Salvia Miltiorrhiza Injection Research Articles

The effects of Salvia miltiorrhiza and ligustrazine injection combined with ACEI/ARB on diabetic kidney disease: A systematic review and meta-analysis.

In China, Salvia miltiorrhiza and ligustrazine (SML) injection are widely used as adjunctive therapy for patients with diabetic kidney disease (DKD). However, different studies have reported conflicting results. Therefore, a systematic review and meta-analysis are necessary to assess the efficacy and safety of SML injection for the treatment of DKD. We searched 6 electronic literature databases comparing randomized controlled trials (RCTs) of angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB), SML injection in combination with ACEIs/ARBs that were conducted from inception until September 5, 2023. Two reviewers extracted data and independently assessed the risk of bias. Using the Cochrane Risk of Bias Tool for Risk Assessment. Mean differences (MD) were combined with random-effects models and the corresponding 95% confidence intervals (CI) were reported. Review Manager 5.4 software was used for meta-analysis. Stata 17.0 software was used for sensitivity analysis and Egger test. The combined results show that the use of SML injection along with ACEI/ARB led to better outcomes than the use of controls in terms of enhancing recovery: renal function: Serum creatinine (MD = -14.69, 95% CI (-19.38, -10.00)), Blood urea nitrogen (MD = -1.23, 95% CI (-1.72, -0.74)), Urinary β2-microglobulin (MD = -4.58, 95% CI (-7.72, -1.44)); urinary protein: Urinary albumin excretion rate (MD = -45.74, 95% CI (-58.92, -32.56)), Urine albumin-creatinine ratio (MD = -11.93, 95% CI (-13.89, -9.96)), 24-h urine proteinuria (MD = -0.59, 95% CI (-0.86, -0.32)), Urine microalbumin (MD = -13.50, 95% CI (-20.18, -6.83)). Additionally, adjuvant therapy with SML injection enhanced results in blood glucose, blood pressure, lipids, and inflammatory responses, and no significant variations in adverse events were discovered between the 2 groups. In patients with DKD, combining SML injection with ACEI/ARB improves renal function, renal proteinuria, hyperglycemia, blood pressure, dyslipidemia, and inflammatory response.

Xueshuantong injection combined with Salvianolate lyophilized injection improves the synaptic plasticity against focal cerebral ischemia/reperfusion injury in rats through PI3K/AKT/mTOR and RhoA/ROCK pathways

The combined use of two or more different drugs can better promote nerve recovery and its prognosis for treatment of stroke. Salvianolate lyophilized injection (SLI) made from the aqueous extraction of salvia miltiorrhiza and Xueshuantong injection (lyophilized) (XST) made from the Panax Notoginseng extraction are two herbal standardized preparations that have been widely used in China for the treatment of ischemic stroke. In this study, we investigated the neuroprotective effects of XST combined with SLI in the recovery stage of middle cerebral artery occlusion / reperfusion (MCAO/R) injury rat. Wistar rats were subjects to MCAO/R, then were treated with SLI or XST alone, or with their combination (1X1S) via tail injection daily for 14 days. The pathological status of the brain was detected by neurological deficit scores, TTC, regional cerebral blood flow and Nissl staining. Golgi-Cox staining was used to assess dendritic, axonal and synaptic remodeling. The expression of MAP-2, β-Tubulin, PSD95, SYN, BDNF and VEGF were analyzed by western blotting and immunofluorescence. The results showed that administration of 1X1S not only significantly decreased neurological scores and infarct volumes, but also increased regional cerebral blood flow, strengthened dendritic and synaptic remodeling compared with XST, SLI used alone. And the mechanism of combined of 1X1S to exert neuroprotection may be associated with PI3K/ AKT/ mTOR and RhoA/ROCK2 pathways. Overall, these findings suggest that combination of XST and SLI promotes dendritic spine density and synaptic plasticity via upregulation of the PI3K/ AKT/ mTOR pathways and inhabitation the RhoA/ROCK2 signaling pathway in rat with MCAO/R, showing its multiple-action-multiple-target efficacy and suggest a potential new strategy for ischemia.

Salvia miltiorrhiza (SM) Injection Ameliorates Iron Overload-Associated Cardiac Dysfunction by Regulating the Expression of DMT1, TfR1, and FP1 in Rats.

