【摘要】 目的 探究八味益精胶囊联合西医治疗阳虚寒凝型系统性硬化症(systemic sclerosis，SSc)的效果及安全性，以及对T淋巴细胞亚群水平的影响。方法 选择本院2020年11月至2022年10月收治的SSc患者112例，随机分为常规组和联合组，每组56例。常规组采用西医基础治疗，联合组在常规组治疗基础上加用八味益精胶囊，两组均持续治疗12周。分别记录治疗前、后两组皮肤硬度积分、T淋巴细胞亚群水平变化情况，同时比较两组临床疗效和不良反应发生情况。结果 治疗后，常规组治疗总有效率低于联合组(75.00% vs.94.64%，P<0.05)。治疗后，两组皮肤硬度积分均较前降低(P<0.05)，且联合组降低更多(P<0.05)。治疗后，两组CD3~+、CD4~+、CD4~+/CD8~+水平均较前升高，抗Scl-70抗体阳性率、抗SSA/Ro-52kD抗体阳性率、肺动脉内径、Furst’s内脏评分及CD8~+水平较前均下降，且联合组CD3~+、CD4~+、CD4~+/CD8~+水平升高更多(P<0.05)，抗Scl-70抗体阳性率、抗SSA/Ro-52kD抗体阳性率、肺动脉内径、Furst’s内脏评分及CD8~+水平下降更多(P<0.05)。治疗期间两组不良反应发生率无显著差异(12.50% vs.10.71%，P>0.05)。结论 八味益精胶囊联合西医治疗SSc可显著提高临床疗效，有效缓解患者病情，调节T淋巴细胞亚群水平，且安全性较佳。更多还原

【Abstract】 Objective To explore the efficacy and safety of Bawei Yijing capsules combined with western medicine in the treatment of systemic sclerosis(SSc) of Yang deficiency and cold coagulation type,as well as its influence on the levels of T lymphocyte subsets.Methods A total of 112 patients with SSc admitted to our hospital from November 2020 to October 2022 were selected and randomly divided into the conventional group and the combined group,with 56 cases in each group.The conventional group received basic western medical treatment,while the combined group was treated with Bawei Yijing capsules on the basis of the conventional group.Both groups were treated for 12 weeks continuously.The changes of skin hardness scores and the levels of T lymphocyte subsets before and after treatment were recorded in both groups,respectively.Meanwhile,the clinical efficacy and the occurrence of adverse reactions in the two groups were observed and compared.Result After treatment,the total effective rate of the conventional group was lower than that of the combined group(75.00% vs.94.64%,P<0.05).The skin hardness scores of both groups decreased compared with those before treatment(P<0.05),and the combined group showed a greater decrease(P<0.05).After treatment,the levels of CD3~+,CD4~+,and CD4~+/CD8~+ in both groups increased compared with before,while the positive rates of anti-SCL-70 antibody,anti-SSA/Ro-52kD antibody,pulmonary artery inner diameter,Furst’s visceral score,and CD8~+ level decreased compared with before(P<0.05).Moreover,the combined group showed greater increases in CD3~+,CD4~+,and CD4~+/CD8~+ levels(P<0.05),and greater decreases in the positive rates of anti-SCL-70 antibody,anti-SSA/Ro-52kD antibody,pulmonary artery inner diameter,Furst’s visceral score,and CD8~+ level(P<0.05).There was no significant difference in the incidence of adverse reactions between the groups during the treatment period(12.50% vs.10.71%,P>0.05).Conclusion Bawei Yijing capsules combined with western medicine in the treatment of SSc can significantly improve the clinical efficacy,effectively alleviate the condition of patients,regulate the levels of T lymphocyte subsets,and has better safety.更多还原