PA-MSHA菌苗辅助治疗肺癌临床研究

目的　评价Ⅱ类新生物制品绿脓杆菌菌毛株菌苗(PAMSHA菌苗)作为免疫调节剂的有效性和安全性。方法　采用非盲法随机对照试验。试验组纳入肺癌患者44例,对照组45例。两组采用同样的化疗方案,试验组加用PAMSHA菌苗。治疗结束后评价疗效和感染率,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59.09%,对照组为42.23%(P<0.01);试验组感染率为15.91%,对照组为40%(P<0.05)。试验组治疗后C3、C4、CD4/CD8比值、NK细胞活性和IL2水平均高于对照组(P<0.05)。试验组中3例患者出现不良反应,仅1例给予特殊处理,其余自行缓解。结论　作为一类新的免疫调节剂,PAMSHA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。临床应用安全有效

A clinical study on PA-MSHA vaccine in adjuvant therapy of lung cancer.

Objective To evaluate the effectiveness and safety of pseudomonas aeruginosa MSHA vaccine (PA MSHA vaccine) used as immune modulator.Methods The study was carried out by non blinded randomized control trial. The lung cancer patients were divided into experimental group (44 cases) and control group (45 cases).Both groups were given same chemotherapy, and the experimental group was injected PA MSHA vaccine subdermally.After finishing the treatment, tumor response and infection rate were evaluated. Immune function was measured before, during and after the treatment respectively.Results Clinical effective rate (CR+PR) was 59.09% in the experimental group, and 42.23% in the control group (P<0.01). Infection rate was 15.91% in the experimental group and 40% in the control group (P<0.05). After the treatment, C 3 and C 4, the ratio of CD 4 to CD 8, NK cell activity and IL 2 level in the experimental group were significantly higher than those in the control group (P<0.05). Three cases in the experimental group had adverse reactions. One case had fever and was treated with antibiotics, while the other two with swelling in the injection site recovered automatically.Conclusion As a new kind of immune modulator, PA MSHA vaccine can enhance immune function of lung cancer patient and prevent infection. It may improve chemotherapeutic effectiveness in adjuvant therapy of lung cancer with low adverse reaction rate.