Varicella-zoster Virus (VZV) is the causative agent of Varicella and shingles, whose primary infection causes chickenpox. Chickenpox is a common acute respiratory tract transmitted virus disease in children, with an infection rate of 61% ~ 100% in the population. VZV infects the cells by the fusion of the glycoprotein on the surface of the virus and the membrane protein on the surface of cells. The incubation period is 14 to 15 days. VZV is spread by droplets and aerosols secreted by nasopharynx between 1 and 2 d before and 5 to 7 d after rash. After initial infection, the virus remains dormant in the sensory ganglion of the posterior root of the spinal cord, forming a latent infection that can be reactivated years or decades later to cause shingles. Fever is the first clinical manifestation of chickenpox, along with pruritus and mucosal infections. Blisters begin with spots, then quickly enter the papules and blisters, and the vesicles occur in batches, resulting in varying amounts of blisters in all parts of the body. The face and torso are denser than the limbs, and the blisters cause surface damage to the skin, and the scab will disappear within 1 to 2 weeks, and the pigmentation sites can remain for months or even a lifetime.
Varicella Attenuated Live Vaccine (VarV) was first developed in Japan. The vaccine strain was Oka, a live attenuated vaccine isolated from a child with chickenpox. Now VarV is included in the immunization program in some developed countries, such as the United States and Japan. A large number of epidemiological investigation data showed that the adverse reactions were mild and severe abnormal reactions were rare in healthy children after VarV vaccination.
Recently, it was found that after treatment with xiyanping combined with acyclovir, the treatment time of chickenpox was shortened and the treatment efficiency was significantly improved. The reason is that the main ingredient of xiyanping is andrographolide sulfonate, which can effectively kill virus and reduce fever. Besides, Acyclovir is an effective antiviral drug that acts directly on chicken pox by applying it in vitro, interrupting the extension of the virus's DNA strand.
Case Study
Patient recruitment is a big problem in many clinical drug trials. This clinical trial of valaciclovir hydrochlordide and acyclovir for treating chickenpox has many requirements for the children involved. As the child is not yet an adult, informed consent is issued by the child's custodian. We need exclude the children with central nerve damage, secondary infection, lung and other organs seriously damage. Besides, the gender, age, and body temperature of the children were not statistically significant (P > 0.05).
Another difficulty is statistical analysis. SPSS 17.0 statistical software was used to analyze and process the data. The measurement data was expressed as mean +/- standard deviation (x +/- s), t test was used for inter-group comparison, and the counting data was expressed as rate (%). Comparison between groups is performed by the x2 test, and p<0.05 was the threshold for statistical significance.
For effective statistics, we classify therapeutic criteria into the following categories.
- Recovery: the rash disappeared completely; the itch in the affected area disappeared; there was pigmentation or scab, and the body temperature returned to normal within 24 to 48 hours.
- Obvious effect: the original rash had more than 60% crusting or extinction; no new rash appeared; the pruritus in the affected area was relieved or disappeared, and the temperature returned to normal within 48 ~ 72 hours.
- Effectivity: 30% of the original rash was scabbed or subsided; the itch sensation in the affected area was not significantly alleviated; the body temperature did not return to normal or even increased at small 72 ~ 96 hours.
- Invalid: the original skin rash had only a small part scab; the new skin rash appeared; affected area pruritus feeling did not reduce or even aggravate, and temperature did not restore normal even to rise. Total efficiency = cure rate + apparent efficiency + efficiency.
Using the criteria of patient recruitment and statistical strategy above, we recruited appropriate patients and analyzed results in the trial of valaciclovir hydrochlordide and acyclovir treatment in chickenpox disease.
Design:
A randomized and parallel group trial, including complete eligibility criteria, data collection schedule and detailed statistical analysis.
Participants:
Eighty-four children with chickenpox were selected, with 42 cases in each group. The control group included 24 males and 18 females: age 3 ~ 9 years, and average age (5.43 +/- 1.01) years; the body temperature of 30 cases ranged 37.4 ~ 38.0°C, and the temperature in 12 cases ranged 38.0 ~ 39.0°C.The experimental group included 26 males and 16 females: age 3 ~ 9 years, average age (5.37 +/- 1.12) years; the temperature of 28 cases ranged 37.4 ~ 38.0°C, the temperature in 14 cases ranged 38.0 ~ 39.0°C.
Length of Enrollment Period:
5 days
Interventions:
Both groups were given the same general symptomatic treatment. In the control group, acyclovir was administered on the basis of general treatment, 4 times/day, and children took 0.02 g/kg each time. The experimental group was given a dispersible tablet of valaciclovir hydrochlordide on the basis of a general treatment, 2 times/day, and children took 0.3 g/kg each time. The two groups took five days as a treatment course. After treatment, the regression time of symptoms such as blisters, pain and pruritus was compared between the two groups to evaluate the clinical efficacy.
Main Outcomes:
- The duration of symptom resolution between the two groups;
- Clinical efficacy of the two groups of children.
Results:
The crusting time, analgesic time, antipruritic time and antihistamic time of the experimental group were significantly shorter than those of the control group, and the difference was statistically significant(P＜0.05)(Table 1). The total effective rate of the experimental group was 97.62%, significantly higher than the control group's 80.95%, and the difference was statistically significant(P＜0.05). The results showed that compared with acyclovir, the treatment with valaciclovir hydrochlordide in children could significantly shorten the time of scab formation, analgesic time, antipruritic time and antihistamic time, so that it can relieve the clinical symptoms of the children and clinical efficacy (Table 2).
Table 1. The duration of symptom resolution between the two groups
Table 2. Clinical efficacy of the two groups of children
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References:
1. Luo X, Dermatology D O. (2017), ‘Clinical Observation on the Curative Effect of Valaciclovir Hydrochlordide and Acyclovir in the Treatment of Children with Chickenpox’, Clinical Medicine & Engineering, 24(01):51-52.
2. Leung AK, Kao CP, Sauve RS. (2001), ‘Scarring resulting from chickenpox’, Pediatr Dermatol, 18(5):378 -380.
3. Adler A L, Casper C, Boeck M, et al. (2008), ‘An outbreak of varicella with likely breakthrough disease in a population of pediatric cancer patients’, Infect Control Hosp Epidemiol, 29(9):866.