Effects of Shenkang Injection Combined with Hemodialysis on Dialysis Rate and Nutriture in Patients with Chronic Renal Failure

Zhang Huifang (張慧芳), Wu Rongying (吳蓉英)

aNephrology Department, Inner Mongolia Baogang Hospital, Baotou 014010, China;

bPreparation Center for Venous Drug, Pharmacy Department, Inner Mongolia Baogang Hospital, Baotou 014010, China

ABSTRACT OBJECTIVE: To explore the effects of Shenkang Injection combined with hemodialysis on dialysis rate and nutriture in patients with chronic renal failure (CRF). METHODS: A total of 110 CRF patients admitted in the hospital from January 2016 to January 2018 were randomly divided into 2 groups. The control group was treated with hemodialysis while the observation group was additionally treated with Shenkang Injection on the treatment basis of the control group. They were treated for 4 weeks and reexamined 1 d after the treatment. Renal function, nutriture, dialysis adequacy, oxidative stress level and inflammatory factor level in the 2 groups were determined before and after the treatment, and traditional Chinese medicine (TCM) syndrome score, dialysis rate within 1 week and incidence of adverse reactions during the treatment were counted before and after the treatment. RESULTS: After the treatment, the levels of serum creatinine (Scr) and urea nitrogen (BUN) in the observation group were lower than those in the control group, and the endogenous creatinine clearance rate (Ccr) was higher than that in the control group (P ＜ 0.05). After the treatment, the nutriture in the observation group was better than that in the control group (P ＜ 0.05). After the treatment, the dialysis rate and time average concentration of urea (TACurea) in the observation group were lower than those in the control group, while the overall urea clearance rate (Kt/V) and protein catabolic rate (PCR) were higher than those in the control group (P ＜ 0.05). After the treatment, the TCM syndrome scores in the observation group was lower than that in the control group (P ＜ 0.05) and the level of serum malondialdehyde (MDA) in the observation group was lower than that in the control, while the level of superoxide dismutase (SOD) and total antioxidant capacity (T-AOC) in the observation group were higher than those in the control group (P ＜ 0.05). After the treatment, the levels of inflammatory factors in the observation group were lower than those in the control group (P ＜ 0.05). No serious adverse reactions occurred in the 2 groups. CONCLUSION: Shenkang Injection combined with hemodialysis for the treatment of CRF can effectively improve clinical symptoms and nutriture, and reduce the dialysis rate.

KEYWORDS: Shenkang Injection; Chronic renal failure; Dialysis rate; Nutriture

Chronic renal failure (CRF) is a common chronic progressive disease. It is the result of the joint development of kidney diseases induced by different causes, which will eventually turn into uremia. Its pathological features are renal interstitial fibrosis and glomerular sclerosis. And the etiology and pathogenesis are relatively complicated, among which diabetes and hypertension are the main influencing factors[1]. The main cause of CRF patients in China is still chronic glomerulonephritis, but the incidence of CRF caused by other secondary factors is gradually increasing. Chronic damage to the renal parenchyma will cause damage to the nephron, so the renal function will slowly decline, eventually leading to renal failure. The kidney cannot maintain basic functions, therefore, clinical manifestations of renal dysfunction appear, such as water, electrolytes and acid-base balance disorders, metabolic waste retention, etc., resulting in unstable internal environment in the human body[2]. CRF patients need regular hemodialysis to remove metabolic waste and correct metabolic disorders, but cannot completely replace kidney function, and may also lead to malnutrition, anemia and other complications[3]. Traditional Chinese medicine (TCM) believes that CRF belongs to the categories of "submerged toxin" and "edema", which is a syndrome of root cause deficiency and manifestation excess[4]. Shenkang Injection is a TCM compound, which has certain effects on various pathological links of renal failure. Based on this, this study used Shenkang Injection combined with hemodialysis to treat CRF, in order to explore the efficacy of Chinese materia medica.

MATERIALS AND METHODS

General information

A total of 110 CRF patients admitted to the hospital from January 2016 to January 2018 were randomly divided into a control group and an observation group, with 55 cases in each group. There were 29 males and 26 females in the control group; the age was 30 - 68 years old, with an average of (47.13 ± 4.72); the dialysis time was 3 - 52 months, with an average of (25.13 ± 2.54) months; the condition of primary disease was 27 cases of chronic glomerulonephritis, 15 cases of diabetic nephropathy and 13 cases of hypertensive nephropathy. There were 30 males and 25 females in the observation group; the age was 29 - 67 years old, with an average of (47.05 ± 4.71); the dialysis time was 3 - 50 months, with an average of (25.04 ± 2.52) months; the condition of primary disease was 26 cases of chronic glomerulonephritis, 16 cases of diabetic nephropathy and 13 cases of hypertensive nephropathy. The general data in the 2 groups were comparable (P ＞ 0.05).

