Clinical efficacy study of combination of acupuncture and medicine therapy based on "Coordination of Spleen and Stomach Ascending and Descending Theory" in treating non-erosive reflux disease overlapping with functional dyspepsia
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摘要: 目的 评价“脾胃升降协调论”针药结合法治疗非糜烂性反流病(non-erosive reflux disease，NERD)重叠功能性消化不良(functional dyspepsia，FD)的疗效和安全性。 方法 选择2024年1月10日—2024年12月31日就诊于武汉市中西医结合医院消化内科门诊及住院部，诊断为NERD重叠FD的158例患者为研究对象，随机分为试验组与对照组，每组各79例。试验组予以半夏调中颗粒联合背俞针刺治疗，对照组予以泮托拉唑联合莫沙必利治疗，疗程均为4周。比较两组治疗前后临床疗效、GerdQ量表评分、高分辨率食管测压及胃电图指标，并以不良事件发生率进行安全性评价。 结果 试验组的总有效率为88.6%(70/79)，对照组为78.5%(62/79)，两组差异无统计学意义(P>0.05)。与治疗前比较，两组治疗后的GerdQ量表评分、高分辨率食管测压指标LESP、DCI、DL、PA、PV，胃电图餐前/餐后的整体胃慢波百分比及PR均较治疗前下降(P < 0.05)。与对照组比较，试验组的GerdQ量表评分、LESP、DCI、PA、PV、餐前/餐后的整体胃慢波百分比改善更明显(P < 0.05)。 结论 基于“脾胃升降协调论”的半夏调中颗粒联合背俞针刺针药结合法治疗NERD重叠FD疗效显著，且能改善患者食管及胃动力情况，临床应用安全可靠，值得推广。Abstract: Objective To evaluate the efficacy and safety of combination of acupuncture and medicine therapy based on "Coordination of Spleen and Stomach Ascending and Descending Theory" in treating non-erosive reflux disease(NERD) overlapping with functional dyspepsia(FD). Methods A total of 158 patients diagnosed with NERD overlapping with FD who visited the outpatient and inpatient departments of the Department of Gastroenterology, Wuhan Hospital of Traditional Chinese and Western Medicine from January 10, 2024 to November 31, 2024 were randomly divided into the experimental and the control group, with 79 cases in each group. The experimental group was treated with Banxia Tiaozhong granules combined with Back-shu acupuncture, while the control group was treated with pantoprazole combined with mosapride. The treatment course for both groups was 4 weeks. The clinical efficacy, GerdQ scale scores, high-resolution esophageal manometry(HREM) and electrogastrography(EGG) indicators before and after treatment were compared between the two groups, and the safety was evaluated by the occurrence of adverse events. Results The total effective rate of the experimental group was 88.6%(70/79), and that of the control group was 78.5%(62/79), with no significant difference between the two groups(P>0.05). Compared with before treatment, the GerdQ scale scores, high-resolution esophageal manometry indicators LESP, DCI, DL, PA, PV, and the overall gastric slow wave percentage and PR of EGG before and after meals in both groups decreased after treatment(P < 0.05). Compared with the control group, the improvement of GerdQ scale scores, LESP, DCI, PA, PV, and the overall gastric slow wave percentage before and after meals in the experimental group was more significant(P < 0.05). Conclusion The combined therapy of Banxia Tiaozhong granules and Back-shu acupuncture based on the "Coordination of Spleen and Stomach Ascending and Descending Theory" has significant clinical efficacy in treating NERD overlapping with FD, improves esophageal and gastric motility, and is safe and reliable for application, making it worth promoting.
