Yangxue Ruanjian capsule in treatment of knee osteoarthritis: a randomized, double-blind and placebo-controlled clinical trial

PANG Jian; CHEN Yuanchuan; CHEN Bo; ZHANG Min; WU Yuyun; CAO Yuelong; SHI Yinyu; ZHAO Yongfang

doi:10.16305/j.1007-1334.2019.11.010

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Yangxue Ruanjian capsule in treatment of knee osteoarthritis: a randomized, double-blind and placebo-controlled clinical trial

更新时间：2022-08-31

- Yangxue Ruanjian capsule in treatment of knee osteoarthritis: a randomized, double-blind and placebo-controlled clinical trial
- Shanghai Journal of Traditional Chinese Medicine Vol. 53, Issue 11, Pages: 48-52(2019)
- 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,上海市中医药研究院骨伤科研究所,上海,201203
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2019.11.010
  CLC：
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PANG Jian, CHEN Yuanchuan, CHEN Bo, et al. Yangxue Ruanjian capsule in treatment of knee osteoarthritis: a randomized, double-blind and placebo-controlled clinical trial. [J]. Shanghai Journal of Traditional Chinese Medicine 53(11):48-52(2019)
DOI：

PANG Jian, CHEN Yuanchuan, CHEN Bo, et al. Yangxue Ruanjian capsule in treatment of knee osteoarthritis: a randomized, double-blind and placebo-controlled clinical trial. [J]. Shanghai Journal of Traditional Chinese Medicine 53(11):48-52(2019) DOI： 10.16305/j.1007-1334.2019.11.010.

摘要

目的：观察养血软坚胶囊治疗膝骨关节炎的有效性与安全性。方法：采用随机、双盲、安慰剂对照的研究设计,将84例膝骨关节炎患者随机分为治疗组和对照组,每组42例。对照组予养血软坚胶囊模拟剂口服,治疗组予养血软坚胶囊口服。两组疗程均为4周,分别于治疗前、治疗2周、治疗4周时观察中医证候积分、西安大略和麦克马斯特大学骨关节炎指数(Western Ontario and McMaster Osteoarthritis Index,WOMAC)总积分及其疼痛子积分、僵硬子积分、关节功能子积分的变化情况,同时评价安全性。结果：①84例病例均完成了2周节点的访视；治疗4周时,治疗组脱落6例(失访),对照组脱落7例(失访)。②治疗前与治疗2周组内比较,两组WOMAC总积分、疼痛子积分、僵硬子积分、关节功能子积分差异无统计学意义(P＞0.05)。治疗前与治疗4周组内比较,治疗组WOMAC总积分、疼痛子积分、僵硬子积分、关节功能子积分减少(P＜0.05),对照组WOMAC总积分、疼痛子积分、关节功能子积分减少(P＜0.05)。③组间治疗2周与治疗4周、治疗前与治疗4周差值比较,治疗组WOMAC总积分、疼痛子积分、僵硬子积分、关节功能子积分差值大于对照组(P＜0.05)。④治疗前与治疗2周、治疗4周组内比较,两组中医证候积分均较治疗前减少(P＜0.05)。组间中医证候积分各时间点差值比较,差异无统计学意义(P＞0.05)。⑤治疗前后,两组血常规、尿常规、肝肾功能指标无异常,均未见不良反应发生。结论：养血软坚胶囊能有效缓解膝骨关节炎患者的关节疼痛、僵硬、功能障碍等症状,且安全性高,该制剂具有进一步研发的价值。

Abstract

Objective:To observe the efficacy and safety of Yangxue Ruanjian capsule in the treatment of knee osteoarthritis. MethodsIn this randomized, double-blind, placebo-controlled study, 84 patients with knee osteoarthritis were randomly assigned into control group and treatment group, 42 patients in each group. The treatment group was given Yangxue Ruanjian capsule and the control group received placebo. The treatment course was 4 weeks in both groups. The changes in TCM syndrome score and the total score, pain sub-score, stiffness sub-score and joint function sub-score of Western Ontario and McMaster Osteoarthritis Index (WOMAC) were observed and safety was evaluated before treatment and at 2 and 4 weeks of treatment. Results:①All of the 84 patients completed the visit at 2 weeks of treatment; at 4 weeks of treatment, there were 6 and 7 dropouts (lost to follow-up) in the treatment group and the control groups, respectively. ②There were no significant differences in WOMAC total score or sub-scores in the groups before treatment and at 2 weeks of treatment (P＞0.05). At 4 weeks of treatment, WOMAC total score and sub-scores decreased compared to those before treatment in the treatment group (P＜0.05), and WOMAC total score, pain sub-score and joint function sub-score decreased in the control group (P＜0.05).③There were greater differences in WOMAC total scores and sub-scores in the treatment group than in the control group at 2 vs. 4 weeks of treatment and before treatment vs. at 4 weeks of treatment (P＜0.05). ④The TCM syndrome score decreased in both groups before treatment vs. at 2 and 4 weeks of treatment (P＜0.05). There were no significant differences in TCM syndrome score at any time point between the groups (P＞0.05). Conclusion:Yangxue Ruanjian capsule effectively relieves the symptoms of patients with knee osteoarthritis with good safety, including joint pain, stiffness and dysfunction, showing the value for further research and development.

关键词

膝骨关节炎养血软坚胶囊随机对照安慰剂

Keywords

knee osteoarthritisYangxue Ruanjian capsulerandomized controlledplacebo

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