康脉Ⅱ号胶囊口服和篷子菜浸出液湿敷治疗肿瘤术后化疗置管所致输液性静脉炎的临床和实验研究
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摘要
目的：通过临床观察和动物实验,探讨肿瘤化疗置管所致的输液性静脉炎的发病机理,阐述口服康脉Ⅱ号胶囊和湿敷蓬子菜浸出液在治疗肿瘤化疗置管所致的输液性静脉炎的独特优势。
方法：采用随机分组对照法,将符合肿瘤化疗置管所致的输液性静脉炎的30例患者分为观察治疗组(A组)和对照治疗组(B组)。A组患者口服康脉Ⅱ号胶囊,患处湿敷自制蓬子菜浸出液；B组患者口迈之灵片,患处湿敷50%硫酸镁溶液。观察两组患者的治愈率及血清中TNF-α、IL-6、D-二聚体、Hcy变化水平。实验研究采用改良结扎法制成血栓性静脉炎大鼠模型,采用康脉Ⅱ号胶囊口服和蓬子菜浸出液湿敷治疗,迈之灵片口服和硫酸镁湿敷作对照,观察各组大鼠血管病理形态改变和D-二聚体、肿瘤坏死因子、白介素6、同型半胱氨酸、内皮素-1、PAF、PKCa、PAR-1、白介素10的水平变化。
结果：临床研究：康脉Ⅱ号胶囊口服和蓬子菜浸出液湿敷的观察治疗组15例患者治疗后,治愈5例,显效6例,有效3例,无效1例,治愈率为33.3%,总有效率为93.3%。迈之灵片口服和硫酸镁湿敷的对照治疗组15例患者治疗后,治愈2例,显效3例,有效6例,无效4例,治愈率为13.3%,总有效率为73.3%；经x2检验统计学处理,两组患者治愈率及总有效率有显著差异(p<0.05),表明A组患者临床总疗效优于B组。输液性静脉炎患者的TNF-α、IL-6、D-二聚体、Hcy水平均升高,其中TNF-α、IL-6是重要的早期炎症因子,Hcy是一种血管损伤性氨基酸,D-二聚体含量是体内高凝状态和纤溶亢进的分子标记物之一。
血清显示：①康脉Ⅱ胶囊口服和蓬子菜浸出液湿敷患处治疗组血清中TNF-α、IL-6水平明显降低,优于迈之灵口服和硫酸镁注射液湿敷治疗组(P<0.05)。
②康脉Ⅱ胶囊口服和蓬子菜浸出液湿敷患处治疗组血浆中同型半胱氨酸水平明显降低,优于迈之灵口服和硫酸镁注射液湿敷治疗组(P<0.05)。
③康脉Ⅱ胶囊口服和蓬子菜浸出液湿敷患处治疗组血浆中D-二聚体含量水平明显降低,优于迈之灵口服和硫酸镁注射液湿敷治疗组(P<0.05)。
实验研究：①大鼠造模后第二天6小时、三天陆续出现刀口周边红肿,触摸有所条状,下肢肿胀、不喜扎堆、食量减少、饮水减少、少动、弓背等。给药后康脉Ⅱ号组大鼠以上症状减轻程度好于迈之灵组。
②空白对照组：整个血管内膜表面平整、光滑,内皮细胞呈梭形,大小均匀,排列整齐,中膜血管平滑肌排列规整(附图13)。
造模型后6h空白组：部分形成的微小血栓填充于管腔的小部分,管壁轻微变薄,血管内皮细胞无剥脱,血管平滑肌结构疏松,血管壁及组织间隙少量炎细胞局灶性浸润(附图14)。
造模造模后24小时组：血栓较6h时变大,填充于管腔的大部分,管壁变薄,血管内皮细胞部分剥脱,血管平滑肌结构紊乱,血管壁及组织间隙大量炎细胞局灶性浸润(附图15)。
造模型后24h空白组：血栓机化填充于整个管腔,管壁明显变薄,血管内皮细胞完全剥脱,血管平滑肌结构紊乱疏松,血管壁及组织间隙有大量炎细胞浸润(附图16)。
造模型后24h对照组与造模型后24h治疗组：血栓较造模型后24h空白组明显变小,血栓部分填充于管腔,血管内皮细胞尚完整,有少部分剥脱,血管平滑肌结构较紊乱,炎细胞浸润明显减少,造模型后24h治疗组病理改变最为明显(附图17、18)。
③康脉Ⅱ号胶囊可降低D-二聚体、肿瘤坏死因子、白介素6,同型半胱氨酸、内皮素-1、PAF、PKCa、PAR-1的水平,升高白介素10的水平。
④造模组的PAF、PKCa、PAR-1三个基因的表达上调。
结论：
临床观察：
①采用康脉Ⅱ号胶囊内服结合蓬子莱浸出液湿敷治疗肿瘤病人置管化疗致输液性静脉炎,是治疗输液性静脉炎理想的方法,有很好的临床意义。
②蓬子菜浸出液湿敷治疗输液性静脉炎为国内首创。
动物实验：
①本实验通过改良结扎法成功建立了血栓性静脉炎模型。
②康脉Ⅱ号胶囊可降低D-二聚体、肿瘤坏死因子、白介素6,同型半胱氨酸、内皮素-1、PAF、PKCa、PAR-1的水平,升高白介素10的水平。
③PAF、PKCa、PAR-1三个基因的表达上调,是血栓性静脉炎的发生原因。
Objective:Clinical observation and animal experiments to explore the tumor chemotherapeutic set the pathogenesis of infusion tube due to phlebitis of the oral Kangmai Ⅱ Capsule and wet compress Galium verum lixivium, the infusion catheter in the treatment of cancer chemotherapy-induced phlebitis has a unique advantages.
Methods:A randomized controlled method, will comply with the the cancer chemotherapy catheter infusion due to phlebitis30patients divided into observation and treatment group (A) and the control treatment group (B). Group A patients were treated with Kangmai II Capsule, the affected area wet homemade the Galium verum lixivium; the B patients mouth step Tablets, wet compress the affected area50%magnesium sulfate solution. The cure rate of the two groups were observed and serum