Sun Da-zhi, Jiao Jian-peng, Zhang Xuan, Xu Jing-yu, Ye Min, Xiu Li-juan, Zhao Ying, Lu Ye, Liu Xuan, Zhao Jing, Shi Jun, Qin Zhi-feng, Wei Pin-kang
Department of Traditional Chinese Medicine, Changzheng Hospital, Second Military Medical University, Shanghai (, 200003), China.
Chin J Integr Med. 2015 Aug;21(8):579-86. doi: 10.1007/s11655-014-1950-z. Epub 2014 Nov 16.
To evaluate the impact of Jinlongshe Granule (, 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.
评估金龙蛇颗粒（JLSG）对IV期胃癌患者生活质量（QOL）的影响。
本随机、双盲、安慰剂对照临床试验纳入50例晚期胃癌患者。他们被等分为金龙蛇颗粒组和安慰剂组。两组患者均根据中医辨证接受常规中药汤剂治疗。金龙蛇颗粒组患者额外服用金龙蛇颗粒，安慰剂组患者额外服用安慰剂。在金龙蛇颗粒组，19例完成研究的患者用于分析。在安慰剂组，最终20例完成研究的患者的数据用于分析。疗程至少3个月，随访时间至少6个月，进行5次访谈。对5次访谈时获得的欧洲癌症研究与治疗组织核心生活质量问卷C30（EORTC QLQ-C30）的子量表项目和单项进行重复测量，分别比较不同患者组、随时间的变化以及一组内随时间的变化，以观察得分变化趋势。
以时间为变量，4个功能量表（身体、角色、情感和社会，P<0.05）、3个症状量表（疲劳、恶心呕吐和疼痛，P<0.05）、1个总体健康状况/生活质量量表（P<0.05）以及6个单项症状（呼吸困难，P>0.05；失眠，P<0.05；食欲减退，P<0.05；便秘，P<0.05；腹泻，P>0.05；经济困难，P<0.05）存在显著差异。以安慰剂组和随时间变化的组为变量时，两组在这些项目上也存在显著差异（P<0.05或P<0.01）。
在常规中医治疗基础上加用金龙蛇颗粒可改善晚期胃癌患者的躯体功能、角色功能、情感功能、社会功能、认知功能和总体生活质量，并缓解疲劳、恶心呕吐、疼痛、食欲减退和便秘症状。
