National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, 210002, China.
National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, 210018, China.
BMC Nephrol. 2022 May 10;23(1):179. doi: 10.1186/s12882-022-02814-7.
Tripterygium Wilfordii Hook F (TwHF) preparation has been widely used in the treatments of IgA nephropathy (IgAN) in China. However, the effectiveness and safety of the new generation of TwHF preparation, KuxXian capsule, on the treatment of IgAN remains unknown.
Here, we retrospectively describe our experience treating 55 consecutive IgAN patients with KunXian. We defined complete remission as proteinuria < 0.5 g/24 h and partial remission as proteinuria < 1 g/24 h, each also having > 50% reduction in proteinuria from baseline.
At first follow-up after KunXian treatment (5.7 weeks, IQR 4.7-7.9), all but two patients (96%) showed a reduction in proteinuria. The overall median proteinuria decreased from 2.23 g/day at baseline to 0.94 g/day (P < 0.001) at the first follow-up. During a median follow-up of 28 weeks after KunXian administration, 25(45.5%) patients achieved complete remission, 34 (61.8%) patients achieved complete/partial remission. Of the 12 patients discontinued KunXian treatment during the follow-up, the median proteinuria was increased from 0.97 g/24 h to 2.74 g/24 h after a median of 10.9 weeks (P = 0.004). Multivariable Cox models showed that female, treatment switching from previous generation of TwHF preparation, lower initial KunXian dosage, and higher proteinuria at baseline were independently associated proteinuria remission. Of the 20 pre-menopausal females, 12 of them developed oligomenorrhea or menstrual irregularity and ten of them developed amenorrhea.
KunXian is effectiveness and safety for the treatment of IgA nephropathy. Woman of childbearing age to be informed of the risk of ovarian failure after being treated with TwHF preparations.
雷公藤制剂在治疗 IgA 肾病（IgAN）方面已在中国得到广泛应用。然而，新一代雷公藤制剂——坤仙胶囊在治疗 IgAN 方面的疗效和安全性尚不清楚。
我们回顾性描述了使用坤仙治疗 55 例连续 IgAN 患者的经验。我们将完全缓解定义为蛋白尿 <0.5 g/24 h，部分缓解定义为蛋白尿 <1 g/24 h，同时蛋白尿较基线下降 >50%。
在坤仙治疗后的首次随访（5.7 周，IQR 4.7-7.9）中，除 2 例患者外（96%）均出现蛋白尿减少。总体中位数蛋白尿从基线时的 2.23 g/天降至首次随访时的 0.94 g/天（P<0.001）。在坤仙给药后中位数 28 周的随访期间，25 例（45.5%）患者达到完全缓解，34 例（61.8%）患者达到完全/部分缓解。在随访期间 12 例停止使用坤仙的患者中，中位数蛋白尿从 0.97 g/24 h 增加至 2.74 g/24 h，中位数时间为 10.9 周（P=0.004）。多变量 Cox 模型显示，女性、从以前一代雷公藤制剂转换治疗、初始坤仙剂量较低以及基线时蛋白尿较高与蛋白尿缓解独立相关。在 20 例绝经前女性中，12 例出现月经稀少或不规则，10 例出现闭经。
坤仙治疗 IgA 肾病有效且安全。育龄期女性在使用雷公藤制剂治疗后，应被告知卵巢功能衰竭的风险。
