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为评价铜绿假单胞菌MSHA菌毛株菌苗(PA-MSHA菌苗)作为免疫调节剂的有效性和安全性,采用非盲法随机对照试验,分别对88例恶性淋巴瘤和89例肺癌患者进行了临床实验研究,试验组给予化疗+PA-MHSA菌苗,对照组单用化疗。结果:经化疗+PA-MSHA治疗,恶性淋巴瘤和肺癌试验组的治疗有效率(CR+PR)分别为95.56%(43/45)和59.09%(26/44),其对照组分别为69.77%(30/43)和42.22%(19/45);恶性淋巴瘤和肺癌试验组的感染率分别为17.78%(8/45)和15.91%(7/44),其对照组分别为37.21%(16/43)和40.00%(18/45);恶性淋巴瘤和肺癌试验组的综合免疫疗效有效率分别为77.78%(35/45)和84.09(37/44),其对照组分别为23.26%(10/43)和35.56%(16/45)。试验组与对照组上述各项指标比较,均有显著性差异(P<0.05)。实验组有5例出现不良反应,但仅1例给予特殊处理,其余均自行缓解。上述结果表明,PAMSHA菌苗为安全有效的免疫调节剂。
To evaluate the efficacy and safety of Pseudomonas aeruginosa MSHA bacterin (PA-MSHA) as an immunomodulator, an unblinded randomized controlled trial was conducted on 88 cases of malignant lymphoma and 89 cases of lung cancer, respectively. Patients were studied in clinical trials. The experimental group received chemotherapy plus PA-MHSA bacterin, and the control group received chemotherapy alone. Results: After chemotherapy + PA-MSHA treatment, the treatment efficiency (CR+PR) of malignant lymphoma and lung cancer test group was 95.56% (43/45) and 59.09% (26/44), respectively, and the control group was 69.77 % (30/43) and 42.22% (19/45); the infection rates of the malignant lymphoma and lung cancer test groups were 17.78% (8/45) and 15.91% (7/44), respectively, and the control group was 37.21%. (16/43) and 40.00% (18/45); the combined immunological response rates of the malignant lymphoma and lung cancer test groups were 77.78% (35/45) and 84.09 (37/44), respectively, and the control group was 23.26. % (10/43) and 35.56% (16/45). There were significant differences in the above indicators between the experimental group and the control group (P<0.05). There were 5 cases of adverse reactions in the experimental group, but only one case was given special treatment, and the rest were self-relieved. The above results show that PAMSHA bacterins are safe and effective immunomodulators.