牛痘疫苗致炎兔皮提取物在糖尿病足感染保肢治疗中的疗效观察

摘要/Abstract

摘要： 目的观察牛痘疫苗致炎兔皮提取物治疗糖尿病足（DF）感染保肢治疗过程中的应用效果。方法选取2013年1月至2015年6我院DF感染需要行保肢治疗的46例患者,根据治疗方案分为观察组、对照组,各23例,两组患者均按照Wagner分级接受相应手术治疗,术后观察组给予牛痘疫苗致炎兔皮提取物注射液,对照组给予甲钴胺注射液。比较两组患者临床疗效及并发症发生情况。结果两组患者治疗后VAS评分均降低,观察组治疗2周后、治疗3周后VAS评分均低于对照组,其疼痛改善总有效率分别为82.61%、86.96%,均高于对照组的69.57%、73.91%（P<0.05）。两组患者治疗后神经症状、体征评分均较治疗前降低,观察组治疗后神经症状、体征评分均低于对照组,差异有统计学意义（P<0.05）。两组患者治疗后神经传导速度均上升,观察组升高更为明显（P<0.05）。两组患者治疗期间均未见明显并发症及不良反应发生。结论牛痘疫苗致炎兔皮提取物能够有效改善DF感染保肢治疗后患者疼痛感、周围神经症状及体征,促进其神经传导速度的恢复,具有良好的临床疗效与安全性。

关键词: 糖尿病足, 感染, 牛痘疫苗致炎兔皮提取物, 外科治疗, 保肢, 创伤修复

Abstract: Objective To observe the clinical effect of extract from rabbit skin inflamed by vaccinia virus (ERSIVV) in the limb salvage treatment of diabetic foot (DF). Methods From January 2013 to June 2015, 46 DF patients with infection who needed limb salvage treatment in our hospital were selected and divided into the observation group and the control group according to treatment program, 23 cases in each group. All of patients were graded according to the Wagner and accepted surgical treatment. Then observation group received the ERSIVV, the control group was given mecobalamin injection. The clinical efficacy and complications of the two groups were compared. Results The VAS scores of the two groups decreased after treatment, and the VAS scores 2 weeks and 3 weeks after treatment in the observation group were lower than those of the control group, the total effective rates of the pain improvement in the observation group were 82.61% and 86.96%, which were higher than those in the control group (69.57% and 73.91%) (P < 0.05). The scores of neurological symptoms and signs of the two groups decreased after treatment, and the scores in the observation group were lower than those in the control group, the difference was statistically significant (P < 0.05). After treatment, the nerve conduction velocity in the two groups all increased, and the change of the observation group was more obvious (P < 0.05). There were no obvious complication and adverse reaction in the two groups during the treatment period. Conclusion The ERSIVV can effectively improve the pain, neurologic symptoms and signs of the patients with DF infection after the limb salvage treatment, promote the recovery of nerve conduction speed, it has good clinical efficacy and safety.

Key words: diabetic foot, infection, extract from rabbit skin inflamed by vaccinia virus, surgical treatment, limb salvage, wound repair

中图分类号:

R971

王军，邱阳，王一村，代思辉，韦昌辉，时宁文^*. 牛痘疫苗致炎兔皮提取物在糖尿病足感染保肢治疗中的疗效观察[J]. 中国药物警戒, 2016, 13(11): 655-659.

WANG Jun, QIU Yang, WANG Yi-cun, DAI Si-hui, WEI Chang-hui, SHI Ning-wen. Observation on Efficacy of Extract from Rabbit Skin Inflamed by Vaccinia Virus in Limb Salvage Treatment of Diabetic Foot Infection[J]. Chinese Journal of Pharmacovigilance, 2016, 13(11): 655-659.

