Efficacy of ginseng-based Renshenguben oral solution for cancer-related fatigue among patients with advanced-stage hepatocellular carcinoma:A prospective multicenter cohort study

Background:Cancer-related fatigue(CRF)is a common and debilitating symptom experienced by patients with advanced-stage cancer,especially those undergoing antitumor therapy.This study aimed to evaluate the efficacy and safety of Renshenguben(RSGB)oral solution,a ginseng-based traditional Chinese medicine,in alleviating CRF in patients with advanced hepatocellular carcinoma(HCC)receiving antitumor treatment.Methods:In this prospective,open-label,controlled,multicenter study,patients with advanced HCC at BCLC stage C and a brief fatigue inventory(BFI)score of≥4 were enrolled.Participants were assigned to the RSGB group(RSGB,10 mL twice daily)or the control group(with supportive care).Primary and secondary endpoints were the change in multidimensional fatigue inventory(MFI)score,and BFI and functional assessment of cancer therapy-hepatobiliary(FACT-Hep)scores at weeks 4 and 8 after enrollment.Adverse events(AEs)and toxicities were assessed.Results:A total of 409 participants were enrolled,with 206 assigned to the RSGB group.At week 4,there was a trend towards improvement,but the differences were not statistically significant.At week 8,the RSGB group exhibited a significantly lower MFI score(P<0.05)compared to the control group,indicating improved fatigue levels.Additionally,the RSGB group showed significantly greater decrease in BFI and FACT-Hep scores at week 8(P<0.05).Subgroup analyses among patients receiving various antitumor treatments showed similar results.Multivariate linear regression analyses revealed that the RSGB group experienced a significantly substantial decrease in MFI,BFI,and FACT-Hep scores at week 8.No serious drug-related AEs or toxicities were observed.Conclusions:RSGB oral solution effectively reduced CRF in patients with advanced HCC undergoing antitumor therapy over an eight-week period,with no discernible toxicities.These findings support the potential of RSGB oral solution as an adjunctive treatment for managing CRF in this patient population.

Effect of Shuanghuanglian Oral Solution on Liver Function in a Mouse Model of Non-alcoholic Steatohepatitis

[Objectives]To observe the effect of Shuanghuanglian oral solution on liver function in BABL/cJ mice in non-alcoholic steatohepatitis(NASH)model.[Methods]The BABL/cJ mice were randomly divided into three groups:a control group,a model group,and an experimental group.The experimental group was administered with 10%Shuanghuanglian oral solution at a dose of 0.1 mL/(10 g·d),while the control group and experimental group received an equivalent dosage of normal saline.All three groups were treated for a period of 28 d.The liver function of the mice in each group was examined after the treatment.[Results]The body mass,liver index,triacylglycerol(TG),total cholesterol(TC),aspartate aminotransferase(AST),and alanine aminotransferase(ALT)levels were all significantly reduced compared to the model group(P<0.05).[Conclusions]Shuanghuanglian oral solution has a beneficial effect on liver function in BABL/cJ mice.

Effects of Kangfuxin Solution (康复新液) Combined with Low-level Laser on Cytokines and Immune Function in Patients with Radiation-induced Oral Mucositis

Objective:To investigate the effect of Kangfuxin Solution(康复新液)combined with low-level laser therapy(LLLT)on cytokines and immune function in patients with radiation-induced oral mucositis.Methods:There were 84 nasopharyngeal carcinoma patients with oral mucositis after intensity-modulated radiation therapy(IMRT)were randomly divided into the control group(CG)and the observation group(OG),with 42 cases in each group.The CG was given LLLT,and the OG was treated with Kangfuxin Solution in addition to LLLT for 10 consecutive days.The healing time of oral mucosa,mucositis grading,oral pain scores,cytokines(interleukin-6,interleukin-1βand tumor necrosis factor-α)and T lymphocyte subsets were compared between the 2 groups before and after treatment.Results:The healing time of oral mucosa in the OG was(6.8±1.4)d,which was significantly shorter than(8.6±1.9)d in the CG(t=4.943,P<0.01).After treatment,the grading of oral mucositis in the OG was better than that in the CG,with a statistically significant difference(Z=2.942,P<0.05).The oral pain scores of the OG was lower than that in the CG at different time points after treatment,and the difference was statistically significant(t=8.207,11.017,P<0.01).After treatment,the levels of IL-6,IL-1βand TNF-αin peripheral blood of the OG were significantly lower than those in the CG(t=5.217,2.775,4.053,P<0.01).There were statistically significant differences in CD4+,CD8+and CD4+/CD8+between the OG and the CG after treatment(t=5.692,6.093,3.658,P<0.01).Conclusion:Kangfuxin Solution combined with LLLT can significantly shorten the healing time of oral mucosal,reduce the grading of oral mucositis,relieve oral pain,reduce inflammatory response and improve the immune function of patients.

