Effects of Compound α-Ketoacid Tablets on renal function, renal fibrosis indexes and oxidative stress in patients with diabetic nephropathy

Objective: To investigate the effects of Compound α-Ketoacid Tablets on renal function, renal fibrosis indexes and oxidative stress in patients with diabetic nephropathy. Methods: A total of 180 patients with diabetic nephropathy admitted to Nephrology Department of our hospital were randomly divided into control group and observation group, 90 cases in each group. The patients in the control group were given conventional treatment, such as antihypertensive drugs, diet and blood glucose control, and the patients in the observation group were given Compound α-Ketoacid Tablets on the basis of the control group. Renal function, renal fibrosis index and oxidative stress levels were compared between the two groups before and after treatment. Results: After treatment, the levels of serum ALB, BUN, Cr, Hcy, VEGF and MDA in two groups were significantly decreased than those before the treatment, and the levels of ALB, Hcy, VEGF and MDA in the observation group were significantly lower than those in the control group, the difference was statistically significant. After treatment, the levels of serum GFR, HGF, T-AOC and SOD in two groups were significantly increased than that before the treatment, and the levels of HGF, T-AOC and SOD in the serum of the observation group were significantly higher than that in the control group, the difference was significant. Conclusion:The Compound α-Ketoacid Tablets has good effect in the treatment of diabetic nephropathy. It can effectively improve the state of renal fibrosis and reduce the oxidative stress reaction of the patients, so as to achieve the protection of the kidney.

Compound Danshen tablets downregulate amyloid protein precursor mRNA expression in a transgenic cell model of Alzheimer's disease Effects and a comparison with donepezil

After gene mutation, the pcDNA3.1/APP595/596 plasmid was transfected into HEK293 cells to establish a cell model of Alzheimer＇s disease. The cell model was treated with donepezil or compound Danshen tablets after culture for 72 hours. Reverse transcription-PCR showed that the mRNA expression of amyloid protein precursor decreased in all groups following culture for 24 hours, and that there was no significant difference in the amount of decrease between donepezil and compound Danshen tablets. Our results suggest that compound Danshen tablets can reduce expression of the mRNA for amyloid protein precursor in a transgenic cell model of Alzheimer＇s disease, with similar effects to donepezil.

Study on Determination of Tanshinones in Compound Danshen Tablets

[ Objective ] This study was conducted to improve quality standard of Compound Danshen tablets. [ Method] Tanshinones in Compound Danshen tab- lets were determined by HPLC method. [ Result] A good linear relationship was found in the range of 0.10 -0.50 μg, and the average recovery rate was 100.59% （RSD = 1.38% ）. [ Conclusion] The method is simple, rapid and reproducible, and could be used as a method for quality control of Compound Danshen Tablets.

Semi-quantitative analysis on the content of berberine hydrochloride in compound berberine tablets with the fluorescence spectral imaging method

The content of berberine hydrochloride(BH)in compound berberine tablets(CBTs)is subject to strict requirements.Its content is usually measured based on chemical analysis.In this paper,the fluorescence spectral imaging method was used to study the relative content of BH from a physics perspective.By comparing the relative fluorescence intensity of self-made CBTs with di®erent mass percentages of BH,a linear positive relationship was observed between the BH content and the relative fluorescence intensity,and accordingly the quality of CBTs of different brands was evaluated.The results indicate that the fluorescence spectral imaging method can be a simple,fast and nondestructive semi-quantitative analysis method to determine the content of BH in CBTs,and this method has great potential in the quality control of CBTs.

Pseudo-hyperaldosteronism caused by compound glycyrrhizin tablets: a case report

Compound glycyrrhizin tablets(CGT)is a glycyrrhizin-containing preparation for the treatment of chronic hepatic diseases,it contained Glycyrrhizin,Monoammonium Glycyrrhizinate,Aminoacetic Acid and Methionine.CGT has been shown to have anti-inflammatory,anti-oxidative,and anti-viral effects.Although pseudo-hyperaldosteronism was reported as its important side effects,the frequency was unknown.A 59-year-old male patient with tuberculous pleurisy received CGT to prevent impairment in liver function which was caused by antituberculosis drugs.After more than one month,it appeared edema in the lower extremity,blood pressure increased,serum potassium lowed,serum sodium raised at the normal high limit.Finally,it was improved by suspending the CGT and diuretic treatment.

