Evaluation Of The Effect Of "Man Li Kang" Sodium-Limited Salt Formula In Community Hypertesion And Its Compliance And Safety

Objective: The main purpose is to explore the effect of the possible effects of antihypertensive,reducing sodium intake,increasing potassium intake,and reducing the use of antihypertensive drugs in the "Manlikang" sodium-limiting formula salt among patients with essential hypertension who are taking antihypertensive drugs regularly.At the same time,observe the safety of patients,and provide basic data for the next randomized controlled trial.Secondly,observe and collect the patients’ compliance of home blood pressure and salt use during the intervention to provide reference for the management of patients with hypertension.Methods: It’s a single-arm self-controlled pilot.Patients with hypertension were recruited in the jurisdiction at the Sihai Community Health Service Center of Nan’an District People’s Hospital in Chongqing from February to July 2018.Baseline surveys were performed on patients,including epidemiological questionnaires,physical examinations,and collection of 24-hour urine,followed by an 8-week lifestyle intervention at home,and households consumed 18% sodium-restricted formula salt throughout the process.During the intervention,morning and evening home blood pressure measurements were taken by the patients themselves.The follow-up staff visited to the home once a week to collect the information of patient’s salt and medicine usage,etc.And the 24-hour urine test and qualitative interviews were conducted at the end of the intervention.Results: A total of 43 patients with hypertension were enrolled in the study.4 patients withdrew from the trial during the intervention because they could not adapt to the taste of the substitute salt.39 patients completed the intervention and were included in the analysis.After the intervention,the 24-hour urine sodium decreased by 13.83 mmol/L(95% CI:-8.62 ~ 36.26,t = 1.246,P = 0.220),and the urine potassium increased by 8.79mmol/L(95% CI: 1.41 ~ 16.16,T =-2.411,P = 0.021).Morning SBP(-10.0 mmHg,95% CI:-16.5 ~-3.5,P = 0.003),evening SBP(-10.2 mmHg,95% CI:-16.1 ~-4.3,P = 0.001),DBP(-4.0 mmHg,95% CI:-7.1 ~-0.8,P = 0.014)were lower than the baseline,and the difference was statistically significant.And during the intervention period,there was no significant change in other blood pressure variability per week except for the decrease in evening SBP variability(P = 0.001).During the entire trial period,patients with lower baseline SBP in the morning and evening(P <0.05)were more likely to have drug reduction.A total of 14 patients experienced drug reduction,and the blood pressure was relatively stable after drug reduction,and no obvious rebound or fluctuation was seen.The loss rate of the morning BP was 9.45%,and the evening BP was 14.33%.During the intervention,30 patients(69.8%)insisted on taking substitute salt,and 9 patients(20.9%)had mixed common salt.Qualitative interview results suggested that patients have good compliance with home blood pressure measurements,but some of them forgot to measure blood pressure due to going home late.And the compliance of salt consumption was not good,while common causes include poor taste in 18% sodiumrestricted formula salt,eating out,and family influences.Health awareness,researcher concern,and family concern were the main reasons for supporting patients to complete the intervention.There were no serious adverse events during the intervention.There were 6 adverse events,including 1 patient’s family.Five of the six adverse events were study-related adverse reactions to changes in the digestive system and blood pressure,and one of them had a direct cause(arguing with family members).The symptoms of the above patients were mostly dizziness,fatigue and other similar hypotension symptoms,which were recovered at the end of the intervention.Conclusions: "Manlikang" sodium-limiting formula salt has been applied to patients with hypertension to show preliminary effects of reducing sodium,increasing potassium intake,reducing home blood pressure of patients in the morning and evening,and reducing the use of antihypertensive drugs.Besides,the antihypertensive effect is stable.The salt is relatively safe to eat.However,note that the use of antihypertensive drugs may cause hypotension in patients with hypertension.During the intervention period,the patient’s compliance with home blood pressure measurements was good,but 18% substitute salt consumption compliance was poor due to taste,going out,and family reasons.Health awareness,researcher concern,and family concern are the main reasons why patients insist on completing the intervention.