自拟骨八方对股骨干骨折瘀热证及炎症介质影响的研究
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摘要
目的观察骨八方对闭合性股骨干骨折早期瘀热证型的临床疗效,及其对IL-1、IL-6、TNF-a三种炎性因子的调节作用,并进一步探讨骨八方的作用机制。
     方法自2009年8月至2010年2月在佛山市中医院住院治疗闭合性股骨干骨折患者中,选取符合纳入标准而无排除标准的病例60例。男46例、女14例,年龄20-50岁,平均36.8±2.6岁;受伤部位:左侧30例、右侧30例;伤后至就诊时间为6.5±1.5小时。按照分层随机化的方法分成骨八方组、桃红四物汤组、常规治疗组3组。骨八方组从入院第1天开始每天给予骨八方一剂,结合基础治疗,连续给药7天;桃红四物汤组从入院第1天开始每天给予桃红四物汤一剂,结合基础治疗,连续给药7天;常规治疗组每天给予基础治疗,连续7天。每组患者在入院第1天(给药前)第3天、第5天、第7天采集瘀热证临床症状积分并检验IL-1、IL-6、TNF-a血清学水平,比较三组第1天(给药前)、第3天、第5天、第7天瘀热证临床症状积分,IL-1、IL-6、TNF-a血清学水平,并进一步分析瘀热证临床症状积分与IL-1、IL-6、TNF-a血清学水平的相关性。
     结果三组第1天瘀热证临床症状积分比较无显著性差异,具有可比性;第3天、第5天、第7天三组瘀热症状积分中,骨八方最低、桃红四物汤次之,常规治疗组最高,差异具有统计学意义(P<0.05),但是桃红四物汤组与常规组比较差异无统计学意义(P>0.05)。第3天、第5天、第7天三组瘀热症状积分中便秘、肿胀积分比较显示骨八方组积分最低,与桃红四物汤组、常规组比较差异具有统计学意义(P<0.05)。三组炎性因子IL-1、IL-6、TNF-a水平第1天比较无显著性差异,第3天、第5天、第7天骨八方与常规组、桃红四物汤组比较差异有统计学意义(P<0.05)。骨八方组、常规组的IL-1、IL-6、TNF-a血清学水平与两组瘀热证临床症状积分作多重线性回归分析,结果筛选出两组的IL-6、TNF-a分别与两组瘀热证临床症状积分呈正相关性。骨八方组IL-6、TNF-a与瘀热证临床症状积分的相关系数r分别为(0.548、0.7650),常规组的相关系数分别为(0.5170、0.2510),结果有统计学意义(P<0.05),两组中的IL-1均无统计学意义,被删除。
     结论本研究认为,骨八方选药精当、配伍合理,能明显改善瘀热型股骨干骨折早期临床症状,在一定程度调节IL-1、IL-6、TNF-a血清学水平,并且进一步研究发现瘀热证积分变化与IL-6、TNF-a三种炎症因子水平存在正相关关系,推断骨八方的作用机制可能与调节IL-6、TNF-a血清学水平有关。
Objective To observe the clinic effect of Gu Ba decoction in treating the Stagnated Heat syndrome on the early stage of closed femoral shaft fractures and its impact on IL-1, IL-6, TNF-a. Furthermore, explore the machanism of Gu Ba decoction in treating the Stagnated Heat syndrome.
     Methods From August 2009 to February 2010,60 patients with closed femoral shaft fracture were employed to made study in Foshan hospital of traditional Chinese medicine, according to the inclusion criteria and exclusion criteria.Male 46 cases,14 female, aged 20-50 years, mean age 36.8±2.6 years; injured parts:the left legs of 30 cases,30 cases of right; the mean time from injury to treatment was 6.5±1.5 hours.60 patients were randomized into Gu Ba decoction group, TaoHongSiWu decoction group, conventional therapy group in accordance with the method of stratified randomization. The patients of GuBa decoction group were treated with GuBa decoction one day at a time, combined with basic therapy from the first day, and the course of treatment was 7 days; Tao Hong Si Wu decoction group were treated with Tao Hong Si Wu decoction; and similar with GuBa decoction group. Conventional treatment group were only given basic treatment for 7 days. The symptom scores of the Stagnated Heat syndrome were collected and the IL-1, IL-6, TNF-a serum levels were tested on the first day after admission (before administration), the third day, the fifth day and the seventh day in each patient, compared the clinical symptom scores and IL-1, IL-6, TNF-a serum levels, and further analysed the correlation between the Clinical symptom scores and the IL-1, IL-6, TNF-a serum level.
     Results The clinical symptom scores were of no significant difference and comparable between three group on the first day; but the scores in the GuBa decoction group was lowest, the TaoHongSiWu decoction was the second, the conventional treatment group was the highest on the third day, the fifth day, the seventh day. the difference was of significant (P<0.05), but the Taohongsiwu decoction group compared with the conventional group showed no significant difference (P> 0.05). The constipation and swelling scores in GuBa decoction showed the lowest points, and the result was significant in comparing conventional group and the TaoHongSiWu decoction group (P<0.05). The inflammatory cytokines of IL-1, IL-6, TNF-a levels in threen group was of no significant difference on first day. On the third, the fifth and the seventh day, GuBa decoction group compared with Taohongsiwu decoction group and the conventional group showed significant difference(P<0.05). The multiple linear regression and multiple correlation analysis showed positive correlation between IL-6, TNF-a serum levels and Stagnated Heat syndrome scores of GuBa decoction group and TaoHongSiWu decoction group. The correlation coefficient r in GuBa decoction were (0.548、0.7650) respectively, the coefficient in the conventional group were(0.5170、0.2510)respectively, and the results were statistically significant in two group (P<0.05), However, IL-1 in the two groups were not statistically significant, was deleted.
     Conclusion The study suggests that GuBa decoction, with appropriate drug selection, reasonable compatibility, can significantly improve the clinical symptom of the Stagnated Heat syndrome in the early stage of the femoral shaft fractures, regulate IL-1, IL-6, TNF-a serum levels to some extend. Furthermore, this study finds a positive correlation between IL-6, TNF-a serum levels and Stagnated Heat syndrome scores, and infers that theIL-6, TNF-a may be the microscopic pathology material basis of Stagnated Heat syndrome, concludes that the mechanism of Gu Ba Fang's effect may relate with the regulation of IL-6, TNF-a serum levels.
引文
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