Effect of Compound Biejiaruangan Tablets combined with entecavir therapy on liver fibrosis process and immune response state in patients with chronic hepatitis b

Objective:To study the effect of Compound Biejiaruangan Tablets combined with entecavir therapy on liver fibrosis process and immune response state in patients with chronic hepatitis b.Methods: Patients with chronic viral hepatitis b who were treated in the Affiliated Hospital of Inner Mongolia Medical University between May 2015 and March 2017 were selected as the research subjects and divided into the combined group who accepted Compound Biejiaruangan Tablets combined with entecavir therapy and the control group who accepted entecavir monotherapy. The contents of collagen metabolism indexes and inflammatory response molecules in serum as well as the contents of immune cells in peripheral blood were determined before treatment and 24 weeks after treatment.Results: 24 weeks after treatment, PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of both groups of patients were significantly lower than those before treatment whereas Th1 contents in peripheral blood were significantly higher than those before treatment, and PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of combined group of patients were significantly lower than those of control group whereas Th1 content in peripheral blood was significantly higher than that of control group.Conclusion: Compound Biejiaruangan Tablets combined with entecavir therapy can delay the liver fibrosis process and improve the immune response state in patients with chronic hepatitis b.

Effects of tripterygium glycosides combined with compoundα-keto acid tablets on inflammatory response, oxidative stress and urinary TGF-β1, IV-C levels in patients with chronic renal failure

Objective:To investigate the effects of tripterygium glycosides combined with compoundα-ketoacid tablets on inflammatory response, oxidative stress and urinary TGF-β1 and IV-C levels in patients with chronic renal failure.Methods: 102 patients with chronic renal failure admitted to Shuguang hospital from January 2017 to June 2018 were randomly divided into observation group (51 cases) and control group (51 cases). In the control group, the tripterygium glycosides tablets were orally administered, and the observation group was orally administered with tripterygium glycosides tablets and compoundα-keto acid tablets. The inflammatory response, oxidative stress index and urinary TGF-β1, IV-C levels were compared between the two groups.Results: There was no significant difference in CRP and TNF-α levels between the two groups before treatment (P>0.05). After treatment, the levels of CRP and TNF-α in the observation group were (9.32±1.10) mg/L and (3.14±0.36) ng/L, respectively, and the levels of CRP and TNF-α in the control group were (15.34±1.31) mg/ L, (5.01±0.53) ng / L. The CRP and TNF-α levels in the two groups were lower than those before treatment, and the CRP and TNF-α in the observation group were significantly lower than those in the control group (P<0.05). Before treatment, there was no significant difference in MDA, SOD and GSH-PX levels between the two groups (P>0.05). After treatment, the MDA level of the observation group was (3.01±0.32) μmol/L, and the MDA level of the control group was (5.17±0.61) μmol/L. The MDA of the two groups was lower than that before treatment, and the MDA of the observation group was significantly lower than that of the control group (P<0.05). After treatment, the levels of SOD and GSH-PX in the observation group were (101.45±13.16) U/L and (94.83±7.17) U/L, respectively. The levels of SOD and GSH-PX in the control group were (88.87±12.05) U/L, (87.38 ± 6.32) U/L. The SOD and GSH-PX of the two groups were higher than those before treatment, and the SOD and GSH-PX of the observation group were significantly higher than the control group (P<0.05). Before treatment, there was no significant difference in TGF-β1 and IV-C levels between the two groups (P>0.05). After treatment, the levels of TGF-β1 and IV-C in the observation group were (1.05±0.24) ng/L and (5.05±1.13) μg/L, respectively, and the levels of TGF-β1 and IV-C in the control group were (1.36±, respectively). 0.26) ng/L, (7.07±1.24) μg/L. The levels of TGF-β1 and IV-C in the two groups were lower than those before treatment, and the TGF-β1 and IV-C in the observation group were significantly lower than those in the control group (P<0.05).Conclusion: Tripterygium glycosides combined with compound -keto acid tablets can effectively reduce the inflammatory response, oxidative stress and renal interstitial fibrosis in patients with chronic renal failure.

