Objective： To observe the effect of Shenfu injection （参附注射液, SFI） in treating non small cell lung cancer （NSCLC） patients on quality of life with gemcitabine （GEM） plus cisplatin （GP） regimen. Methods： ...Objective： To observe the effect of Shenfu injection （参附注射液, SFI） in treating non small cell lung cancer （NSCLC） patients on quality of life with gemcitabine （GEM） plus cisplatin （GP） regimen. Methods： Thirty-four patients were ready to receive GP regimen chemotherapy for treating NSCLC disease, according to lot-drawing, they were divided into SFI pre-treatment group （18 cases） and SFI post-treatment group （ 16 cases）. SFI pre-treatment group： During the first treatment course, chemotherapy was begun with SFI 60 ml, intravenous dripping on the 3rd day, once daily, consecutively for 10 days; on the 1st day, GP regimen （GEM 1250 mg/m^2 , intravenous dripping, on the 1st and 8th day; cisplatin 70 mg/m^2 on the 2nd day; 21 days as one cycle） was carried out; in the second treatment course GP regimen was merely given to serve as the self-control. SFI post-treatment group： the medicament sequence order was reversed from that of pre-treatment group. Using dual international quality of life （QOL） scores, the effect of SFI on the patients＂ QOL was observed through randomized self pre- and post- crossover control. Results： The QOL in the 34 patients after being treated by SFI in combination with GP chemotherapy regimen in one group, and GP chemotherapy regimen alone in the other, was improved in different degrees, with significant difference （P〈0.01）; comparision of SFI combined with GP chemotherapy regimen with GP chemotherapy alone showed that QOL in patients was significantly different （P〈0.01）. Conclusion： SFI could improve QOL in patients with NSCLC who were treated with GP regimen.展开更多
Objective：To investigate the efficacy of Aidi Injection（艾迪注射液） on overexpression of P-glycoprotein（P-gp） induced by vinorelbine and cisplatin（NP） regimen in patients with non-small cell lung cancer（NSCLC...Objective：To investigate the efficacy of Aidi Injection（艾迪注射液） on overexpression of P-glycoprotein（P-gp） induced by vinorelbine and cisplatin（NP） regimen in patients with non-small cell lung cancer（NSCLC）, and study the difference between intravenous administration and targeting intratumor administration of Aidi Injection with thoracoscope. Methods：Totally 150 patients with NSCLC were randomly assigned to the control group, the intravenous group and the intratumor group by the random envelope method, 50 cases in each group. The patients were treated with NP regimen（2 cycles）, NP regimen（2 cycles） plus Aidi intravenous injection, or NP regimen（2 cycles） plus Aidi intratumor injection with thoracoscope, respectively for 6 weeks. The clinical efficacy was observed based on Response Evaluation Criteria in Solid Tumors（RECIST） rules, the expression of P-gp in the tumor tissue was tested before, 3 and 6 weeks after treatment, the safety was evaluated by monitoring the toxicity in the process of treatment, and the progressionfree survival（PFS） was measured. Results：Fifteen cases dropped out because of the irreconcilable conditions which had no relationship with the treatment, 4 in the control group, 5 in the intravenous group, and 6 in the intratumor group, respectively. Compared with the control group, the response rates（complete remission ＋ partial response） and the disease control rates（complete remission ＋ partial response ＋ stable disease） were significantly higher, the P-gp expressions were significantly decreased after 3 and 6 weeks of treatment, and the Kaplan-Meier survival curves of PFS were significantly longer in the intravenous and intratumor groups（P〈0.05 or P〈0.01）, and the intratumor group showed better effects than the intravenous group（P〈0.05 or P〈0.01）. Compared with the control group, the occurrences of rash, nausea and leukocytopenia were significantly decreased in the intravenous and intratumor groups（P〈0.05）, but without significant difference between the intravenous and intratumor groups（P〉0.05）. Conclusion：Aidi Injection not only improves the efficacy of NP regime, but also has the function of reducing adverse events and preventing against overexpression of P-gp induced by chemotherapy of NP regimen.展开更多
Objective： To study the effect of Aidi Injection （艾迪注射液,ADI） applied in the bronchial artery infused （BAI） neo-adjuvant chemotherapy for stage ⅢA non-small cell lung cancer （NSCLC） before surgical operati...Objective： To study the effect of Aidi Injection （艾迪注射液,ADI） applied in the bronchial artery infused （BAI） neo-adjuvant chemotherapy for stage ⅢA non-small cell lung cancer （NSCLC） before surgical operation.Methods： The 60 patients with NSCLC stage ⅢA underwent two courses BAI chemotherapy before tumor incision were assigned to two groups,the treatment and the control groups,using a random number table,30 in each group.ADI （100 mL） was given to the patients in the treatment group by adding into 500 mL of 5% glucose injection for intravenous dripping once daily,starting from 3 days before each course of chemotherapy,and it lasted for 14 successive days,so a total of 28 days of administration was completed.The therapeutic effectiveness and the adverse reaction that occurred were observed,and the levels of T-lymphocyte subsets,natural killer cell activity,and interleukin-2 in peripheral blood were measured before and after the treatment.Results： The effective rate in the treatment group was higher than that in the control group （70.0% vs.56.7%,P〈0.05）.Moreover,as compared with the control group,the adverse reaction that occurred in the treatment group was less and mild,especially in terms of bone marrow suppression and liver function damage （P〈0.05）.Cellular immune function was suppressed in NSCLC patients,but after treatment,it ameliorated significantly in the treatment group,showing significant difference as compared with that in the control group （P〈0.05）.Conclusion： ADI was an ideal auxiliary drug for the patients in stage ⅢA NSCLC received BAI neo-chemotherapy before surgical operation;it could enhance the effectiveness of chemotherapy,ameliorate the adverse reaction and elevate patients＇ cellular immune function;therefore,it is worthy for spreading in clinical practice.展开更多
