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OBJECTIVE： To analyze the characteristics of adverse drug reactions/events （ADR/ADE） caused by TCM injections in 18 third grade class A hospitals from Xi’an， and to provide reference for rational drug use in clinic. METHODS： Totally 304 ADR/ADE cases of TCM injection reported by 18 third grade class A hospitals of Xi’an were analyzed statistically during 2013-2018 in respect of gender and ages， time distribution of ADR/ADE， distribution of ADR/ADE-inducing drugs， organs/systems involved in ADR/ADE and clinical manifestations， grading of ADR/ADE， outcome and relationship evaluation， drug combination. RESULTS： Totally 6 683 cases of ADR/ADE cases were reported in same period， 304 cases were caused by TCM injection （4.55％）. Among 304 cases of ADR/ADE， the number of women （162 cases， 53.29％） was slightly higher than that of men （142 cases， 46.71％）. The age of patients was mainly over 40 years old （223 cases， 73.35％）. Among them， 118 cases （38.82％） were over 60 years old. ADR/ADE occurred within 1 min to 10 days after administration， especially within 30 min after administration （123 cases， 40.46％）. ADR/ADE involved 36 varieties， mainly including agent for promoting blood circulation and dredging， agent for reinforcing and tonifying and agent for clearing away heat and detoxification， and Danhong injection accounted for the highest proportion （43 cases， 14.14％）. A total of 352 ADR/ADE case times occurred in 304 patients， mainly lesion of skin and appendents （164 case times， 46.59％）， followed by cardiovascular system lesions （54 case times， 15.34％） and systemic lesions （51 case times， 14.49％）. The main clinical manifestations were mainly pruritus （117 case times）， followed by rash （68 case times） and palpitation （34 case times）. Among 304 ADR/ADE reports， 26 cases （8.55％） were severe， 8 cases （2.63％） were new ADR/ADE， 302 cases （99.34％） were cured or improved， 2 cases （0.66％） were unknown， but none of them died. 266 cases （87.50％） were evaluated as likely to be related. 46 patients （15.13％） had combined use of drugs， including 9 cases of combined use of TCM injection and 37 cases of combined use of chemical medicine injection. CONCLUSIONS： TCM injections had a high incidence of ADR/ADE due to the complexity of their components， individual differences and clinical use. Most of them were rapid-onset ADR/ADE within 30 min and mild ADR/ADE commonly seen in lesion of skin and its appendents. The incidence could be reduced by rational clinical use and drug monitoring. For cardiovascular diseases and other basic diseases， attention should be paid to distinguishing their primary diseases from ADR/ADE caused by TCM injections， and more attention should be paid to their individualized drug use.
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Objective To provide references for clinical rational utilization of TCM injections for activating blood circulation to dissipate blood stasis. Methods Retrospective analysis was used to sort and analyze in terms of species, consumption sum, DDDs and DDDc of TCM injections for activating blood circulation to dissipate blood stasis in Lanzhou Second People's Hospital (here in after referred to as our hospital) during 2014‐2016. Results The consumption sum of TCM injections for activating blood circulation to dissipate blood stasis was relatively high in the consumption sum of TCM injections (over 30％), and the type of TCM injections for activating blood circulation to dissipate blood stasis kept stable (up to 9‐11) in our hospital during 2014‐2016. The annual growth rate of consumption sum in 2016 (-5.42％) was significantly lower than it in 2015 (11.63％). Danshen Injection featured high selectivity and economical in the clinical application (DDDs: 12 600 in 2015, 6600 in 2016; DDDc: 32.70 in 2015, 28.46 in 2016; sorting ratio: 5.00 in 2015, 3.00 in 2016). Conclusion The clinical application of TCM injections for activating blood circulation to dissipate blood stasis tends to be rational in our hospital. Danshen Injection features high selectivity and economical in the clinical application. Danhong Injection features high selectivity but the poor economical.
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OBJECTIVE:To provide reference for rational use of TCM injection in the clinic. METHODS:Retrieved from CNKI,VIP,Wanfang database and PubMed database,literatures about top 10 TCM injections in the list of report number stated in 2014 CFDA ADR monitoring report were researched in recent 30 years. By literature retrospective study,ADR/ADE induced by TCM injection were analyzed. Combining with post-marketing drug safety re-evaluation and rationality study,the security of clini-cal use of TCM injection was evaluated. RESULTS:A total of 2013 literatures were retrieved,1354 were. Most organs or systems were involved in ADR,especially cardiovascular system,respiratory system,skin and its appendants. Allergic reaction was main clinical manifestation,among which server ADR was allergic shock. Ten ADR/ADE-inducing TCM injections had the lower consis-tency with instructions in the original diseases,solvent,dosage concentration and compatibility application. Consistency rate of original diseases,solvent and dosage concentration was 78.30%,77.94% and 74.64%;81.73% of them were used individually. CON-CLUSIONS:ADR/ADE induced by TCM injection is serious. It is urgent to improve post-marketing revaluation scheme from the aspects of safety and rationality.
