玉屏风颗粒治疗系统性红斑狼疮患者反复感冒的临床研究

Clinical study of Yupingfeng Granules on the Treatment of Recurrent Colds in Patients with Systemic Lupus Erythematosus.

目的观察玉屏风颗粒治疗系统性红斑狼疮患者反复感冒的临床疗效,评价其在系统性红斑狼疮治疗中的感染防治价值及安全性。方法招募2018年10月~2021年9月潍坊市人民医院收治的系统性红斑狼疮发生反复感冒的患者90例,按照随机数字表法将其分为对照组(n=30)和观察组(n=60)。对照组患者维持原治疗方案不变,观察组患者给予玉屏风颗粒(自节气寒露开始至来年谷雨结束,服药疗程约6个月),治疗结束后继续随访6个月并评估药物安全性。主要观察指标为用药期间感冒次数和中医气虚体质临床表现总积分减分率。次要观察指标为停药后首次、第2次感冒发作时间和免疫指标。结果用药期间观察组患者感冒发作次数明显低于对照组(P<0.01);用药6个月后,观察组气虚体质临床表现总积分减分率为41.50%,高于对照组(40.63%,P<0.01);停药后,观察组首次、第2次出现感冒时间较对照组明显延长(P<0.01);治疗前后两组患者的免疫球蛋白G(immunoglobulin G,IgG)、补体C3(complement 3,C3)、补体C4(complement 4,C4)水平比较,差异无统计学意义(P>0.05);治疗期间,观察组不良反应率较对照组低,但差异无统计学意义(P>0.05)。结论玉屏风颗粒能够改善气虚体质,有效防治系统性红斑狼疮患者反复感冒,且无明显不良反应。

Objective To observe the clinical efficacy of Yupingfeng granules in the treatment of recurrent colds in patients with systemic lupus erythematosus(SLE),and to evaluate its infection prevention and treatment value and safety of SLE.Methods Ninety patients with recurrent colds in SLE were admitted to Weifang People′s Hospital from October 2018 to September 2021 were enrolled and divided into control group(n=30)and observation group(n=60)according to random number table method.The control group maintained the original treatment scheme,and the observation group was given Yupingfeng granules(about 6months from the beginning of Cold Dew to the end of grain rain in the next year),to evaluate safety profiles.After the treatment,they were followed up for 6months.The primary observation indexes were the number of colds during medication and the total score reduction rate of clinical features of Qi-deficiency constitution in traditional Chinese medicine.Secondary observation indexes included time of first and second cold after drug withdrawal and immune indexes.Results During the treatment period,the number of colds attack in observation group was significantly lower than that in the control group(P<0.01);After 6months of treatment,the total score reduction rate of clinical features of Qi-deficiency constitution in the observation group was 41.50%,which was higher than that in the control group 40.63%(P<0.01);After drug withdrawal,the time of first and second colds in the observation group was significantly prolonger than that in the control group(P<0.01);There was no significant difference in immunoglobulin G(IgG),complement 3(C3)and complement 4(C4)between the two groups before and after treatment(P>0.05);During the treatment period,the adverse reaction rate of the observation group was higher than that of the control group,but the difference was not statistically significant(P>0.05).Conclusion Yupingfeng granules can improve Qi-deficiency constitution,and effectively prevent and treat recurrent colds in patients with SLE,and has no obvious adverse reactions.