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Efficacy and safety of cyclophosphamide combined with mycophenolate mofetil for induction treatment of class IV lupus nephritis

机译:环磷酰胺联合霉酚酸酯治疗IV型狼疮性肾炎的疗效和安全性

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摘要

The present study aimed to evaluate the efficacy and safety of combination of cyclophosphamide (CTX) and mycophenolate mofetil (MMF) as induction treatment in Chinese patients with class IV lupus nephritis (LN). 82 patients were randomly divided into control (CTX, n=40) and test (CTX+MMF, n=42) groups, and they received monthly dose of 0.75 g/m2 of body surface area of CTX and monthly dose of 0.4 g/m2 CTX plus 1.0 g/d MMF, respectively. Patients were followed up for six months after treatment; and their efficacy rates, complete remission rates, adverse events, and certain indices in blood were compared between the two groups. Compared with the baseline levels, significant differences in the levels of hemoglobin, urinary proteins, albumin, serum creatinine, erythrocyte sedimentation rate, complement C3 and anti-dsDNA were observed after treatment in both groups (P<0.05). While the two groups did not differ significantly after treatment (P>0.05). There was a trend toward higher complete remission (54.8%) and efficacy rates (88.1%) after treatment in the test group without statistical significance. However, the incidence rate of gastrointestinal reactions (7.1%) and infections (11.9%) in the test group were significantly lower than the control group (P<0.05). The efficacy of lower dose of CTX combined with MMF as induction therapy for LN was not lower than the traditional treatment with CTX. Moreover, the low dose of CTX in combination with MMF could result in lesser adverse events and improved safety.
机译:本研究旨在评估环磷酰胺(CTX)和霉酚酸酯(MMF)联合治疗在中国IV级狼疮性肾炎(LN)患者中的疗效和安全性。将82例患者随机分为对照组(CTX,n = 40)和测试组(CTX + MMF,n = 42),他们每月的剂量为0.75 g / m 2 。 CTX和每月剂量分别为0.4 g / m 2 CTX和1.0 g / d MMF。治疗后对患者进行了六个月的随访;比较两组的疗效,完全缓解率,不良事件和血液中的某些指标。与基线水平相比,两组治疗后血红蛋白,尿蛋白,白蛋白,血清肌酐,红细胞沉降率,补体C3和抗dsDNA水平均存在显着差异(P <0.05)。两组治疗后差异无统计学意义(P> 0.05)。试验组治疗后有更高的完全缓解(54.8%)和有效率(88.1%)的趋势,但无统计学意义。然而,试验组的胃肠道反应发生率(7.1%)和感染(11.9%)明显低于对照组(P <0.05)。较低剂量的CTX联合MMF作为LN的诱导疗法的疗效不低于传统的CTX疗法。此外,低剂量的CTX与MMF联用可减少不良事件并提高安全性。

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