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目的:观察健脾滋肾法治疗脾肾两虚型缓解期系统性红斑狼疮疗效及安全性。方法:将60例患者随机分为治疗组30例和对照组30例,对照组予醋酸泼尼松、硫酸轻氯喹治疗,治疗组在对照组治疗基础上加用补肾健脾方药治疗,2组疗程均为3月,观察2组治疗前后临床疗效、证候疗效及中医脾肾两虚症状总积分变化,观察测实验室指标及疾病活动指标。结果:缓显率、总有效率治疗组分别为60.00%、90.00%;对照组分别为33.33%、76.67%,2组比较,差异均有统计学意义(P<0.05);治疗后2组中医症状积分均较治疗前降低(P<0.01);且治疗组在改善神疲体倦、面色无华、少气懒言、腰膝酸、食少纳呆、大便异常积分方面优于对照组(P<0.05)。治疗后2组红细胞(RBC)、血红蛋白(Hb)、血小板(BPC)及平均红细胞体积(MCV)、平均红细胞血红蛋白含量(MCHC)、血小板分布宽度(PDW)、血小板平均体积(MPV)较治疗前均升高(P<0.05);且治疗组治疗后RBC、BPC、MCV、MCHC升高较对照组更为显著(P<0.05)。治疗后2组血沉(ESR)、超敏C-反应蛋白(hs-CRP)较治疗前均降低(P<0.01),C3、C4较治疗前升高(P<0.01);且治疗组ESR、C3、C4改善较对照组更显著(P<0.05)。治疗组改善系统性红斑狼疮病情活动度(SLEDAI)积分优于对照组(P<0.05)。治疗组在减少面色潮红及胃肠道反应的效果优于对照组(P<0.05)。结论:健脾滋肾中药治疗脾肾两虚型缓解期系统性红斑狼疮能显著改善临床症状,安全性高,适合在临床推广使用。
Objective: To observe the efficacy and safety of invigorating the spleen and nourishing the kidney in treating patients with systemic lupus erythematosus in the period of exacerbation of spleen and kidney deficiency. Methods: Sixty patients were randomly divided into treatment group (n = 30) and control group (n = 30). The control group was given prednisone acetate and light chloride chloroquine sulfate. The treatment group was treated with Bushen Jianpi Recipe The course of treatment was March. The clinical curative effect, the curative effect of TCM syndrome and the total score of TCM syndrome of spleen and kidney were observed before and after treatment. The laboratory indexes and disease activity indexes were observed. Results: The total effective rate was 60.00% and 90.00% respectively in the treatment group and 33.33% and 76.67% in the control group respectively. There were significant differences between the two groups (P <0.05) (P <0.01). And the treatment group was better than the control group in improving the fatigue of the weary, tiredness, lack of breath, lassitude, loss of appetite, abnormal stool score (P <0.01) <0.05). The RBC, Hb, BPC and MCV, MCHC, PDW and MPV in the two groups after treatment were significantly lower than those before treatment (P <0.05). The RBC, BPC, MCV and MCHC in treatment group were significantly higher than those in control group after treatment (P <0.05). The levels of ESR and hs-CRP in the two groups were lower than those before treatment (P <0.01), while the levels of C3 and C4 were higher than those before treatment (P <0.01) C3, C4 improved more significantly than the control group (P <0.05). The treatment group improved the systemic lupus erythematosus disease activity (SLEDAI) score is better than the control group (P <0.05). The treatment group in reducing facial flushing and gastrointestinal reactions better than the control group (P <0.05). Conclusion: Spleen and Kidney Chinese medicine treatment of spleen and kidney deficiency in remission of systemic lupus erythematosus can significantly improve clinical symptoms, high safety, suitable for clinical use.