Randomized, double-blinded and controlled trial of Xiangsha Liujunzi Granule in the treatment of functional dyspepsia with spleen deficiency syndrome
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摘要: 目的 研究香砂六君子颗粒治疗功能性消化不良(FD)脾虚证的有效性与安全性。方法 将2018年10月—2020年1月中国中医科学院西苑医院收治的60例FD脾虚证患者随机分为试验组与对照组，每组30例，试验组予香砂六君子颗粒治疗，对照组予安慰剂治疗，疗程4周。观察2组临床总体印象量表应答率、中医证候积分、生活质量评分、安全性指标。结果 治疗后，与对照组比较，试验组临床总体印象量表应答率升高，但差异无统计学意义(P>0.05)；中医证候总积分明显下降(P< 0.05)，胃脘痞满、胃脘痛、四肢乏力单项症状消失率明显升高(P< 0.01，P< 0.05)；SF-36量表评分中的总体健康、躯体疼痛、生命活力、情感职能、精神健康评分明显升高(P< 0.05)。试验期间未出现明显不良反应。结论 香砂六君子颗粒治疗FD脾虚证具有一定的疗效，且安全性好。Abstract: Objective To study the efficacy and safety of Xiangsha Liujunzi Granule in the treatment of functional dyspepsia (FD) with spleen deficiency syndrome.Methods Sixty patients with FD spleen deficiency syndrome admitted from October 2018 to January 2020 were randomly divided into the treatment and control groups, with 30 patients in each group. The treatment group was treated with Xiangsha Liujunzi Granule, and the control group was treated with placebo. The treatment course was 4 weeks. The response rate of clinical global impression scale, TCM syndrome score, life quality score and safety index were observed in the two groups.Results After treatment, the response rate of clinical impression scale in the treatment group was higher than that in the control group, however, there was no significant difference between the two groups (P>0.05); The total score of TCM syndromes was significantly lower than that in the control group(P< 0.05); The disappearance rate of epigastric fullness, epigastric pain and limb weakness was significantly increased (P< 0.01,P< 0.05); Overall health, physical pain, life vitality, emotional function, mental health scores of SF-36 scale were significantly increased (P< 0.05). No significant adverse reactions were reported in the two groups.Conclusion Xiangsha Liujunzi Granule has a certain curative effect and safety in the treatment of FD with spleen deficiency syndrome.
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表 1 2组患者临床总体印象量表应答率比较
例 组别 例数 完全缓解 明显缓解 轻度缓解 无缓解 轻度恶化 应答率/% 试验组 26 3 15 7 1 0 69.23 对照组 28 1 11 12 2 2 42.86 
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表 2 2组患者中医证候总积分比较
分，X±S 组别 例数 治疗前 治疗后 试验组 26 9.35±3.98 4.69±4.241)2) 对照组 28 11.82±5.20 7.71±5.231) 与同组治疗前比较，1)P < 0.01；与对照组比较，2)P < 0.05。
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表 3 2组患者中医证候单项症状消失率比较
例 症状 试验组 对照组 有症状 消失 未消失 消失率/% 有症状 消失 未消失 消失率/% 胃脘痞满 20 14 6 70.001) 24 7 17 29.17 胃脘痛 18 13 5 72.222) 20 7 13 35.00 纳呆 14 7 7 50.00 11 5 6 45.45 口吐清涎 4 4 0 100.00 7 6 1 85.71 咽部梗阻感 10 4 6 40.00 13 6 7 46.15 口渴不欲饮水 13 7 6 53.85 9 3 6 33.33 少腹胀痛 9 6 3 66.67 14 4 10 28.57 四肢乏力 19 13 6 68.422) 25 8 17 32.00 气短 10 5 5 50.00 16 2 14 12.50 懒言 12 7 5 58.33 15 5 10 33.33 全身及四肢困重 10 6 4 60.00 16 7 9 43.75 畏寒怕冷 14 7 7 50.00 23 6 17 26.09 大便稀溏 14 9 5 64.29 15 6 9 40.00 与对照组比较，1)P < 0.01，2)P < 0.05。
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表 4 2组患者SF-36量表各维度评分比较
分，M(P25，P75)，X±S 维度 试验组(n=26) 对照组(n=28) 治疗前 治疗后 治疗前 治疗后 生理功能 100(95，100) 100(100，100) 100(95，100) 100(95，100) 生理职能 100(100，100) 100(100，100) 100(81.25，100) 100(100，100) 躯体疼痛 82.65±19.05 91.54±10.541)3) 81.11±17.46 83.50±14.12 总体健康 58.92±19.35 72.42±17.752)3) 50.43±19.92 61.82±18.342) 生命活力 72.88±12.58 80.96±13.272)3) 66.61±14.60 73.21±12.642) 社会功能 100(88.89，100) 100(88.89，100) 88.89(77.78，100) 94.44(80.56，100) 情感职能 100(91.67，100) 100(100，100)1)3) 100(66.67，100) 100(100，100) 精神健康 73.54±14.18 81.69±12.451)3) 69.86±14.75 75.14±11.331) 与同组治疗前比较，1)P < 0.05，2)P < 0.01；与对照组比较，3)P < 0.05。
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[1] Sayuk GS, Gyawali CP. Functional Dyspepsia: Diagnostic and Therapeutic Approaches[J]. Drugs, 2020, 80(13): 1319-1336. doi: 10.1007/s40265-020-01362-4
[2] Mahadeva S, Ford AC. Clinical and epidemiological differences in functional dyspepsia between the East and the West[J]. Neurogastroenterol Motil, 2016, 28(2): 167-174. doi: 10.1111/nmo.12657
[3] Kamiya T, Osaga S, Kubota E, et al. Questionnaire-Based Survey on Epidemiology of Functional Gastrointestinal Disorders and Current Status of Gastrointestinal Motility Testing in Asian Countries[J]. Digestion, 2020, 102(1): 73-89.