Diagnostic criteria

Diagnostic criteria in western medicine

Diagnostic criteria for CRF in nephrology[5]: (1) renal functional or structural abnormality has lasted for more than 3 months, with abnormality in blood, urine and imageological examination; (2) glomerular filtration rate (GFR) is less than 60 mL/(min·1.73 m2) for more than 3 months.

Diagnositic criteria in TCM

Diagnostic criteria for CRF of turbid, dampness and blood stasis type in Clinical Guidelines for New Chinese Materia Medica[6]: (1) main symptoms: dark complexion, waist pain, nausea and vomiting, heavy sense in body and limbs and eating less with poor appetite; (2) secondary symptoms: sticky and greasy in the mouth, dry and scaly skin, numbness of body and limbs and abdominal fullness and distention; (3) tongue and pulse: purple and dark tongue, thick and greasy coating and unsmooth pulse.

Inclusion and exclusion criteria

Inclusion criteria: (1) in accordance with the diagnostic criteria of CRF in both western medicine and TCM; (2) continuous hemodialysis for more than 3 months; (3) agreement of the study gained from patients and the hospital ethics committee.

Exclusion criteria: (1) mental patients; (2) patients with severe dysfunction of heart, liver and kidney; (3) females under pregnancy or lactation period; (4) allergic to the medicines in this study; (5) patients with severe infection; (6) complicated with malignant tumor; (7) patients with hemorrhagic tendency; (8) severe malnutrition; (9) patients underwent renal transplant; (10) taking medicines that affect renal function during the treatment.

Therapeutic methods

Both groups of patients were given a low-protein diet, routinely corrected water and electrolyte disorders, controlled infections, and given symptomatic treatment. The control group received hemodialysis treatment, in which the dialysate contained bicarbonate, blood flow velocity was 220 mL/min, dialysate flow rate was 500 mL/min, and the dialysis time was 4 h/time and 3 times/week. On the treatment basis of the control group, the observation group was additionally given Shenkang Injection (SFDA approval No.: Z20040110, Xi'an Shiji Shengkang Pharmaceutical Co., Ltd., 20 mL), and the infusion rate was 30 drops/min, 100 mL/time, once per day. After 4 weeks of the treatment, reexamination was performed 1 d after the end of the treatment.

Observation indexes

(1) Renal function in the 2 groups was tested before and after the treatment, including serum creatinine (Scr), urea nitrogen (BUN) and endogenous creatinine clearance (Ccr); (2) the nutriture in the 2 groups was tested before and after the treatment, including serum total protein (TP), hemoglobin (HGB), serum albumin (ALB) and total number of red blood cells (RBC); (3) dialysis adequacy in the 2 groups was tested, and statistical analysis of dialysis rate within 1 week before and after the treatment was performed, including overall urea clearance (Kt/V), time average concentration of urea (TACurea) and protein catabolic rate (PCR); (4) statistics of the TCM syndrome scores for the 2 groups of patients was performed before and after the treatment, in which the main symptom score range was 0 - 6 points, while the secondary symptom and tongue and pulse score ranges were 0 - 3 points, and the higher the score, the more serious the condition; (5) oxidative stress levels before and after the treatment in the 2 groups were tested, including serum malondialdehyde (MDA), superoxide dismutase (SOD) and total antioxidant capacity (T-AOC); (6) inflammatory factor levels of the patients in the 2 groups were tested before and after the treatment, including interleukin-6 (IL-6), tumor necrosis factor (TNF-α) and C-reactive protein (CRP); (7) statistics of the incidence of adverse reactions in the 2 groups was performed during treatment.

Statistical methods

SPSS 17.0 software was used for data analysis. Metrological research data accorded with normal distribution with equal variance was tested by t test. The Mann-Whitney U test was used for data that did not meet the above applicable condition. Count data of unordered category were tested by chi-square test. P ＜ 0.05 was considered as statistically significant.

RESULTS

Comparison of renal function in the 2 groups before and after the treatment

Before the treatment, there was no significant difference in the renal function between the 2 groups (P ＞ 0.05). After the treatment, the levels of Scr and BUN in the observation group were lower than those in the control group, and the Ccr was higher than that in the control group, the difference was statistically significant (P ＜ 0.05). See Table 1.

Comparison of nutriture in the 2 groups before and after the treatment

Before the treatment, there was no significant difference in the nutriture between the 2 groups (P ＞ 0.05). After the treatment, the TP, RBC, ALB and HGB in the observation group were higher than those in the control group, and the difference was statistically significant (P ＜ 0.05). See Table 2.

Comparison of dialysis adequacy and dialysis rate in the 2 groups before and after the treatment

Before the treatment, there was no significant difference in the dialysis rate between the 2 groups (P ＞ 0.05). After the treatment, the dialysis rate and TACurea in the observation group were lower than those in the control group, the Kt/V and PCR were higher than those in the control group, and the difference was statistically significant (P ＜ 0.05). See Table 3.

