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Objective: To evaluate the effect of Chuankezhi injection on mouse model of pneumonia induced by influenza A (H1N1) FM1 strain. Method: ICR mice were randomly divided into normal group, model group, tamiflu control group (27.5 mg·kg-1·d-1) and Chuankezhi injection group (1.5 mL·kg-1·d-1). In the death protection experiment, mice were infected with 2×half lethal dose (LD50) of influenza virus FM1.The Chuankezhi injection was given once a day for 4 days. The number of death animal within 14 days was counted. The mortality and the death protection rate were calculated. In the treatment experiment, mice were infected with 0.8×LD50 of influenza virus, and the Chuankezhi injection was given once a day for 4 days. On the 5th day after the infection, the levels of interleukin-8 (IL-8) in lung, prostaglandin E2 (PGE2) and vasopressin (AVP) in brain were tested by enzyme-linked immunosorbent assay (ELISA). The viral load of influenza virus in lung was tested by Real-time PCR. In the pre-treatment experiment, mice were given Chuankezhi injection once a day for 5 days. 1 hour after the last treatment, mice were infected with 0.8×LD50 influenza virus. 4 days after the infection, the lung index, spleen index, thymus index, and viral load in lung tissue were calculated. Result: Compared with normal group, the IL-8, PGE2 content, lung index and viral load in the lung tissue of model group were significantly increased (P2, and the viral load of influenza(PPPPConclusion: Chuankezhi injection could effectively prevent the mouse model of pneumonia induced by influenza A (H1N1) virus. The mechanism might be related to the reduction of inflammation and inhibiting viral replication.
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To study the metabolic products of main compounds of Chuankezhi injection in rat, 12 Sprague Dawley rats were classed into 2 groups, a blank control group and an intermuscular administration group, respectively. Rat feces and urine samples were collected from 0-24 h and 24-48 h after administration. All the samples were ultrasonically treated with methanol and then analyzed using LC-LTQ Orbitrap MSn. By comparison with the total ion chromatogram of samples from the blank control group, the metabolites in the samples of drug-treated group were screened. These metabolites were further analyzed by multistage product ion scanning and comparison of retention time with reference substances. As a result, a total of 12 flavonoid metabolites were tentatively identified from the rat feces and no metabolite was discovered in the rat urine. Epimedin C and icariin were detected in the rat blood samples after 30 min of administration, but their metabolites and other original flavones were not detected. Furthermore, no original flavones and their metabolites were detected in rat blood samples after 2 and 4 h of administration. The potential metabolism paths were further characterized and the principal in vivo transformation of flavones from Chuankezhi injection were deglycosylation, dehydration, methylation, oxidation and isomerization in rats.
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To evaluate the inflammatory factors, the pulmonary function, the efficiency and the safety of Chuankezhi injection for treating acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The randomized controlled trials (RCTs) on Chuankezhi injection for treating AECOPD were collected from 7 databases (PubMed, CNKI, et al) between inception to November 2016. Two reviewers independently screened literature and extracted the data according to the inclusion and exclusion criteria, and assessed methodological quality of included studies according to the criteria from Cochrane Reviewer's Handbook 5.3. Then, Meta-analysis was conducted by using RevMan 5.3 software. A total of 13 RCTs involving 1 016 patients were included. Meta-analysis results indicated that Chuankezhi group was superior to the control group in the clinical effectiveness [RR=1.15, 95% CI(1.06, 1.23), P=0.000 3], improved pulmonary functions including forced expiratory volume in one second (FEV1) [MD=0.21, 95% CI (0.15, 0.27), P<0.000 01], forced vital capacity (FVC) [MD=0.36, 95% CI（0.15, 0.56）, P=0.000 6], the first seconds breathing volume percentage of forced vital capacity (FEV1/FVC) [MD=6.85, 95% CI（4.68, 9.02）, P<0.000 01] and decreased the level of inflammatory factors including interleukin-6 (IL-6) [MD=-6.35, 95% CI (-8.23, -4.47), P<0.000 01], IL-8 [MD = -2.00, 95% CI ( -3.13, 0.87), P=0.000 5], tumor necrosis factor-α (TNF-α) [ MD=-2.79, 95% CI (-4.61,-0.97), P=0.003]. Besides, there were no frequently happened or serious adverse reactions observed in Chuankezhi group. The results showed that Chuankezhi injection could improve the efficiency and the pulmonary function, reduce inflammation for AECOPD with a high safety on the basis of routine symptomatic treatment. However, due to limited quantity and quality of the included studies, the conclusion above should be further verified by conducting more high quality RCTs.
