Intensive hospital monitoring of Shuxuening injection in 30 209 cases / 中国中药杂志

In order to obtain the characteristics and incidence of adverse reactions of Shuxuening injection (Xingxue), the design method of a multi-center, large sample intensive monitoring in the hospitals was adopted. The hospitalized patients with use of Shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle. The main content of monitoring included the patients' general information, diagnostic information, medication information, and adverse event information. A total of 30 209 patients with Shuxuening injection were enrolled; adverse reactions occurred in 34 cases, with an incidence of 0.113%, which belonged to the rare adverse reactions. Adverse reactions were characterized by headache, dizziness, pruritus, palpitations, nausea, et al. All the above results showed that Xingxue Shuxuening injection had high safety in clinical application.

Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments) / 中国中药杂志

It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

Technical specifications for rational clinical use of parenterally administered Chinese medicine (draft version for comments) / 中国中药杂志

The regulations on basic clinical use of parenterally administered Chinese medicine, issued jointly in 2008, by the ministry of health (MOH), China food and drug administration (SFDA) and the state administration of traditional Chinese medicine (SATCM). Integrating actual clinical practice, these presented doctors and nurses with detailed specifications for the safe use of parenterally administered Chinese medicine. The regulations emphasize the use of Chinese medicine pattern differentiation, use in strict accordance with instructions, and they prohibit use combined with other medicines. The emphasis of the regulations are practicality and operability, and provide meaningful guidance to doctors and nurses for the rational and safe use of parenterally administered Chinese medicine, to reduce adverse reactions/adverse events caused by improper use.

Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments) / 中国中药杂志

Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring / 中国中药杂志

<p><b>OBJECTIVE</b>To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs).</p><p><b>METHOD</b>A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection.</p><p><b>RESULT</b>A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero.</p><p><b>CONCLUSION</b>A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.</p>

Clinical evaluation of multi-function "rapid" allergic skin test instrument for application in drug allergy testing / 中国中药杂志

<p><b>OBJECTIVE</b>To evaluate the multi-function rapid allergic skin test instrument for application in drug allergy testing.</p><p><b>METHOD</b>Three hundred patients were planned to be treated with cephalosporins Injection were divided randomly into 3 groups, the new allergic skin test instrument group, normal allergic skin test instrument group, and traditional skin test group, the true positive rate and false positive rate were calculated. Using multifunctional rapid allergy skin test was carried out on 210 cases of volunteers preliminary clinical evaluation of traditional Chinese medicine injections skin test.</p><p><b>RESULT</b>There were no significance difference between the new allergic skin test instrument group and control group in the true positive rate. As compared with the control group, a significance difference was found between the new allergic skin test instrument group and control group in false positive rate respectively (P < 0.05).</p><p><b>CONCLUSION</b>The multi-function rapid allergic skin test instrument is safe and easy to use, with a higher rate of accuracy and lower false positive rate.</p>

Clinical re-evaluation of effects of two different "cocktail therapy" to prevent from phlebitis induced by Chansu injection / 中国中药杂志

<p><b>OBJECTIVE</b>To re-evaluate the effects of different "cocktail therapy" to prevent from phlebitis induced by Chansu injection.</p><p><b>METHOD</b>Patients treated with Chansu injection were divided randomLy into 4 groups with 90 per group, control group, phentolaminum group, the magnesium sulfate group-phentolaminum group, and anisodamine-phentolaminum group. Patients in the control group only received the routine nursing treatment, and patients in the various experiment group received different interventions. The comparison was made in the morbidity and the starting time of occurrence of phlebitis, the severity of pain, duration of pain.</p><p><b>RESULT</b>The morbidity of phlebitis was 8%, 8%, 6%, respectively. The starting time of phlebitis occurrence was (22 +/- 4), (27 +/- 5), (28 +/- 7) h, respectively. The NRS of pain was (4.75 +/- 1.51), (3.27 +/- 1.02), (2.71 +/- 1.63), respectively. The duration time of pain was (4.25 +/- 1.36), (2.51 +/- 1.05), (2.19 +/- 1.13) d respectively. In control group, the morbidity of phlebitis, the starting time of occurrence of phlebitis, the severity of pain, duration of pain was 30%, (16 +/- 4) h, (6.34 +/- 1.21), (5.47 +/- 1.07) d, respectively. As compared with the control group, a significance difference was found between every group in three test groups and control group respectively (P<0.05).</p><p><b>CONCLUSION</b>The morbidity and the starting time of occurrence of phlebitis, the severity of pain, duration of pain was significantly reduced respectively by two different "cocktail therapy".</p>

Experimental study of suspicious sensitization component screening on Huachansu injection / 中国中药杂志

<p><b>OBJECTIVE</b>To explore a new experimental method for screening of allergens in post-market traditional Chinese medicine injections by confirming allergens in Huachansu injection.</p><p><b>METHOD</b>First of all, the serum of patients allergic to Huachansu injection were collected, at the same time, the dubious allergen was conjugated to bovine serum albumin (BSA) by EDC coupling procedure to form complete antigen (BNP-BSA), which makes it possible to reproduce the allergic reaction of Huachansu injection in vitro. The histamine liberation ratio, the level of TNF-alpha and Histamine released from RBL-2H3 mast cell were detected; the above data were compared with those obtained in vivo.</p><p><b>RESULT</b>The difference of the histamine liberation ratio, the levels of TNF-alpha and histamine of the resibufogenin-BSA group, group of patients allergic to Huachansu injection were not significant compared with those of normal control group. However, there were significant difference in those data among the cinobufagin-BSA group, the blank control and normal control group (P<0.05).</p><p><b>CONCLUSION</b>The allergen in the serum collected from patients allergic to Huachansu injection is resibufogenin.</p>