Previous studies have found that Salvia miltiorrhiza (SM) injection have a protective effect on the iron overloaded (IO) heart. However, the mechanisms are not completely known. In the present study, we investigated the underlying mechanisms based on the iron transport-related proteins. The rats were randomly divided into five groups: control, IO group, low-dose SM group, high-dose SM group, and deferoxamine control group. Iron dextran was injected to establish the IO model. After 14 days of treatment, cardiac histological changes were observed by hematoxylin and eosin (H&E) staining. Iron uptake-related proteins divalent metal transporter-1 (DMT-1), transferrin receptor-1 (TfR-1), and iron export-related proteins ferroportin1 (FP1) in the heart were detected by Western blotting. The results showed that SM injection decreased cardiac iron deposition, ameliorated cardiac function, and inhibited cardiac oxidation. Most important of all, SM injection downregulated the expression of DMT-1 and TfR-1 and upregulated FP1 protein levels compared with the IO group. Our results indicated that reducing cardiac iron uptake and increasing iron excretion may be one of the important mechanisms of SM injection reducing cardiac iron deposition and improving cardiac function under the conditions of IO.

Salvia miltiorrhiza bunge exerts anti-oxidative effects through inhibiting KLF10 expression in vascular smooth muscle cells exposed to high glucose

Ethnopharmacological relevanceTraditional Chinese medicinal herb Salvia miltiorrhiza Bunge(Danshen) and its components have been widely used to treat cardiovascular diseases for hundreds of years in China, including hypertension, diabetes, atherosclerosis, and chronic heart failure. Salvia miltiorrhiza injection (SMI), an aqueous extracts of Salvia miltiorrhiza Bunge, is one of most widely used traditional Chinese medicine injections. SMI is widely used in the treatment of diabetic vascular complications, However, the mechanisms remain to be defined. Aim of the studyTo investigate protective mechanism of Salvia miltiorrhiza Bunge against ROS generation in VSMCs of diabetic mice and patients. Materials and methodsSalvia miltiorrhiza injection (hereinafter referred to as SMI, 1.5 g mL−1), which was approved by the State Food and Drug Administration (approval number: Z32020161), was obtained from Shenlong Pharmaceutical Co., Ltd. (batch number: 11040314). SMI or vehicle were intraperitoneally administrated to the HFD-fed db/db mice, artery was harvested after 24weeks later. qRT-PCR and Western blot analysis were used to detect the expression of KLF6, KLF5, KLF4, KLF10, KLF12, and HO-1. DCFH-DA staining detected intracellular ROS production. Loss- and gain-of-function experiments of KLF10 were used to investigate the effect of KLF10 on the expression of HO-1. Dual-luciferase reporter assay evaluated the effect of KLF10 on the activity of the HO-1 promoter. ResultsKLF10 expression and ROS generation are significantly increased in the arteries of HFD-fed db/db mice, VSMCs of diabetic patients, as well as in high glucose-treated VSMCs. KLF10 overexpression suppresses, while its knockdown facilitates the expression of heme oxygenase (HO-1) mRNA and protein. Further, Salvia miltiorrhiza injection (SMI) abrogates KLF10 upregulation and reduces ROS generation induced by high glucose in VSMCs. Mechanistically, KLF10 negatively regulates the HO-1 gene transcription via directly binding to its promoter. Accordingly, SMI treatment of VSMCs reduces ROS generation through inhibiting KLF10 expression and thus relieving KLF10 repression of the expression of HO-1 gene, subsequently contributing to upregulation of HO-1. ConclusionSMI exerts anti-oxidative effects on VSMCs exposed to high glucose through inhibiting KLF10 expression and thus upregulating HO-1.

Effects of Astragalus injection and Salvia Miltiorrhiza injection on serum inflammatory markers in patients with stable coronary heart disease: a randomized controlled trial protocol

