摘要
背景:活血化瘀止痛中成药广泛应用于颈椎病的治疗,但目前尚无随机双盲对照研究验证其有效性。目的:进行多中心、随机、双盲、安慰剂对照研究验证活血化瘀止痛中成药治疗神经根型颈椎病的有效性及安全性。方法:研究自2015年8月至2017年7月,由中国国内13家大中型医院联合参与,采用多中心、随机、双盲、安慰剂对照的试验设计,按照3︰1的比例纳入试验组(口服活血化瘀止痛中成药——颈舒颗粒)360例,对照组(口服安慰剂)120例。两组受试者按连续4周,每日3次,每次1袋的剂量口服试验药物或安慰剂,分别在服药后第2周和第4周接受访视,主要疗效指标为疼痛评分(0～100分),观察治疗后疼痛评分变化值及变化率,同时复查相关检验指标并记录不良反应,以评价试验药物的有效性和安全性,根据神经根致压物性质(软压迫、硬压迫及混合压迫)进行亚组分析。结果:完成研究病例数386例,其中试验组299例,对照组87例。试验组、对照组分别有359例和120例进入全分析集(full analysis set,FAS),有299例和91例进入符合方案集(per protocol set,PPS),有358例和117例进入安全性分析集(safety analysis set,SAS)。PPS分析结果显示,对照组和试验组基线VAS评分分别为(49.3±7.0)分和(50.1±7.3)分,两组间无统计学差异(P>0.05),经过4周治疗后,对照组和试验组的VAS评分较基线的下降值分别为(12.9±13.5)分和(22.7±15.1)分,变化率分别为26.52%±27.66%和45.71%±30.10%,与基线比较,各组的前后差异以及变化率均有统计学意义(P<0.001)。比较两组VAS评分下降值和变化率的组间差异有统计学意义(P<0.001)。FAS分析结果类似。亚组分析显示,对于软性压迫者,试验组的VAS评分下降值和变化率较对照组有统计学差异(P<0.05)。结论:该活血化瘀止痛中成药对于治疗神经根型颈椎病在缓解神经根性疼痛方面有效,特别是对于软性压迫的病例。
Background: The traditional Chinese medicine for promoting blood circulation and removing stasis and pain iswidely used in the treatment of cervical spondylotic radiculopathy, but there is no randomized, double-blind, controlled studyto verify its effectiveness. Objects:To evaluate the efficacy and safety of such a granule—Jingshukeli(JSKL) in the treatment of cervical spondylotic radiculopathy by a multicenter, randomized, double-blind, placebo-controlled study. Methods: From Au-gust 2015 to July 2017, a multicenter, randomized, double-blind, placebo-controlled trial was conducted within 13 large-andmedium-sized hospitals in China. Totally 360 cases were included in the trial group and 120 cases in the control group. All thesubjects were treated with a bag of JSKL or placebo 3 times a day for 4 weeks, and were interviewed at the second week and thefourth week, respectively. The main curative effect evaluation index was visual analogue scale(VAS, 0-100 points) score forpain. Related lab indexes were reviewed and adverse reactions were recorded. Subgroup analysis was performed for compressiontype(soft, hard or mixed compression). Results: Totally 299 cases in JSKL group and 87 cases in placebo group completed theexperiment. There were 359 cases in the JSKL group and 120 cases in the control group in the full analysis set(FAS), 299 casesin the JSKL group and 91 cases in the control group in the per protocol set(PPS), 358 cases in the JSKL group and 117 cases inthe control group in the safety analysis set(SAS). PPS analysis showed that baseline VAS scores of the control group and JSKLgroup were 49.3±7.0 and 50.1±7.3, respectively, and there was no significant difference between the two groups(P >0.05). After4-week treatment, VAS scores of the control group and JSKL group were decreased by 12.9±13.5 and 22.7±15.1 with a 26.52%±27.66% and 45.71%±30.10% decline. Compared with the baseline, VAS scores were significantly decreased in both groups af-ter treatment(P<0.001). There were significant differences in the decrease and change rate of VAS score decline between thetwo groups(P<0.001). Moreover, FAS analysis achieved similar results. Subgroup analysis showed that there was a significantdifference in the decrease and change rate of VAS score between the two groups for soft compression type(P<0.05). Conclusions: JSKL is effective in the treatment of cervical spondylotic radiculopathy, especially for soft compression cases.
作者
陈峰
胡建华
邱贵兴
常晓
孙天胜
杨惠林
沈慧勇
童培建
柴益民
张学利
张伟滨
杨志东
姜宏
潘亚林
朱天亮
何承建
CHEN Feng;HU Jianhua;QIU Guixing;CHANG Xiao;SUN Tiansheng;YANG Huilin;SHEN Huiyong;TING Peijian;CHAI Yimin;ZHANG Xueli;ZHANG Weibin;YANG Zhidong;JIANG hong;PAN Yalin;ZHU Tianliang;HE Chengjian(Department of Orthopaedics,Peking Union Medical College Hospital,Peking Union Medical College & Chinese Academy of Medical Sciences,Beijing 100730;Department of Orthopaedics, Suzhou Hospital of Traditional Chinese Medicine,Suzhou 215008,Jiangsu;Department of Orthopaedics,Anyang People's Hospital,Anyang 455002,Henan;Department of Orthopaedics,Chongqing People's Hospital,Chongqing 400013;Department of Orthopaedics,Hubei Traditional Chinese Medicine Hospital,Wuhan 430061,China;Department of Orthopaedics,PLA General Hospital,Beijing 100700;Department of Orthopaedics,The First Affiliated Hospital of Soochow University,Suzhou 215006,Jiangsu;Department of Orthopaedics, Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120;Department of Orthopaedics,Zhejiang Hospital of Traditional Chinese Medicine;Department of Orthopaedics,Shanghai Sixth People's Hospital,Shanghai 201306;Department of Orthopaedics,Tianjin People's Hospital,Tianjin 300121;Department of Orthopaedics,Ruijin Hospital, Shanghai Jiao Tong University School of Medicine,Shanghai 200025;Department of Orthopaedics,The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405)
出处
《中华骨与关节外科杂志》
2018年第11期826-831,835,共7页
Chinese Journal of Bone and Joint Surgery
关键词
颈椎病
中成药
临床研究
Cervical Spondylopathy
Chinese Patent Medicine
Clinical Research
