Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine / 中西医结合学报

In recent years, new preparations of traditional Chinese medicines (TCMs) have been developed, increasing the need for their clinical trials. Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs, as the therapeutic effects of the tested TCMs can be more properly judged. The basic attributes of TCM placeboes include similarity, safety, applicability and controllability. In particular, it is necessary to have similarities in appearance, color, smell and taste between the tested TCMs and placeboes. This is quite difficult for some TCMs due to their distinctive smell and taste. On the other hand, according to the TCM theory on homology of medicine and food, many foods also have certain bioactivities, potentially further complicating the selection of materials for TCM placeboes. In this review, firstly, studies on the special smell and taste of TCMs were introduced. Then, the preparation quality evaluation processes for TCM placeboes were summarized and discussed, based on the relevant literature published in recent years and the research results from our own lab. This review will facilitate the further research and development of TCM placeboes.

Construction and identification of siRNA eukaryotic expression vectors targeting on TGFβ1, TIMP-1 and TIMP-2 genes in vitro / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To construct the siRNA eukaryotic expression vectors targeting on TGFβ1, TIMP-1 and TIMP-2 and to investigate the inhibitory efficiency of target genes expression on rat hepatic stellate cell in vitro.</p><p><b>METHODS</b>The siRNA cDNA sequences of TGFβ1, TIMP-1 and TIMP-2 were designed, synthesized and inserted into plasmid pGenesil-1 respectively to generate eukaryotic expression plasmids. The plasmids were transfected into HSC T6 cells in vitro and the inhibitory efficiency of target genes expression was observed with real-time PCR and Western blot.</p><p><b>RESULTS</b>The eukaryotic expression vectors were constructed successfully. The expressions of TGFβ1 mRNA, TIMP-1 mRNA and TIMP-2mRNA in siRNA-transfected groups were decreased by 63.4% ± 8.0%, 64.5% ± 9.0% and 55.0% ± 17.0% respectively and the expressions of TGFβ1 protein, TIMP-1 protein and TIMP-2 protein were decreased by 57.8% ± 3.0%, 55.1% ± 5.0%, 49.3% ± 1.0% respectively as compared to the control groups.</p><p><b>CONCLUSIONS</b>The siRNA eukaryotic expression vectors constructed targeting on TGFβ1, TIMP-1 and TIMP-2 could reduce the expressions of target genes and they might be able to used for the exploration of new anti-fibrosis drugs genetically.</p>

Effect of sonodynamic therapy on H22 tumor-bearing mice using hematoporphyrin-loaded PLGA ultrasound contrast agents / 中国医学影像技术

Objective To study the treatment effect on H22 tumor-bearing mice using ultrasound (US) combined with hematoporphyrin-loaded PLGA ultrasound contrast agents (HP-PLGA). Methods Hematoporphyrin-loaded PLGA ultrasound contrast agents were prepared using the technique of double emulsion, and the properties of the contrast agents were detected. Then 30 H22 tumor-bearing mice were averagely divided into 5 groups for different treatment. The growth curve of H22 tumor was depicted within 15 days after treatment. The inhibition rate of tumor quality on the 15th day and the index about apoptosis and proliferation on tumor of each group were measured, respectively. Results Self-made hematoporphyrin-loaded PLGA ultrasound contrast agents had mean size of 602.3 nm with encapsulation efficiency of 63.50% and drug loading of 2.15%. After treatment, tumors of the E group (US+HP-PLGA) grew most slowly compared with other groups. The inhibition rate of tumor quality and the apoptotic index in E group were significantly higher than those in other four groups (P＜0.05), while the proliferation index in E group was significantly lower than that in other groups (P＜0.05). Conclusion Ultrasound combined with hematoporphyrin-loaded PLGA ultrasound contrast agents could inhibit growth and promote the apoptosis of H22 tumor in mice, providing a novel strategy for sonodynamic therapy on the tumor.

Study on the therapeutic status of 1242 hospitalized acute myocardial infarction patients in Beijing / 中华流行病学杂志

<p><b>OBJECTIVE</b>To investigate and analyze the therapeutic level and the existing problems on acute myocardial infarction (AMI) management in Beijing.</p><p><b>METHODS</b>We collected clinic data of 1242 AMI patients from 12 hospitals in Beijing, from January 2000 to March 2001, using a uniformed questionnaire, and evaluated the status of the diagnosis and treatment of AMI according to the Chinese guidelines issued on Decmeber 2001. Corresponding factors which influencing the mortality were also analyzed by one-way factor and multiple factors analysis methodologies.</p><p><b>RESULTS</b>The mean age of the 1242 AMI patients was 63.0 years old and about one third of them were under 55 years old. In hospitals, the total mortality was 9.10%. 37.9% of the patients had received therapy of the intravenous thrombolysis and emergency PCI with a total rate of reperfusion therapy as 56.0%. The in-hospital rates of drug use were as follows: Nitrates 90.0%, Aspirin 87.8%, heparin 88.7%, beta-blockers 73.4%, angiotensin converting enzyme inhibitors(ACEI) 77.6%, lipid regulating agents 43.6%. The rate of intravenous therapy of TCM by promoting the blood circulation and supplementing the vital energy was 30.5%. Results from multiple factors analysis showed that the compositive factors which could lower the mortality were reperfusion therapy,lipid regulating agents, intravenous therapy of TCM, beta-blockers, ACEI, lower molecule heparin and digitalis.</p><p><b>CONCLUSION</b>Data from this study showed that there still existed a gap between clinical management on AMI and the guideline in Beijing. To set up a straightway passage of reperfusion therapy, to become more standardized to follow the guideline in undertaking the medical treatment practice, and to go deep into discuss the status of TCM on AMI management seemed the important tasks we are facing.</p>

