同种异体富血小板凝胶在难愈性皮肤溃疡中的临床疗效研究

Clinical efficacy of allogeneic platelet-rich gel in refractory skin ulcer

目的评价同种异体富血小板凝胶(allogeneic rich platelet gel,APG)治疗难愈性皮肤溃疡的有效性和安全性。方法 2016年5月至2017年3月,按照难愈性皮肤溃疡的诊断标准,根据研究对象的纳入及排除标准,共筛选51例患者入组。实验前通过计算机产生随机数字表,按入组时间先后顺序将患者随机分为试验组(26例)和对照组(25例)。两组患者治疗前均做细菌培养+药敏实验,并根据其结果给予抗感染治疗和局部溃疡面标准处理。试验组将同种异体APG外敷溃疡面或注射入窦道,再用凡士林油纱覆盖并用3M医用透明敷贴封闭创面,外用纱布敷料包扎;对照组患者选用新型敷料(速愈乐)治疗溃疡面,外用纱布敷料包扎。以溃疡愈合率、总有效率、窦道愈合率、愈合时间及安全性作为疗效评价指标。结果试验组26例患者溃疡愈合率为77%(20/26),总有效率为100%(26/26),窦道愈合率为100%(4/4),愈合时间为18~42 d,平均30.5 d。对照组25例患者溃疡愈合率为52%(13/25),总有效率为68%(17/25),窦道愈合率为20%(1/5),愈合时间为21~58 d,平均38.5 d。试验组和对照组治疗前后的血常规,输血前ICT(HBV、HCV、HIV、梅毒),T细胞亚群计数(CD4、CD8、CD4/CD8的比值)及血小板抗体检测结果,治疗前后比较差异均无统计学意义(P>0.05),治疗过程中均无不良反应,治疗后随访患者均无不适。结论同种异体APG用于治疗难愈性皮肤溃疡安全有效。

Objective To evaluate the efficacy and safety of allogeneic platelet-rich gel （APG） in the treatment of refractory skin ulcer. Methods Based on the diagnostic standards for refractory skin ulcer and our inclusion and exclusion criteria, a total of 51 patients were enrolled in this study from May 2016 to March 2017. They were randomly divided into the experimental group （n =26） and control group （n =25 ）. On the basis of bacterial culture and drug sensitive experiment before treatment, the patients of both groups were given corresponding antibiotic treatment and standard processing on local ulcer surface, in the experimental group, allogeneic APG was used as topical dressing on the ulcer surface or injected into the fistula, then petrolatum gauze was covered on it, and medical-transparent-application （3M） was used to close wound. Finally the wound was tied up with gauze dressings. In control group, the ulcer surface was treated with a new kind of dressing （Su Yule）, and then the wound was tied up with gauze dressings. The ulcer healing rate, total effective rate, rate of fistula healing, healing time and safety were employed as effectiveness evaluation indexes. Results After the treatment, the ulcer healing rate was 77% （20/26）, total effective rate 100% （26/26）, fistula healing rate 100% （4/4）. and healingtime ranged from 18 to 42 （ mean 30.5 ） d,in tile experimental group. While in the control group, tile ulcer healing rate was 52% （ 13/25 ）, total effective rate 68% （ 17/25 ）, fistula healing rate 20% （ 1/5 ）, and healing time ranged from 21 to 58 （mean 38.5） d. No statistical differences were found in the results of blood routine test, ICT examination before transfusion （HBV, HCV, HIV and syphilis）, T cell subsets counts （CD4, CD8 and CD4/CD8 ratio） and platelet antibudy test before and after the treatment and between the 2 groups （ P 〉 0.05 ）. There were no adverse reactions during the treatment or discomfort in the follow-up. Conclusion Allugeneie APG is safe and effective in the treatment of refraeto^7 skin ulcer.