用医用高分子塑料制造的手术牵开器的研究

The study of the surgical retractor made of the polymer materials for medicine

目的观察医用外科软组织扩张器的力学特性及临床应用结果。方法应用拉力测试装置对医用外科软组织扩张器和金属腹部牵开器进行力学实验，测量在不同的初始牵引力下，牵引器在持续牵引过程中随时间发生的牵引力变化及位移变化。再通过临床对照研究，比较医用外科软组织扩张器与传统的金属牵开器的临床应用结果。结果力学实验结果提示，随时间的延长，医用外科软组织扩张器的残留牵引力逐渐递减，在牵引1h后，残留牵引力较基础牵引力平均减少了10％～13％；而金属腹部牵开器的牵引力在牵引过程中没有发生变化。临床试验中，共120例患者入组，试验组及对照组各60例。试验组50／60例（83．3％）手术使用后，外科医生对术野显露的评价为非常满意，10／60例（16．7％）评价为满意，平均使用效果评分为4．83分；对照组为35／60例（58．3％）评价非常满意，评分4．58分（P〈0．05）。而在围手术期临床结果分析中，试验组与对照组患者在术中出血量、术后胸腔积液发生率和住院天数上结果相似，差异无统计学意义。两组患者围手术期疼痛评分最高值在试验组及对照组患者中分别为（2．60±0．65）分和（4．10±0．45）分（P〈0．05），至术后6个月，两组患者慢性疼痛发生率分别为20／60（33．3％）和44／60（73．3％），持续时间分别为（1．80±1．19）个月和（3．70±1．84）个月（P〈0．01）。试验组在术后所用的器械清理时间平均为（5．0±2．3）min；而对照组为（370．0±5．8）min（P〈0．01）。结论医用外科软组织扩张器在临床使用中评价良好，临床收益与传统的腹部牵开器相似，但减少了术后伤口感染的机会，并显著降低了患者术后的疼痛程度并减少了术后疼痛时间。

Objective To observe the mechanic characteristics and clinical results of self-help surgical retractor. Methods Use tensile testing device to do the mechanic test with the self-help surgical retractor and the medal abdominal retractor, measuring the change of traction and displacement when the two kinds of tractor were under different initial traction, and received continuous traction. We also compare the clinical results of the two retractors. Results The mechanic test show that the left traction of self-help surgical retractor decreased with time, the average left traction decreased by 10%-13% after lh. In the clinical test, there were 120 patients in total, with 60 in experimental group and 60 in control group. In the experimental group, surgeons gave 50/60 （83.3%） very good evaluation. In the analysis of perioperative clinical results, there were no difference between the two groups. The vas paining score of the experimental group and the control group was 2. 6 ± 0.65 and 4.1 ± 0.45 （ P 〈 0.05 ） , 6 months after operation, the incidence of chronic paining was 20/60 （33. 3% ） and 44/60 （73. 3% ）, and duration was （1.80± 1.19） months and （3.70±1.84） months （P 〈 0. 01 ）. The spending of instrument cleaning of the experimental group was significantly less. Conclusion The self-help surgical retractor was evaluated well in the clinical use, and it was similar with the abdominal retractor in clinical profits, but it reduced the incidence of wound infection and significantly reduced the extent and duration of paining.