The inhibitory effect of Lu-Duo-Wei on carbon disulfide-induced generation of hydroxyl radicals / 中华劳动卫生职业病杂志

<p><b>OBJECTIVE</b>To study the scavenging effects of Lu-Duo-Wei, thiourea, superoxide dismutase, and sodium azide on carbon disulfide-induced generation of hydroxyl radicals.</p><p><b>METHODS</b>Phenanthroline-CuSO(4)-Vit C-H(2)O(2) chemiluminescence system (PHEN system) containing alcohol was established to probe the influence of various concentrations of carbon disulfide on hydroxyl radicals emission intensity and the scavenging effects of Lu-Duo-Wei and other antioxidants on carbon disulfide-induced hydroxyl radicals were observed.</p><p><b>RESULTS</b>The average emission intensity of PHEN system containing alcohol appeared lower luminescence [91.03 x 10(3) (cp6s)] and longer time (75 s) to get the peak than the system without alcohol [96.11 x 10(3) (cp6s), 55 s]. The specific scavenger of hydroxyl radical, thiourea, showed clear inhibitory effect on the system. Carbon disulfide in the range of 40 - 160 mmol/L promoted the generation of hydroxyl radical, however, this effect could be efficiently inhibited by thiourea. 160 mmol/L carbon disulfide in PHEN system without copper seemed as an activator to promote the luminescence, while in PHEN system withdrawing phenanthroline appeared some weak action of luminescence agent at low concentration. Meanwhile, Lu-Duo-Wei may efficiently scavenge hydroxyl radicals induced by carbon disulfide in PHEN system but superoxide dismutase and sodium azide had little effects on the system.</p><p><b>CONCLUSION</b>Carbon disulfide may induce PHEN system to generate hydroxyl radicals and Lu-Duo-Wei may efficiently scavenge these free radicals and play an important role in protection against oxidative injury induced by carbon disulfide.</p>

Clinical observation on effect of taizhi'an capsule in treating 150 patients with hyperlipidemia / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To grasp the therapeutic effect of Taizhi'an (TZA) in lowering blood lipid level.</p><p><b>METHODS</b>Three hundred patients with hyperlipidemia were randomly divided adopting numerical table method into 7 groups, the Taizhi'an group (A, n = 90), the half-dose Fenofibrate plus Taizhi'an group (B, n = 30), the full-dose Fenofibrate group (C, n = 30), the half-dose Simvastatin plus Taizhi'an group (D, n = 30), the full-dose Simvastatin group (E, n = 30), the Zhibituo group (F, n = 60) and the Xuezhikang group (G, n = 30). The effect in different groups were compared after 8 weeks treatment.</p><p><b>RESULTS</b>In group A, the total cholesterol (TC) lowered by 12.7%, triglyceride (TG) lowered by 22.1% and the high density lipoprotein cholesterol (HDL-C) increased by 13.1%, the total effective rate being 82%. The therapeutic effect in group B was similar to that in group C, and that in group D was similar to that in group E (P > 0.05). The therapeutic effect of Taizhi'an was similar to that of Xuezhikang and Zhibituo, but was better than Zhibituo in lowering TG, LDL-C and increasing HDL-C, and better than Xuezhikang in lowering TG and increasing HDL-C (P < 0.05).</p><p><b>CONCLUSION</b>When Taizhi'an used in combination with half-dose Simvastatin, it could not only enhance the blood lipid regulatory effect of Simvastatin but also reduce the dosage used and alleviate its adverse reaction. Compared with Xuezhikang and Zhibituo, Taizhi'an got the similar therapeutic effect, but was superior in regulating blood lipids.</p>

The therapeutic effects comparison between one and two hemoperfusion in treatment of chronic hepatitis with hyperbilirubinemia / 重庆医科大学学报

Objective:To investigate the clinical efficacy between one and two hemoperfusion in treatment of chronic hepatitis with hyperbilirubinemia.Methods:The clinical data of 68 chronic hepatitis patients with hyperbilirubinemia were reviewed restropectively.27 patients were treated with one hemoperfusion(HP1)and 41 patients were treated with two hemoperfusion(HP2).The liver function,prothrombin time activity,biochemical indicators before and after hemoperfusion in the two groups were compared and analyzed.Results:After two hemoperfusion treatment.,Compared with HP1,the levels of bilirubin and transaminase were decreased significantly(P0.05).Conclusions:Two hemoperfusion treatment can more effectively make bilirubin and transaminase removed from patients of chronic hepatitis with hyperbilirubinemia,so two hemoperfusion was safe and effective treatment for patients with hyperbilirubinemia.