纳米梅花针导入双氯芬酸二乙胺乳胶剂治疗急性痛风性关节炎临床研究

Clinical Study on Diclofenac Diethylamine Emulsion Delivery via Nano Plum-blossom Needle for Treatment of Acute Gouty Arthritis

目的评价纳米梅花针导入双氯芬酸二乙胺乳胶剂治疗急性痛风性关节炎的有效性。方法选择急性痛风性关节炎患者83例,采用SAS9.1生成随机序列,分为治疗组33例、对照1组33例、对照2组17例。治疗组予纳米梅花针导入双氯芬酸二乙胺乳胶剂,对照1组予安慰纳米梅花针导入双氯芬酸二乙胺乳胶剂,对照2组仅予纳米梅花针针刺,均每日治疗1次。观察患者第1、2、3日治疗前后疼痛视觉模拟法(VAS)评分及次要指标(关节皮肤颜色、局部压痛、关节活动程度)评分。结果治疗第1、2、3日,治疗组与对照1组、对照2组VAS评分差值比较差异有统计学意义(P<0.01),治疗组治疗前后VAS评分差值优于2个对照组;对照1组与对照2组VAS评分差值比较差异无统计学意义(P>0.05)。治疗第1、2、3日,次要指标评分差值治疗组与2个对照组比较差异有统计学意义(P<0.05,P<0.01)。结论纳米梅花针导入双氯芬酸二乙胺乳胶剂对急性痛风性关节炎即刻止痛初步评价有效,并可缓解其他次要症状。

Objective To evaluate the effectiveness of diclofenac diethylamine emulsion delivery via nano plumblossom needle for acute gouty arthritis. Methods Totally 83 patients with acute gouty arthritis were collected. SAS9.1 was used to generate random sequences, which were distributed to the treatment group(33 cases), control group 1(33 cases) and control group 2(17 cases). The patients in the treatment group were treated by the intervention of diclofenac diethylamine delivery via nano plum-blossom needle. The patients in the control group 1 were treated by the intervention of diclofenac diethylamine delivery via placebo nano plum-blossom needle. The patients in the control group 2 were treated by only nano plum-blossom needle. Pain visual analogue scale(VAS) score and the secondary indicators(joint skin color, local tenderness, joint mobility) scores were observed before and after treatment on day 1, 2 and 3. Results On the 1st, 2nd and 3rd day of treatment, the difference between the VAS scores of the treatment group and the control group 1 and the control group 2 was statistically significant(P<0.01), and the difference in VAS score before and after treatment in the treatment group was better than that in the two control groups. There was no statistical significance in VAS score between control group 1 and control group 2(P>0.05). On the 1st, 2nd, and 3rd day of treatment, the difference of the secondary index scores was statistically significant only between the treatment group and the control group 1(P<0.05, P<0.01). Conclusion Diclofenac diethylamine emulsion delivery via nano plum-blossom needle for acute gouty arthritis may has an immediate effect to relieve pain and relieve the other secondary sympotms.