中药注射剂不良反应监测的初步报告

目的了解中药注射剂不良反应情况,探讨与不良反应的发生有关的影响因素。方法采用医院集中监测方法,收集医院内所有使用中药注射剂的住院病人的临床资料和所有相关的不良事件,对不良反应因果关系进行判断,分析各种影响因素与不良反应发生的关系。结果收集到3375例住院患者资料,发生与中药注射剂有关的不良事件共有51例,因果关系判断为“可能”者有11例,判断为“很可能”者有40例。与中药注射剂有关的可能不良反应的发生率为1.51%,92%的不良反应属于过敏反应。所监测的中药注射剂有31种,其中以鸦胆子油乳注射液、灯盏花素注射液和参附注射液的不良反应发生率较高。Logistic逐步回归分析表明,退休相对于体力劳动、较高的教育程度相对于文盲来说,不良反应发生的危险性较高。结论中医内科病房住院病人中药注射剂不良反应的发生较少,但个别中药注射剂不良反应发生率较高,应引起注意。

中药注射剂不良反应原因探讨

本文主要阐述了中药注射剂不良反应出现的原因,重点从中药成分本身、原料杂质、辅料和未知原因等方面,对中药注射剂特殊不良反应进行深入探讨。以期为中药注射剂安全性问题研究及其临床使用提供参考。

10种中药注射剂不良反应原因分析

目的:对2003年~2007年临床上报的不良反应(ADR)报告病例53例进行统计分析,旨在关注用药安全。方法:从17种中药注射剂ADR发生率较高的前10名药品依次归类统计、分析。ADR多为变态(过敏)反应,最严重的为过敏性休克,但无死亡病例。结论:中药注射剂易发生ADR,临床应谨慎使用。

57例中药注射剂不良反应分析

目的:为临床合理使用中药注射剂提供参考。方法:对2009年1月至2011年12月期间发生的中药注射剂ADR进行回顾性分析。结果:57例患者中男性ADR38例,明显高于女性19例(P<0.05);年龄超过60岁,ADR发生率明显较其他年龄组高(P<0.05);ADR发生类型以药物热、皮肤及附件损害表现最多见;ADR分级多数为一般,并且和其他组比较(P<0.05);ADR发生时间多在用药10～30min之内,和其他时间段发生率比较(P<0.05)。结论:中药注射剂ADR可发生在各个年龄段,以药物热、皮肤及附件损害表现最多见;发生时间多集中在用药10～30min之内,临床使用时应注意。

Effects of Shenmai Injection on Blood SOD Activity and MDA Level in Senile Patients with Coronary Heart Disease

In order to approach the effects of Shenmai Injection on SOD activity and MDA level in the senile patients with coronary heart disease, 48 cases, who had stenosis of over 70% in more than one branches of the coronary arteries, were assigned randomly into a treatment group (given Shenmai Injection plus the routine treatment) and a control group (given the routine treatment only). The superoxide dismutase (SOD) activity and malondialdehyde (MDA) level were determined before treatment and at the end of a 3-week treatment. The results showed that in the treatment group, the SOD activity was significantly increased (P＜0.05) and the MDA level markedly decreased (P＜0.01) in the treatment group. It can be concluded that Shenmai Injection may enhance the antioxidant ability of the senile patients with coronary heart disease.

Point injection of Injectio Radici Astragali for Treatment of Post-chemotherapy Adverse Reactions

With injection of Injectio Radici Astragli into the point Zusanli (ST 36), we have obtained quite satisfactory therapeutic results for treating leukopenia and the impairment in immune functions occurred in cancer chemotherapy. A report follows.

Multicenter randomly controlled trial on acupoint injection therapy with Chinese herbal medicines for oculomotor paralysis

Objective To evaluate the clinical effect of acupoint injection therapy for paralysis of oculomotor nerve with Chinese herbal medicines. Methods A total number of 456 patients from 3 centers with paralysis of oculomotor nerve were randomly divided into an acupoint injection group and a control group with 228 cases each. Patients in the acupoint injection group were treated with injection of Chinese herbal medicines to Jingming （晴明 BL 1）, Yangbai （阳白GB 14}, Sibai （四白 ST 24 Tongziliao （瞳子髎 GB I） on the affected side, and Ganshu （肝俞 BL 18） on both sides, Compound Angelica Injection was the main drug, and the corresponding acupoints and other injection drugs were also used according to differentiation of syndrome. Patients in the control group were treated with common western medicine. The treatment was given once a day, 10 times constituted one course with 3 days of interval. After 3 courses, the effect was assessed. TCM syndrome score, eyeball movement degree, the sizes of oculi rimae and pupil of the two groups were recorded before and after treatment. Results The effective rate of acupoint injection group was 91.7% （209/228）, and that of the control group was 73.6% （168/228）. There was statistical significance in comparing the difference between the two groups （P〈0.05）. TCM syndrome scores of the two groups after the treatment became less obviously than those before the treatment （P〈0.01, P〈0.05）, the score of acupoint injection group was more reduced than that of the control group （P〈0.05）. Eyeball movement degree and oculi rimae were enlarged and the pupil reduced in the affected eye in both groups after the treatment Call P〈0.05）. The musculus rectus medialis for the eyeball movement in the acupoint injection group was more improved than that of the control group, and the oculi rimae was bigger in the acupoint injection group than that in the control group （both P〈0.05）. Conclusion Acupoint injection therapy with Chinese herbal medicines has assured effect on the treatment of oculomotor paralysis.

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.