| Objective:This study aims to observe the clinical efficacy and drug safety of Dilong Jiangya Capsule in the treatment of patients with primary hypertension and insomnia with collateral stasis syndrome,analyze and explain the functional advantages of Dilong Jiangya Capsule in reducing blood pressure,promoting blood circulation,calming the nerves,and other aspects,provide theoretical basis and clinical reference for diseases related to primary hypertension and insomnia with collateral stasis syndrome,and promote the promotion and application of Dilong Jiangya Capsule,component o PTimization,and academic research.Methods:This study collected hospitalized patients from the Cardiovascular Department of the Affiliated Hospital of Gansu University of Traditional Chinese Medicine from October 2021 to August 2022,and selected 80 patients who met the diagnostic and treatment standards of traditional Chinese and Western medicine for primary hypertension with insomnia and were identified as collateral stasis syndrome through TCM syndrome differentiation analysis.This study was conducted as a clinical trial and research analysis object.In terms of research methods,80 patients were randomly divided into a trial group with 40 patients and a control group with 40 patients each.The trial group was given Dilong Jiangya Capsules on the basis of routine treatment,while the control group was given Eszolam Tablets on the basis of routine treatment.After 4 weeks of treatment and observation,the changes in efficacy indicators of the two groups of patients before and after treatment were analyzed.In terms of evaluation indicators,the blood pressure and sleep status of patients with primary hypertension accompanied by insomnia with collateral stasis syndrome were mainly observed before and after treatment,including 24-hour ambulatory blood pressure detection indicators(24-hour average blood pressure,nocturnal blood pressure drop rate,nocturnal blood pressure variation coefficient),PSG parameters(total sleep time,sleep efficiency,wake up time after falling asleep,sleep latency),AIS scores,AIS scores Changes in safety indicators(ALT,AST,Scr,BUN,PT,APTT,urinary protein)and TCM sym PTom scores.Results:After 4 weeks of treatment,there were no abnormal changes in vital signs such as pulse,respiration,body temperature,and safety indicators such as liver function,kidney,blood coagulation,and urine routine in both groups.Comparative analysis was conducted on the test indicators of the two groups of patients.The specific indicators were compared as follows:(1)24-hour ambulatory blood pressure monitoring indicators:(1)24-hour mean blood pressure: both groups of patients improved compared to the previous(P<0.05),and the experimental group was better than the control group(P<0.05)Night blood pressure decrease rate: The night blood pressure decrease rate of patients in both groups was improved compared to the previous one(P<0.05),while the night systolic blood pressure decrease rate in the experimental group was better than that in the control group(P<0.05)Night blood pressure variation coefficient: The night blood pressure variation coefficient of both groups of patients was improved compared to the previous one(P<0.05),while the night systolic blood pressure variation coefficient of the experimental group was better than that of the control group(P<0.05).(2)Comparison of PSG parameters: The PSG data of the two groups of patients before and after treatment were compared within the group.The total sleep time(TST)and sleep efficiency(SE)were increased,while the wake up time(WASO)and sleep latency(SOL)after falling asleep were decreased,with a statistically significant difference(P<0.05).After treatment with PSG data from two groups of patients,the effects of TST and WASO in the experimental group were more significant than those in the control group(P<0.05),while the effects of SE and SOL in the control group were more significant than those in the experimental group(P<0.05).(3)Comparison of scores on the Arsens Insomnia Scale(AIS): After treatment,patients in both groups improved compared to before treatment(P<0.05),while patients in the experimental group experienced a more significant decrease in AIS after treatment than those in the control group(P>0.05).(4)Comparison of insomnia severity index(ISI)scores: After treatment,both groups of patients improved compared to before treatment(P<0.05),and the ISI in the experimental group decreased more significantly after treatment than in the control group(P>0.05).(5)Total score of traditional Chinese medicine sym PToms: Compared with the two groups of patients,the total score of traditional Chinese medicine sym PToms decreased after treatment compared with before treatment(P<0.05),and the degree of reduction in the experimental group(p<0.01)was better than that in the control group(P<0.05).The total score of TCM sym PToms between the two groups was better in the experimental group than in the control group(P<0.05).(6)Comparison of single score of TCM sym PToms: Compared within the two groups of patients,the control group had no significant changes in anxiety,forgetfulness,headache,such as acupuncture before and after treatment(P>0.05),while the other sym PToms were better than before treatment(P<0.05);In the test group,the sym PToms of each single item of traditional Chinese medicine were improved compared to those before treatment(P<0.05),and the treatment effects of anxiety,forgetfulness,and headache such as pricking were more significant(P<0.01).After treatment,compared between the two groups of patients,the treatment effect of the test group was significantly better than that of the control group in three groups of sym PToms: anxiety,forgetfulness,headache,and difficulty in falling asleep after waking up(P<0.01);The efficacy of treatment for dizziness,insomnia,and dreaminess in both groups was improved compared to that before treatment,and the difference in treatment efficacy was not significant(P>0.05).Compared between the two groups of patients,the efficacy of the control group with sym PToms of easy to wake up after sleep after treatment was better than that of the experimental group(P<0.05).(7)Comparison of TCM sym PTom efficacy: The total effective rate(68.4%)of the control group was significantly lower than the total effective rate(89.1%)of the test group in terms of TCM sym PTom efficacy after treatment in the two groups,with a statistically significant difference(P<0.01).(8)Safety comparison: Before and after treatment,the safety indicators such as liver function,renal function,and blood coagulation of the two groups of patients were within the normal range.In the control group,there was no statistically significant difference in the safety indicators of ALT,AST,Scr,BUN,PT,and APTT before and after treatment(P>0.05);Compared with ALT,AST,Scr,BUN,PT,and APTT before and after treatment in the test group,exce PT PT and APTT,there was a statistically significant difference(P<0.01),and after treatment,they were within the normal range,while the other safety indicators were not statistically significant(P>0.05).Conclusion:Dilong Jiangya Capsule can improve the blood pressure level and sleep quality of patients with primary hypertension accompanied by insomnia and collateral stasis syndrome.Compared with the control group,it is superior to the control group in improving TCM sym PToms,AIS scores,and ISI scores.In the evaluation of safety indicators,Dilong Jiangya Capsule has the effect of affecting prothrombin time and activating partial thrombin time,without adverse reactions,and is worthy of clinical promotion and application. |
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