Randomized, multicenter, double-blind, double dummy, parallel controlled study of Elian granules in the treatment of chronic atrophic gastritis with precancerous lesions
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摘要: 目的 客观评价莪连颗粒治疗慢性萎缩性胃炎伴癌前病变的临床疗效及药物安全性。方法 纳入慢性萎缩性胃炎伴癌前病变脾虚瘀热证的病例169例，来自曙光医院、华东医院、龙华医院、岳阳医院、普陀区中医医院和奉贤区中医医院门诊，根据治疗方法分为两组，试验组采用莪连颗粒与胃复春片模拟剂治疗(n=87)，对照组采用胃复春片和莪连颗粒模拟剂治疗(n=82)，疗程12周。比较两组患者胃黏膜组织病理学疗效、治疗前后中医证候积分及单项症状积分、并进行安全性分析。结果 两组的病理总有效率在胃黏膜慢性炎症、活动性、萎缩、肠化和异型增生等方面分别为：试验组24.68%、55.56%、57.14%、54.43%、75.00%，对照组21.92%、60.00%、54.79%、55.41%、62.50%，组间比较均差异无统计学意义(P>0.05)。两组在症状总积分的疗效分别为试验组89.66%，对照组87.80%，组间比较差异无统计学意义(P>0.05)；胃脘疼痛、胃脘痞满、胃脘不适、纳差、乏力、便溏、口苦、口气重等单个症状的疗效比较，组间差异无统计学意义(P>0.05)。结论 莪连颗粒治疗脾虚瘀热证型慢性萎缩性胃炎伴癌前病变，可明显改善患者临床症状，逆转胃黏膜的萎缩及肠化生，且安全性较好，与胃复春疗效相当。Abstract: Objective To objectively evaluate the clinical efficacy and drug safety of Elian granules in the treatment of chronic atrophic gastritis with precancerous lesions.Methods One hundred and sixty-nine cases of chronic atrophic gastritis with precancerous lesions conforming to the syndrome of spleen deficiency and blood stasis heat were included. They were from Shuguang Hospital, Huadong Hospital, Longhua Hospital, Yueyang Hospital, Putuo District Hospital of TCM and Fengxian District Hospital of TCM. According to the treatment methods, they were divided into two groups. The test group was treated with Elian granules and Weifuchun tablets simulants(n=87), and the control group was treated with Weifuchun tablets and Elian granules simulants(n=82) for 12 weeks. The score of TCM syndromes and efficacy, score of single symptom, pathological analysis of gastric mucosa and safety of the two groups were compared and summarized.Results The total pathological effective rates of the two groups were 24.68%, 55.56%, 57.14%, 54.43%, 75.00% in the experimental group and 21.92%, 60.00%, 54.79%, 55.41%, 62.50% in the control group in terms of gastric mucosa chronic inflammation, activity, atrophy, intestinal metaplasia and dysplasia, respectively. There was no significant difference between the two groups (P>0.05).The total scores of the two groups in the symptoms of epigastric pain, epigastric distension, epigastric discomfort, anorexia, fatigue, loose stools, bitter mouth, and heavy breath were 89.66% in the test group and 87.80% in the control group, respectively, with no statistical difference between the two groups(P>0.05); There was no significant difference in the efficacy of single symptom between the groups(P>0.05).Conclusion Elian granule can significantly improve the clinical symptoms of patients with chronic atrophic gastritis with precancerous lesions of spleen deficiency and blood stasis heat type, reverse the atrophy of gastric mucosa and intestinal metaplasia, and has good safety, which is equivalent to the effect of gastric rejuvenation.
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表 1 两组患者基线资料比较
例(%) 基线资料 总样本
(n=169)试验组
(n=87)对照组
(n=82)性别 男 87(51.48) 53(60.92) 34(41.46) 女 82(48.52) 34(39.08) 48(58.54) 年龄/岁 57.9±9.5 57.4±10.3 58.4±8.5 胃黏膜病理 萎缩 146 75 71 + 71(48.63) 31(41.33) 40(56.34) ++ 60(41.10) 36(48.00) 24(33.80) +++ 15(10.27) 8(10.67) 7(9.86) 肠化 153 79 74 + 53(34.64) 23(29.11) 30(40.54) ++ 75(49.02) 44(55.70) 31(41.89) +++ 25(16.34) 12(15.19) 13(17.57) 异型增生 13 7 6 + 12(92.31) 7(100.00) 5(83.33) ++ 1(7.69) 0 1(16.67) 
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表 2 两组治疗前后症状总积分和单项症状积分比较
分，X±S 组别 治疗前 治疗后4周 治疗后8周 治疗后12周 有效率/% 试验组 症状总积分 21.60±7.89 13.97±7.58 10.13±5.94 6.54±5.64 89.66 胃脘疼痛 3.25±1.78 2.24±1.77 1.63±1.58 0.87±1.45 70.11 胃脘痞满 3.89±1.50 2.80±1.48 1.93±1.67 1.41±1.62 77.01 胃脘不适 3.60±1.51 2.52±1.62 1.93±1.56 1.54±1.55 64.37 纳差 2.30±1.82 1.54±1.66 1.11±1.54 0.68±1.31 49.43 乏力 2.61±1.54 1.57±1.65 1.03±1.43 0.79±1.33 56.32 便溏 1.53±1.58 0.69±1.31 0.66±1.25 0.21±0.77 42.53 口苦 2.40±1.72 1.45±1.62 1.00±1.42 0.62±1.22 57.47 口气重 1.97±1.86 1.20±1.56 0.79±1.33 0.38±1.00 47.13 对照组 症状总积分 20.10±7.36 12.94±7.21 9.93±5.76 6.01±4.67 87.80 胃脘疼痛 3.22±1.89 2.12±1.62 1.57±1.74 0.90±1.43 69.51 胃脘痞满 3.78±1.71 2.40±1.71 2.01±1.54 1.39±1.51 70.73 胃脘不适 3.65±1.28 2.50±1.62 2.28±1.38 1.82±1.52 62.20 纳差 2.13±1.69 1.65±1.73 1.10±1.45 0.40±1.03 52.44 乏力 2.27±1.91 1.49±1.67 0.93±1.48 0.59±1.20 51.52 便溏 1.24±1.61 0.48±1.10 0.37±0.99 0.11±0.57 36.59 口苦 2.01±1.77 1.27±1.53 1.02±1.43 0.40±1.03 52.44 口气重 2.01±2.51 0.98±1.46 0.65±1.29 0.37±0.99 45.12
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表 3 两组患者治疗后胃黏膜组织病理疗效
例 组别 痊愈 显效 有效 无效 总有效率/% 试验组 慢性炎症 0 1 18 58 24.68 炎症活动性 1 1 13 12 55.56 萎缩 4 6 34 33 57.14 肠化 6 10 27 36 54.43 异型增生 2 0 4 2 75.00 对照组 慢性炎症 0 0 16 57 21.92 炎症活动性 0 1 14 10 60.00 萎缩 7 7 26 33 54.79 肠化 7 7 27 33 55.41 异型增生 0 1 4 3 62.50
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