Studies on the Degranulation of RBL-2H3 Cells Induced by Traditional Chinese Medicine Injections

Aims: To study RBL-2H3 cell degranulation phenomena induced by some TCMIs through cell morphological and ultra-structural observation, released enzyme activity and establish RBL-2H3 cell degranulation test indicated by β- hexosaminidase activity as a method to evaluate TCMIs at nonclinical stage. Methods: RBL-2H3 cells were used to study the degranulation by co-culture with positive control C48/80 and some TCMIs through morphological and ultra-structure observation, β-hexosaminidase activity detection. RBL-2H3 cell degranulation test was established to detect β-hexosaminidase activity caused by 17 kinds of TCMIs and their ingredients. The cytotoxicity effect of some TCMIs on both RBL 2H3 and BRL cells was measured by CCK-8 assay. Results: Toluidine blue staining and ultra-structure of electronic microscope observation of treated RBL-2H3 cells showed degranulation morphologically. Detection of β-hexosaminidase activity in the supernatant of treated cells showed some TCMIs had elevated enzyme release rates. Further analysis of the ingredients and compound in Tanreqing Injection and Shengmai Injection showed Scutellaria baicalensis Georgi in Tanreqing Injection, Red ginseng and Fructus Schisandrae Chinensis in Shengmai Injection were responsible to the degranulation of RBL-2H3 cells. Osmotic pressures and pH influenced RBL-2H3 degranulation. High Osmotic pressure of Tanreqing Injection and low pH of chlorogenic acid at 2.5 and 5.0 mmol/L congcentration might be responsible to high β-hexosaminidase activity. Most of the TCMIs inducing degranulation had cytotoxicity effect for both RBL-2H3 and BRL cells, but some TCMIs inducing degranulation had no cytotoxicity effect. Conclusion: Some TCMIs can induce degranulation of RBL-2H3 cells;RBL-2H3 cell degranulation test can be used in non-clinical stage to detect the risk causing anaphylactoid reactions. Osmotic pressures and pH influenced RBL-2H3 degranulation, and they should be measured before testing. The mechanism of degranulation caused by some TCMIs is cytotoxic, and some are non-cytotoxic and may be through exicytosis.

Clinical Observation on the Improved Short-Term Effects of Anti-Tumor Purified Chinese Medicine Injection Ai-Jing for 138 Cases with Malignant Tumors

The subjects of this study were to observe the improved short-term effects of anti-tumor purified Chinese medicine injection Ai-Jing for 138 cases with malignant tumors. This was a multi-center clinical study, and a total of 138 patients included 96 males and 42 females, with the age from 60 to 76 years. Ai-Jing has obtained the Chinese invention patent since 2008 (ZL991-03528.3). A novel technique acupoint injection method was adopted. Except for lung cancer, patients with other malignant tumors were injected once every other day, 2 ml each time. A course of treatment needs 6 Ai-Jing injections, lung cancer patients need 10 - 20 Ai-Jing injections. At the same time, patients were treated with traditional medicine decoction. Due to the limited number of cases, cure rate, recovery rate and remission rate were calculated as a whole, respectively 18.12%, 44.20% and 32.15%. All the invalid patients were lung cancer, accounting for 16.67% of the patients treated with lung cancer, and the total treatment inefficiency was 6.52%. Conclusion: Chinese Medicine Injection Ai-Jing extracts the effective components of anti-cancer and tumorigenesis, and has the effects of anti-cancer and tumorigenesis, anti-inflam-matory and analgesic, and repairing body damage, with small toxic and side effects and low cost.

Study on the Flow Injection Micro-Column Pre-Separation System Coupled With High Performance Liquid Chromatography for the Determination of Ecdysterone in Traditional Chinese Medicine

A flow injection (FI) micro-column system coupled with high performance liquid chromatography (HPLC) was proposed for the pre-separation and determination of active organic component (ecdysterone) in traditional Chinese medicine, Loulu. The factors influencing separation performance were investigated and optimized. Under the optimal conditions, the contents of ecdysterone in Loulu were determined by HPLC system using MeOH-H_2O (40: 60,V/V) as the mobile phase at a flow rate of 1. 0 mL/min. The calibration curve was linear in the range of 0. 5~ 100 mg/L of ecdysterone concentrations. The detection limit of the analyte was 0. 11mol/L(3) with a precision of 0. 38% RSD (n=7 f c= 10. 0 mg/L). The average recovery of the method was 98. 7%. The proposed method has been applied to determine ecdysterone in practical samples, and the determined values by both external standard method and standard addition method were in good agreement. Compared to the traditional solid extraction method, the system proposed has the advantages of simple procedure, good reproducibility, minimum volume requirement, reduction of matrix interference and low contamination risk.