Effect of compound α-ketoacid combined with routine nutritional intervention on inflammatory response and oxidative stress response in patients with maintenance hemodialysis

Objective: To study the effect of compound α-ketoacid combined with routine nutritional intervention on the inflammatory response and oxidative stress response in patients with maintenance hemodialysis. Methods: A total of 78 patients with uremia who received maintenance hemodialysis in Dangyang Changbanpo Hospital between February 2014 and November 2016 were collected and divided into control group and observation group according to the random number table method, 39 cases in each group. The control group received routine nutritional intervention, and the observation group underwent compound α-ketoacid combined with routine nutritional intervention. The serum levels of inflammatory factors and oxidative stress indicators in two groups of patients were detected before dialysis and 6 months after dialysis. Results: Before dialysis, differences in serum levels of inflammatory factors and oxidative stress indexes were not statistically significant between two groups of patients. After dialysis, serum CRP, IL-6, TNF-α, MDA and AOPP levels of both groups of patients were significantly higher than those before dialysis while SOD and GSHPx levels were significantly lower than those before dialysis and serum CRP, IL-6, TNF-α, MDA and AOPP levels of observation group after dialysis were significantly lower than those of control group while SOD and GSHPx levels were significantly higher than those of control group. Conclusions:Compound α-ketoacid combined with routine nutritional intervention can effectively reduce the systemic microinflammatory state and inhibit the oxidative stress response in patients with maintenance hemodialysis.

微生态制剂联合依达拉奉注射液对急性重症胰腺炎的疗效及肠道菌群、肠黏膜屏障功能改变

目的探讨复方嗜酸乳杆菌片联合依达拉奉对重症急性胰腺炎患者的临床效果。方法选取河南科技大学第一附属医院收治的172例重症急性胰腺炎患者,利用随机数字表法将其分为甲、乙、丙与丁4组,各43例。4组均接受常规综合治疗,乙组另接受依达拉奉治疗,丙组另接受复方嗜酸乳杆菌片治疗,丁组另接受复方嗜酸乳杆菌片联合依达拉奉治疗。对比治疗前后肠道菌群和肠黏膜屏障功能相关指标、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)及住院时间、并发症、病死率。结果4组双歧杆属、乳酸杆菌属相对丰度在治疗前、治疗7 d及14 d后均依次升高(P<0.05),丙组、丁组治疗7、14 d后均高于甲组、乙组(P<0.05),丁组治疗7、14 d后高于丙组(P<0.05);4组肠杆菌属、葡萄球菌属、肠球菌属相对丰度在治疗前、治疗7 d及14 d后均依次降低(P<0.05),丙组、丁组治疗7、14 d后均低于甲组、乙组(P<0.05),丁组治疗7、14 d后低于丙组(P<0.05);4组D-乳酸、内毒素、二胺氧化酶(DAO)水平在治疗前、治疗7 d及14 d后均依次降低(P<0.05),乙组、丙组、丁组治疗7、14 d后均低于甲组(P<0.05),乙组、丁组治疗7、14 d后均低于丙组(P<0.05),丁组治疗7、14 d后低于乙组(P<0.05);丁组住院时间短于甲组、乙组、丙组(P<0.05),丁组并发症发生率、病死率低于甲组(P<0.05);4组APACHEⅡ评分在治疗前、治疗7及14 d后均依次降低(P<0.05),乙组、丙组、丁组治疗7、14 d后均低于甲组(P<0.05),丁组治疗7、14 d后低于乙组、丙组(P<0.05)。结论在常规综合治疗的基础上接受复方嗜酸乳杆菌片能够调节重症急性胰腺炎患者机体肠道菌群,改善肠黏膜屏障功能,给予依达拉奉可改善肠黏膜屏障功能,二者均可减轻病情,且二者联合可增强对肠黏膜屏障功能的改善作用和对病情的控制作用,还可显著缩短住院时间,减少并发症,改善预后。

