| Objective: To observe the efficacy of Shenfu Injection (SHF) decreasing the toxicities and improving the quality of life in the patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Taxol plus Cisplatin(TP) or Vinorelbine plus Cisplatin(NP).Methods: The patients with NSCLC were given at least two cycles of TP or NP regimen(TP:135mg/m~2 of Taxol on day 1 and 75mg/m~2 of Cisplatin on day 2 were administered every 21 days;NP: 30mg/m~2 of Vinorelbine on days 1, 8 and 80mg/m~2 of Cisplatin on day 2 were administered every 21 days). One cycle combined with SHF:SHF 60ml +0.9%NS 250ml, ivd, qd, on days -3—7;Chemotherapy treatment was administered from the 1st day. Another cycle was only given with chemotherapy treatment. The patients were randomly divided into two arms: The SHF first-treatment arm, in which SHF+ Chemotherapy regimen were given in the first cycle, and in the second cycle only with chemotherapy;and the SHF second-treatment arm, in which only chemotherapy was given in the first cycle, and SHF + Chemotherapy regimen were given in the second cycle. The toxicities, symptom, quality of life and the immunologic function were compared. Results: Forty-six patients with NSCLC were enrolled in the study of detoxification of Shenfu injection to TP regimen for treating advanced Non-Small Cell Lung Cancer, a patient was eliminated for uncontrolled brain metastasis and 45 patients were evaluated (Clinical trial 1) . Forty-two patients were evaluated in the study of detoxification of Shenfu injection to NP regimen for treating advanced Non-Small Cell Lung Cancer (Clinical trial 2) . Clinical trial 1:Twenty-three patients in the SHF first-treatment arm and twenty-two patients in the SHF second-treatment arm. The major toxicities of TP regime(?)were hematological and digestive toxicity. The hematological toxicities were grade 1 to 3 leukopenia and anemia, grade 1 to 4 neutropenia and grade 1 thrombocytopenia. The digestive toxicities were grade 1 to 3 nausea/ vomiting and grade 1 to 3 constipation. Among the 45 patients, The hematological toxicities (leukopenia / neutropenia) of SHF+TP were lower than the single TP regimen(P<0. 01=;The hematological toxicities (leukopenia / neutropenia) of SHF+TP were lower than the single TP regimen (P<0. 01) in the SHF first-treatment arm, and were similar to the single TP regimen (P>0. 05) in the SHF second-treatment arm. Among the patients with qi-deficiency plus phlegm and dampness syndromes, the hematological toxicities of SHF+TP were lower than TP (P<0. 01) . As to the digestive toxicity, nausea/ vomiting of SHF+TP was lower than TP both in two arms (P<0. 01, P<0. 05) . TBIL' s toxicity and pulmonary symptom of SHF+TP were lower than TP (P<0. 05) in the 45 patients. Grade 1 allergy occurred by 2. 2% in the SHF+TP regimen, and no significant difference (P>0. 05) compared with the TP regimen (4.4%) . After the treatment, the quality of life of patients given with SHF+TP and TP were both better than the before (P<0. 01, P<0. 05);and the quality of life of patients given with SHF+TP was better than the that of patients given with TP (P<0. 05). The cellular immunologic function improvement in the SHF+TP regimen, especially CD3+and CD4+ increased significantly (P<0. 05, P<0. 01);no significant difference in the TP regimen(P>0. 05). The TCM symptom scoring of both SHF+NP and NP were lower than the those of the before, and significant difference occurred in the fore-and-aft SHF+TP regimen (P<0. 05). Clinical trial 2:Twenty-one patients in the SHF first-treatment arm and twenty-one patients in the SHF second-treatment arm . The major toxicities of NP regimen were hematological and digestive toxicity. The hematological toxicities were grade 1 to 4 leukopenia and neutropenia, grade 1 to 3 anemia and thrombocytopenia. The digestive toxicities were grade 1 to 3 nausea/ vomiting and grade 1 to 2 constipation. Among the 42 patients, The hematological toxicities (leukopenia / neutropenia) of SHF+NP were lower than NP regimen(P <0. 05). The hematological toxicities (leukopenia / neutropenia) of SHF+NP were lower than NP regimen(P<0. 05) in the SHF first-treatment arm, and were similar to NP regimen (P>0. 05) in the SHF second-treatment arm. Among the patients of qi-deficiency plus phlegm and dampness syndromes, thehematological toxicities of SHF+NP were lower than NP (P<0. 05) . As to the digestive toxicity, nausea/ vomiting and constipation of SHF+NP was lower than NP both in two arms (P<0. 01, P<0. 05) . pulmonary symptom relief of SHF+NP was significant than NP (P<0. 05) in the 42 patients. Grade 1 to 2 neurosensorial toxicity and alopecia occurred in both regimens, and?no significant difference was observed (P>0. 05). After the treatment, the symptonu PS (ECOG) scoring and quality of life of both regimens were better than the those of the before;and the SHF+NP was better than NP (P<0. 01, P<0. 05). The cellular immunologic function improvement in the SHF+NP regimen, especially CD4+ and NK increased significantly (P<0. 05, P<0. 01);no significant difference in the NP regimen(P>0. 05). The TCM symptom scoring of both SHF+NP and NP were lower than the those of the before, significant difference occurred in the fore-and-aft of SHF+NP regimen (P<0. 01) and between SHF+NP and NP regimen after the treatment (P<0. 05) . Conclusion: l.The major toxicities of the two chemotherapy regimens s,were hematological and digestive toxicity. The incidence of allergy in TP regimen was low (2. 2%~4. 4%), no phlebitis occurred in NP regimen. 2. Shenfu Injection can decrease the toxicity of the two chemotherapy regimens, enhance the anti-disease ability, relieve the symptom, improve the cellular immunologic function and quality of life of the patients. 3.It is more effective to the patients with syndromes of qi-deficiency plus phlegm and dampness, which is frequent in the NSCLC. 4. It is a better selection that Shenfu Injection be administered early.
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