肝素预防过敏性紫癜性肾炎肾损害的临床随机对照研究

Preventive effect of heparin on the development of nephropathy in Henoch-Schoenlein purpura-a randomized controlled clinical trial

目的 观察肝素预防过敏性紫癜性肾炎 (HSPN)的临床有效性和安全性。方法 采用前瞻性随机对照方法 ,将 2 2 8例过敏性紫癜 (HSP)患儿分为肝素治疗组 (119例 )和对照组 (10 9例 ) ,肝素治疗组患儿在起病和每次复发时给予肝素钠 12 0～ 15 0U/kg加入 10 %葡萄糖水 10 0ml中静脉滴注 ,每天 1次 ,连续 5d ;或肝素钙 10IU/kg皮下注射 ,每天 2次 ,连续 7d。对照组患儿在起病和每次复发时给予 10 %葡萄糖 10 0ml静脉滴注 ,每日 1次 ,连续 5d。两组患儿均同时给予基础治疗 (口服维生素C和芦丁治疗 ) ,直至临床症状消失。以后每 2周观察尿常规至患儿首次治疗后≥ 3个月。结果 平均随访 6个月 ,肝素治疗组发生肾炎 9例 (7 6 %) ,对照组发生肾炎 30例 (2 7 5 %) ,肝素治疗组肾炎的发生率明显低于对照组 (P <0 0 1)。肝素治疗组患儿肾炎出现的时间为 (82± 6 4)d ,对照组为(34± 32 )d(P <0 0 1) ;肝素治疗组在起病 3个月内出现肾炎者 4例 (4 4%) ,对照组 3个月内出现肾炎者 2 8例 (93%) ,其中 15例患儿是在 1个月内出现肾损害的。肝素治疗组中HSPN表现为单纯血尿 2例 ,血尿 +蛋白尿 6例 ,血尿 +肾病 1例 ;对照组单纯血尿 12例 (4 0 %) ,血尿 +蛋白尿 15例 (5 0 %) ,血尿 +肾病 3例 (10 %) ,两组间差异无显著意?

Objective To evaluate the preventive value of heparin on the development of nephropathy in patients with Henoch-Schoenlein purpura (HSP). Methods Two-hundred and twenty-eight patients with HSP were enrolled in the study and divided randomly into two groups: heparin group (H) and control group (C). In H group, 119 patients were administrated with sodium heparin intravenously (120～150 IU/kg·d) for five days or with calcium heparin subcutaneously (20 IU/kg·d ) for seven days at the onset or relapse of HSP; whereas 109 patients as C group only received vehicles. All patients were also medicated with other commonly used drugs, such as vitamin C and vitamin P, and followed up for more than three months. Results The patient numbers of developing nephritis were nine (7.6%) in H group and 30 (27.5%) in C group, respectively (P<0.01). The occurrence of nephritis in H group was significantly delayed than that in C group [(82±64) day vs. (34±32) day, P<0.01]. The clinical characteristics of renal involvement in H and C groups consisted of 2 cases (22.2%) and 12 cases (40.0%) of simple hematuria, 6 cases (66.7%) and 15 cases (50.0%) of hematuria plus proteinuria, 1 case (11.1%) and 3 cases (10.0%) of hematuria plus nephrosis, respectively. There was no significant difference. No severe side effects, such as bleeding, were observed during the process of heparin treatment. Conclusion Heparin, which was safe and tolerant for patients, could significantly reduce the incidence of HSP nephritis (HSPN) and improve the prognosis of HSP.