文摘Objective： To observe the effect of Shenfu injection （参附注射液, SFI） in treating non small cell lung cancer （NSCLC） patients on quality of life with gemcitabine （GEM） plus cisplatin （GP） regimen. Methods： Thirty-four patients were ready to receive GP regimen chemotherapy for treating NSCLC disease, according to lot-drawing, they were divided into SFI pre-treatment group （18 cases） and SFI post-treatment group （ 16 cases）. SFI pre-treatment group： During the first treatment course, chemotherapy was begun with SFI 60 ml, intravenous dripping on the 3rd day, once daily, consecutively for 10 days; on the 1st day, GP regimen （GEM 1250 mg/m^2 , intravenous dripping, on the 1st and 8th day; cisplatin 70 mg/m^2 on the 2nd day; 21 days as one cycle） was carried out; in the second treatment course GP regimen was merely given to serve as the self-control. SFI post-treatment group： the medicament sequence order was reversed from that of pre-treatment group. Using dual international quality of life （QOL） scores, the effect of SFI on the patients＂ QOL was observed through randomized self pre- and post- crossover control. Results： The QOL in the 34 patients after being treated by SFI in combination with GP chemotherapy regimen in one group, and GP chemotherapy regimen alone in the other, was improved in different degrees, with significant difference （P〈0.01）; comparision of SFI combined with GP chemotherapy regimen with GP chemotherapy alone showed that QOL in patients was significantly different （P〈0.01）. Conclusion： SFI could improve QOL in patients with NSCLC who were treated with GP regimen.
基金Supported by the 2011 National Key Specialty Construction of Clinical Projects of China,Science and Technology Projects of Traditional Chinese Medicine Bureau in Jiangsu Province of China(No.LB13042)
文摘Objective：To investigate the efficacy of Aidi Injection（艾迪注射液） on overexpression of P-glycoprotein（P-gp） induced by vinorelbine and cisplatin（NP） regimen in patients with non-small cell lung cancer（NSCLC）, and study the difference between intravenous administration and targeting intratumor administration of Aidi Injection with thoracoscope. Methods：Totally 150 patients with NSCLC were randomly assigned to the control group, the intravenous group and the intratumor group by the random envelope method, 50 cases in each group. The patients were treated with NP regimen（2 cycles）, NP regimen（2 cycles） plus Aidi intravenous injection, or NP regimen（2 cycles） plus Aidi intratumor injection with thoracoscope, respectively for 6 weeks. The clinical efficacy was observed based on Response Evaluation Criteria in Solid Tumors（RECIST） rules, the expression of P-gp in the tumor tissue was tested before, 3 and 6 weeks after treatment, the safety was evaluated by monitoring the toxicity in the process of treatment, and the progressionfree survival（PFS） was measured. Results：Fifteen cases dropped out because of the irreconcilable conditions which had no relationship with the treatment, 4 in the control group, 5 in the intravenous group, and 6 in the intratumor group, respectively. Compared with the control group, the response rates（complete remission ＋ partial response） and the disease control rates（complete remission ＋ partial response ＋ stable disease） were significantly higher, the P-gp expressions were significantly decreased after 3 and 6 weeks of treatment, and the Kaplan-Meier survival curves of PFS were significantly longer in the intravenous and intratumor groups（P〈0.05 or P〈0.01）, and the intratumor group showed better effects than the intravenous group（P〈0.05 or P〈0.01）. Compared with the control group, the occurrences of rash, nausea and leukocytopenia were significantly decreased in the intravenous and intratumor groups（P〈0.05）, but without significant difference between the intravenous and intratumor groups（P〉0.05）. Conclusion：Aidi Injection not only improves the efficacy of NP regime, but also has the function of reducing adverse events and preventing against overexpression of P-gp induced by chemotherapy of NP regimen.
文摘Objective： To study the effect of Aidi Injection （艾迪注射液,ADI） applied in the bronchial artery infused （BAI） neo-adjuvant chemotherapy for stage ⅢA non-small cell lung cancer （NSCLC） before surgical operation.Methods： The 60 patients with NSCLC stage ⅢA underwent two courses BAI chemotherapy before tumor incision were assigned to two groups,the treatment and the control groups,using a random number table,30 in each group.ADI （100 mL） was given to the patients in the treatment group by adding into 500 mL of 5% glucose injection for intravenous dripping once daily,starting from 3 days before each course of chemotherapy,and it lasted for 14 successive days,so a total of 28 days of administration was completed.The therapeutic effectiveness and the adverse reaction that occurred were observed,and the levels of T-lymphocyte subsets,natural killer cell activity,and interleukin-2 in peripheral blood were measured before and after the treatment.Results： The effective rate in the treatment group was higher than that in the control group （70.0% vs.56.7%,P〈0.05）.Moreover,as compared with the control group,the adverse reaction that occurred in the treatment group was less and mild,especially in terms of bone marrow suppression and liver function damage （P〈0.05）.Cellular immune function was suppressed in NSCLC patients,but after treatment,it ameliorated significantly in the treatment group,showing significant difference as compared with that in the control group （P〈0.05）.Conclusion： ADI was an ideal auxiliary drug for the patients in stage ⅢA NSCLC received BAI neo-chemotherapy before surgical operation;it could enhance the effectiveness of chemotherapy,ameliorate the adverse reaction and elevate patients＇ cellular immune function;therefore,it is worthy for spreading in clinical practice.