Identification of Qishen Oral Solution with TLC and HPLC

[Objective] This study aimed to establish the standards for quality control of Qishen oral solution. [Method] Astragalus membranaceus, Atractylodes macro- cephala Koidz. and Glycyrrhiza uralensis in the preparation were identified by using thin layer chromatography （TLC）, and Codonopsis pilosula was identified by using high-performance liquid chromatography （HPLC）. [Result] By using the developed TLC system, experimental solution and reference solution showed clear spots, while negative control presented no interference. By using the developed HPLC system, the chromatographic peak of Iobetyolin was detected in experimental solution. [Con- clusion] The developed TLC and HPLC systems presented high specificity and good repeatability for identification of these four components and could be used in the quality control of Qishen oral solution.

Determination of Astragaloside IV in Yupingfeng Oral Solution by HPLC-ELSD Method

[Objective] This study aimed to establish a method for determining the content of Astragaloside IV in Yupingfeng oral solution.[Method] The HPLC-ELSD method was adopted.The chromatographic column was Venusil MP（4.6 mm × 150 mm,5 μm）.The mobile phase was acetonitrile-water（35∶65）.The ELSD evaporator tube temperature was 65 ℃.N2 was used as the carrier gas（pressure,30 psi）.[Result] When the content of Astragaloside IV ranged from 0.5 to 5.0 μg,the Astragaloside IV content showed a good linear relationship with peak area（r=0.999,n=6）.The average recovery was 96.36%,and the RSD was 2.46%.[Conclusion] This method is accurate and reliable,and can be applied in the quality control of Yupingfeng oral solution.

Development of Better-Quality Assay Method for the Citric Acid and Sodium Citrate in Ophthalmic/Oral Solutions and Their Application to Deformulation Studies

There were several techniques determined for the analysis of citrate and citric acid mixtures in the pharmaceutical dosage forms. Titration methods, photometric and ion chromatographic methods were used for their determination. These methods will restrict too many factors where the accurate quantification of citrate and citric acid is extremely challenging. Citric acid is the natural flavor used as a preservative for many pharmaceutical applications. Deformulation techniques used for the manufacturing of generic drugs require authentic data for their regulatory submissions. Simple accurate and reproducible validated method developed for the determination of citric acid and sodium citrate by titration followed by HPLC analysis. Free citric acid was determined by the titration method and total citric acid was determined by HPLC analysis. After subtracting the free citric acid from total citric acid content, citric acid present in the sodium citrate content was determined. Sodium citrate content was determined by applying sodium correction factor to the subtracted value of the citric acid. The results met all the validation parameters and the method was successfully measured the amount of citric acid and sodium citrate in the marketed ophthalmic/oral solutions.

Near-Infrared Spectroscopy Combined with Absorbance Upper Optimization Partial Least Squares Applied to Rapid Analysis of Polysaccharide for Proprietary Chinese Medicine Oral Solution

Near-infrared (NIR) spectroscopy was applied to reagent-free quantitative analysis of polysaccharide of a brand product of proprietary Chinese medicine (PCM) oral solution samples. A novel method, called absorbance upper optimization partial least squares (AUO-PLS), was proposed and successfully applied to the wavelength selection. Based on varied partitioning of the calibration and prediction sample sets, the parameter optimization was performed to achieve stability. On the basis of the AUO-PLS method, the selected upper bound of appropriate absorbance was 1.53 and the corresponding wavebands combination was 400 - 1880 & 2088 - 2346 nm. With the use of random validation samples excluded from the modeling process, the root-mean-square error and correlation coefficient of prediction for polysaccharide were 27.09 mg·L-1 and 0.888, respectively. The results indicate that the NIR prediction values are close to those of the measured values. NIR spectroscopy combined with AUO-PLS method provided a promising tool for quantification of the polysaccharide for PCM oral solution and this technique is rapid and simple when compared with conventional methods.

