FOLLOWUS
Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial
Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial
- 中国结合医学杂志（英文版） 2015年21卷第8期 页码：579-586
- Affiliations：
Department of Traditional Chinese Medicine, Changzheng Hospital, Second Military Medical University,Shanghai,China
- Author bio：
- Funds：Supported by Shanghai Changzheng Hospital Youth Foundation Project (No. 200917)
DOI：10.1007/s11655-014-1950-z
中图分类号：纸质出版日期：2015，
网络出版日期：2014-11-16，
Scan for full text
Sun, Dz., Jiao, Jp., Zhang, X. et al. Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial., Chin. J. Integr. Med. 21, 579–586 (2015). https://doi.org/10.1007/s11655-014-1950-z
Da-zhi Sun, Jian-peng Jiao, Xuan Zhang, et al. Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial[J]. Chinese Journal of Integrative Medicine, 2015,21(8):579-586.
Sun, Dz., Jiao, Jp., Zhang, X. et al. Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial., Chin. J. Integr. Med. 21, 579–586 (2015). https://doi.org/10.1007/s11655-014-1950-z DOI：
Da-zhi Sun, Jian-peng Jiao, Xuan Zhang, et al. Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial[J]. Chinese Journal of Integrative Medicine, 2015,21(8):579-586. DOI： 10.1007/s11655-014-1950-z.
摘要
To evaluate the impact of Jinlongshe Granule (金龙蛇颗粒
JLSG) on quality of life (QOL) of stage IV gastric cancer patients. This randomized
double-blind and placebo-controlled clinical trial included 50 patients with advanced gastric cancer. They were equally randomized into a JLSG group and a placebo group. Patients in both groups received routine Chinese herbal decoctions according to Chinese medicine (CM) treatment based on syndrome differentiation. Patients in JLSG group received additional JLSG
and those in the placebo group received an additional placebo. In the JLSG group
19 patients who completed the study were used for analysis. In the placebo group
finally the data of 20 patients who completed the study were used for analysis. The treatment course was at least 3 months
and the follow-up duration was at least 6 months in 5 interviews. Repeated measurements of the subscale items and individual items in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) obtained at the 5 interviews were compared using different patient groups
changes over time and changes within one group over time independently to observe the tendency of changes in the scores. Using time as the variant
there was signifificant difference in 4 functional scales (physical
role
emotional and social
P<0.05)
3 symptom scales (fatigue
nausea and vomiting and pain
P<0.05) and a global health status/QOL scale (P<0.05) and 6 single symptoms dyspnoea (P>0.05)
insomnia (P<0.05)
appetite loss (P<0.05)
constipation (P<0.05)
diarrhea (P>0.05) and financial difficulties (P<0.05). There was also signifificant difference in these items between the two groups when the placebo group and group over time were used as variants (P<0.05 or P<0.01). Additional use of JLSG on the basis of routine CM treatment could improve the somatic function
role function
emotional function
social function
cognitive function and general QOL of patients with advanced gastric cancer
and relieve the symptoms of fatigue
nausea and vomiting
pain
loss of appetite and constipation.
Abstract
To evaluate the impact of Jinlongshe Granule (金龙蛇颗粒
JLSG) on quality of life (QOL) of stage IV gastric cancer patients. This randomized
double-blind and placebo-controlled clinical trial included 50 patients with advanced gastric cancer. They were equally randomized into a JLSG group and a placebo group. Patients in both groups received routine Chinese herbal decoctions according to Chinese medicine (CM) treatment based on syndrome differentiation. Patients in JLSG group received additional JLSG
and those in the placebo group received an additional placebo. In the JLSG group
19 patients who completed the study were used for analysis. In the placebo group
finally the data of 20 patients who completed the study were used for analysis. The treatment course was at least 3 months
and the follow-up duration was at least 6 months in 5 interviews. Repeated measurements of the subscale items and individual items in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) obtained at the 5 interviews were compared using different patient groups
changes over time and changes within one group over time independently to observe the tendency of changes in the scores. Using time as the variant
there was signifificant difference in 4 functional scales (physical
role
emotional and social
P<0.05)
3 symptom scales (fatigue
nausea and vomiting and pain
P<0.05) and a global health status/QOL scale (P<0.05) and 6 single symptoms dyspnoea (P>0.05)
insomnia (P<0.05)
appetite loss (P<0.05)
constipation (P<0.05)
diarrhea (P>0.05) and financial difficulties (P<0.05). There was also signifificant difference in these items between the two groups when the placebo group and group over time were used as variants (P<0.05 or P<0.01). Additional use of JLSG on the basis of routine CM treatment could improve the somatic function
role function
emotional function
social function
cognitive function and general QOL of patients with advanced gastric cancer
and relieve the symptoms of fatigue
nausea and vomiting
pain
loss of appetite and constipation.
