Application value of Tacrolimus sustained-release capsules in patients after liver transplantation

doi:10.3877/cma.j.issn.2095-3232.2015.03.011

Abstract

Abstract:

Objective

To investigate the application value of Tacrolimus sustained-release capsules in patients after liver transplantation (LT).

Methods

Clinical data of 48 patients after LT treated in the Third Affiliated Hospital of Sun Yat-sen University between January 2011 and December 2013 were retrospectively studied. The informed consents of all patients were obtained and the local ethical committee approval had been received. Among the 48 patients, 43 were males and 5 were females with an average age of (45±12) years old. According to whether Tacrolimus sustained-release capsules were given after LT, the patients were divided into sustained-release group (18 patients) and control group (30 patients). The patients in both groups received combined immunosuppressive therapy of Tacrolimus + Methylprednisolone in the early stage after operation. Patients in sustained-release group were given Tacrolimus sustained-release capsules of equivalent dose 20 d after LT. The changes of plasma valley concentration of Tacrolimus and the incidence of rejection and adverse reactions of the two groups were compared. The comparison of plasma valley concentration of Tacrolimus was conducted using t test, and the comparison of incidence of rejection and adverse reactions was conducted using Chi-square test or Fisher's exact test.

Results

The plasma valley concentration of sustained-release group decreased gradually and stabilized after 30 d, while that of control group fluctuated widely. On 60 d, the plasma valley concentration of sustained-release group was (7±2) μg/L, which was significantly lower than (10±1) μg/L of control group (t=-15.61, P<0.05). The incidence of rejection of sustained-release group was 0 (0/18), which was significantly lower than 7% (2/30) of control group (P<0.05). The incidence of pneumonia, gastrointestinal symptoms, hyperglycemia and sleep disorders of sustained-release group was respectively 33% (6/18), 28% (5/18), 6% (1/18) and 6% (1/18) , which was significantly lower than 77% (23/30), 37% (11/30), 17% (5/30) and 23% (7/30) of control group (χ²=18.90, 31.53, 12.41, 45.19; P<0.05).

Conclusions

The application of Tacrolimus sustained-release capsules in patients after LT can maintain stable plasma valley concentration of Tacrolimus, have good anti-rejection effect and reduce the incidence of adverse reactions.

Key words: Liver transplantation, Comparative effectiveness research, Immunosuppressive agents, Graft rejection

Shilei Xu, Yingcai Zhang, Qingliang Wang, Qing Yang, Guoying Wang, Bo Liu, Wenjie Chen, Yang Yang, Guihua Chen. Application value of Tacrolimus sustained-release capsules in patients after liver transplantation[J]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2015, 04(03): 176-180.

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References 19

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组别	例数	性别（例）		年龄（岁, ±s）	体重（kg, ±s）	身高（cm, ±s）	术前疾病性质（例）
组别	例数	男	女	年龄（岁, ±s）	体重（kg, ±s）	身高（cm, ±s）	良性	恶性
缓释组	18	17	1	44±9	61±10	171±8	4	14
对照组	30	26	4	43±10	59±12	169±7	6	24
统计值	?	χ²=0.28		t=0.77	t=0.64	t=0.27	χ²=1.32
P值	?	>0.05		>0.05	>0.05	>0.05	>0.05

组别	例数	性别（例）		年龄（岁, ±s）	体重（kg, ±s）	身高（cm, ±s）	术前疾病性质（例）
组别	例数	男	女	年龄（岁, ±s）	体重（kg, ±s）	身高（cm, ±s）	良性	恶性
缓释组	18	17	1	44±9	61±10	171±8	4	14
对照组	30	26	4	43±10	59±12	169±7	6	24
统计值	?	χ²=0.28		t=0.77	t=0.64	t=0.27	χ²=1.32
P值	?	>0.05		>0.05	>0.05	>0.05	>0.05

组别	例数	7 d	14 d	30 d	60 d	180 d
缓释组	18	32±14	28±9	33±23	26±4	19±10
对照组	30	43±8	46±14	39±18	32±11	23±9
t值	?	-0.59	-0.33	-1.75	-0.79	-0.93
P值	?	>0.05	>0.05	>0.05	>0.05	>0.05

组别	例数	7 d	14 d	30 d	60 d	180 d
缓释组	18	32±14	28±9	33±23	26±4	19±10
对照组	30	43±8	46±14	39±18	32±11	23±9
t值	?	-0.59	-0.33	-1.75	-0.79	-0.93
P值	?	>0.05	>0.05	>0.05	>0.05	>0.05

组别	例数	7 d	14 d	30 d	60 d	180 d
缓释组	18	49±11	46±13	40±14	35±11	32±9
对照组	30	56±14	43±9	37±26	30±12	23±7
t值	?	-0.89	1.74	0.13	0.48	0.63
P值	?	>0.05	>0.05	>0.05	>0.05	>0.05

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