【摘要】 目的:探讨生津润燥养血颗粒联合硫酸羟氯喹片治疗原发性口腔干燥综合(pSS)临床疗效和安全性。方法:选取p SS患者128例,随机分为研究组和对照组各64例,对照组口服硫酸羟氯喹治疗,研究组在对照组基础上给予生津润燥养血颗粒治疗。评价2组临床疗效和安全性,应用Schirmer试验、唾液流率、眼干口干症状评分比较2组临床症状改善的情况,比较治疗前后血清免疫指标[血沉(ESR)、C-反应蛋白(CRP)、免疫球蛋白G (IgG)]的变化。结果:治疗前,2组左、右眼泪流量、唾液流率指标比较,差异均无统计学意义(P> 0.05)。治疗后,2组左、右眼泪流量、唾液流率较治疗前升高(P <0.05),研究组左、右眼泪流量、唾液流率均高于对照组(P <0.05)。治疗前,2组眼干和口干症状评分比较,差异无统计学意义(P> 0.05)。治疗后,2组眼干和口干症状评分均较治疗前降低(P <0.05),研究组眼干和口干症状评分低于对照组(P <0.05)。治疗前,2组ESR、CRP、IgG水平比较,差异无统计学意义(P> 0.05)。治疗后,2组ESR、CRP、IgG水平均较治疗前降低(P <0.05),研究组ESR、CRP、IgG水平均低于对照组(P <0.05)。研究组总有效率为79.69%,对照组为62.50%,2组比较,差异有统计学意义(P <0.05)。研究组不良反应率为4.69%,对照组为6.25%,2组比较,差异无统计学意义(P> 0.05)。结论:生津润燥养血颗粒联合硫酸羟氯喹片治疗pSS可显著改善口干、眼干症状,临床疗效确切,安全性高。更多还原

【Abstract】 Objective:To discuss the clinical effect and safety of Shengjin Runzao Yangxue granules combined with hydroxychloroquine sulfate tablets for primary Sjogren’s Syndrome(pSS). Methods:Selected 128 cases of patients with pSS,and divided them into the research group and the control group randomly,64 cases in each group. The control group received the oral administration of hydroxychloroquine sulfate tablets,while the research group additionally received Shengjin Runzao Yangxue granules. Evaluated the clinical effect and safety in both groups,compared the improvements of clinical symptoms in both groups by assessing the saliva flow rate and symptoms scores of dry eyes and dry mouth via Schirmer’s test,and compared the changes of serum immune indexes [erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and immunoglobulin G(IgG)] before and after treatment. Results:Before treatment,comparing indexes of the tear volume of left and right eyes and the saliva flow rate in both groups,there were no significant differences being found(P > 0.05). After treatment,the tear volume of left and right eyes and the saliva flow rate in both groups were higher than those before treatment(P < 0.05),and the tear volume of left and right eyes and the saliva flow rate in the research group were all higher than those in the control group(P < 0.05). Before treatment,comparing the symptoms scores of dry eyes and dry mouth in both groups,there was no significant difference being found(P > 0.05). After treatment,the symptoms scores of dry eyes and dry mouth in both groups were lower than those before treatment(P < 0.05),and the symptoms scores of dry eyes and dry mouth in the research group were lower than those in the control group(P < 0.05). Before treatment,comparing the levels of ESR,CRP and IgG in both groups,there was no significant difference being found(P > 0.05). After treatment,the levels of ESR,CRP and IgG in both groups were lower than those before treatment(P < 0.05),and the levels of ESR,CRP and IgG in the research group were all lower than those in the control group(P < 0.05).The total effective rate was 79.69% in the research group and 62.50% in the control group,difference being significant(P < 0.05). The incidence of adverse reactions was 4.96%in the research group and 6.25% in the control group,difference being insignificant(P > 0.05). Conclusion:Shengjin Runzao Yangxue granules combined with hydroxychloroquine sulfate tablets for pSS can significantly improve such symptoms as dry mouth and dry eyes with exact clinical effect and high safety.更多还原