| OBJECTIVEThe aim is to evaluate the clinical safety of the representative expectorant decoction containing Pinellia ternate and to provide reference for the rational clinical application of such drugs.METHODS1.Meta analysisThe CNrKI database,Chongqing VIP Chinese sci-tech journal database and Wanfang database were searched comprehensively and systematically to collect relevant clinical trials.Cochrane risk bias assessment tool and MOOSE statement recommendations were used to carry out quality scores.RevMan5.3 and Open Meta Analyst 3.13 software were used to carry out meta-analysis of control test and meta-analysis of adverse reactions/events rate of single arm test respectively.The adverse reactions/incident rate of representative expectorant decoction containing Pinellia ternate was compared with conventional western medicine and its adverse reactions/events rate was calculated.2.Literature reviewLiterature research was used to sort out,integrate and statistically analyze the retrieved literature data,including the composition,efficacy and summary of indications of common expectorant decoction containing Pinellia ternate and the statistical analysis of adverse reactions/events in relevant clinical trials.RESULTSErchen Decoction,Banxia Baizhu Tianma Decoction and Wendan Decoction were used as representative expectorants containing Pinellia ternate.1.Meta-analysis of clinical adverse reactions/events of Modified Erchen DecoctionA total of two hundred and eighty-eight documents were searched and twenty-three clinical trials were included after screening.The results showed that the incidence of adverse reactions/events in the intervention group treated with traditional Chinese medicine alone was lower than that in the control group when Erchen Decoction was modified to treat respiratory diseases.However,the incidence of adverse reactions/events in the intervention group treated with traditional Chinese medicine combined with western medicine was not statistically different from that in the control group.After weighting,the total incidence of adverse reactions/events in the treatment of respiratory diseases by modified Erchen Decoction was twenty-one per-mil.And the incidence rate of adverse reactions/events was not connected with the combination of western medicine,whether the dose of Pinellia ternate was more than nine or ten grams,whether the prescription contains toxic traditional Chinese medicine except Pinellia ternate and different varieties of Pinellia ternate.The incidence of adverse reactions/events in the treatment of digestive system diseases,hyperlipemia,type 2 diabetes,cystic and nodular acne and childhood Tourette’s syndrome by modified Erchen Decoction was lower than that by conventional western medicine.When modified Erchen Decoction was used to treat secretory otitis media,there was no statistical difference in the incidence of adverse reactions/events between the two groupsIf modified Erchen Decoction was applied alone,gastrointestinal discomfort,nausea,vomiting,lethargy and fatigue were the most common phenomenon.And diarrhea,anorexia,rash,constipation and other adverse reactions/events will also occur.When modified Erchen Decoction was combined with western medicine or proprietary Chinese medicine,most of the adverse reactions/events were those indicated in the manual of western medicine or proprietary Chinese medicine instructions or indicated by research.The application of addition and subtraction of modified Erchen Decoction assisted western medicine treatment can decrease the incidence of most adverse reactions/events.However,it may increase the risk of diarrhea and anorexia.2.Meta analysis of clinical adverse reactions/events of Modified Banxia Baizhu Tianma DecoctionFour hundred and ninety-one documents were searched and fifty-one clinical trials were included after screening.The results showed that when modified Banxia Baizhu Tianma Decoction was used to treat hypertension and vertigo,the incidence of adverse reactions/events in the intervention group treated with traditional Chinese medicine alone had no statistical difference with that in the control group.However,the incidence of adverse reactions/events in the intervention group treated with traditional Chinese medicine combined with western medicine was lower than that in the control group.When modified Banxia Baizhu Tianma Decoction was used to treat headache,regardless of whether the modified Banxia Baizhu Tianma Decoction was combined with western medicine,the total incidence of adverse reactions/events in the intervention group was lower than that in the control group.After weighting,the incidence rates of adverse reactions/events of modified Banxia Baizhu Tianma Decoction for hypertension,vertigo and headache were thirty-six per-mil,sixteen per-mil and forty-two per-mil respectively.The incidence of adverse reactions/events were small and was not connected with whether western medicine was combined or not and whether toxic traditional Chinese medicine except Banxia was contained in the prescription.The incidence rate of adverse reactions/events of modified Banxia Baizhu Tianma Decoction in the treatment of vertigo was not connected with whether it was more than ten grams.If modified Banxia Baizhu Tianma Decoction was used alone,gastrointestinal discomfort,nausea and vomiting and other adverse reactions/events of digestive system and dizziness and headache were mostly occurred.There were somnolence and fatigue,dry mouth and bitter taste,night sweat and other adverse reactions,too.When modified Banxia Baizhu Tianma Decoction was combined with western medicine or Chinese patent medicine,most of the adverse reactions/events were those indicated in the manual of western medicine or Chinese patent medicine instructions or indicated by research.The application of modified Banxia Baizhu Tianma Decoction prescription assisted with western medicine can decrease the incidence of most adverse reactions/events.However,it may increase the risk of digestive system adverse reactions,dizziness,headache,fatigue,rash and cough.3.Meta analysis of clinical adverse reactions/events of modified Wendan DecoctionA total of nine hundred and eighty-eight documents were searched and eighty-one clinical trials were included after screening.The results show that when modified Wendan Decoction was used to treat cardiovascular and cerebrovascular diseases,the total incidence of