BackgroundCoronary heart disease (CHD) is a clinical syndrome caused by coronary atherosclerosis (AS) or functional changes in coronary arteries. We have previously reported that astragaloside IV (in astragalus) and tanshinone IIA (in Salvia miltiorrhiza) improve myocardial ischemic injury.MethodsThis study will employ the randomized, blinded, prospective, single-center experiments approach. Briefly, a total of 160 eligible patients will be equally randomized into three treatment groups and placebo control groups. Patients will receive appropriate treatments every 24 h for seven days after enrollment and followed up for 28 days. The main evaluation indicators will be cell count, serum high-sensitivity C-reactive protein (hs-CRP) level, monocyte chemoattractant protein 1 (MCP-1), interleukin-6 (IL-6), interleukin-1β (IL-1β), interleukin-8 (IL-8), interleukin-18 (IL-18), interleukin-10 (IL-10), tumor necrosis factor (TNF)-α, oxidized low density lipoprotein (OX-LDL), angina grade, and Traditional Chinese Medicine (TCM) symptom changes scale. Secondary indicators to be evaluated will include B-type natriuretic peptide (BNP) levels, troponin (cTn), muscle enzyme isoenzyme (CK-MB), heart-type fatty acid binding protein (H-FABP), liver and renal functions, as well as blood coagulation. Close monitoring of adverse events during the trial will also be conducted.DiscussionThis randomized controlled trial of Chinese herbal extracts for the treatment of coronary heart disease will generate results that are expected to provide valuable clinical evidence to inform future development of therapies towards management of CHD.Trial registrationChina Clinical Trial Registration Center, ChiCTR1900021590. Registered on 28 February 2019.

Salvia miltiorrhiza Injection Alleviates LPS-Induced Acute Lung Injury by Adjusting the Balance of MMPs/TIMPs Ratio.

Salvia miltiorrhiza injection (SMI) is a classical traditional Chinese medicine, which plays an active role in the treatment of many diseases such as promoting blood circulation, removing blood stasis, reducing inflammatory reaction, and improving acute lung injury (ALI). Previous studies have shown that matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) are involved in the pathophysiological process of ALI. However, the relationship between SMI and MMPs/TIMPs remains unclear. In this study, Wistar rats were randomly divided into control group (NC), Salvia miltiorrhiza group (SM), lipopolysaccharide group (LPS), and Salvia miltiorrhiza treatment group (Tsm). The four groups were subdivided into four time points (2, 6, 12, and 24 hours), and specimens were collected after animal sacrifice at each time point. Serum TNF-α and IL-6 levels were detected by ELISA. The degree of lung injury was determined by lung tissue hematoxylin-eosin staining, lung wet/dry weight (W/D) ratio, and lung permeability index. The changes in lung MMPs/TIMPs protein and mRNA were detected by Western blot and real-time quantitative PCR. The results showed that rats injected with LPS experience acute lung injury, and the ratio of MMPs/TIMPs in lung tissues increased gradually with time. In the Tsm group, the ratio of MMPs/TIMPs decreased gradually, and likewise, the balance was gradually restored, while indicators related to lung injury were gradually declined. These data suggest that SMI alleviates LPS-induced acute lung injury; this protective effect may be related to regulation of the balance of MMPs/TIMPs ratio.

Influence of compound salvia injection on oxidative stress and complications in patients with gestational hypertension

Objective To investigate the influence of compound salvia injection on oxidative stress and complications in patients with gestational hypertension. Methods From August 2015 to Fabuary 2017, 140 patients with gestational hypertension in Binzhou Central Hospital were selected as study objects, and randomly divided into control group and research group according to the digital table, with 70 cases in each group.The control group was treated with routine treatment, the research group was given routine treatment combined with compound salvia injection.After treatment, SOD, MDA, NO, HMGB1, Cys C, hs-CRP, TNF-α, blood pressure and complications between the two groups were compared. Results After treatment, the levels of NO[(942.58±80.69)mmol/L vs.(734.51±78.63)mmol/L] and SOD[(124.65±23.81)U/mL vs.(90.64±24.13)U/mL] in the research group were higher than those in the control group, and the MAD level[(10.47±3.14)nmol/L vs.(15.82±3.32)nmol/L]in the research group was lower than that in the control group, the difference were statistically significant between the two groups(t=15.451, 8.394, 9.795, all P<0.05). After treatment, the levels of HMGB1[(1.81±0.43)mg/L vs.(3.89±0.65)mg/L], Cys C[(1.04±0.18)mg/L vs.(1.42±0.27)mg/L], TNF-α[(15.09±3.14)ng/L vs.(21.45±4.78)ng/L] and hs-CRP[(3.04±0.81)mg/L vs.(6.32±1.45)mg/L] in the research group were lower than those in the control group, the differences were statistically significant(t=22.329, 9.798, 9.304, 16.523, all P<0.05). After treatment, the systolic blood pressure[(131.25±5.74)mmHg vs.(139.61±5.59)mmHg] and diastolic blood pressure[(85.23±5.07)mmHg vs.(90.43±5.81)mmHg] in the research group were lower than those in the control group(t=8.730, 5.642, all P<0.05). The cesarean section rate(61.43% vs.87.14%) and intrauterine distress rate(1.43% vs.11.43%) in the research group were lower than those in the control group(χ2=12.115, 5.818, all P<0.05). Conclusion Compound salvia miltiorrhiza injection has significant control effect on oxidative stress and inflammatory reaction in patients with gestational hypertension, and is beneficial to reduce the complications of childbirth. Key words: Hypertension, pregnancy-induced; Oxidative stress; Inflammation; Pregnancy complications; Parturition; Blood pressure; Pregnancy outcome; Compound salvia injection