The effect of foot bath of Chinese medicine combined with acupoint injection for diabetic peripheral neuropathy:a meta analysis

Objective:The aim of this systematic review was to assess the effect of foot bath of Chinese medicine combined with acupoint injection(FBCMCAI)on patients with diabetic peripheral neuropathy(DPN).Methods:Databases such as Cochrane Library,Pubmed,Web Of Science,China Biology Medicine(CBM),CNKI,VIP and WANFANG DATA were electronically searched to collect the randomized controlled trials(RCTs)(up to October 2016).According to the inclusion and exclusion criteria,literature about effects of FBCMCAI in the treatment of DPN were screened and data were extracted.Literature quality evaluation was appliced by Cochrane Reviewer Handbook 5.1.0.A random or a fixed effects model was used to analyze outcomes by RevMan 5.3 software.Subgroup analysis,sensitivity analysis,and orientation description were performed if necessary.Results:11 randomized controlled trials with a total of 927 patients were included.Meta analysis results revealed that the efficacy of FBCMCAI for DPN was significantly superior to the control treatment(OR=5.07,95%CI:3.23-7.94,Z=7.08,P<0.00001).Besides,there was an increase in motor conduction velocity of peroneal nerve(SMD=1.08,95%CI:0.66-1.48,Z=5.30,P<0.00001),motor conduction velocity of tibial nerve(SMD=1.08,95%CI:0.58-1.58,Z=4.22,P<0.0001)and motor conduction velocity of median nerve(SMD=0.46,95%CI:0.23-0.68,Z=3.96,P<0.0001)in FBCMCAI groups.For another,there was also an increase in sensory motor conduction velocity of the motor nerve(SMD=0.80,95%CI:0.54-1.05,Z=6.06,P<0.00001)and sensory motor conduction velocity of median nerve(SMD=0.66,95%CI:0.38-0.93,Z=4.73,P<0.00001)in the FBCMCAI groups.Symptoms score was significantly reduced after FBCMCAI treatment(WMD=-4.21,95%CI[-4.95,-3.48],Z=11.25,P<0.00001).Conclusion:FBCMCAI may have significant therapeutic efficacy for the treatment of DPN.Diabetic neurologic symptoms and nerve conduction velocities can be improved under FBCMCAI treatment.In-depth research and high quality randomized controlled trials on the efficacy of FBCMCAI are necessary.

Stability and compatibility of common traditional Chinese medicine injections matching with fructose injection

In recent years,China has attached great importance to the work of traditional Chinese medicine(TCM),more and more Chinese patent medicines are included in the national medical insurance catalogue,and the clinical application of TCM injections is also increasing.This article reviews a total of 20 literature reports on the compatibility of fructose injections with TCM injections from 2005 to the present,and evaluates the stability based on the appearance,pH,insoluble particles and content changes after compatibility,and provides for the rational use of fructose injections.Theoretical evidence provides options for special patients with special solvent limit.

Network meta-analysis of 3 kinds of Chinese medicine injection in the treatment of knee osteoarthritis