adverse reactions/events in the intervention group had no statistical difference compared with that in the control group regardless of whether western medicine was combined or not.However,it can increase the risk of adverse reactions in the digestive system.The incidence of total adverse reactions/events in terms of treating insomnia with modified Wendan decoction was lower than that of western medicine.However,it can increase the risk of adverse reactions of digestive system.When modified Wendan Decoction was used to treat digestive system diseases,the total incidence of adverse reactions/events in the intervention group was lower than that in the control group,regardless of whether western medicine was combined or not.When treating mental diseases,the incidence rate of adverse reactions/events in the intervention group was lower than that in the control group for extrapyramidal reactions and insomnia,regardless of whether western medicine was combined or not.For digestive system adverse reactions,lethargy,fatigue,dizziness,headache,dry mouth and liver dysfunction,the incidence of these kinds of adverse reactions/events in the modified Wendan decoction group was not statistical difference compared with the control group.However,the incidence of adverse reactions/events in the combined western medicine group was lower than that in the western medicine control group.After weighting,the incidence rate of adverse reactions/events of modified Wendan Decoction in treating cardiovascular and cerebrovascular diseases,insomnia and digestive system diseases was twenty-six per-mil,seventeen per-mil,nineteen per-mil respectively.The incidence rate was not connected with whether western medicine was used or not.When modified Wendan Decoction was used to treat insomnia,the incidence rate of adverse reactions/events when the dose of Pinellia ternate was less than or equal to nine grams was less than the incidence rate when the dose was more than nine grams.When treating digestive system diseases,the incidence rate of adverse reactions/events was not connected with whether the dose of Pinellia ternate was greater than nine grams or ten grams.When treating ventricular premature beat,insomnia,gastric ulcer,primary fibromyalgia syndrome,hyperuricemia and somatization disorder with modified Wendan Decoction alone,adverse reactions of digestive system such as nausea,vomiting and diarrhea usually occurred.There were reactions such as dry mouth,dizziness,headache,dry mouth,eye dryness,rash and facial flushing.Insomnia was the most common adverse reaction/event in the treatment of mental diseases.There were adverse reactions such as dry mouth,nausea and vomiting.When modified Wendan Decoction was combined with western medicine or Chinese patent medicine,most of the adverse reactions/events were those indicated in the manual of western medicine or Chinese patent medicine instructions or indicated by research.The application of modified Wendan decoction prescription assisted by western medicine can decrease the incidence of most adverse reactions/events.However,it may increase the risk of nausea,vomiting,abdominal pain,diarrhea,insomnia,dry mouth,rash,cough and hypoglycemia.4.Meta-analysis of clinical adverse reactions/events of Banxia Baizhu Tianma Decoction and Wendan DecoctionA total of one hundred and forty-five documents were searched and thirty-seven clinical trial studies were finally included after screening,all of which were studies on the treatment of hypertension.The results showed that the incidence of total adverse reactions/events in the intervention group was lower than that in the control group when treating hypertension,regardless of whether western medicine was combined or not.No matter what kind of treatment scheme was used in the control group,the incidence rate of adverse reactions/events in the traditional Chinese medicine group alone was lower than that in the control group.After weighting,the total incidence rate of adverse reactions/events in the treatment of hypertension with Banxia Baizhu Tianma Decoction and Wendan Decoction was twenty-eight per-mil.And the incidence rate of adverse reactions/events was not connected with the combination of western medicine and whether the dosage of Banxia was more than ten grams and the tapes of Banxia.When treating hypertension with Banxia Baizhu Tianma Decoction and Wendan Decoction alone,adverse reactions such as gastrointestinal discomfort,nausea,vomiting,dizziness,headache,lethargy,debilitation,dry mouth,arrhythmia,etc.will occur.When Banxia Baizhu Tianma Decoction and Wendan Decoction were combined with western medicine or proprietary Chinese medicine,all adverse reactions/events were those of western medicine or proprietary Chinese medicine.The application of Banxia Baizhu Tianma Decoction and Wendan Decoction combined with western medicine can decrease the incidence of most adverse reactions/events.However,it may increase the risk of gastrointestinal discomfort.CONCLUSIONBased on the literature data included in this study,Erchen Decoction,Banxia Baizhu Tianma Decoction and Wendan Decoction are safe.In the treatment of psychiatric diseases,the application of Wendan Decoction can significantly reduce the occurrence of extrapyramidal reaction.And the combination of Chinese and western medicine will not increase the risk of adverse reactions/events.but when treating insomnia and cardiovascular and cerebrovascular diseases with Wendan Decoction,attention should be paid to the occurrence of adverse reactions of digestive system.When treating insomnia with Wendan Decoction,the dosage of Pinellia ternata should be no more than 9g.When using the representative expectorant containing Pinellia ternate,the adverse reactions of digestive system such as nausea and vomiting,the symptoms of fluid injury such as dry mouth and eye dryness and cardiac toxic reactions such as arrhythmia and abnormal electrocardiogram may be caused by Pinellia ternate..However,the symptoms are relatively small.Dialectical treatment should be carried out before the application of expectorants.At the same time,in the process of treatment,besides observing the changes of disease conditions,the changes of syndrome types should also be observed.The composition of prescriptions and the dosage of drugs should be adjusted duly to avoid damaging body fluid and spleen and stomach. |
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