OBJECTIVETo observe the effect and safety of Zhiling Capsule (ZC) in treating lung cancer of middle/advanced stage.

METHODSWith 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.

RESULTSThe 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.

CONCLUSIONZC can improve the symptoms and QOL in patients with lung cancer of middle/advanced stage.