复方高滋斑片联合右佐匹克隆片治疗老年精神疾病伴睡眠障碍的疗效分析

目的探讨复方高滋斑片联合右佐匹克隆片治疗老年精神疾病伴睡眠障碍的疗效。方法将我科收治的72例老年患者,随机分为对照组和观察组,各36例。两组均服用右佐匹克隆片,观察组加用复方高滋斑片,疗程均为4周。治疗前、治疗4周后评定匹兹堡睡眠质量指数(PSOI)、失眠严重程度指数(ISI)、疲劳严重程度指数(FSS)。结果与治疗前比较,治疗4周后观察组和对照组PSQI、ISI以及FSS总分均下降,差异有统计学意义(P<0.01);治疗4周后,与对照组比较,观察组PSQI总分、ISI总分及FSS总分下降,差异有统计学意义(P<0.05)。结论在右佐匹克隆片治疗的基础上加用复方高滋斑片干预精神疾病伴睡眠障碍老年患者,可改善患者的睡眠质量。

复方甘草酸苷结合硫酸羟氯喹片治疗玫瑰痤疮的临床效果分析

目的观察复方甘草酸苷结合硫酸羟氯喹片治疗玫瑰痤疮的临床效果。方法选取本院皮肤科收治的98例玫瑰痤疮患者(2022年1月~2024年1月)作为研究对象。患者均采用复方甘草酸苷结合硫酸羟氯喹片治疗,统计治疗前、治疗后总积分,评估临床疗效,并观察患者是否出现胃肠功能紊乱、皮疹等不良反应。结果98例患者治疗后主要症状(2.60±1.09分)、次要症状评分(1.91±1.21分)和总积分(4.51±1.68分)均显著低于治疗前(8.01±1.17分、5.37±1.14分)(P<0.05)。98例患者治疗后总有效率为94.90%(93/98)。患者不良反应发生率为7.14%(7/98)。结论两者联合治疗效果可靠,可有效改善患者潮红、红斑、毛细血管扩张等症状,总有效率较为理想,且不良反应风险较低,该用药方案安全可靠。

肉苁蓉复方咀嚼片制备工艺及质量控制的研究

目的研究肉苁蓉复方咀嚼片的制备工艺及质量控制方法。方法基于中医理论对肉苁蓉、黄精和党参进行配伍,将其药材提取物与若干辅料等量递加混合,再加入硬脂酸镁,混合后过80目筛3次,每次混合时间超过5 min,压片制成肉苁蓉复方咀嚼片;以外观、硬度和口感等为指标进行工艺初步筛选,用正交实验法优选最佳处方;对用最佳处方制得的咀嚼片进行质量评价,用HPLC法测定有效成分的含量;通过研究肉苁蓉复方咀嚼片低、中、高剂量对小鼠体质量、力竭游泳时间及疲劳代谢产物等的影响来验证该咀嚼片在缓解体力疲劳方面的功效。结果3批工艺验证结果显示,用最佳处方制得的咀嚼片口感细腻、酸甜适宜,片质量为0.5 g·片^(−1),硬度>8 kg·mm^(−2)、脆碎度<1%;每片含松果菊苷>0.025 g,松果菊苷>0.003 g。0.25、0.50、1.50 g·kg^(−1)·d^(−1)剂量的肉苁蓉复方咀嚼片均能显著延长小鼠力竭游泳时间,降低尿素氮和乳酸的含量,增加肝糖原、肌糖原的含量,差异有统计学意义(P<0.01)。结论优选了肉苁蓉复方咀嚼片的处方工艺。用最优处方制备的肉苁蓉复方咀嚼片的外观性状、口感、硬度及脆碎度等均达到预期要求。肉苁蓉复方咀嚼片对体力疲劳有缓解作用。

