通络生骨胶囊治疗股骨头坏死(筋脉瘀滞证)的多中心随机、双盲、双模拟、阳性药对照临床研究

元唯安; 杜炯; 闻辉; 刘又文; 沈霖; 韩永台; 杨凤云; 葛京华; 谷福顺; 张建新; 宁亚功; 陈卫衡; 姜益常; 张杰; 余桦; 董晓俊; 于浩; 詹红生

doi:10.16305/j.1007-1334.2019.08.014

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通络生骨胶囊治疗股骨头坏死(筋脉瘀滞证)的多中心随机、双盲、双模拟、阳性药对照临床研究

临床试验 | 更新时间：2022-08-31

- 通络生骨胶囊治疗股骨头坏死(筋脉瘀滞证)的多中心随机、双盲、双模拟、阳性药对照临床研究
- A multi-center, randomized, double-blind, double-dummy, positive-controlled clinical study on Tongluo Shenggu Capsule in treatment of osteonecrosis of femoral head (syndrome of stagnation of sinews and vessels)
- 上海中医药杂志 2019年53卷第8期页码：53-59
- 作者机构：
  
  1. 上海中医药大学附属曙光医院石氏伤科医学中心,上海,201203
  2. 长春中医药大学附属医院骨伤科,吉林,长春,130021
  3. 河南省洛阳正骨医院,河南省骨科医院骨伤科,河南,洛阳,471000
  4. 华中科技大学同济医学院附属协和医院骨伤科,湖北,武汉,430022
  5. 河北医科大学第三医院骨科,河北,石家庄,050051
  6. 江西中医药大学附属医院骨伤科,江西,南昌,330006
  7. 上海中医药大学附属龙华医院骨伤科,上海,200032
  8. 天津中医药大学第二附属医院骨伤科,天津,300150
  9. 福建省厦门市中医院骨伤科,福建,厦门,361009
  10. 成都军区昆明总医院骨科,云南,昆明,650032
  11. 中国中医科学院望京医院骨伤科,北京,100102
  12. 黑龙江中医药大学附属第一医院骨伤科,黑龙江,哈尔滨,150000
  13. 黑龙江中医药大学附属第二医院骨伤科,黑龙江,哈尔滨,150001
  14. 上海市中西医结合医院骨伤科,上海,200082
  15. 湖北省武汉市中医医院骨伤科,湖北,武汉,430014
  16. 南京医科大学公共卫生学院,江苏,南京,210029
- 作者简介：
- 基金信息：
  
  国家卫生计生委医药卫生科技发展研究中心“重大新药创制”科技重大专项(2017ZX09304002)
- DOI：10.16305/j.1007-1334.2019.08.014
  中图分类号：
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元唯安, 杜炯, 闻辉, 等. 通络生骨胶囊治疗股骨头坏死(筋脉瘀滞证)的多中心随机、双盲、双模拟、阳性药对照临床研究[J]. 上海中医药杂志, 2019,53(8):53-59.

YUAN Weian, DU Jiong, WEN Hui, et al. A multi-center, randomized, double-blind, double-dummy, positive-controlled clinical study on Tongluo Shenggu Capsule in treatment of osteonecrosis of femoral head (syndrome of stagnation of sinews and vessels)[J]. Shanghai Journal of Traditional Chinese Medicine, 2019,53(8):53-59.
元唯安, 杜炯, 闻辉, 等. 通络生骨胶囊治疗股骨头坏死(筋脉瘀滞证)的多中心随机、双盲、双模拟、阳性药对照临床研究[J]. 上海中医药杂志, 2019,53(8):53-59. DOI： 10.16305/j.1007-1334.2019.08.014.

YUAN Weian, DU Jiong, WEN Hui, et al. A multi-center, randomized, double-blind, double-dummy, positive-controlled clinical study on Tongluo Shenggu Capsule in treatment of osteonecrosis of femoral head (syndrome of stagnation of sinews and vessels)[J]. Shanghai Journal of Traditional Chinese Medicine, 2019,53(8):53-59. DOI： 10.16305/j.1007-1334.2019.08.014.

