1.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
2.Clinical trial of omeprazole enteric-coated capsules in the treatment of children with chronic gastritis and peptic ulcer
San-Li FAN ; Hai-Yan HU ; Cui JIN ; Jing-Jie BAI ; Fang DONG ; Jin-Fang SUN ; Yan QIN ; Xiao-Ling MENG ; Hui-Qin XUE
The Chinese Journal of Clinical Pharmacology 2024;40(7):973-976
Objective To observe the effect of omeprazole enteric-coated capsules on clinical symptoms and serum inflammatory factor levels in children with chronic gastritis and peptic ulcer.Methods Children with chronic gastritis and peptic ulcer were divided into treatment group and control group by random number table method.The control group was given triple therapy of ranitidine hydrochloride tablets,amoxicillin and clarithromycin,while the treatment group was treated with omeprazole enteric-coated capsules combined with amoxicillin and clarithromycin.Clinical efficacy,symptom relief time,and changes in serum motilin(MOT),gastrin(GAS)and inflammatory factors[interlrukin-6(IL-6)and interlrukin-8(IL-8)]were compared between the two groups.Results There were 48 cases in treatment group and 48 cases in control group.After treatment,the total effective rates in treatment group and control group were 93.74%(45 cases/48 cases)and 85.42%(41 cases/48 cases),with significant difference(P<0.05).After treatment,the disappearance time of ulcer induced pain in treatment group and control group were(1.51±0.26)and(2.08±0.42)d;the disappearance time of acid regurgitation were(2.29±0.40)and(2.93±0.33)d;the disappearance time of burning sensation were(2.37±0.21)and(2.85±0.54)d;the length of hospital stay were(6.21±1.07)and(6.94±1.25)d;serum MOT levels were(298.48±35.15)and(273.58±31.25)pg·mL-1;serum GAS levels were(167.28±19.46)and(128.32±18.61)ng·L-1;IL-6 levels were(58.67±5.39)and(76.14±6.63)mg·mL-1;IL-8 levels were(50.08±5.16)and(58.68±5.49)mg·mL-1.The above indexes were significantly different between control group and treatment group(all P<0.05).The total incidence of adverse drug reactions in treatment group and control group were 8.33%and 12.50%,with no statistical significance(P>0.05).Conclusion Omeprazole enteric-coated capsules in the treatment of children with chronic gastritis and peptic ulcer can effectively alleviate various clinical symptoms and improve clinical efficacy.At the same time,it can lower serum levels of inflammatory factors and improve inflammation,with good effect.
3.Effects of radiation on pharmacokinetics
Jie ZONG ; Hai-Hui ZHANG ; Gui-Fang DOU ; Zhi-Yun MENG ; Ruo-Lan GU ; Zhuo-Na WU ; Xiao-Xia ZHU ; Xuan HU ; Hui GAN
The Chinese Journal of Clinical Pharmacology 2024;40(13):1996-2000
Radiation mainly comes from medical radiation,industrial radiation,nuclear waste and atmospheric ultraviolet radiation,etc.,radiation is divided into ionizing radiation and non-ionizing radiation.Studying the effects of ionizing and non-ionizing radiation on drug metabolism,understanding the absorption and distribution of drugs in the body after radiation and the speed of elimination under radiation conditions can provide reasonable guidance for clinical medication.This article reviews the effects of radiation on the pharmacokinetics of different drugs,elaborates the changes of different pharmacokinetics under radiation state,and discusses the reasons for the changes.