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表 1 两组患者的临床资料比较
例，X±S 组别 例数 性别 年龄/岁 BMI 病程/月 男 女 试验组 79 36 43 48.09±10.95 23.21±3.16 12.56±4.43 对照组 79 38 41 48.66±10.43 23.31±2.97 12.61±4.36 P 0.750 0.738 0.839 0.942 
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表 2 NERD的诊断标准
项目 诊断依据 临床症状 有典型烧心或反流症状，或胸痛、上腹部烧灼感、嗳气、咽部或胸骨后异物感等不典型症状，即可拟诊NERD GerdQ量表评分 ≥8分 辅助检查 1个月内胃镜检查无食管黏膜损伤，1年内食管24 h pH及阻抗监测提示存在病理性反流 排除其他疾病 排除反流性食管炎、Barrett食管及其他上消化道疾病 注：患者没有食管24 h pH及阻抗监测记录，但症状、GerdQ评分及胃镜符合诊断标准者，可纳入NERD诊断。
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表 3 两组患者的临床疗效比较
例(%) 组别 例数 有效 无效 总有效率/% P 试验组 79 70(88.6) 9(11.4) 88.6 0.132 对照组 79 62(78.5) 17(21.5) 78.5
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表 4 两组患者的GerdQ量表评分比较
分，X±S 组别 例数 治疗前 治疗后 P 试验组 79 11.89±2.03 6.23±1.721)2) < 0.001 对照组 79 11.51±2.63 6.85±1.561) < 0.001 P 0.311 0.019 与治疗前比较，1)P < 0.001；与对照组比较，2)P < 0.05。
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表 5 两组患者的HREM食管上下段动力指标比较
mmHg，X±S 组别 例数 时间 UESPa) LESPa) 试验组 79 治疗前 58.99±20.06 9.61±5.23 治疗后 59.93±17.47 12.96±5.131)2) 对照组 79 治疗前 59.08±22.90 9.86±5.36 治疗后 60.39±15.79 11.23±5.591) 注：a)1 mmHg=0.133 kPa。
与治疗前比较，1)P < 0.05；与对照组比较，2)P < 0.05。
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表 6 两组患者的HREM食管体部动力指标比较
X±S 组别 例数 时间 DCI/(mmHg·s·cm) DL/s PA/mmHg PV/(cm/s) 试验组 79 治疗前 1 159.28±390.69 7.36±1.65 58.77±9.45 3.11±1.25 治疗后 1 628.72±495.971)2) 8.75±1.811) 67.48±11.901)2) 3.27±1.221)2) 对照组 79 治疗前 1 137.29±377.00 7.57±1.52 59.24±7.93 2.81±1.15 治疗后 1 477.12±416.311) 8.62±1.521) 61.77±5.451) 2.89±1.081) 与治疗前比较，1)P < 0.05；与对照组比较，2)P < 0.05。
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表 7 两组患者的整体胃慢波百分比比较
%，X±S 组别 例数 时间 餐前整体胃
慢波百分比餐后整体胃
慢波百分比试验组 79 治疗前 61.31±10.88 59.99±8.90 治疗后 75.46±9.861)2) 74.61±10.371)2) 对照组 79 治疗前 63.86±12.00 62.47±10.03 治疗后 71.34±9.881) 70.92±10.091) 与治疗前比较，1)P < 0.05；与对照组比较，2)P < 0.05。
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表 8 两组患者的整体胃PR比较
例(%) 时间 组别 例数 整体胃
PR>1整体胃
PR≤1P 治疗前 试验组 79 41(51.9) 38(48.1) 0.874 对照组 79 39(49.4) 40(50.6) 治疗后 试验组 79 71(89.9) 8(10.1) 0.250 对照组 79 65(82.3) 14(17.7)
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表 9 两组患者的整体胃PR组内比较
例(%) 组别 例数 时间 治疗后
PR>1治疗后
PR≤1P 试验组 79 治疗前PR>1 41(100.0) 0 0.006 治疗前PR≤1 30(78.9) 8(21.1) 对照组 79 治疗前PR>1 39(100.0) 0 < 0.001 治疗前PR≤1 26(65.0) 14(17.7)
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