Clinical observations on YGK treatment of hepatitis B and cirrhosis
Trial information
Patient conditions
This trial consists of 3 groups with a total of 948 patients.
Group A
Treatment group
642 patients
Group B
Comparing group
306 patients
Table 1
|
Group |
# of Patient |
Male |
Female |
Average age |
|
A |
642 |
482 |
160 |
32.5 |
B |
306 |
229 |
77 |
30.5 |
Total |
948 |
711 |
237 |
31.9 |
|
* P£¾0.05 compared to group B ¡¡¡¡**P£¾0.05 compared to group B
Table 2
|
Group |
# of Patient |
Acute hepatitis B |
Chronic hepatitis B |
Cirrhosis |
|
A |
642 |
282 |
276 |
84 |
B |
306 |
129 |
134 |
43 |
Total |
948 |
391 |
390 |
167 |
|
X2=0.28P£¾0.05 compared to group B
Treatment methodology
Group A
a. 8 YGK capsules 3 times a day
b. 100ml of YGK intravenous injection liquid mixed with 500ml of 5% glucose solution applied intravenously once a day
c. Each treatment period is 90 days
Group B
- 4 Hu Gan tablets (produced by Wu Chang Pharmacy Factory) 3 times a day
- 10ml of Qiang Li Ning intravenous injection liquid mixed with 250ml of 5%glucose solution applied intravenously once per day
- Each treatment period is 90 days
Observation methodology
1. Health check
Blood examination, uroscopy, stool examination, kidney function test, electrocardioscopy, drug allergy.
2. Effect observation
- Symptom: decreased appetite, abdominal or stomach pain, feeling of fullness, liver discomfort, unusual tiredness or weakness, jaundice, hepatosplenomegaly (ultrasonic examination).
- Liver function testing items: ALT, AST, GGT, ALB, A/G, BIL.
- HBV serum testing items: HbsAg, anti-HBs, HbeAg, anti-Hbe, HBV-DNA.
3. Efficacy evaluation methodology
- Success: symptom of hepatitis B feels lost. The swollen liver goes stead or smaller (even to the normal size with acute hepatitis). Not painful when pressed or knocked. Liver function is tested to be normal. Anti-Hbe and HBV-DNA are negative.
- Improvement: symptom of hepatitis B feels lost or basically lost. The swollen liver goes stead. Not painful when pressed or knocked. Liver function is tested to be normal or 50% improvement, but anti-Hbe and HBV-DNA are not negative.
- Inefficacy: not attainable to the improvement standard.
Observation results
1.Treatment observation results
Table 3
|
|
Group |
# of Patient |
Success rate (%) |
Improvement rate (%) |
Inefficacy rate (%) |
Efficacy rate (%) |
X2 |
P |
|
Acute |
A |
282 |
263(93.3) |
19(6.7)) |
0 |
100 |
91.53 |
£¼0.01 |
B |
129 |
68(52.7) |
61(47.3 |
0 |
100 |
|
Chronic |
A |
276 |
162(58.7) |
105(38.0) |
9(3.3) |
96.7 |
63.26 |
£¼0.01 |
B |
134 |
31(23.1) |
74(55.2) |
29(21.6) |
78.4 |
|
Cirrhosis |
A |
84 |
31(36.9) |
36(42.9) |
17(20.2) |
79.8 |
9.06 |
£¼0.05 |
B |
43 |
5(11.6) |
27(62.8) |
11(25.6) |
74.4 |
|
Total |
A |
642 |
456(71.0) |
160(24.9) |
26(4.1) |
95.9 |
120.3 |
£¼0.01 |
B |
306 |
104(34.0) |
162(52.9) |
40(13.1) |
86.9 |
|
|
We can conclude from the data in table 3, that each group has an observable improvement, especially in the case of Group A.
2. Symptom observation results
In Group A, after 13 ~21 days treatment, patients feel the loss of hepatitis B symptom, recovery of appetite and power, fadeaway of jaundice. In Group B, patients feel the loss of hepatitis B symptom after 26.5 days on average. p£¼0.05, Group A has a more observable improvement than Group B.
3. Swollen liver and Swollen spleen treatment results
Tested by ultrasonic before treatment, Group A has 286 patients with swollen liver (0.5~6.0cm), and 82 patients with swollen spleen (0.5~7.0cm); Group B has 92 patients with swollen liver, and 52 patients with swollen spleen. The treatment results are as follows.
Table 4
|
|
Group |
Patient
# |
Shrink |
Change-less |
Enlarged |
Shrink rate |
Average shrink |
X2 |
P |
|
Swollen liver |
A |
286 |
228 |
58 |
0 |
79.7 |
2.8cm |
77.38 |
£¼0.01 |
B |
92 |
28 |
64 |
0 |
30.4 |
1.2cm |
Swollen spleen |
A |
82 |
48 |
34 |
0 |
58.5 |
2.0cm |
11.27 |
£¼0.01 |
B |
52 |
15 |
37 |
0 |
28.8 |
0.8cm |
Total |
A |
368 |
276 |
92 |
0 |
75.0 |
2.7cm |
89.80 |
£¼0.01 |
B |
144 |
43 |
101 |
0 |
29.9 |
1.1cm |
|
The data in table 4 show that Group A has a more observable improvement than Group B.
