丹参酮ⅡA注射液联合美沙拉嗪肠溶片治疗溃疡性结肠炎患者的临床研究

Clinical trial of tanshinone ⅡA combined with mesalazine in the treatment of patients with ulcerative colitis

目的观察丹参酮ⅡA(TanⅡA)注射液联合美沙拉嗪肠溶片治疗溃疡性结肠炎(UC)患者的临床疗效和安全性。方法将86例UC患者随机分为对照组和试验组,每组43例。对照组予以口服美沙拉嗪肠溶片每次1000 mg,每日4次;试验组在对照组治疗的基础上,予以静脉滴注TanⅡA磺酸钠注射液每次80mg,每日1次。2组患者治疗时间均为7 d。比较2组患者的临床疗效、血清中白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)水平、结肠黏膜组织中主要组织相容性复合体-Ⅱ(MHC-Ⅱ)表达情况和药物不良反应发生情况。结果治疗后,试验组和对照组的总有效率分别为95. 35%(41例/43例)和81. 40%(35例/43例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组血清IL-6含量分别为(76. 48±8. 17),(115. 46±3. 82) ng·L^-1,TNF-α分别为(144. 25±20. 48),(189. 63±20. 14) ng·L^-1;MHC-Ⅱ蛋白阳性表达率分别为69. 77%(30例/43例),90. 67%(39例/43例),差异均有统计学意义(均P <0. 05)。2组药物不良反应均以恶心和头晕为主,试验组和对照组总药物不良反应发生率为13. 95%(6例/43例)和11. 63%(5例/43例),差异无统计学意义(P> 0. 05)。结论 TanⅡA联合美沙拉嗪治疗UC临床疗效显著,可减轻患者机体炎症反应,降低结肠黏膜组织中MHC-Ⅱ类分子表达,效果优于单用美沙拉嗪。

Objective To investigate the effects of tanshinone Ⅱ A( Tan Ⅱ A) in combination of mesalazine on the clinical efficacy and safety profile in patients with ulcerative colitis( UC). Methods A total of 86 patients with UC were randomly assigned to control group and treatment group,with 43 cases in each group. The control group was treated with 1000 mg of mesalazine enteric-coated tablets four times a day;while the treatment group was treated with 80 mg of TanⅡA sodium sulfonate injection intravenously on the basis of control group. Both groups were treated for 7 d. The clinical efficacy,levels of serum interleukin-6( IL-6),tumor necrosis factor-α( TNF-α) and expression of major histocompatibility complex-Ⅱ( MHC-Ⅱ),adverse drug reactions were compared between the 2 groups. Results Before treatment,the total effective rates of treatment group and control group were 95. 35%( 41 cases/43 cases) and 81. 40%( 35 cases/43 cases) respectively,the difference was statistically( P < 0. 05). After treatment,the levels of IL-6 in treatment group and control group were( 76. 48 ±8. 17),( 115. 46 ±3. 82) ng·L^-1;the levels of TNF-α were( 144. 25 ±20. 48),( 189. 63 ±20. 14) ng·L^-1;the positive expression rates of MHC-Ⅱprotein were 69. 77%( 30 cases/43 cases) and 90. 67%( 39 cases/43 cases). There was significant differences between the 2 groups( P < 0. 05). There were no significant differences in the incidence of total adverse drug reactions between treatment group and control group [13. 95%( 6 cases/43 cases) vs 11. 63%( 5 cases/43 cases)]( P > 0. 05). Conclusion TanⅡA in combination of mesalazine exerted significant effect on UC,which can reduce inflammation and the expression of MHC-Ⅱmolecules in colonic mucosa,the effect is better than that of mesalazine alone.