Objective:To compare the effect of three kinds of traditional Chinese medicine injection(zhengqing fengtongning injection,shenmai injection,cervus and cucumis polypeptide injection)on knee osteoarthritis with the method of Network meta-analysis.Methods:Two researchers independently used computers to search for randomized controlled clinical trials of zhengqing fengtongning injection,shenmai injection,or cervus and cucumis polypeptide injection for the treatment of knee osteoarthritis published in CNKI,VIP,WANFANG DATA,CBM and PubMed databases(since the date of database establishment to February 2020).After the methodological quality of included researches were evaluated,and the valid data were extracted,statistical analysis was performed With RevMan5.3 and R 3.53.Results:There were including 9 RCTs,which involving 720 patients.The results of network Meta-analysis showed that:All three traditional Chinese medicine injections effects are approximately equal.The probability ranking chart shows that Zhengqingfengtongning injection may have the best effect.Conclusions:Three commonly used traditional Chinese medicine injections can effectively treat knee osteoarthritis,of which Zhengqingfengtongning injection is probably the most effective.Due to the small number of literatures included in this study and the single outcome index,we still need to treat the results of this study with caution.It is suggested that more high-quality,long-term follow-up studies should be carried out for this kind of treatment in the future,so as to provide solid evidence support for the popularization of these treatment measures.

TREATMENT OF PRIMARY PALPEBRAL RETRACTION WITH ACUPOINT-INJECTION AND CHINESE MEDICINAL HERBS

In the present paper, the therapeutic effect of combined therapy of acupoint injection and Chinese medicinal herbs was observed in 59 cases of primary palpebral retraction patients. These 59 patients were divided into treatment group (n=38, treated with acupoint injection and Chinese medicinal herbs) and control group (n=21, treated with Chinese medicinal herbs alone). After 3 courses of treatment, of the 38 cases in treatment group, 25 (65.8%) were cured, 8 (21.1%) had marked improvement and 5 (13.2%) had improvement; of the 21 cases in control group, 8 (38.1%) were cured, 9 (42.9%) had marked improvement, 2 (9.5%) had improvement and 2 (9.5%) were ineffective. Statistical analysis showed a significant difference between the two groups in the therapeutic effect. The cure rate of experimental group was apparently higher than that of the control group, i.e. the therapeutic effect of the combined therapy of acupoint injection and Chinese medicinal herbs was superior to that of Chinese medicinal herbs alone.

Evaluation on Common Hand, Foot and Mouth Disease Treated by Integrative Traditional Chinese Medicine and Western Medicine

Objective To evaluate the efifcacy and safety of traditional Chinese medicine (TCM) combined with Western medicine in the treatment of patients with common hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods A total of 452 patients with common HFMD were randomly assigned to receive Western medicine alone (n=220) or combined with TCM (Reduning or Xiyanping injections) (n=232). The primary outcome was the incidence rate of rash/herpes disappearance within 5 days, while secondary outcomes included the incidence rate for fever, cough, lethargy, agitation, and vomiting clearance within 5 days. Results The rash/herpes disappearance rate was 45.5% (100/220) in Western medicine therapy group, and 67.2% (156/232) in TCM and Western medicine combined therapy group, with significant difference (P<0.001). Moreover, TCM remarkably increased the incidence rate of secondary disappearance, which was 56.4%in Western medicine therapy group and 71.4%in TCM and Western medicine combined therapy group (P=0.001). No drug-related adverse events were observed. Conclusions It’s suggested that the integrative TCM and Western medicine therapy achieved a better therapeutic efficacy. TCM may become an important complementary therapy on relieving the symptoms of HFMD.

Benefit-Risk Assessment of Chinese Medicine Injections for Primary Liver Cancer Based on Multi-criteria Decision Analysis

ObjectiveTo evaluate the benefit-risk of 3 commonly used Chinese medicine injections, Aidi Injection (ADI), Cinobufagin Injection (CINI) and Compound Kushen Injection (CKI), in the treatment of primary liver cancer (PLC), so as to provide a reference for clinical decision-making.MethodsRandomized controlled trials (RCTs) of ADI, CINI and CKI in the treatment of PLC published in the databases of China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, SinoMed, PubMed, Cochrane Library, and Web of Science were retrieved from January 2020 to October 2022. The data of benefit and risk indicators were combined to obtain the effect value. The multi-criteria decision analysis (MCDA) model was applied to build the decision tree. The benefit value, risk value and benefit risk value of the 3 injections in PLC treatment were calculated. Monte Carlo simulation was carried out to calculate the 95% confidence interval and probability of differences among the 3 injections, so as to optimize the evaluation results.ResultsA total of 71 RCTs were included. The benefit values of ADI, CINI and CKI combined with transcatheter arterial chemoembolization (TACE) were 42, 38 and 36, respectively. The risk values were 42, 25 and 37, respectively. The benefit risk values were 42, 31 and 37, respectively. The benefit risk differences of ADI vs. CINI, ADI vs. CKI, and CKI vs. CINI were 11 (−0.86, 17.75), 5 (−5.01, 11.09), and 6 (−1.87, 12.63), respectively. The probability that ADI superior to CINI, ADI superior to CKI, and CKI superior to CINI was 96.26%, 77.27%, and 92.62%, respectively.ConclusionBased on the results of MCDA model, CINI combined with TACE has the greatest risk in the treatment of the PLC. Considering the efficacy and safety, the possible priority of the 3 Chinese medicine injections combined with TACE in the treatment of PLC is ADI, CKI and CINI.

