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目的 评价Ⅱ类新生物制品绿脓杆菌菌毛株菌苗 (PA—MSHA菌苗 )作为免疫调节剂的有效性和安全性。方法 采用非盲性随机对照试验。纳入肺癌患者试验组 44例 ,对照组 45例。试验组给予化疗 +PA -MSHA菌苗 ,对照组单用化疗 ,两组化疗方案一致。结束后评价肿瘤疗效和感染率 ,并在治疗前、中、后分别检测患者免疫功能。结果 在临床疗效评价中 ,试验组有效率 (CR +PR)为 5 9 0 9% ,对照组为 42 2 3 % (P <0 .0 5 ) ;试验组感染发生率为 15 91% ,对照组为 40 0 0 % (P <0 0 5 )。试验组治疗后C3 、C4 、CD4/CD8比值 ,NKz细胞活性和IL— 2水平均高于对照组 (P <0 0 5 )。疗中、疗后各抗体滴度也明显高于对照组 (P <0 .0 5 )有 3例出现不良反应。结论 PA -MSHA菌苗能明显提高肺癌患者的免疫功能 ,与化疗药物合用可提高疗效 ,并有预防感染作用。安全有效。
Objective To evaluate the effectiveness and safety of Class II new biological products of P. aeruginosa strains (PA-MSHA strains) as immunomodulators. Methods A non-blind, randomized, controlled trial was used. There were 44 patients in the experimental group with lung cancer and 45 patients in the control group. The experimental group was given chemotherapy + PA-MSHA bacterins, and the control group was treated with chemotherapy alone. The two groups had the same chemotherapy regimen. After the end of the evaluation of tumor efficacy and infection rate, and before, during and after treatment were detected in patients with immune function. Results In the evaluation of clinical efficacy, the effective rate (CR +PR) of the experimental group was 5.99%, and that of the control group was 42 2 3% (P 0.05). The incidence of infection in the experimental group was 15 91%. The group is 40 0 0 % (P <0 0 5 ). After treatment, the ratios of C3, C4, CD4/CD8, NKz cell activity and IL-2 were higher in the experimental group than in the control group (P < 0.05). After treatment, the antibody titers were also significantly higher in the control group than in the control group (P < 0.05). There were 3 cases of adverse reactions. Conclusion PA-MSHA vaccine can significantly improve the immune function of lung cancer patients. Combined with chemotherapeutic drugs, the efficacy can be improved and the infection can be prevented. Safe and effective.