参考文献

[1] Wukich D K, Hobizal K B, Brooks M M. Severity of diabetic foot infection and rate of limb salvage[J]. Foot & ankle international,2013, 34(3): 351-358.
[2] Eggert J V, Worth E R, Van Gils C C. Cost and mortality data of a regional limb salvage and hyperbaric medicine program for Wagner Grade 3 or 4 diabetic foot ulcers[J]. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc,2015, 43(1): 1-8.
[3] Gil J, Schiff A P, Pinzur M S. Cost Comparison Limb Salvage Versus Amputation in Diabetic Patients With Charcot Foot[J]. Foot & ankle international, 2013, 34(8): 1097-1099.
[4] 朱韶峰, 刘辉, 杨轶萍, 等. 牛痘疫苗接种家兔炎症皮肤提取物联合α-硫辛酸治疗糖尿病周围神经病变的疗效观察[J].中国疼痛医学杂志, 2014, 20(6): 421-423.
[5] Giurato L, Vainieri E, Meloni M, et al. Limb salvage in patients with diabetes is not a temporary solution but a life-changing procedure[J].Diabetes care, 2015, 38(10): e156-e157.
[6] 吴枢武, 姜玲. 合并严重感染的糖尿病足采用持续负压吸引保肢技术治疗的临床效果[J]. 当代医学, 2015, 21(30): 58-59.
[7] Nayak B, Mahapatra K C, Das R R. Management of complex diabetic foot wound by external fixation: An effective way for limb salvage[J].Journal of Health Specialties, 2016, 4(2): 128.
[8] 张翼生, 水源, 樊碧发. 腰2交感阻滞联合牛痘疫苗接种家兔炎症皮肤提取物治疗糖尿病神经病变的观察[J]. 中国疼痛医学杂志, 2015, 21(8): 595-597.
[9] Mills J L, Conte M S, Armstrong D G, et al. The Society for Vascular Surgery lower extremity threatened limb classification system: risk stratification based on Wound, Ischemia, and foot Infection (WIfI)[J].Journal of vascular surgery, 2014, 59(1): 220-234.
[10] Hashimoto I, Abe Y, Morimoto A, et al. Limb salvage and vascular augmentation by microsurgical free flap transfer for treatment of neuropathic diabetic foot ulcers[J]. The Journal of Medical Investigation,2014, 61(3.4): 325-332.
[11] 胡仁明, 樊东升. 糖尿病周围神经病变诊疗规范(征求意见稿)[J].中国糖尿病杂志, 2009, 17(8):638-640.
[12] Kwon K C, Verma D, Singh N D, et al. Oral delivery of human biopharmaceuticals, autoantigens and vaccine antigens bioencapsulated in plant cells[J]. Advanced drug delivery reviews, 2013, 65(6): 782-799.
[13] Larsson P G, Lakshmikanth T, Laitinen O H, et al. A preclinical study on the efficacy and safety of a new vaccine against Coxsackievirus B1 reveals no risk for accelerated diabetes development in mouse models[J]. Diabetologia, 2015, 58(2): 346-354.
[14] 刘冰峰, 谢举临, 彭文要,等. 糖尿病足保肢性治疗方法探讨[J].中华损伤与修复杂志:电子版, 2015, 10(5): 40-42.
[15] Drescher K M, Herrath M, Tracy S. Enteroviruses, hygiene and type 1 diabetes: toward a preventive vaccine[J]. Reviews in medical virology,2015, 25(1): 19-32.
[16] 率红莉, 汪津洋. 糖尿病周围神经病变治疗药物研究进展[J].中国药房, 2014, 25(4): 377-382.
[17] Frasca D, Diaz A, Romero M, et al. Young and elderly patients with type 2 diabetes have optimal B cell responses to the seasonal influenza vaccine[J]. Vaccine, 2013, 31(35): 3603-3610.
[18] Yorek M S, Davidson E P, Poolman P, et al. Corneal Sensitivity to Hyperosmolar Eye Drops: A Novel Behavioral Assay to Assess Diabetic Peripheral NeuropathyCorneal Sensitivity and Diabetic Neuropathy[J]. Investigative ophthalmology & visual science,2016, 57(6): 2412-2419.
[19] Lupachyk S, Watcho P, Stavniichuk R, et al. Endoplasmic reticulum stress plays a key role in the pathogenesis of diabetic peripheral neuropathy[J]. Diabetes, 2013, 62(3): 944-952.
[20] Dong J, Tu H P, Ding W Y, et al. Analgecine, the extracts of Vaccinia-inoculated rabbit skin, effectively alleviates the chronic low back pain with little side effect-A randomized multi-center double-blind placebo-controlled phase 3 clinical trial[J]. Contemporary Clinical Trials Communications, 2016, 15(2): 16-24.