Mass Spectrometry-Sensitive Probes Coupled with Direct Analysis in Real Time for Simultaneous Sensing of Chemical and Biological Properties of Botanical Drugs.

The development of botanical materials as therapeutic agents involves the meticulous assessment of safety, efficacy, and quality. Compared with small-molecule drugs, quality control of botanical drugs confronts with more significant challenges due to their inherent complexity. Current quality control methods for botanical drugs, either prevailing chemical tests or emerging biological assays, are not able to meet recent demands of multiplexing, sensitivity, and speed. Here, we propose an on-demand strategy based on a direct analysis in real time-mass spectrometry (DART-MS) platform, which is capable of simultaneously analyzing multiple constituents and bioactivities of botanical drugs. Notably, the bioactivities are assessed by a multiple-enzyme assay that adopts cleavable mass spectrometry probes as enzymatic substrates: these probes labeled with a piperazine tag make possible sensitive, multiplexed, and quantitative enzyme activity measurements. The concept is successfully demonstrated via a case study of Danshen (Salvia miltiorrhiza) Injection where simultaneous detection of 34 constituents and inhibitory activities on two target enzymes can be achieved in just minutes. This proof-of-concept application also gives evidence that combining MS-sensitive probes with DART-MS can provide an environmentally friendly, highly sensitive analytical approach for botanical quality control.

Therapeutic effects of Salvia miltiorrhiza injection combined with telmisartan in patients with diabetic nephropathy by influencing collagen IV and fibronectin: A case-control study.

Involvement of collagen IV (ColIV) and fibronectin (FN) in the occurrence and development of diabetic nephropathy (DN) and the effects of telmisartan and Salvia miltiorrhiza injection in the treatment of the patients were investigated. Two hundred and fifty-eight patients with stage IV DN were selected as the case group, and another 110 normal healthy subjects were incorporated as the control group. Involved patients were subdivided into different groups according to different treatment therapies; patients in the telmisartan group (T group) were given oral telmisartan; patients in the Salvia miltiorrhiza injection + telmisartan (S + T group) were administered with Salvia miltiorrhiza injection combined with telmisartan treatment, and there was a group of patients who received no intervention as the placebo group. After intervention, levels of glycemic indexes and renal damage indexes indicated downwards trends both in the T group and the S + T group when compared to the placebo group; besides, levels in the S + T group were much lower than those in the T group (all P<0.05). Additionally, in comparison among the above three intervention groups, differences in the fasting blood glucose, 2 h post-prandial blood glucose, glycosylated hemoglobin, blood urea nitrogen, serum creatinine and urinary albumin excretion rate were significant after treatment (all P<0.05). Further, before intervention, both Co1IV and FN in the urine were increased in the case group compared to the control group (all P<0.05). After intervention, both levels were apparently decreased. There were remarkable differences of Co1IV and FN levels in the urine when compared among three different intervention groups after treatment (P<0.05). Increased ColIV and FN levels may be partially responsible for the development of DN. Salvia miltiorrhiza injection with telmisartan have beneficial synergistic effects for DN patients through attenuating the increase in ColIV and FN, reversing hyperglycemia state and postponing ultrastructure changes of glomerular basement membrane.

