Exploring the role and clinical validation of paired drugs in the treatment of reflux esophagitis based on the Traditional Chinese Medicine Inheritance Support System
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摘要: 目的 探讨中医药治疗反流性食管炎(reflux esophagitis，RE)的核心药物、组方规律和核心组合，为临床用药提供理论依据。方法 收集万方、维普、中国知网中中医药治疗RE的相关文献，筛选并建立方剂数据库，运用中医传承辅助系统(V2.5)软件进行用药规律挖掘。并选取2022年1月-2023年1月就诊于南开医院的RE患者60例，以筛选出的核心对药为基础进行辨证施治，观察治疗前后的临床效果。结果 筛选出治疗RE相关方剂101首，涉及中药133种，涉及的主要证型为肝胃郁热证、肝胃不和证、寒热错杂证。肝胃郁热证相关方剂，黄连、吴茱萸、半夏、甘草、柴胡使用频率较高，对药“黄连-吴茱萸”出现频率较高；肝胃不和证相关方剂，柴胡、甘草、白芍、半夏、黄连使用频率较高，对药“白芍-柴胡”出现频率较高；寒热错杂证相关方剂，干姜、黄连、黄芩、半夏使用频率较高，角药“干姜-黄连-黄芩”出现频率较高。用以上核心对药对RE患者三大主要证型进行辨证论治，给予8周的中药治疗后，食管下括约肌静息压及残余压明显升高(P < 0.05)，平均远段收缩积分(DCI)值明显升高(P < 0.05)，Demeester评分明显降低(P < 0.05)。结论 临床RE以肝胃郁热证、肝胃不和证和寒热错杂证多见，中医药防治RE主要从肝胃论治，治法以疏肝泄热、和胃降逆为主，用药多辛苦合用、寒温并调。“黄连-吴茱萸”、“白芍-柴胡”、“干姜-黄连-黄芩”分别为上述不同证型的核心对药或角药，治疗RE的具有良好的临床应用效果，值得推广。Abstract: Objective To explore the core drugs, prescription rules and core combinations of Chinese medicine in the treatment of reflux esophagitis(RE), and to provide a theoretical basis for clinical medication.Methods It collected relevant literature on the treatment of RE with Traditional Chinese Medicine in Wanfang, Weipu, and CNKI, screened and established a prescription database, and utilized the software of Traditional Chinese Medicine Inheritance Support System(V2.5) to excavate the rules of medication. We also selected 60 cases of RE patients who visited Nankai Hospital from January 2022 to January 2023, and used the screened core medicinal pairs as the basis for diagnosis and treatment, and observed the clinical effects before and after treatment.Results One hundred and one formulas were screened for the treatment of reflux esophagitis, involving 133 Traditional Chinese Medicines, and the main syndromes involved were the syndromes of hepatic and gastric depression and heat, the syndromes of hepatic and gastric disharmony, and the syndromes of mixed heat and cold. Among them, for the formulae related to liver-stomach depression and heat syndrome, Rhizoma Coptidis, Fructus Evodiae, Rhizoma Pinelliae, Radix Glycyrrhizae, and Radix Bupleuri were used more frequently, and"Rhizoma Coptidis-Fructus Evodiae"appeared more frequently; for the formulae related to liver-stomach disharmony syndrome, Radix Bupleuri, Radix Glycyrrhizae, Radix Paeoniae Alba, Rhizoma Pinelliae, and Rhizoma Coptidis were used more frequently, and the formulae related to"Radix Paeoniae Alba-Radix Bupleuri"were used more frequently. For formulas related to Cold-Heat Dissonance, the frequency of Dried Ginger, Rhizoma Coptidis, Radix Scutellariae, Pinelliae Rhizoma is high, and the frequency of the pair"Dried Ginger-Rhizoma Coptidis-Radix Scutellaria"is high. After 8 weeks of TCM treatment, the resting and residual pressures of the lower esophageal sphincter increased significantly(P < 0.05), the mean DCI increased significantly(P < 0.05), and the Demeester's score decreased significantly(P < 0.05) after using the above core"Paired Drugs"for the three major syndromes of the patients with RE. The mean DCI value was significantly higher(P < 0.05) and Demeester score was significantly lower(P < 0.05).Conclusion Clinical RE is characterized by liver-stomach depression and heat syndrome, liver-stomach disharmony syndrome and cold-heat mismatch syndrome. Chinese medicine mainly focuses on the treatment of liver and stomach in the prevention and treatment of RE, and the treatment is based on dredging the liver and draining heat, harmonizing the stomach and lowering the rebelliousness, and the medicines used are mostly painstakingly combined with the use of cold and warmth. "Rhizoma Coptidis-Fructus Evodiae", "Radix Paeoniae Alba-Radix Bupleuri", and"Dried Ginger-Rhizoma Coptidis-Radix Scutellaria"are the core or corner drugs for the above mentioned different syndromes, and have good clinical It has good clinical effects in the treatment of RE and is worth popularizing.
