仙灵骨葆胶囊联合阿仑膦酸钠治疗系统性红斑狼疮并发骨质疏松症疗效观察

Clinical observation of Xianling-gubao capsules combined with Alendronate Sodium on system lupus erythematosus complicated with osteoporosis

目的观察仙灵骨葆胶囊联合阿仑膦酸钠治疗系统性红斑狼疮(SLE)并发骨质疏松症的疗效。方法将60例SLE并发骨质疏松症患者随机分为2组,2组患者糖皮质激素及免疫抑制剂剂量稳定,并常规补充钙剂及活性维生素D,对照组30例加阿仑膦酸钠治疗,治疗组30例在对照组治疗基础上加仙灵骨葆胶囊。治疗24周后,评估2组患者临床疗效,检测治疗前后股骨颈骨密度T值以及血清学指标,包括血清钙、血清磷、血清碱性磷酸酶(ALP)、N-端骨钙素(N-MID)、抗酒石酸酸性磷酸酶5b(TRAP5b)和Ⅰ型胶原C末端肽(CTX-Ⅰ)。结果治疗组总有效率86.67%,对照组66.67%,2组总有效率比较差异有统计学意义(P<0.05),治疗组临床疗效优于对照组。2组治疗后股骨颈骨密度T值均较本组治疗前明显升高,比较差异有统计学意义(P<0.05),且治疗组高于对照组(P<0.05)。与本组治疗前相比,2组治疗后骨代谢标志物ALP、TRAP5b和CTX-Ⅰ明显降低,N-MID升高,比较差异有统计学意义(P<0.05);与对照组治疗后相比,治疗组ALP和CTX-Ⅰ更低,N-MID更高,比较差异有统计学意义(P<0.05);2组治疗前后血清钙和血清磷无明显变化(P>0.05)。结论仙灵骨葆胶囊联合阿仑膦酸钠治疗SLE并发骨质疏松症疗效确切。

Objective To observed the effects and security of Xianling-gubao capsules combined with alendronate sodium on the treatment of system lupus erythematosus（ SLE） complicated with osteoporosis. Methods 60 SLE complicated with osteoporosis patients were randomly divided into two groups. The doses of glucocorticoid and immunosuppressive agent were stable in 2 groups,and all patients were routine supplemented with calcium and active vitamin D. 30 cases in control group were treated by alendronate sodium,30 cases in treatment group were treated by Xianling-gubao capsules on the basis of the control group. The clinical effects in two groups were evaluated after 24 weeks treatment. The bone mineral density T score and serum indexes including serum calcium,serum phosphate,serum alkaline phosphatase（ ALP）,N-mid osteocalcin（ N-MID）,tartrate-resistant acid phosphatase 5b（ TRAP5b） and C-telopeptides of Type I collagen（ CTX-I） were detected before and after treatment. Results The total effective rate in treatment group（ 86. 67%） was superior to that in control group（ 66. 67%,P〈0. 05）,thecurative effects intreatmen group was superior to control group. The bone mineral density T score after treatment were increased in two groups with statiscal difference（ P〈0. 05）,and which in treatment group was higher than that in control group（ P〈0. 05）. The ALP,TRAP5 b and CTX-I after treatment were obviously reduced in two groups,and the N-MID were increased（ P〈0. 05）. The ALP and CTX-I after treatment in treatment group were lower than those in control group,and the N-MID was higher（ P〈0. 05）. There was no statistical difference on serum calcium and serum phosphate between before and after treatment in two groups（ P〈0. 05）. Conclusion Xianling-gubao capsules combined with alendronate sodium has exact effects on SLE complicated with osteoporosis.