Effect of butylphthalide and sodium chloride injection combined with salvia miltiorrhiza injection in the treatment of acute ischemic stroke

Objective To investigate the value of butylphthalide and sodium chloride injectio combined with compound salvia miltiorrhiza injection in the treatment of acute ischemic stroke. Methods From January 2016 to December 2017, 104 patients with acute ischemic stroke in Tongji Huangzhou Hospital Affiliated to Huazhong University of Science and Technology were randomly divided into observation group(52 cases) and control group(52 cases) according to the digital table.The control group was given butylphthalide and sodium chloride injectio, and the observation group was combined with the compound salvia miltiorrhiza injection on the basis of the control group.The courses of the treatment in the two groups were 14 d. The effects of the two groups were compared. Results The total effective rate of the observation group(90.38%, 47/52) was higher than that of the control group(73.08%, 38/52)(χ2=5.216, P<0.05). After treatment, the daily living activity(ADL) score of the observation group was (60.49±5.46)points, which was higher than (44.54±4.10)points of the control group(t=16.845, P<0.05). After treatment, endothelin-1(ET-1), C reactive protein(CRP), homocysteine(Hcy) in the observation group were (37.42±5.47)ng/L, (6.51±1.89)mg/L, (7.42±1.27)μmol/L, respectively, which in the control group were (58.98±7.89)ng/L, (12.34±2.65)mg/L, (15.39±2.06)μmol/L, respectively, the levels of ET-1, CRP and Hcy in the observation group were lower than those in the control group(t=16.194, 12.916, 23.749, all P<0.05). After treatment, the plasma viscosity, fibrinogen, whole blood viscosity at high shear and low shear whole blood viscosity of the observation group were (1.20±0.23)mPa/s, (2.54±0.37)g/L, (2.54±0.37)mPa/s and (8.19±0.68)mPa/s, respectively, which of the control group were (2.09±0.32)mPa/s, (3.47±0.58)g/L, (3.46±0.59)mPa/s and (9.81±0.82)mPa/s, respectively, the plasma viscosity, fibrinogen, whole blood viscosity at high shear and low shear whole blood viscosity of water of the observation group after treatment were lower than those of the control group(t=16.286, 9.748, 10.994, 10.966, all P<0.05). Conclusion The effect of butylphthalide and sodium chloride injectio combined with compound salvia miltiorrhiza injection in the treatment of acute ischemic stroke is significant, which is worth studying. Key words: Stroke; Brain ischemia; Drug therapy, combination; Butylphthalide and sodium chloride injection; Compound salvia miltiorrhiza injection

Observation of effects of amino acid combined with Salvia miltiorrhiza injection on fetal growth restriction

Objective To investigate the effects of amino acid combined with Salvia miltiorrhiza injection on fetal growth restriction. Methods 122 pregnant women diagnosed with fetal growth restriction were chosen, and they were divided into study group(amino acid+ Salvia miltiorrhiza injection) and control group(amino acid). The course of treatment was 7d, and the patients were treated for 3 treatment courses.The clinical efficacy, weight increment, uterine height increment, abdominal circumference increment, fetal biparietal diameter (BPD) increment, femur length (FL) increment, umbilical cord blood flow S/D value and neonatal weight between the two groups were compared. Results The total effective rate in the study group was 84.13%, which was higher than 67.79% in the control group (χ2=4.484, P<0.05). In the study group, the body weight gain, the uterine height increment, abdominal circumference increment were (523.21±103.72)g, (2.88±0.52)cm and (3.19±0.75)cm, respectively, which were significantly higher than those in the control group(t=2.215, 4.402, 2.328, all P<0.05). The uterine height increment and abdominal circumference increment in the intermediate stage of the study group were (2.14±0.27)cm and (2.89±0.52)cm, respectively, which were significantly higher than those of the control group, and the differences were significant(t=1.503, 2.097, all P<0.05). In the study group, the BPD increment and FL increment at prophase and intermediate stage were (2.69±1.23)mm and (2.24±0.97)mm, (2.61±1.28)mm and (2.19±1.28)mm, respectively, which were significantly higher than those in the control group (t=2.053 and 2.244, 2.038 and 2.128, all P<0.05). The S/D values of umbilical cord blood flow in early stage, middle stage and anaphase of the study group were (2.33±0.19), (2.46±0.17) and (2.12±0.14), which were significantly lower than those of the control group (t=4.040, 2.9817 and 4.418, all P<0.05), the differences were statistically significant.The neonatal weight of the study group was (2 576.18±621.04)g, which of the control group was (2 384.09±428.76)g, and there was significant difference between the two groups(t=1.999, P<0.05). Conclusion Amino acid combined with Salvia miltiorrhiza injection can effectively improve the clinical indicators of pregnant woman and fetal growth restriction, with good clinical effects. Key words: Fetus growth retardation; Salvia miltiorrhiza injection; Amino acid

Salvia miltiorrhiza injection restores apoptosis of fibroblast-like synoviocytes cultured with serum from patients with rheumatoid arthritis.