Application of Traditional Chinese Medicine injection in treatment of primary liver cancer:a review

OBJECTIVE:To investigate the application of Traditional Chinese Medicine Injections(TCMIs) for treatment of primary liver cancer(PLC).METHODS:A literature review was conducted using PubMed/Medline,Cochrane Library Controlled Clinical Trials Database,China National Knowledge Infrastructure(CNKI),China Scientific Journal Database(CSJD) and China Biology Medicine(CBM).Online websites including journal websites and databases of ongoing trials,as well as some Traditional Chinese Medicine journals that are not indexed in the electronic databases were also searched.RESULTS:The literature review showed that TCMIs as adjunctive medication for the treatment of PLC could regulate patient immunity,reduce bone marrow suppression,relieve clinical symptoms,and improve quality of life,as well as control disease progression and prolong survival time.CONCLUSION:Within the limitations of this review,we conclude that application of TCMIs as adjunctive medication may provide benefits for patients with PLC.Further large,high-quality trials are warranted.

Danhong injection A modulator for Golgi structural stability after cerebral ischemiareperfusion injury

The cerebral ischemia-reperfusion model was established using the suture occlusion method, and rats were intraperitoneally given 8 mL/kg Danhong injection once a day prior to model establishment Rat brain tissues were harvested at 6, 24, 48, 72 hours after reperfusion. Immunohistochemical staining showed that transforming growth factor-J31 expression increased, while Golgi matrix protein GM130 expression decreased after cerebral ischemia-reperfusion. Danhong injection was shown to significantly up-regulate the expression of transforming growth factor-131 and GM130, and expres- sion levels peaked at 7 days after reperfusion. At 7 days after cerebral ischemia-reperfusion, Golgi morphology was damaged in untreated rats, while Golgi morphology breakage was not observed after intervention with Danhong injection. These experimental findings indicate that Danhong injec- tion can up-regulate the expression of transforming growth factor-131 and GM130, and maintain Golgi stability, thus playing a neuroprotective role in rats after cerebral ischemia-reperfusion.

Is Chinese Medicine Injection Applicable for Treating Acute Lung Injury and Acute Respiratory Distress Syndrome?A Systematic Review and Meta-analysis of Randomized Controlled Trials

Objective To assess the efficacy and safety of Chinese medicine injection(CMI)for treating acute lung injury/acute respiratory distress syndrome(ALI/ARDS).Methods Randomized controlled trials(RCTs)were identified by searching 3 English databases and 4 Chinese databases from their inceptions until February 2019.The Cochrane Handbook was used to evaluate risk of bias in the included studies.Data analysis was conducted using RevMan 5.3.3 software.Results A total of 19 eligible RCTs involving 1,334 participants was included in this systematic review and meta-analysis.The main meta-analysis showed that CMI combined with conventional therapy(CT)was more effective than CT alone in reducing the acute physiology and chronic health evaluation(APACHE)H score[mean difference(MD):−1.74 points,95%confidence interval(CI):−2.77 to−0.71,I^2=0]and increasing the total effective rate[relative risk(RR):1.35,95%CI:1.17 to 1.56,I^2=37%].Compared with CT,CMI combined with CT showed improvements in the arterial partial pressure of oxygen(PaO2,MD:9.25 mm Hg,95%CI:0.87 to 17.63,I^2=98%)and oxygenation index[arterial partial pressure of oxygen(PaO2)/fraction of inspired oxygen(FiO2),MD:50.75 mm Hg,95%CI:35.18 to 66.31,I^2=94%].CMI plus CT was superior to CT in reducing the systemic inflammatory response syndrome(SIRS)score(MD:−0.84 points,95%CI:−1.26 to−0.42,I^2=65%),length of hospital stay(MD:−4.22 days,95%CI:−6.49 to−1.95,I^2=92%),and duration of mechanical ventilation(MD:−2.94 days,95%CI:−4.68 to−1.21,I^2=89%).Only 1 study reported adverse events.Conclusions CMI as an adjuvant therapy showed great potential benefits for the treatment of ALI/ARDS.However,we could not make a definite conclusion due to low quality of included studies and uncertain security.Future studies should focus on improving research design,especially in blindness and placebo.The reporting of adverse events was also needed.

