甲钴胺穴位注射结合针刺治疗顽固性面瘫的疗效观察

目的 评价甲钴胺(弥可保)穴位注射结合针刺治疗顽固性面瘫的疗效和安全性. 方法 将70例顽固性面瘫患者随机分为治疗组和对照组,每组各35例.治疗组给予甲钴胺穴位注射和针刺治疗,对照组仅给予针刺治疗.两组均治疗40d后观察疗效. 结果 对总体疗效而言,意向性分析(ITT)结果显示两组愈显率分别为77.14%、51.43%,方案数据分析(PP)结果显示两组愈显率分别为81.26%、56.67%,疗效差异有统计学意义(P＜0.05).ITT分析与PP分析结果一致.临床观察中未发现甲钴胺有明显毒性作用和不良反应.结论 甲钴胺穴位注射结合针刺治疗顽固性面瘫安全有效,值得在临床上推广应用.     

前列地尔联合甲钴胺注射液治疗糖尿病足的疗效观察

目的探讨前列地尔联合甲钴胺注射液治疗糖尿病足的疗效。方法以糖尿病足患者为研究对象,随机分成试验组和对照组。试验组给予前列地尔联合甲钴胺注射液治疗,对照组给予丹参注射液和甲钴胺片治疗。比较两组临床疗效及腓浅神经感觉传导速度和足背动脉血流速度的差别。结果①试验组有效率（97．06％）显著高于对照组（85．29％）,差异有统计学意义（P〈0．05）;②治疗后试验组前腓浅神经感觉传导速度和足背动脉血流速度显著快于对照组,差异有统计学意义（P〈0．05）。结论前列地尔联合甲钴胺注射液治疗糖尿病足具有较好疗效。     

甲钴胺软胶囊的人体生物等效性

目的研究甲钴胺软胶囊在健康人体内的药物动力学及相对生物利用度。方法 20例男性健康受试者采用自身交叉单剂量口服给药对照法服用药物,以微生物比浊法测定受试者服药后72 h内血浆中甲钴胺浓度,计算甲钴胺的药动学参数和生物等效性。结果口服单剂量给药药动学参数计算结果显示,血浆中受试制剂和参比制剂的tmax分别为(7.3±2.6)h和(6.8±2.5)h,ρmax分别为(426.7±165.2)ng·L-1和(420.7±188.6)ng·L-1t,1/2分别为(23.6±8.4)h和(28.5±7.0)h,AUC0-t分别为(9 568±3 265)ng·h.L-1和(9 398±3 733)ng·h.L-1,AUC0-∞分别为(11 245±3 676)ng·h.L-1和(11 333±4 138)ng·h.L-1。以AUC0-t计算,甲钴胺软胶囊的平均相对生物利用度为(105.0±19.3)%。结论两种制剂在人体内具有生物等效性。     

聚乳酸-丙氨酸共聚物的制备及缓释性能研究

丙交酯和丙氨酸在辛酸亚锡催化下通过吗啉环聚合生成聚乳酸-丙氨酸共聚物,并对目标物和聚乳酸对植入性药物甲钴胺的缓释性能做了对比.结果表明,目标物对甲钴胺的缓释性能优于聚乳酸,且与丙氨酸和乳酸的比例有关.     

调制中频电联合弥可保球旁注射治疗神经源性眼外肌麻痹

目的:观察调制中频电联合弥可保球旁注射对神经源性眼外肌麻痹的疗效。方法:选取神经源性眼外肌麻痹患者10例,其中男9例,女1例;平均年龄43.40±7.68岁,病程中位数43.50d。给予调制中频电治疗,20min/次,1次/d,10d为1疗程,联合球旁注射弥可保,500μg/次,隔日1次,10d为1个疗程,根据病情治疗2～4个疗程;观察眼位、复视及眼球运动改善情况。结果:脑外伤性眼外肌麻痹患者3例均治愈,5例脑干梗死所致眼外肌麻痹患者显效,1例脑外伤性眼外肌麻痹患者有效,1例脑外伤性眼外肌麻痹患者未愈。结论:调制中频电联合弥可保球旁注射治疗神经源性眼外肌麻痹有效。     