摘要

目的：观察通络生骨胶囊治疗股骨头坏死(筋脉瘀滞证)的有效性及安全性。方法：采用多中心随机、双盲、双模拟、阳性药对照临床研究设计,将600例股骨头坏死患者按照2∶1的比例随机分为试验组及对照组。对照组予口服通络生骨胶囊模拟剂、健骨生丸治疗,试验组予口服通络生骨胶囊、健骨生丸模拟剂治疗。两组疗程均为12周,比较两组不同观察时间点(治疗前、治疗4周、治疗8周、治疗12周、停药后4周)的髋关节Harris评分、中医证候积分、股骨头坏死ARCO分期的变化情况,同时评价安全性。结果：①=1\*GB3治疗4周、治疗8周、治疗12周和停药后4周,两组Harris评分较本组治疗前基线变化率差异有统计学意义(P<0.05)。治疗12周、停药后4周组间比较,试验组Harris评分高于对照组(P<0.05)；治疗8周、治疗12周、停药后4周组间比较,Harris评分较基线变化率差异有统计学意义(P<0.05)。②=2\*GB3治疗4周、治疗8周、治疗12周、停药后4周,两组中医证候积分较本组治疗前基线下降率差异有统计学意义(P<0.05)。治疗4周、治疗8周、治疗12周、停药后4周组间比较,中医证候积分及较基线下降率差异均无统计学意义(P＞0.05)。③=3\*GB3治疗12周组间比较,ARCO分期差异无统计学意义(P＞0.05)。④=4\*GB3两组安全性评价差异无统计学意义(P＞0.05)。结论：通络生骨胶囊治疗股骨头坏死(筋脉瘀滞证)疗效满意,与健骨生丸相比,能更好地改善患者的髋关节功能功能,且安全可靠。

Abstract

Objective:To observe the efficacy and safety of Tongluo Shenggu (TLSG) Capsule in the treatment of osteonecrosis of the femoral head (ONFH) with syndrome of stagnation of sinews and vessels. MethodsIn a multi-center, randomized, double-blind, double-dummy, positive-controlled clinical study, 600 patients with ONFH were randomly assigned into trial group and control group at a ratio of 2∶1. The control group was treated with Tongluo Shenggu Capsule simulant and Jianggusheng Pill, while the trial group was treated with Tongluo Shenggu Capsule and Jianggusheng Pill simulant. The treatment course was 12 weeks. The changes in Harris score, TCM syndrome score and ARCO staging of ONFH were compared at different time points (before treatment, at 4,8 and 12 weeks of treatment and at 4 weeks after drug withdrawal) and safety was evaluated. Results:①=1\*GB3At 4,8 and 12 weeks of treatment and 4 weeks after drug withdrawal, there was significant difference in Harris score from baseline in both groups (P<0.05). The Harris score was higher in the trial group than in the control group (P<0.05) at 12 weeks of treatment and 4 weeks after drug withdrawal; and there was significant difference from baseline between the groups at 8 and 12 weeks of treatment and 4 weeks after drug withdrawal (P<0.05). ②=2\*GB3At 4,8 and 12 weeks of treatment and 4 weeks after drug withdrawal, the scores of TCM syndrome decreased significantly in both groups compared to baseline before treatment (P<0.05). There was no significant difference from baseline in TCM syndrome scores between the groups at 4,8 and 12 weeks of treatment and 4 weeks after drug withdrawal (P>0.05). ③=3\*GB3There was no significant difference in ARCO staging between the groups at 12 weeks of treatment (P>0.05). ④=4\*GB3There was no significant difference in safety evaluation between the groups (P>0.05). Conclusion:TLSG Capsule shows satisfactory efficacy in treating ONFH (syndrome of stagnation of sinews and vessels), and compared with Jiangusheng Pill, it better improves the hip function of patients, and is safe and reliable.

关键词

通络生骨胶囊股骨头坏死多中心随机对照双盲

Keywords

Tongluo Shenggu Capsuleosteonecrosis of the femoral headmulti-centerrandomized controldouble-blind

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