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中华乳腺病杂志(电子版)

中华乳腺病杂志(电子版) ›› 2014, Vol. 08 ›› Issue (02) : 99 -102. doi: 10.3877/cma. j. issn.1674-0807.2014.02.006

论著

氟哌噻吨-美利曲辛片联合非甾体抗炎药治疗中青年女性乳腺癌保留乳房术后慢性疼痛的疗效观察: 一项前瞻、随机、对照临床研究
王宇1,†(), 崔志超1, 马杰1, 张景华1, 谷峥1, 张顺礼1   
  1. 1.063000 唐山市人民医院乳腺外科
  • 收稿日期:2013-11-22 出版日期:2014-04-01
  • 通信作者: 王宇

Flupentixol and Melitracen plus non-steroidal anti-inflammatory drug to treat chronic postoperative pain after breast-conserving surgery in young and middle-aged patients with breast cancer: a prospective randomized controlled clinical study

Yu Wang1,†(), Zhi-chao Cui1, Jie Ma1, Jinghua Zhang1, Zheng Gu1, Shun-li Zhang1   

  1. 1.Department of Breast Surgery, People’s Hospital of Tangshan City, Tangshan 063000,China
  • Received:2013-11-22 Published:2014-04-01
  • Corresponding author: Yu Wang
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王宇, 崔志超, 马杰, 张景华, 谷峥, 张顺礼. 氟哌噻吨-美利曲辛片联合非甾体抗炎药治疗中青年女性乳腺癌保留乳房术后慢性疼痛的疗效观察: 一项前瞻、随机、对照临床研究[J]. 中华乳腺病杂志(电子版), 2014, 08(02): 99-102.

Yu Wang, Zhi-chao Cui, Jie Ma, Jinghua Zhang, Zheng Gu, Shun-li Zhang. Flupentixol and Melitracen plus non-steroidal anti-inflammatory drug to treat chronic postoperative pain after breast-conserving surgery in young and middle-aged patients with breast cancer: a prospective randomized controlled clinical study[J]. Chinese Journal of Breast Disease(Electronic Edition), 2014, 08(02): 99-102.

目的

探讨氟哌噻吨-美利曲辛片联合非甾体抗炎药对中青年女性乳腺癌保留乳房术后慢性疼痛的疗效。

方法

纳入2011 年3 月至2012 年9 月在本院行乳腺癌保留乳房手术的中青年女性患者120 例,患者术后均有不同程度的慢性疼痛,综合医院焦虑抑郁测定表(HAD)评分为8 ～15 分。 随机数字表法分为治疗组(n=60)及对照组(n=60),对照组采用非甾体抗炎药布洛芬缓释胶囊(芬必得,0.3 g,每日2 次),治疗组采用芬必得联合氟哌噻吨-美利曲辛片(1 片,每日2 次),疗程8 周,分别于入组时、治疗4 周和8 周后进行疼痛模拟评分(VAS)。 采用HAD 进行情绪障碍评分以及采用匹茨堡睡眠质量指数(PSQI)进行睡眠质量评分。 计量资料的比较采用t 检验、重复测量的方差分析,率的比较采用χ2 检验。

结果

治疗4 周和8 周后治疗组疼痛VAS 评分显著降低(F=8.337, P=0.002),有效率高于对照组(38.33% 比20.00%, χ2=4.881,P=0.027;70.00% 比36.67%, χ2=13.393,P=0.000);治疗组焦虑及抑郁指数明显降低(F=16.825, P=0.000;F=10.026, P=0.000),且均低于对照组(F=6.074, P=0.033; F=4.221, P=0.172);治疗组PSQI 下降(F=8.681, P=0.001),两组差异无统计学意义(F=3.587, P=0.284)。

结论

氟哌噻吨-美利曲辛片联合非甾体抗炎药治疗中青年女性乳腺癌保留乳房术后慢性疼痛疗效优于单纯非甾体抗炎药,且伴有情绪及睡眠质量改善。

关键词: 乳腺肿瘤, 抗焦虑药, 抗抑郁药, 疼痛, 手术后, 保留乳房手术, 药物疗法

Objective

To investigate the efficacy of Flupentixol and Melitracen tablets(Deanxit)combined with non-steroidal anti-inflammatory drug in young and middle-aged patients with chronic postoperative pain after breast-conserving surgery of breast cancer.