Drug-Excipient Interaction of Methylphenidate with Glycerin in Methylphenidate Oral Solution and Identification of its Transesterification Products by UPLC-MS/MS

Reactions between active drug substances and excipients are of interest in the drug formulation process should be checked for the interactions during the storage conditions. Some excipients react with certain chemical groups in drug substances which will form new impurities in the finished product formulations. In the present paper transesterification reaction of methylphenidate with glycerin to form different structural isomeric products was described. These impurities identified in forced degradation studies, excipient compatibility studies and stability analysis of the finished product. Stability samples were analyzed and observed that about ~0.6% of the Methylphenidate content was transformed into methylphenidate-glycerin isomers within 3 Months at 40&deg;C/75% RH and 18 Months at 25&deg;C/60% RH conditions. Analysis of two lots of marketed preparations having expiry dates in 2012 and 2013 showed content of the Methylphenidate esters corresponding to ~0.6% of the declared Methylphenidate content. The samples of this impurity were investigated by HPLC, UPLC-MS/MS to generate the mechanism of the impurity formation.

Correspondence: Newer oral rehydration solution OS-1 for emesis gravidarum

Though nausea and vomiting are quite common in pregnancy, hyperemesis is found in only 1 - 2 patients per 100. Appropriate oral fluid and electrolyte replacement is the initial treatment regimen for patients with mild to moderate emesis to avoid hyperemesis gravidarum defined as dehydration, electrolyte unbalance and ketosis. A newer oral rehydration solution OS-1 therapy may be safe and feasible in the mild to moderate emesis gravidarum population. Physicians are encouraged to use this practice to maintain the amount of water in the body and electrolytes and to improve the patient’s comfort.

Safety and Feasibility of Oral Rehydration Solution Prior to Endoscopic Retrograde Cholangiopancreatography

Purpose: The safety of oral rehydration therapy before endoscopic screening with respect to vital signs and complications after the screening procedure was assessed in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Methods: A total of 107 patients scheduled for ERCP were assigned to either the intravenous drip injection (DIV) group during fasting (56 patients) or ORS group given oral rehydration solution (51 patients) prior to endoscopy. Vital signs after ERCP, including blood pressure and temperature, blood biochemical data and the incidence of post-ERCP complications were compared between the groups. Results: No cases of aspiration pneumonia were detected in either groups. Moreover, there were no statistically significant differences between the DIV group and ORS group in terms of the biochemical data and vital signs after ERCP. The intergroup difference in the development of pancreatitis after ERCP was 2.3% [95% CI: ?5.7, 10.3], which was not statistically significant. Conclusions: The safety of oral rehydration therapy was found to be equivalent to that of the customary practice of infusion as a method for managing hydration and replenishing electrolytes in patients receiving ERCP. Oral rehydration therapy may be easily utilized as rehydration therapy prior to endoscopic screening for ERCP and other procedures.

Randomized Study Comparing Pre-Operative Glycemic Profile in Pediatric Cardiac Surgical Patients Administered Oral Carbohydrate Solution Preoperatively versus Those Kept Fasting

Objectives: Hypoglycemia is a recognized danger in pediatric patients. Extended period of preoperative fasting in this subset of patients is not well tolerated with metabolic derangements. The oral carbohydrate loading preoperatively can ameliorate many adverse effects. The aim of this study was to compare the glycemic profile in pediatric cardiac surgical patients kept fasting preoperatively with those fed oral clear solutions of carbohydrate half hour prior to induction of anaesthesia. Also we tried to establish a correlation with other factors contributing to preoperative hypoglycemia. Methodology: We planned a randomized controlled study. Group A included patients who were kept fasting according to the ASA guidelines preoperatively and Group B included patients who received 2 ml per kg of body weight of 10% Dextrose water as oral feeds half hour before the expected time of start of anaesthesia. Results: The mean (SD) preoperative BG concentrations were higher in group B (102.5 ±16.97) as compared to group A (64.08 ± 25.37) (p value -0.86 and -0.67) (pvalue Conclusion: Preoperative oral carbohydrate preloading can develop as the easiest and cheapest path to better perioperative blood glucose concentration management in congenital cardiac disease children.