Salvia miltiorrhiza injection(SMI) is a water‑soluble agent, derived from Salvia miltiorrhiza (SM), that is traditionally used to treat cardiovascular and cerebrovascular diseases. Furthermore it has been demonstrated to possess the ability to induce apoptosis of tumor cells. However, it remains unclear whether SMI can induce apoptosis of rheumatoid arthritis(RA) fibroblast‑like synoviocytes(FLS), which are hyperplastic in RA due to defective apoptosis. There is also evidence that allogenic serum may be associated with the induction of apoptosis. The aim of the present study was to investigate the involvement of serum during SMI‑induced apoptosis in RAFLS. The results demonstrated that SMI could induce apoptosis of RAFLS, cultured with fetal bovine serum(FBS), in a dose‑dependent manner. In addition, SMI decreased the expression of nuclear factor‑κB in RAFLS nuclear extracts and inhibited the secretion of tumor necrosis factor‑α. Fas ligand expression was not detected in RAFLS, in either the presence or absence of SMI. The pro‑apoptotic genes B‑celllymphoma2(Bcl‑2) associated X protein (Bax) and Fas, were shown to be upregulated following SMI stimulation, whereas the expression levels of the anti‑apoptotic gene Bcl‑2, were downregulated. Upon replacement of FBS with normal human serum, the apoptotic rate and Bax mRNA expression levels following SMI stimulation, were unchanged. However, culturing RAFLS with patient' serum(RPS), restored the apoptotic rate and Bax mRNA expression levels following SMI stimulation. There may be numerous mechanisms by which SMI inhibits RAFLS proliferation. The present study demonstrated that SMI can restore apoptosis of RA FLS cultured with RPS. These results indicate that SMI may have a potential role in the treatment of synovial hyperplasia of RA.

Analysis of active components in Salvia miltiorrhiza injection based on vascular endothelial cell protection.

Correlation analysis based on chromatograms and pharmacological activities is essential for understanding the effective components in complex herbal medicines. In this report, HPLC and measurement of antioxidant properties were used to describe the active ingredients of Salvia miltiorrhiza injection (SMI). HPLC results showed that tanshinol, protocatechuic aldehyde, rosmarinic acid, salvianolic acid B, protocatechuic acid and their metabolites in rat serum may contribute to the efficacy of SMI. Assessment of antioxidant properties indicated that differences in the composition of serum powder of SMI caused differences in vascular endothelial cell protection. When bivariate correlation was carried out it was found that salvianolic acid B, tanshinol and protocatechuic aldehyde were active components of SMI because they were correlated to antioxidant properties.

Salvia miltiorrhiza injection on pulmonary heart disease: a systematic review and meta-analysis.

Cor pulmonale (pulmonary heart disease) is a chronic progressive complicated disease for which treatment needs to be sustained all the time, creating a great financial burden on individuals and society. In order to improve the life quality of cor pulmonale patients and decrease the dosage and quantity of the routine treatment, in China, TCM is often administered to patients with cor pulmonale. The results of many clinical trials have indicated that Salvia miltiorrhiza and complex Salvia miltiorrhiza injection may be an alternative medicine for cor pulmonale. With the purpose to prove whether Salvia miltiorrhiza and complex Salvia miltiorrhiza benefit the cor pulmonale patients, respectively, we carried out a systematic review to evaluate the efficacy and safety of Salvia miltiorrhiza and complex Salvia miltiorrhiza injection in cor pulmonale patients. Overall, 2,715 patients were identified from 35 randomized controlled trials. The meta-analysis used I(2) test for heterogeneity and chose random or fixed model according to heterogeneity of included studies. Clinical outcomes were evaluated by total effectiveness rate, partial pressure of oxygen ( PaO 2) and carbon dioxide ( PaCO 2), hemorheology, mPAP and adverse effects. Compared with routine medicine treatment alone, routine medicine treatment plus Salvia miltiorrhiza or complex Salvia miltiorrhiza injection showed better outcomes: A significantly higher clinical effectiveness rate ratio (p < 0.001), increase in PaO 2 (p < 0.001) and decrease in PaCO 2 (p < 0.001), improvement in hemorheology (p < 0.001), and alleviation in mPAP (p < 0.05). There is no obvious adverse effect reported. In summary, there are some evidences suggesting that Salvia miltiorrhiza or complex Salvia miltiorrhiza injection are active in cor pulmonale, however, the results were limited by the methodological flaws of the included studies. Long-term and high quality clinical trials are needed to provide more conclusive evidence for the future use of Salvia miltiorrhiza injection.

