A Clinical Study of Safflower Yellow Injection in Treating Coronary Heart Disease Angina Pectoris with Xin-Blood Stagnation Syndrome

Objective： To evaluate the clinical effect and safety of Safflower Yellow injection （SYI） in treating coronary heart disease angina pectoris （OHD-AP） with Xin-blood stagnation syndrome （XBSS）. Methods： Adopted was the multi-centered, randomized, positive parallel controlled method, 448 patients with CHD-AP-XBSS were enrolled and divided into two groups, 336 in the tested group treated with SYI and 112 in the control group treated with Salvia injection by intravenous dripping once a day for 14 days, so as to observe the conditions of angina, electrocardiogram, and therapeutic effect on traditinal Chinese medicine （TCM） symptoms as well as the safety of the treatment. Results： The significantly effective rate and total effective rate in the tested group were 60.06% （194/323） and 91.02 % （294/323） respectively; those in improvement of TOM symptoms were 40. 18% （129/321） and 75.23% （243/323） respectively, which were better than those in the control group （P〈0.01）. Conclusion： SYI Injection is effective and safe in treating OHD-AP-XBSS.

Biological basis of “depression with liver-qi stagnation and spleen deficiency syndrome”: A digital gene expression profiling study

Objective:To investigate the biological basis of“depression with liver-qi stagnation and spleen deficiency syndrome”.Methods:A digital gene expression profiling method was conducted to explore global changes in the mRNA transcriptome in a rat model of depression with liver-qi stagnation and spleen deficiency syndrome.Real-time quantitative polymerase chain reaction(q-PCR)was performed to verify the five genes most interest based on the Kyoto Encyclopedia of Genes and Genome(KEGG)analysis.Sini San,which disperses stagnated liver qi and strengthens the spleen,was administered to the model rats to observe whether it could reverse these genetic changes in the liver.Results:Forty-six differentially expressed genes were identified.Three of the five genes of most interestdHnf4a,Hnf4g and Cyp1a1dbased on KEGG analysis,were confirmed by realtime q-PCR.Sini San reduced the gene expression changes of Hnf4a,Hnf4g and Cyp1a1 in the rat model.Conclusions:Hnf4a,Hnf4g and Cyp1a1 are involved in“depression with liver-qi stagnation and spleen deficiency syndrome”.These findings indicate that depressed rats with liver-qi stagnation and spleen deficiency syndrome are at risk of liver diseases.Furthermore,our results will inform exploration of the etiology of depression and help in the development of effective therapeutic strategies.

Pharmacological effects of Paeoniflorin and Albiflorin on IL-3, GM-CSF, IL-6 and TNF-α in the rats of syndrome of stagnation of liver qi and blood deficiency

Objective： To observe the effect of paeoniflorin （PF）, albiflorin （AF） on the hemogram, visceral index and hematopoiesis cytokine in the rats of syndrome of stagnation of liver qi and blood deficiency, and to discuss the material base and mechanism of effect of nourishing blood and smoothing the liver of Baishao （Radix Paeoniae Alba）. Methods： Male SD rats were randomly divided into groups according to the sucrose preference test and body weight （n = 12）. Except the normal control, the other groups were treated with the chronic stress stimulation combined with radiation respectively to establish the model of syndrome of stagnation of liver qi and blood deficiency. The body weight, visceral index and the quantity of Leucocyte, Red Blood Cells, Hemoglobin in peripheral hemogram were monitored, then plasma and serum were separated. Radioimmunoassay was used to analyze the levels of Lnterleukin-3, Granulocyte-macrophage Colony-stimulating Factor, Lnterleukin-6 and Tumor Necrosis Factor-α in plasma. Results： Compared with that of model group, 30 mg·kg^-1 PF and 30 mg·kg^-1 AF of the weight, spleen index, quantity of Leucocyte were increased significantly （P 〈 0.05, P 〈 0.01）. The results of Radioimmunoassay showed that the levels of Interleukin-3 increased （P 〈 0.05, P 〈 0.05） and the levels of Tumor Necrosis Factor-α decreased in both 30 mg·kg^-1 PF and 30 mg·kg^-1 AF groups （P 〈 0.05, P 〈 0.05）. Conclusion： The effect of PF and AF on the regulation of bone marrow hematopoietic system and immune system play a role in the blood of rats with syndrome of stagnation of liver qi and blood deficiency, which suggests that both of them are the main active ingredients of nourishing blood and smoothing the liver of Baishao.

