Clinical Non-inferiority Trial on Treatment of Coronary Heart Disease Angina Pectoris of Xin-blood Stasis Syndrome Type with Lyophilized Salvia Salt of Lithospermic Acid Powder for Injection

Objective： To evaluate the effectiveness and safety of lyophilized Salvia salt of lithospermic acid powder for injection （SSLA） in treating coronary heart diseases angina pectoris （CHD-AP） of Xin-blood stasis syndrome type, and to conduct the non-inferiority trial with Danshen injection （丹参注射液, DSI） as positive control. Methods： An non-inferiority clinical layered, segmented, randomized, and blinded trial on three parallel and multiple centered groups was conducted in 480 patients with stable effort angina grade Ⅰ , Ⅱand Ⅲ, who had two or more times of attack every week. The 240 patients in test group A were treated with SSLA 200 mg added in 250 ml of 5% glucose solution for intravenous dripping every day; the 120 patients in test group B were treated with SSLA but the dosage doubled; and the 120 patients in the control group were treated with DSI 20 ml daily in the same method as SSLA was given. The clinical effectiveness and safety were evaluated after the patients were treated for 14 days. Results： The results showed that the markedly effective rate in test groups A, B and control group was 37.45 %, 36.75 % and 30.09 % respectively, while the total effective rate in them was 88.09%, 89.74% and 67.26% respectively. Statistical significance was shown in comparisons of the therapeutic effect between control group with test group A and test group B, with that in the two test groups superior to that in the control group, and non-inferiority trial showed eligibility （P〈0.01）. Adverse reaction appeared in 8 patients in the test groups and 2 in the control group. Conclusion： SSLA has definite therapeutic effect in treating patients with CHD-AP, with its effect not inferior to that of DSI, and no evident toxic-adverse reaction.

Progress in the study of antiplatelet and antithrombotic effects of salvia polyphenolic acid for injection

Salvia polyphenolic acid for injection is a new generation of Chinese medicine injectable,which is developed by extracting and separating the water-soluble phenolic acid active ingredients of Salvia divinorum by using modern advanced technology as raw material.Pharmacological research shows that salvia polyphenolic acid has anti-inflammatory,anti-oxidative stress,neurotrophic,regenerative and protective effects on ischemic brain injury and can reduce myocardial ischemic injury.In clinical practice,it is mainly used in the treatment of stroke(mild to moderate cerebral infarction)in the recovery period of fetish blood obstruction.In recent years,it has also been gradually extended to treating acute cerebral infarction and respiratory syndrome.Since its launch,the pharmacological effects and clinical applications of Danshen polyphenolic acid for injection are reviewed to provide research clues for further essential trials and reference basis for clinical promotion and application.

Research progress on pharmacological effect of Salvianolic acid for injection in post-stroke depression

Post-stroke depression (PSD) is one of the most common affective disorders after acute cerebrovascular injury. It significantly increases the mortality, disability rate and recurrence rate of stroke, which places a heavy burden on families and society. The etiology of PSD is not yet clear, involving a series of complex mechanisms. Inflammatory response, apoptosis, neurotrophic factors, neurotransmitters and many others may play important roles, and there is no effective treatment. Salvianolic acid for injection (SAFI) has the functions of anti-inflammatory, anti-oxidative stress, anti-apoptotic and can improve depressive behavior. It is expected to become a new antidepressant for the treatment of PSD.

Analysis on Common Compatibility Contraindications of Breviscapine for Injection

[Objectives]To analyze the common compatibility contraindications of breviscapine for injection,and to provide references for clinical rational drug use.[Methods]The pH distribution of the combined drugs in the report on the compatibility contraindications of breviscapine for injection and was analyzed.[Results]Breviscapine for injection may become turbid or precipitated when mixed with drugs whose pH are lower;it can make the liquid discoloration in a strong alkaline solution.[Conclusions]Breviscapine for injection should not be combined with drugs whose pH are lower,especially drugs with pH lower than 4.2.Breviscapine for injection should not be used with drugs with strong alkaline.It is recommended to use Breviscapine for injection separately.

Analysis of 8611 Cases of Adverse Reaction Reports of Breviscapine for Injection

[Objectives]To analyze the occurrence rules and factors influencing adverse reactions of breviscapine for injection,explore potential drug risks,and guide the clinical rational medication.[Methods]The retrospective analysis method was used to analyze the case reports of adverse reactions of breviscapine for injection,and analyze the gender and age distribution of the cases,the patient's medication status,the adverse reactions involving organ/system damage and clinical manifestations,the occurrence time,duration,and outcome of the adverse reactions.[Results]Adverse reactions of breviscapine for injection were mainly concentrated in middle-aged and elderly patients aged 45 and above,accounting for 85.35%;in the gender distribution,females were higher than males;adverse reactions involved multiple organ/system damages.Among them,75.86%of patients had adverse reactions after the first medication,and 11.77%of reported patients had concomitant medications.[Conclusions]The adverse reactions caused by breviscapine for injection may be related to the patient's age,gender and irrational medication.

Genetic Algorithm for Injection Mould Design and Moulding

Obtaining the optimal values of the parameters for th e design of a required mould and the operation of the moulding process are diffi cult, this is due to the complexity of product geometry and the variation of pla stic material properties. The typical parameters for the mould design and mouldi ng process are melt flow length, injection pressure, holding pressure, back pres sure, injection speed, melt temperature, mould temperature, clamping force, inje ction time, holding time and cooling time. This paper discusses the difficulties of using the current computer aided optimization methods to acquire the values of the parameters. A method that is based on the concept of genetic algorithm is proposed to overcome the difficulties. The proposed method describes in details on how to attain the optimal values of the parameters form a given product geom etry.