[4] Wauters L, Talley NJ, Walker MM, et al. Novel concepts in the pathophysiology and treatment of functional dyspepsia[J]. Gut, 2020, 69(3): 591-600. doi: 10.1136/gutjnl-2019-318536
[5] Addula M, Wilson VED, Reddymasu S, et al. Immunopathological and molecular basis of functional dyspepsia and current therapeutic approaches[J]. Expert Rev Clin Immunol, 2018, 14(10): 831-840. doi: 10.1080/1744666X.2018.1524756
[6] Ford AC, Mahadeva S, Carbone MF, et al. Functional dyspepsia[J]. Lancet, 2020, 396(10263): 1689-1702. doi: 10.1016/S0140-6736(20)30469-4
[7] Mounsey A, Barzin A, Rietz A. Functional Dyspepsia: Evaluation and Management[J]. Am Fam Physician, 2020, 101(2): 84-88.
[8] Chu M, Wu I, Ho R, et al. Chinese herbal medicine for functional dyspepsia: systematic review of systematic reviews[J]. Therap Adv Gastroenterol, 2018, 11: 1756284818785573.
[9] 戴宁. 功能性消化不良脾虚证证候及香砂六君子加减方的作用机理研究[D]. 北京: 北京中医药大学, 2020.
[10] Stanghellini V, Chan FK, Hasler WL, et al. Gastroduodenal Disorders[J]. Gastroenterology, 2016, 150(6): 1380-1392. doi: 10.1053/j.gastro.2016.02.011
[11] 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.
[12] 中华中医药学会脾胃病分会, 张声生. 功能性消化不良中医诊疗专家共识意见(2017)[J]. 中华中医药杂志, 2017, 32(6): 2595-2598. https://www.cnki.com.cn/Article/CJFDTOTAL-BXYY201706072.htm
[13] 燕东, 王少丽. 姚乃礼治疗脾胃病经验[J]. 中医杂志, 2017, 58(21): 1818-1821. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZYZ201721005.htm
[14] 杨森林, 黄福斌. 香砂六君子汤药理研究及临床应用进展[J]. 国际中医中药杂志, 2016, 38(5): 467-469. doi: 10.3760/cma.j.issn.1673-4246.2016.05.027
[15] Lv L, Wang FY, Ma XX, et al. Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study[J]. World J Gastroenterol, 2017, 23(30): 5589-5601. doi: 10.3748/wjg.v23.i30.5589
[16] Majeed M, Majeed S, Nagabhushanam K, et al. Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study[J]. J Med Food, 2018, 21(11): 1120-1128. doi: 10.1089/jmf.2017.4172
[17] Chey WD, Lacy BE, Cash BD, et al. A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial[J]. Clin Transl Gastroenterol, 2019, 10(4): e00021. doi: 10.14309/ctg.0000000000000021
[18] Wang F, Zhang Q, Lu Z, et al. Identification of chemical constituents in traditional Chinese medicine formula using HPLC coupled with linear ion trap-orbitrap MS from high doses of medicinal materials to equivalent doses of formula: Study on Xiang-Sha-Liu-Jun-Zi-Jia-Jian granules[J]. J Sep Sci, 2016, 39(9): 1619-1627. doi: 10.1002/jssc.201501223
[19] Hantoro IF, Syam AF, Mudjaddid E, et al. Factors associated with health-related quality of life in patients with functional dyspepsia[J]. Health Qual Life Outcomes, 2018, 16(1): 83. doi: 10.1186/s12955-018-0913-z
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