Cvoriscec B, Ustar M, Pardon R, Palecek I, Stipic-Markovic A, Zimic B
Dr. Josip Kajfes' General Hospital, Zagreb, Yugoslavia.
Respiration. 1989;55(3):129-35. doi: 10.1159/000195723.
104 patients with chronic bronchitis were treated under randomized double-blind conditions with either Broncho-Vaxom (BV) or a placebo over a period of 6 consecutive months. The beneficial effect of BV was manifested by a statistically significant reduction in the duration of acute episodes and of fever (p less than 0.001) with respect to the placebo group. The consumption of antibiotics dropped significantly in the BV group (p less than 0.05) but not in the placebo group. The serum IgA levels increased in the BV group and the difference with the placebo group was statistically significant (p less than 0.05) from the 3rd month onwards. In the patients with bronchitic exacerbations during the trial, T-lymphocyte counts increased steadily under BV therapy until 3 months after the exacerbation (p less than 0.05), but not under the placebo. BV was generally well tolerated with the exception of 1 patient who reported nausea and upper abdominal pain. In their assessment of the overall therapeutic effect, the physician judged BV to be significantly superior (p less than 0.001) to the placebo as regards both the curative and prophylactic efficacy.
104例慢性支气管炎患者在随机双盲条件下，连续6个月接受支气管疫苗（BV）或安慰剂治疗。与安慰剂组相比，BV的有益作用表现为急性发作持续时间和发热时间在统计学上显著缩短（p<0.001）。BV组抗生素消耗量显著下降（p<0.05），而安慰剂组未下降。从第3个月起，BV组血清IgA水平升高，与安慰剂组的差异具有统计学意义（p<0.05）。在试验期间出现支气管炎加重的患者中，BV治疗下T淋巴细胞计数在加重后持续稳定增加，直至3个月（p<0.05），而安慰剂组则无此现象。除1例报告恶心和上腹部疼痛的患者外，BV总体耐受性良好。在评估总体治疗效果时，医生判断BV在治疗和预防疗效方面均显著优于安慰剂（p<0.001）。
