志苓胶囊治疗中晚期肺癌的疗效观察

目的观察志苓胶囊治疗中晚期肺癌的疗效和安全性.方法采用多中心随机、双盲、平衡对照方法,分别用志苓胶囊（全方组104例）、志苓胶囊的西药成分（拆方1组52例）、中药成分（拆方2组46例）和平消胶囊（对照组48例）口服2周,观察各组治疗前后中医证侯（气阴两虚）改变及临床症状、生活质量、体重增减情况和毒副反应.结果全方组、拆方1组、拆方2组和对照组中医证候（气阴两虚）改善率分别为91.3%、80.8%、37.0%、14.6%;胸闷胸痛缓解率分别为86.9%、60.5%、20.0%、10.0%;纳食不香改善率分别为80.4%、47.9%、23.7%、10.3%;生活质量治疗后全方组和两拆方组比治疗前显著提高（P＜0.05或（P＜0.01）,且全方组提高幅度优于其他3组（P＜0.01）;体重治疗后全方组显著增加,且增加程度优于其他3组（P＜0.05）.4组均未见明显不良反应.结论志苓胶囊能明显缓解中晚期肺癌患者中医证候和改善生存质量.

Observation on the Effect of Zhiling Capsule in Treating Patients with Lung Cancer of Middle/Advanced Stage

OBJECTIVE: To observe the effect and safety of Zhiling Capsule (ZC) in treating lung cancer of middle/advanced stage. METHODS: With the multi-center, randomized, double-blinded and parallel controlled method, the patients were divided into 4 groups, the 104 patients in the group A were treated with the whole recipe of ZC, the 52 in the group B with the disassembled recipe 1 (Western medicines) of ZC, the 46 in the group C with the disassembled recipe 2 (Chinese medicines) of ZC, and the 48 in the control group with Pingxiao Capsule, all the drugs were administered orally for 2 weeks. The changes of syndrome of qi-yin deficiency, symptoms, quality of life (QOL), body weight and adverse reactions occurred in patients were observed. RESULTS: The effective rate in alleviating syndrome in the groups A-D was 91.3%, 80.8%, 37.0% and 14.6% respectively; in remitting stuffiness and chest pain 86.9% , 60.5%, 20.0% and 10.0%; in improving appetite was 80.4%, 47.9%, 23.7% and 10.3%. QOL in the groups A-C was significantly elevated after treatment (P < 0.05 or P < 0.01), the improvement of group A was superior to that of other treatments (P < 0.01). Body weight in the group A was significantly increased and superior to that of others (P < 0.05). The whole recipe of ZC showed the therapeutic effect superior to that of the other treatments (P < 0.05). No obvious adverse reaction was found in all the 4 groups. CONCLUSION: ZC can improve the symptoms and QOL in patients with lung cancer of middle/advanced stage.