复方芎芍胶囊治疗糖尿病周围神经病变的临床观察(1)
中图分类号 R969.4 文献标志码 A 文章编号 1001-0408(2018)02-0223-06
DOI 10.6039/j.issn.1001-0408.2018.02.19
摘 要 目的：观察复方芎芍胶囊治疗糖尿病周围神经病变(DPN)的临床疗效及安全性。方法：选取我院2015年6月-2016年4月DPN患者97例，按随机数字表法分为A组(复方芎芍治疗组，46例)和对照组(51例)，后者根据患者临床症状和经济情况分为B组(依帕司他+贝前列素钠联合组，12例)、C组(呋喃硫胺+甲钴胺联合组，12例)、D组(依帕司他组，27例)。4组患者均使用降糖药控制血糖。在此基础上，A组患者加服复方芎芍胶囊0.9 g，tid；B患者加服依帕司他片50 mg，tid+贝前列素钠片40 μg，tid；C组患者加服呋喃硫胺片50 mg，tid+甲钴胺片0.5 mg，tid；D组患者加服依帕司他片50 mg，tid。4组患者的疗程均为6个月。观察各组患者的临床疗效，比较其治疗前后多伦多临床评分系统(TCSS)评分，正中神经和腓总神经运动神经传导速度(MCV)、感觉神经传导速度(SCV)及潛伏期、振幅，血液流变学、血糖、糖化血红蛋白、血脂、血肌酐等指标，并记录不良反应发生情况。结果：A、B组患者的总有效率(82.61%、83.33%)显著高于C、D组(33.33%、66.67%)，且D组显著高于C组，差异均有统计学意义(P<0.05)。治疗前，4组患者TCSS评分，正中神经MCV、SCV、潜伏期及振幅，腓总神经MCV及振幅，腓总神经SCV、潜伏期及振幅，全血高切黏度比较，差异均无统计学意义(P>0.05)。治疗后，A、B、D组患者TCSS评分均较治疗前显著降低，且A、B组显著低于C、D组，差异均有统计学意义(P<0.05)；A、B组患者正中神经MCV、潜伏期及振幅，C组患者正中神经振幅，D组患者正中神经MCV及振幅均显著优于治疗前，且A、B组患者正中神经MCV、潜伏期及振幅均显著优于C、D组，差异均有统计学意义(P<0.05)；A、B、C组患者腓总神经MCV、潜伏期及振幅均显著优于治疗前，且A、B组患者腓总神经MCV及振幅均显著优于C、D组，A、B、D组患者腓总神经潜伏期的改善程度显著优于C组，差异均有统计学意义(P<0.05)；A、B、D组患者正中神经SCV、潜伏期及振幅以及腓总神经SCV及振幅均显著优于治疗前，且A组患者正中神经SCV、潜伏期及振幅和腓总神经SCV及振幅，B组患者正中神经SCV、潜伏期及振幅和腓总神经振幅均显著优于C、D组，D组患者正中神经SCV显著优于C组，差异均有统计学意义(P<0.05)；A组患者全血高切黏度较治疗前显著降低，且显著低于B、C、D组，差异均有统计学意义(P<0.05)。而A、B组患者的总有效率和TCSS评分比较，4组患者治疗前后血糖、糖化血红蛋白、血脂、血肌酐水平比较，差异均无统计学意义(P>0.05)。4组患者均未见明显不良反应发生。结论：复方芎芍胶囊治疗DPN疗效显著，可改善患者正中神经和腓总神经传导速度、潜伏期、振幅及全血高切黏度，其效果与依帕司他联合贝前列素钠相当，且优于呋喃硫胺联合甲钴胺以及依帕司他单药治疗；同时，该药不会影响患者的血糖、血脂、血肌酐水平，安全性较高。
关键词 糖尿病周围神经病变；复方芎芍胶囊；依帕司他；贝前列素钠；呋喃硫胺；甲钴胺；神经传导；血液流变学
ABSTRACT OBJECTIVE： To observe clinical efficacy and safety of Compound xiongshao capsules in the treatment of diabetic peripheral neuropathy (DPN). METHODS： A total of 97 DPN patients selected from our hospital during Jun. 2015-Apr. 2016 were divided into group A (compound xiongshao treatment group， 46 cases) and control group (51 cases) according to random number table. The latter was divided into group B (epalrestat+beraprost sodium group， 12 cases)， group C (fursultiamine+mecobalamin group， 12 cases) and group D (epalrestat group， 27 cases) according to clinical symptoms and economic situation of patients. Four groups were given antidiabetic drugs for blood glucose control. Based on it， group A was additionally given Compound xiongshao capsules 0.9 g，tid； group B was additionally given Epalrestat tablets 50 mg， tid+Beraprost sodium tablets 40 μg，tid； group C was additionally given Fursultiamine tablets 50 mg， tid+Mecobalamin tablets 0.5 mg， tid； group D was additionally given Epalrestat tablets 50 mg， tid. All groups were treated for 6 months. Clinical efficacies were observed. TCSS scores， motor nerve conduction velocity (MCV)， sensory nerve conduction velocity (SCV)， incubation period and amplitude of median nerve and common peroneal nerve， the levels of hemorheology indexes， blood glucose， glycosylated hemoglobin， blood lipid， serum creatinine were compared before and after treatment. The occurrence of ADR was recorded. RESULTS： Total response rates of group A and B (82.61%， 83.33%)were significantly higher than those of group C and D (33.33%， 66.67%)， total response rate of group D was significantly higher than that of group C， with statistical significance (P<0.05). Before treatment， there was no statistical significance in TCSS scores， MCV， SCV， incubation period and amplitude of median nerve， MCV and amplitude of common peroneal never， SCV， incubation period and amplitude of common peroneal never or whole blood high-shear viscosity among 4 groups (P>0.05). After treatment， TCSS scores of group A， B and D were decreased significantly compared to before treatment， and those of group A and B were lower than those of group C and D， with statistical significance (P<0.05). MCV， incubation period and amplitude of median nerve in group A and B， amplitude of median nerve in group C， MCV and amplitude of median nerve in group D were significantly better than before treatment； MCV， incubation period and amplitude of median nerve in group A and B were significantly better than group C and D， with statistical significance (P<0.05). MCV， incubation period and amplitude of common peroneal never in group A， B， C were significantly better than before treatment， MCV and amplitude of common peroneal never in group A， B were significantly better than group C， D； the improvement of incubation period of common peroneal never in group A， B， D were significantly better than group C， with statistical significance (P<0.05). SCV， incubation period and amplitude of median nerve， SCV and amplitude of common peroneal nerve in group A， B and D were significantly better than before treatment； SCV， incubation period and amplitude of median nerve， SCV and amplitude of common peroneal nerve in group A， SCV， incubation period and amplitude of median nerve and amplitude of common peroneal nerve in group B were significantly better than group C and D； SCV of median nerve in group D was significantly better than group C， with statistical significance (P<0.05). Whole blood high-shear viscosity of group A was decreased significantly compared to before treatment， and significantly lower than those of group B， C and D， with statistical significance (P<0.05). There was no statistical significance in total response rate and TCSS score between group A and B， and in the levels of blood glucose， glycosylated hemoglobin， blood lipid or serum creatinine among 4 groups (P>0.05). No obvious ADR was found in 4 groups. CONCLUSIONS： Compound xiongshao capsules shows significant therapeutic efficacy for DPN， and improves nerve conduction velocity， incubation period and amplitude of median nerve and common peroneal nerve， whole blood high-shear viscosity. Its effect is similar to that of epalrestat combined with beraprost sodium， and better than those of fursultiamine combined with mecobalamin， epalrestat alone. It does not affect the blood glucose， blood lipid and serum creatinine levels with good safety., http://www.100md.com(崔恒菁 朱伟嵘 周金晶 肖勤 黄菁菁 沈小珩 杨婉花)
