赛肤润对糖尿病皮肤瘙痒症作用效果的非随机对照临床试验

目的：了解赛肤润是否能改善糖尿病皮肤瘙痒患者的皮肤瘙痒症状及作用程度。方法根据患者自愿的原则将221例研究对象进行分组。将其分为赛肤润组（涂抹赛肤润）、炉甘石组（涂抹炉甘石）、对照组共3组。结果建立广义估计方程，以对照组为参照时，可得赛肤润组、炉甘石组β值分别为2.20、1.29，差异有统计学意义（P＜0.01），疗效分别为对照组的9.03（OR=e2.20）、3.63（OR=e1.29）倍，说明赛肤润与炉甘石的疗效均优于对照组；以炉甘石组为参照时，可得赛肤润组、对照组β值分别为0.91、-1.29，差异有统计学意义（P＜0.01），疗效分别为炉甘石组的2.48（OR=e0.91）、0.28（OR=e-1.29）倍，说明赛肤润的疗效优于炉甘石。结论赛肤润治疗糖尿病皮肤瘙痒症有效；其治疗效果比炉甘石洗剂治疗效果好。

注射用鼠神经生长因子治疗儿童及老年视神经损伤的安全性研究

背景 注射用鼠神经生长因子（NGF）治疗视神经损伤的临床疗效和安全性已经过Ⅲ期临床试验的评价,但其在特定人群中使用的安全性和耐受性仍有待进一步证实. 目的 观察和评价应用注射用鼠NGF治疗儿童和老年视神经损伤患者的安全性和耐受性.方法 采用多中心非随机对照研究设计,在以中山大学中山眼科中心、首都医科大学附属北京同仁医院眼科、解放军总医院眼科、北京大学第一医院眼科及第三军医大学西南医院眼科等为主要研究单位的全国100个研究中心纳入各种原因所致的视神经损伤患者2046例,根据年龄分为少儿组（＜18岁）90例和老年组（＞75岁）88例,并以18 ～75岁的中青年组1 868例作为对照组.各组患者均给予注射用鼠NGF肌内注射,每次30 μg,每日1次,连续注射21 d.记录和评价指标包括各组患者用药前和用药结束时血压、心率、眼压以及血常规、尿常规和血液生化指标的变化,评价少儿和老年患者用药过程中发生的所有局部及全身不良事件. 结果 本研究共入组2046例,脱落189例（占9.23％）,完成试验者1857例,其中资料完整者1834例.在脱落的病例中184例失访,均在用药3周以后；另外5例因出现局部疼痛和荨麻疹退出试验,各组病例脱落率均＜10％.与用药前比较,少儿组、老年组及中青年组患者用药后眼压、心率、血压的差异均无统计学意义（P＞0.05）；少儿组、老年组及中青年组不良事件的发生率分别为57.78％、68.18％、60.01％,局部不良事件中,3个组均以注射部位疼痛、红肿、硬结的发生率最高,分别为48.89％、59.09％、54.49％,差异无统计学意义（x2=2.302,P=0.324）；3个组间患者用药后血常规、尿常规检查的各项指标异常率差异均无统计学意义（P＞0.05）；用药后3个组患者空腹血糖异常的发生率分别为7.46％、23.73％、7.79％,老年组高于少儿组和中青年组,差异均有统计学意义（x2=8.685,P=0.005;x2=27.720,P=0.000）.结论 儿童及75岁以上老年患者对注射用鼠NGF的耐受性良好.

Gemcitabine and cisplatin combined with the Chinese herbal medicine compound Fuzhenggubenfang improve quality of life and progression-free survival in patients with advanced non-small cell lung cancer

Objective： To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang （FZGBF）, for treating advanced non-small-cell lung cancer. Methods： A total of 84 eligible patientswere enrolled from October 2013 to July 2016. Patients were randomized to receive either chemotherapy alone as thecontrol group or chemotherapy combined with FZGBF as the experimental group. The primary endpoint of the study wasquality of life （QOL） and progression-free survival （PFS）. Secondary endpoints were tumor response rate, toxicity,dropout rate, and univariate and multivariate analyses of clinicopathologic factors for QOL and PFS. Results： There wasa significant improvement in QOL, including better overall health （P 〈 0.001）, physical function （P 〈 0.001）, rolefunction （P 〈 0.001）, emotional function （P 〈 0.001）, cognitive function （P 〈 0.001）, and social function （P = 0.031）.Less fatigue, nausea or vomiting, insomnia, appetite loss, constipation, and alopecia were noted （All P 〈 0.001） whenFZGBF was combined with chemotherapy in comparison to chemotherapy alone. The experimental group had a betterPFS compared with the control group （P = 0.032）. There was no significant difference in tumor response rate. FZGBFsignificantly reduced chemotherapy-induced anemia （P 〈 0.001）, neutropenia （P = 0.023）, nausea and vomiting （P 〈0.001）. The use of Chinese herbal compounds had only mild side effects. In this study, factors influencing QOL were theuse of the Chinese herbal compounds （P 〈 0.001）, performance status score （P = 0.027）, clinical staging of cancer （P =0.009）, and sex （P = 0.044）. Use of traditional Chinese medicine （P = 0.043） and the number of previous chemotherapysessions （P = 0.003） were the factors influencing PFS in this study. Conclusion： FZGBF could improve QOL,compliance to treatment, relieved chemotherapy-related toxicities of patients, and consequently improved PFS, which isa promising drug combination in complementary medicine for the treatment of advanced NSCLC.