The therapeutic effect of Xinkai Kujiang Compound on functional dyspepsia patients of cold heat complicated syndrome
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摘要: 目的 评价辛开苦降法中药方剂对功能性消化不良(FD)寒热错杂证患者临床症状、睡眠质量、精神心理和生活质量的影响。方法 将符合纳入和排除标准的58例FD寒热错杂证患者随机分成两组,每组29例。两组患者分别接受辛开苦降法中药方剂(治疗组)和安慰剂(安慰剂组)治疗4周;在治疗前后分别对患者的消化不良症状、睡眠质量、精神心理和生活质量进行评价。结果 治疗4周后,治疗组和安慰剂组患者的上腹饱胀、上腹痛、恶心、呕吐等症状均较治疗前有明显改善(P<0.05),且主要症状评分及总评分均显著降低(P<0.05);但治疗组患者上腹痛、早饱、嗳气及主要症状评分、症状总评分均明显低于安慰剂组(P<0.05)。治疗组与安慰剂组治疗前后的睡眠质量评分比较差异无统计学意义(P>0.05)。治疗4周后,治疗组汉密尔顿焦虑量表、汉密尔顿抑郁量表评分较治疗前及安慰剂组均显著降低,差异有统计学意义(P<0.05)。治疗4周后,治疗组患者SF-36量表生活质量评分的8个维度中,生理职能、精神健康两个方面的评分明显改善(P<0.05),其他维度评分改善差异无统计学意义(P>0.05);安慰剂组SF-36量表生活质量评分的8个维度改善情况均差异无统计学意义(P>0.05);治疗组及安慰剂组治疗前后8个维度评分组间比较差异无统计学意义(P>0.05)。结论 辛开苦降法方剂可显著缓解FD寒热错杂证患者的症状,且能改善患者的焦虑、抑郁情绪和生活质量。Abstract: Objective To evaluate the effects on clinical symptoms, sleep quality, anxiety and depression scores and life quality of patients with functional dyspepsia(FD) of cold heat complicated syndrome treated by Xinkai Kujiang Compound.Methods Fifty-eight patients with FD of cold heat complicated syndrome who met the criteria for inclusion and exclusion were randomly divided into two groups. The treatment group received Xinkai Kujiang Compound and the placebo group received placebo for a total of 4 weeks, respectively. The symptoms of dyspepsia, sleep quality, psychological state and life quality were evaluated in pre-treatment and post-treatment(0 w, 4 w).Results After 4 weeks of treatment, the symptom scores of postprandial fullness, nausea and vomiting were significantly improved in both groups compared with pre-treatment(P < 0.05), and the main symptom score and overall score were significantly reduced in both groups(P < 0.05), however the symptom scores of epigastric pain, early satiety and belching in the treatment group were significantly lower than those in the placebo group(P < 0.05) after 4 weeks. There was no significant difference in sleep quality scores in pre-treatment and post-treatment(P > 0.05) in both groups. After 4 weeks of treatment, Hamilton anxiety scale and Hamilton depression scale scores in the treatment group were significantly lower than in pre-treatment (P < 0.05). After 4 weeks of treatment, among the 8 dimensions of the SF-36 quality of life score in the treatment group, the scores of two aspects of physical function and mental health were significantly improved (P < 0.05), and there was no difference in the improvement of other dimension scores (P > 0.05); there was no significant difference in the improvement of 8 dimensions of SF-36 quality of life score in the placebo group (P > 0.05); there was no significant difference in the scores of 8 dimensions between the groups in pre-treatment and post-treatment (P > 0.05).Conclusion Xinkai Kujiang Compound can significantly improve the symptoms of FD patients with cold heat complicated syndrome, and then improve psychological state and quality of life.
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表 1 治疗组及安慰剂组治疗前后症状评分的比较
分,X±S 症状 安慰剂组(n=29) 治疗组(n=29) t P 治疗前 治疗后 治疗前 治疗后 上腹饱胀 3.68±1.53 2.38±1.821) 3.68±1.34 2.38±1.501)2) 1.910 0.046 早饱 1.21±0.81 0.85±0.68 2.05±1.12 0.38±0.181)2) 2.489 0.019 上腹痛 2.68±1.06 0.87±0.451) 1.58±1.06 0.31±0.151)2) 3.036 0.005 上腹烧灼感 1.79±1.07 1.63±1.03 1.84±1.09 1.31±0.89 0.785 0.439 上腹胀气 2.74±1.69 1.62±1.02 2.42±1.92 1.31±0.69 1.620 0.116 嗳气 2.53±1.34 1.44±1.05 1.79±1.07 0.31±0.151)2) 2.696 0.011 恶心 1.21±0.84 01) 0.84±0.54 01) 1.965 0.049 呕吐 0.37±1.21 01) 0.68±0.42 01) 1.733 0.043 主要症状评分 9.37±4.49 6.50±4.121) 9.15±3.32 3.46±1.091)2) 4.335 <0.001 症状总评分 16.21±7.65 9.56±6.561) 14.89±3.32 5.08±2.311)2) 4.165 <0.001 与治疗前比较,1)P<0.05;与安慰剂组比较,2)P<0.05。 表 2 治疗组及安慰剂组治疗前后PSQI评分的比较
分,X±S 组别 例数 治疗前 治疗后 t P 治疗组 29 7.63±3.71 5.67±3.82 1.622 0.116 安慰剂组 29 6.8±2.42 5.44±3.37 1.136 0.265 表 3 治疗组及安慰剂组治疗前后HAMA、HAMD评分的比较
分,X±S 组别 例数 治疗前 治疗后 HAMA HAMD HAMA HAMD 安慰剂组 29 10.22±7.09 9.06±6.06 7.83±5.55 9.06±6.06 治疗组 29 8.55±6.43 8.47±3.87 3.40±2.671)2) 3.10±2.381)2) 与治疗前比较,1)P<0.05;与安慰剂组比较,2)P<0.05。 表 4 治疗组及安慰剂组治疗前后SF-36量表生活质量评分的比较
分, X±S 项目 安慰剂组(n=29) 治疗组(n=29) t P 治疗前 治疗后 治疗前 治疗后 生理功能 76.90±36.24 85.31±17.93 75.95±19.43 90.83±15.49 -1.145 0.261 生理职能 55.95±12.54 73.45±10.57 47.62±15.80 87.50±31.081) -2.195 0.036 躯体疼痛 66.67±12.17 83.33±9.13 61.91±15.31 75.00±13.06 -5.795 0.567 总体健康 66.19±19.29 73.75±19.11 69.05±17.72 77.50±19.59 -1.269 0.214 精力 62.86±21.13 72.75±19.82 64.19±18.61 72.67±17.79 -1.278 0.211 社会功能 81.55±28.67 86.72±24.35 79.17±19.09 91.67±16.28 -1.904 0.066 情感职能 74.64±20.68 79.22±26.02 84.29±20.99 89.38±13.86 -0.749 0.459 精神健康 55.47±21.09 66.56±16.50 54.52±18.02 70.00±20.341) -2.266 0.031 与治疗前比较,1)P<0.05。 -
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