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目的系统评价经肛门内窥镜下微创手术(TEM)与传统根治术(RS)治疗直肠癌的疗效及安全性,为进一步的临床研究与实践提供参考。方法计算机检索Cochrane图书馆临床对照试验资料库、PubMed、OVID、SpringerLink和中国生物医学文献数据库、中国期刊全文数据库。检索范围均为建库至2010年4月,并手工检索《中华外科杂志》等相关期刊。收集TEM与RS比较治疗直肠恶性肿瘤的随机对照试验和临床对照试验。由两名研究者按Cochrane系统评价方法,筛选试验、评价质量、提取资料,并用RevMan 5.0软件进行Meta分析。结果纳入1个随机对照试验,4个非随机对照试验,共929例受试对象。质量评价结果表明,纳入研究质量不高,发生偏倚的可能性较大。Meta分析结果显示:①3个研究报道了T1期患者的术后局部复发率,TEM与RS比较,两组差异有统计学意义[OR=12.61,95%CI(2.59,61.29),P=0.002];②2个研究报道了T1期患者的术后无病生存率,结果显示两组差异无统计学意义[OR=1.12,95%CI(0.31,4.12),P=0.86];③3个研究报道了T1期患者的术后总生存率,结果显示两组差异无统计学意义[OR=1.09,95%CI(0.57,2.08),P=0.80];④3个研究报道了T1期患者术后并发症情况,结果显示两组差异有统计学意义[OR=0.05,95%CI(0.02,0.10),P<0.00001]。结论对于T1期患者,TEM具有创伤小,术中出血量较少,住院时间短,术后并发症发生率低等优点,其总生存率和无病生存率与根治术无差别,但TEM的局部复发率目前仍不够满意。TEM对于T2期患者的疗效目前尚无定论。因本系统评价纳入研究的方法学质量不高,且纳入了非随机对照试验,无法确定偏倚对结论可靠性的影响程度。因此上述结论尚需多中心、大样本的随机对照研究来进一步验证。
Objective To evaluate the efficacy and safety of transanal endoscopic minimally invasive surgery (TEM) and traditional radical mastectomy (RS) in the treatment of rectal cancer, and provide a reference for further clinical research and practice. Methods Cochrane Central Register of Controlled Trials (Cochrane Library), PubMed, OVID, SpringerLink, China Biomedical Literature Database and Chinese Journal Full-text Database were searched by computer. The scope of the search was from the establishment of the database to April 2010 and the manual search of relevant journals such as “Chinese Journal of Surgical Science”. A randomized controlled trial and a controlled clinical trial comparing TEM and RS in the treatment of rectal malignant tumors were collected. Two investigators followed the Cochrane review, screening tests, evaluating quality, extracting data and performing Meta-analysis using RevMan 5.0 software. Results A randomized controlled trial and 4 non-randomized controlled trials were enrolled. A total of 929 subjects were included. The results of quality assessment show that the quality of the included studies is not high and the possibility of bias is high. The results of Meta analysis showed that: (1) Three studies reported the postoperative local recurrence rate in patients with T1 stage. The difference between TEM and RS was statistically significant (OR = 12.61, 95% CI 2.59, 61.29, P = 0.002) ; ② Two studies reported the postoperative disease-free survival rate of T1 patients, the results showed no significant difference between the two groups [OR = 1.12,95% CI (0.31,4.12), P = 0.86]; ③ three studies reported The overall postoperative survival rate of T1 patients showed no significant difference between the two groups [OR = 1.09,95% CI (0.57,2.08), P = 0.80]; 3 studies reported the postoperative complications of T1 patients The results showed that the difference between the two groups was statistically significant [OR = 0.05, 95% CI (0.02,0.10), P <0.00001]. Conclusion For patients with T1 stage, TEM has the advantages of less trauma, less intraoperative blood loss, shorter hospital stay and lower postoperative complication rate. The overall survival and disease-free survival rates are similar to those of radical operation. However, TEM The local recurrence rate is still not satisfactory enough. The efficacy of TEM in patients with T2 stage is currently inconclusive. Because of the poor quality of methodologies included in the systematic reviews and the inclusion of non-randomized controlled trials, the extent to which bias affects the reliability of conclusions can not be determined. Therefore, the above conclusion still needs to be further verified by a multi-center and large sample randomized controlled study.