4.Stability study of umbilical cord mesenchymal stem cells formulation in large-scale production
Wang-long CHU ; Tong-jing LI ; Yan SHANGGUAN ; Fang-tao HE ; Jian-fu WU ; Xiu-ping ZENG ; Tao GUO ; Qing-fang WANG ; Fen ZHANG ; Zhen-zhong ZHONG ; Xiao LIANG ; Jun-yuan HU ; Mu-yun LIU
Acta Pharmaceutica Sinica 2024;59(3):743-750
Umbilical cord mesenchymal stem cells (UC-MSCs) have been widely used in regenerative medicine, but there is limited research on the stability of UC-MSCs formulation during production. This study aims to assess the stability of the cell stock solution and intermediate product throughout the production process, as well as the final product following reconstitution, in order to offer guidance for the manufacturing process and serve as a reference for formulation reconstitution methods. Three batches of cell formulation were produced and stored under low temperature (2-8 ℃) and room temperature (20-26 ℃) during cell stock solution and intermediate product stages. The storage time intervals for cell stock solution were 0, 2, 4, and 6 h, while for intermediate products, the intervals were 0, 1, 2, and 3 h. The evaluation items included visual inspection, viable cell concentration, cell viability, cell surface markers, lymphocyte proliferation inhibition rate, and sterility. Additionally, dilution and culture stability studies were performed after reconstitution of the cell product. The reconstitution diluents included 0.9% sodium chloride injection, 0.9% sodium chloride injection + 1% human serum albumin, and 0.9% sodium chloride injection + 2% human serum albumin, with dilution ratios of 10-fold and 40-fold. The storage time intervals after dilution were 0, 1, 2, 3, and 4 h. The reconstitution culture media included DMEM medium, DMEM + 2% platelet lysate, 0.9% sodium chloride injection, and 0.9% sodium chloride injection + 1% human serum albumin, and the culture duration was 24 h. The evaluation items were viable cell concentration and cell viability. The results showed that the cell stock solution remained stable for up to 6 h under both low temperature (2-8 ℃) and room temperature (20-26 ℃) conditions, while the intermediate product remained stable for up to 3 h under the same conditions. After formulation reconstitution, using sodium chloride injection diluted with 1% or 2% human serum albumin maintained a viability of over 80% within 4 h. It was observed that different dilution factors had an impact on cell viability. After formulation reconstitution, cultivation in medium with 2% platelet lysate resulted in a cell viability of over 80% after 24 h. In conclusion, the stability of cell stock solution within 6 h and intermediate product within 3 h meets the requirements. The addition of 1% or 2% human serum albumin in the reconstitution diluent can better protect the post-reconstitution cell viability.
5.Study on the Effect of Intestinal Flora on Intestinal Motility in Rats with Slow Transit Constipation of Qi Stagnation Pattern Based on Pseudo-Sterile Experiment and Fecal Microbiota Transplantation
Qihong LIU ; Xiao KE ; Yunfeng LUO ; Lunan HU ; Yan REN ; Wenyi FANG ; Peilin ZHAO ; Jinxian YAN
Journal of Traditional Chinese Medicine 2024;65(9):943-948
ObjectiveTo clarify the relationship between intestinal flora and intestinal motility in rats with slow transit constipation (STC) and qi stagnation syndrome by conducting a pseudo-sterile experiment and fecal microbiota transplantation (FMT) technology. MethodsTwenty-four Wistar rats were randomly divided into normal group (n=6), STC with qi stagnation pattern group (n=6) and pseudo-sterile group (n=12). In the STC group with qi stagnation pattern, 3 mg/kg of loperamide suspension by intragastric administration combined with tail clamping stimulation were performed to establish the rat model of STC with qi stagnation pattern. After successful modeling, fresh feces from the rats in the STC with qi stagnation pattern group and the normal group were collected to prepare 100 mg/ml of fecal bacterial suspension. In the pseudo-sterile group, the antibiotic cocktail method was used (a mixed antibiotic suspension containing bacitracin, streptomycin sulfate, and neomycin sulfate at 20 mg/ml each was administered intragastrically) to establish pseudo-sterile rats model. After successful modeling, the rats were randomly divided into normal fecal bacterial liquid group and STC with qi stagnation pattern fecal bacterial liquid group, with six rats in each group, and then were given 10 ml/kg of the prepared corresponding rat fecal bacterial suspension by gavage. Rats in STC with qi stagnation pattern group were given an equal volume of sterile water by gavage. All groups