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为了确定Norplant植入时使用手术刀是否在植入部位引起术后反应。对使用和不用手术刀植入Norplant后引起的局部体征与症状的发生率和严重性进行了前瞻性随机比较研究。受试妇女进行植入手术时随机分入两组:一组应厂家要求使用手术刀(420例),另一组不用手术刀切口(423例)。指定植入后第7天和第30天随访,以估价植入部位体征或症状的变化。每次随访均估价五个参数:疼痛、触痛、水肿/肿胀、瘀斑和瘢痕外观,从检查结果分为正常或有缺陷,对两组进行比较。所有受试妇女都作了随访,但有20％的妇女在第7天或30±7天之内未能随访。这些妇女中第二次随访时间在手术30天之后7天以上者从统计分析中排除,因为超过指定随访日期7天以上时手术创伤所致局部体征很可能消失。植入后第7天,两组
To determine if using a scalpel during Norplant implantation resulted in a postoperative response at the site of implantation. A prospective, randomized, comparative study of the incidence and severity of local signs and symptoms with or without scalpel implantation of Norplant was conducted. Women undergoing implant surgery were randomized into two groups: one group required a manufacturer to use a scalpel (420 patients) and the other a non-surgical incision (423 patients). Follow-up was designated on day 7 and day 30 post-implantation to assess changes in signs or symptoms at the site of implantation. Five parameters were evaluated for each follow-up: pain, tenderness, edema / swelling, ecchymosis and scar appearance. The results were divided into normal and defective, and the two groups were compared. All participants were followed up, but 20% of women failed to follow up on day 7 or 30 ± 7 days. The second follow-up of these women was excluded from the statistical analysis at more than 7 days after surgery for more than 30 days because local signs of surgical trauma that were more than 7 days after the indicated follow-up were likely to disappear. Day 7 after implantation, two groups