甲钴铵在黄斑水肿治疗中对神经功能恢复的影响

目的:观察甲钴铵在黄斑水肿治疗中对神经功能恢复的影响。方法:选择确诊为视网膜血管病所致的黄斑水肿、并符合入选标准的患者312例487眼,分为两组,对照组使用各种促进黄斑水肿消退的治疗方法,试验组在对照组的基础上最少使用1mo的甲钴铵。结果:联合使用甲钴铵的试验组较对照组有更好的视力预后。结论:在黄斑水肿的治疗中,除了积极的消除水肿外,联合使用神经保护药物治疗是非常有意义的。     

The Kampo Medicine Goshajinkigan Prevents Neuropathy in Breast Cancer Patients Treated with Docetaxel

Background: Goshajinkigan (GJG) is used for the treatment of several neurological symptoms. We investigatedthe efficacy of GJG and mecobalamin (B12) against neurotoxicity associated with docetaxel (DOC) in breastcancer patients. Materials and Methods: Sixty breast cancer patients were treated with DOC. Thirty-threepatients (GJG group) received oral administration of 7.5 g/day GJG and 27 patients (B12 group) received oraladministration of 1500 μg/day B12. Neuropathy was evaluated according to DEB-NTC (Neurotoxicity Criteriaof Debiopharm), Common Terminology Criteria for Adverse Events (NCI-CTC) ver. 3.0, and a visual analoguescale (VAS). This study employed a randomized open design. Results: The incidence of neuropathy was 39.3%in the GJG group, and 88.9% in the B12 group (p<0.01). In the GJG group, grade 1 DEB-NTC was observedin 2 cases, grade 2 in 5 cases and grade 3 in 5 cases. Grade 1 NCI-CTC was observed in 7 cases, grade 2 in 6cases, and VAS was 2.7±2.2. In the B12 group, grades 1, 2 and 3 DEB-NTC were observed in one case, 12 casesand 12 cases, respectively; and grades 1, 2 and 3 NCI-CTC were observed in 11 cases, 12 cases and one case,and VAS was 4.9±2.4. Conclusions: Concomitant administration of GJG is useful in preventing neuropathy inbreast cancer patients treated with a DOC regimen.     

前列地尔联合甲钴胺治疗糖尿病周围神经病变的Meta分析

目的比较前列地尔联合甲钴胺治疗糖尿病周围神经病变(DPN)的疗效与安全性。方法应用循证医学方法对符合标准的16个研究进行Meta分析,评价前列地尔联合甲钴胺治疗DPN的神经传导速度、有效率及不良反应发生率方面的差异。结果 Meta分析结果显示,试验组在改善DPN患者的神经传导速度及有效率方面优于对照组,而不良反应发生率多于对照组。治疗后,正中神经(MCV)和腓总神经(SCV)的运动神经传导速度的标准化均数差(SMD)及其95%CI分别是2.37(2.15,2.60)和2.05(1.86,2.25);正中神经和腓总神经的感觉神经传导速度的标准化均数差及其95%CI分别是1.84(1.65,2.03)和1.45(1.27,1.64);有效率方面,合并后的RR为1.35,95%CI为1.26～1.44;不良反应发生率方面,合并后的RR为3.58,95%CI为1.70～7.54。结论前列地尔联合甲钴胺治疗糖尿病周围神经病变是一种有效的方法。     