4. Liver function recovery
Liver function items are as follows:
Table 5
|
Group |
# before treatment |
Patients conditions after treatment |
X2 |
P |
|
Changeless |
decrease¡Ý50% |
Normalized(%) |
|
ALT |
A |
586 |
24 |
43 |
519(88.6) |
45.57 |
£¼0.01 |
B |
277 |
25 |
58 |
194(79.0) |
AST |
A |
581 |
24 |
54 |
503(86.6) |
86.19 |
£¼0.01 |
B |
269 |
35 |
78 |
156(58.0) |
GGT |
A |
360 |
23 |
96 |
241(66.9) |
36.73 |
£¼0.01 |
B |
177 |
38 |
61 |
78(44.1) |
ALB |
A |
153 |
24 |
27 |
102(66.7) |
31.26 |
£¼0.01 |
B |
81 |
40 |
12 |
29(35.8) |
A/G |
A |
158 |
24 |
31 |
103(65.2) |
29.07 |
£¼0.01 |
B |
97 |
40 |
25 |
32(33.0) |
BIL |
A |
345 |
25 |
52 |
268(77.7) |
81.13 |
£¼0.01 |
B |
142 |
19 |
72 |
51(35.9) |
Total |
A |
2183 |
144 |
303 |
1736(79.5) |
266.79 |
£¼0.01 |
B |
1043 |
197 |
306 |
540(51.8) |
|
We can draw the conclusion from the data in table 5 that Group A has a more observable improvement than Group B.
5. HBV serum testing items
Table 6
|
|
Acute hepatitis B
negativity rate(%) |
Chronic hepatitisB
negativity rate(%) |
Cirrhosis
negativity rate(%) |
Total(%) |
|
A |
212/260(81.5)* |
132/206(64.1) |
10/24(41.7) |
354/490(72.2) |
B |
19/78(24.4) |
18/82(22.0) |
4/26(15.4) |
41/186(22.0) |
X2 |
90.65 |
41.70 |
4.28 |
139.93 |
P |
£¼0.01 |
£¼0.01 |
£¼0.05 |
£¼0.01 |
|
P£¼0.05
Table 7
|
|
Acute hepatitis Bnegativity rate(%) |
Chronic hepatitisB
negativity rate(%) |
Cirrhosis
negativity rate(%) |
Total(%) |
|
A |
146/260(55.7)* |
78/216(36.1) |
14/64(21.9) |
238/542(43.9) |
B |
11/84(13.1) |
9/87(10.3) |
3/43(7.0) |
23/214(10.7) |
X2 |
29.34 |
20.15 |
4.26 |
74.69 |
P |
£¼0.01 |
£¼0.01 |
£¼0.05 |
£¼0.01 |
|
P£¼0.05
Table 8
|
|
Acute hepatitis Bnegativity rate(%) |
Chronic hepatitisB
negativity rate(%) |
Cirrhosis
negativity rate(%) |
Total(%) |
|
A |
45/68(66.2) |
36/58(62.1) |
|
81/126(64.3) |
B |
7/29(24.1) |
4/20(20.0) |
|
11/49(22.4) |
X2 |
14.45 |
10.53 |
|
24.76 |
P |
£¼0.01 |
£¼0.01 |
|
£¼0.01 |
|
Table 9
|
|
Anti-HBe |
Anti-HBs |
|
A |
187/490(38.2) |
156/542(28.8) |
B |
21/186(11.3) |
20/214(9.3) |
X2 |
45.77 |
32.43 |
P |
£¼0.01 |
£¼0.01 |
|
6. Drug side effects
There are no obvious drug side effects in both Group A and Group B.
Discussion, analysis and conclusion
Hepatitis B virus (HBV) replicates in the liver cells after infection, which causes the immune system reaction that destroys liver cells and causes the hepatitis. The necrosis and inflammation of the liver cells are the result of the immune system attacking the membrane of the liver cell infected by HBV. The HBV liver damage is mainly caused by immune system killing the infected liver cells. The deposit of the immune compound on sinus hepaticus and on liver tunica vasculosa leads to the dissolution and damage of liver cells. The replication of HBV shed HBsAg and HBeAg in to circulation. The appearance of HBeAg indicates the viral implication and infection. If HBeAg persists in the blood for long time, the hepatitis B tends to be chronic. After treatment, the negativity of HBeAg and HBV-DNA means the end of active virus replication and a decrease in the infectivity. Therefore, the negativity of HBeAg and HBV-DNA is the key of hepatitis B treatment.
YGK as natural TCM has been made into intravenous injection liquid and capsules, which has the functions of soothing the liver, regulating the flow of vital energy, nourishing Yin and kidney, clearing the heat, detoxicating, nourishing spleen, reducing inflammation. Moreover, it has no side effects. The clinical YGK treatment can improve the symptom and health condition of patients, promote the decrease of the swollen liver and the normalization of the impaired liver function, lead to the negativity conversion of HBeAg, HbsAg and HBV-DNA. It is discovered in clinical application that YGK has observable beneficial effects on acute hepatitis B, chronic hepatitis B and cirrhosis due to its functions of promoting blood circulation and removing blood stasis, and of increasing liver blood flow, and of improving the oxidization of cells, and of accelerating the metabolism of enzyme and sugar, and of regulating the immune system, and of reducing the fibrous tissue of a liver with cirrhosis and improving the anti-virus ability.
|