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A quantitative method for epimedin A, B, C and icariin in rat plasma was established using LC-MS/MS after intermuscular administration of Chuankezhi injection to rat. Chromatographic separation was performed on an Agilent Eclipse XDB-C18 column (150 mm×2.1 mm, 5.0 μm) at 40℃. Mobile phase consisted of acetonitrile -0.1% formic acid in water (35:65), and the flow rate was 0.22 mL·min-1. The LC effluent was detected and analyzed using an ESI-triple quadrupole tandem mass spectrometer under the multiple reaction monitoring (MRM) in the negative ion mode. The plasma samples were treated with solid phase extraction prior to LC-MS/MS analysis. As a result, all of the four analytes displayed a good linearity over the concentration of 1-1000 ng·mL-1. The RSDs of intra-day and inter-day assays were less than 5.99% and 10.16%, respectively. The relative recovery of each analyte was between 88.1%-101.1% with RSD<7.9% and the absolute recovery was between 72.0%-86.6% (RSD<6.3%). In conclusion, the established method shows good specificity, sensitivity and efficiency for quantifying the four flavonoid glycosides contained in rat plasma.
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To study pharmacokinetic characteristics of epimedin A, B, C and icariin after intermuscular administration of Chuankezhi injection to rat. The established RRLC-MS/MS method was applied for simultaneous determination of four analytes in rat plasma and calculating their pharmacokinetic parameters. As a result, each analyte showed a good linear relationship in the concentration range of 1-1 000 μg•L⁻¹.The intra-day precise was 96.9%-107.5% with RSD<5.99%, inter-day precise was 92.3%-105.0% with RSD<10.16%. The relative recovery of four analytes was 88.1%-101.1% with RSD<7.9% and their absolute recovery was 72.0%-86.6% with RSD<6.3%. After intermuscular administration of Chuankezhi injection, the plasma concentration of four flavonoid glycosides rapidly arose to peaks at about 10 min, and then quickly declined in rat. Tmax of epimedin A, B, C and icariin was 0.21, 0.19, 0.16 and 0.49 h, respectively, and their mean elimination half-life(t1/2z) was 0.60, 0.62, 0.47 and 0.49 h. The established method was validated to be sensitive, rapid and specific for determination of the four analytes. Serum concentration of 4 species of epimedium flavonoids in Chuankezhi injection was low, and their absorption and elimination seem quickly, displaying similar pharmacokinetic characteristics in this study.
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Objective:To observe the efficacy of Chuankezhi injection combined with budesonide and formoterol fumarate powder for inhalation in the treatment of chronic obstructive pulmonary disease ( COPD) . Methods:Totally 120 patients with COPD were ran-domly divided into two groups:the observation group inhaled budesonide and formoterol fumarate powder for inhalation combined with intramuscular injection of Chuankezhi injection, and the control group inhaled budesonide and formoterol fumarate powder for inhala-tion. The treatment course was 28 days. The pulmonary function indices [ FEV1% expected value, FEV1 /FVC, 6 min walking dis-tance (6MWD)], the times of acute exacerbation and the adverse drug reactions during the treatment were observed and compared be-tween the two groups. Results:After the treatment, the lung function and 6MWD were improved in the two groups, and the improve-ment of FEV1% expected value in the treatment group was more obvious than that in the control group [(59. 7+12. 1)% vs (49. 8+11. 3)%, P<0. 05]. The number of patients with at least once of acute exacerbation was significantly reduced in the treatment group when compared with that in the control group (35% vs 62%, P<0. 01). The incidence of adverse drug reactions in the two groups showed no significant difference. Conclusion:Chuankezhi injection combined with budesonide and formoterol fumarate powder for in-halation can notably improve the lung function in the patients with COPD and reduce the times of acute exacerbation without effect on the incidence of adverse drug reactions.
