Systematic review on the application and adverse reactions of shengmai injection / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate the clinical application and adverse reactions of shengmai injection and their related factors.</p><p><b>METHODS</b>China National Knowledge Infrastructure (CNKI) database was searched with the key word of "Shengmai Injection" from January 1983 to March 2009 to collect the literature regarding clinical study on shengmai injection, and the dose, indication, medicating path and method, solvent of the drug used, as well as the duration of treatment course and adverse reaction occurred were analysed.</p><p><b>RESULTS</b>Finally, 647 documents involving 28,305 patients were included. Adverse reactions occurred in 215 patients, including anaphylactic response (anaphylactic shock, systemic anaphylaxis and skin rash) in 56 patients, and the adverse reactions on various systems, organs and tissues in 159 patients among whom there were a case of acute severe liver damage and a case of heart damage with severe sinus arrest. All patients were improved after treatment with no report of dead case.</p><p><b>CONCLUSION</b>Shengmai injection has been widely applied in clinical practice since it came into the market in 1983, and its chief adverse reaction is the anaphylactic reaction. Excepting the relation with individual constitution, the occurrence of the adverse reaction is also related to its improper clinical application, such as incorrect combination with other drugs, over-high dosage used and age factor, etc. The prevention, monitoring and in time treatment of the adverse reactions and standardized rational medication of the drug should be stressed in the application of Shengmai Injection by clinical physicians.</p>

Effect of Shenqi Fuzheng injection on fractalkine expression in lung tissue of rats with lipopolysaccharide-induced acute lung injury / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe dynamically the Fractalkine (FKN) expression in lung tissue of rats with lipopolysaccharide (LPS)-induced acute lung injury (ALI) and the effect of Shenqi Fuzheng Injection (SFI) on it.</p><p><b>METHODS</b>Rat model of ALI was established by intravenous injection of 4 mg/kg of LPS. Forty-two Wistar rats were randomly divided into 7 groups, the normal group, the model group and the SFI group, the latter two were separated respectively into three time phases (the 1 h, 2 h and 4 h after modeling ) groups, 6 rats in each group. Pathological changes and wet/dry weight ratio (W/D) of lung were observed, serum TNF-alpha and FKN mRNA expression in the lung tissue were examined by ELISA and RT-PCR respectively.</p><p><b>RESULTS</b>Severe pathological changes of lung presented in the model groups of all three time phases with a higher W/D ratio, as well as increased serum TNF-alpha level and FKN mRNA expression in lung tissue. The peak of abnormality of serum TNF-alpha level and FKN mRNA expression was shown in the 2 h time phase group. All the above-mentioned abnormal changes were alleviated after treatment in the SFI group (P<0.05). In addition, the level of FKN mRNA expression was found to be positively correlated to the serum TNF-alpha concentration.</p><p><b>CONCLUSION</b>SFI treatment in early stage could relieve the pathological changes and edema in lung tissue, decrease serum TNF-alpha and down-regulate FKN mRNA expression, playing a protective role in LPS-induced ALI rats.</p>

Randomized controlled trial on treatment of bronchial asthma of qi-deficiency cold syndrome type by pingchuan yiqi granule / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the effect and safety of Pingchuan Yiqi Granule in treating bronchial asthma of qi-deficiency cold syndrome type (BS-QDC).</p><p><b>METHODS</b>With the randomized, positive agent parallel controlled design adopted, the 80 subjects enrolled were assigned in the ratio of 3:1 to two groups, the 60 patients in the trial group were treated with PYG and the 20 in the control group treated with Ruyi Dingchuan Pill (RDP), with the therapeutic course consisting of 7 days for both groups. The clinical effects, effects on TCM syndrome and the changes of lung function after treatment were observed.</p><p><b>RESULTS</b>The effect of the treatment on asthma in the trial group: clinically controlled rate was 6.67%, markedly effective rate 51.67%, improved rate 33.33% and ineffective rate 8.33%; and the corresponding rates in the control group were 5.00%, 50.00%, 30.00%, and 15.00% respectively. Comparison between the two groups showed insignificant difference (P>0.05). The effect on TCM syndrome in the treated group: clinically controlled rate was 11.67%, markedly effective rate 58.33%, effective rate 21.67% and ineffective rate 8.33%; and those in the control group were 10.00%, 50.00%, 30.00% and 10.00% respectively, also showing insignificant difference between the two groups (P>0.05). Lung function test showed that the change on forced expiratory volume in 1 second (FEV1) after treatment in the trial group was of statistical significance (P<0.05), but no significant difference was shown in the change of peak expiratory flow (PEF, P>0.05); while the changes in the control group were just the opposite, showing insignificance in FEV1 (P>0.05) but significance in PEF (P<0.05). Comparison of the therapeutic effect on lung function between the two groups showed no significant difference (P>0.05). No adverse reaction was found in either group in the course of treatment.</p><p><b>CONCLUSION</b>PYG used to treat BS-QDC is effective and safe, it's effect is similar to that of RDP.</p>

Problems and strategies in clinical trials of traditional Chinese medicine / 中国中西医结合杂志

To explore the problems and the strategies in clinical trials of traditional Chinese medicine (TCM), including the method and concealment of randomizing, equipoise of baseline, blindness and outcome measures, adverse reaction observation, statistical method and publication bias. The consolidated standard of reporting trials (CONSORT) is recommended to be applied in order to improve the quality of design and report of randomized controlled trials (RCTs) of TCM, and in case of human is taken as the subject of trial, according to the fundamental ethical principle, the clinical trial design should be censored by institutional review board (IRB), and the informed consent should be signed to protect the rights and interests of the trial participator.