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OBJECTIVE:To explore the ideas for the prescription comment of TCM injections,and provide reference for clini-cal rational use. METHODS:Totally 9 457 prescriptions in PIVAS and 400 hospitalized medical records in our hospital in 2015 were collected. The prescriptions and hospitalized medical records which contained TCM injections were retrospectively commented in aspects of indications,usage and dosage,drug combination,solvent selection and repeat medication,and analysis of typical case. RESULTS:In 2015,there were 2 544 prescriptions(26.90%)in PIVAS and 195 medical records(48.75%)that used TCM injections;the irrational use was mainly inappropriate solvent selection(50.70%),inappropriate usage and dosage(27.00%),inap-propriate indications (10.33%),inappropriate combination therapy (7.51%) and repeat medication (4.46%). CONCLUSIONS:Prescription of TCM injections should be commented with the medical records and individual analyzed;in terms of unreasonable prescriptions and medical records TCM clinical pharmacists should actively intervene unreasonable prescriptions by the bed.
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OBJECTIVE:To provide reference for rational use of TCM injection in the clinic. METHODS:In retrospective survey,the application of TCM injections in 3 hospitals from Changshu area during 2013-2015 were analyzed statistically in re-spects of consumption sum,annual growth rate,constituent ratio,DDDs,B/A,DDC,etc. RESULTS:During 2013-2015,in the sample hospitals,consumption sum of TCM injections in 2014 and 2015 declined by 5.27% and 15.92%,compared with last year. The proportion of consumption sum of TCM injections in total consumption sum were 4.40% in 2013,3.86% in 2014 and 3.13%in 2015. Top 3 TCM injections in the list of consumption sum and DDDs were blood activating and stasis eliminating drugs,the re-suscitation and reviving yang first aid class drugs and tonic drugs. The top single types in the list of consumption sum were Xing-naojing injection,Shuxuetong injection,Xuebijing injection,Shenmai injection and Xue shuantong for injection;the top single types in the list of DDDs were Shenmai injection,Reduning injection,Shuxuetong for injection,etc. B/A of Shenmai injection and Reduning injection were higher,while DDC of Xuebijing injection was the highest. CONCLUSIONS:The utilization of TCM injec-tion is basically reasonable,and shows decreasing tendency in sample hospitals,but great importance should be attached to the safe-ty and effectiveness of TCM injections and reasonable choice.
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OBJECTIVE:To provide reference for the rational use of TCM injections. METHODS:487 medical records using TCM injection in our hospital from Jul. to Dec. 2014 were selected as control group,another 500 from Jan. to Jun. 2015 were inter-vention group. Utilization,rationality and adverse reactions of TCM injection between 2 groups were compared. RESULTS:Accord-ing to the intervention by clinical pharmacists,the sales amount and utilization rate of top 10 TCM injection in our hospital were lower significantly. The irrational utilization rate of 5 types (totally 26 varieties) in intervention group decreased (21.60% vs. 43.33%),incidences of adverse reactions reduced(3.00% vs. 7.39%),compared with control group,the differences were statisti-cally significant (P<0.05). Treatment cost per capita [(217.17 ± 22.64) yuan vs. (480.77 ± 21.35) yuan] and hospitalization time [(6.50 ± 1.99)d vs. (10.02 ± 3.25)d] in intervention group were significantly lower or shorter than control group,the differences were statistically significant (P<0.05). CONCLUSIONS:Implementing pharmaceutical interventions can strengthen the sense of clinicians’rational use of TCM injection,raise the level of rational use of drugs and reduce adverse reactions and medical errors.
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Objective To discuss the effects of Deming cycle on reducing adverse drug reactions (ADR) induced by injections of traditional Chinese medicine (TCM).Methods The TCM injections which induced much more ADRs in 2013 were selected. The usage of these TCM injections and characteristics of the ADRs were analyzed. Strategies for controlling ADRs were developed according to Deming cycle and put into the recycle implementation in 2014. Results The ADRs induced by TCM injections were all reduced; the number of total cases was reduced by 41.3% compared to 2013, among which Tanshinone IIA Sulfonate injection,Xinmailong injection, Mylabris injection,Shenqi Fuzheng injection andShengmai injection were reduced significantly, and their reduction rates were all more than 50%. The clinical manifestations of ADRs, including rash, itching, chills, fever, phlebitis, chest distress and palpitation, were all reduced in 2014 compared to 2013, among which especially the allergic reactions, including phlebitis, rash and itching, were reduced by 14.9% and 13.4%.Conclusion Application of Deming cycle in the practice of TCM injections for clinical rational medication can effectively reduce the occurrence of ADRs and better ensure the safety of clinical use of TCM injections.
