中药自拟方分期治疗股骨头坏死的临床研究

Effective analysis on the treatment of osteonecrosis of femoral head （ONFH） by stages with self designed Chinese medicine formula

目的：探讨中药自拟方治疗分期治疗股骨头坏死（osteonecrosis of the femoral head，ONFH）的临床疗效。方法收集2010年7月至2013年7月本院骨科住院早、中期ONFH患者106例，采用随机数字表法将患者随机分为两组各53例，治疗组患者早期服用自拟健脾活血方，中期服用自拟补肾活血方治疗；对照组口服仙灵骨葆胶囊与洛伐他汀胶囊治疗。两组均治疗6周为1个疗程，治疗2个疗程后评价临床疗效和血液流变学指标。结果治疗后治疗组总有效率为90.6%（48/53），对照组为73.6%（39/53），两组总有效率比较，差异有统计学意义（χ^2＝6.731，P＜0.05）。治疗后治疗组全血黏度高切、中切、低切，血浆黏度（PV）、红细胞压积（HCT）、红细胞聚集指数（Arbe）、红细胞沉降率（ESR）、纤维蛋白原（FIB）[（3.42±0.72）mPa·S、（4.21±0.30）mPa·S、（8.36±0.12）mPa·S、（1.39±0.16）mPa·S、（38.34±2.37）%、（5.47±0.33）、（27.35±2.16）mm/h、（3.83±0.47）g/L]均较同组治疗前[（3.97±0.21）mPa·S、（4.71±0.24）mPa·S、（9.58±0.31）mPa·S、（2.01±0.13）mPa·S、（41.29±1.01）%、（6.51±0.21）、（14.62±0.92）mm/h、（4.94±0.26）g/L]明显改善（ P＜0.05）；且治疗组各检测指标与对照组[（3.76±0.08）mPa·S、（4.47±0.16）mPa·S、（8.99±0.07）mPa·S 、（1.72±0.14）mPa·S 、（40.46±1.06）%、（6.11±0.38）、（24.98±1.42）mm/h 、（4.33±0.57）g/L]比较，差异均有统计学意义（P＜0.01或0.05）。结论中药自拟方分期治疗可改善ONFH患者血液流变学指标，提高骨密度，促进骨小梁生长。

Objective To explore the clinical effects of treating osteonecrosis of femoral head（ONFH） by stages with self designed Chinese medicine formula. Methods 106 ONFH patients in Shantou municipal TCM hospital from July 2010 to July 2013 were recruited and divided randomly into a control group and a treatment group, 53 patients in each. The treatment group was treated with self-designed Chinese medicine formula with the functions of strengthening spleen and promoting blood circulation in the early stage, and self-designed Chinese medicine formula with the functions of supplementing kidney and promoting blood circulation in the middle stage of disease, one dosage daily. The control group was treated with Xianliang Gubao capsule （3 granules per time, twice daily） and lovastatin capsule （10-20 mg per time）. Both groups were treated for two therapeutic courses of 8-12 weeks. X-ray and hemorheology indexes were observed after the treatment. Results The total effects was 90.6%（48/53） and 73.6%（39/53） in the treatment group and the control group respectively, with significant difference（χ^2=6.731,P＆lt;0.05）;Whole blood viscosity, PV, HCT, Arbe, ESR, FIB were obviously improved in the treatment group after the treatment, [after the treatment： whole blood viscosity high cut（3.42±0.72）mPa·S, middle cut（4.21±0.30）mPa·S, low cut（8.36±0.12）mPa·S, PV（1.39±0.16）mPa·S, HCT（38.34±2.37）%, Arbe（5.47±0.33）, ESR（27.35±2.16）mm/h, FIB（3.83±0.47）g/L], [before the treatment：whole blood viscosity high cut（3.97±0.21）mPa·S, middle cut （4.71±0.24）mPa·S, low cut （9.58±0.31）mPa·S, PV（2.01±0.13）mPa·S, HCT（41.29±1.01）%, Arbe（6.51±0.21）,ESR（14.62±0.92）mm/h, FIB（4.94±0.26）g/L, P＆lt;0.05]. After the treatment, the treatment group was obviously improved in such indexes as whole blood viscosity high cut（3.76±0.08）mPa·S, middle cut（4.47±0.16）mPa·S, low cut （8.99±0.07）mPa·S, PV（1.72±0.14）mPa·S, HCT（40.46±1.06）%, Arbe（6.11±0.38）, ESR（24.98±1.42）mm/h and FIB（4.33±0.57）g/L than the control group（P〈0.01 or 0.05）. Conclusion Self-designed Chinese medicine formula stage-therapy had better results in treating ONFH than Xianling Gubao capsule and lovastatin.