目的：探讨参一胶囊联合一线化疗方案与单独化疗治疗不能手术的晚期IIIb／Ⅳ初治非小细胞肺癌（NSCLC）患者血清基质金属蛋白酶9（MMP－9）及组织蛋白酶抑制剂－1（TIMP－1）水平变化，并观察其近期疗效和治疗后不良反应。方法：采用酶联免疫吸附法（ELISA）检测89例肺癌患者化疗前后血浆MMP－9及TIMP－1水平。结果：两组有效率无显著性差异（P＞0．05），两组疾控率比较差异有显著性（P＜0．05）。全部CR＋PR、SD、PD患者治疗前血清MMP－9、TIMP－1水平比较，无显著性差异（P＞0．05），治疗后差异均具有有显著性（P＜0．05），随疗效降低呈升高趋势。两组相比疗前与疗后两次血清MMP－9水平，参一联合化疗组下降更明显，差异有显著性（P＜0．05），而血清TIMP－1水平差异无显著性（P＞0．05）。IV期患者比IIIb 期患者外周血清MMP－9水平明显增高，差异有显著性（P＜0．05）。但外周血清TIMP－1在IIIb 期和IV期无统计学差异。其他因素如年龄、性别、ECOG评分、病理与MMP－9、TIMP－1水平均未发现显著性差异。患者治疗后出现常见不良反应及生活质量（quality of life，QOL）观察：观察组（即参一胶囊联合化疗组）在胃肠道反应（如恶心、呕吐、腹胀等），骨髓抑制（如白细胞减少、贫血、血小板下降等）方面均较单独化疗组减轻（P＜0．05），参一联合组在改善QOL方面也明显高于对照组，且有统计学差异（P＜0．05）。结论：参一胶囊联合化疗组患者外周血清MMP－9水平下降更明显，且有统计学差异，而患者血清TIMP－1水平变化无统计学差异。血清MMP－9、TIMP－1水平治疗后随疗效降低呈升高趋势，因此，两者对患者疗效判定具有一定的参考价值。两组外周血清MMP－9、TIMP－1水平变化不受性别、年龄、ECOG评分影响。肺癌患者TNM分期对NSCLC患者外周血清MMP－9水平变化有影响，分期越晚，其外周血清MMP－9水平值越高。因此，MMP－9血清值越高，提示预后越差。外周血清TIMP－1水平与MMP－9水平在化疗前后NSCLC患者呈正相关。参一胶囊对非小细胞肺癌患者可以增加疗效，减少毒副反应，生活质量得到提高，不良反应如消化道症状及骨髓抑制均可以减轻。%Objective:To study Shenyi capsule combined with chemotherapy and chemotherapy alone on advanced IIIb/IV non small cell lung cancer (NSCLC)and effect on serum MMP-9 and TIMP-1 levels.Methods:Patients were randomly assigned to Shenyi capsule plus chemotherapy group and chemotherapy group.Chemotherapy include:Pacilitaxel 175mg/m2,ivdrip d1,Cisplatin 75mg/m2,ivdrip divided into 3 or 4 days for a period of 21 days,Peme-trexed 500mg/m2,ivdrip dl,Cisplatin 75mg/m2,ivdrip divided into 3 or 4 days with a 21 -day cycle,Gemcit-abine 1 000mg/m2,ivdrip d1,8,Cisplatin 75mg/m2,ivdrip divided into 3 or 4 days with a 21 -day cycle,NP(Vinorel-bine 25mg/m2,ivdrip d1,8,Cisplatin 75mg/m2,ivdrip divided into 3 or 4 days with a 21 -day cycle).Shenyi capsule each oral 20mg,bid,at least 6 weeks.To detect serum MMP-9 and TIMP-1 level before chemotherapy and after the two course of chemotherapy using ELISA method.Results:Total of 45 patients in Shenyi capsule group,44 cases in hemotherapy group.The two groups did not appear completely remission.Capsule plus chemotherapy group,PR 20 (44.4%),SD 17 (37.8%),PD 8 (17.8%)with RR 20 (44.4%)and clinical benefit 82.2%,in chemotherapy group,PR 16(36.4%),SD 11(25.0%),PD 17(38.6%)with RR 16(36.4%)and clinical benefit 61.4%(P>0.05).Disease control had a significant difference (P<0.05).Comparison of CR+PR,SD,PD in all patients be-fore treatment,serum MMP-9,TIMP-1 levels,there was no significant difference (P>0.05).After treatment,there was a significant difference (P<0.05 ),an increasing trend with the effect lowering.Compared two groups before treatment and after treatment two times the level of serum MMP-9,Shenyi capsule and a combined chemotherapy group decreased more significantly,the difference was significant (P<0.05),while no significant difference of serum TIMP-1 level (P>0.05).The relationship between patients with other features and MMP-9,TIMP-1 levels:the levels of MMP-9 in patients with stage IV than patients with stage IIIb in peripheral blood were significantly in-creased,the difference was significant (P<0.05).But the peripheral serum TIMP-1 in IIIb phase and IV phase had no significant difference.Age,gender,ECOG,pathology,significant differences were not found in MMP-9,TIMP-1 levels.Common side effects and QOL (quality of life,QOL)observation:the observation group (Shenyi capsule com-bined with chemotherapy group)in the gastrointestinal tract reaction (such as nausea,vomiting,abdominal distension),bone marrow suppression (such as leukopenia,anemia,thrombocytopenia)were lower than control group reduce (P<0.05),the observation group in improving the quality of life was also significantly higher than that of the control group (P<0.05 ).Conclusion:Shenyi capsule combined with chemotherapy peripheral serum MMP -9 level decreased more significantly,and there is significant difference,but there is no significant difference between the changes of ser-um TIMP-1 level.Serum MMP-9,TIMP-1 levels after treatment with reduced efficacy showed a rising trend, therefore it can be used as a reference index to judge the curative effect.
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