Effect of Modified Shengmaiyin on Children with Acute Lymphocyte Leukemia of Deficiency of Both Qi and Blood / 中国实验方剂学杂志

Objective:To observe the regulatory effect of modified Shengmaiyin adjuvant chemotherapy on the nutritional status and immune function of children with acute lymphocyte （ALL）. Method:One hundred children with ALL chemotherapy were randomly divided into observation group and control group. Both groups were given VDLD regimen as the induction therapy and CAM regimen as the early therapy. Control group was given Shengmaiyin orally， 10 mL/time， 3 times/day. Observation group was given modified Shengmaiyin orally， 1 does/day. The course of treatment for both groups was 3 months. Micro-nutrition assessment （MNA） was carried out before and after treatment， and serum total protein （TB）， albumin （ALB）， prealbumin （PAB）， T cell CD4⁺， CD8⁺， immunoglobulin G （IgG）， IgM， IgA levels were detected before and after treatment. The ratio of CD4⁺/CD8⁺ was calculated. The traditional Chinese medicine （TCM） syndrome before and after treatment and the piper fatigue scale （PFS-R） and universal core scale of children's quality of life （PedsQL） were scored. The changes of white blood cells （WBC）， red blood cells （RBC）， hemoglobin （Hb） and platelets （PLT） were evaluated before and after treatment. Result:The nutritional status of the observation group was better than that of the control group after treatment （<italic>Z</italic>=2.018， <italic>P</italic><0.05）. The observed fatigue was lighter than that of the control group （<italic>Z</italic>=2.029， <italic>P</italic><0.05）. The MNA score of the observation group was higher than that of the control group （<italic>P</italic><0.01）. The scores of PFS-R and deficiency of both Qi and blood were lower than those of the control group （<italic>P</italic><0.01）. The CD4⁺levels and CD4⁺/CD8⁺ levels of TB， ALB and PAB in the observation group were higher than those in the control group （<italic>P</italic><0.01）， while the CD8⁺ was lower than the control group （<italic>P</italic><0.01）. The IgM and IgA levels in the observation group were higher than those in the control group （<italic>P</italic><0.01）. The RBC， Hb and PLT levels of the observation group were higher than those of the control group （<italic>P</italic><0.01）. Conclusion:Modified Shengmaiyin can be used as adjuvant therapy for children with ALL chemotherapy by improving nutritional status， immune function and immune balance， reducing clinical symptoms， promoting the recovery of hematopoietic system and improving the quality of life.

Common issues in safety analysis of clinical trail reports for new drugs of traditional Chinese medicine / 中国中药杂志

Clinical trail report is a summary of the process and results of clinical trail, an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration. Safety analysis is the main part and the most common issue of clinical trial report. In this article, it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM) in combination with the clinical professional evaluation of the application for marketing license of innovative TCM. The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed, including the omissions of adverse events and laboratory test results, the failure to provide a detailed list of laboratory test outliers, the lack of professional depth in the analysis of the causal relationship between adverse events and TCM. In view of the common problems, it is suggested that the drug use degree, adverse events and adverse reactions, as well as laboratory examination should be considered. Check the three dimensions for necessary medical analysis, collation and summary and continuously improve the quality of safety analysis in clinical trial reports.

Evaluation on review quality management and progress and suggestions of reform in traditional Chinese medicine review / 中国中药杂志

Efficient management and evaluation is the primary responsibility of drug regulatory authorities in various countries, whose management services are mainly delivered in accordance with the Good Review Practices(GRPs) and ISO 9001 quality management system. In 2015, Opinions on Reforming the Evaluation and Approval System of Drugs and Medical Devices included the perfection of quality control review system as the content of reform in drug review and approval. On this basis, the traditional Chinese medicine(TCM) review authority has shortened the review time, strengthened the communication, offered technical guidelines, designed the review template with guiding significance, and carried out diversified training and performance evaluation, to continuously strengthen the standardization of TCM review and approval and effectively guarantee the scientificity and consistency of new TCMs. However, the current quality management system for TCM review is not yet mature. It is recommended to employ ISO 9001 quality management system to manage the review work, utilize the GRP for better management of the archive files in the review process, and use quality evaluation indicators to improve the review quality management, thereby further perfecting the TCM review management system.

