| 赵镇玺,陈薇薇,夏嘉,等.风免一号合玉女煎联合PMC方案治疗轻中度活动性(阴虚内热型)SLE的疗效观察[J].浙江中医药大学学报,2024,48(4):465-474. |
| 风免一号合玉女煎联合PMC方案治疗轻中度活动性(阴虚内热型)SLE的疗效观察 |
| Therapeutic Effect of Fengmian No.1 Combined with Yu’nv Decoction Combined with PMC Regimen on Mild to Moderate Active Systemic Lupus Erythematosus of Yin Deficiency and Internal Heat Type |
| DOI：10.16466/j.issn1005-5509.2024.04.015 |
| 中文关键词: 系统性红斑狼疮 阴虚内热 风免一号合玉女煎 PMC 糖皮质激素 疗效 安全性 |
| 英文关键词: systemic lupus erythematosus Yin deficiency and internal heat Fengmian No.1 combined with Yu’nv Decoction PMC glucocorticoids curative effect safety |
| 基金项目:国家自然科学基金项目(81603563)；上海市科学技术委员会科研计划项目(18401901000); 上海医学创新发展基金“未来计划”中医药科技发展项目(WL-YJXYS-2021005K) |
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| 中文摘要: |
| [目的] 探讨风免一号合玉女煎联合小剂量泼尼松联合甲氨蝶呤、羟氯喹(prednisone，methotrexate，chloroquine，PMC)方案治疗轻中度活动性(阴虚内热型)系统性红斑狼疮的疗效和安全性。[方法] 将上海中医药大学附属市中医医院风湿病科2018年10月至2021年3月收治的120例患者随机分为治疗组与对照组，每组各60例。对照组采用PMC方案联合中药安慰剂治疗，治疗组采用PMC方案联合风免一号合玉女煎治疗。比较两组治疗第0、4、12、24周时免疫指标、安全性指标、中医证候积分、疾病活动度积分、激素用量及不良反应情况。[结果] 经24周治疗，对照组和治疗组免疫球蛋白G(immunoglobulin G，IgG)、补体C3、补体C4水平较治疗前改善，差异有统计学意义(P<0.05)，且治疗组总体疗效好于对照组(P<0.05)。对照组和治疗组均能有效改善患者口干、烦躁、手足心热症状，差异有统计学意义(P<0.05)，且治疗组疗效好于对照组(P<0.05)。治疗组总有效率为78.57%，对照组总有效率为44.44%，差异有统计学意义(P<0.05)。治疗组中医证候积分显著低于对照组(P<0.05)；治疗组疾病活动度积分水平显著低于对照组(P<0.05)；治疗期间治疗组不良反应发生率低于对照组。[结论] 风免一号合玉女煎用于轻中度活动性(阴虚内热型)系统性红斑狼疮能够改善疾病活动度，减少激素剂量，且不良反应少。 |
| 英文摘要: |
| [Objective] To investigate the efficacy and safety of Fengmian No.1 combined with Yu’nv Decoction and Prednisone combined with Methotrexate， Hydroxychloroquine(PMC) in the treatment of mild to moderate active systemic lupus erythematosus(SLE) of Yin deficiency and internal heat type. [Methods] One hundred and twenty patients in the Rheumatology Department of Shanghai Municipal Hospital of Traditional Chinese Medicine， Shanghai University of Traditional Chinese Medicine from October 2018 to March 2021 were randomly divided into treatment group and control group， with 60 cases in each group. The control group was treated with PMC regimen combined with traditional Chinese medicine(TCM) placebo， and the treatment group was treated with PMC regimen with Fengmian No.1 combined with Yu’nv Decoction. The immune indexes， safety indexes， TCM syndrome score， disease activity score， hormone dosage and adverse reactions were compared between the two groups at 0，4th，12th and 24th week. [Results] After 24 weeks of treatment， the levels of immunoglobulin G(IgG)， C3 and C4 in control group and treatment group were significantly improved compared with those before treatment(P<0.05)， and the overall curative effect of the treatment group was better than that of the control group(P<0.05). Both two groups could effectively relieve the symptoms of dry mouth， irritability and feverish feeling in palms and soles(P<0.05)， and the curative effect of treatment group was better than that of control group(P<0.05). The total effective rate was 78.57% in treatment group and 44.44% in control group(P<0.05). The TCM syndrome score in treatment group was significantly lower than that in control group(P<0.05); the level of disease activity score in treatment group was significantly lower than that in control group(P<0.05). During the treatment， the incidence of adverse reactions in treatment group was lower than that in control group. [Conclusion] Fengmian No.1 combined with Yu’nv Decoction used in mild to moderate active SLE of Yin deficiency and internal heat type can improve disease activity， reduce hormone dose and have less adverse reactions. |
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