薄芝糖肽注射液联合盐酸奥洛他定片治疗慢性特发性荨麻疹患者的临床研究

Clinical trial of Bozhi glycopeptide injection combined with olopatadine hydrochloride tablets in the treatment of chronic idiopathic urticaria

目的观察薄芝糖肽注射液联合盐酸奥洛他定片治疗慢性特发性荨麻疹患者的临床疗效及安全性。方法将118例慢性特发性荨麻疹患者随机分为对照组和试验组,每组59例。对照组给予盐酸奥洛他定片每次5 mg,bid,口服;试验组在对照组治疗的基础上,给予薄芝糖肽注射液每次2 mL,qod,肌内注射。2组患者均治疗4周。比较2组患者的临床疗效,血清内皮抑素和凝血酶敏感蛋白-1(TSP-1)水平,以及药物不良反应的发生情况。结果试验期间,试验组和对照组分别脱落4例和2例。治疗后,试验组和对照组的总有效率分别为98.18%(54例/55例)和70.18%(40例/57例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清内皮抑素分别为(379.41±55.19)和(348.24±59.03)pg·mL^-1,TSP-1分别为(128.08±26.37)和(107.63±30.12)μg·mL^-1,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应主要有口干、嗜睡、多汗和心悸,对照组发生的药物不良反应主要有口干和嗜睡。试验组和对照组的总药物不良反应发生率分别为12.73%和8.77%,差异无统计学意义(P>0.05)。结论薄芝糖肽注射液联合盐酸奥洛他定片治疗慢性特发性荨麻疹的临床疗效显著优于单用盐酸奥洛他定片,其能有效地改善血清中内皮抑素和TSP-1水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of Bozhi glycopeptide injection combined with olopatadine hydrochloride tablets in the treatment of chronic idiopathic urticaria.Methods A total of 118 patients with chronic idiopathic urticaria were randomly divided into control and treatment groups with 59 cases per group.Control group was given olopatadine hydrochloride tablets 5 mg per time,bid,orally.Treatment group received Bozhi glycopeptide injection 2 mL,qod,intramuscular injection,on the basis of control group.Two groups were treated for 4 weeks.The clinical efficacy,levels of serum endostatin and thrombin sensitive protein-1(TSP-1),and adverse drug reactions were compared between two groups.Results During the trial,4 cases and 2 cases in treatment group and control group were shed.After treatment,the total effective rates of treatment and control groups were 98.18%(54 cases/55 cases)and 70.18%(40 cases/57 cases)with significant difference(P<0.05).After treatment,serum endostatin of treatment and control groups were(379.41±55.19)and(348.24±59.03)pg·mL^-1,TSP-1 in those groups were(128.08±26.37)and(107.63±30.12)μg·mL^-1,the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were dry mouth,sleepiness,hyperhidrosis and palpitations,while those in control group were dry mouth and sleepiness.The incidences of adverse drug reactions in the treatment and control groups were 12.73%and 8.77%without significant difference(P>0.05).Conclusion The clinical efficacy of Bozhi glycopeptide injection combined with olopatadine hydrochloride in the treatment of chronic idiopathic urticaria is significantly better than olopatadine hydrochloride alone,which can effectively improve the levels of serum endostatin and TSP-1,without increasing the incidence of adverse drug reactions.