Rupi Sanjie Xiaotong Plaster in Treating Breast Hyperplasia of Liver Stagnation and Phlegm Coagulation Pattern

Objective:To observe the clinical efcacy and safety of external application of Rupi Sanjie Xiaotong Plaster(乳癖散结消痛膏,RPSJXTP)in treating breast hyperplasia of liver stagnation and phlegm coagulation pattern.Methods:Totally 72 female patients with breast hyperplasia of liver stagnation and phlegm coagulation pattern admitted to the First Hospital Affiliated to Henan University of Chinese Medicine were enrolled by ran-domized,single-blind,placebo-controlled research method,and were divided into the treatment group(36 ca-ses)and the control group(36 cases)according to computer random number method.The treatment group were given RPSJXTP,while the control group were gi ven placebo plaster.The course of treatment in both groups was 8 weeks.The breast pain score,breast color ultrasound score,lump score,depression score,and Chinese medicine syndrome score were compared between the two groups at different times.The levels of estra-diol(E_(2)),progesterone(P)and pituitary prolactin(PRL)were detected and the adverse reactions of two groups were observed during the treatment of both groups.Results:Before treatment,there was no significant difference in total breast pain score,breast color ultrasound score,lump score,depression score and levels of serum P,E_(2)and PRL between the two groups(P>0.05);compared with previous treatment,the total breast pain score,breast color ultrasound score,lump score,and depression score significantly decreased in the treat-ment group(P<0.05),and the total breast pain score and depression score of the control group significantly declined(P<0.05);compared with control group,the total breast pain score,breast color ultrasound score,lump score,and depression score significantly decreased after treatment in the treatment group(P<0.05).The improvement rate of Chinese medicine syndromes and the clinical efective rate in the treatment group were higher than those in the control group(P<0.05).There were no serious systemie adverse reactions during the treatment in both groups.Local pruritus occurred in 3 cases in the treatment group and 1 case in the control group.Conclusion:RPSJXTP is effective in treating breast hyperplasia of liver stagnation and phlegm coagula-tion pattern.It can effectively relieve the breast pain which will not recur after stopping of drug use,which can reduce the color ultrasound score,lump score,and depression score of the patients and improve Chinese medi-cine syndromes without serious adverse reactions.

Multicenter Clinical Randomized Controlled Trial and Network Pharmacology Analysis of Zhenzhu Qingyuan Granules for the Treatment of Gastroesophageal Reflux Disease

Objective To evaluate the clinical efficacy and safety of Zhenzhu Qingyuan Granules through a clinical randomized controlled trial and to analyze the potential action targets and pathways of this formula using network pharmacology.Methods Patients with gastroesophageal reflux disease(GERD)of liver–stomach stagnant heat pattern who met the inclusion and exclusion criteria were randomly divided into the control group and the observation group.The control group received oral rabeprazole,whereas the observation group were given Zhenzhu Qingyuan Granules in addition to the rabeprazole.The treatment duration was 8 weeks.Clinical efficacy was observed in both groups after 8 weeks.Network pharmacology was used to analyze the action targets of ZhenzhuQingyuanGranules and the genes related to GERD,and core targets were inferred.Gene Ontology and Kyoto Encyclopedia of Genes and Genomes enrichment analyses were conducted to explore the potential mechanisms of this formula.Results The clinical research results showed that the total effective rate in the treatment group was 92.68%,compared with 70.00%in the control group,with a statistically significant difference(p<0.05).After treatment,both Chinese medicine syndrome score and endoscopic score improved in both groups compared with before treatment(p<0.05),and the treatment group showed greater improvement than the control group(p<0.05).Network pharmacology identified effective components of Zhenzhu Qingyuan Granules for treating GERD,including quercetin,luteolin,andβ-sitosterol,with potential action targets such as tumor protein 53(TP53),protein kinase B(AKT1),and tumor necrosis factor.Conclusion Zhenzhu Qingyuan Granules can significantly improve clinical symptoms in patients with GERD of liver–stomach stagnated heat pattern,enhance clinical efficacy,and have high safety.This formula may exert therapeutic effects through multiple targets and pathways.