On the disadvantageous factors in foreign oral language teaching and its solution

Oral language teaching plays a more and more important role in foreign language teaching. This paper focuses on the disadvantageous factors in oral language teaching and tries to find out some solutions for those problems.

Effect of adjuvant therapy of transfer factor oral solution on the infection process of children with Mycoplasma pneumonia

Objective:To explore the effect of adjuvant transfer factor oral solution therapy on the infection process of children with mycoplasma pneumonia.Methods:A total of 164 children with mycoplasma pneumonia who were treated in our hospital between January 2017 and January 2018 were selected as the research subjects and divided into control group (n=82) and transfer factor oral solution group (n=82) by random number table method. Control group received clinical routine therapy for children with mycoplasma pneumonia, transfer factor oral solution group received both routine therapy and transfer factor oral solution therapy, and both groups were treated for consecutive 1 week. The differences in infection-related index levels were compared between the two groups before and after treatment.Results:Before treatment, the differences in serum levels of inflammatory factors, coagulation indexes and immunoglobulins were not statistically significant between the two groups. After 1 week of treatment, serum inflammatory factors IL-2, IL-13 and IL-18 contents of transfer factor oral solution group were lower than those of control group;serum coagulation index FIB level was lower than that of control group whereas PT and APTT levels were higher than those of control group;serum immunoglobulins IgG, IgA and IgM contents were lower than those of control group.Conclusion: Adjuvant transfer factor oral solution therapy can effectively relieve the systemic inflammatory response and reduce the coagulation system and humoral immune system function damage in children with mycoplasma pneumonia.

Comparative efficacy of oral glucose solution versus non-nutritive sucking for pain relief in neonates during nociceptive procedures： a systematic review

Background and aims： The comparative efficacy of glucose solution （GS） versus non-nutritive sucking （NNS） for pain re- lief in neonate remains controversial. This systematic review was consequently performed to objectively investigate the analgesic effect of Oral GS related to NNS in newborns during nociceptive procedures. Methods： All potential records were searched in PubMed, Web of Science, EMBASE, and the Cochrane Library to capture the randomized controlled trials comparing GS with NNS in terms of pain scores in neonates through January 2017. Two independent investigators screened the identified articles, extracted the data, and assessed the methodological quality of the included studies. All statistical analyses were completed by using Review Manager （RevMan） version 5.3.0. Results： Four studies, involving 248 neonates, were incorporated into these statistical analyses. For reducing pain scores, no statistical difference was detected when GS compared to NNS （4 trials; mean difference [MD], 0.75; 95% confidence interval [CI], -0.77 to 2.27; P = 0.33）. Conclusion： Both the GS and NNS reduced the pain scores in neonates who undergoing Hepatitis B vaccination and venipuncture, but the NNS is more convenience than GS to some extent. Considered the limited evidences, more randomized controlled trials with high-quality, large-scale and appropriate measures time are warranted to further establish the comparative efficacy of these two options.