基于限定日剂量和帕累托分析法对复方氨林巴比妥注射液和洛芬待因缓释片的药物利用评价

目的基于限定日剂量和帕累托分析法分析医疗机构复方氨林巴比妥注射液(以下简称为复方氨林巴比妥)与洛芬待因缓释片药物利用情况,为医疗机构药品管理及药物滥用主动监测提供参考。方法收集南京医科大学大数据平台(来自4家医院2016年9月—2022年8月电子病历)中复方氨林巴比妥或洛芬待因缓释片的处方信息,最终获得处方中开具复方氨林巴比妥的患者4261例(病历4552份),处方中开具洛芬待因缓释片的患者3278例(病历3817份)。根据限定日剂量评价用药倾向和用药合理性,使用帕累托分析法评价药品使用合理性。采用Spearman秩相关分析探讨年龄与复方氨林巴比妥单次剂量、实际日剂量的关系。结果处方复方氨林巴比妥注射液的患者男女比例为1.14∶1,诊断主要为呼吸道感染,主要就诊科室为急诊科;处方洛芬待因缓释片的患者男女比例为1.05∶1,主要就诊科室为疼痛科。复方氨林巴比妥2019年用药频度(DDDs)最高,洛芬待因缓释片2020年DDDs最高。2019年复方氨林巴比妥的消耗量和实际用药天数最多,同年DDDs也最高,各年药物利用指数(DUI)均<1。Spearman秩相关分析结果显示,年龄与复方氨林巴比妥单次剂量(r_(s)=0.07,P<0.05)和实际日剂量(r_(s)=0.06,P<0.05)均呈弱相关。2020年洛芬待因缓释片的消耗总量和实际用药天数最多,同年DDDs最多,各年DUI均<1。处方开具复方氨林巴比妥、洛芬待因缓释片的患者中开药次数1次为A因素。复方氨林巴比妥开药次数3~7次为C类因素。洛芬待因缓释片开药次数4~11次为C类因素。结论2种药品总体用药情况均符合药品说明书要求,但存在个体用药不合理现象,医疗机构应加强管理,重点关注开药次数较多患者,防止药物过度使用甚至滥用。

米诺环素与复方甘草酸苷治疗进展期白癜风临床疗效观察

目的探讨米诺环素与复方甘草酸苷对进展期白癜风的临床疗效差异。方法收集2019年9月—2021年4月就诊于北京协和医院皮肤科门诊的白癜风患者临床资料,根据治疗方法不同将纳入患者分为米诺环素组和复方甘草酸苷组,比较两组患者在用药第1个月和第2个月时的临床疗效。结果共纳入32例白癜风患者,米诺环素组(n=16)在第1月和第2个月的有效率分别为75.00%和77.78%,而复方甘草酸苷组(n=16)的有效率分别为93.75%和100%;两组患者的临床疗效比较差异无统计学意义(P>0.05),两组药物的不良反应亦无统计学差异(P>0.05)。结论米诺环素与复方甘草酸苷对于控制进展期白癜风的临床疗效与安全性相当。

基于网络药理学和HPLC法建立宠物用复方石淋通片中多指标成分的质量控制方法

建立宠物用复方石淋通片多指标成分含量测定方法。利用网络药理学方法筛选复方石淋通片治疗尿石症、膀胱炎的关键活性成分,结合相关文献及《中国药典》相关要求,确定指标性成分。利用HPLC分析方法,使用CAPCELL PAK C18 MG(S-5)4.6×250 mm色谱柱,柱温30℃,进样量10μL,流速为1.0 mL·min^(-1),检测波长335 nm,以乙腈-0.1%甲酸水为流动相,梯度洗脱,建立指标性成分含量测定的方法。通过网络药理学筛选出槲皮素、咖啡酸、绿原酸等十个关键成分。结合《中国药典》及相关文献选出新绿原酸、绿原酸、隐绿原酸、咖啡酸、夏佛塔苷、异夏佛塔苷六种指标性成分。含量测定方法学结果表明:各成分线性关系良好(r≥0.999);精密度良好,RSD为0.03%~0.21%;重复性良好,RSD为0.70%~2.02%;供试品在24h内稳定性良好,RSD为0.30%~2.02%;平均加样回收率(RSD)在98.31%~104.31%(0.36%~2.28%);三批样品中六种成分的含量分别在0.990~1.434 mg·g^(-1)、1.533~2.083 mg·g^(-1)、1.311~2.023 mg·g^(-1)、0.332~0.353 mg·g^(-1)、1.594~1.768 mg·g^(-1)、0.787~1.057 mg·g^(-1)之间。该含量测定方法有较好的重复性和稳定性,可用于宠物用复方石淋通片的质量分析。

