【作者】 彭德桂；

【导师】 廖世煌；

【作者基本信息】 广州中医药大学 ， 中医临床基础， 2010， 博士

【摘要】 目的本临床对照研究目的旨在通过应用独活寄生汤为对照,观察补肾强督治尫汤治疗强直性脊柱炎的临床有效性和安全性。方法研究对象为符合强直性脊柱炎的西医诊断标准和中医辨证标准的患者,随机分配到补肾强督治尫汤或独活寄生汤组。观察、记录并比较其治疗前后的中医症状(包括腰骶脊背疼痛、脊背疼痛、关节肿胀、发热、腰脊活动受限、晨僵、关节发热、乏力、腰膝酸软、刺痛、口干不欲饮、小便黄、肢体困重、肌肤干燥、遗精、畏寒喜暖在内的17个中医症状)、Bath强直性脊柱炎病情活动指数、Bath强直性脊柱炎功能指数、总体背痛评分、夜间背痛评分以及患者对病情的总体评价VAS评分。统计方法：分类资料用χ2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。统计计算采用SPSS 17.0统计软件完成统计分析。结果一般调查资料显示,患者平均年龄为34.1±3.8岁,平均病程4.8±2.5月。两组中医证候疗效比较显示,试验组临床痊愈率为40％,显效率为27.5%,有效率为25%,总有效率为92.5%；对照组临床痊愈率为7.5%,显效率为17.5%,有效率为35%,总有效率为60%。两组中医症状的总改善率均在50%以上。对两组次要疗效指标——Bath病情活动指数、Bath脊柱功能指数、总体背痛、夜间背痛和的患者对病情总体评价治疗前后比较显示,两组均能有效的降低各观察指标的积分。试验组7.5%患者出现消化道不适,2.5%的患者白细胞减少,无肝酶异常变化；对照组有12.5%的患者出现消化道不适,15%的患者出现白细胞减少,5%的患者发现肝酶异常。试验组的不良反应发生率远低于对照组,且停药后症状就会消失。结论在中医症候总疗效的比较上,补肾强督治尫汤组优于独活寄生汤组(P<0.05)。试验组在腰骶脊背疼痛、关节胀痛、腰脊活动受限、晨僵、关节作冷、刺痛、口干不欲饮、肢体困重的改善上要优于对照组(P<0.05)。对两组次要疗效指标——Bath病情活动指数、Bath脊柱功能指数、总体背痛、夜间背痛和的患者对病情总体评价治疗前后比较显示,两组均能有效的降低积分,但补肾强督治尫汤组要优于独活寄生汤组。安全性分析显示,治疗前后血、尿、大便常规、肝肾功能、心电图等未见异常改变,表明该药临床应用安全。更多还原

【Abstract】 ObjectiveTo observe the clinical efficacy and the safety of BuShenQiangDuZhiWangTang(BST) for treating ankylosing spondylitis(AS) by which adopted the Angelicae Pubescentis and Loranthi Decoction(APD) as controlled trial.MethodsThe patients that were consistent with AS standard of diagnostic criteria in western medicine and Chinese medicine were divided into BST group and APD group in random. Chinese symptom(including waist-sacro-back ache、backache、arthrocele、fever、lumbar vertebrae limitation of activity、early morning stiffness、joint fever、hypodynamia、waista and knee ache、pricking pain、Dry mouth、yellow urine、limbs weary、muscle and skin dry、emissions and chilly 17 Chinese symptom)、BS activity index number、BS function index、overall backache score、backache at night score and overall evaluation (VAS) score were observed and recorded both at after and before treatment time.Statistical methods:The classification data was observed using 2 test and the ranked data by Wilcoxon rank-sum test. T-test or Wilcoxon rank-sum test was applied for group comparison. Matched t-test or Wilcoxon matched-rank-sum test was applied for self-AP:PA comparison. The statistical analysis was used with the software of SPSS17.0.ResultsGeneral investigation data showed that the average of patients’age was 34.1±3.8years old and the course of disease was 4.8±2.5 months. Compared with the curative effect on symptom of Chinese medicine within two groups, it was showed that the clinical recovery rate of the treatment group was 40%, and the excellence rate was 27.5%, the effective rate was 25%, the total effective rate was 92.5%. While in the control group, the clinical recovery rate of the treatment group was 7.5%, and the excellence rate was 17.5%, the effective rate was 35%, the total effective rate was 60%. The total improvement rate of the symptom in Chinese medicine in both two groups were all above at 50%. To the secondary of curative effect index which including BS activity index number、BS function index、overall backache score、backache at night score and overall evaluation (VAS) score, both two groups had significant difference between before and after treatment, which all could decrease the score of the index. In the BST group, there was 7.5 percent of patients had alimentary canal complaint and 2.5 percent of patients had aleucocytosis. There was no abnormal change of liver enzyme. While in the control group, there was 12.5 percent of patients had alimentary canal complaint and 15 percent of patients had aleucocytosis. There was 5% of patients had abnormal change of liver enzyme. The adverse reaction rate of BST group was far lower than which of control group. And the adverse reaction would disappear after stopping medicine.ConelusionThere was significant difference between two groups (P<0.05). The BST group was better than the APD group on the total curative effect of the symptom in Chinese medicine for improving the waist-sacro-back ache、backache、arthrocele、lumbar vertebrae limitation of activity、early morning stiffness、joint cold、pricking pai、Dry mouth and limbs weary (P<0.05). To the secondary of curative effect index which including BS activity index number、BS function index、overall backache score、backache at night score and overall evaluation (VAS) score, both two groups had significant difference between before and after treatment, which all could decrease the score of the index. But the BST group was better than the APD group. The analysis of safety had presented that it had not abnormal change in blood routine test、urine and stool routine test、liver and renal function test and electrocardiogram test. The BST showed that it was safe in the clinical application.更多还原