激素联合雷公藤多苷治疗V型狼疮性肾炎的临床疗效

Prednisone combined with tripterygium glycosides in the treatment of membranous lupus nephropathy

目的:回顾性分析激素联合雷公藤多苷(TW)治疗V型狼疮性肾炎(LN)的临床疗效及不良反应。方法:临床符合系统性红斑狼疮,经肾活检诊断为V型LN(ISN/RPS2003肾脏病理分型标准)的患者60例[女性53例,男性7例,平均年龄(32.7±11.9)岁],尿蛋白均≥1.0g/24h,血清肌酐正常,采用激素联合雷公藤多苷治疗≥6月。根据治疗前尿蛋白水平分为大量蛋白尿组(尿蛋白≥3.5g/24h)和非大量蛋白尿组(尿蛋白<3.5g/24h)两组。观察治疗不同时间的临床疗效。完全缓解定义为尿蛋白<0.4g/24h,血清白蛋白≥35g/L,血清肌酐正常,无肾外活动。部分缓解定义为尿蛋白较基础值减少50%以上,血清白蛋白≥30g/L,血清肌酐正常。结果:激素联合TW平均治疗(23.2±20.2)个月,平均随访(36.4±26.7)个月。随访中共42例(70%)获完全缓解,8例(13.3%)部分缓解,总缓解率83.3%,随访1年、2年、3年、5年的累积完全缓解率分别为71%,83%,83%和83%,累积总缓解率分别为87%,87%,87%和87%。非大量蛋白尿组随访1年、2年、3年、5年的累积完全缓解率(分别为81%vs57%,91%vs73%,91%vs73%,91%vs73%,P<0.01)和累积总缓解率(分别为90%vs82%,90%vs82%,90%vs82%,90%vs82%,P>0.05)均高于大量蛋白尿组。随访期内无一例死亡或进入终末期肾衰,人肾存活率均为100%。共11例(22%)肾病复发,1年、2年、3年、5年的累积复发率分别为9%、17%、21%和39%。不良反应包括闭经(62.8%)和月经紊乱(16.3%),白细胞减少(8.3%),肝酶升高(6.7%),带状疱疹(6.7%),胃肠道症状(3.3%),股骨头坏死(3.3%)和糖尿病(1.7%),无一例并发严重感染。结论:激素联合TW治疗V型LN有显著疗效,但仍需前瞻性对照研究加以证实。TW治疗的主要并发症为闭经,无严重不良反应,临床应用较为安全。

Objective：To analyze the clinical effects and adverse reactions in the treatment of prednisone combined with tripterygium glycosides （TW） in patients with membranous lupus nephropathy （ MLN ）. Methodology： Sixty patients, female 53 and male 7 with a mean of （ 32. 7±11.9 ） years old, suffered from systemic lupus erythematosus （SLE） and biopsy-proven MLN （ISN/RPS 2003 classification criteria） were enrolled in this retrospective study. All patients had urinary protein excretion （Upro） ≥ 1.0 g/24h with normal level of serum creatinine （SCr）. They were divided into two groups according to the amount Upro： non-nephritic group （Upro 〈 3.5 g/24h） and nephritic group （Upro 〉1 3.5 g/24h）. Clinical effects were evalued during the follow-up time. Complete remission （CR） ： Upro 〈0. 4 g/24h,serum albumin≥35 g/L, SCr normal. Partially remission （PR） ： Upro reduce 50% than baseline, serum albumin ≥ 30 g/L and SCr normal. Results ：The treatment lasted （23.2 ± 20. 2） months, with a mean follow-up time of （36. 4±26. 7） months. Forty-two cases （70%） got CR, eight （ 13.3% ） PR, and the total remission（TR） rate was 83.3%. The accumulated CR rate was 71% ,83% ,83%, 83% and the accumulated TR rate was 87% ,87% ,87%, 87% in the first 1,2,3,5 year. The accumulated CR rate of non-nephritic group was 81% vs 57%, 91% vs 73%, 91% vs 73%, 91% vs 73% （P 〈 0. 01 ） ;while the accumulated TR rate were 90% vs 82% ,90% vs 82% ,90% vs 82% ,90% vs 82% （P 〉0. 05 ） compared with the nephritic group in the first 1,2,3,5 year. None of patients died or developed end stage renal failure （ESRF）. 11 cases （22%） relapsed. The accumulated relapse rate were 9% , 17% ,21% and 39% in the first 1,2,3,5 year. The adverse reactions were amenorrhea （62. 8% ）, menstrual disorder （16. 3% ） , leucopenia （8. 3% ） , liver dysfunction（6. 7% ）, herpes zoster（6. 7% ）, gastrointestinal symptom （3.3%） , avascular necrosis （3.3%） and diabetes （ 1.7% ）. None of cases suffered from severe infections. Conclusion： Our data demonstrated that the treatment of prednisone combined with TW was effective and safety in patients with membranous lupus nephropathy. The prospective case-control study needed to confirm.