Barandun S, Skvaril F, Morell A
Schweiz Med Wochenschr. 1976 Apr 17;106(16):533-42.
For accurate evaluation of the usefulness of gamma-globulin treatment, the clinical indications for passive immune prophylaxis and immunotherapy and the specific characteristics of commercially available gamma-globulin preparations have to be considered. Detailed investigations of currently used gamma-globulin preparations have shown that as yet no ideal product is available. Classical standard gamma-globulin and, in particular, enzymatically treated (Gamma-Venin, Veinoglobuline) or chemically modified preparations (Gamma-Globulin i.v. SRK, Intraglobin) for intravenous use have some deficiencies and involve potential risks for the patient. Nor is the infusion of "fresh frozen plasma" a safe and generally applicable alternative to the use of gamma-globulin concentrates. Thus from the outset the preconditions for effective treatment with gamma-globulin are not optimal. Standard and hyperimmune preparations, given once intramuscularly, are suitable for the prophylaxis of viral and bacteriotoxic diseases. In patients apt to react abnormally it is important to distinguish clearly between the few accepted indications and those that are more doubtful. Anti-D immunoglobulin is essential for the prevention of Rhesus sensitization after the delivery of a Rhesus-positive child. In general, gamma-globulin is recommended for substitution therapy and for the prophylaxis of recurrent acute bacterial infections in patients suffering from transient, congenital and acquired antibody-deficiency states. In such cases, high doses of an intravenously administrable preparation with a relatively long biologic half-life are recommended. The evidence for the effectiveness of gamma-globulin treatment of bacterial infections in patients without manifest disturbance of humoral immunity is equivocal. This is true, for example, of the oft-recommended combined use of antibiotics and high doses of intravenous gamma-globulin which is said to provide optimum antibacterial and antitoxic protection. There is even less chance of obtaining beneficial effects if gamma-globulin is given as an "ultimo ratio" in severe generalized bacterial infections resistant to antibiotic treatment. Localized and predominantly chronic infections are barely influenced by gamma-globulin. It is still too early to make a final assessment regarding the place and value of immunoglobulin concentrates for prophylactic and therapeutic purposes. This will only be possible if a preparation becomes available which contains all immunoglobulins in a biologically optimum state and concentration, is well tolerated and can be given in adequate doses both intramuscularly and intravenously.
为了准确评估γ-球蛋白治疗的有效性，必须考虑被动免疫预防和免疫治疗的临床指征以及市售γ-球蛋白制剂的具体特性。对目前使用的γ-球蛋白制剂的详细研究表明，目前尚无理想的产品。经典的标准γ-球蛋白，尤其是经酶处理（γ-静脉球蛋白、静脉球蛋白）或化学修饰的静脉用制剂（γ-球蛋白静脉注射用SRK、静脉内球蛋白）存在一些缺陷，且对患者有潜在风险。输注“新鲜冷冻血浆”也不是使用γ-球蛋白浓缩物的安全且普遍适用的替代方法。因此，从一开始γ-球蛋白有效治疗的前提条件就不理想。标准和高免疫制剂，单次肌内注射，适用于预防病毒和细菌毒素疾病。对于易发生异常反应的患者，明确区分少数公认的适应证和更可疑的适应证很重要。抗-D免疫球蛋白对于预防Rh阳性婴儿出生后发生Rh致敏至关重要。一般来说，推荐使用γ-球蛋白进行替代治疗，以及预防患有短暂性、先天性和获得性抗体缺乏症的患者反复发生急性细菌感染。在这种情况下，建议使用高剂量的具有相对较长生物半衰期的静脉内给药制剂。对于体液免疫无明显紊乱的患者，γ-球蛋白治疗细菌感染的有效性证据并不明确。例如，经常推荐的抗生素与高剂量静脉γ-球蛋白联合使用，据说可提供最佳的抗菌和抗毒素保护，情况就是如此。如果在对抗生素治疗耐药的严重全身性细菌感染中，将γ-球蛋白作为“最后手段”使用，获得有益效果的机会更小。局部性且主要为慢性的感染几乎不受γ-球蛋白影响。对于免疫球蛋白浓缩物在预防和治疗目的中的地位和价值进行最终评估还为时过早。只有当有一种制剂可用，其包含处于生物学最佳状态和浓度的所有免疫球蛋白，耐受性良好，并且可以肌内和静脉内给予足够剂量时，才有可能进行最终评估。
