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ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia （heart-blood deficiency and kidney-essence insufficiency syndrome）. MethodA randomized block， double-blind， placebo-controlled， multi-center clinical trial design method was adopted， and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence （treatment group-control group 3∶1） from seven hospitals （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， The First Clinical Hospital， Jilin Province Academy of Traditional Chinese Medicine（TCM）， The Second Affiliated Hospital of Liaoning University of TCM， The First Affiliated Hospital of Henan University of Chinese Medicine， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine） were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets （4 tablets/time， 3 times/day， 4 weeks of administration， 4 weeks of follow-up after drug withdrawal）. The sleep dysfunction rating scale （SDRS） score， pittsburgh sleep quality index （PSQI） score， TCM， polysomnography （PSG） indicators from four hospital （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine）， and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination， laboratory examination， and observation of adverse events， the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment， the total score of SDRS in the treatment group was lower than that in the control group （P<0.01）. After drug withdrawal for 4 weeks， the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment， indicating that the rebound change of curative effect was not obvious. After treatment， the total score of PSQI in the treatment group decreased as compared with that in the control group （P<0.01）， and the change of total score of PSQI in the treatment group was statistically significant （P<0.05） after drug withdrawal for 4 weeks but small， indicating that the rebound change of curative effect was not obvious. After treatment， the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group （χ2=137.521，P<0.01）. After treatment， the disappearance rates of single indexes in the treatment group， such as difficulty in falling asleep， easily waking up after sleeping， early awakening， short sleep time， dreamfulness， palpitation， forgetfulness， dizziness， mental fatigue， and weakness of waist and knee， increased compared with those in the control group （P<0.01）. After treatment， the treatment group demonstrated fewer awaking times （AT）， longer total sleep time （TST）， lower ATA/TST ratio， and higher sleep efficiency （%） than the control group （P<0.05）. No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.
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Objective To observe the clinical efficacy of Huoxue Rongluo Particles combined with acupuncture in the eight confluent points of spastic cerebral infarction paralysis and its effects on Glu and Asp levels of serum. Methods Totally 60 patients were divided into two groups: the experimental group and the control group. Both groups received basic Western medicine treatment, and the experimental group received Huoxue Rongluo Particles additionally, one dose a day for two times orally taken; Acupuncture was on eight confluent acupoint, every two days. 15 d is a treatment course, with 6 courses in total. Clinical spasticity index (CSI) and TCM symptom scores before treatment and the treatment of half month, 1 month, 3 months were observed. The levels of Glu and ASP in serum were detected, and TCM clinical efficacy was observed. Results The CSI score, levels of Glu and Asp in serum and TCM symptom scores of the patients after half-month, one-month, and three-month treatment were lower than those before treatment (P0.05). The TCM symptom scores in experimental group was lower than the control group after half-month, one-month and three-month treatment (P<0.05). The total TCM effective rate was 86.67% (26/30) in experimental group, and 80.00% (24/30) in the control group, with the experimental group better than the control group (P<0.05). Conclusion Huoxue Rongluo Particles combined with acupuncture eight confluence acupoints in the treatment of spastic cerebral infarction paralyzed patients can relieve spasm degree, improve TCM clinical symptoms, which mechanism may be related to reducing serum excitatory neurotransmitters.
