| Objective: To observe the clinical curative effect of QingreLiangxue Sanyu(QRLXSY)in the treatment of acute radiation proctitis(ARP)and to explore whether the QRLXSY method can reduce the frequency of bowel movements,relieve the symptoms of loose stools,mucous stools,hematochezia,abdominal pain,tenesmus and other clinical symptoms,improve patient Karnofsky(KPS)score.To provide a clinical basis for the treatment of acute radiation proctitis by Chinese medicine.Methods: This project was a randomized controlled clinical trial study,which collected a total of 60 cases in the department of gynecologic Oncology and Radiotherapy at the Fourth Affiliated Hospital of Hebei Medical University from November 2016 to November 2017,including 30 cases in the treatment group and 30 cases in the control group.Strict compliance with the diagnosis and exclusion criteria was included.All cases met the diagnostic criteria for ARP.When ARP symptoms occurred,the treatment group was given HuaihuaSan plus BaitouWeng soup,and combined with Ma Yinglong hemorrhoids ointment and Sanqi Powder into the anus.The control group was given oral glutamine granules and montmorillonite powder,Compound carraghenate suppository into the anus.Continuous treatment for 14 days.Observe the radiation dose and time of ARP in both groups,the time of symptom remission,clinical symptom scores before and after treatment,changes in KPS scores,and adverse reactions to treatment.Results:1.When there are clinical symptoms of ARP,60 patients have an irradiation dose ranging from 3.6 to 40 Gy,and the average irradiation dose is(23.30±5.56)Gy.The time range is between 3 and 15 days.The average time is(11.78±2.00)days.2.When the clinical symptoms of ARP were relieved,the average remission time was(6.60±1.63)days in the treatment group,and(9.50±2.16)days in the the control group(P<0.01).3.There was no significant difference in clinical symptom scores between the two groups before treatment(P>0.05).Symptom scores decreased after treatment(P<0.05),especially in stool frequency,mucous stool,hematochezia,abdominal pain and tenesmus(P<0.01).4.In terms of KPS score,the treatment group: the average number of patients before treatment was 75.33±5.71,and was 89.00±8.85 after treatment.There was a significant difference before and after treatment(P<0.01).In the control group,the average number before treatment was 74.67±5.71,and was 81.67±10.20 after treatment.There was a significant difference before and after treatment(P<0.01).Before treatment,the scores of the two groups were not statistically significant(P>0.05).After treatment,the mean of the two groups was analyzed(P<0.05)by analysis of variance,indicating that the KPS Score of the patients in the treatment group was higher than that of the control group.5.In an efficient treatment of treatment group of 30 people,7 cases were cured with accounting for 23.33%,16 cases were markedly effective with accounting for 53.33%,3 cases were effective with accounting for 10%,4 cases were ineffective with accounting for 13.33%.In an efficient treatment of control group of 30 people,3 cases were cured with accounting for 10%,9 cases were markedly effective with accounting for 30%,8 cases were effective with accounting for 26.67%,10 cases were ineffective with accounting for 33.33%.The effective rate was 86.67% in the treatment group,and was 66.67% in the control group.After the sequential rank sum test of two independent samples,there was a statistically significant difference between the two groups(P=0.038,P<0.05).In terms of treatment efficiency,the control group was superior to the control group.6.In the evaluation of safety indicators,there were no serious abnormalities in safety indicators related to the test drug during the observ-ation period in both groups,suggesting that HuaihuaSan plus Baitouweng soup,Ma Yinglong hemorrhoids ointment and Sanqi Powder topical application,clinical application safety,and no obvious side effects.Conclusions:1.QRLXSY method for treating ARP can shorten the time for symptom relief and reduce the clinical symptoms,especially in stool frequency,mucous stool,hematochezia,abdominal pain and tenesmus.2.QRLXSY method can improve the patient's KPS score and the quality of life.3.QRLXSY method is safe and effective in clinical application. |
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