关键词
Gastric CancerJinlongshe Granulequality of liferandomized placebo controlled study
Keywords
Gastric CancerJinlongshe Granulequality of liferandomized placebo controlled study
references
Van Cutsem E. The treatment of advanced gastric cancer: new findings on the activity of taxanes. Oncologist 2004;9(suppl 2):9–15.
Velikova G, Weis J, Hjermstad MJ, Kopp M, Morris P, Watson M, et al. The EORTC QLQ-HDC29: a supplementary module assessing the quality of life during and after high-dose chemotherapy and stem cell transplantation. Eur J Cancer 2007;43:87–94.
Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, et al. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer 2005;41:1135–1139.
Kato J, Nagahara A, Iijima K, Yoshimura M, Osada T, Yoshizawa T, et al. Evaluation of EORTC QLQ-C30 questionnaire in patients undergoing in-hospital chemotherapy for gastrointestinal cancer in Japan. J Gastroenterol Hepatol 2008;23(Suppl 2):S268–S272.
Que HF, Chen HF, Xu JN, Liu S, Lu DM, Tang HJ. Discussion of relationship between quality of life and clinical effect assessment of malignant tumor treated with traditional Chinese medicine. J Chin Integr Med (Chin) 2005;3:253–256.
Wei PK, Xu L, Sun DZ, Shi J, Qin ZF, Lu Y. Relation between phlegm and generation and development of Gastric Cancer. J Tradit Chin Med 2008;28:152–155.
Vickery CW, Blazeby JM, Conroy T, Arraras J, Sezer O, Koller M, et al. Development of an EORTC disease-specific quality of life module for use in patients with gastric cancer. Eur J Cancer 2001;37:966–971.
Isobe Y, Nashimoto A, Akazawa K, Oda I, Hayashi K, Miyashiro I, et al. Gastric cancer treatment in Japan: 2008 annual report of the JGCA nationwide registry. Gastric Cancer 2011;14:301–316.
Sun DZ, Xu L, Wei PK, Liu L, He J. Syndrome differentiation in traditional Chinese medicine and E-cadherin/ICAM-1 gene protein expression in gastric carcinoma. World J Gastroenterol 2007;13:4321–4327.
Roca O, Pérez-Terán P, Masclans JR, Pérez L, Galve E, Evangelista A, et al. Patients with New York Heart Association class III heart failure may benefit with high flow nasal cannula supportive therapy: high flow nasal cannula in heart failure. J Crit Care 2013;28:741–746.
Combe C1, McCullough KP, Asano Y, Ginsberg N, Maroni BJ, Pifer TB. Kidney Disease Outcomes Quality Initiative (K/DOQI) and the Dialysis Outcomes and Practice Patterns Study (DOPPS): nutrition guidelines, indicators, and practices. Am J Kidney Dis 2004;44(5 Suppl 2):39–46.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–376.
Zheng XY, ed. Chinese medicine clinical research guidelines. Beijing: Chinese Medical Science and Technology Press; 2002:29–32.
World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2000;284:3043-3045.
Food and Drug Administration. Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics. US Food-Washington, DC, US Food and Drug Administration, 2007.
Sun DZ, Ju DW, He J, Lu Y, Wu F, Li C, et al. Tumor interstitial fluid and postoperative recurrence of tumors: an experimental study for verifying hypothesis of "tumor-phlegm microenvironment". J Tradit Chin Med 2010;16:435–441.
Wiig H, Tenstad O, Iversen PO, Kalluri R, Bjerkvig R. Interstitial fluid: the overlooked component of the tumor microenvironment? Fibrogenesis Tissue Repair 2010;3:12.
Wang JY, Xu L, Zhang RX, Lao L. Traditional Chinese medicine for cancer pain. J Chin Integr Med (Chin) 2011;9:129–134.
You J. Significance and necessity of developing quality of life questionnaire for cancer patients adapting to traditional Chinese medicine. J Chin Integr Med (Chin) 2006;4:473–477.
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. Chin J Integr Tradit West Med (Chin) 2006;26:389–393.
Liu X, Hua BJ. Effect of traditional Chinese medicine on quality of life and survival period in patients with progressive gastric cancer. Chin J Integr Tradit West Med (Chin) 2008;28:105–107.