were administered once a day for 7 consecutive days. The small intestinal propulsion rate of the STC with qi stagnation pattern group, the normal fecal bacterial liquid group, and STC with qi stagnation pattern fecal bacterial liquid group were compared. ELISA method was used to detect serum 5-hydroxytryptamine (5-HT) levels. Immunohistochemistry was used to detect the positive expression levels of 5-hydroxytryptamine 3 receptor (5-HT3R) and 5-hydroxytryptamine 4 receptor (5-HT4R) in colon tissue. Western blot method was used to detect the protein expression levels of tryptophan hydroxylase 1 (TPH1), tryptophan hydroxylase 2 (TPH2), serotonin transporter (SERT), and monoamine oxidase A (MAO-A) in colon tissue. ResultsCompared to those in the normal fecal bacterial liquid group, the small intestinal propulsion rate, serum 5-HT level, positive expression of 5-HT3R and 5-HT4R in colon tissue, and protein expression of TPH1, TPH2, SERT and MAO-A significantly decreased in the STC with qi stagnation pattern group and STC with qi stagnation pattern fecal bacterial liquid group (P<0.05). There was no statistically significant difference in the indicators between the STC with qi stagnation pattern group and STC with qi stagnation pattern fecal bacterial liquid group (P>0.05). ConclusionThe intestinal flora in STC rats with qi stagnation pattern can lead to a slowdown in intestinal transmission function, whose mechanism may be related to intestinal motility disorders affected by the synthesis, transport, metabolism and other pathways of 5-HT.
6.Effect and mechanism of pachymic acid on renal function and fibrosis in rats with chronic renal failure
Bin PENG ; Xue FENG ; Li FENG ; Wei XIONG ; Xi HU ; Shuangyi ZHU ; Yang XIAO ; Fang CHEN ; Zhi GAO
China Pharmacy 2024;35(12):1489-1494
OBJECTIVE To investigate the effect of pachymic acid (PA) on renal function and fibrosis in chronic renal failure (CRF) rats and its potential mechanism based on the Ras homolog gene family member A (RhoA)/Rho-associated coiled-coil forming protein kinase (ROCK) signaling pathway. METHODS Using male SD rats as subjects, the CRF model was established by 5/6 nephrectomy; the successfully modeled rats were divided into model group, PA low-dose, medium-dose and high-dose groups (5, 10, 20 mg/kg PA), high-dose PA+ROCK pathway activator lysophosphatidic acid (LPA) group (20 mg/kg PA+1 mg/kg LPA), with 15 rats in each group. Another 15 rats were selected as the sham operation group with only the kidney exposed but not excised. The rats in each drug group were gavaged and/or injected with the corresponding liquid via the caudal vein, once a day, for 12 consecutive weeks. During the experiment, the general condition of rats was observed in each group. After the last administration, the serum renal function indexes (blood urea nitrogen, serum creatinine, uric acid) of rats in each group were detected, the renal histopathological changes were observed; the renal tubule injury score and the area of renal fibrosis were quantified. The levels of oxidative stress indexes [malondialdehyde (MDA), superoxide dismutase (SOD)] and inflammatory factors (tumor necrosis factor-α, interleukin-1β, interleukin-6), the positive expression rates of connective tissue growth factor (CTGF) and collagen Ⅰ were detected as well as the expression levels of pathway-related proteins (RhoA, ROCK1) and fibrosis- related proteins (transforming growth factor-β1, bare corneum homologs 2, α-smooth muscle actin) were determined. RESULTS Compared with the sham operation group, the rats in model group had reduced diet, smaller body size, listless spirit and sluggish response, reduced and atrophied glomeruli, dilated renal tubules with chaotic structure, and a large number of inflammatory cells infiltrated interstitium; the serum levels of renal function indexes, renal tubule injury score, renal fibrosis area proportion, the levels of MDA and inflammatory factors, the positive expression rates of CTGF and collagen Ⅰ, and the expression levels of pathway-related proteins and fibrosis-related proteins in renal tissues were significantly increased, while SOD level was significantly decreased (P<0.05). Compared with the model group, the general condition and pathological injuries of kidney tissue of rats in PA groups were improved to varying degrees,and the above quantitative indexes were significantly improved in a dose-dependent manner (P<0.05). LPA could significantly reverse the improvement effect of PA on the above indicators (P<0.05). CONCLUSIONS PA can improve renal function and alleviate renal fibrosis in CRF rats, which may be related to inhibiting the activation of RhoA/ROCK signaling pathway.
