【摘要】：目的 觀察評價聯合應用rhGM-CSF(重組人粒細胞巨噬細胞刺激因子)凝膠與藻酸鹽敷料治療中老年體表慢性難愈性創(chuàng)面的臨床療效及安全性,探討其有關作用機制,評估將其作為一種治療中老年體表慢性難愈性創(chuàng)面的非手術療法的臨床可行性。 方法 采用非盲法隨機對照設計,選擇于2011-05至2013-05在山東大學附屬濟南市中心醫(yī)院燒傷科住院治療的中老年體表慢性難愈性創(chuàng)面患者60例,采用分層隨機分組的方法將其分為4組,每組各15例。分組如下：rhGM-CSF凝膠+藻酸鹽敷料+凡士林紗布治療組(A組)；rhGM-CSF凝膠+凡士林紗布治療組(B組)；藻酸鹽敷料+凡士林紗布治療組(C組)；凡士林紗布常規(guī)治療組(D組)。試驗周期設為8周。觀察記錄各組用藥后的不良反應發(fā)生情況,評估治療前、治療后1,2,3,4,5,6,7,8周各時相點的創(chuàng)面滲液量、創(chuàng)面色澤及肉芽組織和上皮生長情況、創(chuàng)面疼痛程度、創(chuàng)面愈合率,以及治療后8周各組的創(chuàng)面痊愈率、有效率。 結果 1.創(chuàng)面滲液量：入組治療前各組創(chuàng)面滲液量比較差異無統(tǒng)計學意義(P0.05)；開始治療后,各組創(chuàng)面滲液量均呈減少的趨勢,各時相點組間創(chuàng)面滲液量比較差異有統(tǒng)計學意義(P0.05)；治療后1-4周,A組和C組創(chuàng)面滲液量均少于B組和D組,差異有統(tǒng)計學意義(P0.05)；治療后5-8周,A組、B組和C組創(chuàng)面滲液量均少于D組,差異有統(tǒng)計學意義(P0.05)。 2.大體觀察：入組治療前各組創(chuàng)面色澤及肉芽組織和上皮生長情況比較差異無統(tǒng)計學意義(P0.05)；開始治療后,各組創(chuàng)面基底均呈現出由黃白色蒼老肉芽向鮮紅色新鮮肉芽轉變的趨勢,治療后3-8周,各組間創(chuàng)面色澤及肉芽組織和上皮生長情況比較差異有統(tǒng)計學意義(P0.05)；治療后3-4周,A組和B組在創(chuàng)面色澤、肉芽組織和上皮生長情況方面均好于C組和D組,差異有統(tǒng)計學意義(P0.05)；治療后5-8周,A組、B組和C組在創(chuàng)面色澤、肉芽組織和上皮生長情況方面均好于D組,差異有統(tǒng)計學意義(P0.05)。 3.創(chuàng)面疼痛程度：入組治療前各組間創(chuàng)面疼痛程度比較差異無統(tǒng)計學意義(P0.05)；開始治療后,各組創(chuàng)面疼痛程度總體呈現逐漸降低的趨勢,各時相點組間疼痛程度比較差異有統(tǒng)計學意義(P0.05)；治療后1-4周,A組和C組創(chuàng)面疼痛程度均低于B組和D組,差異有統(tǒng)計學意義(P0.05)；在治療后5-8周,A組、B組和C組創(chuàng)面疼痛程度均低于D組,差異有統(tǒng)計學意義(P0.05)。 4.創(chuàng)面愈合率：治療后1周,各組間創(chuàng)面愈合率比較差異無統(tǒng)計學意義(P0.05)；治療后2周-8周,各組間創(chuàng)面愈合率比較差異有統(tǒng)計學意義(P0.05)；A組、B組和C組的創(chuàng)面愈合率均高于D組,其中A組創(chuàng)面愈合率最高,其后依次為B組,C組,差異有統(tǒng)計學意義(P0.05)。 5.治療后8周各組的創(chuàng)面痊愈率及有效率：治療后8周,各組間創(chuàng)面痊愈率及有效率比較差異有統(tǒng)計學意義(P0.05)；A組、B組和C組的創(chuàng)面痊愈率及有效率均高于D組,其中A組創(chuàng)面痊愈率及有效率高于B組和C組,差異有統(tǒng)計學意義(P0.05)。 6.不良反應：試驗過程中各組均未見明顯不良反應。 結論 rhGM-CSF聯合藻酸鹽敷料治療中老年體表慢性難愈性創(chuàng)面有協同互補作用,不僅能刺激肉芽組織增生,加速再上皮化,促進創(chuàng)面愈合；還能明顯減少創(chuàng)面滲液量,減輕換藥時創(chuàng)面疼痛,提高了患者治療依從性和日常生活護理質量；且未發(fā)現明顯不良反應。將其作為一種治療中老年體表慢性難愈性創(chuàng)面的的非手術療法既安全又有效,具有臨床可行性。
[Abstract]:Purpose To evaluate the clinical efficacy and safety of rhGM-CSF (recombinant human granulocyte-macrophage stimulating factor) gel and alginate dressing in the treatment of chronic refractory wound in the middle-aged and the elderly, and to explore its related effects Mechanism and evaluation as a non-operative treatment for the treatment of chronic refractory wound on the surface of the middle-aged and the elderly line property Methods The non-blind randomized controlled design was used to select 60 cases of chronic refractory wound in the middle-aged and old-aged and middle-aged and middle-aged and old-aged patients who were hospitalized in the Central Hospital of Jinan, Shandong University, from 2011 to 05 to 2013-05. The method of stratified random grouping was divided into 4 groups. Group, 15 in each group. The group was as follows: rhGM-CSF gel + alginate dressing + Vaseline gauze treatment group (group A); rhGM-CSF gel + Vaseline gauze treatment group (group B); alginate dressing + Vaseline gauze treatment group (group C); Vaseline gauze often Gauge treatment group (group D). The test period was set to 8 weeks. The occurrence of the adverse reaction after the treatment was recorded. The amount of the wound exudate, the color of the wound, the tissue of the wound and the growth of the