良性疾病全子宫切除术不同微创术式间比较的系统评价

Comparison among Minor Invasive Surgical Approaches to Hysterectomy for Benign Gynecological Diseases: A Systematic Review and Meta-analysis

目的比较和评价阴式全子宫切除术(total vaginal hysterectomy,TVH)、腹腔镜全子宫切除术(Lapros-copical hyterectomy,LH)、横切口开腹全子宫切除术(minilaporotomy hysterectomy,MiniLPT)等不同微创全子宫切除术式的效果及安全性,以指导临床选择最合理的术式。方法检索CBM、中国期刊全文数据库、万方数据资源系统、MEDLINE、EMbase、Cochrane DSR、ACP Journal Club、DARE、CCTR、CMR、HTA、和NHSEED等数据库中关于比较TVH、LH、MiniLPT术式中至少两种的随机对照试验、比较性研究、经济评价,罕见结局的报道可包括观察性研究。检索截止时间为2009年3月。采用GRADE标准及Cochrane Reviewer Handbook4.2.3对RCT的质量评价标准进行评价。用Cochrane协作网提供的RevMan4.2软件进行Meta分析。结果最终纳入12个研究,包括10个随机对照试验,1个回顾性队列研究、1个前瞻性队列研究。Meta分析结果显示TVH组手术时间最短、出血量最少、术后疼痛最轻、恢复排便或者排气最快、出院最早。MiniLPT组术后住院时间比对照组(TVH/LAVH组)长,差异有统计学意义[WMD=37.0h,95%CI(13.5h,60.5h)];MiniLPT组术中出血量比对照组多,差异有统计学意义[WMD=208.5ml,95%CI(141.4ml,375.7ml)],MiniLPT组发热发生率比对照组高,差异有统计学意义[Peto OR=3.8,95%CI(1.1,12.6)]。TVH组手术时间比LH组短,差异有统计学意义[WMD=47.2min,95%CI(-62.3min,32.19min)];TVH组出血量比LAVH组少,差异有统计学意义[WMD=-158.7ml,95%CI(-190.9ml,-126.4ml)];TVH组住院时间比LH组短,差异有统计学意义[WMD=-18.8h,95%CI(-24.2h,-13.5h)];TVH组术后恢复排气或排便时间比LAVH组短,差异有统计学意义[WMD=8.1h,95%CI(-10.8h,-5.3h)]。另一方面,LH组创面缝合愈合不良事件发生率、继发感染发生率、发热发生率均比TVH组低,但差异无统计学意义。LH组比TVH组术后性功能质量更好。结论在基本符合TVH适应证的情况下,TVH是最微创的手术方式,且性价比高。在TVH适应证以外,只要在可以操作的范围内,TVH仍然是创伤最小且效果最好的手术方式,但这一范围目前尚无统一标准,跟术者经验水平、手术习惯和患者具体情况相关。LH在改善术后生活质量、患者自我感觉方面较为优越。通过提高腹腔镜手术止血技巧减少术中出血量,减少一次性器具费用或其使用、增加其回收,可降低手术费用,并可以提高LH性价比。MiniLPT发展时间尚短,相关比较研究起步也晚,其优越性有待更多研究进一步评估。

Objective To compare and assess the effectiveness between total vaginal hysterectomy （TVH）, Laproscopical hysterectomy （LH） and minilaporotomy hysterectomy （MiniLPT）. Methods We searched CBM, CKNJ, MEDLINE, EMbase, Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED to screen randomized controlled trials （RCTs） comparing one surgical approach to another of extrafascial hysterectomy （between TVH, LH and miniLPT） which were done to those women with benign gynecological diseases. As to economy assessment, studies of cost-effective analysis were also included. Those observational studies reporting rare or important long-term outcome were also included. The quality of the included studies was evaluated by GRADE （Grades of Recommendation, Assessment, Development and Evaluation） system and principle of Cochrane Reviewer Handbook 4.2.3 RCT. Results Finally, we identified 12 trials including 10 RCTs, 1 retrospective cohort study and 1 respective cohort study. Cost-effective analysis showed when in indication of VH, TVH was more cost-effective than LH. When TVH was less but still accessible, meta-analysis showed TVH had significant advantages than the other two approaches in many sides. Compared with LH arm, operation time was shorter at a WMD 47.2 min and 95%CI 32.2 to 62.3 min, blood loss was less at a WMD 158.7 ml and 95%CI ¨C 190.9 to ¨C 126.4 ml, hospital stay was shorter at a WMD 23.9 h and 95%CI ¨C 25.4 to ¨C 13.9 h, and the first stool or to break wind was quicker at a WMD ¨C 8.1 h and 95%CI ¨C 10.8 to ¨C 5.3 h in TVH arm. But on the other side, the incidence rates of bad wound healing （such as vaginal cuff infection, abdominal wall infection, wound dehiscence, etc.）, of secondary infection （such as UTI, URI, unknown infection, etc.）, and of febrility were less common in LH arm than those in TVH arm with no significant difference. Meanwhile, ratio of sexual hypofunction, declined marital life quality and worse body image were more in TVH arm than those in LH arm, implying LH arm provided a better post-operation sexual life recovery. Operation time was longest in miniLPT arm at a WMD 37.0 h and 95%CI 13.5 to 60.5 h and blood loss was most at a WMD 208.5 ml and 95%CI 141.4 to 375.7 ml, too. The febrility rate was also the most common in miniLPT arm at a Peto OR 3.8 and 95% CI 1.1 to 12.6. The differences were significant. Conclusion TVH is the least invasive approach and better in cost-effectiveness when accessible. However, when inaccessible, the limitations remain unclear, depending on surgeons ’ own techniques and experience as well as patients＇ individual conditions. LH does better in improving quality of life and body image. Cost-effectiveness of LH may become much better by reducing blood loss during operation through improving techniques or instruments of hemostasis. Limited application of non-reproducible instrument or cost and promotion of their recycle may help a lot in bringing down LH operation cost, too. Owing to limited studies, the advantage of miniLPT should be evaluated more precisely by its technical development and more penetrating researches. There are huge gaps in standardized high-quality RCTs, performance and research of long-term outcomes and health economy comparing different approaches to total hysterectomy in China.