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Type I allergic reaction is the most common and serious one in the adverse drug reactions (ADR) of TCM injections. Skin test can be used to predict the occurrence of allergic reactions, which is a simple and effective method for safe use of TCM injections. To a certain extent, it can reduce ADR of medicine and ensure the safety of clinical medication. However, the medicine instructions of TCM injections that clearly point out the need for skin test are few, and there are many problems of skin test in clinical practice. For example, lack of systematic research on skin test, no uniform standard for clinical judgment, lack of diagnostic reagents and proprietary methods of skin test. Therefore, specifications for clinical skin test of TCM injections are needed to provide guarantee for the safe use of TCM injections.
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OBJECTIVE:To provide reference for the rational use of TCM injections. METHODS:The related data of using TCM injections was drawn from May 2009 to May 2014. And the data of 5 TCM injections,including Shengmai and Shenmai in-jection,were statistically analyzed,the indications of 8 TCM injections,including Shengmai and Shenmai injection,were also sta-tistically analyzed. RESULTS:In solvents evaluation,the 5 TCM injections were used 501 times,in which 391 times(78.04%)of the solvents used were rational,381 times(76.05%)of the solvent doses used were rational;in clinical indications evaluation,the 8 TCM injections were used for 2 579 patients,in which 1 120 cases were in accordance with the instructions while the other 1 459 cases were not,the qualification ratio was 43.43%. CONCLUSIONS:There were still some problems in using TCM injection in our hospital in the aspects of solvent as well as indications.
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Objective To compare the clinical efficacy and carry out analysis on pharmacoeconomic cost-effect of three therapeutic schemes in the treatment for stroke. Methods Through a retrospective survey method, 115 stroke patients, based on different treatment methods, were divided into 3 groups:Xuesaitong group (A), carthamin yellow group (B), and Xueshuantong group (C). An analysis on pharmacoeconomic cost-effect was conducted. Results The costs of three therapeutic schemes were 1030.4 yuan, 1876 yuan, and 1545.6 yuan, respectively. The total effective rates of stroke patients in groups A, B and C were 85.37%, 88.57% and 90.04%, respectively. The cost-effect ratios of groups A, B and C were 12.07, 21.18, and 17.17. The added cost-effect ratios of groups B and C compared with group A were 264.25 and 110.32, respectively. Conclusion Xueshuantong Injection has more pharmacoeconomic advantage than Xuesaitong and carthamin yellow Injections in treating stroke.
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Objective To review and analyze unreasonable medicine use of TCM injections in inpatient prescriptions in our hospital; To provide reference for reasonable clinical medicine use. Methods According to instructions and requirements in “basic principles for TCM injections in clinical use”, 132 cases (01. 2013-05. 2013) of TCM injections following the doctors’ advice in the hospital were reviewed and analyzed. Results Problems in unreasonable medicine use of TCM injections mainly concentrated in incompatibility, unsuitable solvent, and unsuitable indications, etc. Conclusion TCM injections in clinical use in the hospital showed some cases containing unreasonable medicine use. Therefore, effective intervention should be taken to regulate medicine use and promote TCM injections in clinical application, in order to make it safer, more reasonable, and more effective and reduce the occurrence of adverse reactions.
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OBJECTIVE: To analyze the utilization and tendency of TCM injections in our hospital, and to provide reference for clinical use of drugs. METHODS: Based on hospital database, the category, consumption sum and DDDs of TCM injections in our hospital during the period of 2005～2008 were analyzed statistically. RESULTS: The proportion of consumption sum of TCM injections in the total consumption sum from 2006 to 2008 were 13.06%, 9.33%, 9.97%, 9.08% respectively. The consumption sum of TCM injections was increased year by year. Stasis-removing agent for cardio-cerebral-vascular system took up the first place in the list of category of drugs, comsunption sum and DDDs. CONCLUSION: TCM injections are widely applied in our hospital. The utilization structure of TCM injections is the reasonable basically. But great importance should be attached to the safety and effectiveness of TCM injections and reasonable choice.
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OBJECTIVE: To provide reference for rational use of drugs. METHODS: 200 ADR cases induced by TCM injection from Huizhou were analyzed retrospectively. RESULTS: Of total 200 ADR cases, 133 cases were male, which was significantly higher than females in 67 cases(P
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OBJECTIVE:To provide reference for the improvement of Metaanalysis. METHODS:13 repots about Meta-analysis of randomized controlled trials(RCTs)on antivirus traditional Chinese medicine(TCM)injections for respiratory tract infections were collected and analyzed. Their qualities were evaluated using QUOROM statement,CONSORT statement,Jadad scale and the quality evaluation method for Metaanalysis posed by Sacks,etc. Disagreements were resolved by consensus. RESULTS:The obtained average mark of 13 studies was(64?10.13)with the highest mark of 84 and the lowest of 52. Quality evaluations of reports were conducted from 5 aspects including 25 items. 5 aspects were all considered in 13 studies. 60% of the 25 items were in- volved in 13 reports at least and 88% at most. CONCLUSION:Meta- analysis methods are improved significantly in China. It should be still standardized to make sure correctness and reliability of results of meta-analysis. Meta-analysis method should be stan-dardized to obtain correct and reliable results.