DOI 10.6039/j.issn.1001-0408.2018.02.19
摘 要 目的：观察复方芎芍胶囊治疗糖尿病周围神经病变(DPN)的临床疗效及安全性。方法：选取我院2015年6月-2016年4月DPN患者97例，按随机数字表法分为A组(复方芎芍治疗组，46例)和对照组(51例)，后者根据患者临床症状和经济情况分为B组(依帕司他+贝前列素钠联合组，12例)、C组(呋喃硫胺+甲钴胺联合组，12例)、D组(依帕司他组，27例)。4组患者均使用降糖药控制血糖。在此基础上，A组患者加服复方芎芍胶囊0.9 g，tid；B患者加服依帕司他片50 mg，tid+贝前列素钠片40 μg，tid；C组患者加服呋喃硫胺片50 mg，tid+甲钴胺片0.5 mg，tid；D组患者加服依帕司他片50 mg，tid。4组患者的疗程均为6个月。观察各组患者的临床疗效，比较其治疗前后多伦多临床评分系统(TCSS)评分，正中神经和腓总神经运动神经传导速度(MCV)、感觉神经传导速度(SCV)及潛伏期、振幅，血液流变学、血糖、糖化血红蛋白、血脂、血肌酐等指标，并记录不良反应发生情况。结果：A、B组患者的总有效率(82.61%、83.33%)显著高于C、D组(33.33%、66.67%)，且D组显著高于C组，差异均有统计学意义(P<0.05)。治疗前，4组患者TCSS评分，正中神经MCV、SCV、潜伏期及振幅，腓总神经MCV及振幅，腓总神经SCV、潜伏期及振幅，全血高切黏度比较，差异均无统计学意义(P>0.05)。治疗后，A、B、D组患者TCSS评分均较治疗前显著降低，且A、B组显著低于C、D组，差异均有统计学意义(P<0.05)；A、B组患者正中神经MCV、潜伏期及振幅，C组患者正中神经振幅，D组患者正中神经MCV及振幅均显著优于治疗前，且A、B组患者正中神经MCV、潜伏期及振幅均显著优于C、D组，差异均有统计学意义(P<0.05)；A、B、C组患者腓总神经MCV、潜伏期及振幅均显著优于治疗前，且A、B组患者腓总神经MCV及振幅均显著优于C、D组，A、B、D组患者腓总神经潜伏期的改善程度显著优于C组，差异均有统计学意义(P<0.05)；A、B、D组患者正中神经SCV、潜伏期及振幅以及腓总神经SCV及振幅均显著优于治疗前，且A组患者正中神经SCV、潜伏期及振幅和腓总神经SCV及振幅，B组患者正中神经SCV、潜伏期及振幅和腓总神经振幅均显著优于C、D组，D组患者正中神经SCV显著优于C组，差异均有统计学意义(P<0.05)；A组患者全血高切黏度较治疗前显著降低，且显著低于B、C、D组，差异均有统计学意义(P<0.05)。而A、B组患者的总有效率和TCSS评分比较，4组患者治疗前后血糖、糖化血红蛋白、血脂、血肌酐水平比较，差异均无统计学意义(P>0.05)。4组患者均未见明显不良反应发生。结论：复方芎芍胶囊治疗DPN疗效显著，可改善患者正中神经和腓总神经传导速度、潜伏期、振幅及全血高切黏度，其效果与依帕司他联合贝前列素钠相当，且优于呋喃硫胺联合甲钴胺以及依帕司他单药治疗；同时，该药不会影响患者的血糖、血脂、血肌酐水平，安全性较高。
关键词 糖尿病周围神经病变；复方芎芍胶囊；依帕司他；贝前列素钠；呋喃硫胺；甲钴胺；神经传导；血液流变学
ABSTRACT OBJECTIVE： To observe clinical efficacy and safety of Compound xiongshao capsules in the treatment of diabetic peripheral neuropathy (DPN). METHODS： A total of 97 DPN patients selected from our hospital during Jun. 2015-Apr. 2016 were divided into group A (compound xiongshao treatment group， 46 cases) and control group (51 cases) according to random number table. The latter was divided into group B (epalrestat+beraprost sodium group， 12 cases)， group C (fursultiamine+mecobalamin group， 12 cases) and group D (epalrestat group， 27 cases) according to clinical symptoms and economic situation of patients. Four groups were given antidiabetic drugs for blood glucose control. Based on it， group A was additionally given Compound xiongshao capsules 0.9 g，tid； group B was additionally given Epalrestat tablets 50 mg， tid+Beraprost sodium tablets 40 μg，tid； group C was additionally given Fursultiamine tablets 50 mg， tid+Mecobalamin tablets 0.5 mg， tid； group D was additionally given Epalrestat tablets 50 mg， tid. All groups were treated for 6 months. Clinical efficacies were observed. TCSS scores， motor nerve conduction velocity (MCV)， sensory nerve conduction velocity (SCV)， incubation period and amplitude of median nerve and common peroneal nerve， the levels of hemorheology indexes， blood glucose， glycosylated hemoglobin， blood lipid， serum creatinine were compared before and after treatment. The occurrence of ADR was recorded. RESULTS： Total response rates of group A and B (82.61%， 83.33%)were significantly higher