Table 1. Comparison of renal function in the 2 groups before and after the treatment

Table 2. Comparison of nutriture in the 2 groups before and after the treatment

Table 3. Comparison of dialysis adequacy and dialysis rate in the 2 groups before and after the treatment

Table 4. Comparison of TCM syndrome scores in the 2 groups before and after the treatment (point)

Table 5. Comparison of oxidative stress level in the 2 groups before and after the treatment

Table 6. Comparison of inflammatory factor level in the 2 groups before and after the treatment

Comparison of TCM syndrome scores in the 2 groups before and after the treatment

Before the treatment, there was no significant difference in the TCM syndrome scores between the 2 groups (P ＞ 0.05). After the treatment, the TCM syndrome scores in the observation group were lower than those in the control group, and the difference was statistically significant (P ＜ 0.05). See Table 4.

Comparison of oxidative stress level in the 2 groups before and after the treatment

Before the treatment, there was no significant difference in oxidative stress level between the 2 groups (P ＞ 0.05). After the treatment, the level of MDA in the observation group was lower than that in the control group, while the levels of SOD and T-AOC were higher than those in the control group, and the difference was statistically significant (P ＜ 0.05). See Table 5.

Comparison of inflammatory factor level in the 2 groups before and after the treatment

Before the treatment, there was no significant difference in inflammatory factor level between the 2 groups (P ＞ 0.05). After the treatment, the inflammatory factor level in the observation group was lower than that in the control group, and the difference was statistically significant (P ＜ 0.05). See Table 6.

Comparison on incidence of adverse reactions in the 2 groups

No serious adverse reactions occurred in the 2 groups.

DISCUSSION

The incidence of CRF in natural population is about 0.1%, while the incidence of chronic kidney disease is about 3%, and the incidence is gradually increasing[7]. The prognosis of CRF is poor. If the condition is serious, it will lead to death. With the development of hemodialysis and kidney transplantation, it provides a new way to treat CRF, but it has not been fully popularized for technical and cost reasons. Non-dialysis treatment still occupies a key position. In CRF treatment, protecting the remaining nephron and avoiding the deterioration of the condition is the key to prolonging the life of the patient and improving the quality of life. Some studies have found that oxidative stress and inflammatory state exist in the dialysis treatment of CRF patients. The 2 reactions interact with each other and are closely related to anemia, infection and malnutrition of patients, which is an important cause of complications and death[8].

TCM believes that the CRF pathogenesis is that zang-fu function is impaired by various kidney diseases for a long time, mainly due to spleen and kidney deficiency and kidney collateral stasis, causing kidney dysfunction, qi transformation declining in the body, healthy qi stagnation and retention of urinary toxin, dampness and turbidity, thereby causing the failure of the spleen to raise the clear and transport, and the failure of the stomach to direct turbidity downward. The manifestations are heavy sense in the body, fatigue, nausea, vomiting, and so on[9,10]. The main components of Shenkang Injection are Radix Astragali, Radix et Rhizoma Salviae Miltiorrhizae, Radix et Rhizoma Rhei, and Flos Carthami. Radix et Rhizoma Rhei has the effect of directing turbidity downward and dredging bowels. It can be used together with Radix Astragali to supplement qi and warm yang. Their ascent and descent can dissolve stasis and dispel turbid. Flos Carthami and Radix et Rhizoma Salviae Miltiorrhizae are assistant medicinals,and they have an effect of invigorating blood and unblocking collaterals. The combination of these can benefit qi and invigorate blood, dredge bowels and drain dampness, as well as descend adverse qi and dredge turbidity[11,12].

In this study, the improvement of renal function in the observation group was more significant. The possible reason was that the active ingredients in Radix et Rhizoma Rhei could inhibit the synthesis of mesangial cells, reduce the pathological proliferation of mesangial cells, and alleviate the process of renal tissue sclerosis. In this study, the nutriture in the observation group was better. The possible reason was that in Shenkang Injection, Radix Astragali could benefit qi and nourish blood, while Flos Carthami could invigorate blood and dissolve stasis. The 2 could promote the synthesis of high-quality protein and improve the nutriture. Liu Limin et al[13]using Shenkang Injection combined with hemodialysis treatment in CRF patients showed that the proportion of people with good nutrition was higher than that in the control group, further demonstrating the results of this study. In this study, the observation group had more complete dialysis and better efficacy, indicating that Shenkang Injection could effectively improve clinical symptoms of patients and improve dialysis efficiency. In this study, the oxidative stress level was lower in the observation group, which might be the fact that the active ingredients in Radix Astragali and Radix et Rhizoma Rhei could effectively scavenge oxygen free radicals, which was consistent with the study results of Zhou Jun et al[14]. In this study, the level of inflammatory factors in the observation group was lower, which might be due to the anti-inflammatory effect of the active ingredients in Radix et Rhizoma Salviae Miltiorrhizae. Chen Yongjian et al[15]found that the level of inflammatory factors was lower in patients treated with Shenkang Injection.

In summary, Shenkang Injection combined with hemodialysis treatment in CRF can effectively improve renal function, nutriture and dialysis adequacy, as well as reduce TCM syndrome scores, dialysis rate, oxidative stress and inflammatory factor level.