Effects of Astragalus membranaceus in promoting T-helper cell type 1 polarization and interferon-gamma production by up-regulating T-bet expression in patients with asthma / 中国结合医学杂志

<p><b>OBJECTIVE</b>To explore the effect of Astragalus membranaceus (AM) on T-helper cell type 1 (Thl) specific transcription factor T-box expressed in T cells (T-bet) expression and Thl/Th2 equilibrium.</p><p><b>METHODS</b>The levels of T-bet mRNA in peripheral blood mononuclear cells (PBMCs) from 15 patients with asthma and 15 healthy subjects were determined by reverse transcription-polymerase chain reaction (RT-PCR). PBMCs in asthma patients were incubated with AM and then the concentration of interferon gamma (IFN-gamma) and interleukin-4 (IL-4) in the supernate before and after AM intervention were determined by ELISA. The numbers of CD4 + CCR3 + and CD4 + CCR5 + cells were counted by flow cytometry.</p><p><b>RESULTS</b>The expression of T-bet mRNA and the level of IFN-gamma were lower, but level of serum IL-4 was higher in asthma patients when compared with those in healthy subjects respectively. After AM (60 microg/ml) intervention, the former two parameters raised and showed a positive correlation between them, while the level of IL-4 was decreased. The mean percentage of CD4 + CCR3 + cells in asthma patients was significantly higher but that of CD4 + CCR5 + cells was lower when compared with those in healthy subjects respectively. After AM intervention, the abnormal change in the two indexes was improved to certain extent, showing a reversing status of Th2 polarization.</p><p><b>CONCLUSION</b>AM could increase the expression of T-bet mRNA and Thl cytokines such as IFN-Y, and might reverse the Th2 predominant status in asthma patients.</p>

Study on correlation between bone mineral density and syndrome type of TCM in patients with chronic obstructive pulmonary disease / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore the correlation between bone mineral density and Syndrome type of TCM in patients with chronic obstructive pulmonary disease (COPD) for providing the base of clinical integrative traditional Chinese and western medical therapy for the disease through the Syndrome typing and determination of changes in bone metabolism and bone density.</p><p><b>METHODS</b>Bone mineral density (BMD) of lumbar vertebrae 2-4, femoral neck, Ward's triangle and trochanter in 27 COPD male patients, 25 male control subjects and 25 healthy persons were determined using dual energy X-ray absorptiometry, patient's Syndrome type, their blood levels of total protein, albumin, alkaline phosphatase, bone glaprotein, hydroxyproline, calcium, phosphate, urine levels of calcium/creatine and phosphorous/creatine as well as arterial blood gas were also determined.</p><p><b>RESULTS</b>The BMD in COPD patients accompanied with respiratory failure or with course > 10 years was higher than that in COPD patients without respiratory failure or with course < or = 10 years, BMD in COPD patients of Fei-Pi-Shen type was lower than that in those of Fei-Pi, but the urine hydroxyprdine in the former was higher than that in the latter (all P < 0.05).</p><p><b>CONCLUSION</b>(1) COPD is a risk factor for osteoporosis; (2) Shen Deficiency is the key and nucleus of secondary osteoporosis to COPD; (3) It is inferred that early regulation of Shen may be facilitated to prevent osteoporosis in COPD patients.</p>

Clinical observation on effect of kesuning granule in treating acute onset of chronic bronchitis / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To prove the effect of Kesuning Granule (KSNG) in treating chronic bronchitis in exacerbation (Phlegm-Heat syndrome) and objectively evaluate its safety.</p><p><b>METHODS</b>The double-blinded, double-dummy and randomized controlled method was adopted to observe 120 patients, who were divided into the treated group (n = 60, treated with KSNG 8 g, three times a day) and the control group (n = 60, treated with Jinbei Tankeqing Granule (JBTKQ) 7 g, three times a day). The therapeutic course for both groups was 6 days.</p><p><b>RESULTS</b>In the treated group, the markedly effective rate was 58.33% and effective rate was 93.33%, while in the control group, they were 51.67% and 91.67% respectively, no significant difference was found between the two groups. For therapeutic effects on TCM syndromes, the markedly effective rate and effective rate in the treated group was 68.33% and 93.33% respectively and in the control group, 66.67% and 90.00% respectively, also showed insignificant difference. The effect initiative time was earlier in the treated group than that in the control group significantly (P < 0.05). No adverse effect was found in the observation.</p><p><b>CONCLUSION</b>KSNG shows a definite clinical effect with no obvious toxic-adverse effects.</p>