复方甘草酸苷片与火把花根片治疗掌跖脓疱病疗效比较

目的对比复方甘草酸苷片和火把花根片治疗掌跖脓疱病的临床效果。方法纳入我院在2022年1月—2023年2月收治的35例掌跖脓疱病患者,随机分为甘草组(18例)和火把花组(17例)。甘草组选择采用复方甘草酸苷片治疗,火把花组选择火把花根片治疗,每组均治疗2~3个疗程,分析两组患者的临床治疗效果。结果①甘草组与火把花组临床总有效率未显示出统计学差异(P>0.05)。②两组的银屑病皮损面积和严重程度指数(PASI)评分均较治疗前明显改善(均P<0.05),但改善程度在两组间无统计学差异(均P>0.05)。③两组的IL-17A、IL-22和INF-γ水平均较治疗前明显下降(均P<0.05),但下降程度在两组间无统计学差异(均P>0.05)。④在不良反应发生率方面,甘草组与火把花组之间未显示出统计学差异(P>0.05)。结论在复方甘草酸苷片和火把花根片治疗掌跖脓疱病具有较一致的临床疗效,且两种药物具有较高的安全性。

Composition analysis of Compound Shenhua Tablet,a seven-herb Chinese medicine for IgA nephropathy:evaluation of analyte-capacity of the assays

Compound Shenhua Tablet,a medicine comprising seven herbs,is employed in treating IgA nephropathy.This study aimed to meticulously analyze its chemical composition.Based on a list of candidate compounds,identified through extensive literature review pertinent to the tablet’s herbal components,the composition analysis entailed the systematic identification,characterization,and quantification of the constituents.The analyte-capacity of LC/ESI-MS-based and GC/EI-MS-based assays was evaluated.The identified and characterized constituents were quantified to determine their content levels and were ranked based on the constituents’daily doses.A total of 283 constituents,classified into 12 distinct categories,were identified and characterized in the Compound Shenhua Tablet.These constituents exhibited content levels of 1−10982μg·g^(−1),with daily doses of 0.01−395μmol·d^(−1).The predominant constituents,with daily doses of≥10μmol·d^(−1),include nine organic acids(citric acid,quinic acid,chlorogenic acid,cryptochlorogenic acid,gallic acid,neochlorogenic acid,isochlorogenic acid C,isochlorogenic acid B,and linoleic acid),five iridoids(specnuezhenide,nuezhenoside G13,nuezhenidic acid,secoxyloganin,and secologanoside),two monoterpene glycosides(paeoniflorin and albiflorin),a sesquiterpenoid(curzerenone),a triterpenoid(oleanolic acid),and a phenylethanoid(salidroside).Additionally,there were 83,126,and 55 constituents detected in the medicine with daily doses of 1–10,0.1–1,and 0.01–0.1μmol·d^(−1),respectively.The combination of the LC/ESI-MS-based and GC/EI-MS-based assays demonstrated a complementary relationship in their analyte-capacity for detecting the constituents present in the medicine.This comprehensive composition analysis establishes a solid foundation for further pharmacological research on Compound Shenhua Tablet and facilitates the quality evaluation of this complex herbal medicine.

党参及其传统复方防治消化系统疾病机制研究进展

党参及其传统复方温胃舒胶囊、理中丸、固本益肠片、健脾丸等在临床上广泛用于消化系统疾病的防治,然而其物质基础及分子机制等尚未阐释清楚。本文通过检索国内外数据库,概述党参及其复方防治消化系统疾病的现代研究进展,并提出相应对策。党参治疗消化系统疾病的作用机制与抗脂质过氧化、抑制核因子κB(NF-κB)表达、调节炎症因子分泌等有关,可发挥治疗结肠炎的作用。党参复方温胃舒胶囊的作用机制与抑制NF-κB通路、调节胃蛋白酶及肿瘤坏死因子α(TNF-α)水平等有关,主要用于治疗慢性胃炎。理中丸的作用机制与调节血小板活化因子(PAF)、白细胞介素(IL)-6、IL-8水平等有关,进而发挥治疗胃溃疡的作用。固本益肠片主要用于治疗功能性腹泻、抗生素相关性腹泻。理中丸及固本益肠片能提高肠易激综合征的治疗效果,其作用机制与降低生长抑素(SS)及胃动素(MTL)含量等有关。健脾丸的作用机制虽尚不明确,但临床应用显示,其对功能性消化不良疗效显著。结合党参及其复方现有研究中存在的问题,建议深入党参及其复方防治消化系统疾病的物质基础、体内过程及作用机制研究,为其科学、合理、高效应用提供数据基础。