7.Best evidence of perioperative exercise interventions in patients with liver cancer
Hongyan YAN ; Lin XIAO ; Dou HU ; Mingxue YANG ; Fang LI ; Xiaoli TANG
Modern Clinical Nursing 2024;23(2):11-17
Objective To acquire,evaluate and integrate the best evidence of perioperative exercise interventions in patients with liver cancer and provide evidence-based references for clinical medical staff.Methods Following the"6S"Evidence Resource Pyramid model,literatures in perioperative exercise interventions published between January 2010 and June 2022 were retrieved from various databases,including BMJ Best Practice,UpToDate,Guidelines International Network,National Guideline Clearinghouse,National Institute for Health and Clinical Excellence,Scottish Intercollegiate Guidelines Network,Medlive,Cochrane Library,JBI,Web of Science,PubMed,Embase,CINAHL,CNKI,SinoMed,Wanfang Data,American Cancer Society,American College of Sports Medicine and International Liver Cancer Association from January 2010 to June 2022.Two researchers evaluated the quality of the retrieved literatures and extracted evidences that met the inclusion criteria.Results A total of 22 articles were included,yielding 26 pieces of evidence across seven themes:the necessity of exercise,evaluation before exercise,preoperative exercise program,postoperative exercise program,exercise monitoring,health education and effect evaluation.Conclusions This study provides a summary of the best evidence regarding perioperative exercise interventions in the patients with liver cancer.The findings offer valuable references for clinical healthcare providers to deliver evidence-based care for the patients with liver cancer.
8.Efficiency and safety of belimumab in the treatment of lupus nephritis in Chinese adults:a meta-analysis
Bojiang LI ; Hongxia PAN ; Yixing FU ; Meirong FANG ; Xiang HU ; Jianhua DONG ; Youwen XIAO
China Pharmacy 2024;35(7):853-859
OBJECTIVE To systematically evaluate the real-world effectiveness and safety of belimumab in the treatment of lupus nephritis (LN) in Chinese adult patients. METHODS Retrieved from PubMed, Embase, Web of Science, Cochrane Library, Wanfang data, CNKI, VIP and CBM, real-world studies on belimumab in the treatment of LN in Chinese adult patients were collected from the inception to July 7th, 2023. Two reviewers independently screened the literature, extracted data, and assessed the quality of the included studies. Meta-analysis was then performed using RevMan 5.3 software. RESULTS A total of 10 real- world studies were included, involving 253 Chinese adult patients with LN. The results of the meta-analysis demonstrated that the complete renal response rate, partial renal response rate, and the incidence of adverse reaction rate in Chinese adult patients with LN treated with belimumab were 61% (95%CI was 46%-76%, P<0.000 01), 23%(95%CI was 2%-44%, P=0.03), and 30% (95%CI was 16%-43%, P<0.000 01), respectively. Belimumab could reduce the 24-hour urinary protein (MD=-1.71, 95%CI was -3.02--0.40, P=0.01), urine protein-creatinine ratio (MD=-1.76,95%CI was -2.06--1.46,P<0.000 01), the systemic lupus erythematosus disease activity index (MD=-8.63, 95%CI was -12.12--5.13, P<0.000 01), and glucocorticoids dosage (MD=-18.65, 95%CI was -31.82--5.48, P=0.006). In addition, it could elevate the levels of complement C3 (MD=0.19, 95%CI was 0.08-0.30, P=0.000 6) and complement C4 (MD=0.06, 95%CI was 0.02-0.09, P=0.001). However, belimumab could not improve the levels of serum creatinine and estimated glomerular filtration rate (P>0.05). CONCLUSIONS Belimumab has good efficacy and safety in Chinese adult patients with LN.