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BACKGROUND:To delay the onset of Alzheimer’s disease, transplantation of viable and wel-differentiated stem cel s is expected to repair neural tissue, which has been an issue of concern. OBJECTIVE:To explore the effects of different doses of human umbilical cord mesenchymal stem cel s (hUCMSCs) on learning and memory ability of Alzheimer’s disease rats. METHODS:Fifty Sprague-Dawley rats, 7 months of age, were randomized into normal, model, high-, middle-and low-dose hUCMSCs groups (n=10 per group). Rats in model and UCMSCs groups were used to make Alzheimer’s disease animals through intraperitoneal injection of 150 mg/kg D-galactose for 90 days, and rats in the normal group were given intraperitoneal injection of normal saline for 90 days. In the three hUCMSCs group, passage 3 hUCMSCs at doses of 1×105/0.2 mL/20 g, 5×105/0.2 mL/20 g, and 1×106/0.2 mL/20 g were injected via the tail vein, respectively. Forty-five days after cel transplantation, Morris water maze test was used to detect rat’s learning and memory abilities, and hematoxylin-eosin staining was used to observe pathological changes of the rat hippocampal CA1 region. RESULTS AND CONCLUSION:Compared with the normal group, the rats in the model group showed significant reduction in the ability of learning and memory. Compared with the model group, the escape latency was significantly shortened in the middle-dose hUCMSCs group (P<0.05), while the number of passing times through the platform was increased significantly (P<0.05). In the model group, the cel s in the hippocampal CA1 region were arranged irregularly with unclear nucleoli and a part of cel s were concentrated and deeply stained. In the middle-dose hUCMSCs group, the cel s in the hippocampal CA1 region were arranged regularly with clear nucleoli, and only individual cel s were stained deeply. These findings indicate that middle-dose hUCMSCs transplantation can improve the learning and memory abilities of Alzheimer’s rats.
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Objective To observe the influence of needling the Eight Confluent Points plus Huo Xue Rong Luo granules on the levels of gamma-aminobutyric acid (GABA) and glycine (Gly) in patients with spastic paralysis after cerebral infarction. Method Sixty patients with spastic paralysis after cerebral infarction were randomized into a treatment group and a control group, 3 0 cases each. The control group was intervened by basic treatment, while the treatment group was by Huo Xue Rong Luo granules plus acupuncture at the Eight Confluent Points in addition to the basic treatment, for 6 treatment courses in total. Before the treatment, and after half-a-month, 1-month, and 3-month treatments, the Chinese Stroke Scale (CSS) and activities of daily living (ADL) were evaluated, the levels of GABA and Gly were detected by using high performance liquid chromatography (HPLC), and the therapeutic efficacies were compared. Result After half-a-month treatment, the CSS score dropped significantly in both groups (P0.05). Conclusion Needling the Eight Confluent Points plus Huo Xue Rong Luo granules is effective in treating spastic paralysis after cerebral infarction, which is plausibly associated with the up-regulation of inhibitory neurotransmitters (GABA and Gly).
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BACKGROUND:Vascular endothelial growth factor is a potent angiogenesis and permeability inducible factor. Vascular endothelial growth factor 165 and vascular endothelial growth factor 121 are mainly expressed in vivo, with a strong role of angiogenesis. OBJECTIVE:To observe the feasibility of vascular endothelial growth factor 165 gene transfected bone marrow mesenchymal stem cel s to differentiate into vascular endothelial cel s. METHODS:Bone marrow derived mesenchymal stem cel s were isolated and col ected from 50 g Sprague-Dawley rats,and identified by flow cytometry. The plasmid pGLV-EF1a carrying a vascular endothelial growth factor 165 gene was transfected to the mesenchymal stem cel s using lentiviral. Expression of green fluorescent protein was observed under a fluorescence microscope. RESULTS AND CONCLUSION:After 12 hours of transfection, expression of green fluorescent protein was observed, increased at 48 hours, peaked at 72 hours and gradual y declined thereafter. Results prove that vascular endothelial growth factor 165 gene transfected bone marrow mesenchymal stem cel s have the expression of green fluorescent protein, indicating successful transfection. It is feasible to induce bone marrow mesenchymal stem cel s to differentiate into vascular endothelial cel s.
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72 cases of treatments on insomnia were recorded in the medical books of Ming and Qing dynasties(A.D.1368～1911 years).The compatibility regularity of treating insomnia in these 72 cases were statistically analyzed with frequency and the R type cluster analysis methods. Combining the data and modern recognition, compatibility and medication regularity of treating insomnia was further analyzed.