Abstract:

Objective　To explore the clinical efficacy and safety of Jiawei Zuojin pills combined with rabeprazole sodium in the treatment of patients with gastroesophageal reflux disease of the liver-stomach depression and heat type. Methods　One hundred and twenty patients with gastroesophageal reflux disease of the liver-stomach depression and heat type who were admitted to Department of Spleen, Stomach, and Liver Diseases, Yan'an Hospital of Traditional Chinese Medicine from June 2021 to June 2023 were selected for the randomized controlled trial, and were divided into a control group and a combined treatment group by the random number table method, with 60 cases in each group. There were 28 males and 32 females in the control group; they were (42.32±5.42) years old; their disease course was (3.51±0.87) years; their body mass index was (23.52±1.91) kg/m². There were 31 males and 29 females in the combined treatment group; they were (43.88±6.17) years old; their disease course was (3.92±1.04) years; their body mass index was (24.05±0.47) kg/m². The control group were treated with rabeprazole sodium, and the combined treatment group with Jiami Zuogin pillsand rabeprazole sodium, for 8 weeks. The clinical efficacies, endoscopic scores, scores of clinical symptoms of traditional Chinese medicine, and levels of serum gastrointestinal hormones [gastrin (Gas), motilin (MTL), vasoactive intestinal peptide (VIP), and somatostatin (SS)], and scores of Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) before and after the treatment, and incidences of adverse reactions were compared between the two groups by t and χ² tests. Results　After the treatment, the endoscopic score in the combined treatment group was lower than that in the control group [(0.87±0.23) vs. (1.31±0.58); P<0.05]. The total effective rates of the combined treatment group and the control group were 93.33% (56/60) and 78.33% (47/60), respectively, with a statistical difference (χ²=4.312, P=0.009). After the treatment, the scores of post-sternal burning pain, acid reflux, thoracic and hypochondriac pain, gastrointestinal and epigastric pain, epigastric distension, belching or regurgitation, and irritability in the combined treatment group were lower than those in the control group [(1.49±0.65) vs. (3.51±0.91), (1.34±0.27) vs. (2.64±0.87), (0.34±0.16) vs. (0.51±0.21), (0.24±0.11) vs. (0.46±0.12), (0.31±0.14) vs. (0.57±0.33), (0.19±0.17) vs. (0.32±0.11), and (0.63±0.24) vs. (1.05±0.68); all P<0.05]; there was no statistical difference in the score of being hungery easily between the two groups (P>0.05). After the treatment, the levels of GAS, MTL, VIP, and SS in the combined treatment group were (126.11±11.52) ng/L, (102.66±8.16) ng/L, (45.88±7.44) ng/L, and (9.01±2.17) ng/L, and those in the control group were (105.63±10.21) ng/L, (84.33±7.17) ng/L, (53.52±6.23) ng/L, and (15.43±3.61) ng/L, with statistical differences (all P<0.05). After the treatment, the scores of SAS and SDS in the combined treatment group were lower than those in the control group [(30.66±10.29) vs. (41.31±8.55) and (31.44±8.19) vs. (38.12±11.28); both P<0.05]. The incidence of adverse reactions in the combined treatment group was 6.67% (4/60), and that of the control group was 8.33% (5/60), with no statistical difference (χ²=0.531, P=0.637). Conclusion　Jiawei Zuojin pills combined with rabeprazole sodium in the treatment of patients with gastroesophageal reflux disease of the liver-stomach depressive heat type is effective and safe.

Key words:

Gastroesophageal reflux disease, Jiawei Zuojin pills, Rabeprazole sodium, Liver-stomach depression and heat syndrome

摘要：

目的　探讨加味左金丸联合雷贝拉唑钠治疗肝胃郁热型胃食管反流病患者的临床效果和安全性。方法　选取2021年6月至2023年6月延安市中医医院收治的120例肝胃郁热型胃食管反流病患者进行随机对照试验。采用随机数表法将其分对照组与联合治疗组，各60例。对照组男28例，女32例，年龄（42.32±5.42）岁，病程（3.51±0.87）年，体质量指数（23.52±1.91）kg/m²。联合治疗男31例，女29例，年龄（43.88±6.17）岁，病程（3.92±1.04）年，体质量指数（24.05±0.47）kg/m²。对照组雷贝拉唑钠治疗，联合治疗组加味左金丸联合雷贝拉唑钠治疗，均治疗8周。比较两组临床疗效、治疗前后内镜评分、中医临床症状评分、血清胃肠激素［胃泌素（gastrin，Gas）、胃动素（motilin，MTL）、血管活性肠肽（vasoactive intestinal peptide，VIP）及生长抑素（somatostatin，SS）］水平、焦虑自评量表（Self-Rating Anxiety Scale，SAS）和抑郁自评量表（Self-Rating Depression Scale，SDS）评分及不良反应发生情况。采用t检验和χ²检验。结果　治疗后，联合治疗组内镜评分低于对照组［（0.87±0.23）分比（1.31±0.58）分，P<0.05］。联合治疗组总有效率93.33%（56/60），对照组78.33%（47/60），差异有统计学意义（χ²=4.312，P=0.009）。治疗后，联合治疗组胸骨后烧灼痛、反酸、胸胁疼痛、胃脘疼痛、脘腹胀满、嗳气或反胃、易怒评分均低于对照组［（1.49±0.65）分比（3.51±0.91）分、（1.34±0.27）分比（2.64±0.87）分、（0.34±0.16）分比（0.51±0.21）分、（0.24±0.11）分比（0.46±0.12）分、（0.31±0.14）分比（0.57±0.33）分、（0.19±0.17）分比（0.32±0.11）分、（0.63±0.24）分比（1.05±0.68）分；均P<0.05］；两组易饥评分差异无统计学意义（P>0.05）。治疗后，联合治疗组GAS、MTL、VIP、SS水平分别为（126.11±11.52）ng/L、（102.66±8.16）ng/L、（45.88±7.44）ng/L、（9.01±2.17）ng/L，对照组分别为（105.63±10.21）ng/L、（84.33±7.17）ng/L、（53.52±6.23）ng/L、（15.43±3.61）ng/L，差异均有统计学意义（均P<0.05）。治疗后，联合治疗组SAS、SDS评分均低于对照组［（30.66±10.29）分比（41.31±8.55）分、（31.44±8.19）分比（38.12±11.28）分；均P<0.05］。联合治疗组不良反应发生率为6.67%（4/60），对照组为8.33%（5/60），差异无统计学意义（χ²=0.531，P=0.637）。结论　加味左金丸联合雷贝拉唑钠治疗肝胃郁热型胃食管反流病患者有效、安全。

关键词:

胃食管反流病, 加味左金丸, 雷贝拉唑钠, 肝胃郁热证