Clinical study on Sanjie Tongluo Granule combined with western medicine in treating bone metastases of malignant tumor

Lu YANG; Zhongqi WANG; Jingru QIN; Chengcheng ZHANG; Xinle QIAN

doi:10.16305/j.1007-1334.2022.1908014

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Clinical study on Sanjie Tongluo Granule combined with western medicine in treating bone metastases of malignant tumor

更新时间：2022-07-10

- Clinical study on Sanjie Tongluo Granule combined with western medicine in treating bone metastases of malignant tumor
- Shanghai Journal of Traditional Chinese Medicine Vol. 56, Issue 2, Pages: 49-53(2022)
- 作者机构：
  
  1.上海中医药大学附属龙华医院肿瘤二科（上海 200032）
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2022.1908014
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杨鹭,王中奇,钦敬如等.中药散结通络颗粒联合西药治疗恶性肿瘤骨转移的临床研究[J].上海中医药杂志,2022,56(02):49-53.

YANG Lu,WANG Zhongqi,QIN Jingru,et al.Clinical study on Sanjie Tongluo Granule combined with western medicine in treating bone metastases of malignant tumor[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(02):49-53.
杨鹭,王中奇,钦敬如等.中药散结通络颗粒联合西药治疗恶性肿瘤骨转移的临床研究[J].上海中医药杂志,2022,56(02):49-53. DOI： 10.16305/j.1007-1334.2022.1908014.

YANG Lu,WANG Zhongqi,QIN Jingru,et al.Clinical study on Sanjie Tongluo Granule combined with western medicine in treating bone metastases of malignant tumor[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(02):49-53. DOI： 10.16305/j.1007-1334.2022.1908014.

摘要

目的,2,观察中药散结通络颗粒联合西药治疗恶性肿瘤骨转移的临床疗效。,方法,2,将70例恶性肿瘤骨转移患者随机分为治疗组和对照组，每组35例。对照组予常规西药治疗，治疗组在对照组治疗措施基础上加服中药散结通络颗粒。两组疗程均为6个月，观察临床疗效、无进展时间（PFS）及用药安全性，比较疼痛评价相关指标、血清钙（Ca,2+,）及碱性磷酸酶（ALP）、血清肿瘤标志物相关指标、免疫功能相关指标、中医证候积分、生活质量量表评分的变化情况。,结果,2,①最终完成试验者，治疗组33例，对照组33例。②组间临床疗效比较，治疗组明显优于对照组（,P,<,0.05）；治疗组平均PFS、中位PFS水平均明显长于对照组（,P,<,0.05）。③组间比较，治疗组疼痛数字评分（NRS）明显低于对照组（,P,<,0.05）；治疗组使用止痛药患者的疼痛缓解持续时间及24 h羟考酮用量的改善情况明显优于对照组（,P,<,0.05）。④组间治疗后比较，治疗组ALP水平明显低于对照组（,P,<,0.05）。⑤组间治疗后比较，治疗组CA15-3、CEA水平明显低于对照组（,P,<,0.05）。⑥组间治疗后比较，治疗组CD3,+,、CD4,+,水平明显高于对照组（,P,<,0.05）。⑦组间治疗后比较，治疗组中医证候积分明显低于对照组（,P,<,0.05）。⑧组间治疗后比较，治疗组生活质量量表的疼痛部位、功能障碍、社会心理模块评分明显低于对照组（,P,<,0.05）。,结论,2,中药散结通络颗粒联合西药治疗恶性肿瘤骨转移取得了较单纯西药更为满意的临床疗效。

Abstract

Objective,2,To observe the clinical effect of Sanjie Tongluo Granule combined with western medicine on the treatment of bone metastases （BMs） of malignant tumor.,Methods,2,Seventy patients with BMs of malignant tumor were randomly divided into treatment group （,n,=35） and control group （,n,=35）. The control group was administered with conventional western medicine， while the treatment group was administered with Sanjie Tongluo Granule besides the conventional treatment measures of the control group. The course of treatment in both groups was 6 months. We observed the clinical effect， progression-free survival （PFS） and medication safety， and compared the changes in scores of related indicators including numerical rating scale （NRS） for pain， serum calcium （Ca,2+,）， alkaline phosphatase （ALP）， serum tumor markers， immune function， TCM syndrome， and quality of life scale.,Results,2,①Finally， 33 cases in the treatment group and 33 cases in the control group completed the trial. ②According to the result of inter-group comparison， the treatment group showed significantly better treatment effect than the control group （,P,<,0.05）； The average and median PFS in the treatment group were significantly higher than those in the control group （,P,<,0.05）. ③The pain NRS score in the treatment group was significantly lower than that in the control group （,P,<,0.05）； The duration of pain relief was significantly longer and the dosage of oxycodone in 24 hours was significantly lower in the treatment group than those in the control group （,P,<,0.05）. ④After treatment， the ALP level in the treatment group was significantly lower than that in the control group （,P,<,0.05）. ⑤After treatment， the levels of CA15-3 and CEA in the treatment group were significantly lower than those in the control group （,P,<,0.05）. ⑥After treatment， the levels of CD,3+, and CD,4+, in the treatment group were significantly higher than those in the control group （,P,<,0.05）. ⑦After treatment， the TCM syndrome scores in the treatment group were significantly lower than those in the control group （,P,<,0.05）. ⑧After treatment， the scores of pain location， dysfunction and social psychological modules of the quality of life scale in the treatment group were significantly lower than those in the control group （,P,<,0.05）.,Conclusion,2,Sanjie Tongluo Granule combined with western medicine has achieved more satisfactory clinical effect than western medicine alone in treating bone metastases of malignant tumor.

关键词

恶性肿瘤骨转移转移性骨肿瘤痰瘀互结证散结通络颗粒骨转移疼痛无进展时间中西医结合

Keywords

malignant tumorbone metastasismetastatic bone tumorintermingled phlegm and blood stasis syndromeSanjie Tongluo Granulebone metastasis painprogression-free survivalintegrated traditional Chinese and western medicine

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