| ObjectiveThis topic is based on the safe,effective and rational use of drugs and improving pharmaceutical services.Through literature research,meta-analysis and retrospective study of hospital prescriptions and cases,to analyzes the clinical application and adverse event reports of xiaojin pill,to evaluate the effectiveness and safety of xiaojin pill in the treatment of major diseases,and to investigate the drug use of xiaojin pill outpatients and inpatients in our hospital,further analyze the problems in the administration of xiaojin pill and explore the influencing factors of adverse events,in order to improve the clinical rational drug use level of xiaojin pill,reduce the risk of adverse reactions,provide countermeasures,and provide evidence-based evidence and reference for clinical research evaluation design.MethodsThe methods used in this study are as follows:(1)Literature analysis method:comprehensively search and collect the clinical literature of xiaojin pill,and conduct an inductive analysis of the application research of xiaojin pill clinical treatment and the reported cases of adverse events.(2)Meta-analysis:search for randomized controlled trials of xiaojin pill by 2018,extract basic information from studies that meet the inclusion criteria,use biased risk assessment tools to assess the quality of the included literature,using Revman 5.3 and Open Meta Analyst 3.13 software for statistical analysis of data.(3)Retrospective study:Collecting the prescription and case information for xiaojin pill outpatient and inpatients in 2015-2018,and conducting retrospective analysis,statistical analysis of patient's gender,age,medication department,treatment of diseases and combination medication,etc.The rationality of Xiaojin pill prescription medication was evaluated.Results1.Xiaojin pill clinical application and adverse events literature analysis results:1.1 Xiaojin pill has a wide range of clinical treatments,there are 160 clinical treatment articles on xiaojin pill,which are mainly for the treatment of breast hyperplasia related diseases,accounting for 35.63%,it can also be used to treat thyroid nodules,nodular fasciitis,post-neural neuralgia,chronic pelvic inflammatory disease,benign prostatic hyperplasia,penile sclerosis and other male diseases as well as treatment of tumors such as breast cancer,lung cancer,stomach cancer,and thyroid gland cancer and other diseases.The clinical female patients were significantly higher than the male patients,the dosage of 78.75%of patients had xiaojin pill in accordance with the range of in Chinese pharmacopoeia,the daily dose was 1.2g each time,twice a day for the usual dose,the course of treatment varies from 1 week to 14 months,with 3 months being the main,accounting for 23.13%,xiaojin pill combined medication for treating diseases more than alone,and it is combined with one drug and more with western medicine,mainly used in combination with levothyroxine sodium tablets or tamoxifen tablets.1.2 There are 46 reports on adverse events occurred in xiaojin pill,including the case report of xiaojin pill adverse reactions and the adverse reactions reported in xiaojin pill clinical efficacy observation study,a total of 236 cases of adverse events occurred,mainly female patients,in the cases of adverse events,the patients were mainly affected by breast hyperplasia and nodular goiter diseases,accounting for 47.88%and 28.39%,respectively,the dosage is mainly 1.2g each time,twice a day,the incidence of adverse reactions in combination therapy is higher than drugs alone,adverse reaction cases occurred more than 2 days after taking the drug.Adverse reactions include skin allergic reactions,gastrointestinal system,hepatobiliary system and cardiovascular system damage to varying degrees,The main clinical manifestations are facial and limb rash,papules,urticaria,redness and itching of the skin;stomach discomfort,vomiting,nausea,abdominal pain,diarrhea,etc.,as well as liver and kidney dysfunction,nosebleeds,dizziness and palpitations,insomnia,etc.2.The evaluation results of the efficacy of xiaojin pill in the treatment of 4 diseases are as follows2.1 Xiaojin pill is used to treat breast hyperplasia:A total of 27 studies were included,2914 patients in the experimental group and 2612 patients in the control group.There was no difference between the experimental group in which xiaojin pill was alone use and the control group[RR=1.12,95%CI(0.99,1.26),P=0.07].Xiaojin Pill combined with Western medicine or proprietary Chinese medicine or both combined contrast the control group can improve the clinical total efficiency[RR=1.19,95%CI(1.13,1.26),P<0.00001].There were 38 cases of adverse reactions in the experimental group,and 47 in control group.2.2 Xiaojin pill is used to treat Thyroid nodules:Including 11 studies,a total of 1435 patients were enrolled,753 in the experimental group,and 682 in the control group.Xiaojin pill which was not combined western medicine treatment group compared with control group,has difference was found[RR=2.61,95%CI(1.20,5.65),P=0.02].Xiaojin pill combined western medicine or proprietary Chinese medicine experimental contrast control can improve the clinical total effective rate[RR=1.33,95%CI(1.16,1.52),P<0.0001].There were 45 cases of adverse