Clinical study on the treatment of Helicobacter pylori chronic gastritis with Qingre Huazhuo formula
-
摘要: 目的 观察清热化浊方治疗幽门螺杆菌(Helicobacter pylori，HP)慢性胃炎脾胃湿热证的临床疗效、HP根除率及其可能的作用机制，同时评估其安全性。方法 采用平行随机对照研究的方法，选取符合研究标准的180例HP慢性胃炎脾胃湿热证患者为研究对象，随机分为中医组、西医组和中西医结合组。中医组给予中药汤剂清热化浊方治疗，1剂/d，疗程1个月；西医组给予四联疗法根除HP，疗程2周；中西医结合组在服用清热化浊方基础上，配合四联疗法根除HP。观察治疗前后中医证候积分、胃镜黏膜炎症积分及血清胃蛋白酶原(pepsinogen，PG)、胃泌素-17(gastrin-17，G-17)、细胞毒素相关蛋白A(cytotoxin associated protein A，CagA)、空泡毒素A(vacuolar toxin A，VacA)水平和HP根除率情况，评估治疗效果及安全性。结果 3组治疗后中医证候积分均较治疗前明显降低(P < 0.01)，中医组、中西医结合组优于西医组(P < 0.01)，食少纳呆方面中医组优于中西医结合组和西医组。3组治疗后胃镜黏膜炎症积分均较治疗前降低(P < 0.01)，中西医结合组优于中医组和西医组(P < 0.01或P < 0.05)。中医组、中西医结合组血清G-17、PGⅡ水平较治疗前降低，与西医组比较差异有统计学意义(P < 0.01)；中西医结合组PGⅠ水平较治疗前升高，与西医组比较差异有统计学意义(P < 0.05)。3组CagA、VacA阳性率均较治疗前明显降低(P < 0.01)，其中，中西医结合组CagA阳性率与中医组和西医组比较差异有统计学意义(P < 0.05)。中西医结合组和西医组的HP根除率优于中医组(P < 0.01)，中西医结合组的总有效率优于中医组和西医组(P < 0.01)。结论 中西医结合治疗HP慢性胃炎可有效改善中医证候、胃黏膜炎症，提高HP根除率，其作用机制可能与调控血清G-17、PG、CagA、VacA水平相关。Abstract: Objective To observe the clinical efficacy, Helicobacter pylori(HP) eradication rate and its possible mechanism of Qingre Huazhuo formula in treating HP chronic gastritis with spleen-stomach damp-heat syndrome and to evaluate its safety.Methods A parallel randomized controlled study was used to select 180 cases of HP chronic gastritis with spleen-stomach damp-heat syndrome meeting the study criteria. According to the random principle, they were divided into traditional Chinese medicine(TCM) group, Western medicine group and integrative medicine group. Qingre Huazhuo formula was used to treat patients in the TCM group, one dose per day for one month. The Western medicine group received quadruple therapy to eradicate HP for 2 weeks. On the basis of taking the Qingre Huazhuo formula, the integrated Chinese and Western medicine group combined with quadruple therapy to eradicate HP. The TCM syndrome score, gastroscopy mucosal inflammation integral, serum G-17, PG, CagA, VacA level and HP eradication rate, and then the treatment effect and safety were observed.Results The score of TCM syndrome in all three groups was significantly lower than that before treatment(P < 0.01), the TCM group and integrative medicine group were better(P < 0.01). The TCM group is better than the Western medicine group and integrative medicine group in improving appetite loss. Through treatment, the score of gastroscopy mucositis in the three groups were lower than before(P < 0.01), the integrative medicine group was superior to the TCM group and the Western medicine group(P < 0.01 or P < 0.05). The levels of G-17 and PGⅡ in the TCM group and the integrative medicine group were lower than before, which were significantly different from those in the Western medicine group(P < 0.01). The level of PGⅠ in the integrative medicine group was higher than that before, which was significantly different from that in the Western medicine group(P < 0.05). The positive rates of CagA and VacA in the three groups were significantly lower than before(P < 0.01), among them, the positive rate of CagA in the integrative medicine group was significantly lower than that in the TCM group and the Western medicine group(P < 0.05). In terms of HP eradication rate, the integrative medicine group and the Western medicine group were better than the TCM group(P < 0.01). The total effective rate of the integrative medicine group was better than that of the TCM group and the Western medicine group(P < 0.01).Conclusion Conbined treatment of traditional Chinese medicine and Western medicine in the treatment of HP chronic gastritis can effectively improve traditional Chinese medicine syndromes, gastric mucosal inflammation, and increase the eradication rate of HP. Its mechanism of action may be related to the regulation of serum G-17, PG, CagA, and VacA levels.