Xueshuantong for Injection(Lyophilized,注射用血栓通)Alleviates Streptozotocin-Induced Diabetic Retinopathy in Rats

Objective To investigate the ameliorate effect and underlying mechanism of Xueshuantong for Injection(Lyophilized,注射用血栓通,XST)in streptozocin(STZ)-induced diabetic retinopathy(DR)rats.Methods Diabetes mellitus(DM)model was induced by intraperitoneal(i.p.)injection of STZ(60 mg/kg)in Sprague-Dawley rats.Diabetic rats were randomized into 3 groups(n=10)according to a random number table,including DM,XST50 and XST100 groups.XST treatment groups were daily i.p.injected with 50 or 100 mg/kg XST for 60 days,respectively.The control and DM groups were given i.p.injection with saline.Blood glucose level and body weight were recorded every week.Histological changes in the retina tissues were observed with hematoxylin-eosin staining.Apoptosis and inflammation related factors,including cleaved caspase-3,glial fifibrillary acidic protein(GFAP),tumor necrosis factor-α(TNF-α)and intercellular cell adhesion molecule-1(ICAM-1)were detected by Western blot or real-time polymerase chain reaction.Then,the levels of advanced glycation end product(AGE)and its receptor(RAGE)were investigated.Tight junctions proteins(Zonula occludens-1(ZO-1),Occludin and Claudin-5)of blood-retinal barrier were detected by Western blot.The levels of retinal fifibrosis,transforming growth factor-β1(TGF-β1)-Smad2/3 signaling pathway were evaluated at last.Results There was no signifificant difference in the body weight and blood glucose level between XST and DM groups(P>0.05).Compared with the DM group,XST treatment signifificantly increased the retinal thickness of rats(P<0.05 or P<0.01),and suppressed cleaved caspase-3 expression(P<0.01).XST increased the protein expressions of ZO-1,Occludin and Claudin-5 and decreased the mRNA expressions of matrix metalloproteinase 2(MMP-2)and MMP-9(P<0.05 or P<0.01).Moreover,XST signifificantly reduced the productions of AGE and RAGE proteins in the retina of rats(P<0.05 or P<0.01),suppressed the over-expression of TNF-α,and decreased the elevated level of ICAM-1 in retina of rats(P<0.05 or P<0.01).XST signifificantly reduced the levels ofα-smooth muscle actin(α-SMA),connective tissue growth factor(CTGF),TGF-β1 and phosphorylation of Smad2/3 protein in rats(P<0.05 or P<0.01).Conclusions XST had protective effects on DR with possible mechanisms of inhibiting the inflammation and apoptosis,up-regulating the expression of tight junction proteins,suppressing the productions of AGE and RAGE proteins,and blocking the TGF-β/Smad2/3 signaling pathway.XST treatment might play a role for the future therapeutic strategy against DR.

Study on the anaphylactic shock induced by hemocoagulase for injection based on logistic analysis

In the present study, we aimed to explore the influencing factors of anaphylactic shock caused by hemocoagulase for injection and to provide a scientific basis for clinical safe medication. The cases reports on the adverse reactions induced by hemocoagulase for injection were collected in Chinese and foreign literatures. The clinical characteristics and influencing factors of anaphylactic shock induced by hemocoagulase for injection were evaluated by logistic regression analysis. In this study, 87 articles including 108 cases(68 cases of anaphylactic shock) were collected. Univariate logistic regression indicated that allergic constitution, daily dose, combined anesthesia, first drug delivery, post-dose time and course of treatment were positively associated with the incidence of anaphylactic shock caused by hemocoagulase for injection(P<0.05). The six above-mentioned factors were included in the multivariate logistic stepwise regression analysis to exclude the effects of confounding factors, and the results suggested that allergic constitution(P = 0.048, OR = 8.242), combined anesthesia(P = 0.024, OR = 22.675) and post-dose time(P = 0.006, OR = 20.255) were associated with the incidence of anaphylactic shock caused by hemocoagulase for injection. The clinicians should pay much more attention to risk factors that may cause anaphylactic shock, such as allergic constitution, combined anesthesia and post-dose time. The clinical pharmacists should strengthen pharmaceutical monitoring and improve the safety of medication.

Analysis and Management of Adverse Drug Reactions after Injection of Amphotericin B in AIDS Patients with Fungal Infection

Objective: To understand the condition of adverse drug reactions and the treatment procedures of amphotericin B for injection in patients with AIDS complicated with fungal infection. Methods: For the research object, a retrospective analysis of adverse reactions of amphotericin B injection in 121 patients of AIDS complicated with fungal infection was reported in our hospital from October 2017 to June 2021 to observe the adverse drug reactions of patients after treatment with amphotericin B for injection, 87 cases with general degree (regarded as the general group) and 34 cases with serious degree (regarded as the serious group), and analyze the general data, medication and course of disease of the two groups for symptomatic treatment. Results: Adverse reactions such as hypokalemia, abnormal liver function, renal impairment, leucopenia and drug fever were more common in the two groups, and there were also many adverse reactions such as bone marrow suppression, rash, anemia, thrombocytopenia, nausea, vomiting, fatigue, dizziness, pruritus, angina pectoris, vertigo, abdominal pain and diarrhea. The rates of leukopenia and drug fever in general group were significantly lower than those in severe group (P < 0.05);in the dose of amphotericin B used, the rate of using 25 mg and more than 25 mg in the general group was significantly lower than that in the severe group (P < 0.05). After symptomatic treat-ment, most patients have improved, and a few are unknown or have not improved. Con-clusion: Amphotericin B for injection has great side effects and will cause different degrees of adverse drug reactions. The dose of amphotericin B for clinical treatment should be ad-justed and disposed according to the adverse reactions to avoid serious consequences.