Clinical study on the treatment of chronic radiation enteritis (spleen and kidney deficiency) with Bushen Jianpi Wenchang Prescription combined with enema
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摘要: 目的 探讨补肾健脾温肠方口服联合重组人粒细胞巨噬细胞集落刺激因子(granulocyte macrophage colony-stimulating factor，GM-CSF)灌肠治疗慢性放射性肠炎的疗效及安全性。方法 选取61例慢性放射性肠炎患者为研究对象，随机分为治疗组(31例)和对照组(30例)。治疗组给予补肾健脾温肠方口服联合GM-CSF灌肠，对照组给予谷氨酰胺肠溶胶囊口服联合地塞米松加蒙脱石散灌肠；两组均连续治疗30 d。观察两组治疗前后的疗效、肠道放射反应程度分级、维也纳肠镜评分、患者自评-主观全面评定(patient-generated subjective global assessment，PG-SGA)评分、中医证候评分(腹痛、腹泻)、不良反应。结果 治疗组缓解率为93.5%(29/31)，对照组缓解率为80.0%(24/30)，两组比较差异有统计学意义(Z=-2.202，P=0.043)；两组患者治疗后的肠道放射反应程度分级、维也纳肠镜评分、中医证候评分均较治疗前改善；治疗后治疗组的肠道放射反应程度分级、维也纳肠镜评分、中医证候评分均优于对照组(均P < 0.05)；治疗后两组患者的PG-SGA评分均优于治疗前，治疗后两组比较差异无统计学意义(P>0.05)。结论 补肾健脾温肠方口服联合GM-CSF保留灌肠可降低慢性放射性肠炎患者的肠道损伤程度，改善患者的维也纳肠镜评分以及腹泻、纳差、营养状态，并且安全性好。
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关键词:
- 补肾健脾温肠方 /
- 慢性放射性肠炎 /
- 脾肾双虚证 /
- 重组人粒细胞巨噬细胞集落刺激因子 /
- 复方谷氨酰胺肠溶胶囊 /
- 灌肠
Abstract: Objective To investigate the efficacy and safety of Bushen Jianpi Wenchang Prescription combined with granulocyte-macrophage colony-stimulating factor(GM-CSF) enema in the treatment of chronic radiation enteritis.Methods Sixty-one patients with chronic radiation enteritis were selected as research objects and randomly divided into a treatment group(31 cases) and a control group(30 cases). The treatment group was given Bushen Jianpi Wenchang Prescription oral combined with GM-CSF enema, and the control group was given glutamine enteric coated capsule oral combined with dexamethasone+montmorillonite powder enema for 30 consecutive days. Observe the symptom response rate, the grade of intestinal radiation reaction, the Vienna enteroscopy score(VRS), patient-generated subjective global assessment(PG-SGA), the Traditional Chinese Medicine(TCM) syndrome score(abdominal pain, diarrhea), and adverse reactions before and after treatment.Results The remission rate in the treatment group was 93.5%(29/31), and that in the control group was 80.0%(24/30). The difference between the two groups was statistically significant(Z=-2.202, P=0.043); after treatment, the degree of intestinal radiation reaction, the VRS and TCM syndrome score of the two groups were improved compared with those before treatment; after treatment, the treatment group was superior to the control group in the grading of intestinal radiation reaction, the VRS and the score of TCM syndromes(P < 0.05); the PG-SGA score of the two groups after treatment was better than that before treatment, and there was no significant difference between the two groups after treatment(P>0.05).Conclusion Bushen Jianpi Wenchang Prescription combined with retention enema can reduce the degree of intestinal injury in patients with chronic radiation enteritis, improve the patients' enteroscopy score, diarrhea, anorexia, and nutritional status, and is safe. -
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表 1 两组患者的临床资料比较
例，X±S 组别 例数 年龄/岁 性别 放射治疗至发病时间/月 发病部位 PS评分/分 病程/d 男 女 结肠 直肠 治疗组 31 54.37±6.11 11 20 8.36±0.75 14 17 1.78±0.11 32.34±5.43 对照组 30 54.74±6.32 10 20 8.77±0.61 15 15 1.52±0.43 33.27±5.21 t/χ2 0.794 0.310 0.629 0.140 -0.744 0.651 P 0.539 0.860 0.810 0.705 0.522 0.577 
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表 2 两组患者治疗后的疗效比较
例 组别 例数 完全缓解 部分缓解 轻微缓解 无效 Z P 治疗组 31 9 12 8 2 -2.202 0.043 对照组 30 3 12 9 6
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表 3 两组患者治疗前后CRE肠道放射反应程度分级比较
例 组别 例数 治疗前 治疗后 Z P 0级 1级 2级 3级 4级 0级 1级 2级 3级 4级 治疗组 31 0 8 15 8 0 5 16 9 1 0 -3.751 0.010 对照组 30 0 6 17 7 0 1 12 15 2 0 -2.346 0.019 Z -0.182 -2.154 P 0.855 0.031
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表 4 两组患者治疗前后的VRS评分比较
分，X±S 组别 例数 治疗前 治疗后 t P 治疗组 31 11.21±1.21 4.63±0.96 12.13 < 0.001 对照组 30 11.39±1.75 7.41±1.44 10.91 < 0.001 t -0.225 -9.695 P 0.766 0.012
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表 5 两组患者治疗前后PG-SGA、中医证候评分的比较
分，X±S 组别 例数 PG-SGA 中医证候评分 治疗前 治疗后 t P 治疗前 治疗后 t P 治疗组 31 12.21±2.21 10.63±1.07 -1.447 0.014 7.74±3.14 4.01±1.31 -8.751 < 0.001 对照组 30 12.39±2.75 10.94±2.01 -1.711 0.017 7.62±3.25 5.18±1.77 -6.012 < 0.001 t -0.183 -0.395 -1.653 -2.226 P 0.977 0.167 0.527 0.019
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