Rapid and sensitive liquid chromatography–tandem mass spectrometric method for the quantitative determination of potentially harmful substance 5,5′-oxydimethylenebis (2-furfural) in traditional Chinese medicine injections

With the rapid development and wide application of traditional Chinese medicine injection(TCMI), a number of adverse events of some TCMIs have incessantly been reported and have drawn broad attention in recent years. Establishing effective and practical analytical methods for safety evaluation and quality control of TCMI can help to improve the safety of TCMIs in clinical applications. In this study, a sensitive and rapid high-performance liquid chromatography–tandem mass spectrometry(HPLC–MS/MS)method has been developed and validated for the quantitative determination of potentially harmful substance5,5′-oxydimethylenebis(2-furfural, OMBF) in TCMI samples. Chromatographic separation was performed on a C18 reversed-phase column(150 mm × 2.1 mm, 5 μm) by gradient elution, using methanol–water containing 0.1% formic acid as mobile phase at the flow rate of 0.3 m L/min. MS/MS detection was performed on a triple quadrupole mass spectrometer with positive electrospray ionization in the multiple reaction-monitoring mode. The method was sensitive with a limit of quantification of 0.3 ng/m L and linear over the range of 0.3–30 ng/m L(r = 0.9998). Intra-and inter-day precision for analyte was o9.52% RSD withrecoveries in the range 88.0–109.67% at three concentration levels. The validated method was successfully applied to quantitatively determine the compound OMBF in TCMIs and glucose injections. Our study indicates that this method is simple, sensitive, practicable and reliable, and could be applied for safety evaluation and quality control of TCMIs and glucose injections.

Shuanghuanglian injection downregulates nuclear factor-kappa B expression in mice with viral encephalitis

A mouse model of viral encephalitis was induced by intracranial injection of a Coxsackie virus B3 suspension. Quantitative real-time reverse transcription-PCR and western blot assay were applied to detect mRNA and protein expression of intelectin-2 and nuclear factor-kappa B in the viral encephalitis and control groups. Nuclear factor-kappa B and intelectin-2 mRNA and protein expression were significantly increased in mice with viral encephalitis. After intraperitoneal injection of Shuanghuanglian at a dose of 1.5 mg/kg for 5 successive days, intelectin-2 and nuclear factor-kappa B protein and mRNA expression were significantly decreased. To elucidate the relationship between intelectin-2 and nuclear factor-kappa B, mice with viral encephalitis were administered an intracerebral injection of 107 pfu recombinant lentivirus expressing intelectin shRNA. Both protein and mRNA levels of intelectin and nuclear factor-kappa B in brain tissue of mice were significantly decreased. Experimental findings suggest that Shuanghuanglian injection may downregulate nuclear factor-kappa B production via suppression of intelectin production, thus inhibiting inflammation associated with viral encephalitis.