reactions in the experimental group,and 84 in control group.2.3 Xiaojin pill used for the treatment of Chronic nonbacterial prostatitis:6 trials including 420 cases of patients were divided into 208 cases of experimental group,212 cases of control group.Xiaojin pill combined with Western medicine or proprietary Chinese medicine or both combined contrast the control group can improve the clinical total efficiency[RR=1.27,95%CI(1.05,1.55),P=0.02].2.4 Xiaojin pill is used to treat Chronic pelvic inflammatory disease:Including 5 studies,a total of 584 patients were enrolled,295 in the experimental group,and 289 in the control group.Xiaojin pill combined with Western medicine or proprietary Chinese medicine or both combined contrast the control group can improve the clinical total effective rate[RR=1.31,95%CI(1.20,1.43),P<0.00001].3.The evaluation results of the clinical adverse events of xiaojin pill as followsA total of 19 studies were included,1241 patients in the experimental group and 1169 patients in the control group.Xiaojin pill which was not combined western medicine or proprietary Chinese medicine treatment group compared with control group,no difference was found[RR=0.73,95%CI(0.36,1.50),P=0.40].The incidence of clinical adverse reactions was lower in the experimental group with Xiaojin Pill combined with Western medicine or proprietary Chinese medicine or both compared with the control group[RR=0.69,95%CI(0,56,0.86),P=0.0008].4.The use of xiaojin pill in our hospitalA total of 1831 xiaojin pill outpatient prescriptions and 93 inpatients cases were included in from January 2015 to December 2018.The female patients in xiaojin pill outpatients were higher than male patients,with the majority of middle-aged and elderly patients aged 51-70,accounting for 45.66%.72.62%of patients used doses of 1.2-3g each time,twice a day,in accordance with the Chinese pharmacopoeia and the specifications.51.17%of the prescriptions are combined prescriptions,and mainly combined with one drug,Bailing Capsule is the first combination drug.Xiaojin pill clinic has a wide range of departments,with a higher application of Integrated Traditional Chinese and Western Medicine Department of Oncology,accounting for 53.96%,followed by Chinese medicine surgery and Chinese medicine internal,the treatment diseases are breast hyperplasia,breast cancer,thyroid nodules,etc.However,there are unreasonable use cases of xiaojin pill outpatient prescriptions,mainly including overdose medications with too large a single dose and too many daily doses,such as 5g each time,2 times a day or 1.8g each time,4 times a day.And the combination of the same toxic ingredients in Chinese medicine and the incompatibility contraindications of the"eighteen incompatible-nineteen medicaments",the drugs that should not be used in combination are Fufang Banmao Capsule,Yixinshu Capsule,Yunnan Baiyao Capsule,Shendan Sanjie Capsule,Luofu Shan Rheumatism Plaster and Compound Xianzhuli Liqulid,etc.Xiaojin pill hospitalized women were significantly higher than male patients,accounting for 68.82%,and mainly 51-60 years old patients.The dosage of patients was in accordance with the scope of Chinese Pharmacopoeia,the course of medication is mainly 7 days,accounting for 44.09%.The combination of xiaojin pill inpatients is complicated,and the proportion of cases with 1-5 kinds of drugs is 38.71%,the combination of Chinese patent medicine is mainly Kanglaite injection,inpatient department is mainly in Integrated Traditional Chinese and Western Medicine Department of Oncology,the treatment of diseases has lymph nodes secondary to malignant tumors,breast tumors,and breast hyperplasia.However,there are also irrational drug use cases in xiaojin pill hospitalized patients,mainly because of the unsuitable combination of drugs.It is not suitable for combination drugs such as Shendan Sanjie Capsule,Fufang Banmao Capsule,Yixinshu Capsule,Compound Xianzhuli Liqulid and Luofu Shan Rheumatism Plaster,etc.ConclusionsThe results show that xiaojin pill has a wide range of indications for treatment.For the treatment of breast hyperplasia,thyroid nodules,chronic prostatitis,pelvic inflammatory disease,Xiaojin pill combined with western medicine treatment can achieve better therapeutic effect than western medicine alone,can improve clinical efficiency,and has the certain advantage of synergistic effect,but there are also risks of adverse events in the clinic,involving skin,gastrointestinal,cardiovascular and hepatobiliary system damage,the clinical use needs to pay close attention to the patient's drug response.Xiaojin pill is basically standardized in the use of patients in our hospital,and there are also some areas that need to be improved to overdosing and irrational combination.As a proprietary Chinese medicine containing toxic components,Xiaojin pill should be used according to the principle of syndrome differentiation and treatment according to the patient's condition to ensure accurate drug use;strengthen review the prescription and monitor unreasonable use of drugs,timely regulation and standardize the unreasonable combination of drugs and overdose of drugs,to provide a guarantee for the rational use of drugs in clinic. |
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