中医药治疗股骨头坏死的疗效评价及适应证的初步探索

Exploration of indications and therapeutic effects of herb on femoral head necrosis

目的评估中医药治疗股骨头坏死(ONFH)的临床疗效,分析预后影响因素对股骨头生存率的影响。方法 2009年6月～2011年5月,回顾研究91例133髋中医药治疗的ONFH患者,年龄(38.81±11.99)岁,随访(14.04±6.77)个月。气滞血瘀型31例,肾虚血瘀型37例,痰瘀蕴结型23例;FPS-R评分评估关节疼痛程度,Harris评分评估髋关节功能,SF-36量表评价生存质量,影像学评价塌陷进展;以股骨头塌陷≥4mm为终点,Cox风险模型分析预后因素对中医药治疗后股骨头生存率的影响,探讨中医药治疗ONFH的适应证。结果至末次随访,有6例7髋转为手术。(1)中医药治疗前(133髋)和治疗后末次随访时(126髋)的各证型患者总体FPS-R评分比较有统计学差异(t=7.780,P<0.01);(2)治疗前后患者总体Harris评分比较有统计学差异(t=5.238,P<0.01);(3)影像学进展:49例59髋出现X线进展,中药治疗前后影像总体进展率>50%的因素包括塌陷、疼痛时间≥12个月、坏死范围≥40%、C2型;(4)股骨头生存率:26例31髋塌陷≥4mm,随访至29个月的生存率为76.7%。Cox回归分析示疼痛时间、坏死范围和分期是影响疗效危险因素(OR>1)。Kaplan-Meier生存曲线结果示:无痛、Ⅰ期、A型和中心型坏死生存率均为100%,且无影像进展;B型和稳定Ⅱ期生存率分别为95.8%和96.8%,且影像进展率均<10%;疼痛时间≤6个月、坏死范围<40%、不稳定Ⅱ期、C1型、周围型坏死生存率均>75%,且影像进展<50%。结论合理选择适用范围,中医药治疗ONFH对缓解症状、改善功能具有一定的疗效。中医药保髋适应证:(1)前提条件:疼痛程度属于B级或以下,同时患髋Harris评分等级为优、良或可;(2)绝对适应证:中心型、A/B型坏死或无痛的Ⅰ期坏死,可不考虑疼痛时间、坏死范围、分期与形态;(3)稳定Ⅱ期,若无痛,可不考虑疼痛时间、坏死范围、部位与形态,若疼痛,则与不稳定Ⅱ期条件一致;(4)相对适应证:Ⅱ(不稳定)、Ⅲ或Ⅳ期,同时满足坏死范围<40%、疼痛时间<12个月、C1型。

Objective To evaluate the clinical efficacy of herb therapy for femoral head necrosis and to analyse the influence of prognostic factors for femoral head survival. Methods Between Jule 2009 and May 2011, a retrospective study was carried out in 91 patients with 153 osteoneerotic femoral heads treated with herb. The follow-up of was assessed. The average age at the time of the treatment was （38. 81 ＋ 11.99） years. All patients were available for follow-up with a mean time of （14. 04 ＋ 6.77） months. There were 31 cases of qi stagnation and blood stasis type, 37 cases of the kidney deficiency and blood stasis type, and 23 cases of phlegm stasis and accumulation type. Outcomes were measured by FPS-R score, limb-specific score （Harris hip score）, SF-36 score, and radiographic measures. Femoral head collapse 〉 4 mm was taken as the end point. Multivariate analysis was performed with the Cox proportional hazards model to identify the independent prognostic factors associated with clinical and radiographic failures, so as to determine the indications of herb therapy for femoral head necrosis. Results Seven hips were converted to surgery after treatment with herb. （ 1 ） Compared with the data before herb-treatment （ 133 hips） , the mean FPS-R of the survivor group （ 126 hips） after treatment decreased at the last follow-up （P〈0.01）. （2） Compared with the data before herb-treatment （133 hips）, the mean HHS of the survivor group after treatment increased at the last follow-up （ P 〈 0. 01 ）. （ 3 ） Radiographic progression occurred in 49 cases （59 hips） after treatment of herbs. The prognostic factors related to the radiographic progression ratio over 50% included： collapse, pain time 〉 12 months, necrotic zone volume ratio 1〉 40% , type C2. Survivorship of the femoral head （ collapsing 〉 4 mm as the end point） ： there were 26 cases （31 hips） collapsing 1〉 4 mm. The estimated survival rate was 76.7% at the final follow-up. The Cox proportional-hazards model revealed that pain time ,necrotic zone volume ratio and ARCO classification were risk factors affected the efficacy of herbs （ OR 〉 1 ）. The Kaplan-Meier survivorship curve revealed the results, as follows： the survival rate was 100% in painless type, Stage- ⅠA type, and central type, with no radiographic progression. The survival rates were 95.8% and 96.8% in type B and stable type stage Ⅱ respectively, of which the radiographic progression ratio was less than 10%. The factors of survival rate over 75% included pain time ≤ 6 months, necrotic zone volume ratio 〈 40% , unstable type stage Ⅱ , type C1, peripheral type, and the radiographic progression ratio 〈 50%. Conclusions The herb therapy of femoral head necrosis can resolve the pain, improve the function and the quality of life. The indications of herb therapy for the femoral head necrosis are as follows ： （ 1 ） the prerequisite is that pain level is class B or below, and Harris score is excellent, good or moderate; （2） Absolute indications： central type necrosis, painless ARCO Stage Ⅰ type, and JIC type A/B; （3） painless stable type ARCO stage Ⅱ ; （4） relative indications ： unstable type ARCO stage Ⅱ , stage Ⅲ and stage IV, or stable type ARCO stage Ⅱ with pain, all of which can accept herb therapy only with necrotic zone volume ratio 〈 40% , pain time 〈 12 months, and JIC type C1.