2.2. Medical Treatment

All patients in the non-TCM user group received only standardized chemotherapy according to the National Comprehensive Cancer Network (NCCN,2011) Clinical Practice Guidelines of NSCLC. All patients in the TCM user group received Chinese medicine therapy consisting of Chinese herbal decoction, Chinese patent drug, and correlative injection, together with standardized chemotherapy. Notably, the traditional Chinese medicine should be used for more than six months in the TCM user group. Standardized chemotherapy should be used for four cycles in two groups.

Based on the Chinese Medicine New Medicine Clinical Practice Guideline (Trial Implementation) (published by China Medical Science Press in 2002) and TCM theory of combination of disease and syndrome, combined with years of clinical observation and experience in our department, we summarized the main syndrome differentiation types at the postoperative stage of NSCLC as follows: pulmonary Qi deficiency, Qi and Yin deficiency, and stagnation of phlegm and blood stasis. They were determined by two senior physician. Pulmonary Qi deficiency manifests as the following: cough, shortness of breath, fatigue and weakness, spontaneous sweating, pale tongue, thin coating, and a weak pulse. Qi and Yin deficiency manifests as the following: cough, small amount of sputum, fatigue and weakness, dried mouth without polydipsia, spontaneous sweat, night sweat, reddish tongue or tongue with teeth imprints, and thready and weak pulse. Stagnation of phlegm and blood stasis manifests as the following: cough, constant phlegm, dark tongue, white and greasy coating, and an uneven pulse. Above all, the core pathogenesis (the pathological basis of tumor recurrence and metastasis) was the deficiency of vital Qi and internal toxin of cancer. On this basis, a therapeutic regimen was formulated based on the real diagnosis and treatment: the postoperative patients with pulmonary Qi deficiency syndrome adopted Shen Yi capsule (SDA approval number: Z20030044, Ginsenoside Rg3, orally administered of 20mg, two times each day (BID)); patients with Qi and Yin deficiency syndrome were treated with Yifei Qinghua granules (SDA approval number: Z20050851, whose ingredients included Radix Astragali seu Hedysari, Radix Codonopsis, Radix Glehniae, Radix Ophiopogonis, Semen Armeniacae Amarum, Bulbus Fritillariae Unibracteatae, and Herba Hedyotidis Diffusae; orally administered of 20g, two times each day (BID)); and Fufang Banmao capsule (SDA approval number: Z52020238, whose ingredients included Radix Astragali seu Hedysari, Panax ginseng, Aesculus wilsonii Rehd, and Chinese blister beetle; orally administered 0.75 g, two times each day (BID)), was used to treat patients with stagnation of phlegm and blood stasis syndrome. Additionally, all patients could choose to use oral Chinese medicine decoction added and subtracted from the standardized agent based on their core pathogenesis. The herbal treatment was suitable for the specific condition of each patient in accordance with syndrome differentiation [14]. There are three matched types of CHM decoction for the TCM user group in this study: patients with pulmonary Qi deficiency syndrome adopted LiuJunZi decoction, patients with Qi and Yin deficiency syndrome were treated with ShaShenMaiDong decoction, and patients with stagnation of phlegm and blood stasis syndrome were treated with SiWu decoction together with HuaTan decoction. The general outline of the TCM syndrome differentiation used and fundamental prescriptions given to the patients were described in Table 1. The major therapeutic principle was to strengthen the body resistance to eliminate pathogenic factors.

The most commonly used herbs per traditional Chinese medicine syndrome.

Decocting method is as follows: soak the herbs in water for 30 min with water level 1 cm above the herbs. First, boil with strong heat and then with gentle heat for about 20–40 minutes. Then, decant the decoction, repeat the above course, combine the decoction, and concentrate to 300 mL. Dosage and administration are as follows: one set of herbs per day, 150 mL each time, twice a day, and one hour after breakfast and supper.