TNF-alpha, IL-6, D-dimer, Hcy level of change. Experimental study improved ligation rat model of thrombophlebitis, using the Kangmai Ⅱ Capsule oral and Galium verum lixivium wraps Therapy, Maizhilin Tablets oral and magnesium sulfate wet as a control, rats were observed vascular pathological changes and serum D-dimer, tumor necrosis factor, interleukin-6, homocysteine, endothelin-1, PAF, PKCa, PAR-1white interleukin-10levels.
Results:Clinical study:Kangmai Ⅱ Capsule oral and the Galium verum lixivium wet compress the observed treatment group of15patients after treatment,5patients were cured, six cases markedly effective in3cases, and1case has no effect, the cure rate was33.3%, and the total The efficiency was93.3%. Maizhilin Tablets oral and magnesium sulfate wet control treatment group of15patients after treatment,2cases were cured, three cases markedly effective in6cases,4cases, the cure rate was13.3%, total effective rate was73.3%; x2test statistical treatment, the cure rate and total effective rate of the two groups of patients were significantly different (p<0.05), indicating that the patients in group A clinical total effective than group B. Infusion phlebitis patients the levels of TNF-alpha, IL-6, D-dimer, Hcy water SMA increased, wherein TNF-alpha, IL-6is important proinflammatory factor, Hcy is a vascular injury amino acid, D-dimer is one of the hypercoagulable state in vivo and molecular markers of fibrinolysis.
The serum Show:①The Kangmai Ⅱ Capsule oral and Galium verum leaching solution wet compress to the affected area levels of serum TNF-alpha, IL-6level was significantly lower,it was better than that of Maizhilin Tablets oral and magnesium sulfate injection wet compress treatment group (P<0.05).
②Wet compress to the affected area with the Kangmai Ⅱ Capsule oral and Galium verum leaching solution treatment group, plasma homocysteine levels significantly lower, it was better than that of Maizhilin Tablets oral and magnesium sulfate injection wet compress treatment group (P<0.05).
③With the Kangmai II Capsule oral and Galium verum leaching solution wet dressing the affected area treatment group, plasma D-dimer levels were significantly lower,it was better than that of Maizhilin Tablets oral and magnesium sulfate injection wet compress treatment group (P<0.05).
Experimental study:(1) Rats in the day after6hours to three days after another incision surrounding redness, touch some strips, leg swelling, do not like to get together, reduced food intake, reduced drinking water, lack of exercise, such as arched. Proved successful adoption of the improved ligation into the thrombophlebitis rat model.
