Bergemann R, Brandt A, Zoellner U, Donner C F
Institute for Medical Informatics and Biostatistics (IMIB), Riehen, Switzerland.
Monaldi Arch Chest Dis. 1994 Sep;49(4):302-7.
Chronic bronchitis is a lifelong disease with significant effects on the patient and on the costs to health insurance institutions. Acute exacerbations in chronic bronchitic patients may have a negative impact on patients' quality of life and on the progression of the disease, particularly in more severe patients. The clinical efficacy of the immunoactive bacterial extract OM-85 BV has been shown in several clinical trials, a cost-effectiveness evaluation (CEA) of its use in chronic bronchitic patients has not been fulfilled so far. In this study a meta-analysis on the preventive treatment of acute exacerbations with OM-85 BV and a CEA, focusing on direct costs only, was performed. The meta-analysis showed a mean value of 0.6 prevented acute exacerbations per 6 months per patient, and a reduction of 9 days in antibiotic treatment per 6 months per patient. CEA evaluated the different cost elements. The mean direct cost (consultations, antibiotics, etc.) for the treatment of 1 acute exacerbation in chronic bronchitic patients was calculated as 143, 459 Lira. Thus for 0.6 prevented acute exacerbations per 6 months per patient a reduction in cost of 86,075 Lira (0.6-143,459) could be expected. The additional costs for the preventive treatment with OM-85 BV, based on prices for Italy, are 34,980 Lira per patient per 6 months. In conclusion, the effective cost savings per patient per 6 months are 51, 095 Lira. The sensitivity analysis revealed only one critical parameter, i.e. the clinical effectiveness of OM-85 BV. Even assuming 0.3 prevented exacerbations per 6 months per patient, the preventive treatment still proved to be cost effective.
慢性支气管炎是一种终身疾病，对患者以及医疗保险机构的成本有着重大影响。慢性支气管炎患者的急性加重可能会对患者的生活质量以及疾病进展产生负面影响，尤其是在病情较重的患者中。免疫活性细菌提取物OM-85 BV的临床疗效已在多项临床试验中得到证实，但迄今为止尚未对其在慢性支气管炎患者中的使用进行成本效益评估（CEA）。在本研究中，针对OM-85 BV预防急性加重的治疗进行了荟萃分析，并仅关注直接成本进行了CEA。荟萃分析显示，每位患者每6个月平均预防0.6次急性加重，每位患者每6个月的抗生素治疗时间减少9天。CEA评估了不同的成本要素。慢性支气管炎患者治疗1次急性加重的平均直接成本（会诊、抗生素等）计算为143,459里拉。因此，每位患者每6个月预防0.6次急性加重，预计成本可降低86,075里拉（0.6×143,459）。根据意大利的价格，使用OM-85 BV进行预防治疗的额外成本为每位患者每6个月34,980里拉。总之，每位患者每6个月有效的成本节约为51,095里拉。敏感性分析仅揭示了一个关键参数，即OM-85 BV的临床有效性。即使假设每位患者每6个月预防0.3次加重，预防治疗仍被证明具有成本效益。