Mechanism of Therapeutic Methods for Activating Blood and Removing Blood Stasis in Treatment of Cerebral Hemorrhage / 中国实验方剂学杂志

Intracerebral hemorrhage (ICH) refers to the primary non-traumatic parenchymal hemorrhage, which is one of the common cerebrovascular diseases, with a high incidence, rapid development, slow recovery and high disabling rate. After intracerebral hemorrhage, a series of pathological changes occur in the brain tissue, such as local hematoma and its space occupying effect, secondary cerebral edema, death of brain cells and destruction of blood-brain barrier, which may lead to brain injury and neurological defects, seriously affect the quality of life of patients, and even endanger the life. Therefore, it is great medical value to find effective therapeutic methods and drugs, explore the mechanisms and targets for improving neurological function, reduce sequelae and improve the quality of life of patients. According to the theory of traditional Chinese medicine (TCM), cerebral hemorrhage belongs to " abnormal flow of the blood" , which equals to blood stasis. In recent years, scholars conducted extensive research on drugs for promoting blood circulation to remove blood stasis with modern scientific methods, and made in-depth discussion for the mechanism, and found that therapies for activating blood and removing blood stasis, plays a key role in intervening a series of physiological and pathological changes after cerebral hemorrhage, with significant curative effects in removing hematoma, improving the microcirculation and reducing the mortality and morbidity. This article summarized drugs for promoting blood circulation to remove blood stasis (Notoginseng Radix et Rhizoma, Salviae Miltiorrhizae Radix et Rhizoma, Hirudo), formulas (Buyang Huanwu Tang, Didangtang, Naoxueshu oral liquid, Tongqiao Huoxuetang) and compound injections (Danhong injection) for the treatment of cerebral hemorrhage targets, and discussed the experimental research progress TCM for promoting blood circulation to remove blood stasis in treatment of cerebral hemorrhage in terms of promoting hematoma absorption, reducing brain edema and apoptosis, promoting angiogenesis, inhibiting the inflammatory response, and promoting the repair and regeneration of nerve tissue in nearly five years, and summarized the therapeutic mechanism, so as to provide scientific basis for clinical application of the therapeutic methods for activating blood and removing stasis to treat cerebral hemorrhage and the modern scientific research.

Effect of acupuncture at complementary acupionts on mast cells and histamine/bradykinin released by mast cells in the regions of acupionts / 针灸推拿医学（英文版）

Objective: To observe the changes in numbers and degranulation status of local mast cells (MCs) of the complementary acupionts, as well as the concentrations of serum histamine and bradykinin after acupuncture at rat's complementary acupionts of Yanglingquan (GB 34) and Yinlingquan (SP 10), for exploring the mechanisms of the synergistic effect of complementary acupionts. Methods: Using random number table method, 40 Wistar rats were randomly divided into a blank control group (group K), an acupuncture at Yanglingquan (GB 34) group (group A), an acupuncture at Yinlingquan (SP 9) group (group B), an acupuncture at Yanglingquan (GB 34) and Yinlingquan (SP 9) group (group AB), and an acupuncture at points near Yanglingquan (GB 34) and Yinlingquan (SP 9) group (group CD), 8 rats in each group. Group A received acupuncture at Yanglingquan (GB 34); group B received acupuncture at Yinlingquan (SP 9); group AB received acupuncture at Yanglingquan (GB 34) and Yinlingquan (SP 9); group CD received acupuncture at the control points [points 3 mm away from Yanglingquan (GB 34) and Yinlingquan (SP 9) respectively]. Acupuncture was performed at bilateral points in each group. Rats in group K were fixed using the same method as rats in the other 4 groups without acupuncture stimulation. Needles of 0.35 mm in diameter and 40 mm in length were used for acupuncture. Needle handle was connected to the G6805-Ⅱ mode electroacupuncture (EA) device after needling qi was obtained, with sparse-dense wave, frequency of 2 Hz/100 Hz and current of 1 mA to keep the needle handles slightly tremulous while the rats kept quiet. Rats were continuously stimulated by EA for 20 min each time. Experimental interventions were conducted on the 1st, 3rd, 5th and 7th days when the experiment started, for 4 times in total. Specimens from rats in each group were collected 2 h after the 7th day. The levels of histamine and bradykinin in serum were detected by enzyme-linked immunosorbent assay (ELISA). Local tissues of the points were used to prepare cryosections. The changes of MCs were observed after toluidine blue staining. Results: Compared with group K, the numbers and degranulation rates of MCs in group A, group B, group AB and group CD were significantly increased (all P<0.05). The number and degranulation rate of MCs in group AB were significantly higher than those in group A, group B and group CD (all P<0.05). The order of histamine levels from high to low was: group AB >group B > group A > group CD > group K, and the differences were statistically significant (all P<0.05); the levels of bradykinin in group AB, group A and group B were significantly higher than those in group K and group CD (all P<0.05). There was no significant difference in the bradykinin level between group A and group B, nor between group CD and group K (all P>0.05). Conclusion: The number and degranulation rate of MCs of the complementary acupionts are significantly increased after acupuncture at complementary acupionts of Yanglingquan (GB 34) and Yinlingquan (SP 9) of rats, and the serum levels of histamine and bradykinin are increased, which may be one of the mechanisms of the synergism produced by the combination of complementary acupionts.