Effect of xiaoer feire kechuan oral solution on extrapulmonary injury induced by mycoplasma pneumoniae in infant wistar rats

Objective To observe the effect of Xiaoer Feire Kechuan oral solution on the extrapulmonary injury induced by Mycoplasma pneumoniae in infant Wistar rats. Methods Infant Wistar rats were infected intranasally with M. pneumoniae once a day for four days. In the treatment groups, Xiaoer Feire Kechuan oral solution was administered daily for four days beginning from the day of infection. On day 5, blood of the rats was collected, and blood routine and biochemistry indexes were measured. All rats were sacrificed, and the weight of brain, heart, liver, and kidney was measured to calculate the organ indexes. The GM1 and GALC-Ab content in brain tissue was determined by ELISA. Pathological changes in the brain, heart, liver, kidney, and cerebellum were observed by HE staining. Results Blood routine indexes fluctuated within the normal range in the infection control group and in three of the Xiaoer Feire Kechuan oral solution groups. The serum LDH, CK, and CRE in all three Xiaoer Feire Kechuan oral solution groups were distinctly lower than those in the infection control group (P < 0.01, P < 0.05). Rat brain index and GALC-Ab content in the brain tissue showed an increase in infection control group. In the Xiaoer Feire Kechuan oral solution groups, the GALC-Ab content in brain tissue was decreased significantly. The heart, liver, and kidney tissues showed mild pathological changes in the infection group, which were reversed by Xiaoer Feire Kechuan oral solution treatment. Conclusions The extrapulmonary injury induced by M. pneumoniae in infant Wistar rats was significantly inhibited by Xiaoer Feire Kechuan oral solution.

基于滋水涵木法联合导入不同浓度的氨甲环酸溶液治疗女性黄褐斑疗效评价

目的观察基于“滋水涵木法”指导下的杞黄口服液联合导入不同浓度的氨甲环酸溶液治疗黄褐斑的有效性和安全性。方法选取河南科技大学第二附属医院皮肤科门诊2021年1月至2022年12月就诊的120例黄褐斑志愿者,随机分为3组,每组40例。C组口服维生素C片、维生素E软胶囊、杞黄口服液;B组在C组基础上同时用滚针导入5%氨甲环酸溶液,2次/月;A组在C组基础上同时导入10%氨甲环酸溶液,2次/月;3组疗程均为3个月。治疗前后进行黄褐斑面积及严重程度评分(melasma area severity index,MASI)、皮肤图像检测评分、氧化应激指标[血清丙二醛(Maleic dialdehyde,MDA)、谷胱甘肽过氧化物酶(glutathione peroxidase,GSH-Px)、超氧化物歧化酶(superoxide dismutase,SOD)]水平。结果A组有效率为87.5%,B组有效率为67.5%,C组有效率为52.5%,3组比较差异有统计学意义(P<0.05);3组治疗后,MASI评分、皮肤图像检测评分、MDA水平均下降,GSH-Px、SOD水平升高(P<0.05),组间比较,A组优于B组,B组优于C组(P<0.05)。结论导入高、低浓度氨甲环酸溶液组、杞黄口服液组均可治疗黄褐斑,但导入10%氨甲环酸溶液组能更有效地治疗黄褐斑,提高GSH-Px、SOD,降低MDA,改善MASI,在皮肤图像检测中,肉眼可见斑点、紫外线斑、红区均能改善,安全性较高。

化瘀清热汤联合西帕依固龈液对口腔扁平苔藓患者复发情况的影响

目的探究化瘀清热汤联合西帕依固龈液对口腔扁平苔藓患者复发情况的影响。方法选取2021年7月~2023年8月收治的口腔扁平苔藓患者100例,按照随机数字法分为对照组(n=50)和观察组(n=50),其中对照组采用西帕依固龈液治疗,观察组采用化瘀清热汤联合西帕依固龈液治疗。比较两组口腔黏膜症状面积、炎症因子水平、血液流变学指标、疼痛程度及复发率,评估两组患者的临床疗效。结果观察组的总有效率高于对照组(P<0.05);治疗后观察组的口腔黏膜症状面积均小于对照组(P<0.05);治疗后观察组的炎症因子水平及血液流变学指标低于对照组(P<0.05);治疗后观察组的疼痛程度评分为(0.65±0.13)分,明显低于对照组的(0.97±0.24)分,差异有统计学意义(P<0.001);随访1年后,观察组的复发率为6.00%,明显低于对照组的22.00%,差异有统计学意义(P=0.021)。结论口腔扁平苔藓患者采用化瘀清热汤联合西帕依固龈液治疗具有相对较佳的效果,可改善患者的血液流变学和炎症反应,降低患者的复发率和疼痛程度。

