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目的研究计算机断层扫描(CT)引导下栅状骶髂关节射频神经切断术(PSRN)治疗强直性脊柱炎(AS)患者骶髂关节疼痛的疗效和安全性,并与塞来昔布进行比较。方法本研究为随机、对照临床试验,2010年5月—2012年4月共纳入155例AS患者,随机分入PSRN组(82例,CT引导下行PSRN)和塞来昔布组(73例,口服200mg/次,2次/d,持续24周)。采用0~10cm疼痛视觉模拟评分(VAS评分)评价疼痛相关指标。在治疗12和24周,根据国际强直性脊柱关节炎评估工作组(ASAS)反应标准,分别记录两组取得治疗反应(分值降低20%)的患者比例、总体疼痛强度、AS活动评分(ASDAS)、巴氏AS计量指数评分(BASMI,评价脊柱活动度)、巴氏AS功能指数评分(BASFI,评价身体功能)、总的和夜间背痛的疼痛VAS评分、血清CRP水平。记录在整个研究中发生的不良事件。结果 PSRN组患者治疗12和24周的总体疼痛强度、BASMI、BASFI、总的背痛和夜间背痛的疼痛VAS评分,以及治疗12周的CRP水平均显著低于同组治疗前(P值分别<0.01、0.05);塞来昔布组患者治疗12和24周的总体疼痛强度、总的背痛和夜间背痛的疼痛VAS评分,以及治疗12周的BASFI的疼痛VAS评分、CRP水平均显著低于同组治疗前(P值分别<0.01、0.05)。两组间治疗前疼痛相关指标的差异均无统计学意义(P值均>0.05)。治疗12周,PSRN组取得治疗反应的患者比例为47.6%(39/82),塞来昔布组为57.5%(42/73),两组间差异无统计学意义(P>0.05);治疗24周,PSRN组取得治疗反应的患者比例为45.1%(37/82),塞来昔布组为49.3%(36/73),两组间差异无统计学意义(P>0.05)。治疗12和24周PSRN组的总体疼痛强度、BASMI、BASFI、总的背痛和夜间背痛的疼痛VAS评分均显著低于塞来昔布组同时间(P值均<0.01)。塞来昔布组上腹部疼痛、恶心、腹泻、瘙痒和腹痛的发生率均显著高于PSRN组(P值分别<0.01、0.05)。PSRN组治疗点出血和感染的发生率分别为6.1%(5/82)和3.7%(3/82)。两组均无脊髓损伤和神经损伤等严重不良事件发生。结论 CT引导下PSRN治疗AS患者骶髂关节疼痛安全、有效,在降低总体疼痛强度和改善身体功能、脊柱活动度方面优于塞来昔布。
Objective To study the efficacy and safety of computed tomography (CT) guided sacral and iliac arthrography (PSRN) in the treatment of sacroiliac joint pain in patients with ankylosing spondylitis (AS) and compare with celecoxib. Methods This randomized, controlled clinical trial included 155 AS patients between May 2010 and April 2012. All patients were randomized into the PSRN group (n = 82, CT-guided descending PSRN) and the celecoxib group (n = 73) Oral 200mg / time, 2 times / d, for 24 weeks). Pain-related indicators were assessed using a 0-10 cm pain visual analog scale (VAS score). At 12 and 24 weeks of treatment, the proportion of patients receiving treatment response (20% reduction), overall pain intensity, and AS activity score (ASDAS) were recorded according to the ASAS Response Criteria (ASAS) ), PAS score (BASMI, assessing spine activity), PAS score (BASFI, physical function), pain VAS score for total and nocturnal back pain, and serum CRP levels. Record adverse events throughout the study. Results The overall pain intensity at 12 and 24 weeks, BASMI, BASFI, pain VAS score of total back pain and nocturnal back pain in PSRN group and CRP level at 12 weeks were significantly lower than those before treatment (P value respectively <0.01, 0.05). The VAS score of total pain intensity, the pain of total back pain and nocturnal back pain in patients with celecoxib treatment for 12 and 24 weeks and VAS score and CRP level of BASFI for 12 weeks were significantly Lower than the same group before treatment (P value <0.01,0.05 respectively). There were no significant differences in the pain-related indicators between the two groups before treatment (P> 0.05). After 12 weeks of treatment, the rate of response to treatment in PSRN group was 47.6% (39/82) and in celecoxib group (57.5%, 42/73), there was no significant difference between the two groups (P> 0.05) At 24 weeks, the response rate was 45.1% (37/82) in the PSRN group and 49.3% (36/73) in the celecoxib group, with no significant difference between the two groups (P> 0.05). The overall pain intensity of PSRN group at 12 and 24 weeks of treatment, VAS scores of BASMI, BASFI, total back pain and nocturnal back pain were significantly lower than those in celecoxib group (P <0.01). The incidence of upper abdominal pain, nausea, diarrhea, itching and abdominal pain in the celecoxib group was significantly higher than in the PSRN group (P <0.01, 0.05, respectively). The incidence of bleeding and infection in the PSRN group was 6.1% (5/82) and 3.7% (3/82), respectively. No serious adverse events such as spinal cord injury and nerve injury occurred in both groups. Conclusion CT-guided PSRN treatment of sacroiliac joint pain in AS patients is safe and effective, which is superior to celecoxib in reducing overall pain intensity and improving body function and spine mobility.