摘要
目的观察竹叶石膏汤治疗阴虚内热型系统性红斑狼疮的临床疗效及安全性。方法采用随机、对照、双盲的研究方法,选择2018年12月—2020年12月120例在上海中医药大学附属市中医医院门诊和住院中医辨证为阴虚内热型的符合纳入标准和排除标准的系统性红斑狼疮患者。对照组予中、小剂量糖皮质激素及羟氯喹或环磷酰胺联合与竹叶石膏汤质地、气味、规格、外包装一致的中药安慰剂治疗,治疗组予中、小剂量糖皮质激素及羟氯喹或环磷酰胺联合竹叶石膏汤治疗。经治疗12周后对比两组患者临床疗效、中医证候评分、SLEDAI评分、糖皮质激素使用量、免疫指标水平、红细胞沉降率、谷氨酸丙酮酸转氨酶水平、肌酐水平等。结果(1)经治疗12周,对照组总有效率为84.45%,治疗组总有效率为92.73%,表明治疗组总体疗效好于对照组(P<0.05)。(2)对照组和治疗组中医证候积分、SLEDAI积分总分均较治疗前降低(P<0.01),且治疗组较对照组能更有效减轻疾病活动度(P<0.05)。(3)对照组和治疗组激素用量均较治疗前减少(P<0.01),且治疗组激素用量少于对照组(P<0.01)。(4)对照组和治疗组ANA滴度、抗ds-DNA抗体、补体C3水平均较治疗前改善(P<0.01),且治疗组更能有效降低ANA滴度、抗ds-DNA水平,提高C3水平(P<0.05,P<0.01)。对照组和治疗组IgA均较前改善,差异具有统计学意义(P<0.01),但组间比较差异无统计学意义(P>0.05)。对照组IgG较治疗前改善,差异具有统计学意义(P<0.01),但治疗组组内和与对照组组间比较差异无统计学意义(P>0.05)。对照组和治疗组IgM、补体C4组内和组间差异均无统计学意义(P>0.05)。(5)对照组和治疗组均能改善血沉水平,差异具有统计学意义(P<0.01),且治疗组能更有效降低ESR水平(P<0.05)。(6)对照组和治疗组ALT、肌酐水平组间和组内差异均无统计学意义(P>0.05)。结论竹叶石膏汤联合西药治疗阴虚内热型系统性红斑狼疮具有良好疗效及安全性。不仅可有效降低阴虚内热型系统性红斑狼疮患者的疾病活动的同时有利于糖皮质激素的减量和降低患者体内炎症水平及有利于调节患者免疫功能。
Objective To observe the clinical efficacy and safety of Zhuye Shigao Decoction(竹叶石膏汤)in the treatment of systemic lupus erythematosus(SLE)with Yin deficiency and internal heat syndrome.Methods A randomized,controlled and double-blind clinical study was conducted.A total of 120 patients with SLE who were diagnosed as Yin deficiency and internal heat syndrome in the outpatient department and inpatient department of the Shanghai municipal hospital of traditional Chinese medicine from December,2018 to December,2020 and met the inclusion and exclusion criteria were selected.The control group was treated with medium and small doses of glucocorticoid and hydroxychloroquine or cyclophosphamide combined with Chinese herbal placebo in texture,smell,size and packaging consistent with Zhuye Shigao Decoction,while the treatment group was treated with medium and small doses of glucocorticoid and hydroxychloroquine or cyclophosphamide combined with Zhuye Shigao Decoction.After 12 weeks of treatment,the clinical efficacy,TCM syndrome score,SLEDAI score,glucocorticoid usage amount,immune indicators,glutamate pyruvate aminotransferase and creatinine were compared between the two groups.Results(1)After 12 weeks of treatment,the total effective rate of the control group was 84.45%,and the total effective rate of the treatment group was 92.73%,indicating that the overall efficacy of the treatment group was better than that of the control group(P<0.05).(2)The total scores of TCM syndrome score and SLEDAI score in both control group and treatment group were improved compared with before treatment(P<0.01),and the treatment group was more effective in reducing disease activity(P<0.05).(3)The dosage of glucocorticoids in both control group and treatment group decreased compared with before(P<0.01),and the therapeutic effect in the treatment group was better than that in the control group(P<0.01).(4)ANA titer,anti-DS-DNA and complement C3 levels in the control group and the treatment group were all improved compared with before treatment(P<0.01),and the efficacy in the treatment group was better than that in the control group(P<0.05,P<0.01).IgA in both control group and treatment group was improved compared with before(P<0.01),but there was no statistically significant difference between groups(P>0.05).The IgG in the control group was improved compared with that before treatment(P<0.01),but there was no statistically significant difference between the treatment group and the control group(P>0.05).There were no significant differences in IgM and complement C4 between control group and treatment group(P>0.05).(5)Both the control group and the treatment group could reducing the erythrocyte sedimentation rate level(P<0.01),and the treatment group was more effective in reducing erythrocyte sedimentation rate level(P<0.05).(6)There were no significant differences in ALT and creatinine levels between the control group and the treatment group(P>0.05).Conclusion Zhuye Shigao Decoction combined Western medicine therapy systemic lupus erythematosus with Yin deficiency and internal heat systemic lupus erythematosus has good curative effect and safety.Not only can effectively reduce the patients'disease activity and favorable to the reduction of glucocorticoid and reduce patients body inflammation and is conducive to regulating the immune function of patients.
作者
阿古达木
姚重华
苏晓
A Gudamu;YAO Chonghua;SU Xiao(Guanghua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200052,China;Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)
出处
《辽宁中医药大学学报》
CAS
2023年第11期193-198,共6页
Journal of Liaoning University of Traditional Chinese Medicine
基金
上海市科学技术委员会“科技创新行动计划”项目(17401971000)。
关键词
系统性红斑狼疮
竹叶石膏汤
阴虚内热证
临床疗效
安全性
systemic lupus erythematosus
Zhuye Shigao Decoction(竹叶石膏汤)
Yin deficiency and internal heat syndrome
clinical curative effect
security