(2) After administration of Kangmai II No. rats incision swelling around, touch some strips, leg swelling, do not like to get together, reduced food intake, reduced drinking water, lack of exercise, such as arched degree of symptom relief Mai zhilin Tablets group.
(3) blank control group:The intimal surface smooth, endothelial cells were spindle shape, uniform size, arranged in neat rows, in membrane of vascular smooth muscle cells.(attached map13)
Made model6h after the blank group:A small part of micro thrombosis filling in the lumen, wall slightly thinner, vascular endothelial cells without stripping, vascular smooth muscle loose structure, vascular wall and interstitial inflammatory cell infiltrate.(attached map14)
24hours after the creation of the model:Thrombus is6h bigger, most of filling in the lumen, wall thinning, vascular endothelial cell exfoliation, vascular smooth muscle structure disorder, vascular wall and interstitial inflammatory cell infiltrate e.(attached map15)
24h blank group after the creation of the model:Thrombus of filling in the lumen, wall became thinner, vascular endothelial cells completely denuded vascular smooth muscle, disorder of loose structure, vascular wall and interstitial inflammatory cells infiltrating.(attached map16)
24hours after the creation of the model control group:Thrombus is making a model of24h group was significantly smaller, thrombus partially filled into the lumen, vascular endothelial cell is complete, there are few stripping, vascular smooth muscle structure is disorder, inflammatory cell infiltration was significantly reduced, making a model after24h treatment group was most obvious pathological changes.(attached map17/18)
(4) Kangmai II Capsule can reduce the D-dimer, tumor necrosis factor, interleukin-6, homocysteine, endothelin-1, PAF, PKCa, PAR-1level, elevated level of interleukin10.
(5) model PAF, PKCa, PAR-1three genes were up-regulated.
Conclusion:
Clinical observation:①Using Kangmai Ⅱ Capsule Orally the Galium verum lixivium wet compress to treat cancer patients catheter infusion phlebitis caused by chemotherapy, is the therapeutic infusion phlebitis ideal method, the clinical significance.②Galium verum lixivium Therapy infusion phlebitis originated in China.
Animal experiments:①the present experiment successfully established through an improved ligation thrombophlebitis model.②Kangmai Ⅱ Capsule can reduce the D-dimer, tumor necrosis factor, interleukin-6, homocysteine, endothelin-1, PAF, PKCa, PAR-1level, elevated level of interleukin-10.③PAF, PKCa, PAR-1expression of the three genes up-regulated, may cause thrombophlebitis.