甘草泻心口腔护理液改善脑卒中患者口腔状态的临床研究

目的探讨甘草泻心口腔护理液(甘草泻心口护液)改善脑卒中患者口腔状态的效果。方法采用随机对照试验,选取2021年12月至2023年10月在河南中医药大学第一附属医院神经外科治疗的80例脑卒中患者作为研究对象,以随机数表法分为对照组和观察组,各40例。对照组男25例、女15例,年龄(52.20±4.95)岁,病程(1.84±0.53)个月,予以生理盐水进行口腔护理,2次/d,20 ml/次,治疗10 d;观察组男26例、女14例,年龄(52.20±6.37)岁,病程(1.84±0.53)个月,采用甘草泻心口护液进行口腔护理,2次/d,50 ml/次,治疗10 d。对比两组患者治疗前后牙龈指数、菌斑指数、口腔pH值、口唇湿润度、口腔异味、口腔黏膜炎及不良反应发生情况。统计学方法采用t检验、χ^(2)检验。结果治疗前,两组患者牙龈指数、菌斑指数、口腔pH值、口唇湿润度、口腔异味发生情况比较,差异均无统计学意义(均P>0.05)。治疗5 d、10 d,观察组牙龈指数、菌斑指数、口唇湿润度及口腔异味情况均低于对照组[(1.23±0.42)分比(1.98±0.16)分、(0.65±0.48)分比(1.10±0.30)分、(1.44±0.50)分比(1.93±0.27)分、(0.78±0.48)分比(1.20±0.52)分、(0.65±0.53)分比(0.98±0.42)分、(0.15±0.36)分比(0.65±0.53)分、(2.28±0.45)分比(2.50±0.51)分、(1.45±0.60)分比(1.90±0.38)分],口腔pH值均高于对照组[(6.53±0.08)比(6.42±0.11)、(6.98±0.10)比(6.62±0.14)],差异均有统计学意义(t=10.506、4.987、5.416、3.814、3.086、4.936、2.096、4.007、5.115、13.234,均P<0.05)。治疗后,观察组口腔黏膜炎发生率为5.0%(2/40),低于对照组的15.0%(6/40),差异有统计学意义(χ^(2)=6.486,P<0.05)。两组患者治疗期间均无不良反应情况发生。结论甘草泻心口护液能有效改善脑卒中患者口腔状态,操作简便安全,患者依从性高,值得临床进一步推广应用。

通天口服液治疗脑梗死有效性及安全性的meta分析

目的系统评价通天口服液治疗脑梗死的有效性和安全性。方法全面检索中国知网、万方、维普等数据库,搜索通天口服液治疗脑梗死的临床研究,只纳入随机对照试验(RCT)。检索时间从建库至2023年4月。由2名研究者独立完成筛选文献、数据提取及偏倚风险评估。meta分析使用RevMan 5.3软件完成。结果共纳入9个RCT,共计1148例患者。meta分析结果显示,通天口服液治疗脑梗死的总有效率高于对照组,差异有统计学意义(OR=2.18,95%CI:1.53~3.12,P<0.0001);通天口服液治疗急性脑梗死的美国国立卫生研究院卒中量表(NIHSS)评分低于对照组,差异有统计学意义(MD=-1.63,95%CI:-2.20~-1.07,P<0.00001);两组不良事件发生率比较,差异无统计学意义(P>0.05)。结论循证医学分析表明通天口服液治疗脑梗死有效性和安全性较好。

反相高效液相色谱测定氨溴特罗口服溶液中盐酸克仑特罗的研究

建立氨溴特罗口服溶液中盐酸克仑特罗成分含量测定的方法并开展方法学验证。采用ZORBAX SB-C18色谱柱,流动相为磷酸二氢钾溶液-甲醇,检测波长244 nm,柱温40℃,流速1.0 mL·min^(-1),进样量10μL。结果显示,盐酸克仑特罗在0.0511~0.4099μg·mL^(-1)范围内线性关系良好;平均回收率(n=9)为100.0079%,RSD为1.57%。测得盐酸克仑特罗含量为标示量的98.96%,符合药典标准。