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表 1 主要证候中药用药频次
序号 肝胃郁热证 肝胃不和证 寒热错杂证 中药 频次 中药 频次 中药 频次 1 黄连 22 柴胡 19 干姜 10 2 吴茱萸 21 甘草 17 黄连 10 3 半夏 17 白芍 16 黄芩 9 4 甘草 16 半夏 14 半夏 9 5 柴胡 16 黄连 13 党参 5 6 陈皮 16 白术 11 枳壳 5 7 茯苓 13 枳壳 10 甘草 5 8 浙贝母 11 9 白芍 11 
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表 2 主要证候相关方剂用药频次
序号 肝胃郁热证 肝胃不和证 寒热错杂证 中药 频次 中药 频次 中药 频次 1 黄连、吴茱萸 21 甘草、柴胡 16 黄连、干姜 10 2 黄连、甘草 14 白芍、柴胡 16 黄芩、黄连 9 3 半夏、黄连 14 甘草、白芍 14 黄芩、干姜 9 4 甘草、吴茱萸 13 甘草、白芍、柴胡 14 半夏、黄连 9 5 半夏、吴茱萸 13 半夏、柴胡 13 半夏、干姜 9 6 黄连、甘草、吴茱萸 13 黄连、甘草 11 黄芩、黄连、干姜 9 7 半夏、黄连、吴茱萸 13 黄连、柴胡 11 半夏、黄连、干姜 9 8 陈皮、黄连 12 半夏、甘草 11 9 半夏、甘草 11 半夏、白芍 11
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表 3 治疗前后中医证候积分
分，X±S 证候 例数 治疗前 治疗后 P 肝胃郁热证 20 10.65±1.79 3.80±1.28 < 0.05 肝胃不和证 20 10.55±1.34 3.70±1.26 < 0.05 寒热错杂证 20 10.60±1.34 3.65±1.23 < 0.05
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表 4 治疗后内镜下疗效
例 证候 例数 痊愈 显效 有效 无效 总有效率/% 肝胃郁热证 20 12 3 1 4 80 肝胃不和证 20 13 2 2 3 85 寒热错杂证 20 10 3 2 5 75
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表 5 治疗前后LES静息压、残余压、平均DCI及Demeester评分
分，X±S 证候 时间 例数 LES静息压/mmHga) LES残余压/mmHg 平均DCI/(mmHg·s·cm) Demeester评分/分 肝胃郁热 治疗前 20 8.26±1.73 5.63±1.73 1 447±147.7 18.48±3.93 治疗后 20 17.14±2.071) 8.24±1.711) 5 209±727.41) 9.32±3.131) 肝胃不和 治疗前 20 8.47±1.92 5.64±1.67 1 462±97.6 18.58±3.82 治疗后 20 17.23±2.021) 8.53±1.811) 5 332±767.11) 8.55±3.231) 寒热错杂 治疗前 20 9.04±1.98 5.54±1.64 1 440±139.6 18.42±3.87 治疗后 20 17.23±2.041) 13.44±20.21 5 090±791.11) 8.82±3.161) a)1 mmHg=0.133 kPa；与治疗前比较，1)P < 0.05。
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