补脾益肠丸联合柳氮磺吡啶治疗慢性溃疡性结肠炎临床研究

目的：观察补脾益肠丸联合柳氮磺吡啶治疗慢性溃疡性结肠炎的临床疗效。方法：采用随机数字抽签法将90 例慢性溃疡性结肠炎患者分为对照组与观察组各45 例。对照组采用柳氮磺吡啶治疗，观察组采用补脾益肠丸联合柳氮磺吡啶治疗，2 组连续用药30 d。比较2 组治疗前后中性粒细胞明胶酶相关脂质运载蛋白（NGAL）、基质金属蛋白酶-9（MMP-9）、炎症因子［C-反应蛋白（CRP）、肿瘤坏死因子-α（TNF-α）、白细胞介素-6（IL-6）］ 水平；比较2 组中医证候积分、肠黏膜病变评分、Mayo 活动指数评分，评估2 组临床疗效及不良反应发生情况。结果：观察组治疗总有效率97.78%，高于对照组82.22%（P＜0.05）。2 组治疗后中医证候积分、肠黏膜病变评分、Mayo 活动指数评分均较治疗前降低（P＜0.05），且观察组治疗后上述指标均低于对照组（P＜0.05）。2 组治疗后NGAL、MMP-9、CRP、TNF-α、IL-6 水平均较治疗前降低（P＜0.05），且观察组治疗后炎症因子及NGAL、MMP-9 水平均低于对照组（P＜0.05）。2 组不良反应发生率比较，差异无统计学意义（P＞0.05）。结论：补脾益肠丸联合柳氮磺吡啶治疗慢性溃疡性结肠炎疗效确切，能显著改善患者临床症状，降低炎症因子水平，安全性较高。

Clinical Study on Bupi Yichang Pills Combined with Sulfasalazine for ChronicUlcerative Colitis

Abstract：Objective：To observe the clinical effect of Bupi Yichang Pills combined with Sulfasalazine forchronic ulcerative colitis. Methods： A total of 90 cases of chronic ulcerative colitis were randomly dividedinto the control group and the observation group， with 45 cases in each group according to the randomnumber drawing method. The control group was treated with Sulfasalazine，and the observation group wastreated with Bupi Yichang Pills combined with Sulfasalazine. Both groups were treated continuously for 30days. The levels of neutrophil gelatinase-associated lipocalin (NGAL)，matrix metalloproteinase-9 (MMP-9)，and inflammatory factors [C-reactive protein (CRP)，tumor necrosis factor-α (TNF-α) and interleukin-6(IL-6)] were compared between the two groups before and after treatment. The traditional Chinesemedicine (TCM) syndrome scores，intestinal mucosal lesion scores，and Mayo activity index scores werecompared between two groups. The clinical effects and incidence of adverse reactions were evaluated inthe two groups. Results：The total effective rate was 97.78% in the observation group，higher than that of 82.22% in the control group (P＜0.05). After treatment， the TCM syndrome scores， intestinal mucosallesion scores， and Mayo activity index scores in the two groups were decreased when compared withthose before treatment (P＜0.05)，and the above indexes in the observation group were lower than those inthe control group (P＜0.05). After treatment，the levels of NGAL，MMP-9，CRP，TNF-α and IL-6 weredecreased when compared with those before treatment (P＜0.05)，and the levels of inflammatory factors，NGAL and MMP-9 in the observation group were lower than those in the control group (P＜0.05). Therewas no significant difference in the incidence of adverse reactions between the two groups (P＞0.05).Conclusion： The combination of Bupi Yichang Pills combined with Sulfasalazine has a definite curativeeffect on chronic ulcerative colitis，which can significantly improve clinical symptoms，reduce inflammatoryfactor levels，and have high safety.