Efficacy observation on cervical spondylosis of nerve root type treated by the warm needling at Jiáj ( EX-B 2) and tapping with plum-blossom needle

ObjectiveTo observe the clinical effect on cervical spondylosis of nerve root type treated by warm needling therapy at Jiáj▪ (▪ EX-B 2) and plum-blossom needle therapy. MethodsAccording to the random number table, 150 cases of cervical spondylosis of nerve root type were randomized into an acupuncture-moxibustion group (75 cases) and a control group (75 cases). In the acupuncture-moxibustion group, the warm needling at EX-B 2 and tapping with plum-blossom needle were applied. EX-B 2 on the affected segments were selected and stimulated with warm needling technique for 20–30 min. Afterward, the plum-blossom needle was used to tap the skin around the acupoints, for 3 min on each site. The treatment was given once every day. Seven treatments made one session. The interval between two sessions was 1 day. In the control group, the medication was used in combination with traction therapy. The intravenous drip with 5% glucose 250 mL and compound salvia miltiorrhiza injection 40 mL was used, once a day. In traction treatment, the patient was in a sitting position, neck anteflexion at 15°-30°, traction force at 10%–20% of the body mass, for 20–30 min in each time. The treatment was given once every day. The appointed person evaluated therapeutic effects after the three sessions of treatment in the two groups. ResultsThe clinical curative rate was 49.3% (37/75) and the total effective rate was 94.7% (71/75) in the acupuncture-moxibustion group and those were 24.0% (18/75) and 81.3% (61/75) respectively in the control group. The total effective rate and clinical curative rate in the acupuncture-moxibustion group were superior to the control group (both P<0.05). In the comparison of the duration of treatment and effect in the cured patients between the two groups, the curative rate in the 1st session of treatment in the acupuncture-moxibustion group was higher than that in the control group (P<0.05). In the comparison of the 6-month follow-up visit in the cured patients between the two groups, the effect in the acupuncture-moxibustion group was much more stable (P<0.05). ConclusionThe warm needling therapy at EX-B 2 and tapping therapy with plum-blossom needle achieve the significant effect on cervical spondylosis of nerve root type.

Quality by Design for Herbal Drugs: a Feedforward Control Strategy and an Approach to Define the Acceptable Ranges of Critical Quality Attributes

The concept of quality by design (QbD) has been widely accepted and applied in the pharmaceutical manufacturing industry. There are still two key issues to be addressed in the implementation of QbD for herbal drugs. The first issue is the quality variation of herbal raw materials and the second issue is the difficulty in defining the acceptable ranges of critical quality attributes (CQAs). To propose a feedforward control strategy and a method for defining the acceptable ranges of CQAs for the two issues. In the case study of the ethanol precipitation process of Danshen (Radix Salvia miltiorrhiza) injection, regression models linking input material attributes and process parameters to CQAs were built first and an optimisation model for calculating the best process parameters according to the input materials was established. Then, the feasible material space was defined and the acceptable ranges of CQAs for the previous process were determined. In the case study, satisfactory regression models were built with cross-validated regression coefficients (Q(2) ) all above 91 %. The feedforward control strategy was applied successfully to compensate the quality variation of the input materials, which was able to control the CQAs in the 90-110 % ranges of the desired values. In addition, the feasible material space for the ethanol precipitation process was built successfully, which showed the acceptable ranges of the CQAs for the concentration process. The proposed methodology can help to promote the implementation of QbD for herbal drugs.