Formulation Mechanism of Mailuo Shutong Pills in the Treatment of Varicocele

Varicocele is a common disease in male urology clinic,mainly manifested as testicular pendent distension discomfort,scrotal moisture,less weak semen and other symptoms.There is no specific drug in clinical treatment of modern medicine and traditional Chinese medicine.Mailuo Shutong Pills was created by TANG Zuxuan,a Chinese medical master,for the treatment of damp and heat stasis type thrombotic superficial phlebitis and other vascular diseases.In clinical application,it was found to have a good clinical effect on the treatment of symptoms caused by varicose vein.This paper analyzed the formulation mechanism of Mailuo Shutong Pills in the treatment of varicocele from the perspective of traditional Chinese and western medicine,and provides theoretical basis for clinical application.

Relationship between Two Blood Stasis Syndromes and Inflammatory Factors in Patients with Acute Coronary Syndrome

Objective： To investigate the relationship between inflammatory factors and two Chinese medicine（CM） syndrome types of qi stagnation and blood stasis（QSBS） and qi deficiency and blood stasis（QDBS） in patients with acute coronary syndrome（ACS）. Methods： Sixty subjects with ACS, whose pathogenesis changes belongs to qi disturbance blood stasis syndrome, were divided into 2 groups： 30 in the QSBS group and 30 in the QDBS group. The comparative analysis on them was carried out through comparing general information, coronary angiography and inflammatory factors including intracellular adhesion molecule-1（ICAM-1）, chitinase-3-like protein 1（YKL-40） and lipoprotein-associated phospholipase A2（Lp-PLA2）. Results： Compared with the QSBS group, Lp-PLA2 and YKL-40 levels in the QDBS group showed no-significant difference（P〉0.05）; ICAM-1 was significantly higher in the QDBS group than in the QSBS group in the pathological processes of qi disturbance and blood stasis syndrome of ACS（P〈0.05）. Conclusion： Inflammatory factor ICAM-1 may be an objective basis for syndrome typing of QSBS and QDBS, which provides a research direction for standardization research of CM syndrome types.

Clinical observation on acupuncture treatment for constipation due to intestinal qi stagnation

Objective： To compare the different therapeutic effects of acupuncture and Phenolphthalein for constipation due to intestinal qi stagnation. Methods： A total of 50 patients with constipation due to intestinal qi stagnation were randomly divided into an acupuncture group and a medication group by the random digital table, 25 cases in each group. The patients in the acupuncture group were treated by puncturing Gongsun（SP 4）, Sanyinjiao（SP 6）, Taichong（LR 3）, Zusanli（ST 36）, Shangjuxu（ST 37）, Hegu（LI 4）, Lieque（LU 7）, and Tianshu（ST 25）, once every day, and 7 d as one course, for continuous 3 courses; while the patients in the medication group were given Phenolphthalein, 7 d as one course, for continuous 3 courses. Compared the Cleveland clinic constipation score（CCS） between the two groups after one course, 3 courses and 3 months after the treatment, as well as the frequency of defecation within one week. Results： After one week of treatment, CCS scores and frequency of defecation per week were significantly changed in both groups compared with those before treatment（P〈0.05）, and CCS scores and frequency of defecation per week were improved more significantly in the patients of the medication group than in those of the acupuncture group（P〈0.01）. After 3 weeks of treatment, CCS scores and frequency of defecation per week were significantly changed in both groups compared with those before treatment（P〈0.05）, and CCS scores and frequency of defecation per week were improved more significant in the patients of the acupuncture group than in those of the medication group（P〈0.05）. Three months after the end of treatment, CCS scores and frequency of defecation per week were significantly changed in both groups compared with those before treatment（P〈0.05）, and CCS scores and frequency of defecation per week were improved more significantly in the patients of the acupuncture group than in those of the medication group（P〈0.05）. Conclusion： Acupuncture and medication are effective in the treatment of constipation due to intestinal qi stagnation. Their short-term therapeutic effect is similar, but the long-term therapeutic effect is better in the acupuncture group than in the medication group.