方法：采用随机分组对照法,将符合肿瘤化疗置管所致的输液性静脉炎的30例患者分为观察治疗组(A组)和对照治疗组(B组)。A组患者口服康脉Ⅱ号胶囊,患处湿敷自制蓬子菜浸出液；B组患者口迈之灵片,患处湿敷50%硫酸镁溶液。观察两组患者的治愈率及血清中TNF-α、IL-6、D-二聚体、Hcy变化水平。实验研究采用改良结扎法制成血栓性静脉炎大鼠模型,采用康脉Ⅱ号胶囊口服和蓬子菜浸出液湿敷治疗,迈之灵片口服和硫酸镁湿敷作对照,观察各组大鼠血管病理形态改变和D-二聚体、肿瘤坏死因子、白介素6、同型半胱氨酸、内皮素-1、PAF、PKCa、PAR-1、白介素10的水平变化。
结果：临床研究：康脉Ⅱ号胶囊口服和蓬子菜浸出液湿敷的观察治疗组15例患者治疗后,治愈5例,显效6例,有效3例,无效1例,治愈率为33.3%,总有效率为93.3%。迈之灵片口服和硫酸镁湿敷的对照治疗组15例患者治疗后,治愈2例,显效3例,有效6例,无效4例,治愈率为13.3%,总有效率为73.3%；经x2检验统计学处理,两组患者治愈率及总有效率有显著差异(p<0.05),表明A组患者临床总疗效优于B组。输液性静脉炎患者的TNF-α、IL-6、D-二聚体、Hcy水平均升高,其中TNF-α、IL-6是重要的早期炎症因子,Hcy是一种血管损伤性氨基酸,D-二聚体含量是体内高凝状态和纤溶亢进的分子标记物之一。
血清显示：①康脉Ⅱ胶囊口服和蓬子菜浸出液湿敷患处治疗组血清中TNF-α、IL-6水平明显降低,优于迈之灵口服和硫酸镁注射液湿敷治疗组(P<0.05)。
②康脉Ⅱ胶囊口服和蓬子菜浸出液湿敷患处治疗组血浆中同型半胱氨酸水平明显降低,优于迈之灵口服和硫酸镁注射液湿敷治疗组(P<0.05)。
③康脉Ⅱ胶囊口服和蓬子菜浸出液湿敷患处治疗组血浆中D-二聚体含量水平明显降低,优于迈之灵口服和硫酸镁注射液湿敷治疗组(P<0.05)。
实验研究：①大鼠造模后第二天6小时、三天陆续出现刀口周边红肿,触摸有所条状,下肢肿胀、不喜扎堆、食量减少、饮水减少、少动、弓背等。给药后康脉Ⅱ号组大鼠以上症状减轻程度好于迈之灵组。
②空白对照组：整个血管内膜表面平整、光滑,内皮细胞呈梭形,大小均匀,排列整齐,中膜血管平滑肌排列规整(附图13)。
造模型后6h空白组：部分形成的微小血栓填充于管腔的小部分,管壁轻微变薄,血管内皮细胞无剥脱,血管平滑肌结构疏松,血管壁及组织间隙少量炎细胞局灶性浸润(附图14)。
造模造模后24小时组：血栓较6h时变大,填充于管腔的大部分,管壁变薄,血管内皮细胞部分剥脱,血管平滑肌结构紊乱,血管壁及组织间隙大量炎细胞局灶性浸润(附图15)。
造模型后24h空白组：血栓机化填充于整个管腔,管壁明显变薄,血管内皮细胞完全剥脱,血管平滑肌结构紊乱疏松,血管壁及组织间隙有大量炎细胞浸润(附图16)。
造模型后24h对照组与造模型后24h治疗组：血栓较造模型后24h空白组明显变小,血栓部分填充于管腔,血管内皮细胞尚完整,有少部分剥脱,血管平滑肌结构较紊乱,炎细胞浸润明显减少,造模型后24h治疗组病理改变最为明显(附图17、18)。
③康脉Ⅱ号胶囊可降低D-二聚体、肿瘤坏死因子、白介素6,同型半胱氨酸、内皮素-1、PAF、PKCa、PAR-1的水平,升高白介素10的水平。
④造模组的PAF、PKCa、PAR-1三个基因的表达上调。
结论：
临床观察：
①采用康脉Ⅱ号胶囊内服结合蓬子莱浸出液湿敷治疗肿瘤病人置管化疗致输液性静脉炎,是治疗输液性静脉炎理想的方法,有很好的临床意义。
②蓬子菜浸出液湿敷治疗输液性静脉炎为国内首创。
动物实验：
①本实验通过改良结扎法成功建立了血栓性静脉炎模型。
②康脉Ⅱ号胶囊可降低D-二聚体、肿瘤坏死因子、白介素6,同型半胱氨酸、内皮素-1、PAF、PKCa、PAR-1的水平,升高白介素10的水平。
③PAF、PKCa、PAR-1三个基因的表达上调,是血栓性静脉炎的发生原因。
Objective:Clinical observation and animal experiments to explore the tumor chemotherapeutic set the pathogenesis of infusion tube due to phlebitis of the oral Kangmai Ⅱ Capsule and wet compress Galium verum lixivium, the infusion catheter in the treatment of cancer chemotherapy-induced phlebitis has a unique advantages.
Methods:A randomized controlled method, will comply with the the cancer chemotherapy catheter infusion due to phlebitis30patients divided into observation and treatment group (A) and the control treatment group (B). Group A patients were treated with Kangmai II Capsule, the affected area wet homemade the Galium verum lixivium; the B patients mouth step Tablets, wet compress the affected area50%magnesium sulfate solution. The cure rate of the two groups were observed and serum TNF-alpha, IL-6, D-dimer, Hcy level of change. Experimental study improved ligation rat model of thrombophlebitis, using the Kangmai Ⅱ Capsule oral and Galium verum lixivium wraps Therapy, Maizhilin Tablets oral and magnesium sulfate wet as a control, rats were observed vascular pathological changes and serum D-dimer, tumor necrosis factor, interleukin-6, homocysteine, endothelin-1, PAF, PKCa, PAR-1white interleukin-10levels.
