[1]沈兴潮,夏炳江,凌义龙,等.五福饮加减治疗盘源性腰痛的临床研究[J].中医正骨,2020,32(02):23-29.
　SHEN Xingchao,XIA Bingjiang,LING Yilong,et al.A clinical study of Wufu Yin Jiajian(五福饮加减)for treatment of discogenic back pain[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(02):23-29.
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五福饮加减治疗盘源性腰痛的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期数:
2020年02期
页码:
23-29
栏目:
临床研究
出版日期:
2020-02-20

文章信息/Info

Title:
A clinical study of Wufu Yin Jiajian(五福饮加减)for treatment of discogenic back pain
作者:
沈兴潮; 夏炳江; 凌义龙; 韦金忠; 许杨
(绍兴市中医院,浙江 绍兴 312000)
Author(s):
SHEN Xingchao; XIA Bingjiang; LING Yilong; WEI Jinzhong; XU Yang
Shaoxing Hospital of Traditional Chinese Medicine,Shaoxing 312000,Zhejiang,China
关键词:
腰痛;  五福饮;  临床试验
Keywords:
low back pain;  Wufu Yin;  clinical trial
摘要:
目的:观察五福饮加减治疗盘源性腰痛(discogenic back pain,DBP)的临床疗效和安全性,并探讨其可能的作用机制。方法:将符合要求的100例DBP患者随机分为五福饮组和塞来昔布组,每组50例。五福饮组采用五福饮加减治疗,每日1剂,分早晚2 次空腹温服。塞来昔布组采用口服塞来昔布胶囊治疗,每日2次,每次200 mg。每个疗程均为7 d,均连续治疗4个疗程。治疗期间2组均进行适度腰背肌和腹肌功能锻炼。测定患者的腰部疼痛视觉模拟量表(visual analogue scale,VAS)评分、Oswestry功能障碍指数(Oswestry disability index,ODI)、血清β-catenin含量,评估腰椎间盘MRI分级,观察记录试验期间2组并发症的发生情况。结果:①腰部疼痛VAS评分。时间因素和分组因素不存在交互效应(F=1.734,P=0.171)。五福饮组的腰部疼痛VAS评分总体低于塞来昔布组(F=8.658,P=0.009)。治疗前后不同时点间腰部疼痛VAS评分的差异有统计学意义,即存在时间效应(F=29.821,P=0.000); 2组患者的腰部疼痛VAS评分随时间变化均呈降低趋势,但2组的降低趋势不完全一致[(6.20±1.93)分,(3.30±0.67)分,(3.00±0.82)分,(2.00±0.67)分,F=24.572,P=0.000;(6.50±2.17)分,(4.20 ±1.40)分,(4.30±1.25)分,(4.00±1.05)分,F=5.784,P=0.002]; 治疗前,2组患者的腰部疼痛VAS评分比较,差异无统计学意义(t=0.326,P=0.748); 治疗后1个月、3个月、6个月时,五福饮组的腰部疼痛VAS评分均低于塞来昔布组(t=2.633,P=0.043; t=2.751,P=0.013; t=5.071,P=0.000)。②ODI。时间因素和分组因素存在交互效应(F=2.775,P=0.049)。2组患者的ODI总体比较,组间差异无统计学意义,即不存在分组效应(F=1.815,P=0.195)。治疗前后不同时点间ODI的差异有统计学意义,即存在时间效应(F=85.320,P=0.000); 2组患者的ODI随时间变化均呈先降低后升高的趋势,但2组的变化趋势不完全一致[(68.90±19.68)%,(33.30±9.88)%,(34.50±9.28)%,(38.50±9.42)%,F=17.281,P=0.000;(68.50±22.60)%,(43.10 ±11.94)%,(44.20±10.10)%,(48.80±8.08)%,F=6.819,P=0.001]; 治疗前,2组患者的ODI比较,差异无统计学意义(t=0.042,P=0.967); 治疗后1个月、3个月、6个月时,五福饮组的ODI均低于塞来昔布组(t=2.120,P=0.041; t=2.237,P=0.038; t=2.625,P=0.017)。③腰椎间盘MRI分级。治疗前及治疗后6个月,2组患者的腰椎间盘MRI分级比较,组间差异均无统计学意义(Z=-0.248,P=0.804; Z=-0.811,P=0.417)。④血清β-catenin含量。时间因素和分组因素存在交互效应(F=21.178,P=0.000)。2组患者的血清β-catenin含量总体比较,组间差异无统计学意义,即不存在分组效应(F=3.149,P=0.093)。治疗前后不同时点间血清β-catenin含量的差异有统计学意义,即存在时间效应(F=296.182,P=0.000); 2组患者的血清β-catenin含量随时间变化均呈降低趋势,但2组的变化趋势不完全一致[(70.10±13.82)ng·mL-1,(47.90±15.73)ng·mL-1,(38.50±13.62)ng·mL-1,(27.60±9.00)ng·mL-1,F=18.515,P=0.000;(68.80±13.57)ng·mL-1,(62.60±14.02)ng·mL-1,(52.10±13.92)ng·mL-1,(42.40±13.96)ng·mL-1,F=7.049,P=0.001]; 治疗前,2组患者的血清β-catenin含量比较,差异无统计学意义(t=0.212,P=0.834); 治疗后1个月、3个月、6个月时,五福饮组的血清β-catenin含量均低于塞来昔布组(t=2.206,P=0.041; t=2.208,P=0.040; t=2.808,P=0.011)。⑤并发症。治疗及随访期间2组患者均未出现并发症。结论:五福饮加减可有效改善DBP患者的腰部疼痛症状,改善其腰椎活动功能,效果优于口服塞来昔布胶囊,而且具有较高的安全性; 其作用机制可能是通过调控Wnt/β-catenin通路,延缓腰椎间盘退变来起作用。
Abstract:
Objective:To observe the clinical curative effects and safety of Wufu Yin Jiajian(五福饮加减,WFYJJ)in treatment of discogenic back pain(DBP)and to explore its possible mechanism of actions.Methods:One hundred patients with DBP were enrolled in the study and were randomly divided into WFY group and celecoxib group,50 cases in each group.The patients in WFY group were treated with oral application of WFYJJ,one dose a day in the morning and evening respectively on an empty stomach for consecutive 4 courses of treatment,7 days for each course; while the others in celecoxib group were treated with oral application of celecoxib capsules,twice a day,200 mg at a time for consecutive 4 courses of treatment,7 days for each course.Meanwhile,moderate lumbodorsal muscle exercises and abdominal muscle exercises were conducted in patients in the 2 groups during the treatment period.The low back pain visual analogue scale(VAS)scores,Oswestry disability index(ODI)and serum content of β-catenin were measured and compared between the 2 groups,and