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富含自体血小板的血浆治疗联合全面接触式加压包扎与单纯全面接触式加压包扎治疗麻风性营养性溃疡的疗效和安全性:一项观察者盲、随机对照试验。

Effectiveness and safety of autologous platelet-rich plasma therapy with total contact casting versus total contact casting alone in treatment of trophic ulcer in leprosy: An observer-blind, randomized controlled trial.

机构信息

Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, Birbhum, West Bengal, India.

出版信息

Indian J Dermatol Venereol Leprol. 2020 May-Jun;86(3):262-271. doi: 10.4103/ijdvl.IJDVL_571_18.

Abstract

BACKGROUND

Trophic ulcers secondary to leprosy pose a great stigma to patients and remain a challenge to the treating dermatologists. Platelet-rich plasma (PRP) introduces growth factors directly into the wound and aids in rapid healing. The role of PRP in the treatment of trophic ulcers in leprosy patients has not yet been established by randomized controlled trials.

AIMS

To study the effectiveness and safety of autologous PRP therapy with total contact casting versus total contact casting alone in the treatment of trophic ulcers in leprosy.

METHODS

In an observer-blind, randomized (1:1) controlled study, 118 patients were enrolled. PRP was prepared by the manual double-spin method (1600 rpm for 10 min followed by 4000 rpm for 10 min). After wound bed preparation, activated PRP was injected intra- and perilesionally, and platelet-poor plasma gel was applied over the ulcer bed. Occlusive dressings and total contact casting were then applied in Group A, and only total contact casting was applied in Group B. The same procedure was repeated every 2 weeks for 8 weeks.

RESULTS

In all, 56 patients were analyzable in Group A and 52 in Group B. The surface area of the ulcer decreased significantly from first follow-up onward in both the groups (P < 0.001 in both the groups). Intergroup comparison showed that the reduction in the surface area of the ulcer was significantly more in Group A than in Group B from the first follow-up onward (P = 0.038) and the difference was maintained till the fifth follow-up (P < 0.001). At the end of the study, 91.10 ± 9.65% ulcer surface area reduction had occurred in Group A, whereas it was 79.77 ± 17.91% in Group B (P < 0.001). Trophic ulcers healed completely more often in paucibacillary leprosy patients (P < 0.001) and in those with a lower initial surface area of the ulcer (P < 0.001).

LIMITATION

Short duration of treatment (8 weeks).

CONCLUSION

PRP combined with total contact casting accelerates the healing of trophic ulcers of leprosy and is more effective than total contact casting alone. Complete remission is more likely to occur when the duration and surface area of ulcer are less and in the paucibacillary spectrum.

摘要

背景

麻风继发的营养性溃疡给患者带来了极大的耻辱,仍然是皮肤科医生面临的挑战。富含血小板的血浆(PRP)将生长因子直接引入伤口,有助于快速愈合。随机对照试验尚未确定 PRP 在治疗麻风患者营养性溃疡中的作用。

目的

研究自体 PRP 治疗联合全面接触加压包扎与单纯全面接触加压包扎治疗麻风营养性溃疡的疗效和安全性。

方法

在一项观察者盲法、随机(1:1)对照研究中,纳入了 118 例患者。采用手动双旋法(10 分钟 1600 rpm 后再 10 分钟 4000 rpm)制备 PRP。在准备好创面床后,将激活的 PRP 皮内和皮周注射,将血小板贫血浆凝胶涂抹于溃疡床。A 组应用闭塞性敷料和全面接触加压包扎,B 组仅应用全面接触加压包扎。每 2 周重复一次,共 8 周。

结果

A 组 56 例患者和 B 组 52 例患者可进行分析。两组患者的溃疡面积均从首次随访开始显著减少(两组均 P < 0.001)。组间比较显示,从首次随访开始,A 组溃疡面积的减少明显多于 B 组(P = 0.038),且差异一直持续到第五次随访(P < 0.001)。研究结束时,A 组溃疡面积减少了 91.10 ± 9.65%,B 组减少了 79.77 ± 17.91%(P < 0.001)。在少菌型麻风患者(P < 0.001)和初始溃疡面积较小的患者(P < 0.001)中,营养性溃疡更常完全愈合。

局限性

治疗时间短(8 周)。

结论

PRP 联合全面接触加压包扎可加速麻风营养性溃疡的愈合,其疗效优于单纯全面接触加压包扎。溃疡持续时间和面积越小,在少菌型范围内,完全缓解的可能性越大。

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