-
-
表 1 3组治疗前后中医证候积分比较
分，X±S 组别 脘腹痞满 脘腹疼痛 身体困重 大便黏滞或溏滞 食少纳呆 口苦 口臭 精神困倦 中医组(n=60) 治疗前 4.23± 1.61 2.77± 1.52 1.95± 1.25 2.27± 1.19 1.83± 0.89 2.38± 0.69 2.38± 0.83 1.30± 0.65 治疗后 1.93± 1.101) 1.23± 1.051) 1.07± 1.131) 0.97± 1.011) 0.90± 0.631)2) 1.20± 0.781) 1.15± 0.731) 0.53± 0.541) 中西医结合组(n=60) 治疗前 4.53± 1.27 2.60± 1.34 2.13± 1.10 1.90± 1.07 1.85± 0.78 2.20± 0.71 2.30± 0.72 1.20± 0.55 治疗后 2.23± 0.981) 1.17± 1.061) 1.47± 1.031) 1.00± 1.011) 1.37± 0.641)2) 1.35± 0.661) 1.45± 0.721) 0.72± 0.521) 西医组(n=60) 治疗前 4.03± 1.45 2.73± 1.16 2.27± 0.86 1.80± 1.31 1.82± 0.97 2.08± 0.67 2.22± 0.67 1.17± 0.62 治疗后 3.67± 1.341)2) 1.93± 0.731)2) 2.20± 0.882) 1.70± 1.272) 2.05± 0.911)2) 1.85± 0.661)2) 1.93± 0.691)2) 1.12± 0.582) 与治疗前比较，1)P < 0.01；3组治疗后两两比较，2)P < 0.01。 
下载: 导出CSV
表 2 3组治疗前后胃镜黏膜炎症积分比较
分，X±S 组别 胃黏膜弥漫性、点状发红 黏膜肿胀、皱襞粗大蛇形 白色混浊黏液 鸡皮样改变 中医组(n=60) 治疗前 2.22±0.76 1.90±0.63 1.60±0.64 0.40±0.92 治疗后 1.80±0.631) 1.50±0.621) 1.37±0.641) 0.35±0.80 中西医结合组(n=60) 治疗前 2.10±0.84 2.07±0.63 1.65±0.71 0.45±0.98 治疗后 1.05±0.621)2) 1.18±0.601)3) 1.03±0.551)2) 0.17±0.381) 西医组(n=60) 治疗前 2.17±0.69 1.90±0.73 1.75±0.60 0.47±0.98 治疗后 1.73±0.661) 1.48±0.601) 1.53±0.601) 0.42±0.87 与治疗前比较，1)P < 0.01；3组治疗后两两比较，2)P < 0.01，3)P < 0.05。
下载: 导出CSV
表 3 3组治疗前后血清G-17、PGⅠ、PGⅡ水平比较
X±S 组别 G-17/(pmol/L) PGⅠ/(ng/mL) PGⅡ/(ng/mL) 中医组(n=60) 治疗前 8.24±3.76 107.01±56.46 13.25±3.13 治疗后 5.93±2.581)2) 124.85±47.961) 11.72±2.861)2) 中西医结合组(n=60) 治疗前 8.70±2.88 106.48±54.80 14.25±3.52 治疗后 5.94±1.701)2) 130.94±42.521)3) 12.78±3.141)3) 西医组(n=60) 治疗前 8.84±3.53 109.96±51.45 14.46±3.07 治疗后 8.53±3.32 108.84±51.51 14.51±3.50 与治疗前比较，1)P < 0.01；3组治疗后两两比较，2)P < 0.01，3)P < 0.05。
下载: 导出CSV
表 4 3组治疗前后CagA、VacA阳性率比较
% 组别 CagA VacA 中医组(n=60) 治疗前 71.7 53.3 治疗后 33.31) 36.71) 中西医结合组(n=60) 治疗前 68.3 56.7 治疗后 21.71)2) 31.71) 西医组(n=60) 治疗前 70.0 55.0 治疗后 43.31) 38.31) 与治疗前比较，1)P < 0.01；3组治疗后两两比较，2)P < 0.05。