Pulse changes in patients with cervical spondylosis before and after acupuncture treatment

OBJECTIVE： To study changes in pulse diagram parameters （PDP） in patients with cervical spondylosis （CS） before and after acupuncture treatment, explore the characteristics of PDP and the relationship between PDP changes and therapeutic effectiveness, and provide evidence for outcome prediction and objective evaluation of CS treatment before and after acupuncture treatment. METHODS： Patients with CS were treated with acupuncture and measured with a pulse acquisition device based on image （PADBI） before the first and after the tenth acupuncture sessions. Changes in PDP from before until after the acupuncture sessions and patient impressions were analyzed to judge the effect of acupuncture treatment for. RESULTS： The PDP values in effective patients were closer to normal values. This indicated that Qi stagnation and blood stasis of the patients was improved. The PDP changes from before to after the first acupuncture treatment were more obvious than those from before to after the tenth acupunc- ture treatment. This result indicates that the speed of symptom improvement decreased significantly after several acupuncture courses. Analysis of correlation between efficacy and PDP showed that the changes in PDP in five patients was abnormal, which mainly manifested as values of hl, u, p, Pp, and tl, and no significant changes or differences were increased with standard values. This indicated that the symptoms of CS were not improved in these patients. CONCLUSION; PADBI can provide evidence for outcome prediction of acupuncture treatment in patients with CS. PADBI can provide evidence for objective evaluation of acupuncture treatment of CS.

Effect of Chaihushugan San on expression of the Raf/mitogen-activated protein kinase/extracellular signal-regulated kinase pathway in the hippocampi of perimenopausal rats induced by immobilization stress

OBJECTIVE: We wished to study the impact of Chaihushugan San(CSS) on the behavior of perimenopausal rats with liver-Qi stagnation(LQS) and to investigate the effect of CSS on signal transduction of the Raf/mitogen-activated protein kinase(MEK)/extracellular signal-regulated kinase(ERK) cascade in the hippocampi of rats induced by immobilization.METHODS: Twenty 52-week-old female rats were divided into two groups by the random number table method: model control group(MCG) and CSS group(CSSG), with 10 rats in each group.Ten-week-old female rats were used as the normal control group(NCG). CSS effects were assessed using rats exposed to immobilization stress by measuring body weight and sucrose consumption, serum hormone levels, and observing performance in the open field test(OFT). Molecular mechanisms were examined by measuring the effect of CSS on expression of Raf1, MEK1/2 and ERK1/2 m RNA in hippocampi using quantitative real-time polymerase chain reaction and by measuring levels of these proteins and related phospho-proteins using Western blotting.RESULTS: Perimenopausal rats with LQS had decreased locomotor activity; reduced sucrose consumption; and increased serum levels of corticotropin releasing hormone(CRH) and corticosterone(CORT). Activation of hippocampal Raf/MEK/ERK cascade was suppressed significantly in the MCG,and activation was increased after 21 days of CSS treatment.CONCLUSION: CSS has significant effects upon relief of the symptoms of LQS in immobilization-induced rats. The mechanism underlying this action might(at least in part) be mediated by reversal of disruption of the Raf/MEK/ERK pathway.