Zhou W, Li YJ, Wei PK. Effects of Xiaotan Sanjie Recipe on vasculogenic mimicry of human gastric cancer xenografts in nude mice. Chin J Integr Tradit West Med (Chin) 2011;31:532–536.
Pang B, Wei PK, Li YJ. Effect of xiaotan sanjie recipe on expressions of VEGF-C and VEGFR-3 in nude mice with transplanted human gastric adenocarcinoma cell MKN-45. Chin J Integr Tradit West Med (Chin) 2011;31:204–208.
Li CJ, Wei PK, Yue BL. Study on the mechanism of Xiaotan Sanjie Recipe for inhibiting proliferation of gastric cancer cells. J Tradit Chin Med(Chin) 2010;30:249–253.
Ju DW, Wei PK, Lin HM, Sun DZ, Yu S, Xiu LJ. Effects of Xiaotan Sanjie Decoction on expressions of interleukin-8 and its receptors in gastric tumor xenografts and gastric tissue adjacent to the tumor in mice. J Chin Integr Med (Chin) 2010;8:74–79.
Guo XD, Wei PK. Effect of Xiaotan Sanjie Recipe on growth of transplanted tumor and expressions of proliferating cell nuclear antigen and epidermal growth factor receptor in tissue of gastric carcinoma of nude mice. J Chin Integr Med (Chin) 2007;5:432–436.
Zheng J, Zheng J, Zheng PY. Application of quality of life scale in evaluating the efficacy of gastric cancer treatment. J Chin Integr Med (Chin) 2008;6:304–310.
Perwitasari DA, Atthobari J, Dwiprahasto I, Hakimi M, Gelderblom H, Putter H, et al. Translation and validation of EORTC QLQ-C30 into Indonesian version for cancer patients in Indonesia. Jpn J Clin Oncol 2011;41:519–529.
Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Domínguez Domínguez MA, Lainez Milagro N, Manterola Burgaleta A, et al. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol 2008;61:949–954.
Silpakit C, Sirilerttrakul S, Jirajarus M, Sirisinha T, Sirachainan E, Ratanatharathorn V. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): validation study of the Thai version. Qual Life Res 2006;15:167–172.
Luo N, Fones CS, Lim SE, Xie F, Thumboo J, Li SC. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30): validation of English version in Singapore. Qual Life Res 2005;14:1181–1186.
Groenvold M, Klee MC, Sprangers MA, Aaronson NK. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol 1997;50:441–450.
Park SH, Cho MS, Kim YS, Hong J, Nam E, Park J, et al. Self-reported health-related quality of life predicts survival for patients with advanced gastric cancer treated with first-line chemotherapy. Qual Life Res 2008;17:207–214.
Rodary C, Pezet-Langevin V, Garcia-Acosta S, Lesimple T, Lortholary A, Kaminsky MC, et al. Patient preference for either the EORTC QLQ-C30 or the FACIT Quality Of Life (QOL) measures: a study performed in patients suffering from carcinoma of an unknown primary site (CUP). Eur J Cancer 2004;40:521–528.
Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, et al. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol 2008;19:2053–2060.
Zhao H, Kanda K. Translation and validation of the standard Chinese version of the EORTC QLQ-C30. Qual Life Res 2000;9:129–137.
Sadighi S, Mohagheghi MA, Montazeri A, Sadighi Z. Quality of life in patients with advanced gastric cancer: a randomized trial comparing docetaxel, cisplatin, 5-FU (TCF) with epirubicin, cisplatin, 5-FU (ECF). BMC Cancer 2006;6:274.
Park SH, Lee WK, Chung M, Bang SM, Cho EK, Lee JH, et al. Quality of life in patients with advanced gastric cancer treated with second-line chemotherapy. Cancer Chemother Pharmacol 2006;57:289–294.
Cao ND, Zhao AG, Yang JK. Survival time of advanced gastric cancer patients treated with integrated traditional Chinese and Western medicine therapy. J Chin Integr Med (Chin) 2010;8:116–120.
0
浏览量
169
Downloads
6
CSCD
- Meta-XML下载
- BibTeX下载
- Endnote下载
- RefMan 下载
- NoteExpress下载
- NoteFirst下载
关联资源
相关文章
相关作者
相关机构
- 邮编：100091
- 联系电话：010-62886827, 62877592 传真：010-62874291
- 技术支持由北京北大方正电子有限公司提供 京ICP备05067934号-1
京公网安备11010802024621 - 本系统建议在Chrome、 IE9+ 以上版本浏览器阅读本站内容，360浏览器请切换至极速模式
- Cookies帮助我们提供服务并提供个性化体验。使用本网站，即表示您同意我们使用Cookies