下载: 导出CSV
表 5 3组治疗后HP根除情况比较
例 组别 HP阴性 HP阳性 根除率/% 中医组(n=60) 31 29 51.7 中西医结合组(n=60) 53 7 88.31) 西医组(n=60) 45 15 75.01) 与中医组比较，1)P < 0.01。
下载: 导出CSV
表 6 3组治疗后疗效比较
例 组别 临床痊愈 显效 有效 无效 总有效率/% 中医组(n=60) 5 12 34 9 85.0 中西医结合组(n=60) 10 31 14 5 91.7 西医组(n=60) 6 13 22 19 68.3
下载: 导出CSV
-
[1] Nagy P, Johansson S, Molloy-Bland M. Systematic review oftime trends in the prevalence of Helicobacter pylori infection in China and the USA[J]. Gut Pathog, 2016, 8: 8. doi: 10.1186/s13099-016-0091-7
[2] Sugano K, Tack J, Kuipers EJ, et al. Kyoto global consensus report on Helicobacter pylori gastritis[J]. Gut, 2015, 64(9): 1353-1367. doi: 10.1136/gutjnl-2015-309252
[3] 袁媛. 胃黏膜"血清学活检"临床应用现状与展望[J]. 胃肠病学和肝病学杂志, 2015, 24(2): 121-125.
[4] 房静远, 杜奕奇, 刘文忠, 等. 中国慢性胃炎共识意见(2017年, 上海)[J]. 胃肠病学, 2017, 22(11): 670-687.
[5] 刘文忠, 谢勇, 陆红, 等. 第五次全国幽门螺杆菌感染处理共识报告[J]. 胃肠病学, 2017, 22(6): 346-360.
[6] 张声生, 唐旭东, 黄穗平, 等. 慢性胃炎中医诊疗专家共识意见(2017)[J]. 中华中医药杂志, 2017, 32(7): 3060-3064.
[7] 郑筱萸. 中药新药临床研究指导原则(试行)[M]. 北京: 中国医药科技出版社, 2002: 124-129.
[8] 李佃贵. 中医浊毒论[M]. 北京: 人民卫生出版社, 2016: 6-17.
[9] 王津燕. 中药黄芩药理作用的研究进展[J]. 内蒙古中医药, 2020, 39(2): 167-168.
[10] 黄衍强, 黄干荣, 李晓华, 等. 中药提取物对耐药幽门螺杆菌生物膜形成的影[J]. 医药导报, 2013, 32(11): 1407-1409.
[11] 张彧, 吴东升, 徐寅, 等. 基于网络药理学分析半夏-黄芩-黄连治疗幽门螺杆菌相关性胃炎的作用机制[J]. 天然产物研究与开发, 2020, 32(4): 592-599.
[12] Liu N, Huang Y, Liu F, et al. Serum exosomal miR-122-5p, GAS, and PGR in the non-invasive diagnosis of CAG[J]. Open Med(Wars), 2021, 16(1): 1350-1355.
[13] Zhao K, Zhang Y, Xia S, et al. Epstein-barr virus is associated with gastric cancer precursor: atrophic gastritis[J]. Int J Med Sci, 2022, 19(5): 924-931.
[14] 周明霞, 徐惠明. 疏肝理气方治疗疣状胃炎临床疗效及对血清pgI、pgⅡ及CRP表达水平的影响[J]. 湖北中医药大学学报, 2020, 22(6): 32-35.
[15] 周昕瞳. 柴胡疏肝汤加减治疗慢性萎缩性胃炎肝胃不和证患者的疗效及其对血清胃泌素G17水平的影响[J]. 中国民康医学, 2018, 30(17): 66-67.
[16] 陈莫耶, 徐倩, 孙丽萍, 等. 血清胃泌素17水平与胃癌及癌前疾病的相关性研究[J]. 胃肠病学和肝病学杂志, 2015, 24(2): 161-165.
-