the MRI grading of lumbar intervertebral disc was evaluated.Moreover,the complication incidences were observed and recorded during the trial.Results:There was no interaction between time factor and group factor in low back pain VAS scores(F=1.734,P=0.171).The low back pain VAS scores were lower in WFY group compared to celecoxib group in general(F=8.658,P=0.009).There was statistical difference in low back pain VAS scores between different timepoints before and after the treatment,in other words,there was time effect(F=29.821,P=0.000).The low back pain VAS scores presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(6.20+/-1.93,3.30+/-0.67,3.00+/-0.82,2.00+/-0.67 points,F=24.572,P=0.000; 6.50+/-2.17,4.20+/-1.40,4.30+/-1.25,4.00+/-1.05 points,F=5.784,P=0.002).There was no statistical difference in low back pain VAS scores between the 2 groups before treatment(t=0.326,P=0.748).The low back pain VAS scores were lower in WFY group compared to celecoxib group at 1,3 and 6 months after the treatment respectively(t=2.633,P=0.043; t=2.751,P=0.013; t=5.071,P=0.000).There was interaction between time factor and group factor in ODI(F=2.775,P=0.049).There was no statistical difference in ODI between the 2 groups in general,in other words,there was no group effect(F=1.815,P=0.195).There was statistical difference in ODI between different timepoints before and after the treatment,in other words,there was time effect(F=85.320,P=0.000).The ODI presented a time-dependent trend of decreasing firstly and increasing subsequently in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(68.90+/-19.68,33.30+/-9.88,34.50+/-9.28,38.50+/-9.42%,F=17.281,P=0.000; 68.50+/-22.60,43.10+/-11.94,44.20+/-10.10,48.80+/-8.08%,F=6.819,P=0.001).There was no statistical difference in ODI between the 2 groups before the treatment(t=0.042,P=0.967).The ODI was lower in WFY group compared to celecoxib group at 1,3 and 6 months after the treatment respectively(t=2.120,P=0.041; t=2.237,P=0.038; t=2.625,P=0.017).There was no statistical difference in MRI grading of lumbar intervertebral disc between the 2 groups before the treatment and at 6 months after the treatment(Z=-0.248,P=0.804; Z=-0.811,P=0.417).There was interaction between time factor and group factor in serum content of β-catenin(F=21.178,P=0.000).There was no statistical difference in serum content of β-catenin between the 2 groups in general,in other words,there was no group effect(F=3.149,P=0.093).There was statistical difference in serum content of β-catenin between different timepoints before and after the treatment,in other words,there was time effect(F=296.182,P=0.000).The serum content of β-catenin presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(70.10+/-13.82,47.90+/-15.73,38.50+/-13.62,27.60+/-9.00 ng/mL,F=18.515,P=0.000; 68.80+/-13.57,62.60+/-14.02,52.10+/-13.92,42.40+/-13.96 ng/mL,F=7.049,P=0.001).There was no statistical difference in serum content of β-catenin between the 2 groups before the treatment(t=0.212,P=0.834).The serum content of β-catenin was lower in WFY group compared to celecoxib group at 1,3 and 6 months after the treatment respectively(t=2.206,P=0.041; t=2.208,P=0.040; t=2.808,P=0.011).No complications were found in the 2 groups during the treatment and follow-up period.Conclusion:Oral application of WFYJJ can effectively improve the low back pain and lumbar function of patients with DBP,and its curative effect is better than that of oral application of celecoxib capsules,moreover,it has high safety.Its mechanism of action may be that it works by delaying intervertebral disc degeneration through regulating Wnt/β-catenin signaling pathway.

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备注/Memo

备注/Memo:
(收稿日期:2019-07-10 本文编辑:李晓乐)基金项目:浙江省自然科学基金项目(LQ18H270006); 浙江省中医药科技计划项目(2017ZB091,2018ZA125) 通讯作者:夏炳江 E-mail:xiabj2006@163.com
更新日期/Last Update: 2020-02-15