Effects of Erythropoietin on Nerve Function and Brainstem Auditory Evoked Potential in the Preterm Chil-dren with Brain Damage / 中国药房

OBJECTIVE:To investigate the effects and safety of erythropoietin on nerve function and brainstem auditory evoked potential in the preterm children with brain damage. METHODS:46 preterm children with brain damage were randomly di-vided into treatment group and control group,with 23 cases in each group. Control group received conventional symptomatic treat-ment as respiratory support,nutritional support,vitamin K supplement and ganglioside. Treatment group was additionally given rhE-PO for injection (CHO cell) 500 IU/kg hypodermically,3 times a week,on the basis of control group. Both group received 3-4 weeks of treatment continuously. MDI,PDI,the content of serum nerve injury factor(NSE,S-100β),latent period and peak inter-val of brainstem auditory evoked potential were compared between 2 groups before and after treatment,and the occurrence of ADR was observed in 2 groups. RESULTS:There was no statistical significance in MDI,PDI,the content of serum nerve injury mole-cule,latent period and peak interval of brainstem auditory evoked potential between 2 groups before treatment (P>0.05). After treatment,MDI and PDI of 2 groups increased significantly,while the content of serum nerve injury factor,latent period and peak interval of brainstem auditory evoked potential decreased significantly;the treatment group was better than the control group,with statistical significance (P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:Erythropoietin can significantly im-prove intelligence development,protect the damaged nerve cells and auditory nerve pathways with good safety.

Intervention study of acupuncture on hypoxic-ischemic encephalopathy in newborn rats / 中国小儿急救医学

Objective To observe the intervention effect of acupuncture on mammalian target of rapamycin(mTOR)of hypoxic-ischemic encephalopathy(HIE)model in newborn rats.Methods Seven-day-old SD rats were randomly devided into six groups.Sham-surgery group:the bilateral common carotid arteries were separated,without ligation,and the rats were without hypoxia.HIE model group:the bilateral common carotid arteries were separated and ligated,and the rats were in low oxygen.In the sham-acpuncture group,four positions were acupunctured:from Baihui,Dazhui,Quchi and Yongquan by 1 cm after hypoxia ischemia.In acpuncture group,four positions were acupunctured:Baihui,Dazhui,Quchi and Yongquan after hypoxia ischemia,positioned according to the ordinary acupoints for acupuncture in rats.In the antagonists group,the HIE model rats were injected wortmannin 5 μl to the left ventricle.The acupuncture and antagonists group had the same operations of antagonists group and acupuncture group at the same time.All the groups were subdivided into four subgroups in terms of four time periods of 1 d,3 d,7 d and 21 d.The morphological changes of organizational structures of hypoxic ischemia side in brain tissue were observed by pathological methods.The levels of mTOR mRNA expression were detected by RT-PCR.Results In acupuncture group, acupuncture treatment for 21 d showed that acupuncture group had clearly organizational structure,regular arrangements of neurons,normal cell outline,relatively clear nucleolus,mitigated swell neuron and hyperplas-tic glial cells.Compared with that of the HIE model group,acupuncture treatment increased mTOR mRNA dramatically on day 1 ,day 3,day 7 and day 21 (Q =7.099 1 ,9.009 9,7.894 0,9.914 7,P ﹤0.05 respective-ly).The expression of mTOR mRNA in acupuncture and antagonists group was significantly higher than that in sham-surgery group on day 1 ,day 3 day 7 and day 21 (Q =9.868 9,15.843 4,21.007 2,P ﹤0.05 respec-tively).In day 21 ,compared with the sham operation group and the HIE model group,the expression of mTOR mRNA in acupuncture and antagonists group were significantly higher (Q =18.236 0,4.729 7, P ﹤0.05 respectively).Conclusion Electroacupuncture treatment can promote the expression of mTOR at the mRNA level and protect brain of newborn rats with HIE.

Application of Chinese Medicine Information Science to Ophthalmology of Traditional Chinese Medicine / 中国中医药信息杂志

With the further deepening of the information revolution, traditional Chinese medicine, information science and technology are combined to give birth to Chinese medicine information science. Chinese medicine information science is developed and evaluated by mutual integration of Chinese medicine, computer science and information science, which is composed of the acquisition, processing and interpretation of method and system of patients’ data. Traditional Chinese medicine information technology can be used for ophthalmology of traditional Chinese medicine, so as to solve its dilemma, which there is no set of recognized system of syndrome differentiation and diseases are difficult to combine, with a purpose to take the advantage of traditional Chinese medicine in health management of ophthalmology diseases, and provide new possibilities for the development of traditional Chinese ophthalmology.