.001)and the TCM syndrome score (DID=-9.54, P<0.001) and gastroscopy score (DID=-0.31, P=0.02) before and after intervention were significantly improved compared with omeprazole treatment. The results of DID model showed that the effect of Hongteng Lenge Decoction on the major symptom score of reflux esophagitis (β3=-2.19, P<0.001) and TCM syndrome score (β3=-9.54, P<0.001) was better than those of omeprazole. However, there was no significant difference in the improvement of gastroscopy score (β3=-0.313, P<0.072). Conclusion: Hongteng Lenge decoction can significantly improve the main symptoms and TCM syndrome of reflux esophagitis compared with omeprazole, but there is no significant difference in the improvement of gastroscopy score between Hongteng Lenge Decoction and omeprazole.

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