You Xue-Mei, Qin Xiao, Dong Zhi-Yong, Wang Guan-Liang
Department of Hepatobiliary Surgery, the First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi Province, China.
Zhong Xi Yi Jie He Xue Bao. 2010 Oct;8(10):917-27. doi: 10.3736/jcim20101003.
The conventional therapy for arteriosclerosis obliterans (ASO) is Western medicine. However, it has some adverse effects and does not respond to some patients, and it is also very expensive.
To evaluate the efficacy of integrated traditional Chinese (TCM) and Western medicine (WM) in treatment of ASO.
Electronic and manual searches were conducted and the searches ended on May 20, 2009.
We included randomized controlled trials (RCT) evaluating integrated TCM and WM (as treatment group) versus WM used alone (as control group), and no language limits were set.
Selection of trials for inclusion, assessment for methodological quality, data extraction and data syntheses were conducted according to protocol of a Cochrane systematic review by the authors.
Thirteen RCT were included, which encompassed a total of 968 patients. The results showed that all of the 13 included trials did not report mortality rate of ASO. The studies displayed that the amputation rate in the treatment group was lower than that in the control group, but there was no statistical significance. Ten studies adopted inefficiency analysis and 2 of them showed that the ineffective rate in the treatment group was lower than that in the control group, and the relative risk (RR) and 95% CI were 0.36 [0.13, 0.99]. We performed descriptive analysis on other 8 studies; analyses of secondary outcomes such as intermittent claudication, ankle brachial index, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) showed that integrated TCM and WM therapy was more effective than WM treatment alone; one study showed that WM was better than integrated TCM and WM therapy in decreasing the content of fibrinogen. All of the included trials did not report any critical adverse reactions occurred in the treatment group.
The current evidence shows that integrated TCM and WM therapy is safe and effective in treating ASO, and tends to reduce amputation rate, improve intermittent claudication, decrease the levels of fibrinogen, HDL and LDL, and increase ankle brachial index, without obvious adverse reactions. Due to the low methodological quality of trials included, more prospective, multicenter, large-scale, high-quality RCTs are needed.
动脉硬化闭塞症(ASO)的传统治疗方法是西医治疗。然而,它存在一些不良反应,对部分患者无效,且费用高昂。
评估中西医结合治疗ASO的疗效。
进行了电子检索和手工检索,检索截至2009年5月20日。
纳入评估中西医结合治疗(治疗组)与单纯西医治疗(对照组)的随机对照试验(RCT),且不设语言限制。
作者根据Cochrane系统评价方案进行试验纳入选择、方法学质量评估、数据提取和数据综合分析。
纳入13项RCT,共968例患者。结果显示,所有13项纳入试验均未报告ASO的死亡率。研究表明,治疗组的截肢率低于对照组,但无统计学意义。10项研究采用无效分析,其中2项显示治疗组的无效率低于对照组,相对危险度(RR)及95%可信区间为0.36[0.13,0.99]。对其他8项研究进行描述性分析;对间歇性跛行、踝肱指数、高密度脂蛋白(HDL)和低密度脂蛋白(LDL)等次要结局的分析表明,中西医结合治疗比单纯西医治疗更有效;1项研究表明,西医治疗在降低纤维蛋白原含量方面优于中西医结合治疗。所有纳入试验均未报告治疗组发生任何严重不良反应。
目前证据表明,中西医结合治疗ASO安全有效,且倾向于降低截肢率、改善间歇性跛行、降低纤维蛋白原、HDL和LDL水平并提高踝肱指数,无明显不良反应。由于纳入试验的方法学质量较低,需要更多前瞻性、多中心、大规模、高质量的RCT。