| ObjectiveThrough a series of prospective case-control studies,the efficacy and safety of Zhizhu Runchang Prescription in the treatment of liver stagnation and spleen deficiency functional constipation were preliminarily evaluated,providing objective evidence for clinical application.Methods62 patients with liver-depression and spleen-deficiency FC from January 1,2021 to July 1,2021 in the spleen and Stomach Department of Guang ’anmen Hospital and Beijing Tongren Tang Hospital of Traditional Chinese Medicine were included in the clinical study,and were treated with Zhizhurunchang Prescription(30-60g of rhizoma atractylodes,12-20g of Aurantium Trifoliata,15-30g of Whole Angelica,20-45g of Paeonia alba,12-15g of turpentine,12-15g of Rhizome Phorus,12-15g of peach kernel,15-30g of Cistanche deserticola,15g of semen raphanus,12g of burnt areca,30-45g of trichosanthes trichosanthes and 6g of burnt glycyrrhiza).The patients were treated with 1 dose twice a day for 4 weeks,and were followed up and evaluated 1 month after treatment.The outcomes were as follows:① General indicators(gender,age,chief complaint,history of present disease,past history,personal history,family history,marriage and childbearing history,etc.);②Efficacy indicators(clinical symptoms,quality of life,prognosis);③Safety indicators(blood routine,urine routine,stool routine,liver and kidney function,electrocardiogram).Excel2003 was used to input the data,and SPSS 22.0 was used for statistical analysis after verification.Results1 Baseline situationA total of 62 FC patients were included from January 1,2021 to July 1,2021,among which 6 patients fell off(3 lost to follow-up,3 did not take medicine as required).A total of 56 patients completed this clinical study,so the clinical data of 56 patients were analyzed.Gender distribution:20 males(36%)and 36 females(64%),with a male to female ratio of 5:9.Age Distribution:There were 2 patients aged 18-29(3.57%),7 patients aged 30-39(12.50%),10 patients aged 40-49(17.86%),15 patients aged 50-59(26.79%),14 patients aged 60-69(25.00%),and 8 patients aged 70-75(14.28%).Disease course distribution:24 patients(42.86%)had shorter disease course than 1 year,23 patients(41.07%)had shorter disease course than 1-5 years,7 patients(12.50%)had shorter disease course than 6-10 years,and 2 patients(3.57%)had shorter disease course than 11-15 years.Severity:12 patients(21.43%)were mild,37(66.07%)were moderate,and 7(12.50%)were severe.2 Efficacy evaluation2.1 Evaluation of TCM syndrome efficacyA total of 56 FC patients completed this clinical study.After 4 weeks of treatment,0 patients(0%)were clinically cured of TCM syndromes,27 patients(48.21%)had significant effect,26 patients(46.43%)were effective,and 3 patients(5.36%)had no effect,with a total effective rate of 94.64%.2.2 Comparison of total and individual scores of TCM symptomsThe total score of TCM symptoms was significantly decreased after treatment,and the total score of TCM symptoms at follow-up was lower than before and after treatment,indicating that ZHizhurunchang Prescription could significantly improve the clinical symptoms of FC patients,and the long-term efficacy was stable,with statistical significance(P<0.01).After treatment,the scores of main symptoms of TCM decreased significantly,indicating that ZHizhurunchang Prescription could significantly improve the symptoms of FC patients in five aspects,such as defecation difficulty,prolonged defecation time,dry stool,reduced stool frequency,abdominal distension and pain,with statistical significance(P<0.01).After treatment,the score of TCM secondary symptoms decreased significantly,indicating that ZHizhurunzhang Prescription could significantly improve the symptoms of FC patients in six aspects,namely,belching hiccup,depression/irritability,bowel singing and gas frequency,full tightness of chest and hypoxia,lack of appetite and lethality,with statistical significance(P<0.01).2.3 Comparison of life quality evaluation scoresAfter treatment,compared with before treatment,not only the total score of PAC.QOL decreased significantly(P<0.05),but also the score of all dimensions decreased significantly,indicating that Zhizhurunchang Prescription could significantly improve the quality of life of the four dimensions of physical state,psychological state,worry degree and satisfaction degree of FC patients,with statistical significance(P<0.01).2.4 RecurrenceA total of 56 Patients with FC completed the clinical study,and were followed up one month after the treatment for four weeks.Among them,there were 0 cases of severe recurrence(0%),4 cases of general recurrence(7.55%),6 cases of mild recurrence(11.32%),and 46 cases of non-recurrence(81.13%).There were 10 cases of recurrence,with a total recurrence rate of 18.87%.3 Safety evaluationNone of the 56 FC patients in this study had adverse drug reactions during medication,and there were no obvious abnormalities in safety indicators.ConclusionZhizhurunchang Prescription addition and subtraction in the treatment of LIVER-depression and spleen-deficiency FC clinical efficacy is confirmed,low recurrence rate,no drug-related adverse reactions occurred during the treatment,good safety. |
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