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Objective To observe the clinical efficacy of Chuankezhi acupoint injection combined with nursing health care education for treatment of patients with chronic obstructive pulmonary disease (COPD) at stable stage complicated with spleen kidney deficiency syndrome.Methods A prospective study was conducted. 118 patients with stable COPD and spleen kidney yang deficiency syndrome admitted to Hangzhou Third People's Hospital and Zhejiang Xinhua Hospital from February to April 2014 were enrolled, and they were divided into an experimental group (60 cases) and a control group (58 cases) according to the random number table. Both groups were given conventional treatment [including oxygen therapy, bronchodilators, corticosteroids, rehabilitation therapy in accord with the Global Initiative COPD (GOLD)]. Simultaneously, in the experimental group, Chuankezhi acupoint injection was additionally given, once daily for 12 weeks, and appropriate corresponding health education was mentioned. The lung function, quality of life and prognoses of the patients were regularly followed up for 9 months and compared between the two groups.Results After 12 weeks, one second forced expiratory volume (FEV1), FEV1/forced vital capacity (FVC) and maximum voluntary ventilation (MVV) per minute in the experimental group were significantly higher than those in control group [FEV1 (L): 1.57±0.42 vs. 1.35±0.35, FEV1/FVC: (58.62±4.56)% vs. (50.36±4.35)%, MVV (L/min): 60.62±7.56 vs. 56.95±6.33, allP < 0.05]. The quality of life evaluation form for COPD (QLICD-COPD) was used to evaluate the physical function, psychological function, social function and specific modules scores, showing that the above items in the experimental group were significantly higher than those in control group (total score: 74.69±8.92 vs. 68.62±8.95, physical function score: 74.16±8.55 vs. 66.31±7.15, mental function score: 78.69±9.79 vs. 72.64±8.45, social function score: 75.45±6.75 vs. 70.36±6.12, specific modules score: 67.52±6.33 vs. 61.36±6.17, allP < 0.05); Barthel index score was also significantly higher than that in the control group (75.41±9.24 vs. 68.43±7.95,P < 0.05). Within 9 months of follow-up, the incidence of acute exacerbation of COPD in the experimental group was significantly lower than that in the control group [5.00% (3/60) vs. 17.24% (10/58),P < 0.05]. The re-admission rate was also significantly less in patients in experimental group compared with that of control group [1.67% (1/60) vs. 12.07% (7/58),P < 0.05]. Conclusion Chuankezhi acupoint injection with health education for treatment of patients with COPD at stable stage and spleen kidney yang deficiency syndrome has good clinical efficacy, worthy to be applied more widely.
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Objective To observe the effect of Zusan Li acupoint injection with Chuankezhi injection ( CI) combined with chemotherapy on the quality of life in the stage III or IV senile patients with non-small cell lung cancer (NSCLC) . Methods We adopted research methods for the prospective, randomized, and controlled trial. A total of 62 qualified patients completed the treatment program, and were randomly divided into two groups. Thirty-two patients in the test group received CI combined with chemotherapy and syndrome differentiation treatment, and 30 patients in the control group were given chemotherapy and syndrome differentiation treatment. We used the WHO Quality of Life Older Module Scale ( WHOQOL-OLD) , Functional Assessment of Cancer Therapy-Lung ( FACT-L V4.0) and the Brief Fatigue Inventory ( BFI) to evaluate and analyze the quality of life before and after treatment. Results (1) In the WHOQOL-OLD evaluation, the total scores and the scores of dimensions of sensory abilities, autonomy, social participation, and past, present and future behavior were much improved in the test group after treatment ( P﹤0.01 compared with those before treatment) , while the control group only had statistically significant difference ( P﹤0.01) in the improvement of social participation and the total scores. The test group had higher scores difference in autonomy than the control group (P<0.01) . (2) In the FACT-L V4.0 evaluation, the total scores and the scores of domains of physiological condition, emotional status, functional status, and additional attention were much improved in the test group ( P﹤0.01 compared with those before treatment) , and the control group had an improvement in the total scores and scores of emotional status and additional attention after treatment ( P<0.01) . The test group had higher scores difference in physiological condition, functional status, and additional attention than the control group (P<0.01) . (3) In BFI evaluation, the degree of fatigue and fatigue influence were improved in both group after treatment ( P﹤0.01 compared with those before treatment) , and the improvement in the test group was superior to that in the control group ( P<0.05) . Conclusion Zusan Li acupoint injection with CI can improve the quality of life of senile NSCLC patients treated with chemotherapy in dimensions of sensory abilities, autonomy, social participation, and past, present and future behavior, and in domains of physiological conditions, functional status, additional concern, and it can also improve the degree of fatigue and fatigue influence.
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OBJECTIVE:To observe the effects of aerosol inhalation of Chuankezhi injection on lung index and tissue morphol-ogy of trachea,lung and esophagus in guinea pigs. METHODS:40 guinea pigs were randomly divided into blank control group (normal saline),Chuankezhi high-dose,medium-dose and low dose (2.48,1.24 and 0.62 ml/kg) groups. Each treatment group was administrated by inhaling the atomized injection,once a day,20 ml/kg,for consecutive 2 weeks. The general situation of guin-ea pigs was observed 1 h after each time of medication;1 h after last medication,lung index of guinea pigs was detected,as well as the tissue morphology of left lung,right lung,trachea and esophagus by HE staining. RESULTS:Compared with normal control group,the general situation of guinea pigs were normal in Chuankezhi high-dose,medium-dose and low dose groups;there was no difference in lung index and all of them were about 0.653;tissue section staining showed that no abnormal lesion was found in these tissues. CONCLUSIONS:2 weeks of aerosol inhalation of Chuankezhi injection have no significant effect on lung index and the tissue morphology of trachea,lung and esophagus of guinea pigs.