七芍活血方治疗气滞血瘀型腰椎间盘突出症疗效及血液流变学和血清炎性因子的影响

Effect of Qishao Huoxue Prescription on Hemorheological Parameters and Serum Levels of Inflammatory Mediators in Lumbar Disc Herniation Due to Qi Stagnation and Blood Stasis

目的:观察七芍活血方治疗气滞血瘀型腰椎间盘突出症患者的临床疗效,并对血液流变学和血清炎性因子的影响。方法:选取中国中医科学院望京医院2023年1月至2024年2月收治气滞血瘀型腰椎间盘突出症患者86例,按随机数字表法均分为观察组与对照组,各组43例,两组患者均予以腰椎牵引治疗,观察组予以七芍活血方口服,对照组予以塞来昔布口服,治疗周期为3周,观察比较治疗前、治疗后疼痛视觉模拟(VAS)评分、腰椎Oswestry功能障碍(ODI)评分、生活质量(SF-12)评分、中医证候积分、疗效评价标准、血流变学指标全血高切、中切、低切黏度(WBRV)、血浆黏度(PV)、纤维蛋白原(FIB)及血清炎性因子浓度[肿瘤坏死因子-α(TNF-α)、血清白细胞介素-6(IL-6)、血清白细胞介素-1β(IL-1β)、转化生长因子-β_(1)(TGF-β_(1))],并记录药物不良反应。结果:与治疗前比较,两组患者疼痛VAS评分、腰椎ODI评分、中医证候量化总积分均降低(P<0.05),SF-12评分中PCS及MCS总评分均升高(P<0.05),观察组患者治疗后全血高切、中切、低切黏度、血浆黏度、纤维蛋白原均明显降低(P<0.05),而对照组治疗前后差异无统计学意义,血清TNF-α、IL-6及IL-1β含量均明显降低(P<0.05),TGF-β_(1)含量升高(P<0.05);与对照组治疗后比较,观察组疼痛VAS评分、腰椎ODI评分、中医证候量化总积分及主症候积分降低更明显(P<0.05),次症候积分差异无统计学意义,SF-12生活质量评分中PCS及MCS总评分均提高(P<0.05),全血黏度、血浆黏度、纤维蛋白原、血清TNF-α、IL-6、IL-1β及TGF-β_(1)指标改善更佳(P<0.05);治疗后,观察组患者临床疗效评定总有效率97.5%(40/41),对照组患者临床疗效评定总有效率88.1%(37/42),观察组总有效率高于对照组(P<0.05)。治疗过程中两组未见严重不良反应,观察组1例下肢皮下瘀斑,予以停药后瘀斑逐渐消除。结论:七芍活血方治疗气滞血瘀型腰椎间盘突出症获得显著的临床疗效,改善患者血液流变学水平,抑制血清炎性因子的表达,未发生明显不良反应,值得临床推广。

Objective:To observe the therapeutic effects of Qishao Huoxue prescription on patients with lumbar disc herniation due to Qi stagnation and blood stasis and the effects of this prescription on hemorheological parameters and serum levels of inflammatory mediators.Method:A total of 86 patients with lumbar disc herniation due to Qi stagnation and blood stasis treated in the Wangjing Hospital of China Academy of Chinese Medical Sciences from January 2023 to February 2024 were selected and assigned according to the random number table into observation and control groups(n=43).Patients in both groups received lumbar traction treatment.In addition,the observation group was orally treated with Qishao Huoxue prescription and the control group with celebrex for 3 weeks.The visual analogue scale(VAS)score,Oswestry disabilitiy index(ODI)score,12-item Short-Form Survey(SF-12)score,traditional Chinese medicine(TCM)symptom score,hemorheological parameters[whole blood high shear viscosity,middle shear viscosity,low shear viscosity,plasma viscosity(PV),and fibrinogen(FIB)],and the serum levels of inflammatory mediators[tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),interleukin-1β(IL-1β),and transforming growth factor-β_(1)(TGF-β_(1))]were determined before and after treatment.In addition,the clinical efficacy and adverse reactions were observed and compared between the two groups.Result:After treatment,both groups showed declined VAS,ODI,and TCM symptom scores(P<0.05),increased SF-12 physical component summary(PCS)and mental component summary(MCS)scores(P<0.05).After treatment,the whole blood high shear viscosity,middle shear viscosity,low shear viscosity,PV,and FIB decreased in the observation group(P<0.05),while they did not show significant variations in the control group.After treatment,both groups of patients showed reductions in TNF-α,IL-6,and IL-1βlevels and an elevation in the TGF-β_(1) level(P<0.05).Compared with the control group after treatment,the observation group showed decreases in VAS,ODI,TCM symptom scores and main symptom scores(P<0.05),no significant differences in the secondary symptom scores,increased PCS and MCS scores(P<0.05).The observation group outperformed the control group in terms of recovering whole blood high shear viscosity,middle shear viscosity,low shear viscosity,PV,FIB,TNF-α,IL-6,IL-1β,and TGF-β_(1)(P<0.05).The total response rate in the observation group was 97.5%(40/41),which was higher than that(88.1%,37/42)in the control group(P<0.05).No serious adverse reaction was observed in the two groups during the observation period.One case in the observation group showed subcutaneous bruising on the lower limbs,which gradually disappeared after withdrawal.Conclusion:Qishao Huoxue prescription demonstrated definite effect in treating lumbar disc herniation due to qi stagnation and blood stasis by recovering hemorheological parameters and inhibiting the expression of inflammatory mediators in the serum without inducing adverse reactions.It is worth applying in clinical practice.