Results:Clinical study:Kangmai Ⅱ Capsule oral and the Galium verum lixivium wet compress the observed treatment group of15patients after treatment,5patients were cured, six cases markedly effective in3cases, and1case has no effect, the cure rate was33.3%, and the total The efficiency was93.3%. Maizhilin Tablets oral and magnesium sulfate wet control treatment group of15patients after treatment,2cases were cured, three cases markedly effective in6cases,4cases, the cure rate was13.3%, total effective rate was73.3%; x2test statistical treatment, the cure rate and total effective rate of the two groups of patients were significantly different (p<0.05), indicating that the patients in group A clinical total effective than group B. Infusion phlebitis patients the levels of TNF-alpha, IL-6, D-dimer, Hcy water SMA increased, wherein TNF-alpha, IL-6is important proinflammatory factor, Hcy is a vascular injury amino acid, D-dimer is one of the hypercoagulable state in vivo and molecular markers of fibrinolysis.
The serum Show:①The Kangmai Ⅱ Capsule oral and Galium verum leaching solution wet compress to the affected area levels of serum TNF-alpha, IL-6level was significantly lower,it was better than that of Maizhilin Tablets oral and magnesium sulfate injection wet compress treatment group (P<0.05).
②Wet compress to the affected area with the Kangmai Ⅱ Capsule oral and Galium verum leaching solution treatment group, plasma homocysteine levels significantly lower, it was better than that of Maizhilin Tablets oral and magnesium sulfate injection wet compress treatment group (P<0.05).
③With the Kangmai II Capsule oral and Galium verum leaching solution wet dressing the affected area treatment group, plasma D-dimer levels were significantly lower,it was better than that of Maizhilin Tablets oral and magnesium sulfate injection wet compress treatment group (P<0.05).
Experimental study:(1) Rats in the day after6hours to three days after another incision surrounding redness, touch some strips, leg swelling, do not like to get together, reduced food intake, reduced drinking water, lack of exercise, such as arched. Proved successful adoption of the improved ligation into the thrombophlebitis rat model.
(2) After administration of Kangmai II No. rats incision swelling around, touch some strips, leg swelling, do not like to get together, reduced food intake, reduced drinking water, lack of exercise, such as arched degree of symptom relief Mai zhilin Tablets group.
(3) blank control group:The intimal surface smooth, endothelial cells were spindle shape, uniform size, arranged in neat rows, in membrane of vascular smooth muscle cells.(attached map13)
Made model6h after the blank group:A small part of micro thrombosis filling in the lumen, wall slightly thinner, vascular endothelial cells without stripping, vascular smooth muscle loose structure, vascular wall and interstitial inflammatory cell infiltrate.(attached map14)
24hours after the creation of the model:Thrombus is6h bigger, most of filling in the lumen, wall thinning, vascular endothelial cell exfoliation, vascular smooth muscle structure disorder, vascular wall and interstitial inflammatory cell infiltrate e.(attached map15)
24h blank group after the creation of the model:Thrombus of filling in the lumen, wall became thinner, vascular endothelial cells completely denuded vascular smooth muscle, disorder of loose structure, vascular wall and interstitial inflammatory cells infiltrating.(attached map16)
24hours after the creation of the model control group:Thrombus is making a model of24h group was significantly smaller, thrombus partially filled into the lumen, vascular endothelial cell is complete, there are few stripping, vascular smooth muscle structure is disorder, inflammatory cell infiltration was significantly reduced, making a model after24h treatment group was most obvious pathological changes.(attached map17/18)
(4) Kangmai II Capsule can reduce the D-dimer, tumor necrosis factor, interleukin-6, homocysteine, endothelin-1, PAF, PKCa, PAR-1level, elevated level of interleukin10.
(5) model PAF, PKCa, PAR-1three genes were up-regulated.
Conclusion:
Clinical observation:①Using Kangmai Ⅱ Capsule Orally the Galium verum lixivium wet compress to treat cancer patients catheter infusion phlebitis caused by chemotherapy, is the therapeutic infusion phlebitis ideal method, the clinical significance.②Galium verum lixivium Therapy infusion phlebitis originated in China.
Animal experiments:①the present experiment successfully established through an improved ligation thrombophlebitis model.②Kangmai Ⅱ Capsule can reduce the D-dimer, tumor necrosis factor, interleukin-6, homocysteine, endothelin-1, PAF, PKCa, PAR-1level, elevated level of interleukin-10.③PAF, PKCa, PAR-1expression of the three genes up-regulated, may cause thrombophlebitis.
引文
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