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Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (7): 611-615.doi: 10.3736/jcim20090703

• Original Clinical Research • Previous Articles     Next Articles

Effects of Feitai Capsule on quality of life in patients with advanced non-small-cell lung cancer: A randomized controlled trial

Zhi-zhen Liu, Zong-yang Yu, Xue-nong Ouyang,Xi-hu Dai, Xi Chen, Zhong-quan Zhao, Wen-wu Wang, Jie Li, Hua Tu, Lei Ye, Yan Yan   

  1. Department of Oncology, Fuzhou General Hospital of Nanjing Military Region, Fuzhou 350025, Fujian Province, China
  • Received:2008-12-22 Accepted:2009-04-27 Online:2009-07-20 Published:2009-07-15
  • Contact: Xue-nong Ouyang E-mail:oyxn@pulic.fz.fj.cn

Background

Recently the maintenance therapy of non-small-cell lung cancer (NSCLC) patients who completed required treatment cycles has caused widespread interests in the medical field. Traditional Chinese medicine may be a useful complement in maintenance treatment of mid-to-late stage NSCLC.
Objective

To observe the effects of Feitai Capsule, a compound traditional Chinese herbal medicine for expelling blood stasis and phlegm, on the quality of life of the NSCLC patients as a maintenance treatment.Design, setting, participants and interventions: A total of 62 mid-to-late stage NSCLC patients from Fuzhou General Hospital of Nanjing Military Region were included and randomly divided into treatment group (31 cases) and control group (31 cases). Patients in the treatment group were treated with Feitai Capsule, and patients in the control group did not accept any intervention. Regular observations and follow-up were performed for patients in the two groups.Main outcome measures: Analysis of variance, nonparametric test, and analysis of covariance were used to compare clinical features, amelioration of clinical symptoms, physical constitution and energy, and quality of life.
Results

There were two dropouts and 60 valid cases. The baseline characteristics of the two groups were similar. In the treatment group, symptom response and physical energy level were improved by 36.6% (Z=–2.632, P=0.008) and 26.7% (Z=–2.182, P=0.029), respectively. There was a positive correlation between these two factors (r=0.917, P<0.001). The patients in treatment group had a significantly improved quality of life after treatment. No serious adverse events were observed.
Conclusion

Feitai Capsule as maintenance treatment can improve the quality of life of the patients with mid-to-late stage NSCLC.

Key words: Non-small-cell lung carcinoma, Compound (traditional Chinese drug), Quality of life, Randomized controlled trial

Figure 1

Flow diagram of this randomized trial"

Table 1

Comparison of general information in patients between two groups"

Item n Control group (n=30) Treatment group (n=30) χ2 P
Sex
Male [Cases (%)] 39 20(66.7) 19(63.3) 0.073 0.787
Female [Cases (%)] 21 10(33.3) 11(36.7)
Age [Median (Q25, Q75)] 60 56(35, 73) 59(38, 77) 0.523
Smoking
Smoker [Cases (%)] 32 15(50.0) 17(56.7) 0.268 0.605
Non-smoker [Cases (%)] 28 15(50.0) 13(43.3)
Stage
Ⅲa [Cases (%)] 9 4(13.3) 5(16.7) 0.271 0.602
Ⅲb [Cases (%)] 17 8(26.7) 9(30.0)
Ⅳ[Cases (%)] 34 18(60.0) 16(53.3)
KPS scale
60 [Cases (%)] 18 10(33.3) 8(26.7) 0.603 0.740
70-80 [Cases (%)] 31 14(46.7) 17(56.7)
90-100 [Cases (%)] 11 6(20.0) 5(16.7)

Table 2

Clinical symptom responses and KPS changes of patients in two groups [Cases (%)]"

Observation item Control group (n=30) Treatment group (n=30)
Symptom response
Good improvement 3(10.0) 7(23.3)
Improvement 8(26.7) 15(50.0)
Stability 12(40.0) 5(16.7)
Non-effective 7(23.3) 3(10.0)
Total improvement rate 11(36.7) 22(73.3)**
KPS scale
Good improvement 2(6.67) 5(16.7)
Improvement 6(20.0) 11(36.7)
Stable 17(56.7) 12(40.0)
Non-effective 5(16.7) 2(6.7)
Improvement rate 8(26.7) 16(53.4)*

Figure 2

Baseline changes of FACT-L scale in two groups before and after treatment Data were reprented as ?x±s, n=3. *P<0.05, vs control group."

[1] Lin LZ, Zhou DH, Zheng XT . Effect of traditional Chinese medicine in improving quality of life of patients with non-small cell lung cancer in late stage[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2006,26(5):389-393
林丽珠, 周岱翰, 郑心婷 . 中医药提高晚期非小细胞肺癌患者生存质量的临床观察[J]. 中国中西医结合杂志, 2006,26(5):389-393
[2] Zhou YM, Piao BK, Hou W, Lin HS, Hua BJ, Xiong L, Zheng HG . Clinical observation of Feiliuping ointment on immune state and prognosis in patients with non-small-cell lung cancer[J]. Zhongguo Zhong Yi Yao Xin Xi Za Zhi, 2008,15(5):78-79
周雍明, 朴炳奎, 侯炜, 林洪生, 花宝金, 熊露, 郑红刚 . 肺瘤平膏改善非小细胞肺癌患者免疫状态及预后的临床观察[J]. 中国中医药信息杂志, 2008,15(5):78-79
[3] Zheng XY. Guidelines of clinical research on Chinese new herbal medicines[M]. Beijing: Medical Science and Technology Publishing House of China, 2002: 216-221
郑筱萸 . 中药新药临床研究指导原则[M]. 北京: 中国医药科技出版社, 2002: 216-221
[4] Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E, Bonomi P . Reliability and validity of the Functional Assessment of Cancer Therapy-Lung(FACT-L) quality of life instrument[J]. Lung Cancer, 1995,12(3):199-220
doi: 10.1016/0169-5002(95)00450-F
[5] Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker Jr S, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR . American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline[J]. J Clin Oncol, 2004,22(2):330-353
doi: 10.1200/JCO.2004.09.053
[6] Goldie JH, Coldman AJ . A mathematical model for relating the drug sensitivity of tumors to their spontaneous mutation rate[J]. Cancer Treat Rep, 1979,63(11-12):1727-1733
[7] Brodowicz T, Krzakowski M, Zwitter M, Tzekova V, Ramlau R, Ghilezan N, Ciuleanu T, Cucevic B, Gyurkovits K, Ulsperger E, Jassem J, Grgic M, Saip P, Szilasi M, Wiltschke C, Wagnerova M, Oskina N, Soldatenkova V, Zielinski C, Wenczl M ; Central European Cooperative Oncology Group CECOG.Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: A phase Ⅲ trial[J]. Lung Cancer, 2006,52(2):155-163
doi: 10.1016/j.lungcan.2006.01.006
[8] Fathi AT, Brahmer JR . Chemotherapy for advanced stage non-small cell lung cancer[J]. Semin Thorac Cardiovasc Surg, 2008,20(3):210-216
doi: 10.1053/j.semtcvs.2008.09.002
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