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目的观察白芍总苷联合沙利度胺治疗活动性强直性脊柱炎(AS)患者的临床疗效与安全性。方法选取2012年10月—2014年3月接受治疗的AS患者80例,随机分为二组,每组40例,观察组患者给予白芍总苷联合沙利度胺进行治疗,对照组患者仅给予沙利度胺进行治疗。主要疗效指标为达到AS疗效评价(ASAS)20%改善程度(ASAS 20)的受试者比例;次要疗效指标包括与基线比较BASFI、BASDAI、BASMI、患者对病情的总体评价、夜间背部疼痛和总体背部疼痛、晨僵时间、ESR、CRP的改善情况。结果观察组治疗4、8、12周时达到ASAS20的受试者比例分别为52.5%、67.5%、77.5%,对照组分别为37.5%、42.5%、55%。8周、12周观察组达到ASAS20的受试者比例均显著高于对照组(P<0.05)。观察组的BASDAI、BASFI、患者总体评价、夜间痛、总体背痛、晨僵时间、ESR、CRP在8、12周时均较基线时改善(P<0.05)。部分指标(BASDAI、患者总体评价、总体背痛、晨僵时间)的改善治疗组优于对照组(P<0.05)。治疗组总不良事件发生率35%,明显低于对照组67.5%(P<0.01)。结论白芍总苷联合沙利度胺治疗活动性强直性脊柱炎可以有效的改善患者临床症状和体征,降低疾病活动度,与单用沙利度胺相比,提高治疗有效率,降低不良反应发生率。
Objective To observe the clinical efficacy and safety of total glucosides of paeony plus thalidomide in patients with active ankylosing spondylitis (AS). Methods Eighty AS patients treated from October 2012 to March 2014 were randomly divided into two groups (n = 40). Patients in the observation group were treated with total glucosides of paeony plus thalidomide, while those in the control group Thalidomide was given for treatment. The primary outcome measure was the proportion of subjects who achieved an ASAS 20 improvement of 20% (ASAS 20); secondary efficacy indicators included BASFI, BASDAI, BASMI compared with baseline, overall patient evaluation of the disease, nocturnal back pain and Overall back pain, morning stiffness time, ESR, CRP improvement. Results The proportion of subjects who reached ASAS20 at 4, 8 and 12 weeks after treatment was 52.5%, 67.5% and 77.5% in the observation group and 37.5%, 42.5% and 55% in the control group respectively. The proportion of subjects who reached ASAS20 in the observation group at 8 weeks and 12 weeks was significantly higher than that of the control group (P <0.05). BASDAI, BASFI, overall patient evaluation, nocturnal pain, total back pain, morning stiffness time, ESR and CRP in observation group were all improved at baseline (P <0.05) at 8 and 12 weeks. Some indicators (BASDAI, overall patient evaluation, overall back pain, morning stiffness time) were better in the treatment group than in the control group (P <0.05). The incidence of total adverse events in the treatment group was 35%, which was significantly lower than 67.5% in the control group (P <0.01). Conclusion Total glucosides of paeony combined with thalidomide in the treatment of active ankylosing spondylitis can effectively improve the clinical symptoms and signs of patients and reduce the activity of the disease, compared with the single thalidomide, improve the treatment efficiency, reduce adverse reactions Occurrence rate.