大剂量甲钴胺联合灯盏花注射液治疗糖尿病足对TNF-α、CRP水平及AT-Ⅲ活性的影响

目的观察大剂量甲钴胺联合灯盏花注射液对糖尿病足(DF)患者血清肿瘤坏死因子-α(TNF-α)、C反应蛋白(CRP)水平及抗凝血酶Ⅲ(AT-Ⅲ)活性的影响。方法 240例DF患者按随机数字表法分为4组:大剂量甲钴胺+灯盏花注射液治疗组60例(Ⅳ组),常规剂量甲钴胺+灯盏花注射液治疗组60例(Ⅲ组),单纯灯盏花注射液治疗组60例(Ⅱ组),单纯常规剂量甲钴胺治疗组60例(Ⅰ组),4周为1疗程。治疗前后检测TNF-α、CRP水平及AT-Ⅲ活性并进行对比分析。结果治疗前4组血清TNF-α、CRP及AT-Ⅲ检测结果之间差异无统计学意义(P0.05);分别行治疗前后比较,4组治疗后血清TNF-α及CRP结果均较治疗前降低,AT-Ⅲ水平升高,差异有统计学意义(P0.05);Ⅳ组与Ⅰ、Ⅱ、Ⅲ组治疗后比较,差异有统计学意义(P0.05)。结论甲钴胺联合灯盏花注射液能降低DF患者血清中炎性因子如TNF-α及CRP的水平,并使AT-Ⅲ活性升高,尤其是甲钴胺浓度增加时效果更显著。因此,采取增加甲钴胺浓度联合灯盏花注射液的治疗方法能更明显地降低DF的炎症反应,且安全性好,是提高治疗DF的有效手段之一。     

Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy:a meta-analysis of 16 randomized controlled trials

OBJECTIVE:This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction(HGWWD) for treating diabetic peripheral neuropathy.DATA SOURCES:Six electronic databases,including the Cochrane Library,MEDLINE database,Chinese Biomedical Database,Chinese National Knowledge Infrastructure Database,Chinese Science and Technique Journals Database,and the Wanfang Database,were search ed on the internet for randomized controlled trials published up until 1 December 2015.The search terms included "Chinese herbal medicine","diabetic peripheral neuropathy" and "randomized controlled trials" in Chinese and in English.DATA SELECTION:We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group,without restriction for the control group.We assessed literature quality in accordance with the Cochrane Review Handbook.A random or a fixed effects model was used to analyze outcomes using Rev Man 5.2 software.OUTCOME MEASURES:The primary outcomes were changes in symptoms and nerve conduction velocities.The secondary outcomeswere fasting blood glucose and hemorheological indexes.RESULTS:Sixteen randomized controlled trials,with a total of 1,173 patients,were included.Meta-analysis revealed that the efficacy of HGWWD for diabetic peripheral neuropathy was significantly superior compared with the control treatment(i.e.,control group)(risk ratio = 0.36,95% confidence interval(CI):0.29–0.46,Z =8.33,P 0.00001) Compared with the control group,there was an increase in median motor nerve conduction velocity(mean difference(MD) = 3.46,95%CI:1.88–5.04,Z = 4.30,P 0.01) and median sensory nerve conduction velocity(MD = 3.30,95%CI:2.04–4.56,Z = 5.14,P 0.01).There was also an increase in peroneal motor nerve conduction velocity(MD = 3.22,95%CI:2.45–3.98,Z = 8.21,P 0.01) and peroneal sensory nerve conduction velocity(MD = 3.05,95%CI:2.01–4.09,Z = 5.75,P 0.01) in the treatment groups.No significant difference in fasting blood glucose was found between the treatment groups and the control groups(MD =-0.12,95%CI:-0.42–0.19,Z = 0.76,P = 0.45).Plasma viscosity was significantly decreased after treatment(MD =-0.11,95%CI:-0.21 to-0.02,Z = 2.30,P = 0.02).No significant difference in fibrinogen was detectable(MD =-0.53,95%CI:-1.28–0.22,Z = 1.38,P = 0.17).Four trials reported that treatment groups experienced no adverse reactions.Adverse events were not mentioned in the other 12 trials.No trial reported the incidence of complications,quality of life outcomes,or health economics.CONCLUSION:HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities.Our study suggests that HGWWD may have significant therapeutic efficacy for the treatment of diabetic peripheral neuropathy.However,the methodological quality of the randomized controlled trials was generally low.Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.