than those of group C and D (33.33%， 66.67%)， total response rate of group D was significantly higher than that of group C， with statistical significance (P<0.05). Before treatment， there was no statistical significance in TCSS scores， MCV， SCV， incubation period and amplitude of median nerve， MCV and amplitude of common peroneal never， SCV， incubation period and amplitude of common peroneal never or whole blood high-shear viscosity among 4 groups (P>0.05). After treatment， TCSS scores of group A， B and D were decreased significantly compared to before treatment， and those of group A and B were lower than those of group C and D， with statistical significance (P<0.05). MCV， incubation period and amplitude of median nerve in group A and B， amplitude of median nerve in group C， MCV and amplitude of median nerve in group D were significantly better than before treatment； MCV， incubation period and amplitude of median nerve in group A and B were significantly better than group C and D， with statistical significance (P<0.05). MCV， incubation period and amplitude of common peroneal never in group A， B， C were significantly better than before treatment， MCV and amplitude of common peroneal never in group A， B were significantly better than group C， D； the improvement of incubation period of common peroneal never in group A， B， D were significantly better than group C， with statistical significance (P<0.05). SCV， incubation period and amplitude of median nerve， SCV and amplitude of common peroneal nerve in group A， B and D were significantly better than before treatment； SCV， incubation period and amplitude of median nerve， SCV and amplitude of common peroneal nerve in group A， SCV， incubation period and amplitude of median nerve and amplitude of common peroneal nerve in group B were significantly better than group C and D； SCV of median nerve in group D was significantly better than group C， with statistical significance (P<0.05). Whole blood high-shear viscosity of group A was decreased significantly compared to before treatment， and significantly lower than those of group B， C and D， with statistical significance (P<0.05). There was no statistical significance in total response rate and TCSS score between group A and B， and in the levels of blood glucose， glycosylated hemoglobin， blood lipid or serum creatinine among 4 groups (P>0.05). No obvious ADR was found in 4 groups. CONCLUSIONS： Compound xiongshao capsules shows significant therapeutic efficacy for DPN， and improves nerve conduction velocity， incubation period and amplitude of median nerve and common peroneal nerve， whole blood high-shear viscosity. Its effect is similar to that of epalrestat combined with beraprost sodium， and better than those of fursultiamine combined with mecobalamin， epalrestat alone. It does not affect the blood glucose， blood lipid and serum creatinine levels with good safety., http://www.100md.com(崔恒菁 朱伟嵘 周金晶 肖勤 黄菁菁 沈小珩 杨婉花)