加减肾附丸治疗腰椎间盘突出症肾虚寒凝证的疗效观察

Effect of Modified Shenfuwan on Lumbar Disc Herniation Due to Kidney Deficiency and Cold Coagulation

目的:观察加减肾附丸治疗腰椎间盘突出症肾虚寒凝证的近远期疗效。方法:100例患者被随机分为对照组和观察组,各50例。对照组口服美洛昔康片,每次7.5 mg,每日1次;观察组口服加减肾附丸,每次300 mL,每日2次,疗程均为3个月。治疗前后分别观察两组简化McGill疼痛积分量表(SF-MPQ),Oswestry腰背及下肢功能障碍指数(ODI),中医证候评分;检测全血黏度(高切、中切、低切),血清炎性因子[肿瘤坏死因子-α(TNF-α),白细胞介素-1β(IL-1β),白细胞介素-6(IL-6)],疼痛介质[内皮素-1(ET-1),前列腺素E2(PGE2),环氧化酶-2(COX-2)]。观察两组临床疗效,随访12,24个月的复发率。记录研究期间两组患者出现的不良反应类型及时间。结果:治疗后,观察组患者总有效率98.0%(49/50),高于对照组的82.0%(41/50()P<0.05)。随访12个月,观察组复发率23.9%(11/46)低于对照组的52.5%(21/40)(χ^(2)=5.193,P<0.05)。随访24个月,观察组复发率43.9%(18/41),低于对照组的80.6%(29/36()P<0.05)。与对照组治疗后比较,观察组SF-MPQ,ODI,中医证候,全血黏度,IL-6,TNF-α,IL-1β,ET-1,PGE2,COX-2明显降低(P<0.05)。观察组不良反应发生率2.0%(1/50),低于对照组的52.0%(26/50)(χ^(2)=6.264,P<0.05)。结论:加减肾附丸可明显改善腰椎间盘突出症肾虚寒凝证的患者的近远期临床疗效,不良反应发生率低。

Objective: To observe short-term and long-term effect of modified Shenfuwan on lumbar disc herniation due to kidney deficiency and cold coagulation. Method: 100 cases were randomly divided into the control group and observation group,50 cases each. The control group were taken meloxicam tablets,7.5 mg each time,once a day and the observation group were given modified Shenfuwan,300 mL each time,twice a day.The treatment course was 3 months. The short form McGill pain questionnaire(SF-MPQ),oswestry disability index(ODI),and lumbar intervertebral disc herniation due to kidney deficiency and cold coagulation by traditional Chinese medicine(TCM)syndrome were observed before and after treatment. Whole blood viscosity(high,medium,low),serum inflammatory factors[tumor necrosis factor-alpha(TNF-α),interleukin-1β(IL-1β),interleukin-6(IL-6),pain mediators[endothelin-1(ET-1),prostaglandin E2(PGE2),cyclooxygenase-2(COX-2)]were detected. The clinical efficacyand,recurrence rate followed up for 12 and 24 months was was observed. The type and time of adverse reactions were recorded during the study. Result: After treatment,the total effective rate in the observation group was 98.0%(49/50)higher than that 82.0%(41/50)in the control group(P<0.05).After 12 months of follow-up,the recurrence rate in the observation group was 23.9%(11/46)lower than that52.5%(21/40)in the control group(χ^(2)=5.193,P<0.05). After 24 months of follow-up,the recurrence rate in the observation group was 43.9%(18/41) lower than that that 80.6%(29/36) in the control group(P<0.05).Compared with the control group after treatment,SF-MPQ,ODI,TCM symptoms,whole blood viscosity,TNF-α,IL-1β,IL-6,ET-1,PGE2 and COX-2 were significantly reduced in the observation group(P<0.05). The incidence of adverse reactions in the observation group was 2.0%(1/50)lower than that 52.0%(26/50)in the control group(χ^(2)=6.264,P<0.05). Conclusion: Modified Shenfuwan can significantly improve the short-term and long-term clinical efficacy of patients with lumbar disc herniation due to kidney deficiency and cold coagulation syndrome,and the incidence of adverse reactions is low.