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首页> 外文期刊>Journal of minimally invasive gynecology >Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery.
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Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery.

机译：自体血小板组织移植在妇科手术中的I / II期前瞻性试验。

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STUDY OBJECTIVE: To perform the original phase I/II trial of autologous platelet tissue graft in gynecologic surgery to evaluate toxicity and efficacy on decreasing pain. DESIGN: Prospective nonrandomized trial (Canadian Task Force classification II-A). SETTING: Teaching hospital. PATIENTS: Fifty-five consecutive patients undergoing major gynecologic surgery were entered into this prospective phase I/II trial and were matched with 55 patients from the previous 6 months. INTERVENTION: After anesthesia was induced, peripheral venous blood (55 mL) was obtained from the patient producing, autologous platelet tissue graft (20 mL). At completion of surgery, autologous platelet tissue graft was directly applied to the surgical site. MEASUREMENTS AND MAIN RESULTS: Median pain on the day of surgery was 2.7 (mild) in the autologous platelet tissue graft group vs 6.7 (severe) in the control group, p <.001. Likewise, pain on postoperative day 1 was 2.1 (mild) in the autologous platelet tissue graft group vs 5.5 (moderate) in the control group, p < or =.001. Median of morphine per hospital stay for the autologous platelet tissue graft group was 17 mg (range 1-98 mg) vs 26 mg (range 3-90 mg) in the control group, which was statistically significant at p = .02. There were no adverse effects associated with autologous platelet tissue graft. CONCLUSIONS: In the original phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery, there were no apparent adverse effects, and pain was significantly reduced.
机译：目的：开展妇科手术中自体血小板组织移植的I / II期临床试验，以评价减轻疼痛的毒性和疗效。设计：前瞻性非随机试验（加拿大工作组II-A级）。地点：教学医院。患者：连续55例接受大妇科手术的患者进入了这项前瞻性I / II期试验，并与前6个月的55例患者进行了配对。干预：诱导麻醉后，从产生患者的自体血小板组织移植物（20 mL）中获取外周静脉血（55 mL）。手术完成后，将自体血小板组织移植物直接应用于手术部位。测量和主要结果：自体血小板组织移植组手术当天的中位疼痛为2.7（轻度），而对照组为6.7（轻度），p <.001。同样，自体血小板组织移植组术后1天的疼痛为2.1（轻度），而对照组为5.5（中度），p <或= .001。自体血小板组织移植组每次住院的吗啡中位数为17 mg（1-98 mg），而对照组为26 mg（3-90 mg），在p = .02时具有统计学意义。自体血小板组织移植没有不良反应。结论：在妇科手术中自体血小板组织移植的最初I / II期前瞻性试验中，没有明显的不良反应，并且疼痛明显减轻。

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