小儿复方鸡内金咀嚼片对幼龄大鼠28 d重复灌胃给药毒性研究

目的为小儿复方鸡内金咀嚼片临床安全用药的剂量设计和临床毒副反应监测提供参考。方法取幼龄SD大鼠120只,随机分为溶剂对照组(A组,羧甲基纤维素钠),小儿复方鸡内金咀嚼片低、中、高剂量组(B1组、B2组、B3组,六神曲鸡内金混合粉以生药计0.375,1.125,3 g/kg,相当于临床拟用剂量的6倍、18倍、48倍),按体质量每100 g灌胃给药1 mL,连续4周,恢复期30 d,给药结束和恢复期结束时剖杀,进行一般生理指标观察、临床病理学检查、组织病理学检查、神经行为测试。结果与A组比较,给药结束时雌鼠B1组的平均红细胞血红蛋白浓度显著降低(P<0.05);雌鼠B2组、B3组的甘油三酯均显著降低(P<0.05),雌鼠B3组的氯离子浓度显著升高(P<0.05),雌鼠B1组的钙离子浓度显著降低(P<0.05),雄鼠B1组的乳酸脱氢酶水平显著升高(P<0.05),雄鼠B3组的总胆固醇显著降低(P<0.05),雄鼠B1组、B3组的钠离子浓度均显著升高(P<0.05),但上述指标改变均无毒理学意义。各组大鼠组织病理学检查均未见与给药相关的蓄积性或延迟性毒性病理改变。结论小儿复方鸡内金咀嚼片未见明显毒性反应剂量为3 g/kg,相当于临床拟用剂量的48倍。

Herb induced liver injury by Xianling Gubao Tablets: A case assessed for causality using updated RUCAM and integrated evidence chain

Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the laboratory.Methods:A patient with herb-induced liver injury(HILI)and a history of taking XLGB Tablets before disease onset was engaged as the study subject,and the case was diagnosed according to the updated Roussel Uclaf Causality Assessment Method(RUCAM)and the integrated evidence chain(iEC)method recommended by the Guidelines for Diagnosis and Treatment of Herb-induced Liver Injury(HILI Guidelines).Results:Clinical history,biochemical indexes and imaging tests were used to exclude the influence of fundamental diseases and confusing liver diseases such as viral,alcoholic and autoimmune liver diseases on the diagnosis.Based on an investigation of the patient’s medication history,she was suspected to have HILI caused by XLGB Tablets,as the patient was only taking an oral preparation of XLGB Tablets,and the influence of other drugs on the diagnosis was excluded.This patient with alanine aminotransferase(ALT)3 upper limit of normal(ULN)and a calculated R of 6 was diagnosed with possible acute drug-induced hepatocellular injury.The relationship was considered“highly probable”(score of 9)using the updated RUCAM of 2016.Moreover,the fingerprint similarity between the preparation taken by the patient and a commercially available preparation was 0.99,suggesting that the patient was consuming XLGB Tablets rather than another drug.LC-MS technology and the Agilent Fake TCM-Drugs database were used to investigate the drug,and no chemical additions were found.Examination of the drug for pesticide residues,heavy metals,aflatoxins and other exogenous substances indicated compliance with the content limits of the Chinese Pharmacopoeia.Conclusion:In summary,the final diagnosis of XLGB-induced liver injury reached the clinical diagnosis of HILI and was acute severe hepatocellular injury type by the updated RUCAM and iEC.Therefore,this study provides scientific evidence regarding the causality evaluation of compound preparations of traditional Chinese medicines-induced liver injury.