9.Electrochemical Sensor for Sensitive Detection of Cadmium(Ⅱ)and Lead(Ⅱ)Based on Zeolitic Imidazolate Framework-8/Multi-Walled Carbon Nanotubes
Xiao-Geng FENG ; Di SUN ; Jing-Yi SUN ; Ying HU ; Wen-Qian FANG ; Ying XIONG
Chinese Journal of Analytical Chemistry 2024;52(4):541-549
A a novel composite ZIF-8/MWCNT was synthesized by combining zeolitic imidazolate framework-8(ZIF-8)with multi-walled carbon nanotubes(MWCNT).The composite was modified on glassy carbon electrode(GCE)to obtain ZIF-8/MWCNT/GCE,which was served as an effective electrochemical sensor for detection of Pb2+ and Cd2+.Benefiting from the high electrical conductivity of MWCNT and the synergistic effect between ZIF-8 and MWCNT,ZIF-8/MWCNT showed excellent electrocatalytic activity in individual and simultaneous detection of Cd2+ and Pb2+.Under the optimized conditions,the linear ranges were 0.03?8.00 μmol/L and 0.03?6.00 μmol/L with corresponding limits of detection(S/N=3)of 0.019 and 0.035 μmol/L for individual detection of Cd2+and Pb2+,respectively.Whereas for simultaneous detection of Cd2+and Pb2+in their mixture solutions,the linear ranges were 0.03?5.00 μmol/L and 0.03?5.00 μmol/L with corresponding limits of detection(S/N=3)of 0.022 and 0.048 μmol/L,respectively.In addition,the sensor exhibited good stability,reproducibility and anti-interference ability.Moreover,the sensor showed good feasibility and accuracy for determination of Cd2+ and Pb2+ in actual river water samples with spiking recoveries of 98.1%?104.0%and 98.3%?102.2%,respectively.
10.Expert consensus on pediatric orthodontic therapies of malocclusions in children
Zhou CHENCHEN ; Duan PEIPEI ; He HONG ; Song JINLIN ; Hu MIN ; Liu YUEHUA ; Liu YAN ; Guo JIE ; Jin FANG ; Cao YANG ; Jiang LINGYONG ; Ye QINGSONG ; Zhu MIN ; Jiang BEIZHAN ; Ruan WENHUA ; Yuan XIAO ; Li HUANG ; Zou RUI ; Tian YULOU ; Gao LI ; Shu RUI ; Chen JIANWEI ; Liu RENKAI ; Zou SHUJUAN ; Li XIAOBING
International Journal of Oral Science 2024;16(2):186-196
Malocclusion,identified by the World Health Organization(WHO)as one of three major oral diseases,profoundly impacts the dental-maxillofacial functions,facial esthetics,and long-term development of~260 million children in China.Beyond its physical manifestations,malocclusion also significantly influences the psycho-social well-being of these children.Timely intervention in malocclusion can foster an environment conducive to dental-maxillofacial development and substantially decrease the incidence of malocclusion or reduce the severity and complexity of malocclusion in the permanent dentition,by mitigating the negative impact of abnormal environmental influences on the growth.Early orthodontic treatment encompasses accurate identification and treatment of dental and maxillofacial morphological and functional abnormalities during various stages of dental-maxillofacial development,ranging from fetal stages to the early permanent dentition phase.From an economic and societal standpoint,the urgency for effective early orthodontic treatments for malocclusions in childhood cannot be overstated,underlining its profound practical and social importance.This consensus paper discusses the characteristics and the detrimental effects of malocclusion in children,emphasizing critical need for early treatment.It elaborates on corresponding core principles and fundamental approaches in early orthodontics,proposing comprehensive guidance for preventive and interceptive orthodontic treatment,serving as a reference for clinicians engaged in early orthodontic treatment.

Result Analysis
Print
Save
E-mail