Sany J, Clot J, Combe B, Franchimont P, Malaise M, Hauwaert C, Dreiser R L, Bourgeois P, Kahn M F, Veys E
Presse Med. 1987 Apr 25;16(15):723-4.
A double-blind multicenter study comparing the effect of placenta eluted IgG and venoglobulins in the treatment of rheumatoid arthritis was conducted in 113 hospitalized patients. Rheumatoid arthritis was severe, classical (92 cases) or definite (21 cases), seropositive in 87 cases, with nodules in 32 cases; the mean duration of the disease was 10 years. The majority of patients had previously received numerous slow-acting drugs without result or with side-effects. A statistically significant decrease of all the quantitative indices but one (grip strength) was obtained with both products on the 8th day of treatment; the effect of placenta eluted IgG was statistically superior for the number of swollen joints (P less than 0.025), Ritchie's index (P less than 0.0005) and some extra-articular manifestations. There was no significant decrease in associated treatments and biological parameters (erythrocyte sedimentation rate, rheumatoid factor). Tolerance was excellent; some cases of benign venulitis were observed; treatment was never discontinued on account of side-effects. Further placebo-controlled of each of these immunoglobulins of placental origin are needed for firm conclusions to be drawn.
对113例住院患者进行了一项双盲多中心研究,比较胎盘洗脱IgG和静脉注射球蛋白治疗类风湿性关节炎的效果。类风湿性关节炎病情严重,为典型(92例)或确诊(21例),87例血清学阳性,32例有结节;疾病平均病程为10年。大多数患者此前曾使用多种慢效药物但无效或出现副作用。治疗第8天时,两种产品均使除一项指标(握力)外的所有定量指标出现统计学上的显著下降;胎盘洗脱IgG对肿胀关节数(P<0.025)、里奇指数(P<0.0005)和一些关节外表现的效果在统计学上更优。相关治疗和生物学参数(红细胞沉降率、类风湿因子)无显著下降。耐受性良好;观察到一些良性静脉炎病例;治疗从未因副作用而中断。需要对每种胎盘来源的免疫球蛋白进一步进行安慰剂对照研究,以便得出确切结论。