Danshen (Salvia miltiorrhiza) Injection Suppresses Kidney Injury Induced by Iron Overload in Mice

ObjectivesExcessive iron can accumulate in the kidney and induce tissue damage. Danshen (Salvia miltiorrhiza) injection is a traditional Chinese medicinal preparation used for preventing and treating chronic renal failure. The aim of the present study was to evaluate the effects of treatment with Danshen injection on iron overload-induced kidney damage.MethodsMice were mock-treated with saline (control group) or given a single dose of iron dextran without treatment (iron overload group, 50 mg/kg/day for 2 weeks) or with daily treatments of low-dose Danshen (3 g/kg/day), high-dose Danshen (6 g/kg/day) or deferoxamine (100 mg/kg/day).ResultsTreatment of iron-overloaded mice with Danshen injection led to significant improvements of body weight and decreased iron levels in the kidney. Danshen injection treatment also reduced concentrations of blood urea nitrogen, creatinine and malondialdehyde and enhanced glutathione peroxidase and superoxide dismutase activities. Histopathological examinations showed that Danshen injection ameliorated pathological changes and reduced iron deposition in kidneys of iron overloaded mice. Furthermore, the treatment was demonstrated to suppress apoptosis in nephrocytes.ConclusionsThese results indicated that Danshen injection exerted significant renal protective effects in iron-overloaded mice, which were closely associated with the decrease of iron deposition and suppression of lipid peroxidation and apoptosis in the kidney.

GW24-e0777 The observation of the fleabane injection clinical curative effect on the old patients with acute coronary syndrome

ObjectivesTo observe the fleabane injection clinical curative effect and security on the patients with acute coronary syndrome.MethodsWe divided 66 patients with acute coronary syndrome into 2 groups. The experimental group...

A clinical study on ulinastatin combined with salvia miltiorrhiza in adjuvant treatment of acute lung injury

Objective To explore the clinical efficacy and safety of ulinastatin combined with salvia miltiorrhiza in adjuvant treatment of acute lung injury.Methods 100 patients with acute lung injury were randomly divided into study group and control group,50 for each group.Both groups received routine treatment.The study group received additional uhnastin of 3000 U/(kg· d) combined with salvia miltiorrhiza injection of 30ml/d.Changes in symptoms,hs-CRP,lactate acid,TNF-α,and IL-6 were observed.The efficacy was analyzed 7 days after treatment.Results 7 days after treatment,the total effectiveness rate was significantly higher in the study group than in the contol group (92％ vs.72％,x2 =6.775,and P ＜ 0.01).Before treatment,plasma levels of hs-CRP,lactate acid,TNF-α,and IL-6 did not differ significantly (P＞ 0.05).7 days after treatment,levels of hs-CRP,lactate acid,TNF-α,and IL-6 were significantly lower in the study group (P＜ 0.01).The respiratory rate dropped sharply while Pa02 and PaO2/Fi02 were dramatically elevated in both groups after treatment (P＜ 0.05),with a more obvious change in the study group.The respiratory rate,Pa02,and Pa02/Fi02 were improved better in the study group (P＜ 0.01).Conclusions Ulinastatin combined with salvia miltiorrhiza injection in the adjuvant treatment of acute lung injury can significantly improve patient condition and reduce inflammatory reaction.It is worth popularizing clinically. Key words: Acute lung injury; Ulinastatin ; Salvia miltiorrhiza injection

The protective effect of low molecular dextran combined with salvia miltiorrhiza Injection against kidney damage from contrast agent

Objective To explore the protective effect of low molecular dextran combined with salvia miltiorrhiza injection against kidney damage from contrast agent after percutaneous coronary intervention(PCI) and the effect of preventing kidney damage.Methods 120 patients who underwent PCI were randomly divided into two groups:the treatment group( low molecular dextran combined with salvia miltiorrhiza treatment) and the control group,each group 60 cases.The control group was given the conventional treatment,and the treatment group was treated with 250ml low molecular dextran and 16ml salvia miltiorrhiza injection for 7d on the basis of conventional treatment.The levels of blood urea nitrogen ( BUN ),serum creatinine ( SCR),β2 microglobulin ( β2-MG),24h urine protein were detected before and 1 d,6d after surgery.Results At one day after application of contrast agent,the levels of BUN,SCR,β2-MG,24h urine protein were increased,and returned to baseline level at 6th day.The levels of BUN,SCR,β2-MG,24h urine protein of the treatment group were significantly lower than those of the control group at 6th day ( P ＜ 0.05 ).Conclusion The low molecular dextran combined with danshen injection treatment in the perioperative period could effectively reduce the kidney impairment from contrast agent and the incidence of renal insufficiency. Key words: Agents; Renal damage; Low molecular dextran; Danshen injection