Methods

Totally 120 patients undergoing breast-conserving surgery in our hospital from March 2011 to September 2012 were enrolled and randomly divided into treatment group (n=60) and control group (n=60). All patients had chronic pain to different degree, with the scores of 8-15 by the hospital anxiety and depression(HAD) scale. Control group was treated with nonsteroidal anti-inflammatory drug Ibuprofen sustained release capsules (Fenbid, 0.3 g, bid), while treatment group took Fenbid plus Flupentixol and Melitracen tablets (1 tablet, bid). The treatment lasted for 8 weeks. At 0, 4, 8 weeks after treatment, the postoperative pain, emotional disorder and sleep quality were assessed using visual analogue scale(VAS),HAD scale,and Pittsburgh sleep quality index (PSQI). The t test and repeated analysis of variance were used to compare measurement data, chi-square test was used to compare the rates.

Results

At 4 weeks and 8 weeks after treatment, in treatment group, VAS showed a significant improvement (F=8.337, P=0.002), the effective rate was higher than that in control group (38.33% vs 20.00%, χ2=4.881,P=0.027; 70.00% vs 36.67%, χ2 =13.393,P＜0.001); the indexes of anxiety and depression were significantly reduced (F=16.825, P＜0.001; F=10.026, P＜0.001), and both were lower than those in control group (F=6.074, P=0.033; F=4.221, P=0.172); PSQI was decreased (F=8.681,P=0.001), but the difference was not statistically significant between two groups (F=3.587, P=0.284).

Conclusion

Flupentixol and Melitracen tablets combined with non-steroidal anti-inflammatory drug show a better efficacy than non-steroidal anti-inflammatory drug used alone in the treatment of chronic pain after breastconserving surgery in young and middle-aged patients with breast cancer, accompanied by the improvement of emotion and sleep quality.

Key words: Breast neoplasms, Antianxiety agents, Antidepressive agents, Pain, postoperative, Breast-conserving surgery, Drug therapy
表1 治疗组和对照组临床病理特征比较
分组 例数 年龄(岁) VAS评分 TNM分期(例)
Ⅰ Ⅱ
治疗组 60 38.6±3.51 5.23±1.43 42 18
对照组 60 39.4±5.20 5.15±2.34 40 20
t值 0.664 0.716 0.154
P值 0.580 0.482 0.695
表2 氟哌噻吨-美利曲辛片治疗乳腺癌保留乳房术后慢性疼痛疗效观察
时间 例数 治疗有效例数 有效率(%) χ 2值 P值
第4周末
治疗组 60 23 38.33 4.881 0.027
对照组 60 12 20.00
第8周末
治疗组 60 42 70.00 13.393 0.000
对照组 60 22 36.67
图1 两组乳腺癌保留乳房术后患者慢性疼痛VAS 评分 VAS: 疼痛模拟评分;各时间点比较,F=8.337, P=0.002;组间比较,F=4.802, P=0.036;时间与分组有交互作用,F=5.337,P=0.023
表3 氟哌噻吨-美利曲辛片治疗乳腺癌保留乳房术后慢性疼痛VAS 观察
分组 例数 入组时 第4周末 第8周末
治疗组 60 6.11±2.12 3.82±1.45ab 1.39±1.10ab
对照组 60 5.97±2.38 4.73±2.17 2.43±1.68a
表4 氟哌噻吨-美利曲辛片对乳腺癌保留乳房术后慢性疼痛患者心理状态及睡眠的影响
指数 例数 入组时 第4周末 第8周末
焦虑
治疗组 60 10.54±1.17b 6.90±1.57ab 5.57±1.32ab
对照组 60 9.93±1.11 10.47±0.90a 10.10±1.10
抑郁
治疗组 60 9.11±2.13b 6.85±0.85ab 6.04±1.07ab
对照组 60 7.87±0.87 8.23±1.47 8.07±1.21a
PSQI
治疗组 60 6.07±2.07b 4.29±1.46a 3.75±1.24a
对照组 60 4.37±1.45 4.33±1.03 4.13±1.17a
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