epithelium, the degree of wound pain, the rate of wound healing, and the 8-week post-treatment were evaluated before and after the treatment. the creation of each group face-to-face Results 1. The recovery rate and the effective rate. Results 1. The amount of the wound exudate in each group was not statistically significant (P0.05). After the treatment, the amount of the wound exudate in each group was decreased, and the difference of the amount of wound exudate between the groups at the time of treatment was statistically significant (P <0.05). There was no difference between group A and group D in group A and group C after treatment for 1-4 weeks after treatment (P <0.05), and the amount of wound liquid in group A, group B and group C was less than that of group D and poor in group A, group B and group C. There was no significant difference in the difference between the color of the wound and the tissue of the granulation and the growth of the epithelium (P0.05). There was a significant difference in the color of the wound, the tissue of the wound and the growth of the epithelium in the 3-8 weeks after the treatment (P0.05). The difference was statistically significant between the group C and the D group in the group A and group B after 3-4 weeks of treatment. significance (P0.05); 5-8 weeks after treatment, group A, group B and group C were good in the color of the wound, the tissue of granulation and the growth of the epithelium. There was no significant difference in the degree of wound pain in the group (P0.05). The degree of pain in group A, group B and group C was significantly lower than that in group B and D (P0.05). The degree of pain in group A, group B and group C were all lower than that of group B and group D after 1-4 weeks after treatment (P0.05). There was no significant difference in the rate of wound healing in group D (P0.05). 4. The rate of wound healing was not significant (P0.05). The rate of wound healing in group A, group B and group C was higher than that of group D, and the rate of wound healing in group A was the highest. In group B and group C, the difference was significant (P0.05). The recovery rate and the effective rate of the wound in each group at 8 weeks after treatment were statistically significant (P0.05). 5) The recovery rate and effective rate of wound surface in group A, group B and group C were higher than that of group D. The effective rate was higher than that of group B and group C (P0.05). 5). 6. Adverse reaction: no obvious adverse reaction was found in each group during the test. Conclusion The combination of rhGM-CSF and alginate dressing in the treatment of chronic refractory wound surface in the middle-aged and the elderly has a synergistic effect, not only can stimulate the proliferation of granulation tissue, accelerating and re-epithelialization, and promoting wound healing; and also can obviously reduce the amount of the wound exudate and reduce the drug change, The wound pain is improved, the patient's treatment compliance and daily life care quality are improved, and no obvious adverse reaction is found.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R644

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