Rapid determination of tannin in Danshen and Guanxinning injections using UV spectrophotometry for quality control

A technique for the determination of tannin content in traditional Chinese medicine injections(TCMI)was developed based on ultraviolet(UV)spectroscopy.Chemometrics were used to construct a mathematical model of absorption spectrum and tannin reference content of Danshen and Guanxinning injections,and the model was veried and applied.The results showed that the established UV-based spectral partial least squares regression(PLS)tannin content model performed well with a correlation coefficient(r)of 0.952,root mean square error of calibration(RMSEC)of 0.476
g/ml,root mean square error of validation(RMSEV)of 1.171
g/ml,and root mean square error of prediction(RMSEP)of 0.465
g/ml.Pattern recognition models using linear discriminant analysis(LDA)and k nearest neighbor(k-NN)classiers based on UV spectrum could successfully classify different types of injections and different manufacturers.The established method to measure tannin content based on UV spectroscopy is simple,rapid and reliable and provides technical support for quality control of tannin in Chinese medicine injections.

Efficacy and safety of Kang’ai injection adjunct with TP chemotherapy for the treatment of non-small cell lung cancer: a systematic review and meta-analysis of randomized controlled trials

Background:Combination therapy with traditional Chinese medicine and chemotherapy was proposed as a therapeutic strategy for non-small cell lung cancer patients.Therefore,we performed a systematic review and metaanalysis of randomized controlled trials to assess effects of this combination therapy on non-small cell lung cancer.To evaluate the efficacy and safety of the Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy in the treatment of non-small cell lung cancer.Methods:A randomized controlled study of the Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy in the databases of China National Knowledge Infrastructure Database,WanFang Database,VIP Database,Sino-Med Database,PUBMED,EMBASE and Cochrane library was searched by computer.The literatures published from the database establishment to July 1,2020 were included in the search scope.After 2 evaluators independently evaluated and cross checked the quality of the study,Revman 5.3 was used to meta analyze the clinical effect of the Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy on patients with non-small cell lung cancer.Results:A total of 1,370 lung cancer patients were included in 20 RCTs.The results of meta-analysis showed that there were significant differences between the 2 groups in clinical efficacy(RR=1.32,95%CI(1.20,1.44)),quality of life(RR=1.44,95%CI(1.32,1.57)),immune function(MD=0.53,95%CI(0.23–0.83)),adverse reactions(RR=0.49,95%CI(0.41,0.58)).Conclusion:The Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy is effective and safe in the treatment of non-small cell lung cancer,and has great prospects for further development.However,the quality of evidence was very low-to-moderate.Considering the poor quality of evidence,we are not very confident in the results.We look forward to more research and update results in the future and improve the evidence quality.

Allergenicity studies of Naoluotai injection and H3 injection before and after ultrafiltration

OBJECTIVE To explore the influence of ultrafiltration on the allergenicity of Naoluotai injection and H3 injectable powder in guinea pig.METHODS The ultra filtrated and non-ultra filtrated Naoluotai injection was utilized to do the sensitization test of guinea pig.The guinea pig was sensitized three times by subcutaneous injection of test solution every other day.After 16 dof the first sensitization.All guinea pigs were challenged.The serotonin level in guinea pig plasma before and after the challenge was recognized as the evaluation criteria of allergenicity.RESULTS The increasing rate of serotonin in guinea pigs sensitized by ultra filtrated Naoluotai injection was 5.80% while by non-ultra filtrated Naoluotai injection was 37.03%.The increasing rate in ultra filtrated and non-ultra filtrated H3 injection was 23.59% and 61.94%,respectively.CONCLUSION The animal protein in tradition Chinese medicine injection was thought to be allergized.The ultrafiltration technology could reduce the allergenicity of tradition Chinese medicine injection and improve its safety.

Clinical Observation on Treatment of Mammary Gland Hyperplasia by Acupoint Injection Combined with Ion-Introduction of Chinese Herbal Medicine

Objective: To observe the effect of combined therapy of acupoint Injection and Chinese herbal medicine ion-introduction in treating mammary gland hyperplasia (MGH). Methods: Eighty-six patients of MGH were treated with the combined therapy and compared with a control group treated with other Chinese or western drugs. Results: Therapeutic effect evaluated after 3 courses of treatment showed that the effect of combined therapy was superior to that of the control groups treated by Xiaoyao Pill, Rupixiao tablet, Asparagine tablet and combined therapy of vitamin E + oryzanol + vitamin B6. Conclusion: Combined treatment of acupoint injection and ion-introduction of Chinese herbal medicine is an effective treatment for mammary gland hypertrophy.